Publications by authors named "Allen Hamdan"

86 Publications

Validation of the Global Limb Anatomic Staging System in first-time lower extremity revascularization.

J Vasc Surg 2020 Oct 20. Epub 2020 Oct 20.

Division of Vascular and Endovascular Surgery, Department of Surgery, Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, Mass. Electronic address:

Objective: The Global Limb Anatomic Staging System (GLASS) was developed as a new anatomic classification scheme to grade the severity of chronic limb threatening ischemia. We evaluated the ability of this anatomic grading system to determine major adverse limb events after lower extremity revascularization.

Methods: We performed a single-institutional retrospective review of 1060 consecutive patients who had undergone 1180 first-time open or endovascular revascularization procedures for chronic limb threatening ischemia from 2005 to 2014. Using the review of angiographic images, the limbs were classified as GLASS stage 1, 2, or 3. The primary composite outcome was reintervention, major amputation (below- or above-the-knee amputation), and/or restenosis (>3.5× step-up by duplex criteria) events (RAS). The secondary outcomes included all-cause mortality, failure to cross the lesion by endovascular methods, and a comparison between bypass vs endovascular intervention. Kaplan-Meier estimates were used to determine the event rates at 1 and 5 years, and Cox regression analysis was used to adjust for baseline differences among the GLASS stages.

Results: Of all patients undergoing first-time revascularization, imaging studies were available for 1180 procedures (91%) for GLASS grading. Of these procedures, 552 were open bypass (47%) and 628 were endovascular intervention (53%). Compared with GLASS stage 1 disease (n = 267, 23%), stage 2 (n = 367; 31%) and stage 3 (n = 546; 42%) disease were associated with a greater risk of RAS at 1 year (stage 1, 33% vs stage 2, 48% vs stage 3, 53%) and 5 years (stage 1, 45% [reference]; stage 2, 65%; hazard ratio [HR], 1.7; 95% confidence interval [CI], 1.3-2.2; P < .001; stage 3, 69%; HR, 2.3; 95% CI, 1.7-2.9; P < .001). These differences were mainly driven by reintervention and restenosis rather than by major amputation. The 5-year mortality was similar for stage 2 and 3 compared with stage 1 disease (stage 1, 40% [reference]; stage 2, 45%; HR, 1.1; 95% CI, 0.8-1.4; P = .69; stage 3, 49%; HR, 1.2; 95% CI, 1.0-1.6; P = .11). For all attempted endovascular interventions, failure to cross a target lesion increased with advancing GLASS stage (stage 1, 4.5% vs stage 2, 6.3% vs stage 3, 13.3%; P < .01). Compared with open bypass (n = 552; 46.8%), endovascular intervention (n = 628; 53.3%) was associated with a higher rate of 5-year RAS for GLASS stage 1 (49% vs 34%; HR, 1.9; 95% CI, [1.1-3.5; P = .03), stage 2 (69% vs 52%; HR, 1.7; 95% CI, 1.2-2.5; P < .01), and stage 3 (83% vs 61%; HR, 1.5; 95% CI, 1.2-2.0; P < .01) disease.

Conclusions: For patients undergoing first-time lower extremity revascularization, the GLASS can be used to predict for reintervention and restenosis. Bypass resulted in better long-term outcomes compared with endovascular intervention for all GLASS stages.
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http://dx.doi.org/10.1016/j.jvs.2020.08.151DOI Listing
October 2020

Wound location is independently associated with adverse outcomes following first-time revascularization for tissue loss.

J Vasc Surg 2021 Apr 29;73(4):1320-1331. Epub 2020 Aug 29.

Division of Vascular and Endovascular Surgery, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Mass. Electronic address:

Objective: Few studies adequately evaluate the impact of wound location on patient outcomes after lower extremity revascularization. Consequently, we evaluated the relationship between lower extremity wound location and long-term outcomes.

Methods: We reviewed all patients at our institution undergoing any first-time open surgical bypass or percutaneous transluminal angioplasty with or without stenting for tissue loss between 2005 and 2014. We categorized wounds into three distinct groups: forefoot (ie, toes and metatarsal heads), midfoot (ie, dorsal, plantar, lateral, medial surfaces excluding toes, metatarsal heads, or heel), and heel. Limbs with multiple wounds were excluded from analyses. We compared rates of perioperative complications, wound healing, reintervention, limb salvage, amputation-free survival, and survival using χ, Kaplan-Meier, and Cox regression analyses.

Results: Of 2869 infrainguinal revascularizations from 2005 to 2014, 1126 underwent a first-time revascularization for tissue loss, of which 253 patients had multiple wounds, 197 had wounds proximal to the ankle, 100 had unreliable wound information, and 576 (forefoot, n = 397; midfoot, n = 61; heel, n = 118) fit our criteria and had a single foot wound with reliable information regarding wound specifics. Patients with forefoot, midfoot, and heel wounds had similar rates of coronary artery disease, hypertension, diabetes, and smoking history (all P > .05). Conversely, there were significant differences in patient age (71 vs 69 vs 70 years), prevalence of gangrene (41% vs 5% vs 21%), and dialysis dependence (18% vs 17% vs 30%) (all P < .05). There were no statistically significant differences in perioperative mortality (1.3% vs 4.9% vs 4.2%; P = .06) or postoperative complications among the three groups. Between forefoot, midfoot, and heel wounds, there were significant differences in unadjusted 6-month rates of complete wound healing (69% vs 64% vs 53%), 3-year rates of amputation-free survival (54% vs 57% vs 35%), and survival (61% vs 72% vs 41%) (all P < .05). After adjustment, compared with forefoot wounds, heel wounds were associated with higher rates of incomplete 6-month wound healing (hazard ratio [HR], 1.6; 95% confidence interval [CI], 1.1-2.]), major amputation or mortality (HR, 1.7; 95% CI, 1.1-2.7), and all-cause mortality (HR, 1.8; 95% CI, 1.1-3.0), but not major amputation alone (HR, 2.1; 95% CI, 0.9-4.5). In open surgical bypass-first patients, heel wounds were solely associated with an increased risk of all-cause mortality (HR, 1.7; 95% CI, 1.1-2.8), whereas heel wounds in percutaneous transluminal angioplasty-first patients were associated with an increased risk of incomplete wound healing (HR, 2.2; 95% CI, 1.3-3.7), major amputation or mortality (HR, 2.3; 95% CI, 1.1-5.4), and all-cause mortality (HR, 2.8; 95% CI, 1.1-7.2).

Conclusions: Heel wounds confer considerably higher short- and long-term morbidity and mortality compared with midfoot or forefoot wounds in patients undergoing any first-time lower extremity revascularization.
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http://dx.doi.org/10.1016/j.jvs.2020.07.091DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7914284PMC
April 2021

Commentary: Quality metrics are important, but we must also become stewards of health care value.

J Thorac Cardiovasc Surg 2020 Mar 4. Epub 2020 Mar 4.

Department of Thoracic Surgery, St Charles Medical Center, Bend, Ore.

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http://dx.doi.org/10.1016/j.jtcvs.2020.02.081DOI Listing
March 2020

Preoperative risk score for access site failure in ultrasound-guided percutaneous aortic procedures.

J Vasc Surg 2019 10 7;70(4):1254-1262.e1. Epub 2019 Mar 7.

Division of Vascular and Endovascular Surgery, Beth Israel Deaconess Medical Center, Boston, Mass. Electronic address:

Objective: The factors associated with access site failure after ultrasound-guided percutaneous access for aortic endograft procedures remain poorly characterized. We developed a prediction model to risk stratify patients for access site failure.

Methods: We performed a retrospective institutional review of consecutive patients who underwent endovascular aneurysm repair (EVAR), fenestrated EVAR (FEVAR), or thoracic endovascular aortic repair (TEVAR) from 2014 to 2016. We excluded patients undergoing direct aortic access through sternotomy and patients treated with physician-modified endografts, given reporting restrictions. Our primary outcome was groin access site failure, which included bleeding and thrombosis. An 8-point risk model was created for access site failure using multivariable fractional polynomials and internally validated using bootstrapping.

Results: We identified 469 femoral arteries from 247 patients undergoing endovascular aortic repair procedures (EVAR, 75%; FEVAR, 8.0%; TEVAR, 17%). Surgeons performed percutaneous access in 97.2% of the femoral arteries, with 99.6% ultrasound use. Twenty-seven (5.9%) access site failures occurred (17 bleeding, 10 thrombosis), all treated with groin cutdown, for a successful percutaneous femoral artery access rate of 94%. Of the 215 patients with attempted bilateral percutaneous access, 90% had successful bilateral access. However, FEVAR had lower rates of successful bilateral access (FEVAR, 78%; EVAR, 91%; TEVAR, 94%; P = .03). Factors independently associated with percutaneous access site failure were femoral artery outer wall diameter (per millimeter increase: odds ratio [OR], 0.003 [0.0002-0.1]; P < .001), femoral artery stenosis >50% (OR, 22.3 [2.7-183.2]; P < .01), and urgent/emergent intervention (OR, 3.6 [1.2-11.0]; P = .03). A risk prediction model based on these criteria produced a C statistic of 0.89, a Hosmer-Lemeshow goodness of fit of 0.99, and a Brier score of 0.04. Excluding treatment for ruptured aneurysms, cutdown for access failure and planned initial groin cutdown resulted in longer postoperative lengths of stay and higher rates of access-related readmission, return to operating room, groin infection, and myocardial infarction compared with successful percutaneous access. There was no difference in major adverse events between planned initial groin cutdown and cutdown after failure; however, the small number of patients in these two comparison groups limits the statistical power to detect a difference.

