Publications by authors named "Rens R B Varkevisser"

20 Publications

  • Page 1 of 1

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

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
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

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

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

The Influence of Surgical Specialty on Oncoplastic Breast Reconstruction.

Plast Reconstr Surg Glob Open 2019 May 3;7(5):e2248. Epub 2019 May 3.

Department of Surgery, Division of Plastic Surgery, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Mass.

Background: The integration of oncological surgery with reconstructive techniques has gained popularity in the treatment of breast cancer. oncoplastic reconstruction after partial mastectomy can be performed by the breast surgeon or in cooperation with a consulted plastic surgeon. This study aims to objectively assess the differences in outcomes for partial mastectomy and subsequent oncoplastic reconstruction performed by either general surgery alone or in combination with a plastic and reconstructive surgery team.

Methods: Unilateral oncoplastic breast reconstruction cases were extracted from the National Surgical Quality Improvement Program databases from 2005 to 2017. Outcomes of cases performed by the general surgery team alone were compared with those in which the partial mastectomy was performed by the general surgeon with subsequent reconstruction performed by plastic surgeons. To account for cohort baseline differences, propensity score-matched analysis was performed.

Results: In total, 4,350 patients were included in this study; 3,759 procedures were performed by general surgery alone versus 591 combined with plastic surgery. The analysis of propensity score-matched cohorts, comprising 490 patients each, showed no statistical difference in the risk for postoperative complications when surgery was performed by either of the 2 specialty services. A longer operative time and length of stay were found in the group reconstructed by plastic surgeons.

Conclusions: This study found no significant differences in adverse postoperative outcomes for oncoplastic reconstructions after partial mastectomy between the 2 groups. The data may indicate collaboration between both surgical specialties in oncoplastic breast care was not associated with increased morbidity in these patients.
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http://dx.doi.org/10.1097/GOX.0000000000002248DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6571338PMC
May 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

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

Fenestrated endovascular aneurysm repair is associated with lower perioperative morbidity and mortality compared with open repair for complex abdominal aortic aneurysms.

J Vasc Surg 2019 06 13;69(6):1670-1678. Epub 2018 Dec 13.

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

Objective: The Zenith Fenestrated Endovascular Graft (ZFEN; Cook Medical, Bloomington, Ind) has expanded the anatomic eligibility of endovascular aneurysm repair (EVAR) for complex abdominal aortic aneurysms (AAAs). Current data on ZFEN mainly consist of single-institution experiences and show conflicting results. Therefore, we compared perioperative outcomes after repair using ZFEN with open complex AAA repair and infrarenal EVAR in a nationwide multicenter registry.

Methods: We identified all patients undergoing elective AAA repair using ZFEN, open complex AAA repair, and standard infrarenal EVAR between 2012 and 2016 within the American College of Surgeons National Surgical Quality Improvement Program targeted vascular module. Open complex AAA repairs were defined as those with a juxtarenal or suprarenal proximal AAA extent in combination with an aortic cross-clamping position that was above at least one renal artery. The primary outcome was perioperative mortality, defined as death within 30 days or within the index hospitalization. Secondary outcomes included postoperative renal dysfunction (creatinine concentration increase of >2 mg/dL from preoperative value or new dialysis), occurrence of any complication, procedure times, blood transfusion rates, and length of stay. To account for baseline differences, we calculated propensity scores and employed inverse probability-weighted logistic regression.

Results: We identified 6825 AAA repairs-220 ZFENs, 181 open complex AAA repairs, and 6424 infrarenal EVARs. Univariate analysis of ZFEN compared with open complex AAA repair demonstrated lower rates of perioperative mortality (1.8% vs 8.8%; P = .001), postoperative renal dysfunction (1.4% vs 7.7%; P = .002), and overall complications (11% vs 33%; P < .001). In addition, fewer patients undergoing ZFEN received blood transfusions (22% vs 73%; P < .001), and median length of stay was shorter (2 vs 7 days; P < .001). After adjustment, open complex AAA repair was associated with higher odds of perioperative mortality (odds ratio [OR], 4.9; 95% confidence interval [CI], 1.4-18), postoperative renal dysfunction (OR, 13; 95% CI, 3.6-49), and overall complication rates (OR, 4.2; 95% CI, 2.3-7.5) compared with ZFEN. Compared with infrarenal EVAR, ZFEN presented comparable rates of perioperative mortality (1.8% vs 0.8%; P = .084), renal dysfunction (1.4% vs 0.7%; P = .19), and any complication (11% vs 7.7%; P = .09). Furthermore, after adjustment, there was no significant difference between the odds of perioperative mortality, postoperative renal dysfunction, or any complication between infrarenal EVAR and ZFEN.

Conclusions: ZFEN is associated with lower perioperative morbidity and mortality compared with open complex AAA repair, and outcomes are comparable to those of infrarenal EVAR. Long-term durability of ZFEN compared with open complex AAA repair warrants future research.
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http://dx.doi.org/10.1016/j.jvs.2018.08.192DOI Listing
June 2019

Twenty-year experience with stentless biological aortic valve and root replacement: informing patients of risks and benefits.

Eur J Cardiothorac Surg 2018 06;53(6):1272-1278

Department of Cardiothoracic Surgery, Leiden University Medical Center, Leiden, Netherlands.

Objectives: The aim of this study was to provide predictive data on the performance of the Freestyle stentless bioprosthesis that can be used to support and improve the shared decision-making process of prosthetic valve choice for aortic valve replacement.

Methods: Between 1993 and 2014, 604 patients received the Freestyle stentless bioprosthesis (143 subcoronary, 58 root inclusion and 403 full-root replacement). Perioperative data were collected retrospectively, and follow-up data were collected prospectively from 2015. Follow-up was 96% complete (median 4.3 years), with 114 (19%) patients having a follow-up period exceeding 10 years. A competing risks regression model was developed to predict the probability of mortality, structural valve deterioration (SVD) and reoperation for other causes than SVD.

Results: The median age of patients was 64 years, 91 (15%) patients had undergone previous aortic valve replacement and 351 (58%) underwent concomitant procedures. The 15-year probability of SVD, reoperation for other causes and death were 16.9%, 8.1% and 47.7%, respectively. Linearized occurrence rates for prosthesis endocarditis, thromboembolic events and bleeding were 0.5%, 0.9% and 0.1% per patient-year, respectively. The constructed predictive model, including age, renal function and implantation technique as significant covariates, had good to fair predictive performance up to 19 years.

Conclusions: The Freestyle stentless bioprosthesis is an efficient prosthesis for aortic valve replacement or root replacement, with low incidences of SVD and valve-related events at long-term follow-up. The predictive model designed in this study can be used to fully inform patients about their expected individual trajectory after implantation of this prosthesis. This improves the shared decision-making process between patients and clinicians.
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http://dx.doi.org/10.1093/ejcts/ezx478DOI Listing
June 2018