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hospital
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Volume 36
IHE Sept./October 2010 Weekly news updates on www.ihe-online.com

INTENSIVE CARE SPECIAL

Strict or loose glycemic control in critically
ill patients?
Nurse staffing level standards in CCUs

Also in this issue

HIFU in prostate cancer

Triple negative breast cancer (TNBC)
LESS and NOTES: recent trends in urological surgery

Image-guided radiotherapy Contrast enhanced spectral Solid state detector for

and radiosurger y mammography AEC-equipped X-ray systems
Page 30 Page 32 Page 33

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 Editor’s Letter 3 – September/October 2010

Risk/benefit assessment – getting it right

The long-awaited pooling of data from different studies cations and in such cases the drug is Some commentators even go so far
decisions on the that were not designed to assess car- important for them. Reflecting the as to suggest that in cases such as
fate of the diabetes diovascular risk in the first place can lack of clear-cut evidence one way or Avandia where even the experts are
drug Avandia were lead to invalid conclusions. The data another, the rosiglitazone controversy divided, the regulatory authorities
finally announced are still being debated, with some cli- is thus special because there are dia- should not even attempt to judge the
late September by nicians arguing that the drug should metrically opposed positions regard- data but leave the final decision as to
the drug authorities be retained, particularly in cases where ing the risk/benefit ratio of the drug. whether to prescribe the drug to the
on either side of the Atlantic (the FDA other drugs have been less success- Such diverging views are strongly treating clinician.
in the US and the European Medicines ful. As the Commissioner of the FDA held, not only by expert advisers to
Agency, EMA in Europe). Access to herself put it, some diabetes patients the regulatory bodies, but also in the
the drug will be severely restricted in cannot tolerate other diabetes medi- bio-medical community as a whole.
the United States, and it has been sim-
ply withdrawn completely from the
market in Europe. Far from ending the
long-running Avandia story, the regu-
latory decisions however look set to
open up a new debate on the very abil-
ity of the drug regulatory authorities
to handle cases where the risk-benefit
ratio is finely balanced. Marketed by
Glaxo Smith Kline, Avandia, whose
active ingredient is rosiglitazone, is one
of two drugs (the other being pioglita-
zone marketed as Actos) in a unique
therapeutic group. This is the class of
thiazolidinediones which are used as
antidiabetic agent and indicated as an
adjunct to diet and exercise as a sec-
ond line drug to improve glycemic
control in adults with type 2 diabetes
mellitus. Thiazolidinediones reduce
the blood levels of glucose and fatty
acids by sensitising cells to insulin,

concept: www.glamlab.it
and function by binding to the peroxi-
some proliferator-activated receptors
(PPARs), which in turn affects gene Visit us at Medica 2010
expression. The drugs have very com- Hall 9 - Stand C41
plex biological effects as they can result

Anywhere,
in the up-or down-regulation of mul-
tiple genes. Ever since its introduction,
rosiglitazone has been recognised as
being associated with fluid retention

when (you) need.

and an increased risk of heart failure.
Data from clinical trials, observational
studies and meta-analyses of other
existing studies that have become
available over the last three years have
suggested a possibly increased risk of
ischemic heart disease. In particular,
Cardiovascular diseases are the world’s largest killers, claiming
a meta-analysis of controlled clinical 17.1 million deaths a year*. Over 40% are caused by heart attack
trials found increases in the risk of in the presence of a witness. Today the defibrillator is one of the
myocardial infarction and a near sig- most effective solutions to help save life.
* World Health Organization, Fact sheet No. 317, Sept, 2009
nificant increased risk of death from
cardiovascular causes when compared
Rescue SAM Rescue Life
to standard diabetes drugs. One prob- Public access defibrillator Professional monitor defibrillator
lem however is the fact that each of
the data sources behind this conclu-
sion has its limitations, including the
potential for bias in observational www.progettimedical.com
studies not to mention the fact that
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 – September/October 2010 6 UROLOGY

High-intensity focused ultrasound (HIFU)

in prostate cancer treatment
Prostate cancer is the cancer with the highest incidence in men and is the second Patients are generally discharged the day after
cause of cancer mortality in industrialised countries. The introduction of PSA testing treatment, and receive antibiotics and anti-
in clinical practice has increased the identification of patients with organ-confined inflammatory drugs for at least 14-21 days.
The urine drainage system is removed as soon
prostate cancer, suitable for a curative approach.
as possible.
Current management of localised prostate cancer can vary from surveillance
only, expectant management to radical prostatectomy (with open, laparoscopic Contraindications
or robotic approaches) or can involve radiation therapy using conformal external The main and obvious contraindication to
HIFU is accessibility. The procedure requires
beam radiation therapy (EBRT) in patients with long life-expectancy.
a transrectal approach, so all pathologic or
High Intensity Focused Ultrasound (HIFU) is a relatively new technology which is anatomic conditions which prevent probe
able to destroy cancer tissue through coagulative necrosis; together with brachy- introduction are absolute contraindications;
therapy and cryosurgical ablation of the prostate, HIFU is one of the most attractive all patients with local rectal disease should be
carefully excluded. Another relative contrain-
options for the non-invasive treatment of localised prostate cancer.
dication is the presence of major intrapros-
tatic calcification: the treatment is based on
by Dr Luigi Mearini ultrasound and calcification acts as an acoustic
barrier to the progression and diffusion of the
ultrasound waves. Pre-operative trans-urethral
HIFU technology by a condom or balloon, is manually inserted resection of the prostate (TURP) can not only
The focused waves used in High Intensity into the rectum and fixed. Degassed and remove calcification, but can also remove a
Focused Ultrasound are emitted from an cooled water is circulated within the rectum prominent median lobe and/or a large volume
ultrasound transducer and are absorbed in to cool the rectal wall and to eliminate acous- prostate, which are the other relative contrain-
the target area, causing limited damage to the tic interferences between the transducer and dications to HIFU.
surrounding tissue. Ultrasound studies and the rectal mucosa, and the treatment is started
parameters for treating prostate conditions after selection of the treatment zone. At the Side-effects of HIFU treatment
were defined in 1992, with Madersbacher end of the procedure, a transurethral catheter These have been extensively described. Imme-
being the first to develop a prototype instru- or a percutaneous cystostomy is inserted. diate acute urinary retention is a normal effect
ment for benign prostatic hyperplasia in 1994,
and for prostate cancer in 1995 [1]. The first Investigator Low risk Intermediate risk High risk
use of the approach on organ-confined pros-
tate cancer was described by Gelet in 1996 Uchida [3] 92% 75% 64%
using the Ablatherm device [2], which was
the first commercially available HIFU system, Blana [4] 90% 84%
developed by the French company EDAP and
introduced to the European market in 2001. Mearini [5] 86.1% 79.6% 56.4%
The other device currently on the market, the
Table I. Successful outcome of HIFU is higher with low risk patients than with high risk patients. The above
Sonablate 500, originated at Indiana Univer- table shows the successful outcome reported by different investigators as a function of D’Amico risk.
sity School of Medicine in Indianapolis, USA,
and was developed by the US company, Focus
Surgery of Indianapolis, Indiana, USA for the Study Device N° Clinical Definition of DFSR Years
treatment of prostate cancer. patients stage response

Although each of these systems uses high Mearini [5] S 163 T1c-T3a N0M0 ASTRO 2005 78% 3 yrs
intensity-focused ultrasound to induce coagu-
lative necrosis, there are technical differences Chaussy [6] A 271 T1-T2 Nx/0M0 ASTRO 1997 82% 3 yrs
between the two devices, such as differences
Blana [7] A 140 T1-T2 Nx/0M0 ASTRO 2005 59% 7 yrs
in the imaging and therapeutic transducers,
in the requirements for the position of the
Uchida [3] S 181 T1c-T2b N0M0 ASTRO 1997 78% 5 yrs
patient, and in the type of software used for
treatment planning and safety monitoring. Misrai [8] A 119 T1-T2 N0M0 ASTRO 2005 30% 5 yrs

HIFU treatment is generally administered in Poissonnier [9] A 227 T1-T2 N0M0 PSA < 1 ng/ml 66% 5 yrs
a day-surgery setting. Patients are anesthe-
tized by epidural anesthesia with sedation or Table 2. Disease-free survival rates (DFSR) outcomes following HIFU as reported in various studies.
general anaesthesia. The HIFU probe, covered Device S = Sonablate; device A = Ablatherm.

Study Device N° patients
Mearini [5] S 163
Blana [7] A 146
Chaussy [6] A 271
Misrai [8] A 119
Uchida [3] S 115
Table 3. Outcomes, as measured by prostate biopsy, following HIFU.
Device S = Sonoblate; Device A = Ablatherm
induced by thermal injury and
subsequent edema and swelling of
the prostate, which may increase
its volume by up to 30% of its ini-
tial volume. A TURP procedure
carried out prior to HIFU, and/or
the use of a catheter or suprapu-
bic tube is the simplest way to
solve this immediate complica-
tion. A long-term, relatively fre-
quent, complication (occurring
in approximately 3.6% to 22% of
cases) is bladder outlet obstruc-
tion caused by a stricture of the
bladder neck and/or the prostatic
urethra. This can usually be man-
aged with dilation; few such cases
require pre-operative trans-ure-
thral resection (TUR).
During the period of sloughing,
that is the passage of necrotic
tissue in which debris is elimi-
nated through voiding, patients
sometimes report dysuria and
present irritative and/or obstruc-
tive symptoms. Symptomatic
treatment with drugs is usually
sufficient for this. One other
important complication arising
from necrotic tissue is the high
risk of urinary infection, which
can usually be managed by
long-term antibiotics.
A major complication of HIFU is
the creation of urethro-rectal fis-
tulae, which usually occur in the
first two months after the pro-
cedure. This is generally caused
by edema, urinary infection, an
inappropriate monitoring of the
rectal wall or the carrying out
of a procedure in a pre-treated
gland (re-HIFU, HIFU for radio-
relapse). The incidence of fistula
creation has been dramatically
7 – September/October 2010
unacceptable risk of biochemical Control of the disease, as indi-
Clinical stage Neg biopsy,
and/or local persistence/relapse cated by negative biopsy findings,
%
[Table 1]. usually measured six months
T1c-T3a N0M0 66 after HIFU, was observed to lie
The end points used in these stud- between 66 and 93.4%, with a
ies are either biochemical (i.e. using difference between low/interme-
T1-T2 N0M0 93.4
varying definitions of PSA end- diate risk and high risk patients
points to determine disease-free [Table 3].
T1-T2 Nx/0M0 84.6 survival rates) and/or biopsy data.
One method of determining failure If the control biopsy is posi-
T1-T2 N0M0 35 of treatment is the use of the ASTRO tive, HIFU should be repeated.
criteria (i.e. three consecutive The safety profile of the HIFU
T1-T2 N0M0 64 PSA increases after the PSA nadir technique permits an unlimited
has been reached), although the number of sessions, and up to
ASTRO-Phoenix definition of bio- five sessions have been described.
chemical failure (i.e. PSA nadir plus However, the safety of re-HIFU
2 ng/mL) is more usually accepted. has been a subject of discussion
decreased (now in the range More recently, other authors have with world HIFU users; in partic-
0.5% - 1.2% of cases) as increased used the Stuttgart Criteria for treat- ular, the rate of incontinence and
experience is gained in the prac- ment failure, namely PSA nadir plus erectile dysfunction seems to be
tical use of the procedure and 1.2 ng/mL at call [Table 2]. increased by re-HIFU sessions.
with the use of cooling systems
and safety monitors.
5
B0
d
Urinary incontinence, usu- an
St
9
ally urge incontinence, tends to
ll
Ha
decrease with time till the end
of edema and the elimination of
necrotic debris. The incidence
of urinary incontinence ranges
from 0.6 to 15.4% of cases; stress
urinary incontinence is rare.
As regards the incidence of impo-
tence, this usually occurs in 20 to
50% of cases although the litera-
ture data on this are controver-
sial. The preservation of the lat-
eral edges of the prostate, the so
called nerve-sparing HIFU, per-
mits erectile function to be saved.
The presence of colour Doppler in
new software should help identify
neurovascular bundles and so to
retain sexual function.
Outcomes
Several publications describing
the use of the Ablatherm and
Sonablate devices have con-
firmed the efficacy and safety of
HIFU. Appropriate patient selec-
tion is vital: in general HIFU is
recommended for patients with
localised prostate cancer (clini-
cal stage T1-T2 N0M0, Gleason
score <=7, a baseline PSA value
<=15-20 ng/mL, and a prostate
volume < 40 mL). Best results
are achieved for patients with
low risk disease and interme-
diate risk disease according to
the D’Amico risk classification;
high risk disease presents an
www.ihe-online.com & search 45614
 – September/October 2010 8 UROLOGY
Study Device N° patients
Mearini [5] S 163
Uchida [3] S 115
Blana [10] A 146
Ganzer [11] A 103
Misrai [8] A 119
Table 4. PSA nadir (i.e. the lowest post-operative PSA value, usually achieved within 3-4 months) can
be used to predict the risk of resdiual disease.
Prognostic factors capable of indicating the
risk of treatment failure would be useful
for the clinician so that the patient could be
informed about the likelihood of the need for
salvage treatment. Most authors agree that
level of the PSA nadir (i.e. the lowest post-
operative PSA value, usually achieved within
3-4 months) shows a clear association with
the risk of treatment failure. The PSA nadir
was found to be strongly associated with pre-
operative baseline PSA and prostate volume
and can be used to predict the risk of residual
disease, shown by six months post-operative
prostate biopsy [Table 4].
Salvage HIFU
HIFU should be proposed as salvage ther-
apy after external beam radiation therapy
(EBRT) or failure after brachytherapy, as
between 20% to 50% of patients may experi-
ence a PSA failure over time. Before a local
salvage approach is undertaken, local recur-
rence must be verified and documented by
prostate biopsies. Respecting the appropri-
ate indications for best results is particularly
important in the context of HIFU after EBRT
or brachytherapy, since the rate of complica-
tions is significant, e.g. the incidence of the
occurrence of fistula can reach 7% and that
of incontinence can reach 50% [Table 5].
Future developments
One of the most promising new develop-
ments in the field is the use of MRI-guided
N° pts Local control
rate
Gelet [12] 71 80%
Zacharakis [13] 31 93%
Murat [14] 167 73%
Table 5. Results and complications when HIFU is used as a salvage procedure.
Clinical stage PSA nadir (ng/
ml)
T1c-T3a N0M0 0.40
T1-T2 N0M0 0.20
T1-T2 N0M0 0.50
T1-T2 N0M0 0.20
T1-T2 N0M0 1
HIFU, and a prototype of an endorectal
probe coupled with focused ultrasound has
been developed and presented. New imaging
methods such as fat-saturated gadolinium-
enhanced MRI can demonstrate accurately
the extent of tissue damage induced by
HIFU, and multi-sequence MR imaging of
the prostate gland should help physicians to
discriminate between local and systemic fail-
ure after HIFU procedures, thus reducing the
significance of false-negative data from post-
operative prostate biopsies in patients with a
rising PSA level.
The immediate future looks likely to involve
the use of HIFU as a focal therapy when
there is an accurate and reliable diagnosis of
mono-focal prostate cancer. The technique
enables the treatment to be limited to areas
of prostate cancer only, thus saving as much
as possible the ‘healthy’ gland, and minimis-
ing the risk of incontinence and impotency
as far as possible.
The major arguments against such focal ther-
apy can be classified under the broad head-
ing of ‘understaging’, the argument centred
around the multifocality of prostate cancer.
Currently there is an increasing proportion
of cases of early-stage, organ-confined, low-
volume prostate cancer and it would appear
that 13%–33% of patients have true unifo-
cal disease. Focal therapy seems particularly
appropriate for such patients [15,16].
Mean follow G3 Inconti- Fistula
up (months) nence
14.8 7% 6%
7.4 7% 6.4%
18.1 11% 5%
HIFU is already being used (unfortunately
also outside of formal clinical trials) and the
preliminary data are encouraging, although
the variability in the criteria for eligibility of
enrolling patients in trials, the parameters of
treatment, the length of follow-up and the
absence of patient-reported outcomes make
these results hard to interpret.
Conclusions
High-intensity focused ultrasound is a rela-
tively new procedure for treatment of prostate
cancer and promises to become the method
of choice for patients with localised prostate
cancer. HIFU has, of course, both advantages
and disadvantages which should always be
considered in the decision-making process.
Patients receiving HIFU should be carefully
selected; the technique should be reserved
for patients with low-intermediate risk dis-
ease. The ASTRO-Phoenix criteria, prostate
biopsy and PSA nadir are the best surrogates
to define post-procedure disease control.
The immediate future looks set to involve the
use of HIFU as a focal therapy when mono-
focal prostate cancer is accurately and reli-
ably diagnosed. Organ-sparing focal therapy
may fill the gap between an active surveil-
lance strategy and whole-gland treatment
thus providing a reasonable balance between
cancer control and quality of life issues in
the future.
References
1. Madersbacher S, et al. Cancer Res 1995; 55: 3346.
2. Gelet A, et al. Eur Urol 1996; 29: 174.
3. Uchida Tet al. BJU Int 2006; 98: 537.
4. Blana A et al. Urology 2008; 72:1239.
5. Mearini et al. J Urol 2009; 181: 105.
6. Chaussy C & Thuroff S. Expert Rev Med Devices
2010; 7; 209.
7. Blana A et al. World J Urol 2006; 24: 585.
8. Misrai V et al. World J Urol 2008; 26: 481.
9. Poissonier L Eur Urol 2007; 51(2): 381.
10. Blana A et al. Urology 2004; 63: 297.
11. Ganzer R et al. Eur J Urol 2008; 53: 547.
12. Gelet A et al. Urology 2004; 63: 625.
13. Zacharakis E et al. BJU Int 20087; 102: 786.
14. Murat FJ et al. Eur J Urol 2009; 55: 640.
15. Muto S et al. Jpn J Clin Oncol 2008; 38: 192.
16. Ahmed et al. Nat Clin Pract Oncol 2007; 4: 632.
The author
Luigi Mearini, MD, Urologist
Urology Department
University of Perugia, Italy
&
Ospedale Santa Maria della Misericordia
Sant’Andrea delle Fratte
06100 Perugia,
Italy
e-mail: luigi.mearini@tin.it
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 – September/October 2010
10
ASIR reduces radiation dose
associated with coronary CTA
A low-dose coronary
computed tomogra-
phy angiography (CTA)
technique, namely adap-
tive statistical iterative
reconstruction (ASIR),
can reduce the radia-
tion dose associated with
coronary CTA by 27 per-
cent, according to a study
in the September issue of
the American Journal of Roentgenology. ASIR
is a technique that allows radiologists to reduce
the noise in an image and improve image quality
while reducing the radiation dose.
The large multicentre study included 574
patients undergoing coronary CTA at three
imaging centres. Comparisons with regard to
patient and scan characteristics, radiation dose,
and diagnostic study quality were performed
between consecutive groups, initially using the
standard CTA method and filtered back projec-
tion (FBP,) and subsequently using ASIR
There was a 44 percent reduction in the median
radiation dose between the FBP and ASIR
cohorts. After adjustment for scan settings,
ASIR was associated with a 27 percent reduc-
tion in radiation dose compared with FBP.
ASIR permits reduction in tube current while
imparting a statistically significant reduction
in radiation dose due to the direct relationship
between tube current and dose.
www.ajronline.org
Drug-eluting stents confirmed safe
and effective for long-term use
Researchers at
the Rabin Medi-
cal Centre in
Israel have deter-
mined that the
use of drug-elut-
ing stents (DES)
improves the
long-term clini-
cal outcome for
patients undergo-
ing percutaneous coronary intervention (PCI).
Randomised clinical trials indicate that DES
decreases in-stent restenosis and the frequency
of repeat revascularisation procedures in
patients undergoing PCI, yet questions remain
about the long-term safety and/or effective-
ness of DES in routine clinical practice among
large unselected population cohorts. In the
current study, the Israeli team examined the
benefits and long-term risks of DES by evalu-
ating the established pattern of DES versus
bare-metal stent (BMS) use in routine clinical
practice in Israel. The study population com-
prised all consecutive cases of PCI with stent
implantation over a 4-year period. The entire
NEWS IN BRIEF
cohort consisted of 6,583 patients, 2,633 (40%)
patients with a DES and 3,950 (60%) patients
with BMS. The minimal follow-up time was 6
months, and the maximal follow-up time was
5.2 years, with a mean follow-up time of 3
years. Results show that use of DES reduced the
occurrence of myocardial infarction and the
need for clinically-driven target vessel revas-
cularization (TVR). Mortality was significantly
lower in the DES group, showing a persistent
benefit of DES over time.
http://tinyurl.com/2v4ouxb
New nuclear breast imaging technolo-
gies associated with higher cancer risks
The risks and benefits
of screening mam-
mography are under
constant scrutiny.
Meanwhile, newer
breast imaging tech-
nologies, such as
BSGI and PEM have
been approved by
the U.S. Food and
Drug Administration (FDA) and introduced
into clinical practice. Preliminary studies have
shown both to be promising at detecting can-
cer; however, both involve the injection of
radioactive material into the patient. BSGI uses
a high-resolution gamma camera that allows
for imaging with mild compression of the
breast along with an injection of a nuclear radi-
otracer, which is absorbed at a higher rate by
cancerous cells. In PEM, radioactive material
is injected into the body to measure metabolic
activity and determine the presence of disease.
Other technologies, not yet approved by the
FDA, include dedicated breast CT and digital
breast tomosynthesis.
Dr R. Edward Hendrick, clinical professor of
radiology at the University of Colorado-Denver,
School of Medicine in Aurora, Co, USA reviewed
recent studies on radiation doses from radiolog-
ical procedures and organ doses from nuclear
medicine procedures, along with Biologic Effects
of Ionizing Radiation (BEIR) VII age-dependent
risk data, to estimate the lifetime risk of radia-
tion-induced cancer incidence and death from
breast imaging exams using ionizing radiation.
Two-view digital mammography and screen-
film mammography were found to have an aver-
age lifetime risk of fatal breast cancer of 1.3 and
1.7 cases, respectively, per 100,000 women aged
40 years at exposure and less than one case per
one million women aged 80 years at exposure.
Annual screening mammography (digital or
screen-film) performed in women from age 40
to age 80 is associated with a lifetime risk of fatal
breast cancer of 20 to 25 cases in 100,000. Dedi-
cated breast CT and digital tomosynthesis were
both found to have an average lifetime risk of
fatal breast cancer of 1.3 to 2.6 cases, respectively,
per 100,000 women 40 years of age at exposure.
A single BSGI exam was estimated to involve a
lifetime risk of fatal cancer 20 to 30 times that of
digital mammography in women aged 40 years,
while the lifetime risk of a single PEM was 23
times greater than that of digital mammography.
In addition, while mammography only slightly
increases a woman’s risk for breast cancer, BSGI
and PEM may increase the risk of cancers in
other organs as well, including the intestines,
kidneys, bladder, gallbladder, uterus, ovaries
and colon. Currently, no one is advocating using
PEM or BSGI as a screening method to replace
mammography. These exams are typically per-
formed on women with suspicious breast lesions
and in women with dense breasts who are dif-
ficult to examine with other techniques. Despite
the increased radiation dose, these exams have
shown promise in detecting cancer accurately
and may have a good risk-benefit ratio for some
specific indications.
http://radiology.rsna.org/
Molecular imaging identifies
high-risk patients with heart disease
A study published in the August Journal of
Nuclear Medicine (JNM) finds that molecular
imaging can identify high-risk patients with
potentially life-threatening cardiovascular con-
ditions and help physicians determine which
patients are best suited for implantable cardio-
verter defibrillator (ICD) therapy. According to
researchers from Sapporo University, Sapporo,
Japan, molecular imaging can play an important
role in diagnosing and guiding the treatment
strategy for arrhythmia, coronary artery disease
and heart failure. In their study, the researchers
hypothesised that both the impairment of myo-
cardial perfusion and/or cell viability and car-
diac sympathetic innervations are responsible
for heart arrhythmia and sudden cardiac death,
but there was no established, reliable molecular
imaging method. The researchers investigated
prognostic implications of cardiac pre-synaptic
sympathetic function quantified by cardiac
MIBG activity, and myocyte damage or viabil-
ity quantified by cardiac tetrofosmin activity, in
patients treated with prophylactic use of ICD, by
correlation with lethal arrhythmic events which
would have been documented during a prospec-
tive follow-up. The study is the first to show
the efficacies of the method for more accurate
identification of patients at greater risk of lethal
arrhythmias and sudden cardiac death (SCD).
http://jnm.snmjournals.org
 INTENSIVE CARE 11 – September/October 2010