Conclusions: Percutaneous ultrasound-guided access can be safely performed in almost all patients undergoing endovascular aortic procedures, but access site failures do occur. This risk score can help users select patients with high likelihood of success, identify patients who need close scrutiny with postclosure femoral duplex ultrasound, and provide patient guidance about risk of unplanned groin cutdown.
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http://dx.doi.org/10.1016/j.jvs.2018.12.025DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6731168PMC
October 2019

Vascular fellow and resident experience performing infrapopliteal revascularization with endovascular procedures and vein bypass during training.

J Vasc Surg 2018 11;68(5):1533-1537

Division of Vascular and Endovascular Surgery, Department of Surgery, Beth Israel Deaconess Medical Center, Boston, Mass. Electronic address:

Objective: Endovascular aneurysm repair has led to a significant reduction in vascular trainee experience in the surgical treatment of aortic aneurysms. We sought to evaluate whether the vascular training paradigm or the "endovascular first" approach to lower extremity vascular disease has had a similar effect on trainee experience with infrapopliteal endovascular therapy and vein bypass.

Methods: Deidentified data were provided by the Vascular Surgery Board on the number of procedures performed by each 2014 fellowship and residency (0 + 5) graduate during training. Data were analyzed using parametric and nonparametric methods, where appropriate.

Results: Of 125 trainees (109 fellows, 16 residents), 33 (27%) performed 10 or fewer infrapopliteal vein bypasses and 37 (29%) performed 10 or fewer infrapopliteal endovascular procedures during their training. Eleven trainees (9%) performed 10 or fewer of both procedures. There was a positive correlation between number of infrapopliteal vein bypass and endovascular procedures performed (r = 0.19; P = .03). There was no difference between fellows and residents in the mean number of bypass operations performed during training (17.3 vs 19.1; P = .50; range, 0-53). However, residents performed more infrapopliteal endovascular procedures than fellows did (median, 29 vs 16; P = .03; range, 0-128).

Conclusions: More than one in four graduates of both training paradigms finish with a low number of infrapopliteal bypasses and endovascular interventions. The number of these procedures needed for proficiency is not known. Vascular surgery training programs should critically evaluate the number of infrapopliteal procedures required to achieve proficiency.
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http://dx.doi.org/10.1016/j.jvs.2018.01.054DOI Listing
November 2018

Outcomes after first-time lower extremity revascularization for chronic limb-threatening ischemia in insulin-dependent diabetic patients.

J Vasc Surg 2018 11;68(5):1455-1464.e1

Division of Vascular and Endovascular Surgery, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Mass. Electronic address:

Objective: Historically, open surgical bypass provided a durable repair among diabetic patients with chronic limb-threatening ischemia (CLTI). In the current endovascular era, however, the difference in long-term outcomes between first-time revascularization strategies among patients with insulin-dependent diabetes mellitus (IDDM) is poorly understood.

Methods: We reviewed the records of all patients with IDDM undergoing a first-time infrainguinal bypass graft (BPG) or percutaneous transluminal angioplasty with or without stenting (PTA/S) for CLTI at our institution from 2005 to 2014. We defined IDDM as use of chronic insulin administration at baseline to control blood glucose levels and recorded the most recent glycated hemoglobin value available within 3 months before the procedure and fasting blood glucose level on the day of the procedure. We compared rates of wound healing, restenosis, reintervention, major amputation, and mortality between BPG and PTA/S in our population using χ, Kaplan-Meier, and Cox regression analyses. As a sensitivity analysis, we calculated propensity scores and employed inverse probability weighting to account for nonrandom assignment to BPG vs PTA/S.

Results: Of 2869 infrainguinal revascularizations from 2005 to 2014, 655 limbs (316 BPG, 339 PTA/S) in 580 patients fit our criteria and underwent a first-time revascularization for CLTI. Patients undergoing BPG, compared with PTA/S, were similar in age (69 vs 68 years; P = .55), had similar rates of tissue loss (87% vs 91%; P = .07) and dialysis dependence (26% vs 28%; P = .55), were less likely to be hypertensive (84% vs 92%; P < .001), and were more likely to be current smokers (21% vs 14%; P = .02). There were no differences between BPG and PTA/S patients in mean glycated hemoglobin levels (8.1% vs 8.0%; P = .51) or mean fasting blood glucose levels (158 vs 150 mg/dL; P = .18). Although total hospital length of stay was significantly longer among BPG patients (11 vs 8 days; P < .001), perioperative complications did not differ, including acute kidney injury (19% vs 23%; P = .24), hematoma (6.0% vs 3.8%; P = .20), acute myocardial infarction (1.3% vs 2.1%; P = .43), and mortality (3.8% vs 3.0%; P = .55). BPG-first patients had significantly lower unadjusted 6-month rates of incomplete wound healing (49% vs 57%) and 5-year rates of restenosis (53% vs 72%) and reintervention (47% vs 58%; all P < .05). After adjustment, multivariable analysis suggested PTA/S-first intervention to be significantly associated with higher risk of restenosis (hazard ratio, 1.9; 95% confidence interval, 1.3-2.7) and reintervention (1.9 [1.2-2.7]). These results remained robust after inverse probability weighting.

Conclusions: Among patients with IDDM and CLTI, a bypass-first strategy is associated with similar 30-day outcomes and lower restenosis and reintervention rates. These data suggest that a bypass-first approach may best serve appropriately selected, anatomically suitable patients with IDDM and pedal ischemia that requires revascularization.
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http://dx.doi.org/10.1016/j.jvs.2018.01.055DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7106939PMC
November 2018

Treatment outcomes in diabetic patients with chronic limb-threatening ischemia.

J Vasc Surg 2018 08 22;68(2):487-494. Epub 2018 Mar 22.

Division of Vascular and Endovascular Surgery, Department of Surgery, Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, Mass. Electronic address:

Objective: There are conflicting reports about outcomes after infrainguinal bypass for chronic limb-threatening ischemia (CLTI) in patients with diabetes. We compared perioperative outcomes between patients with and patients without diabetes in the current era.

Methods: The National Surgical Quality Improvement Program vascular module, 2011 to 2014, was used to identify patients undergoing infrainguinal revascularization for CLTI. Patients with and without diabetes were compared in terms of presentation, comorbidities, operative approach, and 30-day outcomes. Major adverse limb events (MALEs) included 30-day major reintervention or amputation, and major adverse cardiovascular events (MACEs) included 30-day myocardial infarction, cardiac arrest, stroke, or death. Multivariable logistic regression was used to adjust for baseline differences.

Results: We identified 8887 patients undergoing open (5744; 50% diabetic) or endovascular (3143; 62% diabetic) treatment for CLTI. Patients with diabetes were younger and more often nonwhite, nonsmokers, and obese. Patients with diabetes presented more often with tissue loss (71% vs 47%; P < .001) and were more likely to be treated with endovascular intervention (41% vs 29%; P < .001). The 30-day mortality was similar before (open, 3.1% vs 2.8% [P = .53]; endovascular, 2.6% vs 2.1% [P = .37]) and after adjustment for baseline differences (open: odds ratio [OR], 1.1 [95% confidence interval (CI), 0.7-1.5]; endovascular: OR, 1.2 [95% CI, 0.7-2.0]). Patients with diabetes had longer lengths of stay (open, 8 vs 6 days [P < .001]; endovascular, 3 vs 2 days [P < .001]) and higher 30-day readmission rates (open, 21% vs 18% [P < .01]; endovascular, 20% vs 15% [P < .01]); however, these differences were no longer significant after adjustment for baseline differences. Patients with diabetes had a higher rate of MACEs (7.0% vs 5.1%; P < .01) and lower rate of MALEs (8.1% vs 10%; P < .01) after bypass. After adjustment, patients with diabetes still had a lower rate of MALEs (OR, 0.7; 95% CI, 0.6-0.9) but no longer had a higher rate of MACEs (OR, 1.2; 95% CI, 0.9-1.6).

Conclusions: CLTI patients with diabetes undergoing revascularization have similar 30-day outcomes compared with those without diabetes, although they appear to be at lower risk for MALEs after bypass. Prolonged length of stay and readmission in patients with diabetes is not due to underlying diabetic disease but likely secondary to other baseline comorbidities, such as higher rates of tissue loss. Concern for worse perioperative outcomes in patients with diabetes after lower extremity bypass is unsubstantiated and should not discourage a physician from performing an open bypass.
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http://dx.doi.org/10.1016/j.jvs.2017.11.081DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6057811PMC
August 2018

Modern Fixed Imaging Systems Reduce Radiation Exposure to Patients and Providers.

Vasc Endovascular Surg 2018 Jan 21;52(1):52-58. Epub 2017 Nov 21.

1 Division of Vascular and Endovascular Surgery, Department of Surgery, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA.

