Publications by authors named "Nicholas Swerdlow"

41 Publications

Epidemiology of Endovascular and Open Repair for Abdominal Aortic Aneurysms in the United States from 2004-2015 and Implications for Screening.

J Vasc Surg 2021 Feb 13. Epub 2021 Feb 13.

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

Introduction: Contemporary national trends in repair of ruptured abdominal aortic aneurysms and intact abdominal aortic aneurysms are relatively unknown. Furthermore, screening is only covered for patient's 65 to 75 years old with a family history or men with a smoking history. It is unclear what proportion of patients who present with a ruptured aneurysm would have been candidates for screening.

Methods: Using the National Inpatient Sample from 2004 to 2015, we identified rupture and intact AAA admissions and repairs based on International Classification of Diseases codes. We generated the screening eligible cohort using previously identified proportions of male smokers (87%) and all patients with a family history of aneurysm (10%) and applied these proportions to patients aged 65-75. We accounted for those who may have had a prior AAA diagnosis (17%) either from screening or incidental detection in patients over age 75 presenting with rupture. The primary outcomes were treatment and in-hospital mortality stratified by patients meeting criteria for screening versus those who did not.

Results: We evaluated 65,125 admissions for ruptured AAA and 461,191 repairs for intact AAA. Overall, an estimated 45,037 (68%) of patients admitted and 25,777 (59%) of patients undergoing repair for ruptured AAA did not meet criteria for screening. Of the patients who did not qualify; 27,653 (63%) were older than 75 years old; 10,603 (24%) were younger than 65 years old; and 16,103 (36%) were females. EVAR use increased for ruptured AAA from 10% in 2004 to 55% in 2015 (P<0.001) with an operative mortality of 35%, and for intact AAA from 45% in 2004 to 83% in 2015 (P<0.001) with an operative mortality of 2.0%.

Conclusions: The majority of patients who underwent repair for ruptured AAA did not qualify for screening. EVAR is the primary treatment for both ruptured AAA and intact AAA with a relatively low in-hospital mortality. Therefore, expansion of screening criteria to include selected women and a wider age range should be considered.
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http://dx.doi.org/10.1016/j.jvs.2021.01.044DOI Listing
February 2021

Outcomes after transfemoral carotid artery stenting stratified by preprocedural symptom status.

J Vasc Surg 2020 Dec 2. Epub 2020 Dec 2.

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

Objective: The available data on outcomes after transfemoral carotid artery stenting (TFCAS) originate from the early experience with TFCAS. Although most previous studies stratified outcomes according to a symptomatic or asymptomatic presentation, they often did not specify the degree of presenting neurologic injury. We previously reported that the outcomes after carotid endarterectomy differed according to neurologic injury severity, the contemporary perioperative outcomes of TFCAS stratified by the specific presenting symptom status are unknown.

Methods: Patients with data in the Vascular Quality Initiative database who had undergone TFCAS from 2016 to 2020 were included. We stratified patients according to their preprocedural symptom status as asymptomatic, formerly symptomatic (last symptoms >180 days before the procedure), or recently symptomatic (symptoms <180 days before the procedure). The symptoms included stroke, hemispheric transient ischemic attack (TIA), and ocular TIA. We compared the occurrence of in-hospital stroke or death (stroke/death) among the asymptomatic, formerly symptomatic, and specific subtypes of recently symptomatic patients. Multivariable logistic regression models were constructed to adjust for the baseline differences among the groups.

Results: Of the 9807 included patients, 2650 (27%) had had recent stroke, 842 (9%), recent hemispheric TIA, and 360 (4%), recent ocular TIA. In addition, 795 patients (8%) were formerly symptomatic and 5160 (53%) were asymptomatic. The patients with recent stroke had a perioperative stroke/death rate of 5.5%, higher than that of patients with recent hemispheric TIA (2.4%; P < .001) or recent ocular TIA (2.8%; P = .03) and asymptomatic patients (1.4%; P < .001). The stroke/death rate was greater for patients with recent ocular TIA than for asymptomatic patients (2.8% vs 1.4%; P = .04). Formerly symptomatic patients had higher stroke/death rates compared with asymptomatic patients (3.5% vs 1.4%; P < .001). On multivariable-adjusted analysis, recent stroke was associated with higher stroke/death compared with recent hemispheric TIA (odds ratio [OR], 2.6; 95% confidence interval [CI], 1.6-4.3; P < .001) and asymptomatic status (OR, 4.1; 95% CI, 3.0-5.6; P < .001) and demonstrated a trend toward higher stroke/death compared with recent ocular TIA (OR, 2.0; 95% CI, 1.0-3.9; P = .06). Furthermore, asymptomatic status was associated with lower stroke/death compared with formerly symptomatic status (OR, 0.4; 95% CI, 0.2-0.6; P < .001).

Conclusions: For patients undergoing TFCAS, recent stroke was associated with greater odds of in-hospital stroke/death after TFCAS compared with recent hemispheric TIA. Also, formerly symptomatic status was associated with greater odds of stroke/death compared with asymptomatic status. These findings support further symptom stratification by the degree of the presenting neurologic injury in the preoperative risk assessment.
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http://dx.doi.org/10.1016/j.jvs.2020.11.031DOI Listing
December 2020

Editor's Choice - Mortality is High Following Elective Open Repair of Complex Abdominal Aortic Aneurysms.

Eur J Vasc Endovasc Surg 2021 Jan 9;61(1):90-97. Epub 2020 Oct 9.

Department of Surgery, Division of Vascular and Endovascular Surgery, Beth Israel Deaconess Medical Centre, Harvard Medical School, Boston, MA, USA. Electronic address:

Objective: To evaluate the 30 day mortality of elective open complex abdominal aortic aneurysm (cAAA) repair and identify factors associated with death.

Methods: This was a retrospective cohort study using a Targeted Vascular Module from the American College of Surgeons National Surgical Quality Improvement Program (NSQIP). All patients undergoing elective repair for juxta- and suprarenal abdominal aortic aneurysm (AAA), or type IV thoraco-abdominal aneurysms (TAAA) from 2011 to 2017 were identified. Thirty day mortality and complication rates for open repair were established. A comparison endovascular aneurysm repair (EVAR) group was extracted from the same time period, and inverse probability weighting was applied for comparison. Logistic regression was used to identify factors independently associated with open repair mortality.

Results: Of the 957 patients who underwent an elective open cAAA repair over the study period, 65 (6.8%) died. The mean age of the patient was 71.3 ± 8.0 years. The distribution by aneurysm type was 605 juxtarenal AAA (28 deaths, 4.6%); 284 suprarenal AAA (16 deaths, 9.5%), and 68 type IV TAAA (10 deaths, 14.7%). During the same time period, there were 1149 endovascular repairs for cAAA, with 43 deaths (3.7%). After inverse probability weighting and weighted logistic regression, open repair 30 day mortality yielded an OR 1.9, 95% CI 1.2-3.1, p = .01 compared with EVAR. Factors independently associated with death included more proximal extent aneurysm (referent [ref]: juxtarenal: OR 2.0 per extent increase, 95% CI 1.4-3.0, p < .001), BMI < 18.5 (OR 4.0, 95% CI 1.6-10.1, p = .003), history of severe chronic obstructive pulmonary disease (COPD) (OR 2.6, 95% CI 1.5-4.4, p = .001), more severe chronic kidney disease (CKD) (ref: none/mild): OR 1.9, 95% CI 1.2-2.8, p = .004), and age (OR 1.06/year, 95% CI 1.02-1.09, p = .002.

Conclusion: The 30 day mortality was 4.6% for juxtarenal AAA, 9.5% for suprarenal AAA, and 14.7% for type IV TAAA. The open repair odds of 30 day mortality was nearly twice that of endovascular repair for cAAA. Independent associations with death included BMI <18.5, more severe CKD level, more proximally extending aneurysm, age, and history of advanced COPD.
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http://dx.doi.org/10.1016/j.ejvs.2020.09.002DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7855830PMC
January 2021

A comparison of administrative data and quality improvement registries for abdominal aortic aneurysm repair.