Strict or loose glycemic control in critically

ill patients? Conflicting evidence
There is a substantial body of evidence showing the negative effect of hyperglycemia A multi–centre RCT of patients with severe
in critically ill patients, thus quantifying the adoption of strict glycemic control (SGC) sepsis from Germany was stopped prematurely
measures in which insulin is administered to enable a pre-determined blood glucose on safety grounds, namely an increased inci-
dence of severe hypoglycemia with SGC [5]. At
level to be reached. Two randomised controlled trials (RCTs) showed that SCG did
28 and 90 days, there was not a significant dif-
indeed reduce mortality and morbidity. Since then, however, other RCTs have failed ference in mortality (24.7% and 39.7% respec-
to reproduce the conclusions of the original trials. This article discusses possible rea- tively in the intervention group versus 26.0%
sons for the discrepancies in the trial results and discusses the future outlook. and 35.4% in the control group).
In a RCT carried out in Australia/New Zealand
by Dr Marcus J Schultz and Canada, the 90–day mortality was unex-
pectedly even higher with SGC (27.5% in the
intervention group versus 24.9% in the control
Strict glycemic control (SGC) has been shown showed that SGC reduced morbidity — but not group) [6].
to decrease mortality and morbidity in inten- mortality — in a medical ICU [2]. The power Finally, in a European multi–centre RCT, SGC
sive care unit (ICU) patients in two randomised analysis for this RCT was based on the number of was again not associated with a reduction in
controlled trials (RCTs) [1,2]. However five patients requiring ≥ 3 days in the ICU. This trial, mortality (15.3% in the intervention group
subsequent RCTs failed to show the benefit of however, only recruited 767 patients who stayed versus 17.2% in the control group) [7].
SGC [3-7], with one trial even suggesting that ≥ 3 days in the ICU, and not the 1200 patients
SGC was harmful [6]. There are several expla- as required by calculation of the power analy- Differences between the randomised
nations as to why these five negative RCTs of sis. Consequently, the RCT was not powered to controlled trials of SGC
SGC showed no beneficial effects. detect a difference in mortality in the intention Apart from the basic possibility that SGC may
to treat analysis. In fact, a per protocol analysis of indeed not benefit ICU patients, there are sev-
Randomised controlled trials of Strict patients who stayed in the ICU ≥ 3 days did show eral possible explanations as to why the five
Glycemic Control (SGC) a difference in mortality (43.0% in the interven- negative RCTs did not show beneficial effects
The first single–centre RCT was carried out in tion group versus 52.5% in the control group). for SGC.
Leuven, Belgium and showed that SGC signifi-
cantly decreased mortality in a single–centre sur- Subsequent trials Variability in the administration of SGC
gical ICU (4.6% in the intervention group versus A single–centre RCT from Saudi Arabia SGC may on the face of it appear easy to imple-
8.0% in the control group) [1]. In addition, SGC revealed no significant difference in ICU mor- ment, but there are several potentially impor-
reduced the incidence of bloodstream infections, tality (13.5% in the intervention group versus tant practical aspects of SGC that are frequently
acute renal failure requiring dialysis or hemofil- 17.1% in the control group) [3]. In a single– overlooked [8]. In the two positive RCTs from
tration, red–cell transfusions and critical illness centre RCT carried out in Colombia, the Leuven, SGC was applied using a reliable con-
polyneuropathy. SGC was also associated with a 28–day mortality rate was not affected by SGC tinuous infusion of insulin exclusively via a cen-
shorter period of ventilatory support. (36.6% in the intervention group versus 32.4% tral venous line, using accurate syringe–driven
The second single–centre RCT from Leuven in the control group) [4]. infusion pumps. Subtle insulin dose adaptations

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 – September/October 2010 12
were made only by ICU nurses, based on guide-
lines aiming for blood glucose levels close to the
lower normal limit, but also requiring a high level
of intuitive decision–making. The blood glucose
level in arterial blood was measured by the ICU
nurses using accurate blood gas analysers at strict
time points, and at intermediate time points
between these predetermined points whenever
this seemed necessary. Finally, patients were kept
in a non–fasting state at all times.
Several of these methodological aspects of SGC
were substantially different in the later RCTs.
Indeed, instead of accurate syringe–driven infu-
sion pumps, volumetric infusion pumps were
sometimes, or always, used [3,4]. Alternatively,
the type of pump used was not mentioned at all
[7]. The level of knowledge of, and training in,
the guidelines on the part of ICU nurses was
not specified [5,7], or was restricted to training
related more to the prevention and correction
of hypoglycemia [3]. It was also not specified
whether insulin was administered exclusively
by ICU nurses [5]. Blood glucose measure-
ments could have been made in capillary whole
blood samples, using less accurate glucose ana-
lysers [3-7]. Finally, glucose administration on
the first day was often not specified and thus
probably not a part of the protocol [3,5,7].
More problematic is the “expertise–based
control system” applied by the ICU nurses
from Leuven. This involved an algorithm that
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contained only a set of simple rules. In particu-
lar, there was an absence of explicit rules, such
as are used in closed–loop systems, computer–
based decision support systems, and paper–
based systems using sliding scales. A high level
of intuitive decision–making by the nurses was
thus required. It is difficult, if not impossible, to
identify and copy the specific elements of this
“intuitive control system” that undoubtedly
contributed to the outcome observed in the tri-
als from Leuven. The same may apply for the
skill and motivation of ICU nurses from Leu-
ven. In this context it is important to note that
the interventional arms of some of the multi–
centre RCTs contained very low numbers of
patients [5,7]. The question can be raised as to
whether the staff involved in these trials were
experienced enough and truly skilled in SGC.
Design of randomised controlled
trials of SGC
The smaller RCTs were all statistically under-
powered to detect a reasonable mortality differ-
ence [3-5]. In particular, the early termination
of the RCT from Germany was inopportune [5]:
while this study performed best in the interven-
tion group, with blood glucose levels closer to
the upper limit of SGC than the other negative
trials, the study protocol allowed for early ter-
mination on safety grounds. The increase in the
incidence of severe hypoglycemia forced the
investigators to stop the study, leaving us with
yet another underpowered RCT analysis.
A light adapted to the rapidity of sur-
geries in intensive care units
These units are places often equipped with
the most technologically innovative medical
machinery. Work done in intensive care units
is characterized by the permanent checking of
illnesses and the need to react very quickly in
the case of an emergency. Given the complexity
of the work done, and the concentrated imple-
mentation of medical equipment to check and
follow-up on vulnerable patients, light must
absolutely contribute to creating the best pos-
sible vision and work conditions for the physi-
cians and care staff.
Light for the recovery rooms
The gravity of surgeries and the resulting anxi-
ety can still act upon the patients waking up
from anesthesia. Therefore, it is highly recom-
mendable to have special rooms which radiate
a sense of soothing and security. But, generally
the reality is far from this. Medical machinery
emits penetrating noises and the medical staff
must learn to check the patient’s state with a
quick glance, not having the time to look after
them individually. Thanks to our luminaires,
Change in standard of care –
hyperglycemia is not longer accepted
A policy of insulin therapy to target lower blood
glucose levels has been adopted in many ICUs
since the publication of the first RCT of strict
glycemic control [1]. Accordingly, in all trials
except for two, glycemic control had improved
in the control group compared to the original
RCT. In addition, an increase was noticed in the
number of patients who received insulin, or there
was an increase in the amount of infused insulin
in the control group [2-7]. This factor makes the
subsequent RCTs fundamentally different from
the original trial. Indeed, these RCTs were car-
ried out in the “flattened” part of the observa-
tional blood glucose level – mortality risk curve
[9]. In the most recent two RCTs [6,7], the extent
of the expected effect, namely an absolute reduc-
tion of – 4% in the risk of death — that is, similar
to that observed in the original RCTs [1,2] was
therefore too optimistic [10].
Timing of the start of SGC
When the time till target is too long, the time
window for the prevention of toxicity cause by
hyperglycemia may have passed and irrevers-
ible damage may already have occurred [11].
This phenomenon has also been suggested by
the pooled analysis of the two original RCTs
[10]. In most trial descriptions the time taken
to reach the preset blood glucose level target
is insufficiently reported. In one trial, this
appeared indeed to be an important factor,
we can bring valuable support to this complex
and demanding work of medical professionals.
Strong points
• Quickly obtaining a highly-intense light to
treat a patient with a reduced ambient light
• Ideal visual assistance for short surgeries such
as placing perfusions or giving shots, etc.
• Easy and simple usage thanks to a compact
and easy-to-use luminaire design
• Combination of examination light and read-
ing light
• Indirect light to avoid too much glare for
patients in the recovery phase.
• Wall-mounted luminaires in warm tones cre-
ating a feeling of well-being
• Energy efficient – Energy savings thanks to
a low electric consumption and electronic
ballasts
• Extremely easy up-keep. Perfect and simple
cleaning thanks to the closed design of the
luminaire (closed wiring passage)
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 13 – September/October 2010

since initiation of SGC in that trial was delayed by more than 13 hours
because of randomisation [6].
The blood glucose levels achieved with SGC
None of the RCTs carried out after the two original trials managed to
achieve the strict degree of glycemic control achieved by the Leuven
investigators [1,2]. Indeed, no trial had a median or mean blood glu-
cose level in the intervention group below the upper normal target of
blood glucose. It is interesting to note that one meta–analysis suggests
that studies which managed to achieve the blood glucose target showed
a reduced mortality whereas studies that did not succeed in reaching the
target reported no benefit or even an increased mortality [12].
Discussion and future perspectives
Lowering blood glucose levels has the potential to prevent injury to
already threatened vital organs. However, the precise optimum blood
glucose level target is still to be defined as is the optimal methodology
as to how to reach that level. The observations that SGC showed both
positive [1,2] and negative effects [6] thus presents a fascinating impasse.
The currently available evidence from all seven RCTs does not allow a
confident, overall recommendation to be drawn.
In the absence of a defined optimal target level of glycemic control,
any advice on the interpretation of RCTs on SGC remains pragmatic:
it should be verified that the extent of expected benefit was realistic,
whether the statistical power was sufficient and whether the level of evi-
dence of the studies was appropriate. Likewise, it should be verified that
the methods and equipment used to measure and control blood glucose
were adequate, it should be checked whether the targets were achieved,
and finally it should be checked whether the levels of glycemic control
were significantly different. Clinicians should also determine how com-
parable the patients in the different RCTs are to their own and decide on
what is their best target for glycemic control.
10. Van den Berghe G et al. Diabetes 2006; 55: 3151-3159.
11. Ceriello A et al. J Clin Endocrinol Metab 2009; 94: 410-415.
12. Griesdale DE et al. CMAJ 2009; 180: 821.
13. Finney SJ et al. JAMA 2003; 290: 2041-2047.
14. Krinsley JS. Mayo Clin Proc 2003; 78: 1471-1478.
15. Falciglia M et al. Crit Care Med 2009:
The author
Marcus J Schultz, internist–intensivist, MD PhD FCCP 1,2
Academic Medical Center, University of Amsterdam,
Amsterdam, the Netherlands
1
Department of Intensive Care
2
Laboratory of Experimental Intensive Care and Anesthesiology
Correspondence:
Marcus J. Schultz, Dept of Intensive Care Medicine C3–415
Academic Medical Center, University of Amsterdam
Meibergdreef 9
1105 AZ Amsterdam, The Netherlands
Tel: +31–20–5669111; Fax: +31–20–5669568
E–mail: m.j.schultz@amc.uva.nl
Dmed® halux LED Dmed® halux LED

Alternatively, we could perform yet another trial, using the same targets
as in the RCTs from Leuven [1,2], both for the interventional and the
control group. This, however, may be unethical, if not impossible, for
two reasons. The standard of care regarding glycemic control has defi-
nitely changed over the last decade. How could we justify carrying out
a new trial in which critically ill patients would be deliberately exposed
to the risks of hyperglycemia? Secondly, one could also argue that it is
unethical to discard the evidence from the two positive RCTs, and we
are obliged to repeat this study.

