Expert Review of Cardiovascular Therapy

ISSN: 1477-9072 (Print) 1744-8344 (Online) Journal homepage: http://www.tandfonline.com/loi/ierk20

Interventions to reduce major vascular

complications of TAVR

Marco Barbanti & John G Webb

To cite this article: Marco Barbanti & John G Webb (2013) Interventions to reduce major
vascular complications of TAVR, Expert Review of Cardiovascular Therapy, 11:7, 891-901

To link to this article: http://dx.doi.org/10.1586/14779072.2013.811983

Published online: 10 Jan 2014.

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 THEMED ARTICLE ❙ Vascular Disease Review

Interventions to reduce major

vascular complications of TAVR
Expert Rev. Cardiovasc. Ther. 11(7), 891–901 (2013)

Marco Barbanti and Vascular complications are still an important cause of morbidity and mortality with transcatheter
John G Webb* aortic valve replacement. The aim of the present review is to review some of the recent
developments and techniques, which have resulted in a reduction in the risk of vascular
St Paul’s Hospital, 1081 Burrard Street,
Vancouver, BC V6Z 1Y6, Canada complications during transfemoral transcatheter aortic valve replacement.
*Author for correspondence:
Tel.: +1 604 806 8804 Keywords: TAVI • TAVR • vascular complications
Fax: +1 604 806 9878
webb@providencehealth.bc.ca
The first in-human percutaneous aortic valve calcification, minimal artery diameter and a
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implantation procedures incorporated a ­sheath-to-femoral artery ratio of more than 1.05

­transvenous transeptal approach [1] . However,
it was soon evident that advancing a bulky device
through the interatrial septum, mitral valve, left
ventricle and only then to the aortic valve, was
problematic [2] . A transarterial approach proved
easier and more reproducible [3] . However, this
retrograde approach to the aortic valve was
severely limited by the relatively crude and bulky
valves and catheter systems initially available [3,4] .
Transcatheter aortic valve replacement (TAVR)
has rapidly evolved from the initial experience
with bulky 24/25 Fr catheter systems requiring
open surgical access into smaller profile devices.
The initial reductions in device profile
were accomplished with the self-expanding
CoreValve® (Medtronic, Inc., MN, USA) with
an 18 Fr delivery system compatible with valve
sizes suitable for a full range of currently available
valves sizes. The balloon-expandable Edwards
SAPIEN™ XT valve (Edwards Lifesciences,
CA, USA) followed with 16–20 Fr expandable
sheath delivery systems. Further reductions in
delivery catheter profile are currently undergoing
evaluation by both manufacturers. Despite this
rapid progress, currently available devices remain
relatively bulky resulting in the ­development
of various strategies to reduce access-related
­complications [5–7] .
Vascular complications with the attendant
blood loss, transfusion requirements, and
­hemodynamic instability remains a major limi-
tation of TAVR. Several predictors of vascular
complications have been identified includ-
ing early site experience, early operator expe-
rience, moderate/severe ilio–femoral artery
[8–10] . Using a large diameter (22/24 Fr) deliv-
ery system the SOURCE, PARTNER 1B and
PARTNER 1A studies reported major vascu-
lar complication rates of 17.9, 17.5 and 13.7%,
respectively [11,12] . The aim of the present review
is to discuss the techniques that have been devel-
oped to minimize the risk of vascular complica-
tions during transfemoral TAVR. There are two
main steps where operators can act to accomplish
this purpose: vascular access screening phase,
vascular access management (­arterial puncture,
closure devices placement and sheath manage-
ment). The definitions of vascular ­complications
according to the Valve Academic Research
Consortium are summarized in Box 1 [13] .
Access evaluation
Assessing the feasibility of a femoral approach
is among the first steps when a patient is con-
sidered for TAVR. The diameter of the femo-
ral and iliac arteries must be large enough to
accommodate the necessary sheath. Ta ble  1
provides the internal and external diameters
of the sheaths currently used for transfemo-
ral TAVR and the reference minimal lumen
­d iameter needed for each of them. The risk of
vascular injury is largely a function of small
artery diameter, severe tortuosity, heavy calci-
fications and operator experience [8,9] . These
features r­ eemphasize the need to respect some
basic rules that should lead to the exclusion
of the femoral approach in case of the fol-
lowing: iliac artery diameter smaller than the
requested sheath size when it is severely calci-
fied, extreme iliac artery tortuosity along with