J Vasc Surg 2021 Mar 16;73(3):874-888. Epub 2020 Jul 16.

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

Objective: Databases are essential in evaluating surgical outcomes and gauging the implementation of new techniques. However, there are important differences in how data from administrative databases and surgical quality improvement (QI) registries are collected and interpreted. Therefore, we aimed to compare trends, demographics, and outcomes of open and endovascular abdominal aortic aneurysm (AAA) repair in an administrative database and two QI registries.

Methods: We identified patients undergoing open and endovascular repair of intact and ruptured AAAs between 2012 and 2015 within the National Inpatient Sample (NIS), the National Surgical Quality Improvement Program (NSQIP), and the Vascular Quality Initiative (VQI). We described the differences and trends in overall AAA repairs for each data set. Moreover, patient demographics, comorbidities, mortality, and complications were compared between the data sets using Pearson χ test.

Results: A total of 140,240 NIS patients, 10,898 NSQIP patients, and 26,794 VQI patients were included. Ruptured repairs composed 8.7% of NIS, 11% of NSQIP, and 7.9% of VQI. Endovascular aneurysm repair (EVAR) rates for intact repair (range, 83%-84%) and ruptured repair (range, 51%-59%) were similar in the three databases. In general, rates of comorbidities were lower in NIS than in the QI registries. After intact EVAR, in-hospital mortality rates were similar in all three databases (NIS 0.8%, NSQIP 1.0%, and VQI 0.8%; P = .06). However, after intact open repair and ruptured repair, in-hospital mortality was highest in NIS and lowest in VQI (intact open: NIS 5.4%, NSQIP 4.7%, and VQI 3.5% [P < .001]; ruptured EVAR: NIS 24%, NSQIP 20%, and VQI 16% [P < .001]; ruptured open: NIS 36%, NSQIP 31%, and VQI 26% [P < .001]). After stratification by intact and ruptured presentation and repair strategy, several discrepancies in morbidity rates remained between the databases. Overall, the number of cases in NSQIP represents 7% to 8% of the repairs in NIS, and the number of cases in VQI grew from 12% in 2012 to represent 23% of the national sample in 2015.

Conclusions: NIS had the largest number of patients as it represents the nationwide experience and is an essential tool to evaluate trends over time. The lower in-hospital mortality seen in NSQIP and VQI questions the generalizability of the studies that use these QI registries. However, with a growing number of hospitals engaging in granular QI initiatives, these QI registries provide a valuable resource to potentially improve the quality of care provided to all patients.
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http://dx.doi.org/10.1016/j.jvs.2020.06.105DOI Listing
March 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

Protamine use in transfemoral carotid artery stenting is not associated with an increased risk of thromboembolic events.

J Vasc Surg 2021 Jan 12;73(1):142-150.e4. Epub 2020 Jun 12.

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

Background: Protamine use in carotid endarterectomy has been shown to be associated with fewer perioperative bleeding complications without higher rates of thromboembolic events. However, the effect of protamine use on complications after transfemoral carotid artery stenting (CAS) is unclear, and concerns remain about thromboembolic events.

Methods: A retrospective review was performed for patients undergoing transfemoral CAS in the Vascular Quality Initiative from March 2005 to December 2018. We assessed in-hospital outcomes using propensity score-matched cohorts of patients who did and did not receive protamine. The primary outcome was in-hospital stroke or death. Secondary outcomes included bleeding complications, stroke, death, transient ischemic attack, myocardial infarction, and congestive heart failure exacerbation. Bleeding complications were categorized as bleeding resulting in intervention or blood transfusions.

Results: Of the 17,429 patients undergoing transfemoral CAS, 2697 (15%) patients received protamine. We created 2300 propensity score-matched pairs of patients who did and did not receive protamine. There were no statistically significant differences in stroke or death between the two cohorts (protamine, 2.5%; no protamine, 2.9%; relative risk [RR], 0.85; 95% confidence interval [CI], 0.60-1.21; P = .37). Protamine use was not associated with statistically significant differences in perioperative bleeding complications resulting in interventional treatment (0.9% vs 0.5%; RR, 2.10; 95% CI, 0.99-4.46; P = .05) or blood transfusion (1.2% vs 1.2%; RR, 0.92; 95% CI, 0.53-1.61; P = .78). There were also no statistically significant differences for the individual outcomes of stroke (1.8% vs 2.3%; RR, 0.78; 95% CI, 0.52-1.16; P = .22), death (0.9% vs 0.8%; RR, 1.17; 95% CI, 0.62-2.19; P = .63), transient ischemic attack (1.4% vs 1.3%; RR, 1.10; 95% CI, 0.67-1.82; P = .70), myocardial infarction (0.5% vs 0.4%; RR, 1.20; 95% CI, 0.52-2.78; P = .67), or heart failure exacerbation (1.0% vs 0.9%; RR, 1.05; 95% CI, 0.58-1.90; P = .88). Protamine use in patients presenting with symptomatic carotid stenosis was associated with lower risk of stroke or death (3.0% vs 4.3%; RR, 0.69; 95% CI, 0.47-0.998; P = .048), whereas there were no statistically significant differences in stroke or death with protamine use in asymptomatic patients (1.6% vs 1.0%; RR, 1.63; 95% CI, 0.67-3.92; P = .28).

Conclusions: Heparin reversal with protamine after transfemoral CAS is not associated with an increased risk of thromboembolic events, and its use in symptomatic carotid disease is associated with a lower risk of stroke or death.
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http://dx.doi.org/10.1016/j.jvs.2020.04.526DOI Listing
January 2021

Thoracic Endovascular Aortic Repair With Left Subclavian Artery Coverage Is Associated With a High 30-Day Stroke Incidence With or Without Concomitant Revascularization.

J Endovasc Ther 2020 10 21;27(5):769-776. Epub 2020 May 21.

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

To evaluate the perioperative stroke incidence following thoracic endovascular aortic repair (TEVAR) with differing left subclavian artery (LSA) coverage and revascularization approaches in a real-world setting of a nationwide clinical registry. The National Surgical Quality Improvement Program registry was interrogated from 2005 to 2017 to identify all nonemergent TEVAR and/or open LSA revascularization procedures. In this time frame, 2346 TEVAR cases met the selection criteria for analysis. The 30-day stroke incidence was compared between patients undergoing TEVAR with (n=888) vs without (n=1458) LSA coverage, for those with (n=228) vs without (n=660) concomitant LSA revascularization among those with coverage, and following isolated LSA revascularization for occlusive disease (n=768). Multivariable logistic regression was employed for risk-adjusted analyses and to identify factors associated with stroke following TEVAR. Results of the regression analyses are presented as the adjusted odds ratio (OR) with 95% confidence interval (CI). The stroke incidence was 2.3% following TEVAR without vs 5.2% with LSA coverage (p<0.001). In TEVARs with LSA coverage, the stroke incidence was 7.5% when the LSA was concomitantly revascularized and 4.4% without concomitant revascularization, while stroke occurred in 0.5% of isolated LSA revascularizations. Of 33 TEVAR patients experiencing a perioperative stroke, 8 (24%) died within 30 days. LSA coverage was associated with stroke both with concomitant revascularization (OR 4.0, 95% CI 2.2 to 7.5, p<0.001) and without concomitant revascularization (OR 2.2, 95% CI 1.3 to 3.8, p=0.002). Other preoperative factors associated with stroke were dyspnea (OR 1.8, 95% CI 1.1 to 3.0, p=0.014), renal dysfunction (OR 2.2, 95% CI 1.0 to 3.8, p=0.049), and international normalized ratio ≥2.0 (OR 3.6, 95% CI 1.0 to 13, p=0.045). Stroke following TEVAR with LSA coverage occurs frequently in the real-world setting, and concurrent LSA revascularization was not associated with a lower stroke incidence.
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http://dx.doi.org/10.1177/1526602820923044DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7804158PMC
October 2020

Contemporary mortality after emergent open repair of complex abdominal aortic aneurysms.

