Long-Term Outcome of Inferior Vena Cava Filter Placement in Patients Undergoing Gastric Bypass

Long-Term Outcome of Inferior Vena Cava Filter Placement in Patients Undergoing Gastric Bypass

Long-Term Outcome of Inferior Vena Cava Filter Placement in Patients Undergoing Gastric Bypass Nicholas J. Gargiulo III, 1 David J. O’Connor,1 Frank J...

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Long-Term Outcome of Inferior Vena Cava Filter Placement in Patients Undergoing Gastric Bypass Nicholas J. Gargiulo III, 1 David J. O’Connor,1 Frank J. Veith,2,3 Evan C. Lipsitz,1 Pratt Vemulapalli,1 Karen Gibbs,1 and William D. Suggs,1 Bronx and New York, New York; Cleveland, Ohio

Background: It has been well established that inferior vena cava (IVC) filter placement at the time of open gastric bypass (OGB) surgery in patients with a body mass index of more than 55 kg/m2 reduces both the pulmonary embolism rate and the perioperative mortality. However, little is known about the long-term effects of IVC filter placement in this particular group of patients. Methods: Over an 8-year period, a total of 571 morbid obese patients underwent OGB procedures, and 58 (10%) of them required placement of an IVC filter before their procedure. All IVC filters were placed percutaneously through a femoral vein approach using a portable OEC fluoroscope. Types of IVC filters used in our study included the TrapEase (n ¼ 35), Simon-Nitinol (n ¼ 9), Greenfield (n ¼ 2), and Bard Recovery (n ¼ 12). Results: Of the 58 patients who required an IVC placement, 56 remained free of any thromboembolic phenomena over the 8-year period (range, 1-8 years). The remaining two patients developed deep venous thrombosis. One patient was successfully treated with intravenous heparin and a 6-month course of Coumadin. She had complete resolution of her deep venous thrombosis and was incidentally noted to have a prothrombin 20210 gene mutation. The other patient, who had multiple gastric bypass complications, could not be successfully treated with intravenous heparin and thus progressed on to complete IVC thrombosis. She developed phlegmasia cerulea dolens and required bilateral above-the-knee amputations. She subsequently died 3 months after her procedures. Conclusion: It appears that IVC filter placement at the time of OGB surgery is a relatively benign intervention with a maximal benefit. A note of caution should be exerted for those obese patients who have a hypercoagulable disorder and for those who have complications related to the gastric bypass. An aggressive posture, which may consist of immediate anticoagulation after their procedures (only when it is deemed safe), should be advocated in this small sub-group of morbid obese patients.

INTRODUCTION 1

Divisions of Vascular and Bariatric Surgery, Department of Surgery, Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, NY. 2 3

Division of Vascular Surgery, The Cleveland Clinic, Cleveland, OH. Department of Surgery, New York University, New York, NY.

Correspondence to: Nicholas J. Gargiulo III, MD, Department of Surgery, Montefiore Medical Center, Albert Einstein College of Medicine, 3400 Bainbridge Avenue, 4th floor, Bronx, New York 10467, USA, E-mail: [email protected] Ann Vasc Surg 2010; 24: 946-949 DOI: 10.1016/j.avsg.2010.05.004 Ó Annals of Vascular Surgery Inc.

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The importance of inferior vena cava (IVC) filter placement in a select group of high-risk super-obese patients undergoing gastric bypass surgery has been previously established.1-5 IVC filter placement prevents pulmonary embolism and indirectly the morbidity and mortality associated with this untoward event.1,2 Our previous work prospectively matched super morbidly obese patients with body mass indices (BMI) greater than 55 kg/m2 to either preoperative IVC filter placement versus no intervention just before open gastric bypass (OGB)

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Table I. Comparison of PE-related morbidity and mortality rates in morbidly obese patients (BMI ¼ >55) receiving an IVC filter versus a matched control group Group

Number of patients

BMI >55 kg/m2

IVC filters

PE rate (%)

PE mortality (%)

IVC filter Control

17 18

17 18

17 0

0 28

0 11

PE, pulmonary embolism; BMI, body mass index; IVC, inferior vena cava.

surgery performed between 2003 and 2005. The control group included 18 patients, with 5 (28%) developing a pulmonary embolus (PE) and 2 (11%) dying from a PE. The group treated with IVC filters had no PEs or PE-related deaths (Table I).2 These observations helped establish a survival benefit for super morbidly obese (BMI ¼ >55 kg/m2) patients receiving a preoperative IVC filter during the perioperative period. Despite the apparent short-term perioperative benefits of IVC filter placement, the procedure has several potential disadvantages including filter migration, perforation, thrombosis, and recurrent small emboli syndrome.6,7 These long-term complications are influenced by both patient and device characteristics. Several well-established reports have determined the safety and efficacy of IVC filter placement in a variety of clinical situations involving trauma victims and pediatric patients.6,7 There have been no reports on morbid obese patients undergoing OGB surgery. Our objective was to report on the long-term effects of IVC filter placement on super-obese patients who underwent an OGB surgery.

