Publications by authors named "Mark Wyers"

80 Publications

A multicenter, prospective randomized trial of negative pressure wound therapy for infrainguinal revascularization with a groin incision.

J Vasc Surg 2021 Feb 4. Epub 2021 Feb 4.

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

Background: Wound complications after open infrainguinal revascularization are a frequent cause of patient morbidity, resulting in increased healthcare costs. The purpose of the present study was to assess the effects of closed incision negative pressure therapy (ciNPT) on groin wound complications after infrainguinal bypass and femoral endarterectomy.

Methods: A total of 242 patients who had undergone infrainguinal bypass (n = 124) or femoral endarterectomy (n = 118) at five academic medical centers in New England from April 2015 to August 2019 were randomized to ciNPT (PREVENA; 3M KCI, St Paul, Minn; n = 118) or standard gauze (n = 124). The primary outcome measure was a composite endpoint of groin wound complications, including surgical site infections (SSIs), major noninfectious wound complications, or graft infections within 30 days after surgery. The secondary outcome measures included 30-day SSIs, 30-day noninfectious wound complications, readmission for wound complications, significant adverse events, and health-related quality of life using the EuroQoL 5D-3L survey.

Results: The ciNPT and control groups had similar demographics (age, 67 vs 67 years, P = .98; male gender, 71% vs 70%, P = .86; white race, 93% vs 93%, P = .97), comorbidities (previous or current smoking, 93% vs 94%, P = .46; diabetes, 41% vs 48%, P = .20; renal insufficiency, 4% vs 7%, P = .31), and operative characteristics, including procedure type, autogenous conduit, and operative time. No differences were found in the primary composite outcome at 30 days between the two groups (ciNPT vs control: 31% vs 28%; P = .55). The incidence of SSI at 30 days was similar between the two groups (ciNPT vs control: 11% vs 12%; P = .58). Infectious (13.9% vs 12.6%; P = .77) and noninfectious (20.9% vs 17.6%; P = .53) wound complications at 30 days were also similar for the ciNPT and control groups. Wound complications requiring readmission also similar between the two groups (ciNPT vs control: 9% vs 7%; P = .54). The significant adverse event rates were not different between the two groups (ciNPT vs control: 13% vs 16%; P = .53). The mean length of the initial hospitalization was the same for the ciNPT and control groups (5.2 vs 5.7 days; P = .63). The overall health-related quality of life was similar at baseline and at 14 and 30 days postoperatively for the two groups. Although not powered for stratification, we found no differences among the subgroups in gender, obesity, diabetes, smoking, claudication, chronic limb threatening ischemia, bypass, or endarterectomy. On multivariable analysis, no differences were found in wound complications at 30 days for the ciNPT vs gauze groups (odds ratio, 1.4; 95% confidence interval, 0.8-2.6; P = .234).

Conclusions: In contrast to other randomized studies, our multicenter trial of infrainguinal revascularization found no differences in the 30-day groin wound complications for patients treated with ciNPT vs standard gauze dressings. However, the SSI rate was lower in the control group than reported in other studies, suggesting other practice patterns and processes of care might have reduced the rate of groin infections. Further study might identify the subsets of high-risk patients that could benefit from ciNPT.
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http://dx.doi.org/10.1016/j.jvs.2020.12.100DOI Listing
February 2021

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

Surgical treatment patterns and clinical outcomes of patients treated for expanding aneurysm sacs with type II endoleaks after endovascular aneurysm repair.

J Vasc Surg 2021 Feb 29;73(2):484-493. Epub 2020 Jun 29.

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

Objective: Persistent type II endoleaks (T2ELs) after endovascular aneurysm repair (EVAR) with sac growth have been associated with adverse events, including rupture. Whereas intervention in the presence of aneurysm growth has become an accepted treatment paradigm for T2ELs, the efficacy and clinical success of such interventions remain unclear. Therefore, we examined the treatment patterns and clinical outcomes of patients undergoing T2EL interventions after EVAR.

Methods: We performed a retrospective review of all patients treated for expanding aneurysm sacs with T2ELs after EVAR at an academic medical center between 2006 and 2017. The primary outcomes assessed were need for repeated intervention; intervention types; and achievement of clinical success, defined as stable aneurysm sac size on computed tomography angiography after treatment.

Results: Fifty-six patients underwent 119 interventions, of which 107 (90%) were technically successful. The median time from EVAR to index T2EL procedure was 37 months (interquartile range, 17-56 months), and the median follow-up time from first T2EL procedure was 27 months (interquartile range, 10-51 months). The most common index procedure was transarterial lumbar embolization (64%), followed by transarterial inferior mesenteric artery (20%), transcaval (14%), and translumbar embolization (1.8%). Thirty-three (59%) patients required further procedures for persistent aneurysm sac expansion. For subsequent T2EL interventions, the most common endovascular procedure was transarterial lumbar embolization (21%), followed by transcaval (21%), translumbar (11%), and transarterial inferior mesenteric artery embolization (8.6%). Twelve patients (21%) were found to have loss of proximal or distal seal on subsequent imaging and required graft extensions to stabilize aneurysm sac size. Ten patients (18%) ultimately underwent graft explantation or sacotomy with oversewing of the endoleak source. Freedom from any endoleak-related reintervention was 57% at 1 year and 36% at 3 years. Freedom from open treatment was 93% at 1 year and 82% at 3 years. Of the 44 patients with ≥6-month follow-up, 39 (89%) achieved clinical success. However, only 11 patients (25%) achieved clinical success without any further reintervention, and 29 patients (66%) achieved clinical success without open treatment.

