Publications by authors named "Marc Schermerhorn"

312 Publications

Racial Differences in Isolated Aortic, Concomitant Aortoiliac, and Isolated Iliac Aneurysms: This is a Retrospective Observational Study.

Ann Surg 2020 Dec 29. Epub 2020 Dec 29.

*The Divisions of Vascular and Endovascular Surgery, Beth Israel Deaconess Medical Center, Boston, MA †The Department of Vascular Surgery, University Medical Center, Utrecht, The Netherlands ‡The Department of Surgery, Hospital of the University of Pennsylvania, Philadelphia, PA §The Department of Surgery, Howard University and Hospital, Washington, D.C.

Objective: Our aim was to describe the racial and ethnic differences in presentation, baseline and operative characteristics, and outcomes after aortoiliac aneurysm repair.

Summary Of Background Data: Previous studies have demonstrated racial and ethnic differences in prevalence of abdominal aortic aneurysms and showed more complex iliac anatomy in Asian patients.

Methods: We identified all White, Black, Asian, and Hispanic patients undergoing aortoiliac aneurysm repair in the VQI from 2003 to 2019. We compared baseline comorbidities, operative characteristics, and perioperative outcomes by race and ethnicity.

Results: In our 60,435 patient cohort, Black patients, followed by Asian patients, were most likely to undergo repair for aortoiliac (W:23%, B:38%, A:31%, H:22%, P < 0.001) and isolated iliac aneurysms (W:1.0%, B:3.1%, A:1.5%, H:1.6%, P < 0.001), and White and Hispanic patients were most likely to undergo isolated aortic aneurysm repair (W:76%, B:59%, A:68%, H:76%, P < 0.001). Black patients were more likely to undergo symptomatic repair and underwent rupture repair at a smaller aortic diameter. The iliac aneurysm diameter was largest in Black and Asian patients. Asian patients were most likely to have aortic neck angulation above 60 degree, graft oversizing above 20%, and completion endoleaks. Also, Asian patients were more likely to have a hypogastric artery aneurysm and to undergo hypogastric coiling.

Conclusion: Asian and Black patients were more likely to undergo repair for aortoiliac and isolated iliac aneurysms compared to White and Hispanic patients who were more likely to undergo repair for isolated aortic aneurysms. Moreover, there were significant racial differences in the demographics and anatomic characteristics that could be used to inform operative approach and device development.
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http://dx.doi.org/10.1097/SLA.0000000000004731DOI Listing
December 2020

Association of Adoption of Transcarotid Artery Revascularization With Center-Level Perioperative Outcomes.

JAMA Netw Open 2021 Feb 1;4(2):e2037885. Epub 2021 Feb 1.

Section of Vascular Surgery, Dartmouth-Hitchcock Medical Center, Geisel School of Medicine at Dartmouth, Lebanon, New Hampshire.

Importance: Transcarotid artery revascularization (TCAR) may serve as a safer alternative to carotid endarterectomy (CEA) for certain patients with carotid artery stenosis.

Objective: To determine the center-level association of TCAR adoption with overall perioperative outcomes for TCAR and CEA combined at centers performing both procedures.

Design, Setting, And Participants: This comparative-effectiveness research was conducted with a difference-in-difference analysis using retrospective data from 2015 to 2019 from the Vascular Quality Initiative registry, a consortium of more than 400 centers in North America. Included patients underwent TCAR or CEA for carotid artery stenosis. Patients who underwent transfemoral carotid stenting were excluded. Data were analyzed from December 2019 through August 2020.

Exposures: Center-level adoption of TCAR vs not.

Main Outcomes And Measures: The rate of major adverse cardiovascular events (MACE), a composite of in-hospital stroke, myocardial infarction, or death at 30 days, was measured.

Results: Among 86 027 patients who underwent revascularization for carotid artery stenosis, 7664 patients (8.9%) underwent TCAR (mean [SD] age, 73.1 [9.6] years; 2788 [36.4%] women; 6938 White patients [90.6%]; and 3741 patients with symptoms [48.8%]) and 78 363 patients (91.1%) underwent CEA (mean [SD] age, 70.6 [9.2] years; 30 928 [39.5%] women; 70 663 White patients [90.2%]; and 37 883 patients with symptoms [48.3%]). The number of centers performing both TCAR and CEA increased from 15 centers in 2015 to 247 centers in 2019, a more than 16-fold increase. The proportion of all carotid procedures that were TCARs increased from 90 of 12 276 (0.7%) in 2015 to 2718 of 15 956 (17.0%) in 2019, a 24-fold increase. Overall, the crude rate of MACE was similar for TCAR and CEA (178 patients [2.3%] after TCAR vs 1842 patients [2.4%] after CEA; P = .91). However, the rate of MACE over time decreased for CEA (406 of 16 404 patients [2.5%] in 2015 vs 189 of 10 097 patients [1.9%] in 2019; P for trend < .001). The rate of MACE over time decreased for TCAR as well, but the change was not statistically significant (4 of 128 patients [3.1%] in 2016 vs 59 of 2718 patients [2.2%] in 2019; P for trend = .07). Difference-in-difference analysis demonstrated that centers that adopted TCAR had a 10% decrease in the likelihood of MACE at 12 months after TCAR adoption vs if those centers had continued to perform CEA alone (odds ratio, 0.90; 95% CI, 0.81-0.99; P = .04).