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 Review Barbanti & Webb

Box 1. Vascular access site and access-related complications, according to Valve Academic Research
Consortium’s recommendation.
• Major vascular complications
– Any aortic dissection, aortic rupture, annulus rupture, left ventricle perforation or new apical aneurysm/pseudo-aneurysm;
– Access site or access-related vascular injury (dissection, stenosis, perforation, rupture, arterio-venous fistula, pseudoaneurysm,
hematoma, irreversible nerve injury, compartment syndrome, percutaneous closure device failure) leading to death, life-threatening
or major bleeding, visceral ischemia or neurological impairment;
– Distal embolization (noncerebral) from a vascular source requiring surgery or resulting in amputation or irreversible end-organ
damage;
– The use of unplanned endovascular or surgical intervention associated with death, major bleeding, visceral ischemia or neurological
impairment;
– Any new ipsilateral lower extremity ischemia documented by patient symptoms, physical exam and/or decreased or absent blood
flow on lower extremity angiogram;
– Surgery for access site-related nerve injury;
– Permanent access site-related nerve injury.
• Minor vascular complications
– Access site or access-related vascular injury (dissection, stenosis, perforation, rupture, arterio-venous fistula, pseudoaneuysms,
hematomas and percutaneous closure device failure) not leading to death, life-threatening or major bleeding, visceral ischemia or
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neurological impairment;
– Distal embolization treated with embolectomy and/or thrombectomy and not resulting in amputation or irreversible end-organ
damage;
– Any unplanned endovascular stenting or unplanned surgical intervention not meeting the criteria for a major vascular complication;
– Vascular repair or the need for vascular repair (via surgery, ultrasound-guided compression, transcatheter embolization or stent-graft).
• Percutaneous closure device failure
– Failure of a closure device to achieve hemostasis at the arteriotomy site leading to alternative treatment (other than manual
compression or adjunctive endovascular ballooning).

Table 1. Internal and external diameter of large sheaths.

Manufacturer, location Sheath Sheath internal Sheath external Recommended minimal
diameter (Fr) diameter (mm) lumen diameter (mm)
Edwards Lifesciences, CA, USA RetroFlex 3 introducer sheath 22 8.4 7
24 9.2 8
NovaFlex introducer sheath 18 7.2† 6
19 7.5 6.5
Expandable Sheath 14 5.9 †
5
16 6.6† 5.5
18 7.2 †
6
20 7.8 †
6.5
Cook Medical, Inc., IN, USA Check-Flo Introducer
®
18 7.2 6
St Jude Medical, Inc., MN, USA Ultimum™ 18 6.8 6
20 7.6 6.5
22 8.2 7
Terumo Corp., Tokyo, Japan SoloPath™ Balloon Expandable 19 7.3‡ 6
Transfemoral Introducer
20 7.7‡ 6
21 8 ‡
6.5
Gore Medical, DE, USA DrySheath™ 16 6.2 5.5
18 6.8 6
20 7.5 6.5
†
The pre-expanded diameter is indicated. The fully expanded diameter depends on the size of the catheter that is used for the procedure.
‡
The final outer diameter is indicated for the SoloPath Balloon Expandable Transfemoral Introducer. The unexpanded outer diameter is 4.3 mm.

892 Expert Rev. Cardiovasc. Ther. 11(7), (2013)

 Interventions to reduce major vascular complications of TAVR Review

severe calcifications, circumferential arterial calcifications in

case of sheath/artery ratio approaching 1 and severe kinking or
tortuosity of the abdominal or intrathoracic aorta. A number
of imaging modalities, including angiography, multidetector
computed tomography (MDCT) [14] and MRI [15] may be help-
ful. The preferred imaging tools may vary depending on the
experience and expertise of an individual center.

