- Email: [email protected]
Venous Conduits Have Superior Patency Compared with Prosthetic Grafts for Femorofemoral Bypass
Accepted Manuscript Venous conduits have superior patency compared to prosthetic grafts for femorofemoral bypass Khanh Nguyen, Gregory Moneta, Gregory Landry PII:
S0890-5096(18)30363-7
DOI:
10.1016/j.avsg.2018.03.024
Reference:
AVSG 3856
To appear in:
Annals of Vascular Surgery
Received Date: 21 October 2017 Revised Date:
8 March 2018
Accepted Date: 19 March 2018
Please cite this article as: Nguyen K, Moneta G, Landry G, Venous conduits have superior patency compared to prosthetic grafts for femoro-femoral bypass, Annals of Vascular Surgery (2018), doi: 10.1016/j.avsg.2018.03.024. This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.
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Venous conduits have superior patency compared to prosthetic grafts for femoro-femoral
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bypass
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Authors: Khanh Nguyen, Gregory Moneta and Gregory Landry
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Division of Vascular Surgery, Knight Cardiovascular Institute, Oregon Health & Science
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University, Portland, Oregon
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Corresponding Author:
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Khanh Nguyen
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Division of Vascular Surgery, Knight Cardiovascular Institute
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Oregon Health & Science University
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Portland, Oregon, 97239
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Phone: 503-494-7593
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Fax: 503-494-4324
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Email: [email protected]
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Abstract
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Objective: To compare outcomes of externally supported polytetrafluoroethylene (PTFE) grafts
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and femoral vein as conduits for femoro-femoral crossover grafts.
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Methods: This is a retrospective review of consecutive femoro-femoral crossover grafts at our
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institution between January 2005 and March 2016. Patient demographics, indications,
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complication rates, patency rates and survival rates were compared between femoro-femoral
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grafts created with either PTFE or femoral vein conduits, autogenous or cryopreserved.
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Results: 119 femoro-femoral crossover bypasses (89 PTFE, 30 vein (18 autogenous and 12
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cryopreserved femoral veins) were performed. Most patients underwent isolated femoro-femoral
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bypass alone (76% isolated femoro-femoral bypass versus 24% axillo-bifemoral bypass). A
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greater proportion of patients who received vein grafts were female (PTFE 37% vs vein 60%,
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P=.028) and had prior bypasses (PTFE 33% vs vein 73%, p<0.001).
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PTFE bypasses were performed primarily for chronic limb ischemia (61.8%), while most venous
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bypasses were for infections (80%, P<.001). Femoral vein conduits were used in cases of
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infected aortic or extra-anatomical grafts (N=20) or groin infection (N=5). The 30-day
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complication rate was 38.7% and was not different between groups (36% for PTFE, 44.4% for
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autologous vein grafts and 50% for cryovein, P=.33) with wound complications being most
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frequent (18% PTFE, 27.8% autologous vein, 16.7% cryovein, P=.25). Patients receiving vein
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grafts were more likely to receive blood transfusion (34.8% PTFE vs 70% vein, P=.001).
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Overall, median follow up was 9.8 months (range 0-107). Primary patency rates at 1, 2 and 3
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years were 83.7 %, 73.7% and 69.8%, respectively, for PTFE bypasses, and 100% for all time
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points for venous grafts, respectively (Log rank, P=.03). Primary assisted and secondary patency
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rates were not significantly different between the two groups (Log rank, P=.16). Survival rates at
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1, 2 and 3 years were 82%, 76.4% and 69.7%, respectively, for patients with PTFE grafts versus
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76.7%, 73.3% and 55%, respectively, for patients with vein grafts, respectively (Log rank,
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P=.17).
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Conclusions: While the indications for procedure differed in this series, femoral veins in
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femoro-femoral bypasses have overall superior primary patency and similar complication rates
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compared to PTFE grafts. Based on this series, femoral vein, either autologous or cryopreserved,
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appears to be a suitable conduit for femoro-femoral bypasses, and in some cases may be the
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preferred conduit.
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Keywords: femoro-femoral bypass grafts, peripheral arterial disease, PTFE, vein, patency
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Introduction Trans-femoral subcutaneously tunneled femoro-femoral bypass grafts were initially
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devised for elderly patients with unilateral iliac occlusive disease and for patients with
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significant comorbidities that prohibited open surgery. Dr. R. Mark Vetto at the University of
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Oregon Medical School and Veteran Affairs Portland Healthcare System in Portland, Oregon
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reported the first femoro-femoral bypass in 19601-3. Since then the utility of the femoro-femoral
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bypass has expanded beyond initial indications of high risk patients with unilateral iliac
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occlusive disease. Femoro-femoral bypasses are useful as adjunctive procedures to axillo-
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femoral bypasses for aorto-iliac occlusive disease, infected aorto-femoral prosthetic bypasses or
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in cases where patients with intra-abdominal sepsis require suprainguinal revascularization. In
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addition, patients who are not anatomic candidates for endovascular repair or who have had
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failed attempts of endovascular iliac artery stenting are also candidates for femoro-femoral
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bypass. Femoro-femoral bypass may also be an adjunct procedure to aorto-uni-iliac grafts as an
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endovascular approach to aortic aneurysm repair. Despite advances in endovascular approaches
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for aorto-iliac revascularization, the femoro-femoral bypass remains a useful and important
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procedure in situations where an endovascular approach is not feasible or for patients who cannot
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tolerate general anesthesia or open surgery.
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The patency of femoro-femoral bypasses has been evaluated in previous retrospective
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studies4-19. Femoro-femoral bypasses can be created using polytetrafluoroethylene (PTFE) or
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Dacron grafts, autogenous femoral vein or cryopreserved femoral vein. The ideal conduit to use
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for femoro-femoral bypass is unknown. This study compares the patency of femoro-femoral
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bypasses created with either externally supported PTFE graft or femoral vein, specifically either
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autogenous femoral vein harvested from the patient or commercially prepared cryopreserved
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femoral vein from a deceased donor. The objective of this study is to directly compare the patency and clinical outcomes after
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femoro-femoral bypasses created with prosthetic PTFE graft versus femoral vein conduit.
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Material and Methods
This retrospective study was approved by Oregon Health & Science University (OHSU)
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Institutional Review Board and these methods are consistent with the Declaration of Helsinki. As
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this was a retrospective review, informed consent was waived. All femoro-femoral and axillo-
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bifemoral bypasses performed at OHSU from January 2005 to March 2016 were reviewed for
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indication for procedures, complications, conduit patency and patient survival. Conduits used for
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bypass include prosthetic PTFE graft, autogenous femoral vein and commercially supplied
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cryopreserved femoral vein. The choice of conduit was at the discretion of the operating surgeon
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based on the specific clinical circumstances of each patient. All conduits were tunneled supra-
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pubically above the inguinal ligament. For femoral vein conduits, meticulous attention during
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tunneling was paid to ensure adequate space for and prevent kinking of the graft and avoid
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external compression or other issues potentially associated with an extra-fascial subcutaneous
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tunnel.
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All patients were treated postoperatively with antiplatelet therapy. Anticoagulation was
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not routine and only used in patients with documented or suspected hypercoagulability. Femoro-
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femoral bypasses were evaluated with duplex ultrasound every 3 months for the first year and
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then every 6 months for the second year. If there were no complications or concerning ultrasound
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findings suggesting significant stenosis or impending graft failure, then patients were followed
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annually with surveillance ultrasound. The following information was recorded from the electronic medical record including
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sex, smoking status, race, history of coronary disease or treatment for coronary artery disease,
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prior myocardial infarction, previous major cerebrovascular accident, diastolic or systolic
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congestive heart failure, prior or current diagnosis of atrial or ventricular arrhythmia, COPD,
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creatinine of greater than 1.5 at time of surgery, dialysis dependence at least twice a week within
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the last two weeks, diabetes mellitus requiring either oral anti-glycemics or insulin therapy,
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hyperlipidemia or current treatment for hyperlipidemia, hypertension requiring medical treatment
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with anti-hypertensives, or prior malignancy. In addition, patients were assessed for prior history
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of peripheral artery disease including claudication, rest pain or tissue loss or open vascular
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procedures including previous femoro-femoral bypass, Rutherford classification and
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hypercoagulable state defined as history of inherited hypercoagulable conditions such as Factor
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V Leiden, prothrombin gene mutation, Protein C deficiency or Protein S deficiency, history of
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cancer, antiphospholipid antibody syndrome, or a history of prior deep venous thrombosis or
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pulmonary embolism. Indications for the femoro-femoral bypass were reviewed and categorized.