High-definition fluoroscopic imaging is required to perform endovascular procedures safely and precisely, especially in complex cases, resulting in longer procedures and increased radiation exposure. This is of importance for training institutions as trainees, even with sound instruction in as low as reasonably achievable (ALARA) principles, tend to have high radiation exposures. Recently, there was an upgrade in the imaging system allowing for comparison of radiation exposure to patients and providers. We performed an analysis of consecutive endovascular aneurysm repair (EVAR) and superficial femoral artery (SFA) interventions in the years 2013 to 2014. We recorded body mass index (BMI) and fluoroscopy time (FT) and subsequently matched 1:1 based on BMI, FT, or both. We determined radiation dose using air kerma (AK) and also recorded individual surgeons' badge readings. Allura Xper FD20 was upgraded to AlluraClarity with ClarityIQ. We identified a total of 77 EVARs (52 pre and 25 post) and 134 SFA interventions (99 pre and 35 post). Unmatched results for EVAR were BMI pre 26.2 versus post 25.8 (kg/m, P = .325), FT 28.1 versus 21.2 (minutes, P = .051), and AK 1178.5 versus 581 (mGy, P < .001), respectively. After matching, there was a 53.2% reduction in AK (846.1 vs 395.9 mGy; P = .004) for EVAR. Unmatched results for SFA interventions were BMI pre 28.1 versus post 26.6 ( P = .327), FT 18.7 versus 16.2 ( P = .282), and AK 285.6 versus 106.0 ( P < .001), respectively. After matching, there was a 57.0% reduction in AK (305.0 vs 131.3, P < .001). The total deep dose equivalent from surgeons' badge readings decreased from 39.5 to 17 mrem ( P = .029). Aortic and peripheral endovascular interventions can be performed with reduced radiation exposure to patients and providers, employing modern fixed imaging systems with advanced dose reduction technology. This is of particular importance in the light of the increasing volume and complexity of endovascular and hybrid procedures as well as the prospect of decades of radiation exposure during training and practice.
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http://dx.doi.org/10.1177/1538574417742211DOI Listing
January 2018

Outcomes after first-time lower extremity revascularization for chronic limb-threatening ischemia between patients with and without diabetes.

J Vasc Surg 2018 04 22;67(4):1159-1169. Epub 2017 Sep 22.

Division of Vascular and Endovascular Surgery, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Mass. Electronic address:

Objective: The effect of diabetes type and insulin dependence on short- and long-term outcomes after lower extremity revascularization for chronic limb-threatening ischemia (CLTI) warrants additional study and more targeted focus. We sought to address this paucity of information by evaluating outcomes in insulin-dependent and noninsulin-dependent patients after any first-time revascularization.

Methods: We reviewed all limbs undergoing first-time infrainguinal bypass grafting (BPG) or percutaneous transluminal angioplasty with or without stenting (PTA/S) for CLTI at our institution from 2005 to 2014. Based on preoperative medication regimen, patients were categorized as having insulin-dependent diabetes (IDDM), noninsulin-dependent diabetes (NIDDM), or no diabetes (NDM). Outcomes included wound healing; major amputation; RAS events (reintervention, major amputation, or stenosis); major adverse limb events; and mortality. Outcomes were evaluated using χ, Kaplan-Meier, and Cox regression analyses.

Results: Of 2869 infrainguinal revascularizations from 2005 to 2014, 1294 limbs (646 BPG, 648 PTA/S) fit our criteria. Overall, our analysis included 703 IDDM, 262 NIDDM, and 329 NDM limbs. IDDM patients, compared with NIDDM and NDM patients, were younger (69 vs 73 vs 77 years; P < .001) and more often presented with tissue loss (89% vs 77% vs 67%; P < .001), coronary artery disease (57% vs 48% vs 43%; P < .001), and end-stage renal disease (26% vs 13% vs 12%; P < .001). Perioperative complications, including mortality (3% vs 2% vs 5%; P = .07), did not differ between groups; however, complete wound healing at 6-month follow-up was significantly worse among IDDM patients (41% vs 49% vs 61%; P < .001). IDDM patients had significantly higher 3-year major amputation rates (23% vs 11% vs 8%; P < .001). Multivariable analyses illustrated that compared with NDM, IDDM was associated with significantly higher risk of both major amputation and RAS events after any first-time intervention (hazard ratio, 2.0 [95% confidence interval, 1.1-4.1] and 1.4 [1.1-1.8], respectively). Similar associations between IDDM and both major amputation and RAS events were found in patients undergoing a PTA/S-first intervention (4.1 [1.3-12.6] and 1.5 [1.1-2.2], respectively), whereas IDDM in BPG-first patients was associated with only incomplete wound healing (2.0 [1.4-4.5]). Last, compared with NDM, NIDDM was associated with lower late mortality (0.7 [0.5-0.9]).

Conclusions: Compared with NDM, IDDM is associated with similar perioperative and long-term mortality but a higher risk of incomplete wound healing, major amputation, and future RAS events, especially after a PTA/S-first approach. NIDDM, on the other hand, is associated with lower long-term mortality and few adverse limb events. Overall, these data demonstrate both the importance of distinguishing between diabetes types and the potential long-term benefit of a BPG-first strategy in appropriately selected IDDM patients with CLTI.
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http://dx.doi.org/10.1016/j.jvs.2017.06.119DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5862717PMC
April 2018

Lifelong limb preservation: A patient-centered description of lower extremity arterial reconstruction outcomes.

J Vasc Surg 2017 10 11;66(4):1117-1122. Epub 2017 May 11.

Division of Vascular and Endovascular Surgery, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Mass.

Background: Life expectancy is short for patients with critical limb ischemia (CLI), many of whom may fear amputation more than death. In light of the reduced life expectancy of these patients, the traditional 5-year freedom from amputation (FFA) statistic may not accurately address their concern. We developed a more relevant patient-centered calculation of major amputation risk during a patient's remaining lifetime to better answer the question, Will I ever lose my leg?

Methods: We identified all limbs undergoing first-time intervention for CLI in a large institutional database from 2005 to 2013. We calculated the traditional metrics of amputation-free survival (AFS, for which failure is death or amputation) and FFA (for which failure is amputation but deaths are censored and removed from further analysis). In addition, we propose a new term, lifelong limb preservation (LLP). LLP defines amputation as failure, but deaths are not censored and therefore reflect that LLP has been achieved. All deaths before 30 days were considered a failure in all three metrics, reflecting the risk of surgery.

Results: There were 1006 limbs identified as having first-time intervention for CLI (22% rest pain, 45% ulcer, 27% gangrene; 46% treated by angioplasty with or without stenting, 54% bypass). Using life-table analysis, 7-year AFS was 14% (561 events), FFA was 78% (123 events), and LLP was 86% (123 events). LLP was similar between patients undergoing angioplasty with or without stenting and bypass (7-year rates, 86% and 85%, respectively). For patients undergoing intervention for rest pain, 7-year rates were 14% for AFS, 84% for FFA, and 92% for LLP. For those undergoing treatment for ulcer, 7-year rates were 14% for AFS, 77% for FFA, and 86% for LLP. Finally, in those with gangrene, rates were 10% for AFS, 67% for FFA, and 79% for LLP. Using LLP, patients presenting with an ulcer can be told that although we cannot guarantee how long they will live, with revascularization there is approximately an 86% chance they will not lose the leg.

Conclusions: These results show that the durability of our limb preservation efforts often exceeds the life expectancy of our patients. Using LLP as an outcomes assessment provides a more accurate and patient-centered answer to the question, If I have this procedure, will I ever lose my leg?
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http://dx.doi.org/10.1016/j.jvs.2017.02.043DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5612858PMC
October 2017

Results for primary bypass versus primary angioplasty/stent for lower extremity chronic limb-threatening ischemia.

J Vasc Surg 2017 08 6;66(2):466-475. Epub 2017 Mar 6.

Division of Vascular and Endovascular Surgery, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Mass. Electronic address:

Background: Long-term results comparing percutaneous transluminal angioplasty with or without stenting (PTA/S) and open surgical bypass for chronic limb-threatening ischemia (CLTI) in patients who have had no prior intervention are lacking.

Methods: All patients undergoing a first-time lower extremity revascularization for CLTI by vascular surgeons at our institution from 2005 to 2014 were retrospectively reviewed. Outcomes included perioperative complications, wound healing, restenosis, primary patency, reintervention, major amputation, RAS events (ie, reintervention, major amputation, or stenosis), and mortality. Outcomes were evaluated using χ, Kaplan-Meier, and Cox regression analyses.

Results: Of the 2869 total lower extremity revascularizations performed between 2005 and 2014, there were 1336 that fit our criteria of a first-time lower extremity intervention for CLTI (668 bypass procedures and 668 PTA/S procedures). Bypass patients were younger (71 vs 72 years; P = .02) and more often male (62% vs 56%; P < .02). Total mean hospital length of stay (LOS) was significantly longer after a first-time bypass (10 vs 8 days; P < .001), as were mean preoperative LOS (4 vs 3 days; P < .01) and postoperative LOS (7 vs 5 days; P < .001). There was no difference in perioperative mortality (3% vs 3%; P = .63). Surgical site infection occurred in 10% of bypass patients. Freedom from reintervention was significantly higher in patients undergoing a first-time bypass procedure (62% vs 52% at 3 years; P = .04), as was freedom from restenosis (61% vs 45% at 3 years; P < .001). Complete wound healing at 6-month follow-up was significantly better after an initial bypass (43% vs 36%; P < .01). A Cox regression model of all patients showed that reintervention was predicted by a first-time PTA/S (hazard ratio, 1.6; 95% confidence interval, 1.3-2.1) and both preoperative femoropopliteal TransAtlantic Inter-Society Consensus (TASC) C and TASC D lesions (2.0 [1.3-3.1] and 1.8 [1.3-2.7], respectively). Major amputation among all patients was predicted by an initial presentation of gangrene (2.5 [1.3-5.0]), dialysis dependence (1.9 [1.3-2.9]), diabetes (2.0 [1.1-3.8]), and preoperative femoropopliteal TASC D lesions (2.1 [1.1-4.0]) and was not predicted by procedure type.