Given the substantial evidence of the generation of harm from hyperg-

lycemia [9,13-15] and the conflicting results from the seven published
RCTs [1-7], considerable work remains to be done in identifying the con-
founding factors in the clinical application of SGC. This process needs
to be explicit and systematic, and should at least include the points as
brought up here. If new RCTs of SGC are to be performed, investigators A CLEAn viEw – CLEAr ADvAntAgES
should recognise the several shortcomings of the recent negative trials,
as described. An individual patient data meta–analysis examining the • 50 000 lux / 0.5 m State-of-the-art LED technology
discrepancies between studies may be a good alternative. • No heat radiation from the light
Flexible regulation of luminosity
• Considerable energy savings
• Adjustment of light intensity in
References five stages
• Free of maintenance
1. Van den Berghe G et al. N Engl J Med 2001; 345: 1359. Compact design
2. Van den Berghe G et al. N Engl J Med 2006; 354: 449. Changeable light color
• Practical and space-saving
3. Arabi YM et al. Crit Care Med 2008; 36: 3190. • 3 color levels allow better
• Simple, intuitive operation with
viewing of contrasts
4. De La Rosa GDC et al. Crit Care 2008; 12: R120. controls directly on the light
5. Brunkhorst FM et al. N Engl J Med 2008; 358: 125-139. head
6. Finfer S et al. N Engl J Med 2009; 360: 1283-1297.
7. Preiser JC et al. Intensive Care Med 2009; 35(10):1738-48.
8. Van den Berghe G et al. J Clin Endocrinol Metab 2009; 94: 3163-3170. Derungs Licht AG • Hofmattstrasse 12 • 9200 Gossau • Switzerland
Phone +41 71 388 11 66 • Fax +41 71 388 11 77 • mailbox@derungslicht.com • www.derungslicht.com
9. Bagshaw SM et al. Crit Care Med 2009; 37: 463-470.
www.ihe-online.com & search 45451
 – September/October 2010
14 INTENSIVE CARE

Standards for the level of nurse staffing

in critical care units
The gold standard for nurse staffing levels in critical care stable ventilated patient may require recommendations for nurse staffing
in the United Kingdom has been established since 1967 at far less nursing input than an agi- levels in critical care.
one nurse for each patient. Recent evidence suggests how- tated high dependency patient. This
prompted the challenge on tradi- The standards committee met on a
ever that there is a great deal of difference in the staffing
tional staffing levels in critical care. number of occasions to agree terms
levels and skill mix between individual critical care units in of reference and develop a structure
the UK, with the result that nurses are being challenged to The BACCN started to receive for the staffing standards docu-
justify and defend the 1:1 ratio. The aim of this article is to enquiries from its members who ment, but the main work involved
provide the wider intensive care community with an over- were under pressure from their the review of evidence. A number
view of the Standards for Nurse Staffing in Critical Care employers to work more flexibly. of bibliographic databases were
Whilst the nurses were not averse searched, which resulted in approxi-
units as proposed by the organisations representing critical
to this, they were concerned about mately 3000 pieces of evidence being
care nurses in the UK. patient safety and that the set ratios reviewed. The evidence included in
would be lost completely once a prec- the standards supports the higher
by Vanessa Gibson edent had been set for working with ratio of nurses to deliver safe and
fewer staff. Therefore the BACCN, effective critical care, and has been
RCN and CC3N worked collabora- grouped into the following themes:
In this period of straitened eco- Developing safe standards tively and published the Standards
nomic circumstances, nurse for nurse staffing levels for Nurse staffing in Critical Care in • Infection control
staffing levels in critical care in ICUs 2010 [7]. Representation was sought • The individual experience and
units (CCU) are a contentious The safety of the critically ill, ven- from the members of the three competence of each nurse
issue. This article will highlight tilated patient is paramount hence organisations: a standards committee • Size, geographical layout and
the main points of recently pub- the traditional nurse to patient ratio was formed with the remit to review number of beds in a unit
lished guidelines for nurse staff- of 1:1. In recent years nurses have a wide range of evidence and make • The need for larger units to have a
ing levels in the UK with a view come under mounting pressure to
to sharing the UK experiences review this ratio. Nurses in the UK Standards for Nurse Staffing in Critical Care Units Determined By:
with the wider intensive care turned to their professional organi- The British Association of Critical Care Nurses
The Critical Care Networks National Nurse Leads
community. Traditionally nurse sations for guidance on this matter. Royal College of Nursing Critical Care & In-flight Forum
staffing levels in the UK were set As there are several organisations in
1. Every patient in a Critical Care Unit must have immediate access to a registered nurse with a post
in 1967 at one nurse for one ven- the UK with an interest in critical registration qualification in this specific speciality
tilated patient [1]. Staffing costs care nursing, it was deemed appro- 2. Ventilated patients should have a minimum of one nurse to one patient
represent 50-60% of the total priate that these should collaborate 3. The nurse patient ratio within any Critical Care Unit should not go below 1 nurse to 2 patients
budget for critical care in the UK to review previously published 4. The level of care needs required by each patient should equate to the skills and knowledge of the
and nurse staffing represents a guidelines and review the evidence registered nurse delivering and/or supervising that care
sizable proportion of this [2]. It base for staffing levels in critical 5. Critical Care Units should employ flexible working patterns as determined by unit size, activity, case
is therefore not surprising that care. The organisations involved mix and the fluctuating levels of care for each patient, to ensure patient safety and care delivery
nurses have been challenged to included the British Association of 6. A supernumerary clinical co-ordinator, who is a senior critical care qualified nurse will be required
for larger and geographically diverse units of more than 6 beds. The clinical co-ordinator’s role is
defend these staffing levels. Critical Care Nurses (BACCN), the to ensure effective, safe and appropriate care is delivered each shift, by managing and supporting
Royal College of Nursing Critical staff and patients, and acting as a communicator and liaison between the rest of the multi-discipli-
nary team.
In the year 2000 the UK Depart- Care and In Flight Forum (RCN)
ment of Health recommended and the Critical Care Networks 7. The layout of beds and use of side wards in a Critical Care Unit must be taken into account when
setting staffing levels to ensure safe patient care.
that the existing division into National Nurse Leads (CC3N) [see
8. On-going education for all nursing staff working in critical care is of principal importance to ensure
high dependency (HDU) and side-bar at the end of the article]. knowledgeable and competent staff care for patients. Clinical Educator posts should be utilised to
intensive care (ICU) beds be support this practice.
replaced by a classification based Previously published guidance on 9. Health Care Assistants (HCAs) have a key role in assisting registered nurses in delivering direct
patient care and in maintaining patient safety. These roles should be developed to meet the
on the level of care required by staffing levels have included that demands of patients and of the unit. However, the registered nurse remains responsible for the
the patient, and therefore in this issued by BACCN in 2001 [3] and assessment, planning, delivery and evaluation of patient care.
article the term “critical care” revised in 2005 [4] as well as that 10. The Assistant Practitioner’s (APs) role in Critical Care can provide direct patient care under
will be used as an overarching issued by the RCN in 2003 [5]. In the indirect supervision of a registered nurse, who will remain responsible for the assessment,
planning and evaluation of patient care. The effectiveness of the role of Assistant Practitioners in
term for HDU and ICU [2]. The 1999 the Audit Commission [6] Critical Care Units requires further evaluation and research.
British Association of Critical found that there was significant 11. Administrative staff should be employed to ensure registered nurses are free to give direct patient
Care Nurses (BACCN) has an variation in the number of nurses care, and to support the critical care units and staff with essential data collection.
exemplary history for publishing employed in critical care units. In 12. Critical Care nurses should be proactive in the development of multi-professional team working to
position statements (guidelines) addition to this, although the ratio optimise quality patient care and ensure a quality service.

in order to provide evidence- of nurse to patients for high depend- The standards recommended by the three UK professional CCU nursing levels to
based information for nurses. ency or Level 2 patients [2] was 1:2, a allow flexible working yet maintain patient safety.
 15 – September/October 2010

supports a high nurse-to-patient Critical Care: A Review of Adult

Nurse staffing costs are a large part of total ICU budgets, so staffing levels are being
challenged. Nurses should participate in ICU data collection and evidence reviews to
defend appropriate staffing levels, with the goal of maintaining patient safety.
supernumerary shift co-ordinator
•C  ase mix and patient dependency
• S afety in relation to ventilated
patients
•M  ixed sex accommodation needs
• Team working
• Use of evidence based protocols
•O  ngoing education and develop-
ment of critical care nursing
• Administrative support for
mandatory data collection
The staffing standards document
acknowledged that nurses’ roles
in critical care in the UK may be
distinct from other countries and
therefore these staffing levels may
not be applicable in other coun-
tries. National critical care organi-
sations in other countries are
therefore encouraged to conduct
their own reviews and develop
their own standards.
After the lengthy review process the
final document was launched at the
BACCN National Conference in
September 2009 and can be found
on the website at www.baccn.org.uk.
In order to reach a wider audience, a
shortened version was published in
the BACCN’s professional journal,
Nursing in Critical Care May/June
edition 2010 [8].
Conclusion
The review of the evidence related
to staffing levels in critical care has
demonstrated that the contribu-
tion of nursing can be difficult to
measure. Despite this there is an
emerging body of evidence which
ratio in critical care. The safety of
patients is paramount, and nurses
need to protect patients and their
current working conditions with
firm evidence. In order to do this
nurses need to be pro-active in the
necessary data collection processes
which are now part of the modern-
day critical care unit. Nurses need
to develop valid and reliable meas-
urement tools to collect data on the
contribution of nursing to patient
outcomes in critical care. Only by
developing and participating in
data collection and evidence review
will nurses be able to develop and
defend appropriate staffing levels.
Intensive care organisations and
societies should think more broadly
than just about nurse staffing levels,
and work collaboratively to pro-
vide joint staffing standards across
all professional groups for safe and
effective critical care services.
Acknowledgement
With thanks to the British Association
of Critical Care Nurses, Royal College
of Nursing Critical Care and In-Flight
Forum, the Critical Care Networks
National Nurse Leads and original
authors Bray K, Wren I, Baldwin A, St
Ledger U, Goodman S, and Walsh D.
References
1. British Medical Association. Intensive
Care planning Unit Report No. 1. Brit-
ish Medical Association, London 1967.
2. Department of Health. Comprehensive
Critical Care Services. Department of
Health, London, 2000.
3. B ritish Association of Critical Care
Nursing. Position Statement. Nurse-
patient ratios in critical care. Nursing
in Critical Care 2001; 6(2): 59-63.
4. British Association of Critical Care
Nurses. Position Statement On Nurse-
Patient Ratios in Critical Care (Revi-
sion) 2005. www.baccn.org.uk
5. Royal College of Nursing. Guidance for
Nurse Staffing in Critical Care. Royal
College of Nursing, London, 2003.
6. Audit Commission. Critical to success:
the place of efficient and effective criti-
cal care services within the acute hos-
pital. The Audit Commission, London,
1999.
7. Standards for Nurse staffing in Critical
Care www.baccn.org.uk
8. Bray K, Wren I, Baldwin A, St Ledger
U, Gibson V, Goodman S, and Walsh
D. Standards for nurse staffing in criti-
cal care units determined by: The Brit-
ish Association of Critical care Nurses,
The Critical Care Networks National
Nurse Leads, Royal College of Nurs-
ing Critical Care and In-flight Forum.
Nursing in Critical Care 2010; 15(3):
109-111.
The author
Vanessa Gibson
Professional Advisor BACCN
Teaching Fellow, Critical Care Nursing
Northumbria University
Newcastle, UK
e-mail :
vanessa.gibson@northumbria.ac.uk

The three UK nursing organisations which collaborated on the new standards are BACCN, RCN and CC3N
The British Association of Critical
Care Nurses (BACCN)
The BACCN was set up 25 years ago and
is dedicated to the promotion of excellence
in the provision and delivery of critical care
nursing through mutual support, education
research and multi-disciplinary collaboration.
The BACCN has over 3000 members and 15
regions that cover the UK. The BACCN pro-
vides guidance for nurses but a vital role of the
BACCN is in ensuring that critical care nursing
is represented in many national arenas, such as
at the Department of Health and National Insti-
tute of Health and Clinical Excellence (NICE).
This ensures that critical care nurses help shape
national policy and contribute to the develop-
ment of national guidelines. The BACCN is
managed by an elected national board and each
region has a regional committee. The BACCN
holds an annual national conference and each
of the regions hold regular study events. The
BACCN is a member of the European Federa-
tion of Critical Care Nursing Association and
the World Federation of Critical Care Nurses.
The Royal College of Nursing Criti-
cal Care and In-Flight Forum (RCN)
The RCN is a very large, general nursing
organisation which provides a wide range of
services for nurses. It represents nurses and
nursing, promotes excellence in practice and
shapes health policy. As the RCN is a general
nursing organisation, the RCN forums were
set up to bring together members working
in similar nursing specialities or with similar
interests. There are 41 RCN forums with the
Critical Care and In-Flight Forum dedicated
to representing critical care nurses.
Critical Care Networks National
Nurse Leads (CC3N)
In its seminal publication “Comprehensive
Critical Care: A review of adult critical care
services”, the Department of Health suggested
in 2000 that hospital trusts form networks with
the objective being that healthcare providers and
commissioners work together to meet the needs
of all critically ill patients in their geographical
area. Therefore Critical Care Networks were set
up to represent regions across the UK to assess
the needs of critically ill patients, plan services
and agree common standards and protocols.
Each critical care network has a lead nurse. The
CC3N is a professional advisory group, as well
as a group which shares best practice and bench
marks across regions to ensure consistency
and standards of care. This group advises on
nursing elements of critical care at all levels.
 – September/October 2010
16 Medical Imaging