Conclusions And Relevance: This comparative-effectiveness study of a cohort of patients who underwent TCAR or CEA found that availability of TCAR at a hospital was associated with a decrease in the likelihood of perioperative MACE after carotid revascularization.
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http://dx.doi.org/10.1001/jamanetworkopen.2020.37885DOI Listing
February 2021

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

The Variable Impact of Aneurysm Size on Outcomes After Open Abdominal Aortic Aneurysm Repairs.

J Vasc Surg 2021 Feb 3. Epub 2021 Feb 3.

Division of Cardiac, Thoracic, and Vascular Surgery, NYP-Columbia University Medical Center, New York, NY. Electronic address:

Objective: Previous studies evaluating the association between abdominal aortic aneurysm (AAA) size with postoperative outcomes after open repairs seldom accounted for renal or visceral artery involvement, proximal clamp site, intraoperative renal ischemia time, and hospital volume. This study examined the association between aneurysm size with outcomes after open repairs.

Methods: We identified patients who underwent open repairs of infrarenal versus juxtarenal non-ruptured AAAs, defined by proximal clamp site, in the 2004-2019 Vascular Quality Initiative. Outcomes included 30-day mortality, postoperative complications, failure-to-rescue, and one-year mortality. Multivariable logistic regressions adjusted for patient characteristics, operative factors, hospital volume, and hospital clustering.

Results: We identified 8011 patients (54% infrarenal, 46% juxtarenal). Median aneurysm size did not differ between infrarenal versus juxtarenal aneurysms (5.7cm vs 5.9cm, P=0.12). For infrarenal aneurysms, every one-centimeter increase in size raised the adjusted odds or hazards ratio of 30-day mortality by 18% (OR 1.18 [95%-CI 1.06-1.31]), failure-to-rescue by 20% (OR 1.20 [1.06-1.34]), one-year mortality by 18% (HR 1.18 [1.10-1.26]), but not complications (OR 1.03 [0.98-1.07]). For juxtarenal aneurysm, larger aneurysm sizes were not associated with any outcome. Proximal clamp site, ischemia time, and volume were associated with outcomes.

Conclusions: The association between AAA size and outcomes matters less with renal and visceral artery aneurysmal involvement, having important implications for surgical decision-making, operative planning, and patient counseling.
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http://dx.doi.org/10.1016/j.jvs.2020.12.109DOI Listing
February 2021

Rationale and Design of the SAFE-PAD Study.

Circ Cardiovasc Qual Outcomes 2021 Jan 13;14(1):e007040. Epub 2021 Jan 13.

Richard A. and Susan F. Smith Center for Outcomes Research in Cardiology (E.A.S., A.R., C.S., L.R.V., R.W.Y.), Beth Israel Deaconess Medical Center, Boston, MA.

Background: Recent evidence from randomized controlled trials has raised concerns about the long-term safety of paclitaxel-coated peripheral devices used for femoropopliteal artery revascularization. In response to a call for more real-world data on the safety of these devices, the SAFE-PAD study (Safety Assessment of Femoropopliteal Endovascular treatment with Paclitaxel-coated Devices) was designed with input from the Food and Drug Administration to provide a long-term, comprehensive evaluation of the mortality risk associated with paclitaxel-coated devices among Medicare beneficiaries.

Methods And Results: SAFE-PAD is an observational cohort study of fee-for-service Medicare beneficiaries that underwent femoropopliteal artery revascularization with either a drug-coated device or nondrug-coated device from 2015 through 2018. All patients age 66 years or older who underwent revascularization will be identified using a combination of procedural codes, Current Procedural Terminology codes, and Healthcare Common Procedure Coding System C-codes. The safety end point of all-cause death will be updated semiannually and continued until the median duration of follow-up surpasses 5 years. Sub-group analyses will be conducted by device type, patient characteristics, and procedural setting. Registration: The SAFE-PAD study has been registered on URL: https://www.clinicaltrials.gov; Unique identifier: NCT04496544.