Conclusions: Despite high technical success, endoleak recurrence after T2EL treatment is common, and multiple interventions are often needed to stabilize aneurysm sac size in patients diagnosed with T2EL-associated sac growth. Notably, one in five patients treated for T2ELs was discovered, on further evaluation, to have proximal or distal seal zone loss that necessitated repair to achieve sac stability. Thus, thorough assessment of all endoleak types should be performed in patients with T2ELs associated with sac growth before T2EL treatment to ensure appropriate care and to minimize ineffective interventions.
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http://dx.doi.org/10.1016/j.jvs.2020.05.062DOI Listing
February 2021

The role of transfemoral carotid artery stenting with proximal balloon occlusion embolic protection in the contemporary endovascular management of carotid artery stenosis.

J Vasc Surg 2020 11 3;72(5):1701-1710. Epub 2020 Apr 3.

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

Objective: Recent data have shown that transcarotid artery revascularization (TCAR) with flow reversal provides a superior method of embolic protection compared with transfemoral carotid artery stenting (tfCAS) with distal embolic protection. Flow reversal or flow arrest systems with proximal endovascular balloon occlusion can also be used through the transfemoral approach; however, their outcomes compared with TCAR with flow reversal and tfCAS with distal embolic protection are poorly described.

Methods: We performed a retrospective review of all patients undergoing tfCAS with proximal balloon occlusion, tfCAS with distal embolic protection, and TCAR with flow reversal in the Society for Vascular Surgery Vascular Quality Initiative from March 2005 to May 2019. We assessed in-hospital outcomes in propensity score-matched cohorts of patients using tfCAS with proximal balloon occlusion as the comparison cohort. The primary outcome was stroke or death. Secondary end points included the individual outcomes of stroke, death, transient ischemic attack (TIA), and myocardial infarction.

Results: Of the 24,232 patients undergoing carotid artery stenting, 561 (2.3%) procedures were performed through tfCAS with proximal balloon occlusion, 18,126 (74%) through tfCAS with distal embolic protection, and 5545 (22.9%) through TCAR with flow reversal. After matching, 463 pairs of patients undergoing tfCAS with proximal balloon occlusion and tfCAS with distal embolic protection were identified. There were no differences in stroke or death (proximal balloon, 3.2%; distal embolic protection, 3.7%; relative risk [RR], 0.88; 95% confidence interval [CI], 0.45-1.73; P = .73), stroke (2.4% vs 2.6%; RR, 0.92; 95% CI, 0.42-2.00; P = .83), death (1.1% vs 1.5%; RR, 0.71; 95% CI, 0.41-3.15; P = .80), TIA (1.7% vs 1.5%; RR, 1.14; 95% CI, 0.41-3.15; P = .80), or myocardial infarction (0.4% vs 0.6%; RR, 0.67; 95% CI, 0.11-3.99; P = .65). However, after matching 357 pairs of patients undergoing tfCAS with proximal balloon occlusion and TCAR with flow reversal, tfCAS with proximal balloon occlusion was associated with higher rates of stroke or death (3.1% vs 0.8%; RR, 3.67; 95% CI, 1.02-13.14; P = .03) and a trend toward higher rates of stroke (2.5% vs 0.8%; RR, 3.00; 95% CI, 0.81-11.08; P = .08) and death (0.8% vs 0.0%; P = .08), but no statistically significant differences in TIA (0.8% vs 0.8%; P > .99) or myocardial infarction (0.6% vs 0.3%; RR, 2.00; 95% CI, 0.18-22.06; P = .56).

Conclusions: Compared with tfCAS with distal embolic protection, tfCAS with proximal balloon occlusion has similar major outcomes. However, tfCAS with proximal balloon occlusion does not offer the same degree of embolic protection compared with TCAR with flow reversal, given the significantly higher risk of perioperative stroke or death.
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http://dx.doi.org/10.1016/j.jvs.2020.02.036DOI Listing
November 2020

Contemporary outcomes after carotid endarterectomy in high-risk anatomic and physiologic patients.

J Vasc Surg 2020 01 20;71(1):104-110. Epub 2019 Aug 20.

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

Objective: Current guidelines state that the acceptable 30-day postoperative stroke/death rate after carotid endarterectomy (CEA) is <3% for asymptomatic patients and <6% for symptomatic patients. The Centers for Medicare and Medicaid Services has identified certain high-risk characteristics used to define patients at highest risk for CEA for whom carotid artery stenting would be reimbursed. We evaluated the impact of the Centers for Medicare and Medicaid Services physiologic and anatomic high-risk criteria on major adverse event rates after CEA in asymptomatic and symptomatic patients.

Methods: We retrospectively reviewed all patients undergoing CEA from 2011 to 2017 in the American College of Surgeons National Surgical Quality Improvement Program vascular targeted database. Patients with high-risk anatomic or physiologic characteristics were identified by a predefined variable and were compared with normal-risk patients. The primary outcome was 30-day stroke/death, stratified by symptom status.