J Vasc Surg 2021 Jan 29;73(1):39-47.e1. Epub 2020 Apr 29.

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

Objective: Mortality after open repair for emergent complex abdominal aortic aneurysm (AAA) is poorly defined. This study evaluated the 30-day mortality of open complex AAA repair performed for rupture or other emergent indication using a national surgical registry. We subsequently identified factors associated with mortality.

Methods: The targeted vascular module from the American College of Surgeons National Surgical Quality Improvement Program was queried to identify patients undergoing open repair for juxtarenal and suprarenal AAAs or type IV thoracoabdominal aneurysms (TAAAs) for rupture or other emergent indication from 2011 to 2017. Univariate analyses were performed using the Fisher's exact test for categorical variables and the Wilcoxon rank sum test for continuous variables. Multivariable logistic regression was performed to identify factors independently associated with mortality.

Results: We included 374 patients who underwent an emergent complex open AAA repair during the study period. There were 142 (38%) cases performed for rupture with hypotension, 141 (38%) for rupture without hypotension, 40 (11%) for symptomatic AAA, and 51 (14%) for another indication. The distribution by aneurysm type was 224 juxtarenal AAAs, 122 suprarenal AAAs, and 28 type IV TAAAs. Overall, there was a 30-day mortality of 32% (118 deaths). For those with juxtarenal AAA repair, 67 (30%) patients died within 30 days; there were 38 (31%) deaths within 30 days in those with suprarenal AAA, and 13 (46%) deaths within 30 days in those with type IV TAAA. On univariate analysis, preoperative variables associated with death were increasing age, use of a transperitoneal surgical approach, lower preoperative estimated glomerular filtration rate, low baseline albumin concentration (<3.5 g/dL), need for preoperative transfusion, low body mass index (<18.5 kg/m), and hypotension at presentation. Intraoperative variables associated with mortality were supraceliac clamp location and concurrent renal revascularization. On multivariable analysis, factors independently associated with death included rupture with associated hypotension (reference: other emergent indication; adjusted odds ratio [AOR], 3.28; confidence interval [CI], 1.75-5.41; P < .001), age >60 years (reference: <60 years; AOR, 1.59; CI, 1.18-2.13; P = .002), longitudinal laparotomy incision (reference: retroperitoneal; AOR, 3.28; CI, 1.75-6.16; P < .001), and supraceliac cross-clamp (reference: clamp above one renal artery; AOR, 2.14; CI, 1.31-3.50; P = .003).

Conclusions: Nearly one-third of patients die within 30 days of emergent open complex AAA repair. Mortality is particularly high for patients with type IV TAAAs, approaching 50%. Predictors of 30-day mortality include rupture with associated hypotension, increasing age, supraceliac clamp location, and longitudinal transperitoneal repair approach. These results will help inform surgical decisions preoperatively and intraoperatively.
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http://dx.doi.org/10.1016/j.jvs.2020.03.059DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7606433PMC
January 2021

Stroke rate after endovascular aortic interventions in the Society for Vascular Surgery Vascular Quality Initiative.

J Vasc Surg 2020 11 2;72(5):1593-1601. Epub 2020 Apr 2.

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

Objective: The stroke rate after endovascular aneurysm repair (EVAR), particularly complex EVAR such as fenestrated EVAR (FEVAR) and chimney EVAR (chEVAR), is not well defined. Whereas stroke is a well-established risk of thoracic endovascular aortic repair (TEVAR), the impact of procedural characteristics on stroke remains unclear. Therefore, we characterized the risk of stroke after endovascular aortic interventions in the Vascular Quality Initiative database and identified procedural characteristics associated with stroke.

Methods: We performed a retrospective cohort study of patients undergoing infrarenal EVAR, complex EVAR, and TEVAR within the Vascular Quality Initiative between 2011 and 2019. Complex EVAR included FEVAR (with either a Food and Drug Administration-approved custom-manufactured device or physician-modified endovascular graft) and chEVAR. We excluded emergent procedures. The primary outcome was in-hospital stroke. We used multivariable logistic regression to identify procedural characteristics associated with stroke.

Results: We identified 41,540 EVARs, 1371 complex EVARs, and 4600 TEVARs. The in-hospital stroke rate was 0.1% after EVAR, 0.9% after complex EVAR, and 2.9% after TEVAR. In patients undergoing EVAR, aneurysm diameter >6.5 mm (odds ratio [OR], 1.7; 95% confidence interval [CI], 1.1-2.7; P = .03) and use of a proximal extension cuff (OR, 3.3; 95% CI, 1.4-7.9; P < .01) were independently associated with stroke. Among complex EVARs, stroke rate was 0.7% after FEVAR with a custom-manufactured device, 0.4% after FEVAR with a physician-modified endovascular graft, and 2.1% after chEVAR (P = .08). In multivariable analysis, arm access was associated with 8.4-fold higher odds of stroke (95% CI, 1.7-41; P < .01). Whereas chEVAR was associated with higher odds of stroke in crude analysis, this association did not persist after adjustment for arm access (OR, 1.0; 95% CI, 0.2-4.4; P = .99). In patients undergoing TEVAR, more proximal landing zones were associated with higher risk of stroke compared with zone 4/5 (zone 3: OR, 2.0 [95% CI, 0.9-4.2]; zone 2: OR, 3.8 [95% CI, 1.8-8.2]; zone 0/1: OR, 6.3 [95% CI, 2.8-14]). In terms of procedural characteristics, any involvement of the left subclavian artery was associated with stroke (bypass: OR, 2.5 [95% CI, 1.5-4.0]; stent: OR, 2.7 [95% CI, 0.9-8.5]; covered or occluded: OR, 2.5 [95% CI, 1.5-4.1]).

Conclusions: Stroke, although rare after elective EVAR, is substantially more common after complex EVAR and TEVAR. Increasing procedural complexity in complex EVAR and TEVAR is associated with a higher stroke rate, a risk that should be factored into clinical decision-making. The strong association between stroke and upper extremity access during complex EVAR is alarming and warrants further study.
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http://dx.doi.org/10.1016/j.jvs.2020.02.015DOI Listing
November 2020

Midterm survival after endovascular repair of intact abdominal aortic aneurysms is improving over time.

J Vasc Surg 2020 08 21;72(2):556-565.e6. Epub 2020 Feb 21.

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

Objective: There is a growing body of literature raising concerns about the long-term durability of endovascular aneurysm repair (EVAR) for abdominal aortic aneurysms (AAAs), suggesting that long-term outcomes may be better after open AAA repair. However, the data investigating these long-term outcomes largely originate from early in the endovascular era and therefore do not account for increasing clinical experience and technologic improvements. We investigated whether 4-year outcomes after EVAR and open repair have improved over time.

Methods: We identified all EVARs and open repairs for intact infrarenal AAA within the Vascular Quality Initiative database (2003-2018). We then stratified patients by procedure year into treatment cohorts of four years: 2003-2006, 2007-2010, 2011-2014, and 2015-2018. We used Kaplan-Meier analysis and Cox proportional hazards models to assess whether the survival after EVAR or open repair changed over time. In addition, we propensity matched EVAR and open repairs for each time cohort to investigate whether the relative survival benefit of EVAR over open repair changed over time.