METHODS Placement of IVC Filter All patients in whom IVC filters were placed at the time of their open Roux-en-Y gastric bypass surgery between 1999 and 2005 had a BMI of more than 55 kg/m2, or a history of deep venous thrombosis (DVT), PE, or pulmonary hypertension, and they were placed on a Skytron Heavy Duty 6500 fluoroscopic table that was reversed (Skytron, Grand Rapids, MI). A cephalad extension was added to the ‘‘head’’ (‘‘original foot’’) of the table to permit imaging of the patient’s abdomen. Imaging was performed using a portable OEC 9800 digital fluoroscope (GE, Wauwatosa, WI). A transfemoral puncture was made with an 18-G needle, and a Magic Torque (Boston Scientific, Watertown, MA) wire was fluoroscopically guided into the IVC. The needle was then exchanged for a 6F, 7F, or 12F sheath supplied by the TrapEase (Cordis,

Warren, NJ), Simon-Nitinol (Nitinol Medical Technologies, Boston, MA), Greenfield (Boston Scientific) or Bard Recovery (Nitinol Medical Technologies) IVC filter systems, respectively. Vena cavography was performed to measure IVC diameter, confirm patency, and identify the confluence of the iliac veins. Selective left and right renal venography was then performed using a Cobra 1 (C1) catheter (Cook, Bloomington, IN). A TrapEase (n ¼ 35), Simon-Nitinol (n ¼ 9), Greenfield (n ¼ 2), or Bard Recovery (n ¼ 12) filter was then deployed into the infrarenal IVC under fluoroscopic control. Completion venography after IVC filter deployment confirmed filter position as well as patency of the IVC and renal veins.

Study Design Indications for IVC filter placement included a BMI of more than 55 kg/m2, a previous history of DVT, PE, or pulmonary hypertension (mean pulmonary artery pressure ¼ >40 mm Hg) as measured by noninvasive echocardiography or SwaneGanz catheterization.1-5 These indications for IVC filter placement were selected on the basis of previous work conducted by our group and others.1-5 On the basis of these indications, 58 (10%) patients had IVC filters placed at the time of surgery. All the patients in our study underwent routine pre- and postoperative lower extremity venous duplex examination and postoperative abdominal radiographs. Two bariatric surgeons and three vascular surgeons performed all of the OGB procedures and IVC filter placements. Additionally, all of the patients received systemic compression devices, and weight-adjusted subcutaneous heparin (50 U/kg of actual body weight) injection preoperatively and every 12 hours postoperatively until they were ambulating for more than 4 hours/day. Routine perioperative pulmonary angiography, spiral computed tomography scanning, or ventilation-perfusion scanning was performed if the patient showed clinical after-effects of a PE. Pulmonary emboli were documented by carrying out a spiral tomography, ventilation-perfusion scan, or

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Table II. Characteristics of patients receiving preoperative IVC filters Variable

Number of patients, N ¼ 58 (Percent of total)

Age (mean ± SD) Female Male BMI, kg/m2 (mean ± SD) Before PE/DVT Pulmonary hypertension Diabetes mellitus Hypertension

37 36 22 62 9 6 41 46

±6 (62) (38) ±4 (16) (10) (71) (79)

IVC, inferior vena cava; SD, standard deviation; BMI, body mass index; PE, pulmonary embolus; DVT, deep venous thrombosis.

post-mortem autopsy within the perioperative period (30 days postoperatively).