Results: We identified 25,788 patients undergoing CEA, of whom 60% were treated for asymptomatic carotid disease. Among all patients, high-risk physiology or anatomy was associated with higher rates of 30-day stroke/death compared with normal-risk patients (physiologic risk, 4.6% vs 2.3% [P < .001]; anatomic risk, 3.6% vs 2.3% [P < .001]). Patients who met criteria for high-risk physiology or anatomy also had higher rates of cardiac events (physiologic risk, 3.1% vs 1.6% [P < .001]; anatomic risk, 2.3% vs 1.6% [P < .01]), but only patients with high-risk anatomy had higher rates of cranial nerve injury (physiologic risk, 2.4% vs 2.5% [P = .81]; anatomic risk, 4.3% vs 2.5% [P < .001]). Asymptomatic patients with high-risk physiology or anatomy had higher rates of 30-day stroke/death, especially in the physiologic high-risk group (physiologic risk, 4.7% vs 1.5% [P < .001]; anatomic risk, 2.6% vs 1.5% [P < .01]), compared with normal-risk patients. However, among symptomatic patients, differences in stroke/death were seen only with high-risk anatomic patients and not with high-risk physiologic patients (physiologic risk, 4.6% vs 3.4% [P = .12]; anatomic risk, 4.8% vs 3.4% [P = .01]).

Conclusions: As currently selected, contemporary real-world outcomes after CEA in asymptomatic carotid disease patients meeting high-risk physiologic criteria show an unacceptably high 30-day stroke/death rate, well above the 3% threshold. These results suggest the need for better selection of patients and preoperative optimization before elective CEA.
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http://dx.doi.org/10.1016/j.jvs.2019.05.041DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6926142PMC
January 2020

Thirty-Day Outcomes After Open Revascularization for Acute Mesenteric Ischemia From the American College of Surgeons National Surgical Quality Improvement Program.

Ann Vasc Surg 2019 Nov 2;61:148-155. Epub 2019 Aug 2.

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

Background: Open revascularization for acute mesenteric ischemia (AMI) is associated with high perioperative morbidity and mortality; however, results from contemporary studies are varied. Therefore, we evaluated 30-day mortality after open revascularization for AMI and identified preoperative factors associated with mortality.

Methods: We performed a retrospective cohort study of patients in the American College of Surgeons National Surgical Quality Improvement Program database undergoing open mesenteric revascularization for AMI from 2005 to 2017. The primary outcome was 30-day mortality. We used multivariable logistic regression to identify preoperative factors independently associated with 30-day mortality.

Results: The study cohort included 918 patients; their median age was 70 years (interquartile range: 59-80 years), 62% were female, and 90% were white. Thirty-day mortality after open revascularization for AMI was 32%, specifically 35% after embolectomy, 31% after thromboendarterectomy, and 28% after mesenteric bypass. Mortality was higher in patients requiring concomitant bowel resection (38% vs. 29%, respectively, P < 0.01). The preoperative factor most strongly associated with 30-day mortality was disseminated cancer (odds ratio = 8.8, 95% confidence interval = 2.4-32, P = 0.001). Other factors independently associated with mortality were renal dysfunction, preoperative intubation, preoperative blood transfusion, diabetes, elevated preoperative international normalized ratio, elevated preoperative white blood cell count, and increasing age.

Conclusions: In this retrospective cohort study using a real-world, nationwide cohort, open revascularization for AMI was associated with high mortality, with nearly one-third of patients dying within 30 days of their operation. The factors identified to be independently associated with 30-day mortality, particularly disseminated cancer, preoperative renal dysfunction, and elevated preoperative WBC count, are an important tool for preoperative risk stratification.
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http://dx.doi.org/10.1016/j.avsg.2019.05.024DOI Listing
November 2019

Intraoperative Unfractionated Heparin Unresponsiveness during Endovascular Repair of a Ruptured Abdominal Aortic Aneurysm following Administration of Andexanet Alfa for the Reversal of Rivaroxaban.

Pharmacotherapy 2019 08 18;39(8):861-865. Epub 2019 Jul 18.

Division of Hemostasis and Thrombosis, Department of Hematology, Beth Israel Deaconess Medical Center, Boston, Massachusetts.

The authors describe a case of unfractionated heparin (UFH) unresponsiveness in the operating room secondary to reversal of rivaroxaban with coagulation factor Xa (recombinant) inactivated-zhzo (andexanet alfa). A 70-year-old man with a known 4.5- to 5.0-cm abdominal aortic aneurysm and atrial fibrillation managed with rivaroxaban presented with severe right-sided flank pain radiating to the left side of his abdomen. Computed tomography-angiography on arrival demonstrated a left retroperitoneal hematoma and a suspected ruptured abdominal aortic aneurysm. He received andexanet alfa to reverse rivaroxaban prior to an emergent endovascular aneurysm repair. During surgery, he received a total of 14,000 units (167 units/kg) of UFH with minimal changes in activated clotting time (132-144 sec; baseline 135 sec [reference range 74-137 sec]). This case highlights the potential complications of using UFH anticoagulation following reversal of factor Xa inhibitors with andexanet alfa and underscores the importance of peri-procedural anticoagulation planning. For patients who require intra-operative anticoagulation, providers should consider anticoagulation reversal with prothrombin complex concentrate instead of andexanet alfa or administration of a parenteral direct thrombin inhibitor, such as argatroban or bivalirudin during the surgical procedure.
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http://dx.doi.org/10.1002/phar.2306DOI Listing
August 2019

Response by O'Donnell and Wyers to Letter Regarding Article, "The Weekend Effect in Carotid Endarterectomy".

Stroke 2019 04;50(4):e111

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

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http://dx.doi.org/10.1161/STROKEAHA.119.024441DOI Listing
April 2019

Anatomic eligibility for transcarotid artery revascularization and transfemoral carotid artery stenting.

J Vasc Surg 2019 05 8;69(5):1452-1460. Epub 2019 Mar 8.