Assessing the glucose metabolic

phenotype of cancer using FDG-PET/CT
Imaging procedures using 18F - FDG PET/CT has improved the both diagnostic and prognostic. can provide important prognostic
diagnostic performance of the individual techniques of PET and PET imaging is therefore used for information. Such tumours can be
CT and, with its ability to simultaneously acquire both ana- diagnosing, staging or restaging of readily identified with CT and their
cancer as well as for monitoring the growth behaviour can be monitored
tomic and molecular/functional information, FDG PET/CT is
effects of therapeutic interventions. using CT.
emerging as the most important diagnostic tool in oncology. In addition, the degree of tumour
This article briefly reviews the technique and its applications. 18
F-FDG uptake carries important 18
F-FDG - PET/CT imaging is now
With progress being made on the standardisation of proto- prognostic information. most often used for staging, restag-
cols, as well as the development of new probes, the use of ing and monitoring of head and
PET/CT is being expanded to all major cancers. However, the metabolic switch to neck cancer, solitary lung nodules
a glycolytic phenotype is not can- and lung cancer, breast cancer,
cer specific. For instance, activated colorectal cancer, lymphoma and
by Dr J Czernin lymphocytes, which divide just as unknown primary tumours.
rapidly as cancer cells, also consume
large amounts of glucose, as do mac- Imaging protocols
Glucose metabolic imaging of can- relatively low when compared to rophages. Therefore, false positive Unfortunately, PET/CT imaging
cer using PET/CT with 18F-fluoro- the 25 million straightforward CT findings are not uncommon and protocols frequently vary from
deoxyglucose (18 FDG) is based on scans performed for tumour imag- occur most frequently in granuloma institution to institution, which
the fundamental, well documented ing in the United States alone (with disease, acute infections, benign highlights the need for standardi-
fact that, metabolically, malignant proportionally similar numbers in tumours and inflammation. sation. In the most frequently used
tumours consume large amounts other developed countries). Recent protocol, patients fast for 4–6 h prior
of glucose even in the presence of changes in PET/CT reimbursement The addition of CT imaging to PET to the injection of FDG. Again, the
oxygen; this is the process known as in the United States look set how- has mostly improved the specificity injected dose is variable. At our insti-
aerobic glycolysis that was first dis- ever to result in a higher utilisation of PET. However, some tumours tution in UCLA a dose of 0.20mCi/
covered (in vitro) by Otto Warburg of the technique to the benefit of exhibit a low glycolytic phenotype. kg (7.4mBq/kg) is administered.
in the 1920s. Other historical high cancer patients. While PET cannot be used for Imaging commences one hour after
points in the development of the diagnostic purposes in such can- the tracer injection. We have adopted
FDG-based PET/CT technique was The glycolytic phenotype cers their low glycolytic phenotype a “one-stop shop” protocol and give
the fluorination in the 1960s of the of cancer
glucose analogue 2-deoxyglucose 18
F-FDG PET imaging of cancer is
and the development by Michael E. based on the high glucose consump-
Phelps of the first PET scanner in the tion of malignant tissue. In other
1970s. Advances in computational words, cancer cells switch to a glyco-
capabilities in the late 1980s allowed lytic phenotype in order to provide
for the acquisition of whole body energy for rapidly growing tissue,
PET data. The final breakthrough and, equally important, to provide
occurred with the development of the carbon backbone for DNA and
combined PET/CT imaging systems RNA synthesis.
in the late 1990s; such systems are
capable of acquiring anatomic and After transport of 18F-FDG into
molecular/functional information tumour cells via the glucose trans-
near simultaneously. porters 1 and 3 (GLUT 1 & 3
respectively), 18F-FDG is phosphor-
Current PET/CT systems combine ylated by the enzyme hexokinase to
high-end CT with high-end PET 18
F-FDG-6-phosphate which cannot
systems. It is therefore now possi- be further metabolised and is there-
ble to conduct whole body surveys fore essentially trapped in tumour
of glucose metabolism and acquire cells. 18F-FDG tumour uptake thus
fully diagnostic CT studies at the depends upon GLUT expression
same time. More than 3000 PET/CT and activity as well as hexokinase
systems have been installed world- expression/activity which them-
wide and more than 2.5 million can- selves depend on various signal
cer patients have been studied glo- transduction pathways.
Figure 1. 71 year old male with a history of colorectal cancer. PET MIP (A) and
bally using FDG-PET/CT. Although selected fused axial images demonstrate metastatic disease to the lungs (A, white
this number is in itself impressive, it The information that can be derived arrow), mediastinal lymph nodes (B, white arrows), liver (C, white arrow) and right
should be noted that it is actually from 18F-FDG-PET imaging is adrenal gland (C, white arrow head).
 17 – September/October 2010

both oral and intravenous contrast of tumour proliferation (18F-Fluor- performance of PET and CT alone. Auerbach M. European Journal of
whenever clinically justified. othymidine), amino acid metabo- Attempts to standardise imaging Radiology 2010; 73: 470–480
PET/CT images are acquired during lism (18F-FDOPA and others), lipid protocols are underway and PET-
shallow breathing. The whole body metabolism (18F-choline, 11C-ace- based response criteria have been The author
contrast CT is used as diagnostic tate) as well as markers of tumour proposed in Europe and the United Johannes Czernin, MD
InHosAd/HR_InHosAD/HR
CT scan and is also used 22/07/2010
for attenu- hypoxia, 16:21
apoptosis Pageothers.
and 1 States. FDG-PET/CT imaging has Ahmanson Biological Imaging
ation correction. For PET imaging These will be important for char- emerged as the most important Division, Nuclear Medicine
we use a weight-based protocol that acterising tumours before and after diagnostic tool in oncology. Department of Molecular
can be as short as one minute/bed treatment and may lead to more and Medical Pharmacology
position in very thin patients or as rational treatment and treatment References David Geffen School of Medicine at
long as five minutes/bed position in monitoring approaches. 1. PET/CT imaging: The incremental UCLA
obese patients. value of assessing the glucose meta- 10833 Le Conte Avenue
Conclusion bolic phenotype and the structure Los Angeles, CA 90095-6948,
Clinical applications: F-FDG
18
PET/CT imaging of cancers in a single examina- USA
A large body of evidence supports has improved the diagnostic tion. Czernin J, Benz MR, Allen- e-mail: jczernin@mednet.ucla.edu
the notion that 18F-FDG PET/CT
imaging is more accurate than PET
or CT imaging alone for diagnosing,

GLOBAL
staging or restaging of cancer. Studies
conducted in patients with sarcoma,
head and neck cancer, lung cancer,
colorectal cancer, lymphoma, breast
cancer and others that support this
notion were recently reviewed in

REACH.
detail [1]. Most confirm that the
combination of the glucose meta-
bolic and the anatomic phenotypes
provides powerful diagnostic and
prognostic information.

An imaging modality that does

not impact patient management
is, fundamentally, meaningless. To
determine the impact of PET/CT
imaging on patient management,
the National Oncology PET registry
(NOPR) has been established in the
US and more than 120,000 patients
have been enrolled in the registry.
Published studies are summarised ONE
©Carestream Health 2010. Carestream and SuperPACS are trademarks of Carestream Health.

in reference 1. They confirm that

18
F-FDG -PET/CT imaging infor-
mation affects management deci-
sions in more than 30% of all cancer Workstation. Location. Solution. CARESTREAM RIS+PACS.
patients and that this impact was
Introducing the new CARESTREAM RIS/PACS that allows healthcare professionals to collaborate
near identical for staging, restaging seamlessly across multiple sites, platforms and clinical specialties to provide timely, quality patient care at
or monitoring the effects of thera- reduced costs. All personnel involved—schedulers, technologists, radiologists, referring physicians—can
peutic interventions across all can- contribute to the efficient delivery of patient care. From order initiation through distribution of results,
cers. Based on these data, coverage ONE desktop optimizes productivity for the entire radiology workflow. IT’S TIME YOU PUT IT TO WORK.
for PET/CT by the US Center of
Medicare and Medicaid (CMS) has
recently been expanded to include
all major cancers. PET/CT can now
be used for initial and subsequent ONE Solution.
treatment strategy assessments in
breast, cervix, colorectal, oesopha-
gus, head/neck and lung cancer, as
well as lymphoma, melanoma, mye-
loma, ovarian cancer and others. Visit us at

Many other imaging probes are

emerging that will allow more com-
prehensive non-invasive cancer
phenotyping. These include probes
www.ihe-online.com & search 45610
 – September/October 2010 18 It Case study

RIS/PACS developments in the north of

the Netherlands
Recently a consortium of independent hospitals in the north east of the Nether-
lands, each with their own individual RIS/PACS systems, decided to get together
and implement a new single RIS/PACS system that would enable total interchange
of data yet still be compatible with the individual way of working of each hospi-
tal. The system that the East Groningen Hospital Collaboration Foundation (the
organisation grouping the three hospitals) decided to implement was the eHealth
PACS system from Carestream. In addition to the image management services this
also provides for a remote back-up and disaster recovery system, operated for the
hospitals by the company.
International Hospital (IHE) wanted to know how this ambitious project was coming
along, so we spoke to Mark van den Heuvel, the project manager responsible for
the implementation of the new PACS system. Mark van den Heuvel is responsible for the installa-
tion and operation of the RIS/PACS system.

Q: Exactly what (and where) is the services to patients. All three hospitals had each site was, for historicaal reasons supplied
East Groningen Hospital Collaboration their own individual RIS/PACS system. by a different vendor. Thus, Refaja currently
Foundation? How big are the institutions uses an AGFA RIS/PACS system whereas the
involved in the collaboration? Q: With all these imaging systems, how Lucas site of the OZG hospital works with an
many radiology studies does that add up to AGFA RIS and a FUJI PACS system. As for the
Known by its Dutch language acronym of in total for the three hospitals? What about Delfzicht site of the OZG, they use an AGFA
SSZOG (Stichting Samenwerking Ziekenhui- these individual PACS systems that each RIS and a Siemens PACS.
zen Oost Groningen), the foundation involves hospital uses?
a collaboration between two separate hospital Q: What was the basic rationale behind the
groups, which jointly have three different phys- In the OZG (the hospital with the two sepa- decision to implement the new RIS/PACS
ical locations, so that they can cooperate and rate sites), there are a total of 85.000 radiology systems and how will it work?
work together for their mutual benefits. The exams carried out per year. As for the Rejafa
first hospital group, Ommelander Ziekenhuis hospital, they do 45000 exams per year. One of the main driving forces behind our
Groep (OZG), has two sites, one at in Delfzijl, Regarding PACS/RIS, the original system at desire to instal the new system was the clear
which is about 25 km north-Eeast of the city of
Groningen (itself in the far north of The Neth-
erlands, relatively near to the German border),
and the other in Winschoten, which is approxi-
mately 45 km due east of the city of Groningen.
Together, these two facilities of the OZG hos-
pital have about 420 beds. The other hospital
in the collaborative group is Refaja Hospital,
which is located in the town of Stadskanaal,
approximately 55 km south east of Groningen.
The Refaja hospital has 200 beds.

Q: What services do the hospitals offer, and

what radiology facilities do they have?

All three facilities of the hospitals provide a

full range of modern healthcare services. The
radiology departments in the three hospitals
each have an MRI scanner and a CT scanner.
All departments work with DR systems, and
DR mammography is also carried out by each
of the three hospitals. Ultrasound and angi-
Apart from the advantage of having one single RIS/PACS supplier (Carestream), who are also reponsible for
ography examinations are also performed in the provision of secure remote image archiving and access as well as disaster recovery, the new system pro-
all three hospitals. In short, each individual vides many advantages for radiologists. For example, the simple fact of being able to interrupt the dictation
location can deliver a full range of radiology of one patient report whenever there is a more urgent case, can result in a big saving of time overall.

advantage of being able to work with one sin-
gle supplier of both RIS and PACS systems.
We chose Carestream Health for this. We
estimate that the new RIS and PACS systems
are capable of providing several functions
which, in the future, will actually reduce hos-
pital time and costs.
As to how the new system works, the founda-
tion representing the three hospitals bought
the RIS servers and system, and decided to go
for a PACS based on an Application Service
Provider (ASP) model. This basically means
that the PACS and the associated data storage
system are paid for by the using hospitals as
a function of how much we use them. For us,
large investments in storage capacity and the
personnel necessary to maintain an adequate
level of service would be hard to sustain in the
future, particularly since CT and MRI imag-
ing modalities create huge amounts of data,
which look certain to continue to increase in
the future. The ASP model should therefore
save us significant costs in the long term.
Under the new system, the Fryslan data cen-
tre in Leeuwarden, to the west of Groningen,
will provide secure remote image archiving
and access together with disaster recovery.
Fryslan is one of eight separate data centres
operated by Carestream in five countries
throughout Europe and North America.
The new system is thus a big step forward,
not only from the financial point of view of
the hospitals, but it is in many respects also
advantageous for the radiologists. For exam-
ple, the simple fact of being able to interrupt
the dictation of one patient report whenever
there is a more urgent case, can result in a big
saving of time overall. Likewise, if the radi-
ologist has a question about another patient,
he can open that study and dictate a report
about the new patient, and then return to
the first report without any additional work
being required.
In the end this, of course, also results in
benefits for the patients. For example in the
dictation case above, this means that at the
moment of dictating, the temporary report
will be immediately available, and using Edi-
fact (Electronic Data Interchange system For
Administration, Commerce and Transport),
the final report can be with the referring
physician the same day.
Q: How difficult was the practical
implementation of the new system,
especially in light of the fact that different
PACS systems were previously used at each
of the hospitals?
Of course the conversion from three different
RIS and PACS to one system was a big chal-
lenge. The fact that our hospitals were in differ-
ent physical locations was in itself not a major
issue since Carestream has a vast experience
19
OmmelanderZiekenhuis Groep (above) is one of the
two hospitals in the consortium. The particular nature
of the consortium — two separate hospitals spread
over three physical locations, with each site having
its own RIS/PAC system — meant that customisa-
tion of the basic system supplied by Carestream was
required. The “proof of the pudding” of the new
system will only be assessed when the new system
goes fully on stream.
of implementing systems in such cases. The
real challenge came from the fact that in our
consortium we had two different hospitals
each with their own systems and sets of inter-
nal procedures and regulations. For example,
this meant that images taken in one hospital
and stored on one PACS would only be made
available in a second hospital if the patient
had previously agreed to such an exchange
of medical information. To make things even
more complex, the nuclear medicine depart-
ment, which works for the foundation/consor-
tium as a whole, is an exception to this restric-
tion. Because the department works for the
whole foundation, the clinicians must be able
to see all the X-rays from all three locations.
Because of the particular aspects of our set-up
we significantly customised the basic RIS 11
system from Carestream. In the modifications
that we introduced, we can not only book in
the patient but also include all the additional
information required. Thus data such as scan,
patient information and referring physician
are included on one form, so it isn’t necessary
to use a tab page.
One other customisation we introduced was a
feature to cater for the fact that, in most hos-
pitals here in the Netherlands, patients don’t
need to make an appointment. To handle this,
we created a “walk-in” patient option which
means that we can book in the patient with-
out having to access time and room choices.
All that is needed in the “walk-in” system is
to enter the patient number, the doctor and
the requested exam and the scheduling for the
appropriate modality pops up directly, i.e. with
no need to search for a first scheduled time
and then add a “patient arrived” message.
Of course all this required some work from
us. This was however facilitated by the hospi-
tal agreeing to my request for a work-room to
accommodate the four technicians who were
– September/October 2010
involved on a daily basis to customise the sys-
tem. This was a near-perfect dedicated room
of about 40 square meters containing six work
stations, with each desk having two PCs: one
to open the old RIS/PACS system and one to
open the new one. In addition I requested five
spare internet connections for the Carestream
people so that every one could work at the
same time.
I have several recommendations for any hospi-
tal IT personnel involved in the sort of imple-
mentation/customisation process in which we
were involved. One simple, but practical, rec-
ommendation is never to forget to make sure
that there is a printer installed in the work
room. It’s amazing how much time can be saved
if you don’t have to walk down a hallway to get
to the first available printer. Likewise, another
time-saving tip was having access to six inter-
nal mobile telephones so that we could call
our colleagues and key users directly without
putting the whole X-ray department on hold.
Of course it is always possible to use ordinary
mobile phones but calls on these can cost a lot
of money. Another advantage is that the inter-
nal mobile phones will retain their usefulness
when the system is in routine operation. In
addition, from the personal point of view of
the IT staff, it can be inconvient to give access
to external mobile phones to clinicians since
when the system is in routine operation there
is always the danger that the clinicians will call
up even for the smallest question including at
the weekend. The internal mobile phones can
also be used by the clinicians as a number for
when we go live.
Q: Were there any qualms about giving
management of data between and within
the individual hospital sites to a private
company?
This wasn’t an issue — Carestream is a profes-
sional organisation and it has a lot of experience
in treating patient information in an appropri-
ate and confidential manner.
Q: How about accommodating future
changes e.g handling future growth ?
It was for this very reason that we plumped for
the ASP model since by giving responsibility for
the management and storage of the data, any
requirements that future growth places on the
system becomes Carestream’s problem. Even if
we grow 10 or even 20 % each year, for us it
doesn’t matter: Carestream will make it work
as stipulated in the contract that binds us. Even
if other hospitals want to join in our existing
collaboration, that in principle shouldn’t be a
problem particularly since, with one exception,
most of the hospitals in the region are already
working with Carestream. We look forward to
the moment when the whole system goes live.
 – September/October 2010 20 WOMen’s HEALth

Triple negative breast cancer (TNBC)