Alternative access routes

The transfemoral route is considered the ‘first choice’ for TAVR
because of its minimal invasiveness. However, in a certain number
of subjects, TAVR cannot be performed using this route, due to IEA
significant peripheral artery disease. In such cases, using alterna-
tive routes (apical, aortic and subclavian) may represent the safest
approach to accomplish the procedure and to prevent vascular
complications [16] . The first and most studied alternative route to
the transfemoral TAVR is the transapical TAVR. The only con-
traindications for transapical access might be severe previous skin
injury following radiation therapy for breast cancer or severely
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depressed left ventricular function, which may make apical man-

CFA
agement unsafe. The subclavian and aortic approaches have been
more recently described and several studies have demonstrated
their feasibility and effectiveness. Porcelain and horizontal aorta
are the main features, which may contraindicate apical access. On
the other hand, in contrast to the femoral/iliac vessels, the sub­
clavian artery is usually relatively free of atheroma and thus fulfills
the anatomic and morphologic requirements in most patients [16] .
All the mentioned approaches have demonstrated encouraging out-
comes, even though recently the apical TAVR has been ­associated PFA
with lower survival compared with transfemoral TAVR [16] .

Angiography
Preprocedural angiography remains the imaging technique of
reference for most centers as it allows for rapid assessment of
arterial anatomy, diameter, tortuosity and calcium. This is best
­performed by placing a calibrated pigtail in the abdominal aorta
just above the bifurcation and injecting 20–35 ml of contrast
dye. The common femoral artery and the level of the femoral
bifurcation in relation to the femoral head should be assessed
(F igure 1) . Localized femoral disease, extensive calcification or
SFA
a high femoral bifurcation may influence the site of puncture
and reliability of closure. Using a calibrated pigtail catheter can
facilitate measurement of the minimal lumen diameters of the
iliac and femoral arteries (Figure 2) . Angiography offers a very
high resolution and requires much less contrast than a stand-
ard MDCT study. The ability to straighten a tortuous artery
can be assessed in the presence of a diagnostic catheter or stiff
guidewire. Calcification can be assessed prior to contrast opaci- Figure 1. Angiographic appearance of the common femoral
fication, although this may not be appreciated with subtraction artery which bifurcates in the profunda and superficial
techniques. Angiography is limited in the evaluation of athero- femoral arteries at the level of the bottom white line. The
sclerotic disease burden as well as the 3D assessment of vessel IEA originates from the external iliac artery, just above the
tortuosity. Still, angiography demonstrating a minimal arterial inguinal ligament (upper white line) and serves as a useful
landmark to demarcate the retroperitoneal space.
diameter approximating the diameter of the planned sheath CFA: Common femoral artery; IEA: Inferior epigastric artery;
along with minimal calcification or tortuosity can be a reliable PFA: Profunda femoral artery; SFA: Superficial femoral artery.
predictor of a minimal risk of vascular injury.