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

Objective: Transcarotid artery revascularization (TCAR) has emerged as an alternative to transfemoral carotid artery stenting (tfCAS). We investigated the proportion of carotid arteries undergoing revascularization procedures that would be eligible for TCAR based on anatomic criteria and how many arteries at high anatomic risk for tfCAS would be amenable to TCAR.

Methods: We performed a retrospective review of consecutive patients who underwent carotid endarterectomy or carotid stenting between 2012 and 2015. Patients were excluded if computed tomography angiography of the neck was not performed within 6 months of the procedure. We assessed TCAR eligibility on the basis of the instructions for use of the ENROUTE Transcarotid Neuroprotection System (Silk Road Medical, Sunnyvale, Calif) and high anatomic risk for tfCAS on the basis of anatomic factors known to make carotid cannulation more difficult or hazardous.

Results: Of the 118 patients and 236 carotid arteries identified, 12 carotid arteries were excluded for presence of an occluded internal carotid artery (ICA). Of the remaining 224 carotid arteries, 72% were eligible for TCAR on the basis of the instructions for use criteria; 100% had 4- to 9-mm ICA diameters, 100% had ≥6-mm common carotid artery (CCA) diameter, 75% had ≥5-cm clavicle to carotid bifurcation distance, and 96% lacked significant CCA puncture site plaque. In addition, 7% of carotid arteries had bifurcation anatomy unfavorable for stenting; thus, of the entire cohort of arteries examined, 68% were eligible for TCAR. Hyperlipidemia (odds ratio [OR], 6.7; 95% confidence interval [CI], 1.7-26; P < .01), chronic obstructive pulmonary disease (OR, 3.5; 95% CI, 1.5-8.3; P < .01), and older age (OR, 1.1; 95% CI, 1.0-1.1; P < .01) were independently associated with TCAR ineligibility, whereas white race (OR, 0.2; 95% CI, 0.0-1.0; P = .048) and beta-blocker use (OR, 0.3; 95% CI, 0.1-0.7; P < .01) were independently associated with TCAR eligibility. In addition, 24% of carotid arteries were considered to be at high risk for tfCAS for the presence of a type III aortic arch (7.6%), severe aortic calcification (3.3%), tandem CCA lesions (7.1%), moderate to severe stenosis at the carotid ostium (8.9%), and tortuous distal ICA precluding embolic filter placement (4.5%). Active smoking (OR, 4.4; 95% CI, 1.9-10; P < .01), hyperlipidemia (OR, 4.0; 95% CI, 1.2-14; P = .03), and older age (OR, 1.1; 95% CI, 1.0-1.1; P = .02) were independently associated with tfCAS ineligibility, whereas preoperative aspirin (OR, 0.1; 95% CI, 0.0-0.4; P < .001) or clopidogrel (OR, 0.3; 95% CI, 0.1-0.8; P = .01) use was associated with tfCAS eligibility. Of the arteries that were considered to be at high risk for tfCAS, 69% were eligible for TCAR.

Conclusions: The majority of carotid arteries in individuals selected for revascularization meet TCAR eligibility, making TCAR a viable treatment option for many patients.
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http://dx.doi.org/10.1016/j.jvs.2018.11.051DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6478535PMC
May 2019

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

A Novel Quality of Life Instrument for Patients with an Abdominal Aortic Aneurysm.

Eur J Vasc Endovasc Surg 2019 Jun 23;57(6):809-815. Epub 2019 Feb 23.

Dartmouth-Hitchcock Medical Centre, Lebanon, NH, USA.

Objective: The surveillance and treatment of abdominal aortic aneurysms (AAAs) may impact patient quality of life (QOL). A novel AAA specific QOL instrument was developed and validated to quantify the impact of AAA surveillance on QOL.

Methods: The study was performed in two phases: development (2011-2013) and validation (2013-2014) of a survey instrument. Content was informed by focus groups at three centres (22 patients) and two multidisciplinary physician focus groups (6 vascular surgeons, 7 primary care providers). Cognitive interviews (17 patients) ensured questions were understood as intended. The final survey was mailed to AAA patients at six US institutions. Patients were scored on two AAA specific domains of QOL: emotional impact (EIS) and behavioural change (BCS), range 0-100 with higher scores indicating worse quality of life. Test retest reliability and internal consistency were assessed. Discriminant validity was determined by comparing scores between patients under surveillance vs. those who had undergone AAA repair. Scores were externally validated by correlation with the Short Form (SF)-12.

Results: A total of 1,008 (73%) of 1,373 patients returned surveys: 351 (35%) were under surveillance, 657 (65%) had undergone repair (endovascular, 414; open, 179; unsure, 64). Median EIS was 11 (range 0-95; IQR 7-26). Median BCS was 13 (range 0-100; IQR 9-47). To test reliability, 337 patients repeated the survey after four weeks with no significant differences between scores over time. EIS and BCS demonstrated good internal consistency (Cronbach's Alpha 0.85 and 0.75 respectively). There was strong correlation between scores (r = 0.53) and both related moderately to SF-12 scores (r = 0.45 and r = 0.39, respectively). Patients under AAA surveillance had worse EIS than repair patients (22 vs. 13; p < .001). Patients with a higher perceived rupture risk had a worse EIS (45 vs. 12; p < .001) and BCS (30 vs. 13; p < .001).

Conclusions: An AAA specific QOL instrument was successfully created and validated. The range of impact on QOL by AAA surveillance is broad. For most patients the impact is minimal, but for some, especially those with a greater perceived rupture risk, it is severe.
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http://dx.doi.org/10.1016/j.ejvs.2019.01.018DOI Listing
June 2019

Weekend Effect in Carotid Endarterectomy.