Conclusions: The SAFE-PAD study will evaluate the long-term safety of drug-coated devices compared with nondrug-coated devices for femoropopliteal artery revascularization among a broad, real-world population of patients with peripheral artery disease.
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http://dx.doi.org/10.1161/CIRCOUTCOMES.120.007040DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7886015PMC
January 2021

Association Between Intraoperative Hypotension and Postoperative Adverse Outcomes in Patients Undergoing Vascular Surgery - A Retrospective Observational Study.

J Cardiothorac Vasc Anesth 2020 Nov 5. Epub 2020 Nov 5.

Center for Anesthesia Research Excellence (CARE), Department of Anesthesia, Critical Care, and Pain Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA. Electronic address:

Objective: Intraoperative hypotension (IOH) is associated with adverse outcomes. It could be challenging to define IOH in vascular surgical patients with increased baseline blood pressure (BP). The authors studied the relationship between (1) absolute and relative BP thresholds of IOH, (2) preoperative pulse pressure (PP) and isolated systolic hypertension, and (3) endovascular versus open surgical approach with adverse outcomes in vascular surgical patients.

Design: Retrospective observational study.

Setting: Teaching hospital.

Patients: A total of 566 vascular surgical patients from 2011 to 2018.

Intervention: None.

Measurements And Main Results: BP thresholds were as follows: IOH - absolute mean arterial pressure (MAP) <65 mmHg, relative MAP >20% decrease from baseline, preoperative PP hypertension - PP >40 mmHg, isolated systolic hypertension - baseline systolic BP ≥140 mmHg with diastolic BP <90 mmHg. Thresholds were characterized by (1) total duration and (2) area under the curve. Primary outcome was a composite of postoperative in-hospital complications (acute kidney injury, stroke, myocardial infarction, congestive heart failure, and mortality). Forty-six (8.1%) patients had in-hospital complications. Only IOH duration-MAP <65 mmHg (odds ratio 1.01; 95% confidence interval 1.00-1.02; p = 0.004) was significantly associated with outcome. No associations were found with MAP >20% decrease from baseline and preoperative BP. Significant interaction was observed with the surgical approach and outcome (p = 0.031), which was stronger after 60 minutes of IOH in endovascular approach.

Conclusion: Longer periods of IOH (MAP <65 mmHg for >60 minutes) during endovascular surgery were associated with adverse outcomes. Relative fall in BP from baseline, preoperative isolated systolic, and PP hypertension were not associated with postoperative complications.
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http://dx.doi.org/10.1053/j.jvca.2020.11.005DOI Listing
November 2020

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

Endovascular interventions for claudication do not meet minimum standards for the Society for Vascular Surgery efficacy guidelines.

J Vasc Surg 2020 Nov 27. Epub 2020 Nov 27.

Division of Vascular Surgery, University of California, Los Angeles, Los Angeles, Calif.

Objective: Because the treatment of intermittent claudication (IC) is elective, good short- and long-term outcomes are imperative. The objective of the present study was to examine the outcomes of endovascular management of IC reported in the Vascular Quality Initiative and compare them with the Society for Vascular Surgery guidelines for IC treatment to determine whether real-world results are within the guidelines.

Methods: Patients undergoing peripheral vascular intervention for IC from 2004 to 2017 with complete data and >9 month follow-up were included. The primary outcome measures were IC recurrence and repeat procedures performed ≤2 years after the initial treatment.

Results: A total of 16,152 patients met the inclusion criteria, with a mean age of 66 years. Of the 16,152 patients, 61% were men, 45% were current smokers, and 28% had been discharged without antiplatelet or statin medication. Adjusted analyses revealed that treatment of more than two arteries was associated with a shorter time to IC recurrence (hazard ratio [HR], 1.19; 95% confidence interval [CI], 1.09-1.31) and a shorter time to repeat procedures (HR, 1.25; 95% CI, 1.09-1.45). The use of atherectomy was also associated with a shorter time to IC recurrence (HR, 1.29; 95% CI, 1.08-1.33) and a shorter time to repeat procedures (HR, 1.31; 95% CI, 1.13-1.52). Discharge with antiplatelet and statin medications was associated with a longer time to IC recurrence (HR, 0.84; 95% CI, 0.78-0.91) and a longer time to repeat procedures (HR, 0.77; 95% CI, 0.69-0.87). Life-table analysis at 2 years revealed that only 32% of patients were free from IC recurrence, although 76% had not undergone repeat procedures. Stratified by anatomic treatment level, 37% of isolated aortoiliac interventions, 22% of aortoiliac and femoropopliteal interventions, 30% of isolated femoropopliteal interventions, and 20% of femoropopliteal and tibial interventions had remained free from IC recurrence at 2 years.