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 Review Barbanti & Webb
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Figure 2. Angiographic appearance of the ilio–femoral
axes. This is used to measure the minimal lumen diameter of the
iliac and the common femoral arteries.
Multidetector computed tomography
MDCT offers additional information about cross-sectional
luminal diameter and the nature of the arterial wall. A detailed
MDCT analysis is very important and can predict possible
access problems. Usually, the images are displayed in longitu-
dinal, 3D and axial views. Exact vessel diameter measurements
require that the measurement be done perpendicularly to the
longitudinal axis of the vessel, and this has to be adjusted for
each segment of the ilio–femoral arteries (Figure 3A) . Noncontrast
MDCT is also very important for quantifying the amount of
calcification in both longitudinal and axial views. Concentric
calcifications are of special concern, as these have no yield for
expansion as the large sheath advances. A 3D assessment of the
relationship of arterial tortuousity can be particularly helpful
(Figure 3B) . Imaging of the descending aorta allows assessment of
aortic aneurysms, friable atheroma and tortuosity. Assessment
of the arch and ascending aorta may be particularly impor-
tant when considering transaxillary or direct aortic access. An
unfolded aorta with a vertical valve plane may be problem-
atic for certain valve delivery ­s ystems. Some valves, such as
the CoreValve device, which utilizes ­supra-­coronary fixation,
require measurement of the ascending aortic dimensions. In
addition, a potential advantage of MDCT is the ability to pro-
vide 3D assessment of the aortic annulus and facilitate optimal
transcatheter valve sizing.
Generally, MDCT requires a relatively large amount of intra-
venous contrast, approximately 80–120 ml for visualization of
the ilio–femoral arteries [17] . However, Joshi et al. have recently
894
demonstrated that high-quality aorto–ilio–femoral MDCT
angio­graphy can be obtained even using 10–15 ml of contrast
injected in the abdominal aorta [18] . More contrast may be neces-
sary if combined with assessment of the aortic root and annulus.
This carries some risk for contrast-induced nephropathy. In a
recent study of patients undergoing MDCT, the incidence of con-
trast-induced nephropathy was 0.6% in those with a ­glomerular
filtration rate of 40–60 ml/min and 7.8% in those with a glo-
merular filtration rate <30 ml/min [19] . Therefore, MDCT is often
not performed in patients with severe renal insufficiency [9] . Low
dose ­intra-arterial contrast MDCT protocols may offer a ­desirable
alternative.
Magnetic resonance angiography
Although invasive angiography is the reference method to
evaluate the size and tortuosity of the peripheral arteries, MR
angiography may be an ideal noninvasive alternative imaging
technique in patients with renal failure, since it is less nephro-
toxic [20] . Gadolinium ­contrast-enhanced MR angiography pro-
vides accurate a­ ssessment of the stenosis severity of ilio–femoral
arteries [21,22] . Although Gadolinium is overall considered a safe
agent and, its exposure in patients with chronic renal failure is
rarely associated with nephrogenic systemic fibrosis [23] . In addi-
tion, true-fast ­imaging with steady-state precession sequence
acquisition allows for vessel wall characterization with high
image quality, and atherosclerosis and arterial wall thrombosis
can also be detected [24] . As already mentioned for MDCT, the
cross-sectional diameter of the iliac and femoral arteries can
be determined. In contrast to MDCT, extent and location of
calcifications cannot be e­ valuated with MRI.
Procedure
An appraisal of the femoral artery anatomy, the technique of arte-
rial puncture, and careful management of percutaneous closure
devices, Prostar® XL or Perclose Proglide® (Abbott Vascular, Inc,
CA, USA) and large diameter sheaths, are of extreme impor-
tance for a successful femoral approach and m ­ inimize v­ ascular
­complication rate.
Puncture
Ideally, a femoral arterial puncture should be above the most infe-
rior border of the inferior epigastric artery and above the femoral
bifurcation (Figure 1) , on the vessel’s anterior wall, with an angle
of 45°–60° compared with the plane of the vessel wall in order
to minimize the path between the skin and the artery wall and
facilitate percutaneous closure. A number of techniques can be
used to ensure an optimal puncture.
Angiography performed during screening can be used to
identify the relationship of fluoroscopic landmarks, such as
the markers of the femoral head and the femoral artery, par-
ticularly the bifurcation of the superficial and profunda femoral
arteries (Figur e  1) . Alternatively, femoral artery access can be
assessed angiographically at the time of the procedure using
contralateral access. On occasion it may be helpful to place a
contralateral catheter and use this as a fluoroscopic landmark;
Expert Rev. Cardiovasc. Ther. 11(7), (2013)
 Interventions to reduce major vascular complications of TAVR Review

aiming at a pigtail’s eyelet can facilitate

extremely accurate anterior wall puncture
without contrast, even in obese patients
(F igur e   4) . Ultrasound guidance with a
sterile packed 5–10 MHz linear array
transducer can also be extremely helpful
to ensure accurate front wall ­puncture
and avoid plaque [25] .