Stroke 2018 12;49(12):2945-2952

From the Division of Vascular and Endovascular Surgery, Beth Israel Deaconess Medical Center, Boston, MA (T.F.X.O., M.L.S., P.L., C.L., N.J.S., M.C.W.).

Background and Purpose- Patients undergoing surgery on the weekend may experience worse outcomes, but this weekend effect has not been studied in carotid endarterectomy (CEA). Methods- We identified patients undergoing isolated CEA in the Vascular Quality Initiative between 2003 and 2018. Our primary outcome was in-hospital stroke or perioperative death (stroke/death), stratified by symptom status. For asymptomatic patients, we also compared rates of the Centers for Medicare and Medicaid Services quality metric prolonged length of stay (>2 days or failed discharge home). We calculated propensity scores and used multilevel, inverse probability weighted logistic regression clustering at the hospital level. Results- There were 86 123 repairs during the study period, 53% asymptomatic lesions and 47% symptomatic. Only 0.7% of asymptomatic patients underwent CEA on the weekend, compared with 3.1% of symptomatic patients. Patients undergoing weekend repairs were more often white, with lower rates of most comorbidities. In asymptomatic patients, weekend operations were associated significantly higher odds of stroke/death (odds ratio [OR], 2.3 [1.1-4.8]; P=0.02), and prolonged length of stay (OR, 3.6 [2.7-4.7]; P<0.001). In symptomatic patients, weekend operations were associated with significantly higher adjusted odds of stroke/death (OR, 1.7 [1.2-2.4]; P=0.007) and longer postoperative length of stay (3.3 days versus 2.0 days, P=0.002). However, the difference in stroke/death was driven by patients presenting with stroke (OR, 2.2 [1.5-2.3]; P<0.001), rather than those presenting with transient ischemic attack (OR, 1.2 [0.6-2.1]; P=0.56). Conclusions- We found evidence of a significant weekend effect in CEA, as weekend operations in asymptomatic patients and patients who presented with stroke were associated with higher rates of stroke/death and prolonged length of stay. However, there was no evidence of such an effect in patients with transient ischemic attack. These data suggest that weekend CEA should be avoided except in the case of expedited revascularization after transient ischemic attack.
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http://dx.doi.org/10.1161/STROKEAHA.118.022305DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6309973PMC
December 2018

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

Three-dimensional image fusion is associated with lower radiation exposure and shorter time to carotid cannulation during carotid artery stenting.

J Vasc Surg 2019 04 6;69(4):1111-1120. Epub 2018 Oct 6.

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

Objective: Three-dimensional (3D) image fusion is associated with lower radiation exposure, contrast agent dose, and operative time during endovascular abdominal aortic aneurysm repair. Therefore, we evaluated the impact of this technology on carotid artery stenting (CAS).

Methods: We identified consecutive CAS procedures from 2009 to 2017 and compared those performed with and without 3D image fusion. For image fusion, we created a 3D reconstruction of the aortic arch anatomy based on preoperative computed tomography or magnetic resonance angiography that we merged with two-dimensional fluoroscopy, allowing 3D image overlay. We compared radiation exposure, fluoroscopy time, contrast agent dose, time to common carotid artery (CCA) cannulation, time from CCA cannulation to completion angiography, and total procedure time in procedures with and without image fusion. We also assessed rates of 30-day stroke/death, in-hospital and 30-day stroke, and acute kidney injury. We used multivariable linear regression to adjust for patient and procedural characteristics and used these models to compute the marginal effects of image fusion compared with no image fusion.

Results: There were 46 patients who underwent CAS with a 3D image fusion system and 70 patients without. Patients undergoing CAS with image fusion experienced 31% lower radiation exposure compared with the control group (207 ± 23 mGy vs 300 ± 26 mGy, respectively; P < .01), shorter fluoroscopy time (21 ± 6 minutes vs 24 ± 8 minutes; P = .02), shorter time to carotid cannulation (21 ± 9 minutes vs 31 ± 8 minutes; P < .001), and shorter total procedure time (47 ± 13 minutes vs 54 ± 18 minutes; P = .03). There was no difference in contrast material volume, time from CCA cannulation to completion angiography, or total in-room time. After multivariable adjustment, 3D image fusion remained associated with lower radiation dose, shorter fluoroscopy time, and shorter time to carotid cannulation (all P < .05). The rate of 30-day stroke/death was 2.7% (three strokes and no deaths at 30 days), and the rate of acute kidney injury was 1.8%.

Conclusions: CAS with 3D image fusion was associated with lower radiation exposure and shorter time to CCA cannulation. These results represent the potential technical advantage gained with image fusion and add to the growing body of evidence demonstrating its impact on radiation exposure and operative times during complex endovascular procedures.
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http://dx.doi.org/10.1016/j.jvs.2018.07.038DOI Listing
April 2019

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

A preoperative risk score for transfusion in infrarenal endovascular aneurysm repair to avoid type and cross.

J Vasc Surg 2018 02 26;67(2):442-448. Epub 2017 Jul 26.

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

Objective: Preoperative type and cross are often routinely ordered before elective endovascular aneurysm repair (EVAR), but the cost of this practice is high, and transfusion is rare. We therefore aimed to stratify patients by their risk of transfusion to identify a cohort in whom a type and screen would be sufficient.