Conclusions: In this retrospective analysis, bypass for the primary treatment of CLTI showed improved 6-month wound healing, higher freedom from restenosis, improved patency rates, significantly fewer reinterventions, and higher survival than PTA/S within 3 years; however, a bypass-first approach was associated with increased total hospital LOS and wound infection. Perioperative mortality and amputation rates were similar between procedure types.
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http://dx.doi.org/10.1016/j.jvs.2017.01.024DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5524588PMC
August 2017

Predictive ability of the Society for Vascular Surgery Wound, Ischemia, and foot Infection (WIfI) classification system after first-time lower extremity revascularizations.

J Vasc Surg 2017 03 7;65(3):695-704. Epub 2017 Jan 7.

Division of Vascular and Endovascular Surgery, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Mass. Electronic address:

Objective: The Society for Vascular Surgery (SVS) Wound, Ischemia and foot Infection (WIfI) classification system was proposed to predict 1-year amputation risk and potential benefit from revascularization. Our goal was to evaluate the predictive ability of this scale in a real-world selection of patients undergoing a first-time lower extremity revascularization for chronic limb-threatening ischemia (CLTI).

Methods: From 2005 to 2014, 1336 limbs underwent a first-time lower extremity revascularization for CLTI, of which 992 had sufficient data to classify all three WIfI components (wound, ischemia, and foot infection). Limbs were stratified into the SVS WIfI clinical stages (from 1 to 4) for 1-year amputation risk estimation, a novel WIfI composite score from 0 to 9 (that weighs all WIfI variables equally), and a novel WIfI mean score from 0 to 3 (that can incorporate limbs missing any of the three WIfI components). Outcomes included major amputation; revascularization, major amputation, or stenosis (>3.5× step-up by duplex; RAS) events; and death. Predictors were identified using Cox regression models and Kaplan-Meier survival estimates.

Results: Of the 1336 first-time procedures performed, 992 limbs were classified in all three WIfI components (524 endovascular and 468 bypass; 26% rest pain and 74% tissue loss). Cox regression demonstrated that a one-unit increase in the WIfI clinical stage increases the risk of major amputation (hazard ratio [HR], 2.4; 95% confidence interval [CI], 1.7-3.2) and RAS events in all limbs (HR, 1.2; 95% CI, 1.1-1.3). Separate models of the entire cohort, a bypass-only cohort, and an endovascular-only cohort showed that a one-unit increase in the WIfI mean score is associated with an increase in the risk of major amputation (all three cohorts: HR, 5.3 [95% CI, 3.6-6.8], 4.1 [2.4-6.9], and 6.6 [3.8-11.6], respectively) and RAS events (all three cohorts: HR, 1.7 [95% CI, 1.4-2.0], 1.9 [1.4-2.6], and 1.4 [1.1-1.9], respectively). The novel WIfI composite and WIfI mean scores were the only consistent predictors of death among the three cohorts, with the WIfI mean score proving most strongly predictive in the entire cohort (HR, 1.4; 95% CI, 1.1-1.7), the bypass-only cohort (HR, 1.5; 95% CI, 1.1-1.9), and the endovascular-only cohort (HR, 1.4; 95% CI, 1.0-1.8). Although the individual WIfI wound component was able to predict mortality among all patients (HR, 1.1; 95% CI, 1.0-1.2) and bypass-only patients (HR, 1.2; 95% CI, 1.1-1.3), neither the additional individual WIfI components nor the WIfI clinical stage were able to significantly predict mortality among any cohort.

Conclusions: This study supports the ability of the SVS WIfI classification system to predict major amputation; however, the novel WIfI mean and WIfI composite scores predict amputation, RAS events, and mortality more consistently than any other current WIfI scoring system. The WIfI mean score allows inclusion of all limbs, and both novel scoring systems are easier to conceptualize, give equal weight to each WIfI component, and may provide clinicians more effective comparisons in outcomes between patients.
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http://dx.doi.org/10.1016/j.jvs.2016.09.055DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5328924PMC
March 2017

Lower Extremity Revascularization in End-Stage Renal Disease.

Vasc Endovascular Surg 2016 Nov 23;50(8):582-585. Epub 2016 Oct 23.

1 Division of Vascular and Endovascular Surgery, Beth Israel Deaconess Medical Center, Boston, MA, USA.

Patients with end-stage renal disease (ESRD) who present with critical limb ischemia (CLI) have become an increasingly common and complex treatment problem for vascular surgeons. Dialysis patients have high short-term mortality rates regardless of whether revascularization is pursued. ESRD patients with CLI can be managed with: local wound care, endovascular or surgical revascularization, or amputation. Some patients may heal small foot wounds with local wound care alone, even if distal perfusion is marginal, as long as any infectious process has been controlled. Surgical revascularization has a mortality rate of 5-10% but has a high chance of limb salvage. However, overall 5-year survival may be as low as 28%. Endovascular therapy also carries a high perioperative mortality risk in this population with similar limb salvage rates. Amputation is indicated in patients with advanced stage CLI, as described by the Society for Vascular Surgery's Wound, Ischemia and foot Infection (WIfI) system. Statistical models predict that endovascular or surgical revascularization strategies are less costly and more functionally beneficial to patients than primary amputation alone. Decisions on how to manage ESRD patients with CLI are complex but revascularization can often result in limb salvage, despite limited overall survival. Dialysis patients with good life expectancy and good quality conduit may benefit most from surgical bypass.
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http://dx.doi.org/10.1177/1538574416674843DOI Listing
November 2016

Outcomes for symptomatic abdominal aortic aneurysms in the American College of Surgeons National Surgical Quality Improvement Program.

J Vasc Surg 2016 Aug 14;64(2):297-305. Epub 2016 Apr 14.

Division of Vascular and Endovascular Surgery, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Mass. Electronic address:

Background: Historically, symptomatic abdominal aortic aneurysms (AAAs) were found to have intermediate mortality compared with asymptomatic and ruptured AAAs; but with wider use of endovascular aneurysm repair (EVAR), a more recent study suggested that mortality of symptomatic aneurysms was similar to that of asymptomatic AAAs. These prior studies were limited by small numbers. The purpose of this study was to evaluate the mortality and morbidity associated with symptomatic AAA repair in a large contemporary population.

Methods: All patients undergoing infrarenal AAA repair were identified in the 2011 to 2013 American College of Surgeons National Surgical Quality Improvement Program, vascular surgery targeted module. We excluded acute conversions to open repair and those for whom the surgical indication was embolization, dissection, thrombosis, or not documented. We compared 30-day mortality and major adverse events for asymptomatic, symptomatic, and ruptured AAA repair, stratified by EVAR and open repair, with univariate analysis and multivariable logistic regression.

Results: There were 5502 infrarenal AAAs identified, 4495 asymptomatic aneurysms (830 open repair, 3665 [82%] EVAR), 455 symptomatic aneurysms (143 open repair, 312 [69%] EVAR), and 552 ruptured aneurysms (263 open repair, 289 [52%] EVAR). Aneurysm diameter was similar between asymptomatic and symptomatic AAAs when stratified by procedure type, but it was larger for ruptured aneurysms (EVAR: symptomatic 5.8 ± 1.6 cm vs ruptured 7.5 ± 2.0 cm [P < .001]; open repair: symptomatic 6.4 ± 1.9 cm vs ruptured 8.0 ± 1.9 cm [P < .001]). The proportion of women was similar in symptomatic and ruptured AAAs (27% vs 23%, respectively; P = .14) but lower in asymptomatic AAAs (20%; P < .001). Symptomatic AAAs had intermediate 30-day mortality compared with asymptomatic and ruptured aneurysms after both EVAR (1.4% asymptomatic vs 3.8% symptomatic [P = .001]; symptomatic vs 22% ruptured [P < .001]) and open repair (4.3% asymptomatic vs 7.7% symptomatic [P = .08]; symptomatic vs 34% ruptured [P < .001]). After adjustment for age, gender, repair type, dialysis dependence, and history of severe chronic obstructive pulmonary disease, patients undergoing repair of symptomatic AAAs were twice as likely to die within 30 days compared with those with asymptomatic aneurysms (odds ratio [OR], 2.1; 95% confidence interval [CI], 1.3-3.5). When stratified by repair type, the effect size and direction of the ORs were similar (EVAR: OR, 2.4 [95% CI, 1.2-4.7]; open repair: OR, 1.8 [95% CI, 0.86-3.9]) although not significant for open repair. Patients with ruptured aneurysms had a sevenfold increased risk of 30-day mortality compared with symptomatic patients (OR, 6.5; 95% CI, 4.1-10.6).

Conclusions: Patients with symptomatic AAAs had a twofold increased risk of perioperative mortality compared with patients with asymptomatic aneurysms undergoing repair. Furthermore, patients with ruptured aneurysms have a sevenfold increased risk of mortality compared with patients with symptomatic aneurysms.
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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5065370PMC
http://dx.doi.org/10.1016/j.jvs.2016.02.055DOI Listing
August 2016

The impact of vascular surgery wound complications on quality of life.