Currently the focus of much clinical, scientific and media attention, triple negative These stark differences in the incidence of
breast cancer (TNBC) is not a new type of cancer, but rather a subtype of breast the disease in different racial groups leads us
cancer that is defined by the lack of the expression of estrogen receptor(ER), pro- to question whether there are genes or muta-
tions that predispose women in general and
gesterone receptor (PR) and HER2 protein. Particularly prevalent in pre-menopausal
pre-menopausal African American women
women of African origin, TNBC has a very poor prognosis. This article reviews the in particular, to TNBC. Studies have shown
epidemiology, molecular pathology and clinical aspects of TNBC and describe that breast cancers in women with germ line
possible new therapeutic approaches. BRCA-1 mutations are more likely to be triple
negative and high grade [6]. Gene expression
by Dr Roohi Ismail-Khan studies have confirmed this phenomenon and
BRCA-1-associated breast cancer appear to
cluster in the basal-like subtype [7].
Breast cancer is the most common female non African American females is much less, at
cancer in the United States, the second most approximately 15 percent. Such ethnic or men- Pathological and molecular features
common cause of cancer death in women, and opausal differences are not seen in the ER+/ Although triple negative breast cancer and
the main cause of death in women ages 45 to HER2 positive breast cancer subgroup nor is it basal-like breast cancers are terms that are
55. In 2009, approximately 192,370 Ameri- seen in the ER+/HER2 negative subgroups [5]. often used interchangeably, it very important
can women were diagnosed with breast can- to realise that they are not the same. TNBC
cer, and 40,170 women are predicted to die Many other studies have confirmed that refers to the immunophenotype of the breast
from the disease [1]. Triple negative breast TNBCs are found in a higher percentage of cancer, which is immunologically negative to
cancer (TNBC) accounts for approximately African American women. Of these triple ER, PR and HER2. Such immunological stud-
15 percent of breast cancers [2]. Although negative breast cancers, about 75% of them ies are carried out on formalin-fixed and par-
recently in the limelight and frequently dis- are also of the basal type molecular classifica- affin-embedded tumour sections. Basal-like
cussed, triple negative breast cancer is not a tion. As presented initially in the San Antonio breast cancer refers to the molecular pheno-
new type breast cancer. In fact, the term has Breast Symposium in 2006, in a study of racial type of the tumour that has been defined by
recently been coined to describe a subtype of differences in the prevalence of triple negative cDNA microarrays. Of these triple negative
breast cancer that is defined by the lack of invasive breast tumours, a team of research- breast cancers, about 75% of them are of the
protein expression of estrogen receptor (ER), ers from Emory University’s Rollins School of basal-like type.
progesterone receptor (PR) and absence of Public Health and Winship Cancer Institute,
HER2 protein over-expression. TNBC is an the Fred Hutchinson Cancer Research Center Perou et al were the first to describe the vari-
important area for both researchers and cli- in Seattle, and the Centers for Disease Con- ous molecular subtypes or molecular pro-
nicians alike because of the following four trol, found the incidence of triple negative dis- files of breast cancers. They described four
important facts: ease in African-American women to be more subtypes of breast cancer based upon cDNA
than twice that of white women. They found microarrays, including a basal-like subtype
1. TNBC is a poor prognostic factor for disease- that 47 percent of tumours in black women of breast cancer. Most triple negative breast
free survival and overall survival were “triple negative” compared to 22 percent cancers clustered in the basal-like subtype [8].
2. As of today, there is no effective specific tar- in white women. After adjusting for age and Since then, multiple studies of gene expression
geted therapy readily available for TNBC stage at diagnosis, black women were found profiling have furthered the understanding of
3. There is clustering of TNBC cases in pre- to be almost 3-fold more likely than white the molecular diagnosis of breast cancer, pro-
menopausal women and in women of Afri- women to have triple negative tumours [2]. viding the background for oncologists to use
can descent
4. There is a significant overlap of BRCA-1
associated breast cancers with the TNBC
phenotype

Epidemiology
It has been estimated that 1 million cases of
breast cancer are diagnosed annually world-
wide [3]. Of these, approximately over 170,000
are of the triple-negative (estrogen receptor/
progesterone receptor/HER2-negative) pheno-
type [3]. Of these TNBC cases, approximately
75 percent are basal-like [4]. The prevalence
of TNBC is highest in premenopausal African
American women. It has recently been reported
that 39 percent of all African American pre-
menopausal women diagnosed with breast
cancer are diagnosed with TNBC [5]. The Black women were found to be almost 3-fold more likely than white women to have triple
prevalence of TNBC in this same age group in negative breast cancer.

the triple negative phenotype to
describe the basal-like molecular
subtype [7, 9-11].
The luminal subtypes of breast
cancers express high amounts of
luminal cytokeratins and express
genetic markers of luminal epi-
thelial cells and normal breast
cells [12, 13]. In contrast, basal-
like breast cancers are so named
because they tend to express
cytokeratins associated with
basal types of cancers, as they
arise from the outer basal layer.
In general, basal-like breast carci-
nomas are morphologically con-
sistent with a high nuclear grade,
high mitotic count and necrosis,
such as a grade 3 invasive ductal
carcinoma, not otherwise speci-
fied. Some have the histomor-
phology of medullary carcinoma
or metaplastic carcinoma. It has
also been demonstrated that
almost 82 percent of basal-like
breast cancers express p53, com-
pared to only 13 percent in the
luminal A subgroup [10].
It is important to realise that
TNBC and basal-like breast can-
cer are not all of high histological
grade. For low grade tumours, the
clinical management strategies
outlined in this article are not
applicable. Oncologists therefore
need to be aware of this when
using triple negative to define
a potentially aggressive group
of breast cancers. Although the
majority of triple negative breast
cancers are basal-like and the
majority of basal-like breast can-
cers are triple negative, there is
a about a 25 percent discord-
ance between the two descrip-
tive subgroups [4]. However, for
the remainder of this article, we
will use the TNBC phenotype to
represent this molecular subtype.
Clinical course and
prognosis
Triple negative breast carcino-
mas are known to be biologically
aggressive. Although it has been
suggested that they respond to
chemotherapy better than other
types of breast cancer, prog-
nosis remains very poor [14].
This can be explained by two
factors: shortened disease-free
interval in the adjuvant and the
21 – September/October 2010
neo-adjuvant setting and more In addition to having a very short are currently being investigated
aggressive clinical course in the disease-free survival, triple nega- include epidermal growth fac-
metastatic setting. tive breast tumours are aggressive tor receptor (EGFR), vascular
in the metastatic setting, signifi- endothelial growth factor (VEGF)
Triple negative tumours have cantly contributing to the short- and poly (ADP-ribose) polymer-
a very good initial response ened overall survival [3]. Progres- ase (PARP) inhibitors [19].
to chemotherapy, particularly sion-free survival is estimated to
anthracycline- and taxane-based be four months at best in TNBC The anti-angiogenic agent beva-
therapy. Although these tumours for first line therapy, even with cizumab (Avastin), a monoclonal
are initially sensitive to stand- Avastin-based therapy [19]. antibody targeting vascular
ard neoadjuvant chemotherapy, endothelial growth factor (VEGF),
they continue to exhibit a very Hope for targeted therapy is active in many solid tumours
short disease-free survival [15]. and future directions in including breast cancer. Miller
Recently published neoadju- research et al demonstrated a significant
vant studies have clarified the As discussed in this paper, improvement in progression-free
fact that patients who have a although TNBC is sensitive to survival (11.8 vs 5.9 months, HR
good pathological outcome from chemotherapy, early relapse is = 0.60, P <.001) when adding
surgery also have a good clini- more likely than in other subtypes, bevacizumab to paclitaxel chemo-
cal response. However, within and visceral metastasis, includ- therapy compared with single-
the group of patients who have ing brain metastasis, is very com- agent paclitaxel alone in first-line
residual disease after complet- monly seen. Targeted agents that treatment of metastatic disease.
ing neoadjuvant chemotherapy,
the worst prognosis is seen in the
triple negative subgroup [16].
Even in early stage TNBC, early
relapse is very common. It has
been noted that there is a predi-
lection for visceral metastases,
including lung, liver, and nota-
bly, brain metastases. Current
estimates are that approximately
15 percent of TNBC patients
develop brain metastases. Patients
with TNBC have a higher risk for
developing cerebral metastases
when compared to other types
of breast cancer. Studies show
that even in patients with cer-
ebral metastases, TNBC patients
have a poorer prognosis, as
metastasis to the brain occurred
earlier [17].
According to NCCN guidelines,
treatment of T1N0 breast cancer
is based both on tumour size and
cellular characteristics. Oncolo-
gists tend to treat patients with
T1N0 triple negative breast can-
cer with more aggressive chemo-
therapy, both in the neoadju-
vant and the adjuvant setting.
When examining the number
of patients treated and also the
type of adjuvant chemotherapy
administered, triple negative
T1N0 patients have greater risk
of recurrence in spite of this
more aggressive therapy. Patients
with T1N0 TNBC have twice the
risk of recurrence, in spite of
receiving much more aggressive
treatment [15, 18].
www.ihe-online.com & search 45642
 – September/October 2010 22
Examining the TNBC subset of patients in this
study confirmed the same improvement (HR
= 0.53, 95% confidence interval = 0.40–0.70)
[19, 20]. It is safe to say that most oncologists,
including myself, would strongly consider an
Avastin combination for first line therapy when
treating patients with metastatic triple negative
breast cancer.
The fact that the majority of BRCA1-asso-
ciated breast cancers are also triple-negative
and basal-like leads researchers to wonder
about the extent to which the BRCA1 path-
way contributes to the behaviour of “spo-
radic” basal-like breast cancers. It has been
shown that basal-like breast carcinomas
frequently harbour defects in DNA double-
strand break repair through homologous
recombination such as BRCA1 dysfunction.
The DNA-repair defects characteristic of
BRCA1-deficient cells confer sensitivity to
poly (ADP-ribose) polymerase 1 (PARP1)
inhibition [21].
PARP1 is a gene that encodes a chromatin
associated enzyme that modifies various
nuclear proteins. This gene is involved in
the molecular events leading to cell recovery
from DNA damage. When PARP1 is inhib-
ited, double-strand DNA breaks accumu-
late that, under normal conditions, would
be repaired via homologous recombination.
Both BRCA1 and BRCA2 are required for
the homologous recombination pathway to
function properly. Therefore, cells deficient
in either BRCA1 or BRCA2 are very sensi-
tive to PARP1 inhibition, resulting in cell
death and apoptosis. Intuitively, inhibition
of the PARP pathway should be of benefit to
patients with BRCA-associated malignancies
[22]. However, as stated above, not all TNBC
are associated with BRCA mutations.
WOMen’s HEALth
Several PARP1 inhibitors are currently in clini-
cal development and hold promise in basal-
like and TNBC breast cancers. As presented
in the plenary session of the American Soci-
ety of Clinical Oncology (ASCO) meeting
in 2009, the results of a randomised phase II
study with BSI-201 (a PARP Inhibitor) showed
benefit in patients with TNBC who had two or
fewer previous lines of chemotherapy. When
BSI-201 was combined with gemcitabine and
carboplatin, the clinical benefit rate improved
to 62 percent when compared to the gemcit-
abine and carboplatin alone arm at 21 percent
(p<0002) [23]. (Clinical benefit rate is defined
as complete response plus partial response plus
stable disease lasting six months or more). In
addition, the overall response rate was nota-
bly improved in the BSI-201 arm at 48 percent
compared to the control arm at 16 percent.
Progression-free survival was improved to 6.9
months in the BSI-201 arm of the study versus
3.3 months in the gemcitabine and carboplatin
alone arm [23]. This initial positive study has
led researchers to examine the use of PARP
inhibitors in the treatment of TNBC and many
such studies are ongoing. In addition, there are
many new agents that are being investigated
that may potentially provide promise in this
subgroup of breast cancer patients.
References
1. Jemal A et al. CA Cancer J Clin 2009; 59(4): p.
225-49.
2. Kaplan HG & Atwood MK San Antonio Breast
Cancer Symposium, 2006(December 2006): p.
poster session VI.
3. Anders CK & Carey LA. Clin Breast Cancer;2009;
9: S73.
4. Rakha EA et al. J Clin Oncol 2008; 26: 2568.
5. Carey LA et al. JAMA 2006; 295: 2492.
6. Lakhani SR. et al. J Clin Oncol 2002; 20: 2310.
7. S orlie T et al. Proc Natl Acad Sci USA 2003;
100: 8418.
8. Perou CM et al. Nature 2000; 406: 747.
9. Sorlie T et al. Mol Cancer Ther 2006; 5: 2914.
10. Sorlie T et al. Proc Natl Acad Sci USA 2001; 98:
10869.
11. Sorlie, T. et al. BMC Genomics 2006; 7: 127.
12. Rakha EA et al. Cancer 2007; 109: 25.
13. Sotiriou C and Pusztai L N Engl J Med 2009; 360:
790.
14. De Giorgi U et al. Ann Oncol 2007; 18: 202.
15. Kaplan HG & Atwood MK, T1N0 Triple Negative
Breast Cancer: Adjuvant Chemotherapy Treat-
ment and Risk of Recurrence. San Antonio Breast
Cancer Symposium, 2007. Abstract 3070.
16. Carey LA et al. Clin Cancer Res 2007; 13: 2329.
17. Heitz F et al Cerebral metastases (CM) in breast
cancer (BC) with focus on triple-negative tumours.
in ASCO meeting 2008. Chicago.
18. Kaplan HG et al. Breast J 2009; 15: 454.
19. Miller K et al. N Engl J Med 2007; 357: 2666.
20. Siziopikou KP & Cobleigh M. Breast 2007;16:
104.
21. Rottenberg S et al. Proc Natl Acad Sci USA 2008.
105: 17079.
22. Farmer H et al. Nature 2005; 434(7035): p.
917-21.
23. O’Shaughnessy J et al. Efficacy of BSI-201, a poly
(ADP-ribose) polymerase-1 (PARP1) inhibitor, in
combination with gemcitabine/carboplatin (G/C) in
patients with metastatic triple-negative breast cancer
(TNBC): Results of a randomized phase II trial. in
ASCO 2009 annual meeting. Orlando, Florida.
The author
Roohi Ismail-Khan, MD
Assistant Professor
Division of Breast Oncology &
Experimental Therapeutics
H. Lee Moffitt Cancer Center
Tel: +1 813 745 4933
Fax: +1 813 745 7287
e-mail: Roohi.Ismail-Khan@moffitt.org
 minimally invasive surgery 23 – September/October 2010

LESS and NOTES:

applications in urological surgery
Laparoendoscopic single site surgery (LESS) and natural orifice transluminal endo- (iii) a wire is passed into the peritoneal cav-
scopic surgery (NOTES) represent novel approaches in minimally invasive surgery. ity using a modified Seldinger technique; (iv)
A common underlying ‘‘hypothesis’’ has driven their development—namely, that a a dilating balloon is variably used to obtain
a suitable access tract; (v) a catheter, guide
reduction in the number of transcutaneous points of access may benefit patients
tube or overtube is placed over the guide-
in terms of port-related complications, recovery time, pain and cosmesis by poten- wire and insufflation is achieved with CO2;
tially performing scarless surgery [1]. (vi) scope is advanced into the peritoneal
NOTES involves diagnostic or therapeutic interventions performed via existing ori- cavity; and (vii) viscerotomy is closed [3].
fices of the human body (mouth, anus, urethra, vagina). Although a pure NOTES
procedure is performed without transabdominal access, the use of accessory LESS access can be obtained either by per-
forming a single-skin and fascial incision,
transabdominal ports has been regarded as part of the evolution of NOTES and
through which a single multichannel access
defined as hybrid NOTES [2]. platform is placed (single-port surgery), or
by placing several low-profile ports through
by Dr Carmelo Quattrone, Dr Carmine Di Palma, Dr Marco De Sio, separate fascial incisions (single-site sur-
Dr Estevão Lima, Dr Jihad H. Kaouk and Dr Riccardo Autorino gery). The access point can be umbilical or
extraumbilical [2]. Despite being an evolu-
tion of standard laparoscopic surgery, LESS
Several urological groups initially used a variety anatomy. NOTES has thus far been success- defies the most basic tenets of laparoscopy
of terms to describe the technique now defined fully completed experimentally by the trans- including triangulation of working instru-
as LESS [2]. LESS appears to provide several of gastric transvaginal, transcolonic, and trans- ments and external spacing to decrease intra-
the benefits of NOTES, with enhanced cosmesis vesical routes [4]. A single NOTES access and extracorporeal clashing [5]. Several mul-
and decreased abdominal wall trauma, without raises limitations while performing complex tichannel platforms have been developed and
the added risks and difficulty encountered by urologic procedures related to exposure, used for LESS in urological surgery [Figure
traversing a natural orifice. It might include a organ retraction, grasping and limited trian- 1]. Standard laparoscopic instrumentation
single laparoscopic access port, an access plat- gulation. The concept of effectively combin- may be used in this setting but often articu-
form with several channels for instrumentation ing transgastric and transvesical access was lating or curved instruments can be benefi-
or a single skin incision through which several demonstrated by Lima et al, who performed cial for providing triangulation with reduced
separate ports can be placed through separate a pure NOTES nephrectomy in a non-sur- clashing of instruments [6]. In some cases
fascial incisions. From a cosmetic standpoint vival porcine model. Overall, the logistics of this may require counterintuitive movements
LESS may be ideally performed via the umbili- NOTES surgery are universal: (i) the natu- when the surgeon’s instruments may cross
cus, an embryonic remnant of development [3]. ral orifice is accessed with the aid of a flex- each other. The use of digital in-line laparo-
ible multichannel scope; (ii) incision is made scopes with only one cord in parallel is also
Urologists have been at the forefront of mini- through the visceral wall using a needle-knife; beneficial for LESS, as additional cords with
mally invasive surgery for 25 years. Stones that
were formerly managed with open lithotomy
are now approached with shockwave lithot-
ripsy (SWL), ureteroscopy and percutaneous
techniques. Large, obstructing prostate glands
once managed with open prostatectomy are
now routinely managed endoscopically. Thus,
urologists are uniquely equipped with the skill
sets necessary to perform pure NOTES or LESS
because they have experience in both endos-
copy and surgery [1].