Closure devices
There are no available percutaneous
devices specifically intended for large
vessel closure; however, ‘preclosure’ with
either the Prostar XL 10 Fr or 2 ProGlide
6 Fr devices are commonly used for this
purpose. Introduced in 1997, the Perclose
device was the first suture-based vascu-
lar closure device on the market. The
6 Fr device, intended for use with 5–8 Fr
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sheaths and routinely used for femoral

access site closure after coronary angio­
graphy and intervention, places a suture
through the arterial wall like a stapler
(i.e., from the outside in) and uses a pre-
tied self-locking surgical sliding knot for
hemostasis. Initially, a braided polyester
suture was used but has been replaced
in the current device generation by a
­monofilament ­polypropylenesuture, which
provides more tensile strength and elicits
less ­inflammatory tissue response. The
first cases of percutaneous closure using
the ProStar device were reported in 1996
[26] . Later, in order to reduce the inva-
Figure 3. Computed tomography of the ilio–femoral axes. (A) 3D computed
tomography reconstruction of the ilio–femoral axes; (B) longitudinal cuts of right and left
siveness of endovascular aortic aneurysm ilio–femoral arteries for precise diameter measurement.
repair, the Prostar and Perclose devices
were utilized off-label to preclose the femoral artery [27,28] . This Percutaneous closure with two Proglides is depicted in Figure 5.
was initially done with surgical exposure and direct visualiza- Usually, the femoral artery is punctured and dilated with a stand-
tion of the femoral artery using two Prostar devices [27] and later ard arterial sheath as described above. Then, the Proglide device is
without a cut-down resulting in totally ­percutaneous aortic aneu- advanced over a 0.035″ guidewire and the first suture is deployed
rysm repair [28,29] . Totally percutaneous endovascular aneurysm slightly angulated at -20°. Guidewire access is maintained and a
repair was found to be associated with a lower rate of late groin second Proglide device is inserted and deployed +20°. After this
complications, shorter procedure time and less severe scar tissue device is removed, a larger dilator is inserted. The regular 0.035″
formation [28,30] . J-tip wire is now exchanged to a stiffer wire and the large sheath
Percutaneous closure has been increasingly utilized [8–10,31–33] . is advanced under fluoroscopy. After conclusion of the proce-
The advantages of this less invasive technique are increased dure, the introducer sheath is slowly removed (but the stiff wire
patient comfort immediately after the procedure and a d ­ iminished is left to maintain access) and the sutures are tightened. In case
requirement for anesthetic drugs during and after the proce- of sufficient hemostasis, the wire can be removed and the sutures
dure. In most patients, the percutaneous technique of placement further tightened using the knot-pusher to ensure approximation
and removal of large-diameter femoral arterial sheaths can be of the knot to the vessel wall. Should hemostasis fail, it is possible
­performed under local anesthesia only [34,35] . to implant a third (or even more) Proglide over the guidewire.
Suture based closure devices have high success and very low Recently, Kahlert et al. [38] reported a series of 94 TAVR patients
vascular complication rates following percutaneous coronary in who preclosure of the arterial access site was accomplished with
angioplasty with 6–8 Fr sheaths [36,37] . In TAVR, larger caliber a single 6 Fr Proglide; an efficient hemostasis with cessation of
sheaths are used requiring a more careful closure. any bleeding within 10 min offinal knot-tying was obtained in