J Vasc Surg 2016 Dec 26;64(6):1780-1788. Epub 2016 Jul 26.

Division of Vascular Surgery, Brigham and Women's Hospital, Boston, Mass.

Objective: In addition to traditional surgical outcomes, perioperative quality of life is being scrutinized as a patient-centric metric. As part of a prospective study in a contemporary surgical cohort, subjective health states were examined in context of postoperative wound complications (WCs). We hypothesized that WCs negatively affect quality of life.

Methods: The EuroQol (EQ)-5D subjective health state data, comprising five domains with 1 (good) to 3 (poor) ordinal scoring, plus visual analog score, were collected at the day of surgery and at 2 and 4 weeks of follow-up in a study evaluating silver-eluting dressings in 500 patients at three centers. A preference-weighted index was calculated. Groups were defined by no complication (NC) or presence of one or more postoperative WCs.

Results: Patients (72% male) were a mean age of 67.6 years. Primary indications included critical limb ischemia (41.4%), claudication (31.6%), and abdominal aortic aneurysm (11.2%; open groin access for endovascular aneurysm repair). At least one WC occurred in 148 patients (29.6%). Baseline demographics were similar except mean age (NC group, 67.9 years; WC group, 65.7 years; P = .042) and body mass index (NC group, 27.0 kg/m; WC group, 28.2 kg/m). WCs were associated with use of conduit for reconstruction (P = .002), below-knee incisions (P = .002), and incision length (P < .001). Compared with the NC group, there was a decrement in quality-of-life scores in the WC group at 2 weeks (mean change, -0.217; P = .001) but not at 4 weeks (mean change, +0.044; P = .065) postoperatively. Subgroup analysis showed quality-of-life change after WC was most significant in the claudication group (P = .008). The EQ-5D visual analog scale score was lowest in groups with rest pain (57.0) and tissue loss (55.1) and highest in the abdominal aortic aneurysm cohort (71.8).

Conclusions: EQ-5D identified a significantly decreased quality-of-life score 2 weeks after WCs in a cohort undergoing elective infrainguinal arterial surgery. This effect was not present 4 weeks postoperatively.
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http://dx.doi.org/10.1016/j.jvs.2016.05.068DOI Listing
December 2016

Patient selection and perioperative outcomes are similar between targeted and nontargeted hospitals (in the National Surgical Quality Improvement Program) for abdominal aortic aneurysm repair.

J Vasc Surg 2017 Feb 25;65(2):362-371. Epub 2016 Jul 25.

Division of Vascular and Endovascular Surgery, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Mass. Electronic address:

Objective: The targeted vascular module in the American College of Surgeons National Surgical Quality Improvement Program (NSQIP) consists of self-selected hospitals that choose to collect extra clinical details for better risk adjustment and improved procedure-specific outcomes. The purpose of this study was to compare patient selection and outcomes between targeted and nontargeted hospitals in the NSQIP regarding the operative management of abdominal aortic aneurysm (AAA).

Methods: We identified all patients who underwent endovascular aneurysm repair (EVAR) or open AAA repair from 2011 to 2013 and compared cases by whether the operation took place in a targeted or nontargeted hospital. EVAR and open repair as well as intact and ruptured aneurysms were evaluated separately. Only variables contained in both modules were used to evaluate rupture status and operation type. All thoracoabdominal aneurysms were excluded. Univariate analysis was performed for intact and ruptured EVAR and open repair grouped by complexity, defined as visceral involvement in open repair and a compilation of concomitant procedures for EVAR. Multivariable models were developed to identify effect of hospital type on mortality.

Results: There were 17,651 AAA repairs identified. After exclusion of aneurysms involving the thoracic aorta (n = 352), there were 1600 open AAA repairs at targeted hospitals (21% ruptured) and 2725 at nontargeted hospitals (19% ruptured) and 4986 EVARs performed at targeted hospitals (6.7% ruptured) and 7988 at nontargeted hospitals (5.2% ruptured). There was no significant difference in 30-day mortality rates between targeted and nontargeted hospitals for intact aneurysms (EVAR noncomplex, 1.8% vs 1.4% [P = .07]; open repair noncomplex, 4.2% vs 4.5% [P = .7]; EVAR complex, 5.0% vs 3.2% [P = .3]; open repair complex, 8.0% vs 6.0% [P = .2]). For ruptured aneurysms, again there was no difference in mortality between the targeted and nontargeted hospitals (EVAR noncomplex, 23% vs 25% [P = .4]; open repair noncomplex, 38% vs 34% [P = .2]; EVAR complex, 29% vs 33% [P = 1.0]; open repair complex, 27% vs 41% [P = .09]). Multivariable analysis further demonstrated that having an operation at a targeted vs nontargeted hospital had no impact on mortality for both intact and ruptured aneurysms (odds ratio, 1.1 [0.9-1.4] and 1.0 [0.8-1.3], respectively).

Conclusions: This analysis highlights the similarities between targeted and nontargeted hospitals within the NSQIP for AAA operative management and suggests that data from the targeted NSQIP, in terms of AAA management, are generalizable to all NSQIP hospitals.
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http://dx.doi.org/10.1016/j.jvs.2016.04.066DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5253340PMC
February 2017

Predictive ability of the Society for Vascular Surgery Wound, Ischemia, and foot Infection (WIfI) classification system following infrapopliteal endovascular interventions for critical limb ischemia.

J Vasc Surg 2016 Sep 2;64(3):616-22. Epub 2016 Jul 2.

Division of Vascular and Endovascular Surgery, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Mass. Electronic address:

Objective: The Society for Vascular Surgery (SVS) Lower Extremity Guidelines Committee has composed a new threatened lower extremity classification system that reflects the three major factors that impact amputation risk and clinical management: Wound, Ischemia, and foot Infection (WIfI). Our goal was to evaluate the predictive ability of this scale following any infrapopliteal endovascular intervention for critical limb ischemia (CLI).

Methods: From 2004 to 2014, a single institution, retrospective chart review was performed at the Beth Israel Deaconess Medical Center for all patients undergoing an infrapopliteal angioplasty for CLI. Throughout these years, 673 limbs underwent an infrapopliteal endovascular intervention for tissue loss (77%), rest pain (13%), stenosis of a previously treated vessel (5%), acute limb ischemia (3%), or claudication (2%). Limbs missing a grade in any WIfI component were excluded. Limbs were stratified into clinical stages 1 to 4 based on the SVS WIfI classification for 1-year amputation risk, as well as a novel WIfI composite score from 0 to 9. Outcomes included patient functional capacity, living status, wound healing, major amputation, major adverse limb events, reintervention, major amputation, or stenosis (RAS) events (> ×3.5 step-up by duplex), amputation-free survival, and mortality. Predictors were identified using Kaplan-Meier survival estimates and Cox regression models.

Results: Of the 596 limbs with CLI, 551 were classified in all three WIfI domains on a scale of 0 (least severe) to 3 (most severe). Of these 551, 84% were treated for tissue loss and 16% for rest pain. A Cox regression model illustrated that an increase in clinical stage increases the rate of major amputation (hazard ratio [HR], 1.6; 95% confidence interval [CI], 1.1-2.3). Separate regression models showed that a one-unit increase in the WIfI composite score is associated with a decrease in wound healing (HR, 1.2; 95% CI, 1.1-1.4) and an increase in the rate of RAS events (HR, 1.2; 95% CI, 1.1-1.4) and major amputations (HR, 1.4; 95% CI, 1.2-1.8).

Conclusions: This study supports the ability of the SVS WIfI classification system to predict 1-year amputation, RAS events, and wound healing in patients with CLI undergoing endovascular infrapopliteal revascularization procedures.
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http://dx.doi.org/10.1016/j.jvs.2016.03.417DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5002363PMC
September 2016

Reporting standards of the Society for Vascular Surgery for endovascular treatment of chronic lower extremity peripheral artery disease.

J Vasc Surg 2016 Jul;64(1):e1-e21

Division of Vascular Surgery, East Carolina University, Greenville, NC.

Peripheral arterial disease (PAD) represents a spectrum from asymptomatic stenosis to limb-threatening ischemia. The last decade has seen a tremendous increase in the variety of endovascular devices and techniques to treat occlusive disease. Like many evolving technologies, the literature surrounding therapy for endovascular arterial disease consists of mixed-quality manuscripts without clear standardization. Accordingly, critical evaluation of the reported results may be problematic. As such, providers and their patients make treatment decisions without the full benefit of a comparative effectiveness framework. The purpose of this document is to provide a summary for the reporting of endovascular revascularization techniques in the setting of chronic disease. Much of the work in this document is based on prior publications and standards proposed by the Society for Vascular Surgery. We have also made recommendations based on current literature and have attempted to acknowledge shortcomings and areas for future research. The various sections contain summaries of required reporting standards and should serve as a guide for the design of clinical trials and as reference for journal editors and reviewers when considering scientific work pertaining to endovascular therapy for chronic lower extremity arterial disease. An Appendix is provided with commonly used abbreviations in this document.
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http://dx.doi.org/10.1016/j.jvs.2016.03.420DOI Listing
July 2016

Reporting standards of the Society for Vascular Surgery for endovascular treatment of chronic lower extremity peripheral artery disease: Executive summary.