Access techniques and

instrumentation
In the debate regarding the best portal for
performing NOTES, several factors need to
be considered: ease of access, ease of clo-
sure, potential for infectious complications,
security of closure, severity of complications
related to closure failure, maximum diam-
eter for instrument insertion and specimen
removal, and the relationship to the target Figure 1. Novel platforms and instruments for LESS.
 – September/October 2010 24
Table 1. LESS vs laparoscopy: comparative studies in urology.
perpendicular insertion into the scope inter-
fere with other instruments and the surgeon’s
movements when space is at a premium [7].
Preclinical experience
The field of NOTES in urology has been exten-
sively explored in experimental setting, mostly
using porcine animal model. Clayman et al
reported transvaginal nephrectomy performed
using a purpose-built, multi-lumen operating
platform [8]. Haber et al assessed the feasibility
of pure NOTES transvaginal nephrectomy in a
porcine model using NOTES-specific instru-
mentation without transabdominal ports [9]. In
the field of nephron-sparing surgery, Crouzet
et al presented their laboratory experience with
NOTES renal cryoablation in pigs performed
with either a transgastric or transvaginal
approach [10]. Boylu et al assessed the feasibil-
ity of NOTES transgastric partial nephrectomy
(PN) without hilar clamping [11]. Humphreys
et al reported their preliminary experience with
the technical development of NOTES RP in a
cadaver model [12]. A pure NOTES approach
for partial cystectomy has also recently been
described by using either a transurethral or a
transgastric approach [13].
Raman and colleagues presented a pioneering
study of LESS for nephrectomy that included
seven successful experimental nephrectomies
on pigs followed by three clinical procedures
[14]. Before embarking on their first clinical
procedure, Barret et al. reported their experi-
ence with LESS extraperitoneal radical prostate-
ctomy in a cadaver model, using both standard
and articulated laparoscopic instruments [15].
More recently, Boylu et al. determined the fea-
sibility, instrumentation and learning curve for
LESS partial nephrectomy in a pig model [16].
Clinical experience
Advances in instrument technology, together
with increasing experience in NOTES and
minimally invasive surgery
LESS approaches, have driven the transition
from porcine models to the human. Clinically,
NOTES experience has been much more lim-
ited than LESS. The first two cases of single-
port surgery in urology were reported by Rane
et al. in abstract form, at the 2007 World Con-
gress of Endourology [17]. In the same period,
the first multitrocar single-incision transum-
bilical nephrectomy was reported by Raman et
al. Following an initial porcine feasibility dem-
onstration, three human nephrectomies were
performed: two for benign nonfunction and
one for clear-cell carcinoma [14].
Since then, several other clinical series have
been reported by a few groups worldwide with
an estimated cumulative clinical experience of
more than 500 cases. Nowadays the entire spec-
trum of urological procedures, both for upper
and lower urinary tract diseases, has been
described and shown to be feasible, including
advanced reconstructive procedures and major
extirpative ones. Comparative series between
conventional laparoscopy and LESS have
recently become available [Table 1]. Raman et
al were the first to report a case-control study
comparing LESS with conventional laparos-
copy. They compared LESS nephrectomies
with conventional laparoscopic nephrectomies.
No differences in operative time, postoperative
hospital stay, narcotic analgesic use, compli-
cation rate or transfusion requirement were
observed between the two techniques. How-
ever, estimated blood loss was significantly
lower in the LESS group than in the conven-
tional laparoscopy group. The authors con-
cluded that the superiority of LESS nephrec-
tomy over standard laparoscopy was limited to
a mere subjective cosmetic advantage. Starting
from the consideration that in this first study
half of the LESS patients had a nephrectomy for
malignancy, necessitating extension of the ini-
tial umbilical incision for specimen extraction,
the same group of investigators speculated that
this may have blunted the potential benefit of
LESS [18].
Raybourn et al matched a total of 11 patients
undergoing LESS laparoscopic simple nephrec-
tomy with a group of 10 patients who previously
underwent simple nephrectomies. All LESS
simple nephrectomy procedures were com-
pleted uneventfully. There were no intraopera-
tive complications in the LESS group. Postop-
erative complications included pyrexia and port
site bruising in two patients. Operative time
and narcotic analgesia requirements were not
significantly different between the two groups
[19]. Jeong et al recently described the first study
comparing LESS vs laparoscopy in the treatment
of benign adrenal adenoma. No significant dif-
ferences in the mean operative time, blood loss
or postoperative hospital stay were observed
between the groups [20]. Finally, Canes et al
reported the first retrospective matched-pair
comparison of LESS to standard laparoscopic
live-donor nephrectomy. Mean warm ischemia
time was significantly longer in the LESS group
(3 vs 6.1 min), even if allograft function was
comparable between groups at three months.
Patients undergoing LESS donor nephrectomy
had similar in-hospital analgesic requirements
and mean visual analogue scores at discharge.
After discharge, their convalescence, as evalu-
ated by using visual analog pain scores and
questionnaires containing patient-reported time
to recovery end-points was faster, including days
on oral pain medication, days off work and days
to full physical recovery [21].
So far, all comparative studies have been lim-
ited by small numbers, their nonrandomised
design, their retrospective nature, and the lack
of standardisation in the assessment of post-
operative outcomes. Overall, these series have
shown a non-inferiority of LESS over conven-
tional laparoscopy in terms of perioperative
outcomes, with an encouraging trend toward
less postoperative pain and better cosmesis.
LESS/NOTES development:
further steps
Several questions must be answered before
Figure 2. The place for LESS and NOTES in minimally
invasive urological surgery.
 25 – September/October 2010

LESS and NOTES could gain widespread acceptance: do LESS and  anes D, Berger A, Aron M et al. Eur Urol 2009; doi: 10.1016/j.
21. C
NOTES provide any objective, reproducible benefit over conventional or eururo.2009.07.023.
robot-assisted laparoscopy? And which patient population is most likely  aber G, White MA, Autorino R et al. Novel robotic daVinci instruments for
22. H
to benefit from LESS and NOTES? Further comparative analyses are still laparoendoscopic single-site surgery. Urology (In press).
needed to answer these questions. Even if there is a universal agreement
that improved cosmesis is clinically apparent, standardised measures The authors
have not yet been employed to scientifically verify these findings. The Carmelo Quattrone1, Carmine Di Palma1, Marco De Sio1, Estevão Lima2,
true marker for its acceptance will likely be whether LESS and NOTES Jihad H. Kaouk3 and Riccardo Autorino1,3
show reduced pain, morbidity and convalescence, thus justifying the
related increase in technical demands and costs. In this respect, well- 1
Urology Clinic, Second University of Naples, Naples, Italy
designed prospective trials are awaited to compare LESS and NOTES 2
Life and Health Sciences Research Institute, School of Health Sciences,
to conventional laparoscopy, including appropriate quality of life (QoL) University of Minho, Braga, Portugal
and outcome analyses, especially in terms of cosmetic benefit, by using 3
Section of Advanced Laparoscopy and Robotics, Glickman Urological
validated patient-reported outcome instruments. Institute, Cleveland Clinic, Cleveland, USA

Finally, as the role of robotic surgery is rapidly growing in urology and it Correspondence to:
is expected that robotics will progressively replace standard laparoscopy, Riccardo Autorino, MD, PhD, FEBU
it will be important to see how robotic technology will affect the devel- Clinica Urologica, AOU Policlinico SUN
opment of LESS and NOTES. Robotic instruments dedicated to LESS Piazza Miraglia 2
and NOTES have recently been introduced and are currently under eval- 80138 Naples, Italy
uation [22]. New robotic systems, including master–slave systems, flex- e-mail: ricautor@tin.it
ible robots, in vivo miniature robots or a combination of those systems,
might bring NOTES to its full potential in the future.

Conclusions
Early clinical experience has shown that NOTES urologic surgery using
currently available instruments is indeed possible. Nevertheless, because
of the immaturity of the instrumentation, early cases have demanded
a technical virtuosity that still precludes widespread application of this
approach. Clinical experience to date has indicated that LESS surgery
can safely and effectively be performed in a variety of urologic settings.
As clinical experience increases, expanding indications are expected
to be documented and the efficacy of the procedure to improve. Fur-
ther clinical research, based on sound scientific principles, will define
the actual place of LESS in urologists’ armamentarium [Figure 2]. In
the meanwhile, it should be recommended that, together with proper 23rd AnnuAl Congress
patient selection, a surgeon possess adequate laparoscopic experience CCIB - BArCelonA - spAIn
and preferably a certain amount of LESS training before embarking on
9 - 13 oCtoBer 2010
a LESS procedure. This is of utmost importance for minimising serious
complications, such as those seen in early reported series. For more information, contact
esICM Congress department
References Rue Belliard 19
1. Gettman MT, Box G, Averch T et al. Eur Urol 2008; 53: 1117–20. For physicians,
1040 Brussels - Belgium
2. Box G, Averch T, Cadeddu J et al. J Endourol 2008; 22: 2575–81. Tel +32 2 559 03 55/71 nurses and other
3. White WM, Haber GP, Doerr MJ et al. Urol Clin North Am 2009; 36: 147–55.vii.
Fax +32 2 559 03 79 allied healthcare
4. Box GN, Bessler M, Clayman RV. J Endourol 2009; 23: 753–7.
5. Canes D, Desai MM, Aron M et al. Eur Urol 2008; 54: 1020–30. Barcelona2010@esicm.org
professionals
6. Kommu S, Rane A. Expert. Rev. Med. Devices 2009; 6: 95–103.
7. Branco AW, Kondo W, Stunitz L et al. BJU Int 2009; 104: 1136–42.
8. Clayman RV, Box GN, Abraham JB et al. J Endourol 2007; 21: 640–4.
9. Haber GP, Brethauer S, Crouzet S et al. BJU Int. 2009; 104: 1260–4.
10. Crouzet S, Haber GP, Kamoi K et al. BJU Int 2008; 102: 1715–18.
11. Boylu U, Oommen M, Joshi V et al. Surg Endosc 2009; 24: 485–9.
12. Humphreys MR, Krambeck AE, Andrews PE et al. J Endourol 2009; 23:
669–75.
13. Sawyer MD, Cherullo EE, Elmunzer BJ et al. Urology 2009; 74: 1049–53.
14. Raman JD, Bensalah K, Bagrodia A et al. Urology 2007; 70: 1039–42. www.esicm.org
15. Barret E, Sanchez-Salas R, Kasraeian A et al. J Endourol 2009; 23: 135–40.
16. Boylu U, Oommen M, Thomas R et al. BJU Int 2009; doi:10.1111/j.1464-
410X. 2009.08916.x.
17. Rane A, Kommu S, Eddy B et al. J. Endourol 2007; 21 (Suppl 1): A22–3.
18. Raman JD, Bagrodia A, Cadeddu JA. Eur Urol 2009;55:1198–204
19. Raybourn 3rd JH, Rane A, Sundaram CP. Urology 2010;75:100–3.
20. Jeong BC, Park YH, Han DH et al. J Endourol 2009; 23: 1957–60.
 – Issue N°1 – Feb./Mar. 2010 26
Ambulatory patient care:
a selection of peer-reviewed literature
The number of peer-reviewed papers
covering the vast field of ambulatory
patient care is huge, to such an extent
that it is frequently difficult for health-
care professionals to keep up with
the literature. As a special service to
our readers, IHE presents a few key
literature abstracts from the clinical
and scientific literature chosen by our
editorial board as being particularly
worthy of attention.
Imaging features of encapsulating
peritoneal sclerosis in continuous
ambulatory peritoneal dialysis
patients.
This article presents the spectrum of radio-
logic findings of encapsulating peritoneal
sclerosis in patients undergoing continu-
ous ambulatory peritoneal dialysis (CAPD).
Although a rare diagnosis, encapsulating
peritoneal sclerosis in patients undergoing
CAPD has a high morbidity and mortality.
Diagnosis is often delayed because clini-
cal features are insidious and nonspecific.
Radiologic imaging may be helpful in the
early diagnosis of encapsulating peritoneal
sclerosis and in facilitating timely interven-
tion for CAPD patients with encapsulating
peritoneal sclerosis.
Ti JP et al. Am J Roentgenol 2010;195:W50.
Peritoneal dialysis without a physical
peritoneal dialysis unit.
Under certain circumstances when patients
need peritoneal dialysis (PD) but no physical
unit or official staff are available, improvi-
sation is needed. This study describes the
authors’ experience with such patients in
the absence of a physical peritoneal dialy-
sis unit. Since 1997 33 patients, mean age
61.7 +/- 12.8 years old, have been trained in
PD. Catheter implantation was carried out
on an out-patient basis in another hospital.
Trained nurses, made available by the com-
pany supplying the PD solution, were used.
After 2004, the entire training took place at
patients’ homes.
Catheter implantation was successful in all 33
patients. The catheter was removed from two
patients (one and four years after implanta-
tion) because of relapsing peritonitis and fun-
gal infection respectively. The overall rate of
scientific literature review
peritonitis was 0.18 episodes per patient year.
Patient survival was 90%, at one year, 83% at
two years and 55% at three years.
Grapsa EI et al. Clin Nephrol 2010; 73:449.
Early initiation of continuous
ambulatory peritoneal dialysis
in patients undergoing surgical
implantation of Tenckhoff catheters
Nephrologists commonly recommend continu-
ous ambulatory peritoneal dialysis (CAPD) with
break-in periods of at least two weeks. This study
investigated the safety and feasibility of shorter
break-in periods following surgical implanta-
tion of Tenckhoff catheters. Three hundred and
ten patients who underwent Tenckhoff catheter
implantation for the first time were examined
retrospectively. An ‘early’ group comprised
226 patients who started CAPD ≤ 14 days after
implantation; the other ‘late’ group comprised
84 patients who started CAPD > 14 days after
implantation. Catheter-related complications
within six months were analysed.
The time to CAPD initiation was shorter in
the early group (2.0 ± 2.7 days) than in the
late group (40.6 ± 42.8 days) (p < 0.001). The
bridge hemodialysis rate was higher in the late
group (57.1%) than in the early group (31.4%)
(p < 0.001). Overall, 33 early-group (14.6%)
and 11 late-group patients (13.1%) developed
catheter-related complications within six
months. The early-group complications were
leakage (n = 5), diminished outflow volume
(n = 7), migration (n = 7), pericatheter hernia
(n = 1), hemoperitoneum (n = 1), pericatheter
infection (n = 3) and peritonitis (n = 9). The
late-group complications were leakage (n = 2),
diminished outflow volume (n = 5), migration
(n = 2), and peritonitis (n = 2). Freedom from
catheter-related complications was similar in
both groups. The authors coclude that early
initiation of CAPD with surgically implanted
Tenckhoff catheters is feasible and safe. Shorter
break-in periods are not associated with more
catheter-related complications. The data sug-
gest that early initiation is not associated with
an increased number of complications, but this
needs to be confirmed in a randomised trial.
Yang YF et al. Perit Dial Int 2010 Jun 30.
The impact of dialysis modality on
arterial stiffness in patients with
end-stage renal disease.
Arterial stiffness determined by brachial-
ankle pulse wave velocity (baPWV) has been
established as a powerful predictor of car-
diovascular mortality in hemodialysis (HD)
patients. There are, however, few studies
regarding the comparative impact of different
renal replacement therapies (RRTs) on pulse
wave velocity,PWV. This cross-sectional
study compared arterial wall properties and
cardiac function between patients treated
with continuous ambulatory peritoneal dial-
ysis (CAPD) and those with HD. Patients
were matched for age, dialysis duration and
blood pressure. Transthoracic echocardiog-
raphy (TTE) and baPWV were performed in
HD patients (n = 23) after 1 h of a midweek
dialysis session and in CAPD patients (n =
26) with an empty abdomen after drainage of
dialysate. The baseline data were retrospec-
tively reviewed. It was found that baPWV
was significantly higher in HD patients than
in CAPD patients (18.1 ± 2.8 vs. 16.1 ± 2.7
m/s, p = 0.015). TTE revealed a signifi-
cantly increased E/E’, left atrial volume index
(LAVI) and inferior vena cava (IVC) diameter
index in HD patients compared with CAPD
patients (p < 0.05). In a multivariate regres-
sion analysis adjusted for dialysis modality,
age, systolic BP, residual glomerular filtration
rate, diabetes and echocardiographic param-
eters, HD was independently associated with
increased baPWV. This study shows that HD
patients had significantly increased arterial
stiffness and severe diastolic dysfunction
compared with CAPD patients.
Chang JH et al. Ren Fail. 2010;32:947.
A case of rare, fungal peritonitis
caused by Histoplasma capsulatum
in a patient on CAPD.
A 62-year-old man with a history of end-stage
renal disease secondary to hypertension who
was on continuous ambulatory peritoneal
dialysis (CAPD), presented to the peritoneal
dialysis clinic with subacute onset of abdom-
inal pain, mainly in the epigastric region. A
full medical history, physical examination,
laboratory tests, cultures of peritoneal dialy-
sis fluid, radiography, ultrasonography and
CT scanning of the abdomen and pelvis was
carried out. Following these investigations
a diagnosis of fungal peritonitis caused by
infection with Histoplasma capsulatum was
made. The peritoneal dialysis catheter was
removed and the patient was treated with
itraconazole for six months.
Ijaz A & Choudhury D. Nat Rev Nephrol 2010;
6: 435.
www.ihe-online.com & search 45635
 – September/October 2010 28 Healthcare facility spotlight

High quality imaging in the Gulf Region

The Gulf region of the Middle East is renowned as
being a centre of dynamic development, even in
these current times of worldwide economic slowdown.
International Hospital (IHE) wanted to find out how
imaging healthcare services are developing in this
fast-growing region so we spoke to Dr Rami Neemtal-
lah, Medical director of Allied Diagnostics, who
have several state-of-the-art facilities with the latest
equipment in diagnostic imaging.
We see all kinds of cases, from adult to pediatric,
and from general to cases requiring specialised
studies. Allied Diagnostics has an excellent rep-
utation and is well-known for its high standards
in the carrying out and reporting of diagnostic
procedures, so a large part of the requests we
receive fall into the categories of subspecial-
ties such as cardiovascular, womens’ health and
breast, musculoskeletal and neuro-imaging. We
also get a lot of referrals for second opinions on
procedures originally done elsewhere.

