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CHAPTER

JOSEPH A. CAPRINI

Risk Assessment as a Guide


to Thrombosis Prophylaxis in
Bariatric Surgical Patients
10
Surgery for morbid obesity has become a popular and success- bleeding complications from anticoagulant use are almost always
ful approach to the escalating problems of obesity and its com- treatable, and the risk of death is exceedingly low.
plications. It has been well documented that the morbidly obese There are a number of other reasons to employ thrombo-
patient undergoing a bariatric surgical procedure is at an elevated sis prophylaxis in addition to mortality prevention. The post-
risk for developing venous thromboembolism (VTE) compared thrombotic syndrome is a serious condition that affects 25% of
to the average surgical patient, and that this risk is proportional individuals following a deep vein thrombosis (DVT). A perma-
to the patients body mass index (BMI). The incidence of fatal nent disability occurs in 7% of these patients, and it is estimated
pulmonary emboli following bariatric surgery has been estimated that 2 million workdays are lost annually secondary to this com-
to be 1%. In 2002, about 900,00 cases of VTE were documented in plication. Moreover, about two thirds of patients with a history of
U.S. hospitals, and pulmonary embolism was the cause of death in DVT will suffer another DVT if they undergo a subsequent oper-
nearly 300,000 patients. About 34% of these latter individuals pre- ative procedure. Another DVT complication is paradoxic stroke,
sented as sudden death, thereby denying the clinician any oppor- which may occur if the patient has a patent foramen ovale (pres-
tunity for treatment. Nearly one third of these cases occurred in ent in 25% of the population). If a clot forms in the legs or pelvis
the community following hospital discharge. Chronic pulmonary and embolizes to the right ventricle, then the right atrium may
hypertension occurred in at least 4% of patients who survived a become dilated. This event can open the foramen so that the clot
pulmonary embolus and has especial importance in the bariatric is able to migrate into the left atrium and then to the brain, caus-
group, because they often have underlying pulmonary abnormal- ing a nonhemorrhagic stroke. At least one autopsy study impli-
ities. In light of these notable morbidity and mortality statistics, cated the presence of a patent foramen ovale in 50% of patients
and the fact that the bariatric patient is at a high risk for this com- suffering this type of stroke who were younger than 60 years of
plication, this chapter will be devoted to the prophylaxis of VTE. age.
Morbidly obese surgical patients are at increased risk of VTE;
this risk is increased further by the presence of venous stasis syn-
THE PROBLEM OF VENOUS THROMBOEMBOLISM drome, a comorbid condition common to this patient group.
Venous stasis syndrome, as defined by pitting leg edema, venous
A recent analysis determined that only 85% of surgical patients stasis ulcers, or pretibial bronze edema, has been associated with
with four or more VTE risk factors received any sort of post- a 4% incidence of fatal pulmonary emboli (PE). The fatal PE rate
operative thrombosis prophylaxis. This fact is concerning when in patients without this syndrome has been shown to be 0.2%.
one considers that the American College of Chest Physicians Patients with venous stasis syndrome have a markedly elevated
(ACCP) chest guidelines have estimated that patients with more mortality risk secondary to VTE, and their overall perioperative
than four risk factors for thrombosis have a postoperative mor- mortality rate is double that seen in patients without the syndrome.
tality rate as high as 5%. These guidelines, which have been pub- In addition, the incidence of postoperative leak, peritonitis, major
lished every other year for over a decade, are based on the data wound infection, and incisional hernia has been shown to be
from about 900 scientific articles. It is conceivable that the lack of significantly higher in patients with venous stasis syndrome.
compliance with VTE prophylaxis is secondary to the clinicians Interestingly, the presence of morbid obesity may exacerbate
fear of postoperative bleeding when anticoagulant prophylaxis is the manifestations of venous stasis syndrome. For example, a
used. The available data do not support this concern, though; a venous stasis ulcer in a morbidly obese patient which fails to heal
controlled trial in 2005 which employed 23,000 surgical patients with compression therapy or skin grafting commonly will heal
and compared postoperative LMWH (low-molecular-weight after major weight loss is achieved. It has been postulated that
heparin) versus unfractionated heparin did not document any the increased pressure of the abdominal pannus reduces venous
deaths from bleeding; furthermore, anticoagulant prophylaxis return to the heart, thereby increasing venous pressure in the
using either drug reduced the incidence of death. In retrospect extremities. In support of this idea is the observation of increased
it is not clear why some clinicians do not use VTE prophylaxis urinary bladder pressure in morbidly obese patients that typically
more uniformly. Sudden death from VTE is not treatable, while returns to normal 1 year after a bariatric procedure. The interplay