Methods: We queried the targeted vascular module of the National Surgical Quality Improvement Program (NSQIP) for all elective EVARs from 2011 to 2015. We included only infrarenal aneurysms and excluded ruptured aneurysms and patients transfused within 72 hours preoperatively. Two-thirds of the cases were randomly assigned to a model derivation cohort and one third to a validation cohort. We created and subsequently validated a risk model for transfusion within the first 24 hours of surgery (including intraoperatively), using logistic regression.

Results: Between 2011 and 2015, there were 4875 patients who underwent elective infrarenal EVAR, only 221 (4.5%) of whom received a transfusion within 24 hours of surgery. The frequency of transfusion during the study period declined monotonously from 6.5% in 2011 to 3.2% in 2015. The factors independently associated with transfusion were preoperative hematocrit <36% (odds ratio [OR], 3.4 [95% confidence interval, 2.1-5.4]; P < .001), aortic diameter (per centimeter increase: OR, 1.2 [1.03-1.4]; P = .02), preoperative dependent functional status (OR, 2.5 [1.1-5.5]; P = .03), and chronic obstructive pulmonary disease (OR, 1.7 [1.04-2.9]; P = .04). A risk prediction model based on these criteria produced a C statistic of 0.69 in the prediction cohort and 0.76 in the validation cohort and a Hosmer-Lemeshow goodness of fit of 0.62 and 0.14, respectively. A score of <3 of 9, corresponding to a <5% probability of transfusion, would avoid preoperative type and cross in 86% of patients. Of the 4203 patients (86%) with a hematocrit >36%, only 6 (0.1%) had a risk score of >3.

Conclusions: Perioperative transfusion for EVAR is becoming increasingly uncommon and is predicted well by a transfusion risk score or simply a hematocrit of <36%. Application of this risk score would avoid unnecessary type and cross in the majority of patients, leading to significant savings in both time and cost.
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http://dx.doi.org/10.1016/j.jvs.2017.05.108DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5785583PMC
February 2018

Trends in Treatment and Mortality for Mesenteric Ischemia in the United States from 2000 to 2012.

Ann Vasc Surg 2017 Jul 28;42:111-119. Epub 2017 Mar 28.

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

Background: It is unknown whether increased endovascular treatment of chronic mesenteric ischemia has led to decreases in open surgery, acute mesenteric ischemia, or overall mortality. The present study evaluates the trends in endovascular and open treatment over time for chronic and acute mesenteric ischemia.

Methods: We identified patients with chronic or acute mesenteric ischemia in the Nationwide Inpatient Sample and Center for Disease Control and Prevention database from 2000 to 2012. Trends in revascularization, mortality, and total deaths were evaluated over time. Data were adjusted to account for population growth.

Results: There were 14,810 revascularizations for chronic mesenteric ischemia (10,453 endovascular and 4,358 open) and 11,294 revascularizations for acute mesenteric ischemia (4,983 endovascular and 6,311 open). Endovascular treatment increased for both chronic (0.6-4.5/million, P < 0.01) and acute mesenteric ischemia (0.6-1.8/million, P < 0.01). However, concurrent declines in open surgery did not occur (chronic: 1-1.1/million, acute: 1.8-1.7/million). Among patients with acute mesenteric ischemia, the proportion with atrial fibrillation (18%) and frequency of embolectomy (1/million per year) remained stable. In-hospital mortality rates decreased for both endovascular (chronic: 8-3%, P < 0.01; acute: 28-17%, P < 0.01) and open treatment (chronic: 21-9%, P < 0.01; acute: 40-25%, P < 0.01). Annual population-based mortality remained stable for chronic mesenteric ischemia (0.7-0.6 deaths per million/year), but decreased for acute mesenteric ischemia (12.9-5.3 deaths per million/year, P < 0.01).

Conclusions: Population mortality from acute mesenteric ischemia declined from 2000 to 2012, correlated with dramatic increases in endovascular intervention for chronic mesenteric ischemia, and in spite of a stable rate of embolization. However, open surgery for both chronic and acute ischemia remained stable.
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http://dx.doi.org/10.1016/j.avsg.2017.01.007DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5502755PMC
July 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

Perioperative clopidogrel is associated with increased bleeding and blood transfusion at the time of lower extremity bypass.

J Vasc Surg 2017 06 20;65(6):1719-1728.e1. Epub 2017 Feb 20.

Section of Vascular Surgery, Dartmouth-Hitchcock Medical Center, Lebanon, NH. Electronic address:

Objective: Controversy persists surrounding the perceived bleeding risk associated with perioperative clopidogrel use in patients undergoing lower extremity bypass (LEB). The purpose of this study was to examine the LEB bleeding risk and clinical sequelae associated with clopidogrel.

Methods: All LEBs in the Vascular Quality Initiative (VQI) from 2008 to 2014 were studied. The exposure was perioperative clopidogrel. Primary outcomes were blood transfusion, estimated blood loss ≥500 mL, and reoperation for bleeding. Secondary outcomes included mean operative time, major cardiac events, respiratory complications, infectious complications, and in-hospital mortality. Univariate and multivariable analyses were used to analyze patients on the basis of clopidogrel use and its association with outcomes. Nonparametric test for trend and Mantel-Haenszel methods were used to analyze association of clopidogrel use with blood transfusion and secondary outcomes.