J Vasc Surg 2016 Jul;64(1):227-8

Division of Vascular Surgery, East Carolina University, Greenville, NC.

Recommended reporting standards for lower extremity ischemia were last published by the Society for Vascular Surgery in 1997. Since that time, there has been a proliferation of endovascular therapies for the treatment of chronic peripheral arterial disease. The purpose of this document is to clarify and update these standards, specifically for reports on endovascular treatment. The document is divided into sections: Claudication Reporting, Critical Limb Ischemia Reporting, Preintervention Assessment and Nonanatomic Treatment, Intervention, Outcome Measures - Procedural, Outcome Measures - Disease Specific, and Complications.
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http://dx.doi.org/10.1016/j.jvs.2016.03.432DOI Listing
July 2016

Risk factors and consequences of persistent type II endoleaks.

J Vasc Surg 2016 Apr 12;63(4):895-901. Epub 2016 Jan 12.

Division of Vascular and Endovascular Surgery, Beth Israel Deaconess Medical Center, Boston, Mass. Electronic address:

Objective: Type II endoleaks are common after endovascular aneurysm repair (EVAR), but their clinical significance remains undefined and their management controversial. We determined risk factors for type II endoleaks and associations with adverse outcomes.

Methods: We identified all EVAR patients in the Vascular Study Group of New England abdominal aortic aneurysm database. Patients were subdivided into two groups: (1) those with no endoleak or transient type II endoleak and (2) persistent type II endoleak or new type II endoleak (no endoleak at completion of case). Patients with other endoleak types and follow-up shorter than 6 months were excluded. Multivariable analysis was used to evaluate predictors of persistent or new type II endoleaks. Kaplan-Meier and Cox regression analysis were used to evaluate predictors of reintervention and survival.

Results: Two thousand three hundred sixty-seven EVAR patients had information on endoleaks: 1977 (84%) were in group 1, of which 79% had no endoleaks at all, and 21% had transient endoleaks that resolved at follow-up. The other 390 (16%) were in group 2, of which 31% had a persistent leak, and 69% had a new leak at follow-up that was not seen at the time of surgery. Group 2 was older (mean age, 75 vs 73 years; P < .001) and less likely to have chronic obstructive pulmonary disease (COPD; 24% vs 34%; P < .001) or elevated creatinine levels (2.6% vs 5.3%; P = .027). Coil embolization of one or both hypogastric arteries was associated with a higher rate of persistent type II endoleaks (12 vs 8%; P = .024), as was distal graft extension (12% vs 8%; P = .008). In multivariable analysis, COPD (odds ratio [OR], 0.7; 95% confidence interval [CI], 0.5-0.9; P = .017) was protective against persistent type II endoleak, while hypogastric artery coil embolization (OR, 1.5; 95% CI, 1.0-2.2; P = .044), distal graft extension (OR, 1.6; 95% CI, 1.1-2.3; P = .025), and age ≥ 80 (OR, 2.7; 95% CI, 1.4-5.3; P = .004) were predictive. Graft type was also associated with endoleak development. Persistent type II endoleaks were predictive of postdischarge reintervention (OR, 15.3; 95% CI, 9.7-24.3; P < .001); however, they were not predictive of long-term survival (OR, 1.1; 95% CI, 0.9-1.6; P = .477).

Conclusions: Persistent type II endoleak is associated with hypogastric artery coil embolization, distal graft extension, older age, the absence of COPD, and graft type, but not with aneurysm size. Persistent type II endoleaks are associated with an increased risk of reinterventions, but not rupture or survival. This reinforces the need for continued surveillance of patients with persistent type II endoleaks and the importance of follow-up to detect new type II endoleaks over time.
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http://dx.doi.org/10.1016/j.jvs.2015.10.088DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4808613PMC
April 2016

Open surgical revision provides a more durable repair than endovascular treatment for unfavorable vein graft lesions.

J Vasc Surg 2016 Jan 17;63(1):142-7. Epub 2015 Oct 17.

Division of Vascular and Endovascular Surgery, Department of Surgery, Beth Israel Deaconess Medical Center, Boston, Mass. Electronic address:

Objective: Lower extremity bypass grafts that develop stenoses are commonly treated with either open surgical or endovascular revision. Vein graft stenoses with unfavorable lesions (multiple lesions, lesions >2 cm in length, lesions in grafts <3 months old, lesions in grafts <3 mm in diameter) fare worse than those with favorable lesions when treated with endovascular therapy. However, it is not known if unfavorable lesions fare better with surgical revision than with endovascular treatment or than favorable lesions treated with surgery.

Methods: We performed a retrospective review of 175 vein graft revisions performed at a single institution from 2000 to 2010. Characteristics of lesions treated with surgical and endovascular revision were identified. Cox proportional hazard models were used to identify predictors of revision failure (restenosis >75%, revision, or amputation).

Results: Ninety-one failing vein grafts (52%) were treated with surgical revision and 84 with endovascular treatment (48%), with a median follow-up of 30 months. Favorable lesions fared better than unfavorable lesions after endovascular treatment, with 12-month freedom from failure of 59% vs 34% (P < .01), but not after surgical revision (66% vs 62%; P = .90). Unfavorable lesions had better freedom from failure after surgery than endovascular treatment (62% vs 34%; P < .01), and results in favorable lesions were similar (66% vs 59%; P = .57).

Conclusions: For the treatment of failing vein grafts, endovascular therapy appears adequate for favorable lesions and surgical revision is more durable for unfavorable lesions.
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http://dx.doi.org/10.1016/j.jvs.2015.08.065DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4698070PMC
January 2016

Outcomes of lower extremity revascularization among the hemodialysis-dependent.

J Vasc Surg 2015 Nov 5;62(5):1183-91.e1. Epub 2015 Aug 5.

Division of Vascular Surgery, Beth Israel Deaconess Medical Center, Boston, Mass.

Objective: Optimal patient selection for lower extremity revascularization remains a clinical challenge among the hemodialysis-dependent (HD). The purpose of this study was to examine contemporary real world open and endovascular outcomes of HD patients to better facilitate patient selection for intervention.

Methods: A regional multicenter registry was queried between 2003 and 2013 for HD patients (N = 689) undergoing open surgical bypass (n = 295) or endovascular intervention (n = 394) for lower extremity revascularization. Patient demographics and comorbidities were recorded. The primary outcome was overall survival. Secondary outcomes included graft patency, freedom from major adverse limb events, and amputation-free survival (AFS). Multivariate analysis was performed to identify independent risk factors for death and amputation.

Results: Among the 689 HD patients undergoing lower extremity revascularization, 66% were male, and 83% were white. Ninety percent of revascularizations were performed for critical limb ischemia and 8% for claudication. Overall survival at 1, 2, and 5 years survival remained low at 60%, 43%, and 21%, respectively. Overall 1- and 2-year AFS was 40% and 17%. Mortality accounted for the primary mode of failure for both open bypass (78%) and endovascular interventions (80%) at two years. Survival, AFS, and freedom from major adverse limb event outcomes did not differ significantly between revascularization techniques. At 2 years, endovascular patency was higher than open bypass (76% vs 26%; 95% confidence interval [CI], 0.28-0.71; P = .02). Multivariate analysis identified age ≥80 years (hazard ratio [HR], 1.9; 95% CI, 1.4-2.5; P < .01), indication of rest pain or tissue loss (HR, 1.8; 95% CI, 1.3-2.6; P < .01), preoperative wheelchair/bedridden status (HR, 1.5; 95% CI, 1.1-2.1; P < .01), coronary artery disease (HR, 1.5; 95% CI, 1.2-1.9; P < .01), and chronic obstructive pulmonary disease (HR, 1.4; 95% CI, 1.1-1.8; P = .01) as independent predictors of death. The presence of three or more risk factors resulted in predicted 1-year mortality of 64%.

Conclusions: Overall survival and AFS among HD patients remains poor, irrespective of revascularization strategy. Mortality remains the primary driver for these findings and justifies a prudent approach to patient selection. Focus for improved results should emphasize predictors of survival to better identify those most likely to benefit from revascularization.
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http://dx.doi.org/10.1016/j.jvs.2015.06.203DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5315419PMC
November 2015

Technique and outcomes of robot-assisted median arcuate ligament release for celiac artery compression syndrome.

J Vasc Surg 2015 May 16;61(5):1278-84. Epub 2015 Jan 16.

Institute for Hepatobiliary and Pancreatic Surgery, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Mass. Electronic address:

Objective: Celiac artery compression by the median arcuate ligament (MAL) is a potential cause of postprandial abdominal pain and weight loss that overlaps with other common syndromes. Robotic technology may alter the current paradigm for surgical intervention. Open MAL release is often performed with concurrent bypass for celiac stenosis due to the morbidity of reintervention, whereas the laparoscopic approach is associated with high rates of conversion to open due to bleeding. We hypothesized that a robot-assisted technique might minimize conversion events to open, decrease perioperative morbidity, and defer consideration of vascular bypass at the initial operative setting.

Methods: We retrospectively analyzed patients treated for MAL syndrome by a multidisciplinary team at a tertiary medical center between September 2012 and December 2013. Diagnosis was based on symptom profile and peak systolic velocity (PSV) >200 cm/s during celiac artery duplex ultrasound imaging. All patients underwent robot-assisted MAL release with simultaneous circumferential neurolysis of the celiac plexus. Postoperative celiac duplex and symptom profiles were reassessed longitudinally to monitor outcomes.