Results: We included 42,293 EVARs (increasing from 549 performed between 2003 and 2006 to 25,433 between 2015 and 2018) and 5189 open AAA repairs (increasing from 561 to 2306). Four-year survival increased for the periods 2003-2006, 2007-2010, 2011-2014, and 2015-2018 after both EVAR (76.6% vs 79.7% vs 83.5% vs 87.3%; P < .001) and open repair (82.2% vs 85.8% vs 87.7% vs 88.9%; P = .026). After risk adjustment, compared with 2003-2006, hazard of mortality up to 4 years after EVAR was lower for those performed between 2011 and 2014 (hazard ratio [HR], 0.72; 95% confidence interval [CI], 0.59-0.87; P = .001) and for those performed between 2015 and 2018 (HR, 0.56; 95% CI, 0.46-0.68; P < .001). In contrast, the risk-adjusted hazard of mortality was similar between open repair cohorts (2011-2014: HR, 0.81 [95% CI, 0.61-1.08; P = .15]; and 2015-2018: HR, 0.86 [95% CI, 0.64-1.17; P = .34]). Finally, in matched EVAR and open repairs, there was no difference in mortality in the first three cohorts, whereas the hazard of mortality was lower for the 2015-2018 cohort (HR, 0.65; 95% CI, 0.51-0.84; P = .001).

Conclusions: Four-year survival improved in more recent years after EVAR but not after open repair. This finding suggests that midterm outcomes after EVAR are improving, perhaps because of technologic improvements and increased experience, information that should be considered by surgeons and policymakers alike in evaluating the value of contemporary EVAR and open AAA repair.
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http://dx.doi.org/10.1016/j.jvs.2019.10.082DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8025309PMC
August 2020

Five-year survival following endovascular repair of ruptured abdominal aortic aneurysms is improving.

J Vasc Surg 2020 07 21;72(1):105-113.e4. Epub 2020 Feb 21.

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

Objective: Increasing experience and improving technology have led to the expansion of endovascular aneurysm repair (EVAR) for ruptured abdominal aortic aneurysms (AAA). We investigated whether the 5-year survival after both EVAR and open repair for ruptured AAA changed over the last 14 years.

Methods: We identified repairs for ruptured infrarenal AAA within the Vascular Quality Initiative registry between 2004 and 2018. We compared the 5-year survival of both EVAR and open repair between the early (2004-2012) and late (2013-2018) cohorts. In addition, we compared EVAR with open repair in the early and late cohorts. We used propensity score modeling to create matching cohorts for each analysis. Kaplan-Meier analysis was used to estimate survival proportions and univariate Cox proportional hazards analysis was used to compare differences in hazard of mortality in the matched cohorts.

Results: We identified 4638 ruptured AAA repairs. This included 409 EVARs in the early cohort and 2250 in the late cohort, as well as 558 open repairs in the early cohort and 1421 in the late cohort. Propensity matching resulted in 366 matched pairs of late vs early EVAR and 391 matched-pairs of late vs early open repair. When comparing EVAR with open repair, propensity matching resulted in 277 matched pairs of early EVAR versus open, and 1177 matched pairs of late EVAR versus open. In matched EVAR patients, 5-year survival was higher in the late cohort (63% vs 49%; hazard ratio [HR], 0.77; 95% confidence interval [CI], 0.61-0.97; P = .027), whereas there was no difference between matched late vs early for open repair patients (52% vs 59%; HR, 1.04; 95% CI, 0.85-1.28; P = .69). In the early cohort, there was no survival difference between EVAR and open repair (51% vs 46%; HR, 0.88; 95% CI, 0.69-1.11; P = .28). However, in the late cohort EVAR was associated with higher survival compared with open repair (63% vs 54%; HR, 0.69; 95% CI, 0.60-0.79; P < .001).

Conclusions: The 5-year survival after EVAR for ruptured AAA has improved over time, whereas survival after open repair remained constant. Consequently, the relative survival benefit of EVAR over open repair has increased over time, which should encourage further adoption of EVAR for ruptured AAA.
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http://dx.doi.org/10.1016/j.jvs.2019.10.074DOI Listing
July 2020

In-hospital outcomes alone underestimate rates of 30-day major adverse events after carotid artery stenting.

J Vasc Surg 2020 04 13;71(4):1233-1241. Epub 2020 Feb 13.

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

Objective: Outcome studies using databases collecting only hospital discharge data underestimate morbidity and mortality because of failure to capture postdischarge events. The proportion of postdischarge major adverse events is well characterized in patients undergoing carotid endarterectomy (CEA) but has yet to be characterized after carotid artery stenting (CAS).

Methods: We retrospectively reviewed all patients undergoing CAS from 2011 to 2017 using the American College of Surgeons National Surgical Quality Improvement Program procedure targeted database to evaluate rates of 30-day major adverse events, stratified by in-hospital and postdischarge occurrences. The primary outcome was 30-day stroke/death. Multivariable analysis using purposeful selection was used to identify independent factors associated with in-hospital, postdischarge, and 30-day stroke/death events.

Results: Of the 899 patients undergoing CAS, reporting of in-hospital outcomes alone would yield a stroke/death rate of 2.7%, substantially underestimating the 30-day stroke/death rate of 4.0%. In fact, 35% of stroke/deaths, 27% of strokes, 73% of deaths, 35% of cardiac events, and 35% of stroke/death/cardiac events occurred after discharge. More postdischarge stroke/death events occurred after treatment of symptomatic compared with asymptomatic patients (47% vs 27%; P < .001). During this same study period, the 30-day stroke/death rate after CEA was 2.6%, with similar proportions of postdischarge strokes (28% vs 27%; P = .51) compared with CAS but lower proportions of postdischarge deaths (55% vs 73%; P < .001). After CAS, patients experiencing postdischarge stroke/death events had a shorter postoperative length of stay compared with patients with in-hospital stroke/death (1 [1-2] vs 5 [3-10] days; P < .001). Chronic obstructive pulmonary disease was independently associated with postdischarge stroke/death (odds ratio [OR], 4.4; 95% confidence interval [CI], 1.2-16; P = .02) after CAS. Nonwhite ethnicity was independently associated with overall 30-day stroke/death (OR, 3.4; 95% CI, 1.4-7.9; P < .01), whereas statin use was associated with not having stroke/death within 30 days (OR, 0.5; 95% CI, 0.2-1.0; P = .049).

Conclusions: More than one-quarter of perioperative strokes occur following discharge after both CAS and CEA. A higher proportion of postdischarge deaths occur after CAS in symptomatic patients, which may reflect treatment of a population of higher risk patients. Further investigation is needed to elucidate the cause of postdischarge stroke to develop methods to reduce these complications.
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http://dx.doi.org/10.1016/j.jvs.2019.06.201DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7096257PMC
April 2020

Clinical impact of sex on carotid revascularization.

J Vasc Surg 2020 05 1;71(5):1587-1594.e2. Epub 2020 Feb 1.

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

Background: The impact of sex in the management of carotid disease is unclear in the current literature. Therefore, we evaluated the effect of sex on perioperative outcomes following carotid endarterectomy (CEA) and carotid artery stenting (CAS).

Methods: We included patients who underwent CEA or CAS between 2012 and 2017 in the Vascular Quality Initiative database. Our primary outcome was perioperative stroke/death. Secondary outcomes were in-hospital stroke, 30-day mortality, and in-hospital MI. We compared perioperative outcomes between female and male patients, stratified by treatment modality and symptom status, and used multivariable regression to account for differences in baseline characteristics.