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Operative times, intraoperative blood loss, transfusion requirement during perioperative period
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and length of hospital stay were compared between groups. Thirty-day complications (including
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acute congestive heart failure exacerbation requiring evaluation by cardiology consult, peri-
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operative myocardial infarction with elevated troponins and diagnosis confirmed by a
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cardiologist, peri-operative arrhythmia including atrial flutter or atrial fibrillation, pulmonary
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embolism confirmed on CT angiogram, or nosocomial pneumonia requiring antibiotic treatment,
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incisional and wound infections that required antibiotic treatment, groin hematoma or seroma)
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were categorized and compared between femoro-femoral bypasses created with PTFE and
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femoral vein. The primary, primary-assisted and secondary patency rates of femoro-femoral
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bypasses, survival rates and amputation free survival rates of patients were calculated and
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analyzed by type of conduit.
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Statistical analyses were performed using IBM SPSS Statistics (version 22) and student’s
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t-test, Chi-Square and Kaplan-Meier analyses were applied as appropriate. A P value of equal to
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or less than 0.05 was set as the level of significance.
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Results
Over an 11 year period between 2005 and 2016, our institution performed 119 femorofemoral crossover bypasses (including isolated femoro-femoral or axillo-bifemoral bypasses). Of
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these, 89 of the femoro-femoral bypasses were created using prosthetic PTFE graft and 30 were
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created using femoral vein. Of those bypasses created with femoral vein, 18 were autogenous
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femoral veins and 12 were cryopreserved femoral veins. The majority of patients underwent
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isolated femoro-femoral bypass alone (N=89, 76%) and a minority of patients underwent
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femoro-femoral bypass in conjunction with axillo-femoral bypass (axillo-bifemoral bypass)
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(N=30, 24%).
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The baseline characteristics of all patients who received bypasses (isolated femoro-
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femoral bypasses and axillo-bifemoral bypasses combined) are shown in Table IA and IB and
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compare bypasses created with prosthetic PTFE versus femoral vein. A greater proportion of
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patients who received femoral vein conduits as compared to PTFE grafts were female (PTFE
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37% vs vein 60%, P=.03), had prior vascular interventions (PTFE 62.9% vs vein 93.3%,
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p<0.001) and had prior femoro-femoral bypasses (PTFE 33% vs vein 73%, P<.001).
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The majority of isolated femoro-femoral and axillo-bifemoral bypasses were performed electively (N=80, 67.2%) while a minority were performed for either urgent or emergent
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indications (Table II). Isolated femoro-femoral and axillo-bifemoral bypasses created with
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prosthetic PTFE graft were performed primarily for chronic limb ischemia (N=55, 61.8%), while
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most venous bypasses were performed for infections (N=25, 80%, P<.001, Table II). Indications
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for isolated femoro-femoral byasses are shown in Table IIB and indications for axillo-bifemoral
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bypasses are shown in Table IIC. The Rutherford classifications were not significantly different
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between two groups by Chi-squared analysis (P>.05). Overall, approximately 18.5% (N=22) of
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all patients had claudication (PTFE 15.7% vs vein 26.7%, P=.267), 33.3% had rest pain (PTFE
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33.3% and vein 51.7%, P=.08), and 20.1% had gangrene or threat of major limb loss (PTFE
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19.1% and vein 23.3%, P=.62). The remaining 14.3% had no symptoms of claudication (PTFE
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13.5% vs vein 20.2%, P=.67).
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who received venous grafts and patients who received PTFE grafts (Table III, P>.05). Overall,
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the outflow vessels were both superficial femoral and profunda femoris arteries in 68.2% of
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patients, only the superficial femoral artery in 10.2% of patients and only the profunda femoris
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artery in 21.2% of patients.
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Operations were done with two operating teams whenever additional staff were available.
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Overall, single team and double teams were used in 66.3% (N=79) and 33.6% (N=40) of
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procedures, respectively. The use of single versus double teams were not significantly different
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between procedures using PTFE versus vein. Single teams were used in 63.3% (N=11) of
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procedures with femoral vein conduit and 67.4% (N=60) of procedures with PTFE grafts
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(P=.87).
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The overall minor and major 30-day complication rate for all bypasses (combined data for isolated femoro-femoral and axillo-bifemoral bypasses) was 38.7% (N=46) and was not
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significantly different among groups (P=.33) (Table IV). Complication rates were 44% (N=40)
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for prosthetic grafts, 44.4% (N=8) for autologous vein grafts and 50% (N=6) for cryopreserved
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femoral vein conduits. Wound complications were the most frequent type of complication for
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femoro-femoral bypass (18% (N=13) PTFE, 27.8% (N=5) autogenous vein, and 16.7% (N=2)
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cryopreserved vein, P=.25).
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Peri-operative outcomes including operative time, intraoperative blood loss and length of hospital stay are shown in Table V. Operative times, reflecting the high complexity of
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procedures, redo procedures and multiple concomitant procedures, were significantly different
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between patients who received prosthetic PTFE grafts as compared to those patients who
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received femoral vein grafts (PTFE 4.6±2.5 vs vein 6.5±3 hr, P=.002). The average number of
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concomitant procedures was 2.6±1.5 (PTFE 2.2±1.3 vs vein 3.6±1.6 hr, P=1.14). In addition,
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procedures that were performed for an indication for infection (7.6±2.8 hr) or cancer (6.6±3.4 hr)
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had significantly longer operative times compared to procedures performed for other indications
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(5.2±2.6 hr, P<0.001).
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femoral and axillo-bifemoral bypasses) created with femoral vein as compared to those bypasses
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created with PTFE, however the amount of blood loss was highly variable and not significantly
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different (PTFE 600±960 vs vein 654±570 ml, P=.77). Moreover, patients receiving femoral vein
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grafts were more likely to receive blood transfusions (PTFE 34.8% vs vein 70%, P=.001) during
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their hospitalization. The overall length of hospital stay was not statistically significant between
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patients who received femoro-femoral bypasses with graft as compared to those who received
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bypasses with femoral vein conduit, however there was a shorter but not statistically different
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length of stay for prosthetic grafts (Table V, PTFE 11.1±12 vs vein 14.9±8 days, P=.121). The overall median follow up was 9.8 months (range 0-107). Primary patency at 1, 2 and
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3 years for PTFE bypasses was 83.7 %, 73.7% and 69.8%, respectively, as compared to 100% at
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all time points for femoral vein grafts (Figure 1A, Log rank, P=.03). For all grafts (combined
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data for isolated femoro-femoral and axillo-bifemoral bypasses), primary assisted (Log rank,
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P=.08) and secondary (Log rank, P=.74) patencies at 1, 2 and 3 years were not significantly
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different between bypasses created with vein as compared to those created with PTFE.
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for isolated femoro-femoral and axillo-bifemoral bypasses) with a prosthetic PTFE graft versus a
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femoral vein conduit show no significant difference in survival in years (Figure 2A, Log rank,
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P=.17). Survival at 1, 2 and 3 years were 82%, 76.4% and 69.7% for patients with PTFE grafts
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and 76.7%, 73.3% and 55% for patients with femoral vein grafts, respectively (Log rank, P=.17).
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Furthermore, amputation free survival was also not significantly different between groups
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(Figure 3A, Log rank, P=.59).
A sub-analysis of isolated femoro-femoral bypasses was performed and showed no
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significant differences in primary patency at 1, 2 and 3 years (PTFE 86.8%%, 74% and 74% vs
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vein 100% for all time points, respectively; Figure 1B, Log rank, P=.40). Primary assisted
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patencies at 1 and 2 years were significantly higher with bypasses created with femoral vein
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(100% for both time points) versus those created with PTFE (87% for both time points) (Log
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rank, P=.02). Secondary patency of isolated femoro-femoral bypasses were not significantly
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different between veins and PTFE grafts (Log rank, P=1). Survival at 1, 2 and 3 years (PTFE
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79.2%, 64.5% and 54.8% vs vein 86.7%, 86.7% and 65%, respectively; Figure 2B, Log rank,
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P=.40) and amputation free survival at 1, 2 and 3 years (PTFE 93% at all time points vs vein
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87% at all time points; Figure 3B, Log rank, P=.86) between grafts created with prosthetic PTFE
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and those created with femoral vein were not statistically different. For axillo-bifemoral bypasses, a subgroup analysis was performed and showed no
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differences in patency rates (primary (Figure 1C, Log rank, P=.12), primary assisted (Log rank,
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P=.36) or secondary patencies (Log rank, P=1) at 1, 2 or 3 years, Log rank, P=1). However,
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survival was significantly higher in patients who received a PTFE conduit for the femoro-
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femoral component of an axillo-bifemoral graft as compared to patients who received a femoral
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vein conduit for the femoro-femoral component. Survival at 1, 2 and 3 years was 93.8%, 93.8%
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and 93.8%, respectively, for patients with a PTFE femoro-femoral component and 58%, 46%
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and 46%, respectively, for patients with femoral vein (Figure 2C, Log rank, P=.001). Amputation
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free survival at 1, 2 and 3 years was not significantly different in patients who received vein
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grafts for the femoro-femoral component as compared to those who received PTFE grafts for the
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femoro-femoral component (Figure 3C, Log rank, P=.21).