Results: Nine patients (67% women) were evaluated for postprandial pain (100%) and weight loss (100%). All patients had celiac stenosis by mesenteric duplex ultrasound imaging (median PSV, 342; range, 238-637 cm/s), and cross-sectional imaging indicated a fishhook deformity in five (56%). Robot-assisted MAL release was completed successfully in all nine patients (100%) using a standardized surgical technique. Estimated blood loss was <50 mL, with a median hospital stay of 2 days (range, 2-3 days). No postoperative complications of grade ≥3, readmissions or reoperations were observed. All patients (100%) improved symptomatically at the 25-week median follow-up. Three patients experienced complete resolution on postoperative celiac duplex ultrasound imaging, and six patients showed an improved but persistent stenosis (PSV >200 cm/s) compared with preoperative velocities (P < .05 by Wilcoxon signed rank). No patients required additional treatment.

Conclusions: Robot-assisted MAL release can be performed safely and effectively with avoidance of conversion events and minimal morbidity. Potential factors contributing to success are patient selection by a multidisciplinary team and replication of the open surgical technique by means of robot-assisted dexterity and visualization. The need for delayed reintervention for persistently symptomatic celiac stenosis is uncertain.
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http://dx.doi.org/10.1016/j.jvs.2014.10.084DOI Listing
May 2015

Routine use of ultrasound-guided access reduces access site-related complications after lower extremity percutaneous revascularization.

J Vasc Surg 2015 Feb 18;61(2):405-12. Epub 2014 Sep 18.

Division of Vascular and Endovascular Surgery, Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, Mass. Electronic address:

Objective: We sought to elucidate the risks for access site-related complications (ASCs) after percutaneous lower extremity revascularization and to evaluate the benefit of routine ultrasound-guided access (RUS) in decreasing ASCs.

Methods: We reviewed all consecutive percutaneous revascularizations (percutaneous transluminal angioplasty or stent) performed for lower extremity atherosclerosis at our institution from 2002 to 2012. RUS began in September 2007. Primary outcome was any ASC (bleeding, groin or retroperitoneal hematoma, vessel rupture, or thrombosis). Multivariable logistic regression was used to determine predictors of ASC.

Results: A total of 1371 punctures were performed on 877 patients (43% women; median age, 69 [interquartile range, 60-78] years) for claudication (29%), critical limb ischemia (59%), or bypass graft stenosis (12%) with 4F to 8F sheaths. There were 72 ASCs (5%): 52 instances of bleeding or groin hematoma, nine pseudoaneurysms, eight retroperitoneal hematomas, two artery lacerations, and one thrombosis. ASCs were less frequent when RUS was used (4% vs 7%; P = .02). Multivariable predictors of ASC were age >75 years (odds ratio [OR], 2.0; 95% confidence interval [CI], 1.1-3.7; P = .03), congestive heart failure (OR, 1.9; 95% CI, 1.1-1.3; P = .02), preoperative warfarin use (OR, 2.0; 95% CI, 1.1-3.5; P = .02), and RUS (OR, 0.4; 95% CI, 0.2-0.7; P < .01). Vascular closure devices (VCDs) were not associated with lower rates of ASCs (OR, 1.1; 95% CI, 0.6-1.9; P = .79). RUS lowered ASCs in those >75 years (5% vs 12%; P < .01) but not in those taking warfarin preoperatively (10% vs 13%; P = .47). RUS did not decrease VCD failure (6% vs 4%; P = .79).

Conclusions: We were able to decrease the rate of ASCs during lower extremity revascularization with the implementation of RUS. VCDs did not affect ASCs. Particular care should be taken with patients >75 years old, those with congestive heart failure, and those taking warfarin.
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http://dx.doi.org/10.1016/j.jvs.2014.07.099DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4308537PMC
February 2015

Prospective, randomized, multi-institutional clinical trial of a silver alginate dressing to reduce lower extremity vascular surgery wound complications.

J Vasc Surg 2015 Feb 28;61(2):419-427.e1. Epub 2014 Aug 28.

Division of Vascular and Endovascular Surgery, Brigham and Women's Hospital, Harvard Medical School, Boston, Mass.

Objective: Wound complications negatively affect outcomes of lower extremity arterial reconstruction. By way of an investigator initiated clinical trial, we tested the hypothesis that a silver-eluting alginate topical surgical dressing would lower wound complication rates in patients undergoing open arterial procedures in the lower extremity.

Methods: The study block-randomized 500 patients at three institutions to standard gauze or silver alginate dressings placed over incisions after leg arterial surgery. This original operating room dressing remained until gross soiling, clinical need to remove, or postoperative day 3, whichever was first. Subsequent care was at the provider's discretion. The primary end point was 30-day wound complication incidence generally based on National Surgical Quality Improvement Program guidelines. Demographic, clinical, quality of life, and economic end points were also collected. Wound closure was at the surgeon's discretion.

Results: Participants (72% male) were 84% white, 45% were diabetic, 41% had critical limb ischemia, and 32% had claudication (with aneurysm, bypass revision, other). The overall 30-day wound complication incidence was 30%, with superficial surgical site infection as the most common. In intent-to-treat analysis, silver alginate had no effect on wound complications. Multivariable analysis showed that Coumadin (Bristol-Myers Squibb, Princeton, NJ; odds ratio [OR], 1.72; 95% confidence interval [CI], 1.03-2.87; P = .03), higher body mass index (OR, 1.05; 95% CI, 1.01-1.09; P = .01), and the use of no conduit/material (OR, 0.12; 95% CI, 0.82-3.59; P < .001) were independently associated with wound complications.

Conclusions: The incidence of wound complications remains high in contemporary open lower extremity arterial surgery. Under the study conditions, a silver-eluting alginate dressing showed no effect on the incidence of wound complications.
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http://dx.doi.org/10.1016/j.jvs.2014.07.034DOI Listing
February 2015

Risk factors for readmission after lower extremity bypass in the American College of Surgeons National Surgery Quality Improvement Program.

J Vasc Surg 2014 May 31;59(5):1331-9. Epub 2014 Jan 31.

Department of Vascular Surgery, Beth Israel Deaconess Medical Center, Boston, Mass. Electronic address:

Objective: Readmission is associated with high mortality, morbidity, and cost. We used the American College of Surgeons National Surgery Quality Improvement Program (ACS-NSQIP) to determine risk factors for readmission after lower extremity bypass (LEB).

Methods: We identified all patients who received LEB in the 2011 ACS-NSQIP database. Multivariable logistic regression was used to assess independent predictors of 30-day readmission. We also identified our institutional contribution of LEB patients to the ACS-NSQIP from 2005 to 2011 to determine our institution's rate of readmission and readmission indications.

Results: Among 5018 patients undergoing LEB, ACS-NSQIP readmission analysis was performed on 4512, excluding those whose readmission data were unavailable, who suffered a death on index admission, or who remained in the hospital at 30 days. Overall readmission rate was 18%, and readmission rate of those with NSQIP-captured complications was 8%. Multivariable predictors of readmission were dependent functional status (odds ratio [OR], 1.40; 95% confidence interval [CI], 1.08-1.79), dyspnea (OR, 1.28; 95% CI, 1.02-1.60), cardiac comorbidity (OR, 1.46; 95% CI, 1.16-1.84), dialysis dependence (OR, 1.44; 95% CI, 1.05-1.97), obesity (OR, 1.28; 95% CI, 1.07-1.53), malnutrition (OR, 1.42; 95% CI, 1.12-1.79), critical limb ischemia operative indication (OR, 1.40; 95% CI, 1.10-1.79), and return to the operating room on index admission (OR, 8.0; 95% CI, 6.68-9.60). The most common postdischarge complications occurring in readmitted patients included wound complications (55%), multiple complications (22%), and graft failure (5%). Our institutional data contributed 465 LEB patients to the ACS-NSQIP from 2005 to 2012, with an overall readmission rate of 14%. Unplanned readmissions related to the original LEB (related unplanned) made up 75% of cases. The remainder 25% included readmissions that were planned staged procedures related to the original LEB (related planned, 11%) and admissions for a completely unrelated reason (unrelated unplanned, 14%). The most common readmission indications included wound infection (37%) and graft failure (10%). Readmissions were attributable to NSQIP-captured postdischarge complications in 44% of cases, an additional 44% had a non-NSQIP-defined reason for readmission, and the remainder (12%) included patients admitted for complications described in NSQIP but not meeting strict NSQIP criteria.

Conclusions: Readmissions are common after LEB. Optimization of select chronic conditions, closer follow-up of patients in poor health and those who required return to the operating room, and early detection of surgical site infections may improve readmission rates. Our finding that 25% of readmissions after LEB are not procedure related informs the broader discussion of how a readmission penalty affects vascular surgery in particular.
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http://dx.doi.org/10.1016/j.jvs.2013.12.032DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4004644PMC
May 2014

Presentation, treatment, and outcome differences between men and women undergoing revascularization or amputation for lower extremity peripheral arterial disease.

J Vasc Surg 2014 Feb 29;59(2):409-418.e3. Epub 2013 Sep 29.