Conclusions: Most patients treated with an endovascular approach to IC did not meet the Society for Vascular Surgery guidelines for long-term freedom from recurrent symptoms of >50% at 2 years. Many lacked preprocedure optimization of medical management. The use of atherectomy and treatment of more than two arteries were associated with poor outcomes after peripheral vascular intervention for IC, because only 32% of these patients were free from recurrent symptoms at 2 years. Even when risk factor modification is optimized before the procedure, vascular specialists should be aware of the association between atherectomy and multivessel interventions with poorer long-term outcomes and counsel patients appropriately before intervention.
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http://dx.doi.org/10.1016/j.jvs.2020.10.067DOI Listing
November 2020

Poststent ballooning during transcarotid artery revascularization.

J Vasc Surg 2020 Nov 27. Epub 2020 Nov 27.

Division of Vascular and Endovascular Surgery, Department of Surgery, University of California San Diego, Calif. Electronic address:

Background: Poststent ballooning/angioplasty (post-SB) have been shown to increase the risk of stroke risk after transfemoral carotid artery stenting. With the advancement of transcarotid artery revascularization (TCAR) with dynamic cerebral blood flow reversal, we aimed to study the impact of post-SB during TCAR.

Methods: Patients undergoing TCAR in the Vascular Quality Initiative between September 2016 and May 2019 were included and were divided into three groups: those who received prestent deployment angioplasty only (pre-SB, reference group), those who received poststent deployment ballooning only (post-SB), and those who received both prestent and poststent deployment ballooning (prepost-SB). Patients who did not receive any angioplasty during their procedure (n = 367 [6.7%]) were excluded because these represent a different group of patients with less complex lesions than those requiring angioplasty. Primary outcome was in-hospital stroke or death. Analysis was performed using univariable and multivariable logistic regression models.

Results: Of 5161 patients undergoing TCAR, 34.7% had pre-SB only, 25% had post-SB only, and 40.3% had both (prepost-SB). No differences in the rates of in-hospital and 30-day stroke, death, and stroke/death were observed among the three groups; in-hospital stroke/death in the pre-SB group was 1.4% (n = 25), post-SB 1.2% (n = 16), and prepost-SB 1.4% (n = 29; P = .92). However, patients undergoing post-SB and prepost-SB had higher rates of in-hospital transient ischemic attacks (TIA) (post-SB, 0.9%; prepost-SB, 1% vs pre-SB, 0.2%, P < .01) and postprocedural hypotension (16.6% and 16.8% vs 13.1%, respectively; P < .001). Post-SB also had longer operative times, as well as flow reversal and fluoroscopy times. On multivariable analysis, no association was seen between post-SB and the primary outcome of in-hospital stroke/death (post-SB odds ratio [OR], 0.88; 95% confidence interval [CI], 0.44-1.73; prepost-SB OR, 0.98; 95% CI, 0.57-1.70). Similarly, no significant differences were noted in terms of postprocedural hemodynamic instability and 30-day outcomes. However, post-SB and prepost-SB were associated with four times the odds of in-hospital TIA compared with pre-SB alone (post-SB OR, 4.24 [95% CI, 1.51-11.8]; prepost-SB OR, 4.76 [95% CI, 1.53-14.79]; P = .01). Symptomatic patients had higher rates of in-hospital stroke/death compared with their asymptomatic counterparts; however, there was no significant interaction between symptomatic status and ballooning in predicting the primary outcome.

Conclusions: Post-SB was used in 65.3% of TCAR patients. This maneuver seems to be safe without an increase in the odds of postoperative in-hospital stroke/death. However, the increased rates of TIA associated with post-SB requires further investigation.
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http://dx.doi.org/10.1016/j.jvs.2020.10.071DOI Listing
November 2020

Emergent thoracic endovascular aortic aneurysm repair for ruptured aneurysm: in-hospital and long-term results.

J Cardiovasc Surg (Torino) 2020 Dec 13;61(6):675-680. Epub 2020 Nov 13.

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

The use of thoracic endovascular aortic repair (TEVAR) has rapidly increased following Food and Drug Administration (FDA) approval in 2005. Initially used for the repair of intact thoracic aneurysms and aortic dissections, TEVAR is now routinely used for the treatment of ruptured thoracic aortic aneurysm as well. Emergent TEVAR for the repair of ruptured aneurysm has demonstrated improved perioperative mortality and morbidity compared to traditional open repair. Spinal cord ischemia and permanent paraplegia rates are also lower following TEVAR compared to open repair. However, TEVAR requires routine surveillance and has demonstrated the need for reintervention compared to open repair. Furthermore, the perioperative survival benefits of TEVAR were attenuated on mid-term and long-term survival analysis.
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http://dx.doi.org/10.23736/S0021-9509.20.11595-7DOI Listing
December 2020

Vascular Quality Initiative risk score for 30-day stroke or death following transcarotid artery revascularization.