Q: Allied Diagnostics have several facilities
in the Gulf area. Where precisely are the
centres and which geographical and
population area do the centres serve?
Currently Allied Diagnostics’ facilities are
located in the Dubai and Sharjah emirates of
the United Arab Emirates (UAE), Muscat and
Salalah in the Sultanate of Oman, and Riyadh
in the Kingdom of Saudi Arabia (KSA). Our
major, hub sites are Dubai, Muscat and Riy-
adh, with the Riyadh site being the newest
and biggest.
In the UAE, our centres located in Dubai and
Sharjah cover mostly these two emirates but we
also receive patients from all the other emirates
in the area, especially for our specialty services
like non-invasive cardiac imaging and breast
imaging. In Oman, we receive patients from
over the whole country for specialized CT and
MRI studies, particularly in Muscat where we
have a hospital-based centre.
In both Oman and the UAE we serve not only
the local population, but also the relatively large
expatriate population (mostly Western, Arabic,
Indian and southeast Asian).
Sophisticated equipment is useless without qualified personnel to operate it. At Allied Diagnostics’ facilities in
Dubai, the medical radiology staff is backed up by a team of radiographers and support personnel, whose
nationalities reflect those of Dubai itself, namely Western, Arabic, Indian and southeast Asian.
Q: How are all these centres staffed? For
example, how many radiologists or other
medically qualified personnel do you have?
What about support staff?
In our Dubai centre we have one nurse and three
clinicians, namely a cardiologist and two radi-
ologists whose subspecialties are neuro, muscu-
loskeletal, women and chest imaging. I am the
cardiologist and my subspecialty is non invasive
cardiovascular imaging (CT and MRI of the
heart and vessels). I split my time between the
two sites of Dubai and Muscat (three days at each
site per week). Supporting all this we have more
than ten radiographers covering different spe-
cialities such as CT/MRI, ultrasonography and
general radiology. The cross-section of nation-
alities we have in our medical staff mirrors that
of Dubai itself and so is a mixture of Western,
Asian and Arabic. All clinicians are western-
trained or certified (most of them from the US,
UK or France). As for the radiographers, are kept up to the highest international levels,
some are western-trained and some locally
trained. The latter work under the supervision
of their internationally trained colleagues until
they are judged able to work on their own and
deliver a service up to international standards.
Q: As regards instrumentation to support all
these activities, how are you equipped?
In all Allied Diagnostics centres we have the latest
state-of-the-art equipment so that we can deliver
absolute top quality images with high diagnostic
accuracy to enable our radiologists to provide
best possible patient care in the safest way.
In our Dubai facility we have the only low radia-
tion CT system in the UAE; this is the 64-slice
CT Lightspeed VCT-XTe from GE Healthcare.
In September 2009, this CT was upgraded with
the low radiation option, the so-called Adapta-
tive Statistical Iterative Reconstruction (ASIR)
system and prospective triggering for cardiac
studies. Since the installation of the ASIR update
we can deliver high resolution 2D and 3D images
with up to 50% less radiation dose compared to
conventional 64-slice CT in body imaging and
up to 85% less radiation in cardiac studies. The
equipment ensures that our practice standards
which is particularly important in the context of
the concerns raised recently regarding radiation
dangers involved in medical procedures.
As for magnetic resonance, we have a GE 1.5
Tesla MRI HDx (with a high field closed mag-
net) which means we can offer our patients the
most advanced high field system and give high
accuracy. The system is ideal for specialized or
difficult cases. For claustrophobic patients we
also have the possibility of an open MRI, namely
a GE 0.35 Tesla MRI/ signa ovation which has a
low field open magnet.
In addition to the CT and MRI systems, we have
three state-of-the-art ultrasound machines (GE
Voluson E8/) that deliver high definition 3D and
4D images.
We also provide digital mammography and radi-
ography services as well as dental imaging and
bone density studies for osteoporosis screening
and monitoring.
All our centres are equipped with PACS systems
for easy and safe digital storage of our diagnostic
procedures, as well as for simple communica-
tion and access to old exams. The implementa-
tion of the PACS system was key in our move to
a completely digital environment where patient

The flagship equipment in the Dubai facility of Allied
Diagnostics is the 64-slice Lightspeed VCT-XTe CT system
from GE Healthcare, which is fitted with the Adaptive
Statistical Iterative Reconstruction (ASIR) system. This
enables high resolution 2D and 3D images to be gener-
ated at much less radiation levels than with conventional
64-slice CT.
confidentiality is strictly observed and the high-
est standard of patient care provided.The PACS
is also a central component in our project to link
all our centres (and also the referring clinics and
clinicians) to our main database so that secure,
remote access to patients’ images and reports
can be provided in a timely manner
Q: In this context, what about links and/or
collaborations with other centres?
As I said, we are well known for the quality of the
services we provide at the highest international
standards throughout the Gulf region and also
for the delivery of specialty services not widely
available in this region. Thanks to this reputa-
tion, many clinics and hospitals (especially those
unable to provide service in their own premises)
use Allied Diagnostics for their diagnostic needs.
Many clinics also refer patients with complicated
pathologies to us for second opinion.
Q: How do you see the future?
As regards our equipment, we make continual
efforts to make sure we have access to the latest
technology via new equipment and new software
The Allied Diagnostics standalone facility in Dubai receives patients from not only the local population but also
from the Gulf expatriate population.
29
updates for our workstations so that we can keep
up to date with the latest advances in radiology.
One of the major projects that we are putting
in place this year is total connectivity between
all our sites throughout the Gulf region for easy
sharing of patient images, particularly in cases
where a second or more specialised opinion is
required. In this way our major referring clin-
ics and hospitals can have direct access to their
patients’ images and to our medical staff.
In terms of new facilities, we plan to expand
over the next few years by opening new centres
in other cities in the region.
Q: It appears that, because of your state-of-
the-art technology and standards of prac-
tice, Allied Diagnostics has been nominated
as a cardiac imaging and demonstration
and training site for the Middle East? What
exactly does this entail?
In practice this means that the Allied Diagnostics
center in Dubai is a recognised demonstration
and training site for CT in general and cardio-
vascular imaging in particular. Thus, we regu-
larly receive people from other hospitals who are
interested in seeing how our equipment operates
under real-life, routine conditions, as well as
of course seeing the quality of the images and
how they are processed and reported. We regu-
larly receive clinicians and radiographers who
come to us to be trained on new technologies;
we give practical training on image acquisition
and interpretation using the latest software on
our workstation and we also give lecture series
covering all aspects of the new techniques.
Q: In contrast to the standalone Dubai facil-
ity, your Muscat operation is hospital-based.
How many beds do you have?
Yes, Allied Diagnostics run the radiology depart-
ment in the Muscat Private Hospital (MPH),
which is the biggest private medical institution in
Oman. The hospital was built approximately 10
years ago and has around 100 beds and several
– September/October 2010
As a recognised demonstration and training site for
CT in general and cardiovascular imaging in particu-
lar, Allied Diagnostics regularly give practical training
courses to visiting clinicians and radiographers.
departments, e.g emergency, outpatient and
pediatrics as well as womens’ services, intensive
care and internal medicine departments.There is
also an operating and surgery block and a physi-
otherapy department. MPH is actively expand-
ing some of its specialty services, in particular
cardiology and cardiac surgery (MPH is the
only private institution in Oman to do cardiac
surgery), comprehensive womens’ medicine
services, general, orthopedic and cosmetic sur-
gery. As for the radiology facilites in Muscat, we
are equipped with roughly the same systems as
in our Dubai facility, although the services we
provide in Muscat are of even greater impor-
tance in Oman because sub-specialty medical
services there are less available than in Dubai.
The MPH hospital is also in the process of
quailifying for Joint commission International
(JCI) accreditation.
Q: Apart from Muscat and Dubai, what
about your other facilities in the region?
Allied Diagnostics has recently opened our new-
est centre, which is in the city of Riyadh (KSA).
This facility has the newest generation of mul-
tislice CT from GE Healthcare, namely the Dis-
covery CT750 HD with increased image reso-
lution and lower radiation exposure, and a GE
3T High Definition MRI, and the latest PET CT,
also from GE, as well as ultrasound and general
radiography. With this range of instrumentation,
the Riyadh facility has the most advanced equip-
ment of our group. We have other centres in the
Middle East and Gulf region, namely in Sharjah
and Salalah where we provide MRI, ultrasound
and mammography services.
For more information on Allied Diagnostics in
the Gulf Region, contact
Dr Rami Neemtallah
Medical Director, Allied Diagnostics,
Po Box 32442, Dubai, UAE
Tel.: 00971 4 3328111
email ramy.neemtallah@allieddiagnostics.com
 – September/October 2010
30
High precision image-guided
radiotherapy and radiosurgery
A radical new approach that expands radio-
therapy treatment options for even the most
challenging cases has been introduced by
Varian Medical Systems. The TrueBeam
platform for image-guided radiotherapy
and radiosurgery is the first fully-integrated
system designed from the ground up to treat
a moving target with unprecedented speed
and accuracy. The new line of “super” accel-
erators is designed to advance the treatment
of lung, breast, prostate, head and neck, and
other types of cancer.
Using a completely re-engineered con-
trol system and a multitude of technical
innovations to dynamically synchronise
imaging, patient positioning, motion man-
agement and treatment delivery, the new
system allows the development of new and
improved approaches for treating cancer
and other medical conditions.
Varian Medical Systems
Palo Alto, CA, USA
www.ihe-online.com & search 45647
Medica stand Hall 10/A78
Easily disinfected one-piece
sphygmomanometer cuff
A one-piece-cuff is now available as standard for
all Riester sphygmomanometers; the new blad-
derless nylon Velcro cuff is reusable over 10 000
times and is washable up to 60°C. Cleaning and
disinfection for the one-piece-cuff is also much
MEDICA PReview
easier than standard cuffs as it can be immersed
completely into an alcohol disinfection solution
between use. Made of latex-free material, it is
especially practical for hospital use as it saves
time and minimises the risk of contamination.
The cuff itself is made of soft material that gives a
comfortable feeling on the skin and comes with a
50 cm length of tubing. It is available as a 1-tube
or 2-tube version, with sizes to fit children,
adults and obese patients and has been tested
according to ISO E01 Standards. The Riester
reusable one-piece-cuff thus makes checking
blood pressure a safer and more efficient proc-
ess, not only providing patient comfort but also
easy disinfection.
Rudolf Riester GmbH
Jungingen, Germany
www.ihe-online.com & search 45644
Medica stand Hall D/G40
Flexible ceiling-mounted supply units
Whenever a clinic sets up a new operating room
or intensive care unit, the equipment should be
able to adapt to all likely future requirements yet
remain affordable. These principles are behind
the development of Trumpf ’s new TruPort
system of ceiling-mounted supply units. The
creative design makes it easy to remodel, con-
vert and expand workstations even after their
installation. As a result, hospital staff can make
adjustments at any time according to safety,
ergonomic or budget requirements. TheTruPort
support heads can be set up individually on all
four sides and over their entire length; the front
and rear are no longer fixed as in previous ceil-
ing-mounted supply units. A spring-aided clip
system means that trained personnel can also
flexibly integrate, remove or vary the arrange-
ment of gas, power and data supply modules
by means of a simple tool. Components such
as rotatable LED lights, cable remote controls
for anesthetics or drawers without handles can
be attached at the desired, optimum place on
a multifunctional rail using the simple click
mechanism. An electro-pneumatic brake system
together with a friction brake facilitates posi-
tioning of the ceiling-mounted supply unit and
enhances safety during handling. All TruPort
models permit 330-degree rotation so users can
easily swivel the supply unit outside the work
area if necessary. An optional motorised lift-
ing mechanism on the TruPort head facilitates
individual positioning of additional equipment,
such as anesthesia or respiration devices, and
provides for foot and floor clearance.
Trumpf Medical
Ditzingen, Germany
www.ihe-online.com & search 45645
Medica stand Hall 13/A42
Portable heart-lung support system
The world’s most compact and lightweight heart-
lung support system — a heart-lung machine
no bigger than a suitcase — is a complete thera-
peutic solution for patients who need cardiac or
pulmonary support in intensive care, cardiol-
ogy, cardiac surgery and emergency medicine.
Thanks to its specific modes of operation and
range of disposables, such as a gas exchanger
and the appropriate cannulae, the Cardiohelp
system is suitable for all patients who require
extracorporeal circulatory support or a reduc-
tion in blood CO2 levels. The system has been
specially designed for use in the intensive care
unit, but is just as easy to use in the operat-
ing room or in the cardiac catheter laboratory.
With its extracorporeal gas exchange and pump
functions the system can supply oxygen to the
heart and other organs as well as assist patients
with reduced lung function. Characterised by
a short preparation time and its user-friendly
operation and management, the system can
be operated and monitored by nursing staff
using a single rotary knob and a touch screen.
Without the need for tubing and clamps, the
various gas exchangers, featuring integrated
VAD (ventricular assist device) pumps, can be
docked directly and are available for immedi-
ate use. Using two software versions and three
different disposables, the Cardiohelp System
can be adapted to the specific requirements for
cardiopulmonary support and CO2 reduction.
Maquet cardiovascular
Rastatt, Germany
www.ihe-online.com & search 45646
Medica stand Hall 12/D51
 MEDICA PReview 31 – September/October 2010

New workflow standards in extremely practical dose is optimised without any compromise to
volumetric echocardiography and safe to handle but image quality. One of the main advantages of
The latest release of the also prevents errors the CT new system is its embedded software,
ACUSON SC2000 vol- and possible probe a speciality of Neusoft Medical and which ena-
ume imaging ultrasound damage. The high- bles the diagnostic capbilities of the CT to be
system supports the needs tech system provides significantly expanded.
of cardiography examina- a complete hard copy
tions and offers a complete documentation of the Neusoft Medical Systems
2D and volume echocar- whole process. The Shenyang, China
diography approach that touch-screen inter- www.ihe-online.com & search 45664
provides excellent imaging face is easy to use Medica Hall 10/D07
performance and one-of- and provides han-
a-kind workflow improvements in conventional dling and a graphic
and real-time volumetric echocardiography. real-time view of the Replacement CT tubes
Featuring an entirely new approach to workflow, cleansing and disinfection process. The system is
the unique eSie Measure workflow acceleration compatible with all disinfection solutions.
package is the first application in the indus-
try to provide semi-automated measurements Mides
for routine echo exams. In addition eSieScan Graz, Austria
workflow protocols are available, which bring www.ihe-online.com & search 45662
higher reproducibility and quality standards to Medica Hall 10/A39
the echocardiography workflow. Customisable
according to user or departmental requirements,
the protocols dramatically reduce the need for FDA-approved CT scanner
user interaction and the number of key strokes Replacement CT tubes from Dunlee are identi-
during the imaging process. The system’s work- cal to the original tube in fit, form and func-
flow protocols can help sonographers decrease tion; the warranty also matches that of the
scan time by 10 to 15 minutes per patient. original equipment producer. Dunlee manu-
factures replacements for all major brands
Siemens Healthcare including GE, Siemens, Toshiba, Picker, Els-
Erlangen, Germany cint, Shimadzu and Philips. The latest Dunlee
www.ihe-online.com & search 45661 replacement tube is the Reevo 240G replace-
Medica Hall 10/A20 ment CT tube, which is specifically designed
Recently approved by the FDA, the NeuViz as a replacement for use in the GE LightSpeed
16 multi-slice CT scanner incorporates the VCT and Pro 16 CT series systems. Addi-
Ultrasound cleansing and latest integrated detector for optimal signal tional products from Dunlee include AKRON
disinfection system to noise ratio (SNR) and scanning time. The replacement tubes designed for use on popular
The Mides TEE-Care all-in-one system is a proprietary technology of dynamic focal spot Siemens multi-slice CT scanners.
fully-automatic all-in-one ultrasound cleans- enables the system to provide a higher spatial
ing and disinfection system that simultaneously resolution during scanning and creates more Dunlee
carries out a leakage test, based on the measure- detailed 3D/MPR images. The product also Best, The Netherlands
ment of leakage
ANNONCE 206*86 current. The fully
horizontale 31THautomatic features
2011:50193 the 2006
join us DoseRight Modulation
15/09/10 9:13 system as
Page 1 www.ihe-online.com & search 45663
operation sequence not only makes the system well as a pediatric protocol to ensure that the Medica Hall 10/A60