Division of Vascular and Endovascular Surgery, Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, Mass. Electronic address:

Objective: Prior studies have suggested treatment and outcome disparities between men and women for lower extremity peripheral arterial disease after surgical bypass. Given the recent shift toward endovascular therapy, which has increasingly been used to treat claudication, we sought to analyze sex disparities in presentation, revascularization, amputation, and inpatient mortality.

Methods: We identified individuals with intermittent claudication and critical limb ischemia (CLI) using International Classification of Diseases, Ninth Revision codes in the Nationwide Inpatient Sample from 1998 to 2009. We compared presentation at time of intervention (intermittent claudication vs CLI), procedure (open surgery vs percutaneous transluminal angioplasty or stenting vs major amputation), and in-hospital mortality for men and women. Regional and ambulatory trends were evaluated by performing a separate analysis of the State Inpatient and Ambulatory Surgery Databases from four geographically diverse states: California, Florida, Maryland, and New Jersey.

Results: From the Nationwide Inpatient Sample, we identified 1,797,885 patients (56% male) with intermittent claudication (26%) and CLI (74%), who underwent 1,865,999 procedures (41% open surgery, 20% percutaneous transluminal angioplasty or stenting, and 24% amputation). Women were older at the time of intervention by 3.5 years on average and more likely to present with CLI (75.9% vs 72.3%; odds ratio [OR], 1.21; 95% confidence interval [CI], 1.21-1.23; P < .01). Women were more likely to undergo endovascular procedures for both intermittent claudication (47% vs 41%; OR, 1.27; 95% CI, 1.25-1.28; P < .01) and CLI (21% vs 19%; OR, 1.14; 95% CI, 1.13-1.15; P < .01). From 1998 to 2009, major amputations declined from 18 to 11 per 100,000 in men and 16 to 7 per 100,000 in women, predating an increase in total CLI revascularization procedures that was seen starting in 2005 for both men and women. In-hospital mortality was higher in women regardless of disease severity or procedure performed even after adjusting for age and baseline comorbidities (.5% vs .2% after percutaneous transluminal angioplasty or stenting for intermittent claudication; 1.0% vs .7% after open surgery for intermittent claudication; 2.3% vs 1.6% after percutaneous transluminal angioplasty or stenting for CLI; 2.7% vs 2.2% after open surgery for CLI; P < .01 for all comparisons).

Conclusions: There appears to be a preference to perform endovascular over surgical revascularization among women, who are older and have more advanced disease at presentation. Percutaneous transluminal angioplasty or stenting continues to be popular and is increasingly being performed in the outpatient setting. Amputation and in-hospital mortality rates have been declining, and women now have lower amputation but higher mortality rates than men. Recent improvements in outcomes are likely the result of a combination of improved medical management and risk factor reduction.
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http://dx.doi.org/10.1016/j.jvs.2013.07.114DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3946884PMC
February 2014

Endovascular management of critical limb ischemia in renal transplant patients.

Ann Vasc Surg 2014 Jan 5;28(1):159-63. Epub 2013 Sep 5.

Department of Surgery, Beth Israel Deaconess Medical Center, Boston, MA. Electronic address:

Background: End-stage renal disease is a significant negative predictor of limb salvage and patient survival in patients with limb ischemia, but little is known of the overall effects of renal transplantation. Endovascular management may be less morbid than open surgery, but technical success and durability in these patients is not well established.

Methods: All patients with functioning renal transplants and critical limb ischemia (CLI) treated with endovascular techniques between 2003 and 2010 were retrospectively reviewed for limb salvage, reintervention, pre- and postprocedure creatinine, and estimated glomerular filtration rate (eGFR), and overall survival. Contralateral common femoral access, low-profile techniques, and isosmolar contrast were standard for all interventions.

Results: Endovascular interventions were performed on 57 limbs in 28 patients with renal transplants. Mean age was 54 years, 78% were male, 85% were diabetic, 100% were hypertensive, and 64% had a positive smoking history. All patients were treated for CLI. Treated regions included 16 iliac, 19 superficial femoral, 16 popliteal, and 12 tibial arteries, as well as 1 bypass graft with initial technical success of 100% and 0% 30-day mortality. Of all lesions, 43% required reintervention during the follow-up period, the majority in the first year. There was no significant change in eGFR or creatinine comparing pre- and post-angiogram value. Limb salvage and 1-year survival were 83% and 82%, respectively.

Conclusions: Endovascular management of CLI in renal transplant patients results in good technical success and can be accomplished without a measurable change in transplant kidney function, although it requires repeat interventions. Endovascular therapy is a reasonable first-line treatment option for this high-risk group.
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http://dx.doi.org/10.1016/j.avsg.2012.12.007DOI Listing
January 2014

The impact of the present on admission indicator on the accuracy of administrative data for carotid endarterectomy and stenting.

J Vasc Surg 2014 Jan 28;59(1):32-8.e1. Epub 2013 Aug 28.

Division of Vascular and Endovascular Surgery, Department of Surgery, Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, Mass. Electronic address:

Background: Administrative data are often hampered by coding errors, absent data, and the difficulty of distinguishing pre-existing conditions from perioperative complications. We evaluated whether the introduction of the present on admission (POA) indicator improved outcome analysis of carotid endarterectomy (CEA) and carotid angioplasty and stenting (CAS) using administrative data.

Methods: State inpatient databases from California (2005-2008), New York (2008), and New Jersey (2008) were used to identify patients undergoing CAS and CEA. We first analyzed morbidity data without the POA indicator, using International Classification of Diseases, Ninth Revision complication codes (eg, 997.02, iatrogenic cerebrovascular infarction or hemorrhage, postoperative stroke) and diagnosis codes (eg, 433.11, occlusion and stenosis of the carotid artery with cerebral infarction). Then, we applied the POA indicator to both diagnosis and complication codes and calculated the proportion of events that were labeled POA. Symptom status and perioperative stroke rate were compared using these coding approaches.

Results: We identified 21,639 patients who underwent CEA and 3688 patients who underwent CAS. Without the POA indicator, the complication code for stroke indicated a postoperative stroke rate of 1.4% for CEA and 2.4% for CAS. After applying the POA indicator, 54% (CEA) and 62% (CAS) of these strokes were labeled POA. These POA strokes were either preoperative or intraoperative events. Proportion of symptomatic patients ranged from 7% to 16% for CEA and from 5% to 22% for CAS. Perioperative stroke rate was the lowest in the POA method (1.1% CEA, 1.8% CAS) compared with two other methods without POA information (1.4% and 9.5% CEA and 2.4% and 16.4% CAS). Kappa indicated a poor (0.2) to fair (0.7) agreement between these approaches.

Conclusions: Administrative data has known limitations for assignment of symptom status and nonfatal perioperative outcomes. Given the uncertain timing of POA events as preoperative vs intraoperative and its apparent underestimation of the perioperative stroke rate, the use of administrative data even with the POA indicator for symptom status and non-fatal outcomes after CEA and CAS is hazardous.
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http://dx.doi.org/10.1016/j.jvs.2013.07.006DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3874266PMC
January 2014

Fate of the contralateral limb after lower extremity amputation.

J Vasc Surg 2013 Dec 3;58(6):1571-1577.e1. Epub 2013 Aug 3.

Department of Surgery, Division of Vascular and Endovascular Surgery, Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, Mass.

Objective: Lower extremity amputation is often performed in patients where both lower extremities are at risk due to peripheral arterial disease or diabetes, yet the proportion of patients who progress to amputation of their contralateral limb is not well defined. We sought to determine the rate of subsequent amputation on both the ipsilateral and contralateral lower extremities following initial amputation.

Methods: We conducted a retrospective review of all patients undergoing lower extremity amputation (exclusive of trauma or tumor) at our institution from 1998 to 2010. We used International Classification of Diseases-Ninth Revision codes to identify patients and procedures as well as comorbidities. Outcomes included the proportion of patients at 1 and 5 years undergoing contralateral and ipsilateral major and minor amputation stratified by initial major vs minor amputation. Cox proportional hazards regression analysis was performed to determine predictors of major contralateral amputation.

Results: We identified 1715 patients. Mean age was 67.2 years, 63% were male, 77% were diabetic, and 34% underwent an initial major amputation. After major amputation, 5.7% and 11.5% have a contralateral major amputation at 1 and 5 years, respectively. After minor amputation, 3.2% and 8.4% have a contralateral major amputation at 1 and 5 years while 10.5% and 14.2% have an ipsilateral major amputation at 1 and 5 years, respectively. Cox proportional hazards regression analysis revealed end-stage renal disease (hazard ratio [HR], 3.9; 95% confidence interval [CI], 2.3-6.5), chronic renal insufficiency (HR, 2.2; 95% CI, 1.5-3.3), atherosclerosis without diabetic neuropathy (HR, 2.9; 95% CI, 1.5-5.7), atherosclerosis with diabetic neuropathy (HR, 9.1; 95% CI, 3.7-22.5), and initial major amputation (HR, 1.8; 95% CI, 1.3-2.6) were independently predictive of subsequent contralateral major amputation.

Conclusions: Rates of contralateral limb amputation are high and predicted by renal disease, atherosclerosis, and atherosclerosis with diabetic neuropathy. Physicians and patients should be alert to the high risk of subsequent amputation in the contralateral leg. All patients, but particularly those at increased risk, should undergo close surveillance and counseling to help prevent subsequent amputations in their contralateral lower extremity.
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http://dx.doi.org/10.1016/j.jvs.2013.06.055DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3844063PMC
December 2013