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Discussion
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Femoro-femoral crossover grafts were originally created using prosthetic material and have been used for over 50 years. The use of a femoral vein conduit, either autogenous femoral
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vein harvested from the patient or cryopreserved femoral vein from cadavers, is an alternative to
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a prosthetic femoro-femoral graft, particularly in settings of infection or redo surgery. In this
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study, a comparison prosthetic PTFE or femoral vein for femoro-femoral bypass showed that
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femoral vein conduits may have superior patency as compared to prosthetic PTFE grafts and no
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difference in complications.
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There are many considerations that should be evaluated prior to choosing the type of conduit for a femoro-femoral bypass. The availability and anatomic suitability, including quality
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and caliber, of autogenous vein should be evaluated. Also, there are cost differences between
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using prosthetic graft that is typically a fraction of the cost of using cryopreserved femoral vein.
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In addition, using femoral vein, may add to costs related to prolonged operative times associated
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with harvesting or preparing an autogenous femoral vein graft. Furthermore, the presence or
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suspicion of infection may preclude the use of prosthetic grafts. While autogenous femoral veins
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may be more resistant to infection, there are risks for the donor limb of the patient that should be
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considered including lower extremity edema, thigh compartment syndrome, surgical site
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infection and wound healing complications. Given these considerations and a national impetus to
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minimize overall health care costs, externally supported PTFE prosthetic grafts are the most
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frequently used conduit for femoro-femoral crossover grafts, particularly in cases of chronic limb
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ischemia. In cases of infection, however, autogenous or cryopreserved femoral vein is more often
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used as the conduit for femoro-femoral bypass.
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The choice to use a particular graft was surgeon dependent and reflected patient
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presentation and co-morbidities. While autogenous femoral vein is preferred in infected fields,
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cryopreserved femoral vein in conjunction with a muscle flap can be used in infected fields.
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Autogenous femoral vein can be used when it is available, and there are no anatomic or
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physiologic contraindications to femoral vein harvest. Contraindications to autologous femoral
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vein harvest included chronic venous disease or evidence of scarred or sclerotic veins, small vein
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diameter less than 5 mm, inadequate vein length, presence of acute or chronic thrombus, history
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of lower extremity compartment syndrome or inability to tolerate the procedure. The indications
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for femoro-femoral bypasses differed between patients who received femoral vein conduits and
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those who received prosthetic PTFE grafts. Although the two groups had similar cardiovascular
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risk factors (Table I), they had different underlying disease processes and indications for femoro-
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femoral bypass. Patients who received prosthetic grafts were more likely to be patients with
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either chronic or acute limb ischemia. This differed from patients who received femoral vein
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grafts as they were more likely to present with failure or infection of a prior prosthetic graft.
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Patients who have had prior vascular interventions using prosthetic grafts that have failed or
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became infected are likely to have subsequent procedures with femoral vein conduit as an
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alternative conduit as autologous tissue is thought to more resistant to infection. Interestingly, the
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indications for procedures were different for men and women. The most common indications for
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women were chronic limb ischemia (37.3% of cases) and infection (27.5%), whereas for men
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were acute (25.3%) and chronic limb ischemia (23.9%). This may explain the reason why
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women were more likely to receive femoral conduits than men.
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Although the femoral vein group may have had more technically challenging procedures due to a significantly higher prevalence of redo procedures and blood transfusion requirements,
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this group still had similar complication rates as compared to the prosthetic group. The most
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common complications were wound complications including surgical site infection, seroma or
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hematoma. Despite the theoretical risk for patients who receive autogenous femoral vein
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conduits to have an increased risk for wound complications from the additional incision at the
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vein harvest site, wound complications were not significantly different between groups. There
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were no immediate or short-term thrombosis complications in either group.
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Previous retrospective publications of femoro-femoral bypasses report 5 year primary patency rates ranging from 35% to 92%1-19. In this study, we report 3 year patency rates within
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this range for both femoro-femoral bypasses created with either prosthetic PTFE graft or femoral
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vein conduit. In the stratified analysis of isolated femoro-femoral bypasses, the primary assisted
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patency rates were significantly higher with bypasses created with femoral vein as compared to
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those created with PTFE. While higher primary patency for all grafts created with vein compared
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to those with PTFE graft and higher primary assisted patency for isolated femoro-femoral
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bypasses created with vein compared to those with PTFE graft are suggestive that a femoral vein
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as conduit is a superior conduit to PTFE graft, the statistical significance detected may represent
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a type I error given a small study and that the overall combined analysis showed no significant
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difference in assisted primary patency rates.
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With respect to survival, the subgroup analysis for axillo-bifemoral bypasses demonstrated decreased survival rates for patients who received femoral vein conduit as
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compared to those who received PTFE grafts. These differences in survival are likely related to
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the different indications for procedures and unmeasured confounding factors.
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As a weakness of any small retrospective review, there is potential for selection bias and confounding by indication. This is evidenced by the differences in the two groups including their
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indications for surgery, proportion of patients with prior vascular procedures, duration of
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procedure or proportion of patients who received blood transfusions. These patient groups may
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be inherently different as patients who received femoro-femoral bypasses created with veins
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were likely to have required more complex operative repair with more extensive dissection due
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to scarring from prior procedures. This hypothesis is supported by the fact that patients who
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received femoral vein conduits had significantly longer operative times and required more
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transfusions. Having all of these factors would seemingly and potentially impair patency of the
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femoral vein conduit and so the patency results perhaps can argue in favor of femoral vein for
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femoro-femoral bypass. If we ignore cases performed for the indication of infection for analysis
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purposes, it is possible that the patency rates may be different between femoro-femoral bypasses
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created with prosthetic graft or femoral vein conduit in patients for the indication of chronic limb
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ischemia; however, we were unable to perform this analysis due to inadequate sample size.
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While the retrospective nature and small sample size is a weakness of the study and may
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contribute to both type I or II error, the decreasing frequency of the procedure along with
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changes in medical management over time make it unlikely that a randomized controlled trial or
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more robustly powered single center series will occur. A multicenter registry may be necessary
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to adequately address the question of optimal conduit.
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While there may be advantages to femoral vein for femoro-femoral bypass, there are situations when autogenous vein or cryopreserved vein is not available or advisable and PTFE
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grafts remain useful conduits and likely less costly. Both types of grafts, either femoral vein or
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PTFE graft, have their inherent advantages and disadvantages depending on patient factors,
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clinical situation and indication for procedure. Femoral vein as a conduit for femoro-femoral
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bypass is clearly useful in procedures for the indication of infection or operations involving
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infected fields and the data suggest it should perform well in such circumstances.
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Conclusion
To summarize, femoro-femoral bypasses created with prosthetic PTFE grafts or those
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created with femoral vein conduits both have excellent short and midterm patency rates and have
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similar complication rates. Based on this small retrospective review, femoral vein, either
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autologous or cryopreserved, is a suitable conduit for femoro-femoral bypasses, and maybe the
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preferred conduit. In this series, we found that femoral vein grafts had superior overall primary
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patency compared to PTFE grafts.
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Acknowledgements
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We thank Rikki Samuel, Nai Saephan and Kathryn Vu for help with chart reviews and data
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abstraction.
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1. McCaughan JJ Jr, Kahn SF. Cross-over graft for unilateral occlusive disease of the ileofemoral arteries. Ann Surg 1960: 151: 26-28 (Jan). 2. Vetto RM. The treatment of unilateral iliac artery obstruction with a transabdominal
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subcutaneous, femorofemoral graft. Surgery 1962: 52: 342-345 (Aug). 3. Vetto RM. The femorofemoral shunt, an appraisal. Amer J Surg 1966: 112: 162-165
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4. Ehrenfeld WK, Levin SM, Wylie EJ. Venous crossover bypass grafts for arterial insufficiency. Ann Surg 1968: 167: 287-291 (Feb).
5. Eugene J, Goldstone J, Moore WS. Fifteen year experience with subcutaneous bypass grafts for lower extremity ischemia. Ann Surg 1977; 186: 177-183.
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6. Maini BS, Mannick JA. Effect of arterial reconstruction on limb salvage: a ten-year appraisal. Arch Surg 1978; 113: 1297-1304. 7. Flanagan DP, Pratt DG, Goodreau JJ, Burnham SJ, Yao JS, Bergan JJ. Hemodynamic and angiographic guidelines in selection of patients for femorofemoral bypass. Arch Surg
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1978; 113: 1257-1262.