www.expert-reviews.com 895
 Review Barbanti & Webb
1 2
Figure 4. Useful techniques to guide the femoral puncture.
(A) To determine the exact puncture site, a radiopaque object
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can be placed over the femoral head. (B) Alternatively, a catheter
can be introduced from the contralateral femoral artery and used
as a target or for contrast injections to facilitate puncture under
fluoroscopy.
83 out of the 94 patients with only one ­closure-failure with con-
tinuous bleeding despite prolonged manual c­ ompression requiring
endovascular treatment.
The Prostar device requires a few minor expedients: a trans-
versal incision at the puncture site with a length 8–10 mm is
necessary; the subcutaneous tissue should also be separated with
rounded-tip forceps both above and below the introducer mount-
ing the dilator and guidewire (Figure 6A) or by using a finger. This
latter maneuver may be ­preferred because it is less traumatic and it
allows optimal subcutaneous tissue separation around the femoral
artery. When inserting the Prostar, it is important to ensure the
Figure 5. Steps of percutaneous closure with two Proglide® (Abbott Vascular, Inc.,
CA, USA). After a regular 7-Fr dilator is introduced (step 1), sutures are deployed at -20°
and +20° (step 2 and 3). After the 16-Fr dilator is inserted, a regular J wire is exchanged
for a stiffer wire and the large sheath is inserted under fluoroscopy (step 4). After
implantation of the valve, the sheath is retrieved (step 5) and the sutures are tightened
(step 6). The wire is removed if sufficient hemostasis is achieved and the sutures are
further tightened using the knot-pusher (step 6).
896
tip of the device does not engage the renal artery; therefore, this
maneuver should be performed under fluoroscopy guidance. Once
the Prostar is inserted, and also during needle extraction, the
blood jet exiting the posterior straight cannula should be pulsatile
(Figure 6B) . Optimal subcutaneous preparation is confirmed by
obtaining a good pulsatile flow without forcing the insertion of
the device within the artery. It is recommended that the system
rests against the artery wall using the left hand and slowly pull
back the four needles with the right hand. A nonpulsatile flow
can be caused by: the occlusion of the lumen of the cannula
by clots or debris of subcutis tissue – in this case, the Prostar
should be retrieved and the cannula flushed with saline to ascer-
tain the patency of the cannula. The hole of the cannula located
in the shaft of the device is not into the lumen; at this point it is
extremely important to recognize whether the Prostar has passed
through the posterior wall of the artery or is still confined proxi-
mally the anterior wall. It is less likely that low flow is caused by
the presence of an obstructive lesion that is localized proximally
in the ilio–femoral artery or by low systemic cardiac output. After
needle deployment (Figure 6C) , if one or more needles do not come
out, it means that they deflected into the subcutis. This situation
often occurs when not all the components of the device are cor-
rectly aligned or in the presence of heavy calcifications. In such
cases the needles should be repositioned in the Prostar device.
This can be done with aid of a surgical needle holder, paying
attention to ensure that the needles are not bent.
Large caliber sheath management
Large sheaths should always be advanced while being observed
fluoroscopically with the support of a stiff guidewire, such as
the AmplatzExtra or Super Stiff wire or the Meier wire (Boston
Scientific, MA, USA). When there is extreme tortuosity even
stiffer wires, such as the Meier wire or the Lunderquist wire (Cook
Medical, Inc., IN, USA) can be helpful.
The bulk of experience with trans-
femoral TAVR has been with the bal-
loon-expandable type valves (Edwards
Lifesciences, CA, USA) and the self-
expanding CoreValve. Over time, the
delivery profile of both valve systems has
fallen dramatically. The Edwards SAPIEN
valve required a 22/24 Fr sheath, while the
newer Edwards SAPIEN XT valve can be
introduced through 18/19 Fr sheaths and
even smaller expandable sheaths. The
next generation Edwards SAPIEN 3 valve
is delivered through a 14 Fr expandable
sheath. Similarly, the Medtronic CoreValve
saw a gradual decrease in sheath size from
25 Fr (first generation) to 18 Fr (third
generation).
Early procedures utilized large sheaths
originally designed for endovascular aor-
tic procedures. Currently, the 18 Fr Cook
introducer is used for implantation of the
Expert Rev. Cardiovasc. Ther. 11(7), (2013)
 Interventions to reduce major vascular complications of TAVR Review