Results: A total of 83,436 patients underwent either a CEA (71,383) or CAS (12,053). Asymptomatic and symptomatic CEA females were less likely to be on a preoperative antiplatelet agent, when compared to males. Females overall, were less likely to be on a preoperative statin and more likely to have chronic obstructive pulmonary disease. Within the CAS cohort, females were more likely to have a previous ipsilateral CEA. There were no differences between males and females in major adverse events following CEA for asymptomatic disease. Following CEA for symptomatic disease, there was no difference in stroke/death rate or in-hospital stroke. However, females experienced a higher 30-mortality after adjustment (univariate: 1.0% vs 0.7%, P = .04; adjusted: odds ratio [OR], 1.4:1.02-1.94). Following CAS for asymptomatic disease, females experienced a higher rate of perioperative stroke/death (2.9% vs 1.9% P = .02; OR, 1.5: 1.05-2.03) and in-hospital stroke (2.1% vs 1.2% P = .01; OR, 1.8: 1.20-2.60). There were no differences in outcomes for symptomatic females vs males undergoing CAS.

Conclusions: Females with carotid disease less frequently receive optimal medical treatment with antiplatelet agents and statins. This is an important target area for quality improvement issue in both females and males. Furthermore, among symptomatic CEA patients the female sex is associated with higher mortality and among asymptomatic CAS patients, females experience higher rates of stroke/death. These findings suggest that careful patient selection is necessary in the treatment of female patients. Quality improvement projects should be created to further investigate and eliminate the disparities of optimal medical management between the sexes.
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http://dx.doi.org/10.1016/j.jvs.2019.07.088DOI Listing
May 2020

Aspartate transaminase to platelet ratio index and Model for End-Stage Liver Disease scores are associated with morbidity and mortality after endovascular aneurysm repair among patients with liver dysfunction.

J Vasc Surg 2020 09 19;72(3):904-909. Epub 2020 Jan 19.

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

Background: Liver cirrhosis dramatically increases morbidity and mortality after open surgical procedures and is often a contraindication to open repair of abdominal aortic aneurysms. However, limited data have evaluated the effect of liver disease on outcomes after endovascular repair of aortic aneurysms.

Methods: The National Surgical Quality Improvement Program was used to evaluate all nonemergent endovascular aneurysm repairs (EVARs) from 2005 to 2016. The aspartate transaminase to platelet ratio index is a sensitive, noninvasive screening tool used to screen for liver disease and was calculated for all patients. A value >0.5 was used to identify those with significant liver fibrosis. Demographics, comorbidities, and 30-day outcomes were then compared between patients with and patients without fibrosis. Additional analysis was then completed to assess the effect of increasing Model for End-Stage Liver Disease (MELD) score on 30-day outcomes. Multivariable regression was used to account for differences in baseline factors.

Results: EVAR was performed on 18,484 patients including 2286 with liver fibrosis and 16,198 without. Patients with liver fibrosis had an increased 30-day mortality (1.5% vs 2.4%; P < .01) and significantly higher rates of major morbidities including return to the operating room, pulmonary complications, transfusion, and discharge other than home. After multivariable analysis, patients with liver fibrosis had a significant increase in 30-day mortality (odds ratio [OR], 1.5; 95% confidence interval [CI], 1.1-2.1), return to the operating room (OR, 1.5; 95% CI, 1.2-1.8), pulmonary complications (OR, 1.6; 95% CI, 1.2-2.0), transfusion (OR, 1.7; 95% CI, 1.5-2.0), and discharge other than home (OR, 1.5; 95% CI, 1.3-1.8). In further analysis, mortality also increased in a stepwise fashion with increasing MELD score (MELD <10, 1.3%; MELD 10-15, 2.3%; MELD >15, 4.7%; P < .01), as did major complications (MELD <10, 7%; MELD 10-15, 11%; MELD >15, 15%; P < .01). These increases persisted in adjusted analysis.

Conclusions: Liver fibrosis significantly increases mortality and major morbidity after EVAR. The aspartate transaminase to platelet ratio index and MELD score should be used for preoperative risk stratification. Moreover, current 30-day morbidity and mortality rates among patients with MELD scores >10 exceed 5%, which is higher than the annual rupture risk for aneurysms <6 cm. Therefore, an increased size threshold of >6 cm may be warranted before EVAR in patients with liver fibrosis.
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http://dx.doi.org/10.1016/j.jvs.2019.10.101DOI Listing
September 2020

The Impact of Proximal Clamp Location on Peri-Operative Outcomes Following Open Surgical Repair of Juxtarenal Abdominal Aortic Aneurysms.

Eur J Vasc Endovasc Surg 2020 Mar 18;59(3):411-418. Epub 2019 Dec 18.

Department of Surgery, Division of Vascular and Endovascular Surgery, Beth Israel Deaconess Medical Centre, Harvard Medical School, Boston, MA, USA. Electronic address:

Objective: Open surgical repair of juxtarenal abdominal aortic aneurysms (AAA) requires an aortic cross clamp location above at least one renal artery. This study investigated the impact of clamp location on peri-operative outcomes using a United States based nationwide clinical registry.

Methods: The National Surgical Quality Improvement Program targetted vascular module was used to identify all elective open juxtarenal AAA repairs (2011-2017). Outcomes were compared between clamping above one vs. above both renal arteries, and above one or both renal arteries vs. supracoeliac clamping. The primary outcome was 30 day mortality and secondary outcomes included post-operative renal dysfunction (creatinine increase ≥ 177 μmol/L or new dialysis) and unplanned re-operations. Multivariable logistic regression models were constructed to perform risk adjusted analyses.

Results: A total of 615 repairs were identified, with a clamp location above one renal artery in 42%, above both renal arteries in 40%, and supracoeliac in 18% of cases. Procedures with a clamp location above one vs. above both renal arteries showed no difference in mortality (3.5% vs. 2.1%, p = .34) or renal dysfunction (6.9% vs. 4.9%, p = .34). In contrast, supracoeliac clamping compared with clamping above one or both renal arteries was associated with a higher mortality rate (8.0% vs. 2.8%, p = .023), renal dysfunction (12% vs. 6.0%, p = .017), and unplanned re-operations (24% vs. 10%, p < .001). In the multivariable adjusted models, outcomes were similar between clamping above both vs. above one renal artery, while supracoeliac clamping vs. clamping above one or both renal arteries was associated with higher mortality (odds ratio [OR]: 3.4; 95% CI: 1.3-8.8; p = .013) and unplanned re-operation (OR: 2.4; 95% CI: 1.4-4.1; p = .002).

Conclusion: Although there is no difference between clamping above one vs. both renal arteries during open juxtarenal AAA repair, a supracoeliac clamp location is associated with worse peri-operative outcomes. Surgeons should avoid supracoeliac clamping when clamping above one or both renal arteries is technically possible.
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http://dx.doi.org/10.1016/j.ejvs.2019.10.004DOI Listing
March 2020

Similar 5-year outcomes between female and male patients undergoing elective endovascular abdominal aortic aneurysm repair with the Ovation stent graft.

J Vasc Surg 2020 07 13;72(1):114-121. Epub 2019 Dec 13.

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

Objective: Female patients undergoing endovascular aneurysm repair (EVAR) for infrarenal abdominal aortic aneurysms present with more challenging anatomy and historically have worse outcomes compared with men. The Ovation Abdominal Stent Graft platform (Endologix, Irving, Calif) contains a polymer-filled proximal sealing ring and has a low-profile delivery system, potentially beneficial in female patients. We therefore investigated differences in long-term outcomes between men and women treated with this device.

Methods: We used data collected prospectively in the Effectiveness of Custom Seal with Ovation: Review of the Evidence (ENCORE) database, comprising five trials and the European Post-Market Registry. Anatomic characteristics of the proximal aneurysm neck and iliac arteries were compared between male and female patients. Outcomes were 5-year freedom from type IA and type I/III endoleaks, abdominal aortic aneurysm-related reinterventions, and overall survival. We used Kaplan-Meier analysis to estimate survival proportions and tested univariate differences in survival using log-rank tests. Cox proportional hazards modeling was used to adjust for baseline differences.