RESULTS A total of 58 IVC filters were successfully placed in the infrarenal IVC in 58 OGB patients (100% technical success rate). The patients’ characteristics are depicted in Table II. The average additional operating room time for IVC filter placement was 20 ± 5 minutes. Average fluoroscopic time was 3 ± 1 minutes, and the average amount of contrast used was 30 ± 10 mL. There was minimal blood loss and no intraoperative complications. Duplex Sonography Postoperative duplex sonography revealed the development of a postoperative insertion-site DVT in the common femoral vein of two patients. These DVTs were diagnosed at 3-month follow-up. Abdominal Radiography Routine abdominal radiography revealed no evidence of filter tilt (greater than 15 of rotation from the vertical axis of the IVC), migration, or strut malposition. Radiography was performed during outpatient follow-up between 6 months to 1 year after insertion. Clinical Follow-up Median follow-up time was 65 ± 12 months (range, 12-96 months). One of the 58 filters was retrieved during clinical follow-up. This was a Bard Recovery filter removed 1 year later, and there were no complications related to its recovery. One patient diagnosed with a common femoral vein thrombosis was successfully treated with intravenous heparin

and coumadin. This patient had a prothrombin 20210 gene mutation and was maintained on lifelong coumadin. The other patient could not be successfully treated with heparin. She developed bilateral venous thrombosis which progressed to symptomatic IVC thrombosis manifested by phlegmasia cerulea dolens. Despite bilateral fasciotomies and venous thrombectomy, the patient still required bilateral above-the-knee amputations. She ultimately died after 3 months of hospitalization from complications related to the gastric bypass procedure.

DISCUSSION Morbid obesity continues to be a national health concern.8-10 There continues to be an increased prevalence in the United States.8 Gastric bypass surgery has been advocated to help mitigate the co-morbidities associated with obesity.10-13 This study confirms the long-term safety of IVC filter placement in super-obese patients undergoing OGB surgery. The perioperative benefit has been previously established with the prevention of pulmonary embolism and the associated mortality.1-5 This study elucidates some of the long-term consequences that IVC filter placement manifests in super-obese patients. Although the majority of patients undergoing OGB appear to benefit from this intervention, a small cohort may still develop significant complications despite filter placement. These patients manifest both hypercoagulability and/or morbid obesity surgical complications. The two patients in this study who developed complications related to IVC filter placement had a prothrombin 20210 gene mutation and gangrenous cholecystitis, respectively, resulting in either deep venous or inferior vena caval thrombosis. Several published reports have described the long-term safety and efficacy of IVC filter placement in trauma, neurosurgical, and pediatric patients.6,7 Several studies have also evaluated these important attributes using a variety of IVC filters.1,2,5,14 Previous studies have reported a slightly higher vena cava thrombosis rate with the TrapEase filter because of its design.14 The patient with the IVC thrombosis in our study too had a TrapEase filter placement. Insertion-related femoral vein thrombosis was presumed to result from femoral vein puncture. Both thrombosis occurred in patients having the TrapEase filter despite the low profile of its introducer sheath. It is evident that technical factors, which might preclude insertion-related thrombosis, fail to mitigate the influential effects of hypercoagulability. The presence of a hypercoagulable disorder

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clearly represents an important contributor to these thrombotic disorders as observed in this study. Gastric bypass complications may also result in transient periods necessitating discontinuation of subcutaneous heparin and systemic compression devices. These difficult clinical situations may induce a transient hypercoagulable disorder resulting in DVT or IVC filter thrombosis. One patient who had an IVC thrombosis, also developed hypovolemia and gangrenous cholecystitis requiring cholecystectomy and temporary discontinuation of subcutaneous heparin. This combination of hypovolemia and infection may have resulted in the thrombosis. Successful management of DVT was possible in one patient. Thrombolytic therapy was not used to treat the underlying thrombosis because of the antecedent risks. This patient remains to be well because of Coumadin and compression stockings, and has minimal chronic venous insufficiency. Despite an aggressive management of the other patient with the IVC thrombosis by using thrombolytic therapy and venous thrombectomy, success was not achieved. Her co-morbidities were too severe to mitigate any process of ongoing thrombosis. Bilateral above-the-knee amputations were inevitable for any chance of survival. With the advent of laparoscopy, the amount of bariatric procedures being performed through the laparoscopic technique has increased tremendously. A previous retrospective review by our institution has established a relatively low rate of PE in patients with a BMI >55 kg/m2, with only 1 of 109 patients developing an event without a filter.1 For institutions still performing OGB surgery, or for patients whose circumstances require an open technique, this study helps establish a clear long-term survival benefit with preoperative IVC filter placement for patients with a BMI over 55 kg/m2, or a history of PE, DVT, or pulmonary hypertension.

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