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

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

Objective: Transcarotid artery revascularization (TCAR) using a flow-reversal neuroprotection system has gained popularity for the endovascular treatment of carotid artery atherosclerotic disease owing to its lower risk of stroke or death compared with transfemoral carotid artery stenting. However, specific risk factors associated with stroke or death complications after TCAR have yet to be defined.

Methods: All patients undergoing TCAR for the treatment of asymptomatic or symptomatic atherosclerotic carotid disease were identified between September 2016 and September 2019 in the Vascular Quality Initiative TCAR Surveillance Project. Our primary outcome was 30-day stroke or death. We created a risk model for 30-day stroke or death using multivariable fractional polynomials and internally validated the model using bootstrapping.

Results: During the study period 7633 patients underwent TCAR, of which 4089 (53.6%) were treated for symptomatic and 3544 (46.4%) for asymptomatic disease. The average age of patients undergoing TCAR was 73.3 ± 9.1 years and 63.7% were male. Stroke or death events within 30 days of the index operation occurred in 153 patients (2.0%). Factors independently associated with a higher odds of 30-day stroke or death included the severity of presenting stroke symptoms (cortical transient ischemic attack, odds ratio [OR], 2.17 [95% confidence interval (CI), 1.21-3.90; P = .009]; stroke, OR, 3.30; 95% CI, 2.25-4.85; P < .001), advancing age (OR, 1.03 per year; 95% CI, 1.01-1.06; P = .003), and history of unstable angina or myocardial infarction within the past 6 months (OR, 2.20; 95% CI, 1.29-3.77; P = .004), moderate or severe congestive heart failure (OR, 2.44; 95% CI, 1.31-4.55; P = .005), chronic obstructive pulmonary disease (on medications, OR, 1.61 [95% CI, 1.06-2.43; P = .024]; on home oxygen, OR, 2.52 [95% CI, 1.44-4.41; P = .001]), and prior ipsilateral carotid endarterectomy (OR, 1.56; 95% CI, 1.09-2.25; P = .016), whereas preoperative P2Y use was associated with a lower odds of 30-day stroke or death (OR, 0.57; 95% CI, 0.39-0.85; P = .005). A 30-point risk prediction model created based on these criteria produced a C statistic of 0.72 and Hosmer-Lemeshow goodness of fit of 0.97. Internal validation demonstrated good discrimination with a bias corrected area under the receiver operating characteristic curve of 0.70 with a calibration slope of 1.00.

Conclusions: This Vascular Quality Initiative TCAR risk score calculator can be used to estimate the risk of stroke or death within 30 days of the procedure. Because TCAR is commonly used to treat patients with high surgical risk for carotid endarterectomy, this risk score will help to guide treatment decisions in patients being considered for TCAR.
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http://dx.doi.org/10.1016/j.jvs.2020.10.023DOI Listing
October 2020

Validation of the Global Limb Anatomical Staging System in First-time Lower Extremity Revascularization.

J Vasc Surg 2020 Oct 19. Epub 2020 Oct 19.

Department of Surgery, Division of Vascular and Endovascular Surgery, Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, MA 02215. Electronic address:

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

Methods: We performed a single-institutional retrospective review of 1,060 consecutive patients undergoing 1,180 first-time open or endovascular revascularization procedures for CLTI from 2005-2014. Based on review of angiographic images, limbs were classified as GLASS Stage 1, 2, or 3. The primary composite outcome was reintervention, major amputation (below or above knee amputation), or restenosis (>3.5x step-up by duplex criteria) events (RAS). Secondary outcomes included all-cause mortality, failure to cross the lesion by endovascular methods, and comparison between bypass versus endovascular intervention. Kaplan-Meier estimates were used to determine event rates at 1- and 5-years and Cox regression analysis to adjust for baseline differences among the GLASS stages.

Results: Of all patients undergoing first-time revascularization, 1,180 patients (91%) had imaging available for GLASS grading, of which 552 limbs were treated with open bypass (47%) and 628 limbs with endovascular intervention (53%). Compared with GLASS Stage 1 disease (N=267, 23%), Stage 2 (N=367, 31%) and Stage 3 (N=546, 42%) were associated with higher risk of RAS at 1-year (Stage 1: 33% vs. Stage 2: 48% vs. Stage 3: 53%) and 5-year follow-up (Stage 1: 45%, reference; Stage 2: 65%, HR 1.7 [1.3-2.2], P < .001; Stage 3: 69%, HR 2.3 [1.7-2.9], P < .001). These differences were mainly driven by reintervention and restenosis rather than by major amputation. Five-year mortality was similar in Stage 2 and 3 compared with Stage 1 disease (Stage 1: 40%, reference; Stage 2: 45%, HR 1.1 [0.8-1.4], P = .69; Stage 3: 49%, HR 1.2 [1.0-1.6], P = .11). For all attempted endovascular interventions, failure to cross a target lesion increased with advancing GLASS Stage (Stage 1: 4.5% vs. Stage 2: 6.3% vs. Stage 3: 13.3%, P < .01). Compared with open bypass (N=552, 46.8%), endovascular intervention (N=628, P=53.3%) was associated with a higher rate of 5-year RAS for GLASS Stage 1 (49% vs 34%; HR 1.9 [1.1-3.5], P=.03), Stage 2 (69% vs 52%, HR 1.7 [1.2-2.5], P < .01), and Stage 3 disease (83% vs 61%, HR 1.5 [1.2-2.0], P < .01).