Results: We identified 1045 (81%) male and 251 (19%) female patients undergoing EVAR. Female patients were older (mean age, 75 ± 8.4 years vs 73 ± 8.1 years; P < .006). Aneurysm diameter (52 ± 7.5 mm vs 55 ± 9.2 mm; P < .001) and proximal neck diameter (21 ± 3.3 mm vs 23 ± 2.9 mm; P < .001) were smaller in female patients, but adjusted for body surface area, female patients had relatively larger aneurysms and aneurysm necks. Furthermore, female patients presented with shorter proximal necks, smaller iliac artery diameters, more angulated necks, and higher rates of reverse-tapered necks. Five-year freedom from type IA endoleak was similar between men and women (97% vs 96%; P = .38), as was freedom from type I/III endoleaks (91% vs 94%; P = .37) and reinterventions (91% vs 93%; P = .67). Five-year survival was 81% for female patients, similar to the 79% in male patients (P = .55), with one aneurysm-related death in female patients (0.4%) and five in male patients (0.8%; P = .76). Risk-adjusted analyses showed no association between sex and type IA endoleak (hazard ratio [HR], 1.4; 95% confidence interval [CI], 0.6-3.1; P = .41), type I/III endoleak (HR, 1.4; 95% CI, 0.7-2.8; P = .33), reintervention (HR, 1.0; 95% CI, 0.6-2.0; P = .77), and overall mortality (HR, 0.7; 95% CI, 0.4-1.1; P = .14).

Conclusions: Female patients undergoing EVAR with the Ovation platform presented with substantially more adverse proximal neck characteristics. Despite these differences, 5-year freedom from endoleaks and overall survival did not differ between sexes.
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http://dx.doi.org/10.1016/j.jvs.2019.08.275DOI Listing
July 2020

Readmissions after acute type B aortic dissection.

J Vasc Surg 2020 07 12;72(1):73-83.e2. Epub 2019 Dec 12.

Division of Cardiovascular Medicine, Department of Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Mass.

Objective: Acute type B aortic dissection can be treated with medical management alone, open surgical repair, or thoracic endovascular aortic repair (TEVAR). The nationwide burden of readmissions after acute type B aortic dissection has not been comprehensively assessed.

Methods: We analyzed adults with a hospitalization due to acute type B aortic dissection between January 1, 2010, and December 31, 2014, in the Nationwide Readmissions Database. International Classification of Diseases, Ninth Revision, Clinical Modification codes were used to identify hospitalizations with a primary diagnosis code for thoracic or thoracoabdominal aortic dissection. The primary outcome was nonelective 90-day readmission. Predictors of readmission were determined using hierarchical logistic regression.

Results: The study population consisted of 6937 patients with unplanned admissions for type B aortic dissections from 2010 through 2014. Medical management alone was the treatment for 62.6% of patients, 21.0% had open surgical repair, and 16.4% underwent TEVAR. Nonelective 90-day readmission rate was 25.1% (23.6% with medical management alone, 26.9% with open repair, and 28.7% with TEVAR; P < .001). An additional 4.7% of patients were electively readmitted. The most common cause for nonelective readmission was new or recurrent arterial aneurysm or dissection (24.8%). Of those with unplanned readmissions, 5.2% underwent an aortic procedure. The mortality rate during nonelective readmission was 5.0%, and the mean cost of the rehospitalization was $22,572 ± $41,598.

Conclusions: More than one in four patients have a nonelective readmission 90 days after hospitalization for acute type B aortic dissection. Absolute rates of readmission varied by initial treatment received but were high irrespective of the initial treatment. The most common cause of readmission was aortic disease, particularly among those treated with medication alone. Further research is required to determine potential interventions to decrease these costly and morbid readmissions, including the role of multidisciplinary aortic teams.
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http://dx.doi.org/10.1016/j.jvs.2019.08.280DOI Listing
July 2020

Five-year results of endovascular abdominal aortic aneurysm repair with the Ovation abdominal stent graft.

J Vasc Surg 2020 05 9;71(5):1528-1537.e2. Epub 2019 Sep 9.

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

Objective: Endovascular abdominal aortic aneurysm repair (EVAR) has been rigorously compared with open repair for the treatment of abdominal aortic aneurysms in randomized trials and observational studies, but a comparison of individual devices is lacking, and single-device registries and trials are limited by small sample size. Here we report a descriptive analysis of the Effectiveness of Custom Seal with Ovation: Review of the Evidence (ENCORE) database, pooled results of multiple studies evaluating the midterm results of EVAR with the Ovation Abdominal Stent Graft Platform.

Methods: This is a retrospective analysis of the ENCORE database, a cohort of patients undergoing EVAR with the Ovation platform composed of pooled, prospectively collected data from 1296 patients from five clinical trials and the prospectively maintained European Union Post-Market Registry. The primary outcomes were 5-year rates of type IA and type I or III endoleak. Secondary outcomes included were 30-day mortality, 30-day major adverse event, technical success (successful deployment of the aortic body and iliac limbs), as well as 5-year survival, and freedom from aneurysm-related mortality, type II endoleak, device-related intervention, aneurysm rupture, sac expansion, and conversion to open repair.

Results: A total of 1296 patients were included in the analysis. The average age was 73 ± 8 years and 81% of patients were male. Fifty percent of patients had complex aortic anatomy, (neck length <10 mm, neck diameter >28 mm, neck angle >60°, reverse neck taper >10%, distal common iliac artery diameter <10 mm, or external iliac artery diameter <6 mm). Technical success was 99.7%. Thirty-day mortality was 0.3%, 30-day rate of major adverse event was 1.6%, and polymer leak rate was 0.2%. Freedom from type IA endoleak at 1, 3, and 5 years was 97.6%, 97.1%, and 95.8%, respectively; type I or III endoleak at 1, 3, and 5 years was 96.9%, 95.7%, and 94.0%, respectively. Freedom from device-related reintervention at 1, 3, and 5 years was 96.2%, 94.4%, and 92.4% and primary freedom from sac expansion was 97.0% at 1 year, 90.3% at 3 years, and 84.9% at 5 years. Freedom from all-cause mortality and aneurysm-related mortality at 5 years were 78.9% and 99.3%, respectively.

Conclusions: This analysis of the ENCORE database demonstrates that EVAR with the Ovation platform has favorable midterm durability evidenced by successful aneurysm exclusion and 5-year freedom from aneurysm-related mortality.
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http://dx.doi.org/10.1016/j.jvs.2019.06.196DOI Listing
May 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

Sex differences in perioperative outcomes after complex abdominal aortic aneurysm repair.

J Vasc Surg 2020 02 4;71(2):374-381. Epub 2019 Jul 4.

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

Objective: Female sex is associated with worse outcomes after infrarenal abdominal aortic aneurysm (AAA) repair. However, the impact of female sex on complex AAA repair is poorly characterized. Therefore, we compared outcomes between female and male patients after open and endovascular treatment of complex AAA.

Methods: We identified all patients who underwent complex aneurysm repair between 2011 and 2017 in the American College of Surgeons National Surgical Quality Improvement Program targeted vascular module. Complex repairs were defined as those for juxtarenal, pararenal, or suprarenal aneurysms. We compared rates of perioperative adverse events between female and male patients stratified by open AAA repair and endovascular aneurysm repair (EVAR). We calculated propensity scores and used inverse probability-weighted logistic regression to identify independent associations between female sex and our outcomes.