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SECTION II Stomach

of morbid obesity with venous stasis syndrome, and the associ- of the drug among clinicians. The disadvantages of unfraction-
ated risk for VTE, emphasizes the need to inform patients about ated heparin include poorly predictable bioavailability, resis-
the consequences of the venous stasis syndrome, as well as the tance in some patients, need for frequent administration, and the
clinicians need to minimize the thromboembolic complications development of the relatively rare but potentially disastrous com-
of this syndrome. plication known as heparin-induced thrombocytopenia (HIT).
The incidence of VTE in hospitalized patients has attracted In this syndrome the heparin actually causes the platelets to
the attention of national groups such as The National Quality clump, resulting in widespread thrombosis (and occasionally
Forum, which introduced a policy (Safe Practice 17) stating that even death). The incidence of HIT in a recent meta-analysis was
each patient should be evaluated upon admission, and period- 2.6% for unfractionated heparin and 0.2% for LMWH. LMWH
ically thereafter, for the risk of developing deep vein thrombo- agents have increased the utilization of thrombosis prophylaxis.
sis and/or pulmonary embolism. Furthermore clinicians should Compared to unfractionated heparin, these heparin derivatives
utilize clinically appropriate methods to prevent DVT and PE. have improved bioavailability when injected subcutaneously and
Currently, the Joint Commission on Accreditation of Healthcare show stable dose-response curves; these qualities improve the
Organizations is piloting measures to document compliance with clinical utility of these drugs compared with unfractionated hep-
Safe Practice 17, and mandatory measures soon may be intro- arin. Although the proper dosing scheme has yet to be worked
duced. The goal of the Surgical Care Improvement Project is to out, it is likely that the usual dose for prophylaxis in the typical
reduce rates of preventable surgical morbidity and mortality by general surgical patient will not be adequate for the typical bariat-
25% by the year 2010. This organization has endorsed voluntary ric surgical patient (see the section, Recommendations).
hospital reporting on (1) the proportion of patients who receive
recommended VTE prophylaxis, and on (2) the proportion of Vena Cava Filter
patients who receive recommended VTE prophylaxis within 24
hours before or after surgery. Currently only voluntary report- The indications for preoperative vena cava filter insertion in the
ing is required, but mandatory reporting soon may be necessary. bariatric surgical patient has included those with a past history
In addition, the next step likely will be a pay-for-performance of VTE or pulmonary hypertension. The concept of routine fil-
clause; so if compliance with VTE prophylaxis is not achieved, ter utilization in the super-morbidly obese bariatric patient (vari-
then reduced payments for services will occur for both the ably defined as BMI over 50 kg/m2), however, has represented a
hospital and physician. change in clinical practice; but this additional indication has been
supported by data that indicate a 10% incidence of fatal pulmo-
nary emboli in the subgroup of patients with a BMI greater than
TECHNIQUES OF VTE PROPHYLAXIS 55 kg/m2. If vena cava filter placement is routine in this patient
group, then the incidence of fatal pulmonary emboli drops to
Current prophylactic measures to prevent VTE in bariatric zero. Filter placement is not a benign procedure, however, and
patients include intermittent pneumatic compression, anticoagu- some protection from PE is offset by the morbidity associated
lation, and the vena cava filter. The primary intention of the first with the placement. The size of the patient (including a mas-
two treatments is to prevent thrombotic events, while the inten- sive abdominal pannus), the difficulty in obtaining good-quality
tion of filter placement is to prevent pulmonary embolism. fluoroscopic images, and the need to selectively catheterize the
renal veins are some of the issues that complicate filter place-
Intermittent Pneumatic Compression ment in these patients. Further study is needed to help resolve
these issues.
Intermittent pneumatic compression (IPC) is an essential prophy-
lactic modality in the morbidly obese patient undergoing a bariat-
ric procedure. The value of IPC has been demonstrated in clinical
trials both when used alone and when combined with anticoagu- RECOMMENDATIONS
lants. When combination therapy is used, very low thrombosis In order to tailor prophylaxis to the individual patient, includ-
rates have been achieved in the general surgical patient. There are ing the modality and length of prophylaxis, individual risk assess-
specialized IPC sleeves designed for the bariatric surgical patient; ment for VTE is important. We use a form that summarizes a
these devices should be fitted before the start of anesthesia and comprehensive history and physical examination, outlining the
should be continued until the patient is discharged from the hos- factors that could predispose the patient to thrombosis. Each fac-
pital. The IPC sleeves may be removed for ambulation only; at all tor is weighted according to the relative incidence of thrombosis
other times the patient should wear them. seen with that factor in controlled trials. A prospective validation
of this treatment schema is underway at our institution. Variants
Anticoagulation of this form for the preoperative assessment of VTE risk have
Studies in general surgery cancer patients demonstrated that been in use by the author since 1988; in addition, this form is
the administration of a LMWH for the first 30 days postopera- easily modified for the bariatric surgical patient (Fig. 10-1).
tively produces a reduction in total VTE compared to 7 days of All patients should be fitted preoperatively with appropriate
LMWH. At least 12 trials in orthopedic patients demonstrated antiembolism stockings and intermittent pneumatic compres-
that using a variety of anticoagulants for 30 days produced a low- sion devices. These devices should be worn at all times before,
ered incidence of deep venous thrombosis. The use of small doses during, and after surgery, unless the patient is fully ambula-
of unfractionated heparin for thrombosis prophylaxis in general tory. All patients should receive LMWH (40 mg once every 12
surgery has been employed since the 1970s. The advantages of hours), beginning 12 hours after completion of the procedure
this drug include a short half-life, the ability to measure the drugs and lasting for at least 10 days. We recommend the 40-mg dose
effect, the ability to reverse the drugs effect, and the familiarity of LMWH in all bariatric surgical patients unless a contraindication