369 370 371 372 373 374
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experience with femorofemoral crossover grafts. Arch Surg 1980; 115: 1359-1365.
9. Mosley JG, Marston A. Long term results of 66 femorofemoral bypass grafts: 9-year follow-up. Br J Surg 1983; 70: 631-634.
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8. Dick LS, Brief DK, Alplert J, Brener BJ, Goldenkranz R, Parsonnet V. A 12-year
10. Plechaft FT, Plecha FM. Femorofemoral bypass grafts: ten-year experience. J Vasc Surg 1984; 1: 555-561.
11. Lamerton AJ, Nicolaide AN, Eastcott HH. The femorofemoral graft: hemodynamic improvement and patency rate. Arch Surg 1985; 120: 1274- 1278.
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12. Brief DK, Brener BJ. Extra-anatomic bypasses: femorofemoral crossover grafts. In: Wilson SE, Veith FJ, Hobson RW, eds. Vascular surgery: principles and practice. New
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York: McGraw-Hill; 1987; pp. 415-418.
378 379 380 381 382
13. Harrington, ME, Harrington EB, Haimov M, Schanzer H, Jacobson JH 2nd. Iliofemoral versys femorofemoral bypass: the case for an individualized approach. J Vasc Surg 1992;
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16: 841-52.
14. Criado E, Burnham SJ, Tinsley EA Jr., Johnson G Jr., Keagy BA. Femorofemoral bypass graft: analysis of patency and factors influencing long term outcome. J Vasc Surg 1993 18: 495-504; discussion 504-505.
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15. Kim YW, Lee JH, Kim HG, Hugh S. Factors affecting the long term patency of crossover femorofemoral bypass graft. Eur J Vas Endovasc Surg 2005: 30: 376-80. 16. Pursell R, Sideso E, Magee TR, Galland RB. Critical appraisal of femorofemoral crossover grafts. Br J Surg 2005: 92: 565-9.
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17. Schneider JR, Besso SR. Walsh DB, Zwolak RM, Cronenwett JL. Femorofemoral versus
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aortobifemoral bypass: outcome and hemodynamic results. J Vasc Surg 1994: 19: 43-55.
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18. Foley WJ, Dow RW, Fry WJ. Crossover femoro-femoral bypass grafts. Arch Surg.
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1969;99(1): 83-97.
19. Mingoli A, Sapienza P, Feldhaus RJ, Di Marzo L, Burchi C, Cavallaro A. Femorofemoral
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bypass graft: factors influencing patency rate and outcome. Surgery 2001: 129: 451-8.
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Prosthetic PTFE (N=89) % N
Significance P value
Female
60%
18
37.1%
33
.03*
Smoker Caucasian Coronary artery disease Previous myocardial infarction Previous stroke Congestive heart failure Arrhythmia COPD Creatinine >1.5 Dialysis DM Hyperlipidemia Hypertension Hypercoagulable Malignancy Peripheral arterial disease Prior open vascular interventions Prior femorofemoral bypass Required transfusion during hospitalization
90% 100% 30%
27 30 9
94% 95.5% 36.0%
81 85 32
20.0%
6
21.3%
13.3% 10.0%
4 3
20.2% 12.4%
20% 30% 13.3% 0% 13.3% 36.7% 66.7% 13.3% 23.3% 80.0%
6 9 4 0 4 11 20 4 7 24
93.3%
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A. All grafts: dichotomous variables Dichotomous Femoral Vein (N=30) variables % N
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Table I. Baseline characteristics of all patients who received bypasses (either isolated femoro-femoral and axillo-bifemoral bypasses) created with either prosthetic PTFE graft or femoral vein conduit (autogenous and cryopreserved femoral vein groups combined).
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.99 .50 .47 .88
18 11
.40 .73
18.0% 21.3% 13.4% 4.5% 18.0% 43.0% 68.5% 5.6% 25.8% 74.2%
16 19 12 4 16 38 61 5 23 66
.81 .33 .98 .24 .35 .56 .72 .33 .70 .52
28
62.9%
56
.006*
73.3%
22
33%
29
.001*
70%
21
34.8
31
.001*
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B. All grafts: continuous variables Continuous Femoral Vein variables Mean SD Age (y) 65.5 8.5 Weight (kg) 68 17 BMI (kg/m2) 25.1 6
Prosthetic PTFE Mean SD 66.5 10.8 76.9 23.5 25.5 10
P value .67 .06 .83
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16.7% (N=2) 6.7% (N=2)
Infection
5.6% (N=5) 94.5% (N=17) 66.7% (N=8) 73.3% (N=25)
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B. Indications for isolated femoro-femoral grafts Conduit Chronic Acute Infection limb limb ischemia ischemia PTFE 64.4% 21.9% 4.1% (N=47) (N=16) (N=3) Autogenous 12.5% 0% 87.5% Femoral Vein (N=1) (N=7) Cryopreserved 25% 25% 50% Femoral Vein (N=2) (N=2) (N=4) Overall 18.8% 12.5% 68.8% Femoral Vein (N=3) (N=2) (N=11) C. Indications for axillo-bifemoral grafts Conduit Chronic Acute Infection limb limb ischemia ischemia PTFE 28.6% 14.3% 7.1% (N=8) (N=4) (N=2) Autogenous 0% 0% 28.6% Femoral Vein (N=8) Cryopreserved 0% 0% 14.3% Femoral Vein (N=4) Overall 0% 0% 42.9% Femoral Vein (N=12)
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Significance P value <.001*
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A. Indications for all grafts Conduit Chronic limb ischemia PTFE 61.8% (N=55) Autogenous 5.5% Femoral Vein (N=1) Cryopreserved 16.7% Femoral Vein (N=2) Overall 10% Femoral Vein (N=3)
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Table II. A. Indications for all grafts (combined data for isolated femoro-femoral and axillo-bifemoral bypasses) created with either prosthetic PTFE graft, autogenous femoral vein or cryopreserved femoral vein. Comparison of indications for prosthetic PTFE graft versus combined femoral venous conduits (autogenous and cryopreserved femoral vein groups were combined). B. Subgroup analysis for indications of isolated femoro-femoral grafts. C. Subgroup analysis for indications of axillobifemoral grafts.
0%
Other (Trauma, Malignancy) 9.6% (N=7) 0%
Significance P value <.001*
0% 0%
Other (Trauma, Malignancy) 7.1% (N=2) 0% 0% 0%
Significance P value <.001*
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Table III. Run-off of isolated femoral-femoral and axillo-bifemoral bypasses were compared for patients who received bypasses created with PTFE and those who received either autologous or cryopreserved femoral vein. Conduit Run-Off Both SFA and PFA SFA only PFA only N % N % N % Prosthetic 58 65.2 9 10.1 22 24.7 PTFE (N=89) Femoral 23 80 3 10 3 10 Vein (N=30) All Grafts 119 68.6 12 10.2 25 21..2 (N=119) Chi .17 .94 .11 Squared, P
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Table IV. Thirty-day complication rates after all grafts (combined isolated femorofemoral and axillo-bifemoral bypasses) created with either prosthetic PTFE graft or femoral vein (autogenous and cryopreserved femoral vein combined). Complication Femoral Vein Prosthetic PTFE P value % N % N Overall, any 46.7% 14 35.9% 32 .39 complication Congestive heart 0% 0 2.2% 2 1 failure Peri-operative 10% 3 8 9% 1 myocardial infarction Arrhythmia 6.7% 2 12.4% 11 .51 Pulmonary 0% 0 1.1% 1 1 embolism Pneumonia 0% 0 0% 0 1 Respiratory 10% 3 11.2% 10 1 complications Wound infection 23.3% 7 14.6% 13 .27 Hematoma 0% 0 4.5% 4 .57 Seroma 6.7% 2 5.6% 5 1 Renal insufficiency 6.7% 2 9% 8 1 Hemodialysis 0% 0 0% 0 1 Anastomotic 3.3% 1 2.2% 2 1 pseudoaneurysm Skin rash 3.3% 1 4.5% 4 1
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Table V. Peri-procedural outcomes for all grafts (combined data for isolated femorofemoral and axillo-bifemoral bypasses) created with either prosthetic PTFE graft, autogenous femoral vein or cryopreserved femoral vein Peri-procedural Femoral Vein Prosthetic PTFE P value outcomes Mean SD Mean SD 3 575
4.6 600
2.5 962
2.7
2.6
3.2
10
14.9 15.7 1.8
8 22 2.6
11.1 23.3 2.2
12.5 27 2.3
.002* .77
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6.5 654
.80 .12 .17 .43
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Operative Time (hr) Intraoperative Blood Loss (ml) Number of units of packed RBC transfused Length of stay (days) Follow up (months) Survival (y)
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S0890-5096(18)30363-7
DOI:
10.1016/j.avsg.2018.03.024
Reference:
AVSG 3856
To appear in:
Annals of Vascular Surgery
Received Date: 21 October 2017 Revised Date:
8 March 2018
Accepted Date: 19 March 2018
Please cite this article as: Nguyen K, Moneta G, Landry G, Venous conduits have superior patency compared to prosthetic grafts for femoro-femoral bypass, Annals of Vascular Surgery (2018), doi: 10.1016/j.avsg.2018.03.024. This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.