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

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

Effects of Timing on In-hospital and One-year Outcomes after TransCarotid Artery Revascularization.

J Vasc Surg 2020 Oct 7. Epub 2020 Oct 7.

University of California San Diego, San Diego, CA, USA. Electronic address:

Objective: Current recommendations are to perform carotid endarterectomy (CEA) within two weeks of symptoms due to superior long-term stroke prevention, although urgent CEA within 48-hours has been associated with increased perioperative stroke. With the development and rapid adoption of TransCarotid Artery Revascularization (TCAR), we aim to study the impact of timing on outcomes after TCAR.

Methods: Symptomatic patients undergoing TCAR in the Vascular Quality Initiative between September 2016 and November 2019 were stratified by time to procedure: urgent (TCAR within 48-hours), early (TCAR between 3-14 days after symptoms), and late (TCAR greater than 14 days after symptoms). Primary outcome was in-hospital rates of stroke/death and evaluated using logistic regression. Secondary outcome was one-year rate of recurrent ipsilateral stroke and mortality, analyzed using Kaplan Meier Survival Analysis.

Results: A total of 2608 symptomatic patients undergoing TCAR were included: 144 urgent (5.52%), 928 early (35.58%), and 1536 (58.90%) late. Patients undergoing urgent intervention had increased risk of in-hospital stroke/death that was driven primarily by increased risk of stroke. No differences were seen in in-hospital death. On adjusted analysis, urgent intervention had a 3-fold increased odds of stroke [OR:2.8, 95%CI:1.3-6.2, p=0.01] and a 3-fold increased odds of stroke/death [OR:2.9, 95%CI:1.3-6.4, p=0.01] when compared to late intervention. Patients undergoing early intervention had comparable risks of stroke [OR:1.3, 95%CI:0.7-2.3, p=0.40] and stroke/death [OR:1.2, 9%CI:0.7-2.1, p=0.48] when compared to late intervention. On subset analysis, the type of presenting symptoms was an effect modifier. Both patients presenting with stroke and patients presenting with transient ischemic attacks (TIA) or amaurosis fugax (AF) had increased risk of stroke/death when undergoing urgent compared to late TCAR: [OR:2.7, 95%CI:1.1-6.6, p=0.04] and [OR:4.1, 95%CI:1.1-15.0, p=0.03] respectively. However only patients presenting with TIA or AF had experienced increased risk of stroke when undergoing urgent compared to late TCAR: [OR:5.0, 95%CI:1.4-17.5, p<0.01]. At one-year follow-up, no differences were seen in recurrent ipsilateral stroke (urgent:0.7%, early:0.2%, late:0.1%, p=0.13) or post-discharge mortality (urgent:0.7%, early:1.6%, late:1.8%, p=0.71).

Conclusion: TCAR has a reduced incidence of stroke when performed 48-hours after onset of symptoms. Urgent TCAR within 48 hours of onset of stroke is associated with a three-fold increased risk of in-hospital stroke/death with no added benefit up to one year after the intervention. Further studies are needed on long-term outcomes of TCAR stratified by timing of the procedure.
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http://dx.doi.org/10.1016/j.jvs.2020.08.148DOI Listing
October 2020

Prediction Model for Freedom from TLR from a Multi-study Analysis of Long-Term Results with the Zilver PTX Drug-Eluting Peripheral Stent.

Cardiovasc Intervent Radiol 2021 Feb 6;44(2):196-206. Epub 2020 Oct 6.

Department of Medicine, Ohio Health/Riverside Methodist Hospital, Columbus, OH, USA.

Purpose: Develop a prediction model to determine the impact of patient and lesion factors on freedom from target lesion revascularization (ffTLR) for patients who are candidates for Zilver PTX drug-eluting stent (DES) treatment for femoropopliteal lesions.

Methods: Patient factors, lesion characteristics, and TLR results from five global studies were utilized for model development. Factors potentially associated with TLR (sex, age, diabetes, hypertension, hypercholesterolemia, renal disease, smoking status, Rutherford classification, lesion length, reference vessel diameter (RVD), popliteal involvement, total occlusion, calcification severity, prior interventions, and number of runoff vessels) were analyzed in a Cox proportional hazards model. Probability of ffTLR was generated for three example patient profiles via combinations of patient and lesion factors. TLR was defined as reintervention performed for ≥ 50% diameter stenosis after recurrent clinical symptoms.