CoreValve device and many of the newer

valves from other manufacturers. Several
manufacturers are developing new and
improved sheath systems compatible with
their delivery catheters, while others are
incorporating sheaths into the delivery
system itself.
The expandable Edwards eSheath fea-
tures a dynamic expansion mechanism
Figure 6. The most important steps of the Prostar® (Abbott Vascular, Inc., CA,
that allows for transient sheath expan-
USA) implantation. (A) Separation of the subcutaneous tissue with rounded tip forceps
sion during valve delivery. The trauma of both above and below the introducer mounting the dilator and guidewire; (B) pulsatile
dilation during sheath insertion is greatly blood flow from the straight tube indicating that the ProStar is an optimal position;
reduced. Immediately after the transcath- (C) maintaining the position using the left hand while the needles are gently extracted
eter heart valve passes, the sheath returns and removed with the right hand.
to a low profile diameter [39] . This reduces
the time the access vessel is expanded, thereby hypothetically So long as wire access to the access artery is maintained,
minimizing the risk of vascular trauma (F igur e  7) . Since the ­problematic bleeding can be managed with reinsertion of the
sheath transiently expands and then contracts there is the pos- sheath. Alternatively, placement of a dedicated occlusion balloon
sibility of incomplete arterial sealing. To avoid this it is best to proximal to the perforation from the ipsi- or contra-lateral artery
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advance the sheath all the way into the patient where the larger can provide reliable temporary hemostasis and hemodynamic
and nonexpandable strain relief portion of the sheath provides stability while the bleeding site is appropriately managed. Some
reliable sealing. groups have advocated routine use of a wire placed from the
The Solopath™ sheath (Terumo, Tokyo, Japan) has been contralateral femoral artery. Another approach involves a 0.018″
widely used with CoreValve implantation, although a SAPIEN hydrophilic wire inserted from the contralateral femoral artery
XT compatible system has also been available. This introducer down the ipsilateral superficial femoral artery prior to preclosure.
consists of a flexible, reinforced p­ olymer sheath mounted over a The wire is advanced in crossover from the contralateral femoral
central balloon-dilatation catheter (the expander). The folded artery or a radial artery and kept in place until the end of the
­ assage procedure, so as to be ready to intervene with an occlusion bal-
distal region of the sheath is 14 Fr in diameter, facilitating p
through small-diameter and tortuous arteries. Once inserted loon or covered stent in case of dissection or rupture of the com-
through the femoral artery and into the abdominal aorta, the mon femoral artery where the large sheath is inserted (Figure 10)
SoloPath expander is briefly inflated, deflated and then removed [40,41] . On occasion, reversal of heparin with protamine may be
l­eaving a large central lumen (up to 21 Fr) (Figure 8) . helpful, particularly if there is persistent oozing; however, this
Although sheath diameters continue to fall, femoral access may is not generally necessary and may increase the risk of femoral
still be limited by atherosclerotic stenosis. Balloon angioplasty can artery thrombosis, particularly when femoral compression is
often facilitate sheath insertion, although stent implantation may also utilized [42] .
be problematic if these are not adequately
sized and expanded (Figure 9) . Alternatively,
direct surgical access to the iliac artery is
often a reasonable option.
After sheath removal, it is prudent to
leave a guidewire in place until hemosta-
sis is confirmed. Should this fail, a sheath
can be reinserted or an occlusion balloon
advanced proximal to the bleeding site to
allow surgical closure. The blood p ­ ressure
should be monitored for rapid detection of Unexpanded Expanded
signs of perforation, such as hypo­tension
and/or tachycardia. Once the sheath is
removed, the ProGlide or ProStar sutures
are tightened. If hemostasis is accom-
Unexpanded Expanded Reduced
plished the wire is removed and the sutures profile
are further tightened. Completion angio­
graphy from the ­contralateral side may be Figure 7. The eSheath (Edwards Lifesciences, CA, USA) expandable introducer
performed to rule out residual internal sheath and the mechanism of transient expansion during the passage of the
leaks or stenosis. delivery catheter.

www.expert-reviews.com 897
 Review Barbanti & Webb

Hydrophilic coating
enhances access

Low profile tip reduces

insertion force
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Figure 8. The SoloPath™ (Terumo, Tokyo, Japan) expandable sheath. The unexpanded sheath (A) is advanced over a stiff wire (B).
The sheath is then expanded (C–E). The self-expanding CoreValve® (Medtronic, Inc., MN, USA) prosthesis can easily navigate through the
expanded sheath (F, G).