Results: We identified 2270 complex aneurysm repairs, of which 1260 were EVARs (21.4% female) and 1010 were open repairs (30.7% female). After EVAR, female patients had higher rates of perioperative mortality (6.3% vs 2.4%; P = .001) and major complications (15.9% vs 7.6%; P < .001) compared with male patients. In contrast, after open repair, perioperative mortality was not significantly different (7.4% vs 5.6%; P = .3), and the rate of major complications was similar (29.4% vs 27.4%; P = .53) between female and male patients. Furthermore, even though perioperative mortality was significantly lower after EVAR compared with open repair for male patients (2.4% vs 5.6%; P = .001), this difference was not significant for women (6.3% vs 7.4%; P = .60). On multivariable analysis, female sex remained independently associated with higher perioperative mortality (odds ratio [OR], 2.5; 95% confidence interval [CI], 1.3-4.9; P = .007) and major complications (OR, 2.0; 95% CI, 1.3-3.2; P = .002) in patients treated with EVAR but showed no significant association with mortality (OR, 0.9; 95% CI, 0.5-1.6; P = .69) or major complications (OR, 1.1; 95% CI, 0.8-1.5; P = .74) after open repair. However, the association of female sex with higher perioperative mortality in patients undergoing complex EVAR was attenuated when diameter was replaced with aortic size index in the multivariable analysis (OR, 1.9; 95% CI, 0.9-3.9; P = .091).

Conclusions: Female sex is associated with higher perioperative mortality and more major complications than for male patients after complex EVAR but not after complex open repair. Continuous efforts are warranted to improve the sex discrepancies in patients undergoing endovascular repair of complex AAA.
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http://dx.doi.org/10.1016/j.jvs.2019.04.479DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6942245PMC
February 2020

Factors associated with in-hospital complications and long-term implications of these complications in elderly patients undergoing endovascular aneurysm repair.

J Vasc Surg 2020 02 24;71(2):470-480.e1. Epub 2019 Jun 24.

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

Objective: Perioperative complications in elderly patients undergoing endovascular aneurysm repair (EVAR) occur frequently. Although perioperative mortality has been well-described in the elderly patient population, factors associated with in-hospital complications and their impact on long-term survival remain poorly characterized.

Methods: We identified all patients undergoing elective EVAR for infrarenal AAA within the Vascular Quality Initiative registry (2003-2018) and compared in-hospital complication rates between elderly (age ≥75) and nonelderly patients (<75). We used logistic regression to identify independent factors associated with in-hospital complications, whereas Kaplan-Meier analysis and Cox proportional hazards models were used to determine associations between complications and long-term survival. To assess the effect of complications on early and late survival, we stratified survival periods into the first 30 days after discharge, and between 1 and 6 months, 7 and 12 months, and 1 and 8 years after the index procedure. To investigate the implications of in-hospital morbidity on long-term outcomes, we estimated the adjusted population-attributable fractions of individual complications on both perioperative and long-term survival.

Results: We identified 17,156 elderly patients and 19,922 nonelderly patients. Elderly patients experienced higher complication rates compared with nonelderly patients (17% vs 10%; P < .001). The factors with the strongest associations with morbidity in elderly patients were anemia (odds ratio [OR], 2.4; 95% confidence interval [CI], 2.2-2.6), female gender (OR, 1.9; 95% CI, 1.7-2.1), and large AAA diameter (OR, 1.7; 95% CI, 1.6-1.9). Patients with any in-hospital complication had lower unadjusted survival estimates than patients without complications at 1 year (83% vs 95%; P < .001), 5 years (66% vs 80%; P < .001), and 8 years (60% vs 72%; P < .001). After risk adjustment, in-hospital complications were independently associated with higher mortality, although the association attenuated over time (first month after discharge: hazard ratio [HR], 5.9; 95% CI, 3.9-9.1; 1-6 months after the procedure: HR, 2.1; 95% CI, 1.7-2.7; P < .001; 7-12 months after the procedure: HR, 1.5; 95% CI, 1.1-1.9; 1-8 years after the procedure: HR, 1.2; 95% CI, 1.01-1.3). Of all deaths occurring within 8 years after procedure, 9.5% were independently associated with in-hospital complications. Complications with the greatest impact on long-term mortality were renal dysfunction (2.4%), blood transfusion (3.4%), and reintubations (2.4%).

Conclusions: Elderly patients are at higher risk for in-hospital complications after EVAR. These in-hospital complications have a significant impact on both short- and long-term survival. To further improve the delivery of EVAR care nationally, quality improvement efforts should be focused on preventing postoperative morbidity in elderly patients, as well as refining out of hospital surveillance strategies for subjects who experience in-hospital complications to improve overall survival.
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http://dx.doi.org/10.1016/j.jvs.2019.03.059DOI Listing
February 2020

The Weekend Effect in AAA Repair.

Ann Surg 2019 06;269(6):1170-1175

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

Background: Conflicting reports exist regarding whether patients undergoing surgery on the weekend or later in the week experience worse outcomes.

Methods: We identified patients undergoing abdominal aortic aneurysm (AAA) repair in the Vascular Quality Initiative between 2009 and 2017 [n = 38,498; 30,537 endovascular aneurysm repair (EVAR) and 7961 open repair]. We utilized mixed effects logistic regression to compare adjusted rates of perioperative mortality based on the day of repair.

Results: Tuesday was the most common day for elective repair (22%), Friday for symptomatic repairs (20%), and ruptured aneurysms were evenly distributed. Patients with ruptured aneurysms experienced similar adjusted mortality whether they underwent repair during the week or on weekends. Transfers of ruptured AAA were more common over the weekend. However, patients transferred on the weekend experienced higher adjusted mortality than those transferred during the week (28% vs 21%, P = 0.02), despite the fact that during the week, transferred patients actually experienced lower adjusted mortality than patients treated at the index hospital (21% vs 31%, P < 0.01). Among symptomatic patients, adjusted mortality was higher for those undergoing repair over the weekend than those whose surgeries were delayed until a weekday (7.9% vs 3.1%, P = 0.02). Adjusted mortality in elective cases did not vary across the days of the week. Results were consistent between open and EVAR patients.

Conclusion: We found no evidence of a weekend effect for ruptured or symptomatic AAA repair. However, patients with ruptured AAA transferred on the weekend experienced higher mortality than those transferred during the week, suggesting a need for improvement in weekend transfer processes.
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http://dx.doi.org/10.1097/SLA.0000000000002773DOI Listing
June 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

Open and Endovascular Management of Aortic Aneurysms.

Circ Res 2019 02;124(4):647-661

From the Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA.

Aneurysmal disease can affect any segment of the aorta, from the aortic root to the aortic bifurcation. The treatment of aortic aneurysms has evolved dramatically in the past 3 decades, with the introduction of endovascular aneurysm repair using stent grafts causing a major paradigm shift in the field of aortic aneurysm surgery. While the technical details of the management of aortic aneurysms vary greatly depending on the location of an aneurysm, the principles remain the same. Successful aortic aneurysm treatment depends on either open replacement or endovascular exclusion of the aneurysmal segment with healthy artery proximal and distal to the repair. Major aortic branches of the arch and visceral segment add additional technical complexity to aneurysms involving these regions. Even as endovascular repair becomes the primary treatment modality for most aortic aneurysms, open repair remains an essential treatment modality in many circumstances. Additionally, long-term results of endovascular repair suggest that younger patients with long life expectancy and low-perioperative risk may benefit more from open repair. Therefore, technical expertise in both endovascular and open treatment is necessary for a comprehensive aortic aneurysm surgery practice.
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http://dx.doi.org/10.1161/CIRCRESAHA.118.313186DOI Listing
February 2019

The state of complex endovascular abdominal aortic aneurysm repairs in the Vascular Quality Initiative.

J Vasc Surg 2019 08 2;70(2):369-380. Epub 2019 Feb 2.

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

Background: Endovascular repair of complex abdominal aortic aneurysms has become increasingly common, but reports have mostly been limited to single centers and single devices.

Methods: We studied all endovascular repairs of complex abdominal aortic aneurysms (zone 6 or caudal) from 2014 to 2018 in the Vascular Quality Initiative. This included all commercially available fenestrated endovascular aneurysm repair (FEVAR), chimney/snorkel repairs, and physician-modified endografts (PMEGs), exclusive of investigational device exemptions and clinical trial devices. We used inverse probability-weighted multilevel logistic regression to compare rates of perioperative outcomes including death, acute kidney injury (AKI), and major adverse cardiac events (MACEs; the composite of death/stroke/myocardial infarction) and Cox regression for long-term mortality.