92
CHAPTER 10 Risk Assessment as a Guide to Thrombosis Prophylaxis

exists. Those individuals with additional risk factors but no with positive markers, multiple risk factors, BMI greater than
venous stasis or past history of VTE (high-risk group) should 50 kg/m2, or venous stasis syndrome) should undergo preopera-
receive this LMWH therapy for at least 30 days. A bilateral leg tive insertion of a permanent vena cava filter, in addition to 30
duplex scan should be done on postoperative day 30 as a sur- days of LMWH. We do not yet recommend removable filters,
vey for asymptomatic clots. Finally, the highest risk patients because long-term results are not available in the bariatric
(i.e., those with a past history of VTE, a family history of VTE surgical group.

VENOUS THROMBOEMBOLISM RISK FACTOR ASSESSMENT

Patients Name:___________________ Age: ___ Sex: ___ Wgt:___ pounds

Choose all that apply

Each risk factor represents 1 point Each risk factor represents 2 points
Age 4160 years Age 6074 years
Minor surgery planned Major surgery (>60 min)
History of prior major surgery Arthroscopic surgery (>60 min)
Varicose veins Laparoscopic surgery (>60 min)
History of inflammatory bowel disease Previous malignancy
Swollen legs (current) Central venous access
Obesity (BMI > 30 kg/m2) Morbid obesity (BMI > 40 kg/m2)
Acute myocardial infarction (<1 month)
Congestive heart failure (<1 month)
Each risk factor represents 5 points
Sepsis (<1 month)
Serious lung disease incl. pneumonia Elective major lower extremity
(<1 month) arthroplasty
Abnormal pulmonary function (COPD) Hip, pelvis or leg fracture (<1 month)
Medical patient currently at bed rest Stroke (<1 month)
Leg plaster cast or brace Multiple trauma (<1 month)
Other risk factors _________________ Acute spinal cord injury (paralysis)
(<1 month)
Each risk factor represents 3 points Major surgery lasting over 3 hours

Age over 75 years


For women only (each represents 1 point)
Major surgery lasting 23 hours
BMI >50 (venous stasis syndrome) Oral contraceptives or hormone
History of SVT, DVT/PE replacement therapy
Family history of DVT/PE Pregnancy or postpartum (<1 month)
Present cancer or chemotherapy History of unexplained stillborn infant,
Positive factor V Leiden recurrent spontaneous abortion (3),
Positive prothrombin 20210A premature birth with toxemia or
Elevated serum homocysteine growth-restricted infant
Positive lupus anticoagulant
Elevated anticardiolipin antibodies
Heparin-induced thrombocytopenia (HIT)
Other thrombophilia
Type ____________________________

Total risk factor score


Please see following page for prophylaxis safety considerations

VTE risk and suggested prophylaxis for surgical patients

Total risk Incidence


Risk level Prophylaxis regimen Legend
factor score of DVT
No specific measures;
01 <10% Low risk
early ambulation
ESElastic stockings
ES, IPC, LDUH (5000U BID), IPCIntermittent pneumatic
2 1020% Moderate risk
LMWH (<3400 U) compression
IPC, LDUH (5000U TID), or LDUHLow-dose unfractionated
34 2040% High risk heparin
LMWH (>3400U)
LMWHLow-molecular-weight
Pharmacological: LDUH, heparin
4080%
LMWH (>3400 U),* Warfarin,* FXa IFactor X inhibitor
5 or more 15% Highest risk
or FXa I* alone or in
mortality
combination with ES or IPC