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Venous conduits have superior patency compared to prosthetic grafts for femoro-femoral
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bypass
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Authors: Khanh Nguyen, Gregory Moneta and Gregory Landry
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Division of Vascular Surgery, Knight Cardiovascular Institute, Oregon Health & Science
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University, Portland, Oregon
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Corresponding Author:
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Khanh Nguyen
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Division of Vascular Surgery, Knight Cardiovascular Institute
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Oregon Health & Science University
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Portland, Oregon, 97239
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Phone: 503-494-7593
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Fax: 503-494-4324
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Email: [email protected]
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Abstract
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Objective: To compare outcomes of externally supported polytetrafluoroethylene (PTFE) grafts
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and femoral vein as conduits for femoro-femoral crossover grafts.
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Methods: This is a retrospective review of consecutive femoro-femoral crossover grafts at our
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institution between January 2005 and March 2016. Patient demographics, indications,
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complication rates, patency rates and survival rates were compared between femoro-femoral
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grafts created with either PTFE or femoral vein conduits, autogenous or cryopreserved.
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Results: 119 femoro-femoral crossover bypasses (89 PTFE, 30 vein (18 autogenous and 12
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cryopreserved femoral veins) were performed. Most patients underwent isolated femoro-femoral
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bypass alone (76% isolated femoro-femoral bypass versus 24% axillo-bifemoral bypass). A
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greater proportion of patients who received vein grafts were female (PTFE 37% vs vein 60%,
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P=.028) and had prior bypasses (PTFE 33% vs vein 73%, p<0.001).
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PTFE bypasses were performed primarily for chronic limb ischemia (61.8%), while most venous
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bypasses were for infections (80%, P<.001). Femoral vein conduits were used in cases of
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infected aortic or extra-anatomical grafts (N=20) or groin infection (N=5). The 30-day
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complication rate was 38.7% and was not different between groups (36% for PTFE, 44.4% for
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autologous vein grafts and 50% for cryovein, P=.33) with wound complications being most
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frequent (18% PTFE, 27.8% autologous vein, 16.7% cryovein, P=.25). Patients receiving vein
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grafts were more likely to receive blood transfusion (34.8% PTFE vs 70% vein, P=.001).
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Overall, median follow up was 9.8 months (range 0-107). Primary patency rates at 1, 2 and 3
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years were 83.7 %, 73.7% and 69.8%, respectively, for PTFE bypasses, and 100% for all time
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points for venous grafts, respectively (Log rank, P=.03). Primary assisted and secondary patency
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rates were not significantly different between the two groups (Log rank, P=.16). Survival rates at
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1, 2 and 3 years were 82%, 76.4% and 69.7%, respectively, for patients with PTFE grafts versus
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76.7%, 73.3% and 55%, respectively, for patients with vein grafts, respectively (Log rank,
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P=.17).
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Conclusions: While the indications for procedure differed in this series, femoral veins in
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femoro-femoral bypasses have overall superior primary patency and similar complication rates
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compared to PTFE grafts. Based on this series, femoral vein, either autologous or cryopreserved,
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appears to be a suitable conduit for femoro-femoral bypasses, and in some cases may be the
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preferred conduit.
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Keywords: femoro-femoral bypass grafts, peripheral arterial disease, PTFE, vein, patency
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Introduction Trans-femoral subcutaneously tunneled femoro-femoral bypass grafts were initially
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devised for elderly patients with unilateral iliac occlusive disease and for patients with
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significant comorbidities that prohibited open surgery. Dr. R. Mark Vetto at the University of
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Oregon Medical School and Veteran Affairs Portland Healthcare System in Portland, Oregon
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reported the first femoro-femoral bypass in 19601-3. Since then the utility of the femoro-femoral
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bypass has expanded beyond initial indications of high risk patients with unilateral iliac
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occlusive disease. Femoro-femoral bypasses are useful as adjunctive procedures to axillo-
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femoral bypasses for aorto-iliac occlusive disease, infected aorto-femoral prosthetic bypasses or
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in cases where patients with intra-abdominal sepsis require suprainguinal revascularization. In
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addition, patients who are not anatomic candidates for endovascular repair or who have had
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failed attempts of endovascular iliac artery stenting are also candidates for femoro-femoral
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bypass. Femoro-femoral bypass may also be an adjunct procedure to aorto-uni-iliac grafts as an
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endovascular approach to aortic aneurysm repair. Despite advances in endovascular approaches
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for aorto-iliac revascularization, the femoro-femoral bypass remains a useful and important
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procedure in situations where an endovascular approach is not feasible or for patients who cannot
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tolerate general anesthesia or open surgery.
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The patency of femoro-femoral bypasses has been evaluated in previous retrospective
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studies4-19. Femoro-femoral bypasses can be created using polytetrafluoroethylene (PTFE) or
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Dacron grafts, autogenous femoral vein or cryopreserved femoral vein. The ideal conduit to use
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for femoro-femoral bypass is unknown. This study compares the patency of femoro-femoral
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bypasses created with either externally supported PTFE graft or femoral vein, specifically either
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autogenous femoral vein harvested from the patient or commercially prepared cryopreserved
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femoral vein from a deceased donor. The objective of this study is to directly compare the patency and clinical outcomes after
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femoro-femoral bypasses created with prosthetic PTFE graft versus femoral vein conduit.
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Material and Methods
This retrospective study was approved by Oregon Health & Science University (OHSU)
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Institutional Review Board and these methods are consistent with the Declaration of Helsinki. As
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this was a retrospective review, informed consent was waived. All femoro-femoral and axillo-
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bifemoral bypasses performed at OHSU from January 2005 to March 2016 were reviewed for
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indication for procedures, complications, conduit patency and patient survival. Conduits used for
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bypass include prosthetic PTFE graft, autogenous femoral vein and commercially supplied
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cryopreserved femoral vein. The choice of conduit was at the discretion of the operating surgeon
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based on the specific clinical circumstances of each patient. All conduits were tunneled supra-
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pubically above the inguinal ligament. For femoral vein conduits, meticulous attention during
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tunneling was paid to ensure adequate space for and prevent kinking of the graft and avoid
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external compression or other issues potentially associated with an extra-fascial subcutaneous
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tunnel.
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All patients were treated postoperatively with antiplatelet therapy. Anticoagulation was
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not routine and only used in patients with documented or suspected hypercoagulability. Femoro-
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femoral bypasses were evaluated with duplex ultrasound every 3 months for the first year and
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then every 6 months for the second year. If there were no complications or concerning ultrasound
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findings suggesting significant stenosis or impending graft failure, then patients were followed
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annually with surveillance ultrasound. The following information was recorded from the electronic medical record including
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sex, smoking status, race, history of coronary disease or treatment for coronary artery disease,
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prior myocardial infarction, previous major cerebrovascular accident, diastolic or systolic
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congestive heart failure, prior or current diagnosis of atrial or ventricular arrhythmia, COPD,
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creatinine of greater than 1.5 at time of surgery, dialysis dependence at least twice a week within
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the last two weeks, diabetes mellitus requiring either oral anti-glycemics or insulin therapy,
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hyperlipidemia or current treatment for hyperlipidemia, hypertension requiring medical treatment
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with anti-hypertensives, or prior malignancy. In addition, patients were assessed for prior history
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of peripheral artery disease including claudication, rest pain or tissue loss or open vascular
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procedures including previous femoro-femoral bypass, Rutherford classification and
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hypercoagulable state defined as history of inherited hypercoagulable conditions such as Factor
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V Leiden, prothrombin gene mutation, Protein C deficiency or Protein S deficiency, history of
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cancer, antiphospholipid antibody syndrome, or a history of prior deep venous thrombosis or
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pulmonary embolism. Indications for the femoro-femoral bypass were reviewed and categorized.