31st International Symposium

on Intensive Care and Emergency Medicine
BRUSSELS MEETING CENTER, (SQUARE)
March 22-25, 2011
CME Accreditation
Plenary Sessions, Mini-Symposia, Workshop, Technical Forums, Round Tables, Tutorials, Posters
Endorsed by: Meeting Chairman: JL Vincent
European Society of Intensive Care Medicine Email: jlvincen@ulb.ac.be
Society of Critical Care Medicine
American Thoracic Society Manager: V De Vlaeminck
European Society for Emergency Medicine Email: veronique.de.vlaeminck@ulb.ac.be
European Shock Society
Dept of Intensive Care , Erasme University Hospital
The Institute of Critical Care Medicine
Route de Lennik, 808, B-1070 Brussels, Belgium
The Canadian Critical Care Society
Phone 32.2.555.32.15/36.31, Fax 32.2.555.45.55
Australian and New Zealand Intensive Care Society
Email: sympicu@ulb.ac.be
International Pan Arab Critical Care Medicine Society
World Federation of Societies of Intensive Website: http://www.intensive.org
and Critical Care Medicine
International Sepsis Forum Deadline for abstract submission: December 15, 2010
 – September/October 2010
32
Contrast Enhanced Spectral
Mammography
The process of cancer evolution is often linked
to a proliferation of small blood vessels (ang-
iogenesis). In the breast, the presence of these
small vessels is an indirect clinical indication
of breast cancer. The new SenoBright system
from GE healthcare uses Contrast Enhanced
Spectral Mammography (CESM), in which
intravenous injections of standard contrast
agents are used to locate the small vessels
linked to the cancer. The approach has been
shown in clinical trials to identify more can-
cers than are detected with current mammog-
raphy techniques. The method also shows
potential for measuring the extension of the
lesion to help to plan surgery and treatment.
The technology reduces ambiguity in screen-
ing results, enabling physicians to detect
and diagnose cancer in dense breast tissue
more rapidly and accurately. To generate the
enhanced image, the system uses X-rays at
multiple energies to create two separate expo-
sures, specifically illuminating and highlight-
ing areas where there is angiogenesis. The
flash used to look for the suspicious regions
is of a particular spectrum that highlights the
contrast agent in the areas with proliferation
of angiogenesis. A special proprietary image
combination algorithm enables visualisation
of the blood vessel information together with
the usual breast tissue structure images side
by side. The system is easy to use and operates
at a dose level inferior to stringent guidelines
for digital mammography. Clinical trials have
proven that the use of SenoBright Contrast
Enhanced Spectral Mammography has sig-
nificantly improved the accuracy of the exam.
GE Healthcare
Buc, France
www.ihe-online.com & search 45665
Medica Hall 10/A56
MEDICA PReview
Ultrasound probe disinfection
and testing system
The C-10 Probetester
is an automated device
that measures electrical
leakage in ultrasound
probes during the dis-
infection cycle. The new
system thus provides
an efficient way of con-
firming that the probe is
electrically safe for fur-
ther use with a patient
and that there is no damage on the surface
which could impair the function of the probe.
The device also protects hospital personnel by
minimising exposure to disinfection solutions.
In addition, the fully automatic operation of
the system frees up personnel for other duties.
Optima
Uppsala, Sweden
www.ihe-online.com & search 45669
Medica Hall 08b/C03
Identification of AKI risk
in critically ill patients
A novel bedside
blood test, the
Triage NGAL test
has been devel-
oped by Alere for
use in critically
ill patients on
their admittance
to the intensive
care unit to help identify which patients are at risk
of acute kidney injury (AKI). This is a common
and often devastating complication that can affect
up to 25% of critically ill patients admitted to the
ICU and can lead to increasing length of hospi-
tal stay and associated costs, not to mention an
increased risk of death. AKI is often detected too
late in its clinical progression when a substantial
portion of kidney function may already have been
lost and the window for initiating treatment to
prevent further harm has closed. The new test is
based on the detection in plasma of NGAL (neu-
trophil gelatinase associated lipocalin) which is a
new early marker for acute kidney injury. NGAL
levels rise rapidly after renal injury and can thus
be used in a variety of clinical situations includ-
ing intensive care, emergency medicine and renal
transplantation. In a recent study of several hun-
dred critically ill patients, plasma NGAL levels
measured with the new test system were found to
be a statistically significant diagnostic marker for
AKI development within the next 48 hours.
Alere
Morges, Switzerland
www.ihe-online.com & search 45666
Medica Hall 03/C70
Complete blood pressure control
Continuous blood
pressure informa-
tion is now avail-
able to all medical
disciplines where
previously it may
not have been
possible due to
cost, complication
risk or environ-
mental factors.
The CNAP Moni-
tor 500 offers
continuous non-invasive arterial pressure
measurement either via a stand alone-device
or connected to existing patient monitor-
ing equipment. The new system provides the
physician with beat-to-beat systolic, diastolic
and mean blood pressure, a high fidelity blood
pressure curve as well as the pulse rate. In its
default setting, the new monitor presents mul-
tiple information on its large anti-reflective
display, such as high fidelity blood pressure
curves, beat-to-beat blood pressure values, the
pulse rate and a trend view of blood pressure
and pulse rate. The highly customisable alarm
systems can be set to different blood pressure
values or the pulse rate.
CNSystems
Graz, Austria
www.ihe-online.com & search 45668
Medica Hall 17/D20
ECG monitor
The new CardiMax FX-8322/R monitor from
Fukuda Denshi is equipped with a large LCD
screen to display clear ECG waveforms. The
system can be operated either through the key-
board/buttons or via the touch panel keys. Data
can be saved to an SD card, a USB memory or
sent to a DMS (Data Management System) via
either a hard-wired or wireless network. For
carrying out stress examinations, it is possible
to connect the system to an external monitor
so that the examination results can be seen
while still making sure that the condition of the
patient is satisfactory.
Fukuda Denshi
Tokyo, Japan
www.ihe-online.com & search 45667
Medica Hall 09/E67
 PRODUCT NEWS 33 – September/October 2010

Vessel closure device

As the only vessel closure
device approved in Europe for
Solid state detector for AEC-equipped X-ray systems the closure of large femoral
The T-20 Translucent artery access sites, the Prostar
Detector is designed XL system has been shown
specifically for measure- to improve patient recov-
ments on Rad/Fluoro- ery from abdominal aortic
scopic systems when it is aneurysm (AAA) and tho-
crucial that the detector racic aortic aneurysm (TAA)
itself does not affect the repair and valve replacement. The device has been granted the CE mark
system output or disturb for use following minimally invasive procedures that leave large holes of
the automatic exposure up to 24F in the femoral artery in the upper thigh. Less invasive procedures
control (AEC) system. Up in the cardiac catheterisation lab, such as those used to repair abdominal
till now, measurements aortic aneurysms or thoracic aortic aneurysms, generally involve delivery
like this were often per- of therapeutic devices using relatively large sheaths in the access site in the
formed with an ion cham- patient’s leg, leaving behind a larger hole that needs to be closed.
ber because of the adverse
effects caused by the Abbott Vascular
density, size and design Diegem, Belgium
of solid state detectors when placed in the beam. The T-20 provides www.ihe-online.com & search 45655
a unique solid state solution with its “almost not there” design char-
acteristics; the size is small enough to not adversely affect the X-ray
system or AEC. The unique design has the detector separated from the ECG processing and storage
cable attachment by a carbon fibre rod, long enough to do measure- The IMPAX HeartStation solution for ECG
ments on a digital detector/image intensifier as large as 45 x 45 cm yet analysis is Agfa’s comprehensive data manage-
“invisible” because of the carbon fibre material. To ensure that a detec- ment solution for automating the processing
tor this small is positioned correctly and securely, carbon fibre “wings” and storage of electrocardiograms. The solu-
are added to the sides of the detector. These “wings” make sure that tion offers an extensive range of ECG-related
the detector surface lies flat against the incident beam while having no clinical tasks and is now available across
effect on the system output, and not disturbing the X-ray beam. Europe. The new system allows specialists
to digitally review and archive 15-lead ECG
RTI Electronics studies. Compared to more commonly found
Mölndal, Sweden 12-lead ECG equipment, 15-lead ECG pro-
www.ihe-online.com & search 45648 vides more data for detecting heart attacks
in the right and posterior ventricle walls.
IMPAX HeartStation’s innovative features analyse and prioritise 12- and
Surgical sealant film reduces air leaks during lung operations 15-lead ECG exams as they come into the system and alert care providers
TissuePatchThoracic is an ultra thin adhe- if an ECG indicates that a patient is experiencing a critical condition.
sive film that is resilient and conformable
to the tissues, and has improved handling Agfa Healthcare
characteristics. Available in sizes suit- Mortsel, Belgium
able for use in keyhole procedures, such as www.ihe-online.com & search 45650
Video Assisted Thoracic Surgery (VATS),
the product has been specifically designed
to enable thoracic surgeons to seal internal
air leaks during complicated lung surgery
PRO2XY
cases in which part of the lung is resected, On-site
most commonly for tumour removal. Sur- medicinal
gical resection lines are usually closed with staples, and the addition of Tis-
suePatchThoracic adhesive film over these staple lines provides the surgeon oxygen
with reassurance that air will not leak through the tissue and between the generator
staples. Literature data suggest that 70% of lung surgeries result in air leaks
Your source of on-site oxygen :
and, of these, 15% can be prolonged and problematic. If the surgeon can
• turnkey system
reduce the number and duration of air leaks, patients can have surgical drains
• economically interesting
removed more quickly, and so suffer fewer complications and be discharged
• complying with
from hospital more quickly. The film functions by bonding to proteins on the ISO 10083 Standard
surface of internal organs and tissues, enhancing traditional suture or staple
• guaranteed flow
line closure and supporting healing tissues. The product requires no advance and rate of oxygen
preparation and is easy to apply to even complex tissue surfaces. • output pressure 5 or 12 bar

Tissuemed www.mils.fr Hall 17

sales@mils.fr Stand A 23 C
Leeds, UK
www.ihe-online.com & search 45649
www.ihe-online.com & search 45546
 – September/October 2010
34 PRODUCT NEWS

Endovascular treatment of
abdominal aortic aneurysms
order to create lesions, or tiny scars, that interrupt
such abnormal electrical signals. With its fully
Calendar of events
irrigated and flexible tip the new system allows November 16-18, 2010 March 3-7, 2011

for more successful procedures and reduced com- Doppler-Echocardiography in ECR 2011
Intensive Care Medicine Vienna, Austria
plications. The new features provided by the cath- Brussels, Belgium Tel. +43 1 533 40 64 - 0
eter allow greater flexibility in movement which Tel. +32 2 555 36 31 Fax +43 1 533 40 64 - 448

can improve the targeting of the area of heart Fax +32 2 555 45 55 e-mail: communications@myESR.org
e-mail:sympicu@ulb.ac.be http://myESR.org
tissue causing problems. They also reduce some www.intensive.org
of the risk factors such as blood coagulation, March 17-20, 2011

charring and more serious complications. November 17-20, 2010 KIMES 2011
MEDICA Coex, Seoul, Korea
Düsseldorf, Germany Tel. +82 2 551 0102
St Jude Medical e-mail: info@medica.de Fax +82 2 551 0103

The Zenith low profile AAA endovascular St Paul, MN, USA www.medica.de e-mail: kimes@kimes.kr
www.kimes.kr
graft from Cook Medical has just received CE www.ihe-online.com & search 45652 Nov 28 – Dec 3, 2010
approval, and the advanced technology device RSNA 2010 March 22-25, 2011

will now be available initially at 20 European Chicago, IL, USA 31st International Symposium on
Tel. +1 630 571 2670 Intensive Care and Emergency
centres where the company will conduct a clini- High intensity focussed ultrasound www.rsna.org Medicine (ISICEM)
cal registry intended to capture patient outcome (HIFU) system Brussels, Belgium

data for later publication. At 16 French, the Nov 30 - Dec 2, 2010 Tel. +32 2 555 36 31
16th Postgraduate Refresher Fax +32 2 555 45 55
device is significantly smaller than most com- Course: “Cardiovascular and e-mail: sympicu@ulb.ac.be
monly used EVAR delivery systems, which typi- Respiratory Physiology Applied to www.intensive.org

cally measure 20-24 French. This reduction in the Intensive Care Medicine”
Brussels, Belgium March 29-31, 2011
diameter of the delivery device opens EVAR to a Tel. +32 2 555 36 31 14th SE-Asian Healthcare Show
wider range of patients. The newly engineered Fax +32 2 555 45 55 & Conferences

stent-graft is based on Cook’s ARC Technology, e-mail: sympicu@ulb.ac.be Kuala Lumpur, Malaysia
www.intensive.org Tel +603 79 54 65 88
which combines a series of barbs that engage the Fax +603 79 54 23 52
vessel wall to provide active fixation, radial force Nov 30 – Dec 2, 2010 e-mail: sales@abcex.com

from self-expanding z-stents for stability and Clinical Excellence Asia www.abcex.com
Marina Bay Sands, Singapore
optimal graft-to-vessel apposition. In addition www.iirme.com/clinicalasia April 6-8, 2011
the device has a long main body with columnar Med-e-Tel 2011

strength that mimics the aorta’s natural anatomy. December 5-8, 2010 Luxembourg, Luxembourg
Respiratory Monitoring Tel. +32 2 269 84 56
The new system is good news for surgeons treat- Rome, Italy Fax +32 2 269 79 53
ing patients with difficult or tortuous arterial Tel. +32 2 555 36 31 e-mail: info@medetel.eu

access who might otherwise have been ineligi- Fax +32 2 555 45 55 www.medetel.lu
e-mail: sympicu@ulb.ac.be
ble for EVAR. This patient group includes many www.intensive.org May 10-13, 2011
women and smaller-bodied adults whose more World of Health IT 2011

narrow and angulated arteries can impede the December 13-15, 2010 Budapest, Hungary
Medifest India 2010 e-mail: customerservice@worldof-
accurate positioning of an endovascular graft New Delhi, India healthit.org
using the currently available larger-diameter Combining proprietary multi-focal length trans- Tel. +91 11 30580444 www.worldofhealthit.org

delivery systems. ducer technology in a custom, transrectal imaging e-mail: info@vantagemedifest.com

www.vantagemedifest.com May 24-27, 2011
and therapy probe, the Sonablate 500 system high Hospitalar 2011
Cook Medical intensity focussed ultrasound (HIFU) system January 19-21, 2011 São Paulo, Brazil

Bloomington, IN, USA uses ultrasound imaging for treatment planning The International Medical Distributor www.hospitalar.com/ingles/
Meeting (IMDM): Cardiovascular
www.ihe-online.com & search 45651 and monitoring. Both Split-Beam HIFU and Sin- Budapest, Hungary June 7-9, 2011
gle-Beam HIFU are available for targeted, non- Tel: +41 22 533 0948 Medifest South Africa

invasive tissue treatment. The proprietary HIFU www.internationalmedicaldistribu- Cape Town, South Africa
tormeeting.org www.vantagemedifest.com
Ablation catheter approved Simu-plan therapy treatment software allows the
surgeon to select multiple treatment zones as nec- January 24-27, 2011 June 11-14, 2011

essary for a clinician-directed, computer-control- Arab Health 2011 Euroanaesthesia 2011

Dubai, UAE Amsterdam, The Netherlands
led treatment. A new colour-coded overlay plan- Tel. +971 4 336 5161 Tel. +32 2 743 3290
ning system with enhanced prostate visualisation e-mail: info@iirme.com www.euroanesthesia.org

simplifies the process. The active cooling and www.arabhealthonline.com

June 22 - 25, 2011
circulation system, along with the RIM (reflec- February 24-27, 2011 CARS 2011 - Computer Assisted
tivity index measurement) and RDM (rectal wall International Conference on Prehyper- Radiology and Surgery

distance measurement) systems provide for treat- tension & Cardio Metabolic Syndrome Berlin, Germany
Vienna, Austria Tel: +49-7742-922 434
ment safety. A slim, space-saving cabinet with Tel. +41 22 5330948 e-mail: office@cars-int.org
a reduced footprint has been matched with a Fax +41 22 5802953 www.cars-int.org

European CE Mark approval has been granted
to the Therapy Cool Flex ablation catheter from
St Jude Medical. Ablation catheters are used to
help treat cardiac arrhythmias, i.e. irregular heart
rhythms often caused by abnormal electrical sig-
nals. The catheter tube delivers radiofrequency
(RF) energy to specific areas of cardiac tissue in
17-inch, true colour, flat panel monitor with 1280
x 1024 high resolution capability for ease of use
and volumetric prostate visualisation.
Focus surgery
Indianapolis, IN, USA
www.ihe-online.com & search 45654
e-mail: Secretariat@prehypertension.org
www.prehypertension.org
For more events see
www.ihe-online.com/events/
Dates and descriptions of future events have been obtained from
usually reliable official industrial sources. IHE cannot be held
responsible for errors, changes or cancellations.
 24-27 JANUARY 2011
DUBAI INTERNATIONAL EXHIBITION CENTRE
DUBAI, UAE
GE Healthcare

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