* Use for major orthopedic surgery

FIGURE 10-1 Form for the preoperative risk assessment and prophylaxis of venous thromboembolism (VTE). DVT, deep vein thrombosis; PE, pulmonary embolism; SVT,
superficial vein thrombosis.
Continued

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SECTION II Stomach

Prophylaxis safety considerations: Check box if answer is YES

Anticoagulants: Factors associated with increased bleeding


Is patient experiencing any active bleeding?
Does patient have (or has had history of) heparin-induced thrombocytopenia?
Is patients platelet count <100,000/mm3?
Is patient taking oral anticoagulants, platelet inhibitors (e.g., NSAIDs, clopidogrel, salicylates)?
Is patients creatinine clearance abnormal? If yes, please indicate value ___________
If any of the above boxes are checked, the patient may not be a candidate for anticoagulant therapy and
you should consider alternative prophylactic measures: elastic stockings and/or IPC
Intermittent pneumatic compression (IPC)
Does patient have severe peripheral arterial disease?
Does patient have congestive heart failure?
Does patient have an acute superficial/deep vein thrombosis?
If any of the above boxes are checked, then patient may not be a candidate for intermittent compression
therapy and you should consider alternative prophylactic measures.

Based on Geerts WH et al: Prevention of venous thromboembolism. Chest 2004;126(suppl 3):338S-400S; Nicolaides AN
et al: 2001 International Consensus Statement: Prevention of Venous Thromboembolism, Guidelines According to Scientific
Evidence; Arcelus JI, Caprini JA, Traverso CI: International perspective on venous thromboembolism prophylaxis in surgery.
Semin Thromb Hemost 1991;17(4):322-5; Borow M, Goldson HJ: Postoperative venous thrombosis. Evaluation of five
methods of treatment. Am J Surg 1981;141(2):245-51; Caprini JA, Arcelus I, Traverso CI et al: Clinical assessment of
venous thromboembolic risk in surgical patients. Semin Thromb Hemost 1991;17(suppl 3):304-12; Caprini JA, Arcelus JI
et al: State-of-the-art venous thromboembolism prophylaxis. Scope 2001;8:228-240; Caprini JA; Arcelus JI, Reyna JJ:
Effective risk stratification of surgical and nonsurgical patients for venous thromboembolic disease. Semin Hematol
2001;38(2)Suppl 5:12-19; Caprini JA: Thrombosis risk assessment as a guide to quality patient care. Dis Mon 2005;
51:70-78; Oger E: Incidence of venous thromboembolism: A community-based study in Western France. Thromb Haemost
2000; 657-660; Turpie AG, Bauer KA, Eriksson BI et al: Fondaparinux vs. Enoxaparin for the prevention of venous
thromboembolism in major orthopedic surgery: A meta-analysis of 4 randomized double-blind studies. Arch Intern Med
2002;162(16):1833-40; Ringley et al: Evaluation of intermittent pneumatic compression boots in congestive heart failure.
Am Surg 2002;68(3):286-9; Morris et al: Effects of supine intermittent compression on arterial inflow to the lower
limb. Arch Surg 2002;137(11):1269-73; Sugerman HJ et al: Ann Surg 2001;234(1):41-46.
REVISED NOVEMBER 4, 2006.
THIS DOCUMENT IS FOR EDUCATIONAL PURPOSES ONLY AND THE OPINIONS EXPRESSED ARE SOLELY THOSE
OF THE AUTHOR.

Examiner _____________________________________________ Date ________________

FIGURE 10-1 CONTD.

Geerts WH, Pineo GF, Heit JA, et al: The seventh ACCP conference on antithrombotic
Suggested Reading and thrombolytic therapy. Chest 2004;126(Suppl 3):338S400S.
Hamad GG, Choban PS: Low molecular weight heparin prophylaxis (PROBE study).
Bergqvist D, Agnelli G, Cohen AT: Duration of prophylaxis against venous
Obesity Surg 2002;15:13681374.
thromboembolism with enoxaparin after surgery for cancer. N Engl J Med
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tionated and low molecular weight heparin thromboprophylaxis: A meta-analysis.
Caprini JA (guest editor): Venous thromboembolism. Disease-a-Month Monograph
Blood 2005;106(8):27102715.
2005;51(23):6869.
Scholten DJ, Hoedema RM, Scholten SE: A comparison of two different prophylactic
Carmody BJ, Sugerman HJ, Kellum JM, et al: Pulmonary embolism complicating
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Sugerman HJ, Sugerman EL, Wolfe L, et al: Risks and benefits of gastric bypass
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