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Operative times, intraoperative blood loss, transfusion requirement during perioperative period
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and length of hospital stay were compared between groups. Thirty-day complications (including
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acute congestive heart failure exacerbation requiring evaluation by cardiology consult, peri-
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operative myocardial infarction with elevated troponins and diagnosis confirmed by a
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cardiologist, peri-operative arrhythmia including atrial flutter or atrial fibrillation, pulmonary
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embolism confirmed on CT angiogram, or nosocomial pneumonia requiring antibiotic treatment,
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incisional and wound infections that required antibiotic treatment, groin hematoma or seroma)
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were categorized and compared between femoro-femoral bypasses created with PTFE and
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femoral vein. The primary, primary-assisted and secondary patency rates of femoro-femoral
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bypasses, survival rates and amputation free survival rates of patients were calculated and
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analyzed by type of conduit.
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Statistical analyses were performed using IBM SPSS Statistics (version 22) and student’s
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t-test, Chi-Square and Kaplan-Meier analyses were applied as appropriate. A P value of equal to
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or less than 0.05 was set as the level of significance.
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Results
Over an 11 year period between 2005 and 2016, our institution performed 119 femorofemoral crossover bypasses (including isolated femoro-femoral or axillo-bifemoral bypasses). Of
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these, 89 of the femoro-femoral bypasses were created using prosthetic PTFE graft and 30 were
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created using femoral vein. Of those bypasses created with femoral vein, 18 were autogenous
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femoral veins and 12 were cryopreserved femoral veins. The majority of patients underwent
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isolated femoro-femoral bypass alone (N=89, 76%) and a minority of patients underwent
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femoro-femoral bypass in conjunction with axillo-femoral bypass (axillo-bifemoral bypass)
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(N=30, 24%).
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The baseline characteristics of all patients who received bypasses (isolated femoro-
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femoral bypasses and axillo-bifemoral bypasses combined) are shown in Table IA and IB and
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compare bypasses created with prosthetic PTFE versus femoral vein. A greater proportion of
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patients who received femoral vein conduits as compared to PTFE grafts were female (PTFE
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37% vs vein 60%, P=.03), had prior vascular interventions (PTFE 62.9% vs vein 93.3%,
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p<0.001) and had prior femoro-femoral bypasses (PTFE 33% vs vein 73%, P<.001).
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The majority of isolated femoro-femoral and axillo-bifemoral bypasses were performed electively (N=80, 67.2%) while a minority were performed for either urgent or emergent
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indications (Table II). Isolated femoro-femoral and axillo-bifemoral bypasses created with
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prosthetic PTFE graft were performed primarily for chronic limb ischemia (N=55, 61.8%), while
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most venous bypasses were performed for infections (N=25, 80%, P<.001, Table II). Indications
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for isolated femoro-femoral byasses are shown in Table IIB and indications for axillo-bifemoral
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bypasses are shown in Table IIC. The Rutherford classifications were not significantly different
164
between two groups by Chi-squared analysis (P>.05). Overall, approximately 18.5% (N=22) of
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all patients had claudication (PTFE 15.7% vs vein 26.7%, P=.267), 33.3% had rest pain (PTFE
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33.3% and vein 51.7%, P=.08), and 20.1% had gangrene or threat of major limb loss (PTFE
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19.1% and vein 23.3%, P=.62). The remaining 14.3% had no symptoms of claudication (PTFE
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13.5% vs vein 20.2%, P=.67).
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who received venous grafts and patients who received PTFE grafts (Table III, P>.05). Overall,
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the outflow vessels were both superficial femoral and profunda femoris arteries in 68.2% of
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patients, only the superficial femoral artery in 10.2% of patients and only the profunda femoris
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artery in 21.2% of patients.
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Operations were done with two operating teams whenever additional staff were available.
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Overall, single team and double teams were used in 66.3% (N=79) and 33.6% (N=40) of
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procedures, respectively. The use of single versus double teams were not significantly different
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between procedures using PTFE versus vein. Single teams were used in 63.3% (N=11) of
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procedures with femoral vein conduit and 67.4% (N=60) of procedures with PTFE grafts
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(P=.87).
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The overall minor and major 30-day complication rate for all bypasses (combined data for isolated femoro-femoral and axillo-bifemoral bypasses) was 38.7% (N=46) and was not
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significantly different among groups (P=.33) (Table IV). Complication rates were 44% (N=40)
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for prosthetic grafts, 44.4% (N=8) for autologous vein grafts and 50% (N=6) for cryopreserved
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femoral vein conduits. Wound complications were the most frequent type of complication for
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femoro-femoral bypass (18% (N=13) PTFE, 27.8% (N=5) autogenous vein, and 16.7% (N=2)
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cryopreserved vein, P=.25).
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Peri-operative outcomes including operative time, intraoperative blood loss and length of hospital stay are shown in Table V. Operative times, reflecting the high complexity of
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procedures, redo procedures and multiple concomitant procedures, were significantly different
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between patients who received prosthetic PTFE grafts as compared to those patients who
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received femoral vein grafts (PTFE 4.6±2.5 vs vein 6.5±3 hr, P=.002). The average number of
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concomitant procedures was 2.6±1.5 (PTFE 2.2±1.3 vs vein 3.6±1.6 hr, P=1.14). In addition,
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procedures that were performed for an indication for infection (7.6±2.8 hr) or cancer (6.6±3.4 hr)
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had significantly longer operative times compared to procedures performed for other indications
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(5.2±2.6 hr, P<0.001).
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femoral and axillo-bifemoral bypasses) created with femoral vein as compared to those bypasses
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created with PTFE, however the amount of blood loss was highly variable and not significantly
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different (PTFE 600±960 vs vein 654±570 ml, P=.77). Moreover, patients receiving femoral vein
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grafts were more likely to receive blood transfusions (PTFE 34.8% vs vein 70%, P=.001) during
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their hospitalization. The overall length of hospital stay was not statistically significant between
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patients who received femoro-femoral bypasses with graft as compared to those who received
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bypasses with femoral vein conduit, however there was a shorter but not statistically different
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length of stay for prosthetic grafts (Table V, PTFE 11.1±12 vs vein 14.9±8 days, P=.121). The overall median follow up was 9.8 months (range 0-107). Primary patency at 1, 2 and
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3 years for PTFE bypasses was 83.7 %, 73.7% and 69.8%, respectively, as compared to 100% at
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all time points for femoral vein grafts (Figure 1A, Log rank, P=.03). For all grafts (combined
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data for isolated femoro-femoral and axillo-bifemoral bypasses), primary assisted (Log rank,
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P=.08) and secondary (Log rank, P=.74) patencies at 1, 2 and 3 years were not significantly
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different between bypasses created with vein as compared to those created with PTFE.
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for isolated femoro-femoral and axillo-bifemoral bypasses) with a prosthetic PTFE graft versus a
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femoral vein conduit show no significant difference in survival in years (Figure 2A, Log rank,
214
P=.17). Survival at 1, 2 and 3 years were 82%, 76.4% and 69.7% for patients with PTFE grafts
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and 76.7%, 73.3% and 55% for patients with femoral vein grafts, respectively (Log rank, P=.17).
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Furthermore, amputation free survival was also not significantly different between groups
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(Figure 3A, Log rank, P=.59).
A sub-analysis of isolated femoro-femoral bypasses was performed and showed no
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significant differences in primary patency at 1, 2 and 3 years (PTFE 86.8%%, 74% and 74% vs
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vein 100% for all time points, respectively; Figure 1B, Log rank, P=.40). Primary assisted
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patencies at 1 and 2 years were significantly higher with bypasses created with femoral vein
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(100% for both time points) versus those created with PTFE (87% for both time points) (Log
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rank, P=.02). Secondary patency of isolated femoro-femoral bypasses were not significantly
224
different between veins and PTFE grafts (Log rank, P=1). Survival at 1, 2 and 3 years (PTFE
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79.2%, 64.5% and 54.8% vs vein 86.7%, 86.7% and 65%, respectively; Figure 2B, Log rank,
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P=.40) and amputation free survival at 1, 2 and 3 years (PTFE 93% at all time points vs vein
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87% at all time points; Figure 3B, Log rank, P=.86) between grafts created with prosthetic PTFE
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and those created with femoral vein were not statistically different. For axillo-bifemoral bypasses, a subgroup analysis was performed and showed no
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differences in patency rates (primary (Figure 1C, Log rank, P=.12), primary assisted (Log rank,
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P=.36) or secondary patencies (Log rank, P=1) at 1, 2 or 3 years, Log rank, P=1). However,
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survival was significantly higher in patients who received a PTFE conduit for the femoro-
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femoral component of an axillo-bifemoral graft as compared to patients who received a femoral
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vein conduit for the femoro-femoral component. Survival at 1, 2 and 3 years was 93.8%, 93.8%
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and 93.8%, respectively, for patients with a PTFE femoro-femoral component and 58%, 46%
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and 46%, respectively, for patients with femoral vein (Figure 2C, Log rank, P=.001). Amputation
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free survival at 1, 2 and 3 years was not significantly different in patients who received vein
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grafts for the femoro-femoral component as compared to those who received PTFE grafts for the
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femoro-femoral component (Figure 3C, Log rank, P=.21).