New devices complications has been demonstrated to be the ratio of the outer
Downsizing of the transcatheter heart valve delivery systems is diameter of the sheath to the minimal lumen diameter of the
already playing an important role in reducing the risk of vas- access vessel [9] . To this regard, while the 26 mm SAPIEN requires
cular complications, since the strongest predictor for vascular a 24 Fr sheath and the 26 mm SAPIEN XT a 19 Fr sheath (or
18 Fr expandable sheath), the new 26 mm
SAPIEN 3 is accommodated by a 14 Fr
expandable sheath. Some patients cur-
rently considered unsuitable or at high risk
for femoral access because of small vessel
diameters may safely undergo TAVR with
the SAPIEN 3 in the future. The authors
showed that the use of low profile 14–18 Fr
sheaths was associated with a sharp drop
in vascular complication rates after trans-
femoral TAVR [9] ; a major ­vascular com-
plication requiring unplanned vascular
surgery occurred in 0.5% of cases. Minor
vascular complications occurred in 5.4% of
cases; eight of these were the result of clo-
sure device failure and most of these were
1 2 3 4
­successfully managed with ­percutaneous
techniques (balloon a­ngioplasty or
Figure 9. Treatment of severe right common iliac stenosis in a patient considered
­stenting). By contrast, unplanned vascular
for transfemoral transcatheter aortic valve replacement. After predilatation with a surgery was dramatically more frequent in
5.0 mm balloon catheter a 9.0 × 25 mm balloon-expandable Express® stent (Boston the patients who underwent TAVR using
Scientific, MA, USA) was deployed with a good final result. Eight days later patients ≥19 Fr sheath (14.6 vs 1.9%). TAVR pro-
underwent transfemoral transcatheter aortic valve replacement without adverse events. cedures using ≥19 Fr sheaths were also

898 Expert Rev. Cardiovasc. Ther. 11(7), (2013)

 Interventions to reduce major vascular complications of TAVR Review

is higher in patients with ­vascular complications than in those

without [8,11,44–46] .

Expert commentary & five-year view

* being less invasive, is the predominant access for device delivery.
Figure 10. Treatment of common femoral artery injury.
The injury (asterisk) was treated with a Fluency® Plus 9 x 60 mm
covered self-expanding stent-graft (Bard Canada, Inc., Oakville,
Canada).
associated with more than a threefold risk of any vascular compli-
cations, regardless of the presence of peripheral ­vascular disease,
the severity of calcifications and the ratio between the ­minimal
Downloaded by [NSTL] at 01:47 05 October 2015
TAVR has been a major advance in the management of aortic
valve disease and is now a valid ­therapeutic option for many
patients with severe aortic stenosis. The transfemoral approach,
However, vascular complications in transfemoral TAVR remain
one of the most significant issues despite improving operator
experience, and the trend towards reduced sheath size led to a
significant reduction. Reducing vascular complications can be
accomplished by optimal arterial pre-procedural arterial imaging
and evaluation; invasive angiography is the method of reference
to evaluate the luminal diameter of the peripheral arteries and
tortuosity. However, MDCT provides fundamental additional
assessment of luminal diameter, tortuosity and calcification.
Evaluation by a multidisciplinary team is pivotal for determining
the optimal access techniques. Complications can also be reduced

­femoral artery and external sheath diameters.
Outcomes after vascular complications
Vascular complications are still among the most frequent after
TAVR. A recent meta-analysis reported a pooled estimate rate of
vascular complications defined according to the Valve Academic
Research Consortium of 18% [43] . Vascular complications have
been associated with mortality, morbidity, reduced quality of life
and increased costs. Several studies have shown that mortality
by using optimized techniques for femoral access, arterial closure
and expertise and by managing complications appropriately.
Financial & competing interests disclosure
J Webb is a consultant to Edwards Lifesciences. The authors have no other
relevant affiliations or financial involvement with any organization or entity
with a financial interest in or financial conflict with the subject matter or
materials discussed in the manuscript apart from those disclosed.
No writing assistance was utilized in the production of this manuscript.

Key issues
• Transfemoral transcatheter aortic valve replacement (TAVR), being a less invasive technique, is the predominant approach for
transcatheter heart valve delivery.
• Vascular complications represent a major limitation of TAVR as they may result in blood loss requiring transfusion, hemodynamic
compromise and mortality.
• Several predictors of vascular complications after transfemoral TAVR have been identified: early site experience, early operator
experience, moderate/severe ilio–femoral artery calcification, minimal artery diameter and a higher sheath:femoral artery ratio.
• Careful preprocedural evaluation with imaging techniques including invasive angiography, multidetector computed tomography,
MRI and ultrasound, as appropriate, is important to avoid vascular complications.
• Expertise with advanced percutaneous techniques for access, closure and management of vascular complications is important.
• The ongoing development of ever-smaller profile delivery systems is enhancing the safety of TAVR procedures and expanding the
number of eligible patients.

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