Results: Among the LEB cohort (N = 9179), 28% (n = 2544) were taking clopidogrel and 72% (n = 6635) were not. Patients taking clopidogrel were more likely to have coronary disease, prior coronary intervention, abnormal findings on stress test, and aspirin use (P < .001 for all). Patients taking clopidogrel were more likely to receive blood transfusion (38% vs 24%; P < .001) and to have estimated blood loss ≥500 mL (21% vs 12%; P < .001). Reoperation for bleeding rates were similar (0.9% vs 1.1%; P = .9). Clopidogrel use was also associated with increased mean operative times (244 minutes vs 232 minutes; P < .001) as well as with cardiac complications (8.8% vs 6.5%; P = .001), respiratory complications (2.5% vs 1.6%; P = .007), and in-hospital mortality (1.3% vs 0.8%; P = .03). Multivariable analysis demonstrated that clopidogrel was associated with increased risk of 1- or 2-unit blood transfusion (odds ratio [OR], 1.8; 95% confidence interval [CI], 1.5-2.1; P < .001) and >2-unit blood transfusion (OR, 2.0; 95% CI, 1.7-2.5; P < .001). Major cardiac events (OR, 1.2; 95% CI, 1.0-1.5; P = .05) and respiratory complications (OR, 1.4; 95% CI, 1.0-2.0; P = .03) were also independently associated with clopidogrel use. Weighted Mantel-Haenszel ORs controlling for blood transfusion amount revealed no remaining effect of clopidogrel on major cardiac events (OR, 1.1; P = .4) or respiratory complications (OR, 1.0; P = .8).

Conclusions: Perioperative clopidogrel use in LEB surgery is associated with increased blood loss and blood transfusion. Associated clinical sequelae include increased cardiac and pulmonary complications. Accordingly, surgeons should consider discontinuation of perioperative clopidogrel when it is clinically appropriate unless it is strongly indicated at the time of LEB.
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http://dx.doi.org/10.1016/j.jvs.2016.12.102DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6114130PMC
June 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

Clinical presentation, management, follow-up, and outcomes of isolated celiac and superior mesenteric artery dissections.

J Vasc Surg 2017 Jan 20;65(1):91-98. Epub 2016 Oct 20.

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

Objective: Isolated visceral artery dissections are rare entities with no current consensus guidelines for treatment and follow-up. This study aims to evaluate the presentation, management, outcomes, and follow-up practices for patients with isolated visceral artery dissections and to compare those with and without symptoms.

Methods: In this retrospective analysis, we identified all patients with isolated celiac artery and/or isolated superior mesenteric artery dissections at a single institution between September 2006 and December 2014. Patients with concomitant aortic dissections were excluded. Cases were stratified by symptom status. Presentation, anatomic findings, treatment, outcomes, and follow-up imaging were then compared between symptomatic and asymptomatic patients.

Results: We identified 25 patients including 15 with symptoms and 10 without. There were no differences in patient comorbidities; however, symptomatic patients more frequently presented with thrombus (n = 10; 67% vs n = 1; 10%; P = .01) and inflammation (n = 8; 53% vs n = 1; 10%; P = .04), and trended toward increased stenosis (n = 12; 80% vs n = 4; 40%; P = .09) compared with asymptomatic patients. All asymptomatic patients were treated with observation alone with vessel diameter enlargement noted in 33% (n = 2) of patients on follow-up imaging. Among symptomatic patients, standard treatment included a short course of anticoagulation (mean, 4.5 months) with lifelong antiplatelet therapy. Three patients underwent operative intervention for persistent or worsening symptoms, two during the index admission and one 10 months after presentation for chronic abdominal pain. Approximately 70% (n = 17) of patients in each group had follow-up imaging (computed tomography angiography: n = 14; 56%; magnetic resonance angiography: n = 4; 16%; ultrasound: n = 13; 52%). Among patients treated nonoperatively, no patients complained of symptoms at follow-up, and 50% of those with inflammation on initial imaging had resolution. Twenty-five percent (n = 4) of patients had an increase in vessel size; however, all vessels remained less than 2 cm in maximal diameter. There were no ruptures or related deaths in either group.

Conclusions: Among patients with visceral artery dissection, no ruptures occurred but diameter enlargement was documented. This disease progression suggests that routine surveillance may be appropriate; however, transitioning early to ultrasound imaging should be considered to decrease radiation, contrast, and associated costs.
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http://dx.doi.org/10.1016/j.jvs.2016.08.080DOI Listing
January 2017

Predictors of renal dysfunction after endovascular and open repair of abdominal aortic aneurysms.

J Vasc Surg 2017 04 26;65(4):991-996. Epub 2016 Sep 26.

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

Objective: Renal complications after repair of abdominal aortic aneurysms (AAAs) have been associated with increased morbidity and mortality. However, limited data have assessed risk factors for renal complications in the endovascular era. This study aimed to identify predictors of renal complications after endovascular AAA repair (EVAR) and open repair.

Methods: Patients who underwent EVAR or open repair of a nonruptured infrarenal AAA between 2011 and 2013 were identified in the National Surgical Quality Improvement Project Targeted Vascular module. Patients on hemodialysis preoperatively were excluded. Renal complications were defined as new postoperative dialysis or creatinine increase >2 mg/dL. Patient demographics, comorbidities, glomerular filtration rate (GFR), operative details, and outcomes were compared using univariate analysis between those with and without renal complications. Multivariable logistic regression was used to identify independent predictors of renal complications.