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Discussion
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Femoro-femoral crossover grafts were originally created using prosthetic material and have been used for over 50 years. The use of a femoral vein conduit, either autogenous femoral
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vein harvested from the patient or cryopreserved femoral vein from cadavers, is an alternative to
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a prosthetic femoro-femoral graft, particularly in settings of infection or redo surgery. In this
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study, a comparison prosthetic PTFE or femoral vein for femoro-femoral bypass showed that
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femoral vein conduits may have superior patency as compared to prosthetic PTFE grafts and no
248
difference in complications.
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There are many considerations that should be evaluated prior to choosing the type of conduit for a femoro-femoral bypass. The availability and anatomic suitability, including quality
252
and caliber, of autogenous vein should be evaluated. Also, there are cost differences between
253
using prosthetic graft that is typically a fraction of the cost of using cryopreserved femoral vein.
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In addition, using femoral vein, may add to costs related to prolonged operative times associated
255
with harvesting or preparing an autogenous femoral vein graft. Furthermore, the presence or
256
suspicion of infection may preclude the use of prosthetic grafts. While autogenous femoral veins
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may be more resistant to infection, there are risks for the donor limb of the patient that should be
258
considered including lower extremity edema, thigh compartment syndrome, surgical site
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infection and wound healing complications. Given these considerations and a national impetus to
260
minimize overall health care costs, externally supported PTFE prosthetic grafts are the most
261
frequently used conduit for femoro-femoral crossover grafts, particularly in cases of chronic limb
262
ischemia. In cases of infection, however, autogenous or cryopreserved femoral vein is more often
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used as the conduit for femoro-femoral bypass.
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The choice to use a particular graft was surgeon dependent and reflected patient
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presentation and co-morbidities. While autogenous femoral vein is preferred in infected fields,
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cryopreserved femoral vein in conjunction with a muscle flap can be used in infected fields.
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Autogenous femoral vein can be used when it is available, and there are no anatomic or
268
physiologic contraindications to femoral vein harvest. Contraindications to autologous femoral
269
vein harvest included chronic venous disease or evidence of scarred or sclerotic veins, small vein
270
diameter less than 5 mm, inadequate vein length, presence of acute or chronic thrombus, history
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of lower extremity compartment syndrome or inability to tolerate the procedure. The indications
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for femoro-femoral bypasses differed between patients who received femoral vein conduits and
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those who received prosthetic PTFE grafts. Although the two groups had similar cardiovascular
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risk factors (Table I), they had different underlying disease processes and indications for femoro-
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femoral bypass. Patients who received prosthetic grafts were more likely to be patients with
276
either chronic or acute limb ischemia. This differed from patients who received femoral vein
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grafts as they were more likely to present with failure or infection of a prior prosthetic graft.
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Patients who have had prior vascular interventions using prosthetic grafts that have failed or
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became infected are likely to have subsequent procedures with femoral vein conduit as an
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alternative conduit as autologous tissue is thought to more resistant to infection. Interestingly, the
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indications for procedures were different for men and women. The most common indications for
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women were chronic limb ischemia (37.3% of cases) and infection (27.5%), whereas for men
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were acute (25.3%) and chronic limb ischemia (23.9%). This may explain the reason why
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women were more likely to receive femoral conduits than men.
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Although the femoral vein group may have had more technically challenging procedures due to a significantly higher prevalence of redo procedures and blood transfusion requirements,
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this group still had similar complication rates as compared to the prosthetic group. The most
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common complications were wound complications including surgical site infection, seroma or
289
hematoma. Despite the theoretical risk for patients who receive autogenous femoral vein
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conduits to have an increased risk for wound complications from the additional incision at the
291
vein harvest site, wound complications were not significantly different between groups. There
292
were no immediate or short-term thrombosis complications in either group.
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Previous retrospective publications of femoro-femoral bypasses report 5 year primary patency rates ranging from 35% to 92%1-19. In this study, we report 3 year patency rates within
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this range for both femoro-femoral bypasses created with either prosthetic PTFE graft or femoral
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vein conduit. In the stratified analysis of isolated femoro-femoral bypasses, the primary assisted
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patency rates were significantly higher with bypasses created with femoral vein as compared to
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those created with PTFE. While higher primary patency for all grafts created with vein compared
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to those with PTFE graft and higher primary assisted patency for isolated femoro-femoral
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bypasses created with vein compared to those with PTFE graft are suggestive that a femoral vein
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as conduit is a superior conduit to PTFE graft, the statistical significance detected may represent
302
a type I error given a small study and that the overall combined analysis showed no significant
303
difference in assisted primary patency rates.
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With respect to survival, the subgroup analysis for axillo-bifemoral bypasses demonstrated decreased survival rates for patients who received femoral vein conduit as
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compared to those who received PTFE grafts. These differences in survival are likely related to
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the different indications for procedures and unmeasured confounding factors.
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As a weakness of any small retrospective review, there is potential for selection bias and confounding by indication. This is evidenced by the differences in the two groups including their
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indications for surgery, proportion of patients with prior vascular procedures, duration of
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procedure or proportion of patients who received blood transfusions. These patient groups may
312
be inherently different as patients who received femoro-femoral bypasses created with veins
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were likely to have required more complex operative repair with more extensive dissection due
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to scarring from prior procedures. This hypothesis is supported by the fact that patients who
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received femoral vein conduits had significantly longer operative times and required more
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transfusions. Having all of these factors would seemingly and potentially impair patency of the
317
femoral vein conduit and so the patency results perhaps can argue in favor of femoral vein for
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femoro-femoral bypass. If we ignore cases performed for the indication of infection for analysis
319
purposes, it is possible that the patency rates may be different between femoro-femoral bypasses
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created with prosthetic graft or femoral vein conduit in patients for the indication of chronic limb
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ischemia; however, we were unable to perform this analysis due to inadequate sample size.
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While the retrospective nature and small sample size is a weakness of the study and may
323
contribute to both type I or II error, the decreasing frequency of the procedure along with
324
changes in medical management over time make it unlikely that a randomized controlled trial or
325
more robustly powered single center series will occur. A multicenter registry may be necessary
326
to adequately address the question of optimal conduit.
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While there may be advantages to femoral vein for femoro-femoral bypass, there are situations when autogenous vein or cryopreserved vein is not available or advisable and PTFE
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grafts remain useful conduits and likely less costly. Both types of grafts, either femoral vein or
330
PTFE graft, have their inherent advantages and disadvantages depending on patient factors,
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clinical situation and indication for procedure. Femoral vein as a conduit for femoro-femoral
332
bypass is clearly useful in procedures for the indication of infection or operations involving
333
infected fields and the data suggest it should perform well in such circumstances.
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Conclusion
To summarize, femoro-femoral bypasses created with prosthetic PTFE grafts or those
337
created with femoral vein conduits both have excellent short and midterm patency rates and have
338
similar complication rates. Based on this small retrospective review, femoral vein, either
339
autologous or cryopreserved, is a suitable conduit for femoro-femoral bypasses, and maybe the
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preferred conduit. In this series, we found that femoral vein grafts had superior overall primary
341
patency compared to PTFE grafts.
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Acknowledgements
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We thank Rikki Samuel, Nai Saephan and Kathryn Vu for help with chart reviews and data
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abstraction.
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1. McCaughan JJ Jr, Kahn SF. Cross-over graft for unilateral occlusive disease of the ileofemoral arteries. Ann Surg 1960: 151: 26-28 (Jan). 2. Vetto RM. The treatment of unilateral iliac artery obstruction with a transabdominal
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References
subcutaneous, femorofemoral graft. Surgery 1962: 52: 342-345 (Aug). 3. Vetto RM. The femorofemoral shunt, an appraisal. Amer J Surg 1966: 112: 162-165
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(Aug).
4. Ehrenfeld WK, Levin SM, Wylie EJ. Venous crossover bypass grafts for arterial insufficiency. Ann Surg 1968: 167: 287-291 (Feb).
5. Eugene J, Goldstone J, Moore WS. Fifteen year experience with subcutaneous bypass grafts for lower extremity ischemia. Ann Surg 1977; 186: 177-183.
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6. Maini BS, Mannick JA. Effect of arterial reconstruction on limb salvage: a ten-year appraisal. Arch Surg 1978; 113: 1297-1304. 7. Flanagan DP, Pratt DG, Goodreau JJ, Burnham SJ, Yao JS, Bergan JJ. Hemodynamic and angiographic guidelines in selection of patients for femorofemoral bypass. Arch Surg
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1978; 113: 1257-1262.