Results: The model used records from 2227 patients. The median follow-up time was 23.9 months (range: 0.03-60.8). The Kaplan-Meier estimates for ffTLR were 90.5% through 1 year and 75.2% through 5 years. In a multivariate analysis, sex, age, Rutherford classification, lesion length, RVD, total occlusion, and prior interventions were significant factors. The example patient profiles have predicted 1-year ffTLRs of 97.4, 92.3, and 86.0% and 5-year predicted ffTLRs of 92.8, 79.5, and 64.8%. The prediction model is available as an interactive web-based tool ( https://cooksfa.z13.web.core.windows.net ).

Conclusions: This is the first prediction model that uses an extensive dataset to determine the impact of patient and lesion factors on ffTLR through 5 years and provides an interactive web-based tool for expected patient outcomes with the Zilver PTX DES.

Clinical Trial Registrations: Zilver PTX RCT unique identifier: NCT00120406; Zilver PTX single-arm study unique identifier: NCT01094678; Zilver PTX China study unique identifier: NCT02171962; Zilver PTX US post-approval study unique identifier: NCT01901289; Zilver PTX Japan post-market surveillance study unique identifier: NCT02254837.

Levels Of Evidence: Zilver PTX RCT: Level 2, randomized controlled trial; Single-arm study: Level 4, large case series; China study: Level 4, case series; US post-approval study: Level 4, case series Japan PMS study: Level 4, large case series.
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http://dx.doi.org/10.1007/s00270-020-02648-6DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7806559PMC
February 2021

Editor's Choice - International Variations and Sex Disparities in the Treatment of Peripheral Arterial Occlusive Disease: A Report from VASCUNET and the International Consortium of Vascular Registries.

Eur J Vasc Endovasc Surg 2020 Dec 29;60(6):873-880. Epub 2020 Sep 29.

Division of Vascular Surgery, University of Vermont Medical Centre, Burlington, VT, USA.

Objective: The aim of this study was to determine sex specific differences in the invasive treatment of symptomatic peripheral arterial occlusive disease (PAOD) between member states participating in the VASCUNET and International Consortium of Vascular Registries.

Methods: Data on open surgical revascularisation and peripheral vascular intervention (PVI) of symptomatic PAOD from 2010 to 2017 were collected from population based administrative and registry data from 11 countries. Differences in age, sex, indication, and invasive treatment modality were analysed.

Results: Data from 11 countries covering 671 million inhabitants and 1 164 497 hospitalisations (40% women, mean age 72 years, 49% with intermittent claudication, 54% treated with PVI) in Europe (including Russia), North America, Australia, and New Zealand were included. Patient selection and treatment modality varied widely for the proportion of female patients (23% in Portugal and 46% in Sweden), the proportion of patients with claudication (6% in Italy and 69% in Russia), patients' mean age (70 years in the USA and 76 years in Italy), the proportion of octogenarians (8% in Russia and 33% in Sweden), and the proportion of PVI (24% in Russia and 88% in Italy). Numerous differences between females and males were observed in regard to patient age (72 vs. 70 years), the proportion of octogenarians (28% vs. 15%), proportion of patients with claudication (45% vs. 51%), proportion of PVI (57% vs. 51%), and length of hospital stay (7 days vs. 6 days).

Conclusion: Remarkable differences regarding the proportion of peripheral vascular interventions, patients with claudication, and octogenarians were seen across countries and sexes. Future studies should address the underlying reasons for this, including the impact of national societal guidelines, reimbursement, and differences in health maintenance.
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http://dx.doi.org/10.1016/j.ejvs.2020.08.027DOI Listing
December 2020

TransCarotid Revascularization with Dynamic Flow reversal versus Carotid Endarterectomy in the Vascular Quality Initiative Surveillance Project.

Ann Surg 2020 Sep 15. Epub 2020 Sep 15.

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

Objective: To compare the outcomes of TransCarotid Artery Revascularization with flow reversal (TCAR) to the gold standard carotid endarterectomy (CEA) using data from the Society for Vascular Surgery Vascular Quality Initiative TCAR Surveillance Project.

Summary Background Data: TCAR is a novel minimally invasive procedure for carotid revascularization in high-risk patients that is associated with significantly lower stroke rates compared with carotid artery stenting via the transfemoral approach.

Methods: Patients in the United States and Canada who underwent TCAR and CEA for carotid artery stenosis (2016- 2019) were included. Propensity scores were calculated based on baseline clinical variables and used to match patients in the two treatment groups (n=6,384 each). The primary endpoint was the combined outcome of perioperative stroke and/or death.