Results: We identified 4503 patients who underwent elective repair of an infrarenal AAA (EVAR: 3869, open repair: 634). Renal complication occurred in 1% of patients after EVAR and in 5% of patients after open repair. There were no differences in comorbidities between patients with and without renal complications. A preoperative GFR <60 mL/min/1.73m occurred more frequently among patients with renal complications (EVAR: 81% vs 37%, P < .01; open: 60% vs 34%, P < .01). The 30-day mortality was also significantly increased (EVAR: 55% vs 1%, P < .01; open: 30% vs 4%, P < .01). After adjustment, renal complications were strongly associated with 30-day mortality (odds ratio [OR], 38.3; 95% confidence interval [CI], 20.4-71.9). Independent predictors of renal complications included GFR <60 mL/min/1.73m (OR, 4.6; 95% CI, 2.4-8.7), open repair (OR, 2.6; 95% CI, 1.3-5.3), transfusion (OR, 6.1; 95% CI, 3.0-12.6), and prolonged operative time (OR, 3.0; 95% CI, 1.6-5.6).

Conclusions: Predictors of renal complications include elevated baseline GFR, open approach, transfusion, and prolonged operative time. Given the dramatic increase in mortality associated with renal complications, care should be taken to use renal protective strategies, achieve meticulous hemostasis to limit transfusions, and to use an endovascular approach when technically feasible.
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http://dx.doi.org/10.1016/j.jvs.2016.06.113DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5366267PMC
April 2017

Clinical results of single-vessel versus multiple-vessel infrapopliteal intervention.

J Vasc Surg 2016 Dec 31;64(6):1675-1681. Epub 2016 Aug 31.

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

Objective: The effects of concomitant endovascular interventions on multiple infrapopliteal vessels are not well known, and the short-term and long-term sequelae of such procedures have not been reported.

Methods: From 2004 to 2014, 673 limbs in 528 patients 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%). Outcomes included wound healing, RAS events (reintervention, major amputation, or stenosis [>3.5x step-up by duplex]), and mortality. Patients without an initial indication of critical limb ischemia (CLI) were excluded. Patients were characterized as having undergone either a single-vessel infrapopliteal intervention or a multiple-vessel infrapopliteal intervention.

Results: Of the 673 limbs, 558 underwent a successful infrapopliteal endovascular intervention for CLI (86% for tissue loss, 14% for rest pain). During a single procedure, 503 limbs (90%) underwent a single-vessel intervention and 55 (10%) underwent a multiple-vessel intervention. Patients undergoing a single-vessel intervention more commonly underwent a prior ipsilateral endovascular procedure (17% vs 6%; P = .03) or a prior ipsilateral bypass procedure (20% vs 9%; P = .04). Kaplan-Meier analysis revealed that a RAS event ≤1 year occurred in 229 limbs (49%), with no significant difference in the 1-year rates of reintervention (22% vs 20%; P = .53), major amputation (16% vs 10%; P = .24), or stenosis (29% vs 21%; P = .25). After adjustment for baseline characteristics, multivariable regression illustrated that neither major amputation rates nor RAS events differed between patients undergoing a single-vessel vs a multiple-vessel intervention (P = .26 and P = .61, respectively).

Conclusions: Our data suggest that a multiple-vessel intervention does not improve outcomes when compared to a single-vessel intervention following infrapopliteal angioplasty for CLI.
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http://dx.doi.org/10.1016/j.jvs.2016.05.080DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5120993PMC
December 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

Transperitoneal versus retroperitoneal approach for open abdominal aortic aneurysm repair in the targeted vascular National Surgical Quality Improvement Program.

J Vasc Surg 2016 Sep 16;64(3):585-91. Epub 2016 Mar 16.

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

Objective: We sought to compare current practices in patient selection and 30-day outcomes for transperitoneal and retroperitoneal abdominal aortic aneurysm (AAA) repairs.

Methods: All patients undergoing elective transperitoneal or retroperitoneal surgical repair for AAA between January 2011 and December 2013 were identified in the Targeted Vascular National Surgical Quality Improvement Program database. Emergency cases were excluded. Baseline characteristics, anatomic details, and intraoperative and postoperative outcomes were evaluated among those with infrarenal or juxtarenal AAA only.

Results: We identified 1135 patients: 788 transperitoneal (69%) and 347 retroperitoneal (31%). When only infrarenal and juxtarenal AAAs were evaluated, the retroperitoneal patients were less likely to have an infrarenal clamp location (43% vs 68%) and had more renal revascularizations (15% vs 6%; P < .001), more visceral revascularizations (5.6% vs 2.4%; P = .014), and more lower extremity revascularizations (11% vs 7%; P = .021) compared with the transperitoneal approach. Postoperative mortality and return to the operating room were similar. Transperitoneal patients had a higher rate of wound dehiscence (2.4% vs 0.4%; P = .045), and retroperitoneal patients had higher incidence of pneumonia (9% vs 5%; P = .034), transfusion (77% vs 71%; P = .037), and reintubation (11% vs 7%; P = .034), and a longer median length of stay (8 vs 7 days; P = .048). After exclusion of all concomitant procedures, only transfusions remained more common in the retroperitoneal approach (78% vs 70%; P = .036). Multivariable analyses showed only higher rates of reintubation in the retroperitoneal group (odds ratio, 1.7; 95% confidence interval, 1.0-3.0; P = .047).

Conclusions: The retroperitoneal approach is more commonly used for more proximal aneurysms and was associated with higher rates of pneumonia, reintubation, and transfusion, and a longer length of stay on univariate analyses. However, multivariable analysis demonstrated similar results between groups. The long-term benefits and frequency of reinterventions remain to be proven.
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http://dx.doi.org/10.1016/j.jvs.2016.01.055DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5002367PMC
September 2016