369 370 371 372 373 374
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experience with femorofemoral crossover grafts. Arch Surg 1980; 115: 1359-1365.
9. Mosley JG, Marston A. Long term results of 66 femorofemoral bypass grafts: 9-year follow-up. Br J Surg 1983; 70: 631-634.
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8. Dick LS, Brief DK, Alplert J, Brener BJ, Goldenkranz R, Parsonnet V. A 12-year
10. Plechaft FT, Plecha FM. Femorofemoral bypass grafts: ten-year experience. J Vasc Surg 1984; 1: 555-561.
11. Lamerton AJ, Nicolaide AN, Eastcott HH. The femorofemoral graft: hemodynamic improvement and patency rate. Arch Surg 1985; 120: 1274- 1278.
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12. Brief DK, Brener BJ. Extra-anatomic bypasses: femorofemoral crossover grafts. In: Wilson SE, Veith FJ, Hobson RW, eds. Vascular surgery: principles and practice. New
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York: McGraw-Hill; 1987; pp. 415-418.
378 379 380 381 382
13. Harrington, ME, Harrington EB, Haimov M, Schanzer H, Jacobson JH 2nd. Iliofemoral versys femorofemoral bypass: the case for an individualized approach. J Vasc Surg 1992;
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14. Criado E, Burnham SJ, Tinsley EA Jr., Johnson G Jr., Keagy BA. Femorofemoral bypass graft: analysis of patency and factors influencing long term outcome. J Vasc Surg 1993 18: 495-504; discussion 504-505.
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384 385 386
15. Kim YW, Lee JH, Kim HG, Hugh S. Factors affecting the long term patency of crossover femorofemoral bypass graft. Eur J Vas Endovasc Surg 2005: 30: 376-80. 16. Pursell R, Sideso E, Magee TR, Galland RB. Critical appraisal of femorofemoral crossover grafts. Br J Surg 2005: 92: 565-9.
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17. Schneider JR, Besso SR. Walsh DB, Zwolak RM, Cronenwett JL. Femorofemoral versus
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aortobifemoral bypass: outcome and hemodynamic results. J Vasc Surg 1994: 19: 43-55.
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18. Foley WJ, Dow RW, Fry WJ. Crossover femoro-femoral bypass grafts. Arch Surg.
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1969;99(1): 83-97.
19. Mingoli A, Sapienza P, Feldhaus RJ, Di Marzo L, Burchi C, Cavallaro A. Femorofemoral
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bypass graft: factors influencing patency rate and outcome. Surgery 2001: 129: 451-8.
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Prosthetic PTFE (N=89) % N
Significance P value
Female
60%
18
37.1%
33
.03*
Smoker Caucasian Coronary artery disease Previous myocardial infarction Previous stroke Congestive heart failure Arrhythmia COPD Creatinine >1.5 Dialysis DM Hyperlipidemia Hypertension Hypercoagulable Malignancy Peripheral arterial disease Prior open vascular interventions Prior femorofemoral bypass Required transfusion during hospitalization
90% 100% 30%
27 30 9
94% 95.5% 36.0%
81 85 32
20.0%
6
21.3%
13.3% 10.0%
4 3
20.2% 12.4%
20% 30% 13.3% 0% 13.3% 36.7% 66.7% 13.3% 23.3% 80.0%
6 9 4 0 4 11 20 4 7 24
93.3%
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A. All grafts: dichotomous variables Dichotomous Femoral Vein (N=30) variables % N
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Table I. Baseline characteristics of all patients who received bypasses (either isolated femoro-femoral and axillo-bifemoral bypasses) created with either prosthetic PTFE graft or femoral vein conduit (autogenous and cryopreserved femoral vein groups combined).
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.99 .50 .47 .88
18 11
.40 .73
18.0% 21.3% 13.4% 4.5% 18.0% 43.0% 68.5% 5.6% 25.8% 74.2%
16 19 12 4 16 38 61 5 23 66
.81 .33 .98 .24 .35 .56 .72 .33 .70 .52
28
62.9%
56
.006*
73.3%
22
33%
29
.001*
70%
21
34.8
31
.001*
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B. All grafts: continuous variables Continuous Femoral Vein variables Mean SD Age (y) 65.5 8.5 Weight (kg) 68 17 BMI (kg/m2) 25.1 6
Prosthetic PTFE Mean SD 66.5 10.8 76.9 23.5 25.5 10
P value .67 .06 .83
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16.7% (N=2) 6.7% (N=2)
Infection
5.6% (N=5) 94.5% (N=17) 66.7% (N=8) 73.3% (N=25)
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B. Indications for isolated femoro-femoral grafts Conduit Chronic Acute Infection limb limb ischemia ischemia PTFE 64.4% 21.9% 4.1% (N=47) (N=16) (N=3) Autogenous 12.5% 0% 87.5% Femoral Vein (N=1) (N=7) Cryopreserved 25% 25% 50% Femoral Vein (N=2) (N=2) (N=4) Overall 18.8% 12.5% 68.8% Femoral Vein (N=3) (N=2) (N=11) C. Indications for axillo-bifemoral grafts Conduit Chronic Acute Infection limb limb ischemia ischemia PTFE 28.6% 14.3% 7.1% (N=8) (N=4) (N=2) Autogenous 0% 0% 28.6% Femoral Vein (N=8) Cryopreserved 0% 0% 14.3% Femoral Vein (N=4) Overall 0% 0% 42.9% Femoral Vein (N=12)
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Significance P value <.001*
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Acute limb ischemia 22.5% (N=20) 0%
0%
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Table II. A. Indications for all grafts (combined data for isolated femoro-femoral and axillo-bifemoral bypasses) created with either prosthetic PTFE graft, autogenous femoral vein or cryopreserved femoral vein. Comparison of indications for prosthetic PTFE graft versus combined femoral venous conduits (autogenous and cryopreserved femoral vein groups were combined). B. Subgroup analysis for indications of isolated femoro-femoral grafts. C. Subgroup analysis for indications of axillobifemoral grafts.
0%
Other (Trauma, Malignancy) 9.6% (N=7) 0%
Significance P value <.001*
0% 0%
Other (Trauma, Malignancy) 7.1% (N=2) 0% 0% 0%
Significance P value <.001*
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Table III. Run-off of isolated femoral-femoral and axillo-bifemoral bypasses were compared for patients who received bypasses created with PTFE and those who received either autologous or cryopreserved femoral vein. Conduit Run-Off Both SFA and PFA SFA only PFA only N % N % N % Prosthetic 58 65.2 9 10.1 22 24.7 PTFE (N=89) Femoral 23 80 3 10 3 10 Vein (N=30) All Grafts 119 68.6 12 10.2 25 21..2 (N=119) Chi .17 .94 .11 Squared, P
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Table IV. Thirty-day complication rates after all grafts (combined isolated femorofemoral and axillo-bifemoral bypasses) created with either prosthetic PTFE graft or femoral vein (autogenous and cryopreserved femoral vein combined). Complication Femoral Vein Prosthetic PTFE P value % N % N Overall, any 46.7% 14 35.9% 32 .39 complication Congestive heart 0% 0 2.2% 2 1 failure Peri-operative 10% 3 8 9% 1 myocardial infarction Arrhythmia 6.7% 2 12.4% 11 .51 Pulmonary 0% 0 1.1% 1 1 embolism Pneumonia 0% 0 0% 0 1 Respiratory 10% 3 11.2% 10 1 complications Wound infection 23.3% 7 14.6% 13 .27 Hematoma 0% 0 4.5% 4 .57 Seroma 6.7% 2 5.6% 5 1 Renal insufficiency 6.7% 2 9% 8 1 Hemodialysis 0% 0 0% 0 1 Anastomotic 3.3% 1 2.2% 2 1 pseudoaneurysm Skin rash 3.3% 1 4.5% 4 1
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Table V. Peri-procedural outcomes for all grafts (combined data for isolated femorofemoral and axillo-bifemoral bypasses) created with either prosthetic PTFE graft, autogenous femoral vein or cryopreserved femoral vein Peri-procedural Femoral Vein Prosthetic PTFE P value outcomes Mean SD Mean SD 3 575
4.6 600
2.5 962
2.7
2.6
3.2
10
14.9 15.7 1.8
8 22 2.6
11.1 23.3 2.2
12.5 27 2.3
.002* .77
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6.5 654
.80 .12 .17 .43
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Operative Time (hr) Intraoperative Blood Loss (ml) Number of units of packed RBC transfused Length of stay (days) Follow up (months) Survival (y)
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