Results: During the study period, surgeons performed 1396 complex endovascular repairs: 1308 (94%) elective, 63 (4.5%) for symptomatic aneurysms, and 25 (1.8%) for rupture. The number of centers performing complex endovascular repairs expanded steadily from 39 in 2014 to 81 in 2017. There were 880 FEVAR (63%), 256 PMEG (18%), and 260 chimney/snorkel repairs (19%). In elective cases, 3214 visceral vessels were incorporated and revascularized; 120 repairs (9%) involved one vessel, 481 (38%) repairs involved two vessels, 560 (44%) involved three vessels, and 113 (9%) involved four vessels. The mean number of arteries incorporated was 2.5 ± 0.8, with PMEGs involving the most arteries (3.3 ± 0.8 for PMEG vs 2.5 ± 0.6 for FEVAR and 1.9 ± 0.9 for chimney/snorkel; P < .001). PMEGs were used to treat more extensive aneurysms, and more incorporated the celiac and superior mesenteric arteries. There was no change in aneurysm extent, but the length of proximal seal extended over time. Chimney/snorkel cases employed more arm or neck access, had longer procedure times, and used more contrast material. Rates of perioperative death (3.4% for FEVAR vs 2.7% for PMEG vs 6.1% for chimney/snorkel; P = .13) and AKI (17% vs 18% vs 19%; P = .42) were similar, but chimney/snorkel was associated with higher rates of stroke (0.8% vs 0.9% vs 3.3%; P = .03) and MACEs (6.1% vs 5.4% vs 11.7%; P = .02). After adjustment, rates of perioperative death, AKI, and overall complications remained similar, but chimney/snorkel was associated with significantly higher odds of stroke (odds ratio [OR], 7.3 [1.5-36.4]; P = .015), myocardial infarction (OR, 18.7 [2.6-136.8]; P = .004), and MACEs (OR, 11.1 [2.1-58.9]; P = .005). Overall survival after elective repair was 91% at 1 year and 88% at 3 years, with no difference between repair types in crude or adjusted analysis.

Conclusions: The Vascular Quality Initiative provides a unique opportunity to study the real-world application and outcomes of complex endovascular aneurysm repair. Perioperative morbidity appears to be higher after chimney/snorkel repair, but further study is needed to confirm these findings and to establish the durability of these novel technologies.
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http://dx.doi.org/10.1016/j.jvs.2018.11.021DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6660373PMC
August 2019

Risk of insulin-dependent diabetes mellitus in patients undergoing carotid endarterectomy.

J Vasc Surg 2019 03 24;69(3):814-823. Epub 2018 Oct 24.

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

Objective: There is conflicting evidence regarding the association of diabetes mellitus (DM) and insulin use with outcomes after carotid endarterectomy (CEA). Therefore, we sought to evaluate the risk of insulin-dependent DM (IDDM) and noninsulin-dependent DM (NIDDM) on 30-day outcomes after CEA.

Methods: We identified patients undergoing CEA from the Targeted Vascular module of the National Surgical Quality Improvement Program (2011-2015) and stratified patients on the basis of their preprocedural symptom status. We compared 30-day outcomes between nondiabetics and patients with NIDDM or IDDM, with 30-day stroke/death as the primary end point.

Results: Of 16,739 CEA patients, 9784 (58%) were asymptomatic, of whom 6720 (69%) had no diagnosis of DM, 1109 (11%) had IDDM, and 1955 (20%) had NIDDM. Of the 6955 symptomatic patients, 4982 (72%) had no diagnosis of DM, 810 (12%) had IDDM, and 1163 (17%) had NIDDM. Among asymptomatic patients, patients with IDDM experienced higher rates of 30-day stroke/death compared with those without DM (3.4% vs 1.5%; P < .001), whereas those with NIDDM experienced rates similar to those of patients without DM (2.1% vs 1.5%; P = .1). Moreover, asymptomatic patients with IDDM and an anatomic high-risk criterion experienced a 30-day stroke/death rate of 6.6%. After adjustment, IDDM was associated with 30-day stroke/death in asymptomatic patients compared with patients without DM (odds ratio, 2.3; 95% confidence interval, 1.5-3.4; P < .001), but NIDDM was not (odds ratio, 1.4; 95% confidence interval, 1.0-2.1; P = .1). In comparison, among symptomatic patients, those with IDDM and NIDDM experienced similar rates of 30-day stroke/death as patients without DM (4.9% vs 3.6% and 4.0% vs 3.6%; both P > .1). After adjustment, neither IDDM nor NIDDM was associated with 30-day stroke/death in symptomatic patients compared with symptomatic patients without DM.

Conclusions: Rates of 30-day stroke/death after CEA in asymptomatic patients with IDDM exceed international vascular societies' guideline thresholds for acceptable outcomes in asymptomatic patients, especially those with anatomic high-risk criteria. Thus, asymptomatic patients with IDDM may not benefit from CEA, although more data are needed about the natural history of carotid disease in this population.
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http://dx.doi.org/10.1016/j.jvs.2018.05.250DOI Listing
March 2019

Select type I and type III endoleaks at the completion of fenestrated endovascular aneurysm repair resolve spontaneously.

J Vasc Surg 2019 08 21;70(2):381-390. Epub 2018 Dec 21.

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

Objective: The Society for Vascular Surgery reporting standards for endovascular aneurysm repair (EVAR) consider the presence of a type I or type III endoleak a technical failure. However, the nature and implications of these endoleaks in fenestrated EVAR (FEVAR) are not well understood.

Methods: We performed a single-center retrospective review of 53 patients who underwent FEVAR with the Zenith Fenestrated AAA Endovascular Graft (Cook Medical, Bloomington, Ind) from 2013 to 2018. We excluded one patient without contrast-enhanced postoperative imaging who was lost to follow-up after discharge. Small, slow, type I and type III endoleaks on completion angiography were routinely observed. We identified patients with completion type I or type III endoleaks by angiography review and characterized endoleak type, location, and rate of resolution on initial postoperative imaging.

Results: Fifty-two patients were included; mean age was 75 ± 8 years, 75% were male, and 91% were white. Of 146 visceral vessels (100 renal arteries and 46 superior mesenteric arteries), 145 (99%) were preserved with 103 fenestrations and 43 scallops; 102 (70%) target vessels were stented. After implantation of all device components, 31 patients (60%) had evidence of type I or type III endoleak. Twelve patients (39%) underwent further intervention at the index procedure, and three endoleaks resolved completely. Twenty-eight patients (54%) had a type I or type III endoleak on completion angiography. There were no differences between patients with and without completion endoleaks in baseline demographics, graft design, neck anatomy, or proportion of cases performed within the instructions for use of the device. Perioperative mortality was 1.9%. On initial postoperative imaging, 27 of 28 (96%) endoleaks resolved spontaneously. One small, persistent type IA or type III endoleak was identified on postoperative day 27 and was observed. This endoleak had resolved completely on computed tomography angiography 6 months postoperatively. In patients without a completion endoleak, one type IA endoleak secondary to graft infolding was discovered on postoperative imaging and was successfully treated with placement of endoanchors and Palmaz stent. Median follow-up was 269 days. No additional type I or type III endoleaks were identified in any patient for the duration of follow-up.

Conclusions: Whereas completion type I and type III endoleaks are common after FEVAR with the ZFEN device, nearly all of these endoleaks resolve spontaneously by the initial postoperative imaging. These results suggest that select completion endoleaks after FEVAR with the ZFEN device do not require intervention at the index procedure.
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http://dx.doi.org/10.1016/j.jvs.2018.09.066DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6588517PMC
August 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