Results: No significant differences were observed between TCAR and CEA in terms of in-hospital stroke/death [TCAR,1·6% vs.CEA,1·6%, RR (95% CI):1·01(0·77-1·33), P=·945], stroke [1·4% vs.1·4%, RR(95%CI):1·02(0·76-1·37), P=·881], or death [0·4% vs.0·3%, RR (95%CI):1·14 (0·64-2·02), P =·662]. Compared to CEA, TCAR was associated with lower rates of in-hospital myocardial infarction [0·5% vs. 0·9%, RR (95%CI):0·53 (0·35-0·83), P =·005], cranial nerve injury [0·4% vs.2·7%, RR(95%CI):0·14(0·08-0·23), P<·001], and post-procedural hypertension [13% vs.18·8%, RR(95% CI):0·69(0·63-0·76), P <·001]. They were also less likely to stay in the hospital for more than one day [26·4% vs.30·1%, RR (95%CI):0·88(0·82-0·94), P<·001]. No significant interaction was observed between procedure and symptomatic status in predicting postoperative outcomes. At one year, the incidence of ipsilateral stroke or death was similar between the two groups [HR (95%CI):1·09(0·87-1·36), P=·44].

Conclusions: This propensity-score matched analysis demonstrated significant reduction in the risk of postoperative myocardial infarction and cranial nerve injury after TCAR compared to CEA, with no differences in the rates of stroke/death.
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http://dx.doi.org/10.1097/SLA.0000000000004496DOI Listing
September 2020

Protocolized Based Management of Cerebrospinal Fluid Drains in Thoracic Endovascular Aortic Aneurysm Repair Procedures.

Ann Vasc Surg 2020 Sep 11. Epub 2020 Sep 11.

Department of Anesthesia, Critical Care and Pain Medicine, Cardiovascular Institute, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA. Electronic address:

Background: Spinal cord ischemia (SCI) resulting in paraplegia is a devastating complication associated with thoracic endovascular aortic aneurysm repair (TEVAR) whose incidence has significantly declined over time. In this review, we present our experience with a multidisciplinary clinical protocol for cerebrospinal fluid (CSF) drain management in patients undergoing TEVAR. Furthermore, we aimed to characterize complications of CSF drain placement in a large, single center experience of patients who underwent TEVAR.

Methods: This retrospective review is of patients undergoing TEVAR with and without CSF drain placement between January 2014 and December 2019 at a single institution. Patient demographics, hospital course, and drain-related complications were analyzed to assess the incidence of CSF drain-related complications.

Results: A total of 235 patients were included in this study, of which 85 received CSF drains. Eighty patients (94.1%) were placed by anesthesiologists, while 5 (5.9%) were placed under fluoroscopic guidance by interventional neurosurgery. The most common level of placement was L3-L4 in 38 (44.7%) cases followed by L4-L5 in 36 (42.4%) cases. The mean duration of CSF drain was 1.9 ± 1.4 days. Complications due to CSF drainage occurred in 5 (5.9%) patients and included partial retainment of catheter, subdural edema, epidural hematoma, headache, and bleeding near the drain site. The overall 30-day mortality rate was 5.5% and did not differ between those who received a CSF drain and those who did not (P = 0.856). The overall incidence of SCI resulting in paraplegia was 1.7% in the studied patients.

Conclusions: A protocol-based CSF drainage program for spinal cord protection involves a multifaceted approach in identification and selection of patients meeting criteria for prophylactic drain placement, direct closed loop communication, and perioperative management by an experienced team. Despite the inherent advantages of CSF drain placement, it is not without complications, thus risk and benefit need to be weighed in context of the procedure and the patient with close communication and team approach.
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http://dx.doi.org/10.1016/j.avsg.2020.08.134DOI Listing
September 2020

Update on paclitaxel for femoral-popliteal occlusive disease in the 15 months following a summary level meta-analysis demonstrated increased risk of late mortality and dose response to paclitaxel.

J Vasc Surg 2021 Jan 2;73(1):311-322. Epub 2020 Sep 2.

Department of Interventional Radiology, Auckland Hospital and University of Auckland School of Medicine, Auckland, New Zealand.

Background: Peripheral vascular devices (stents and balloons) coated with paclitaxel were developed to address suboptimal outcomes associated with percutaneous revascularization procedures of the femoral-popliteal arteries. In randomized controlled trials (RCT), paclitaxel-coated devices (PCD) provided increased long-term patency and a decreased need for repeat revascularization procedures compared with uncoated devices. This finding resulted in the adoption of their use for endovascular lower extremity revascularization procedures. However, in late 2018 a study-level meta-analysis showed increased all-cause mortality at 2 years or more after the procedure in patients treated with PCDs. This review examines the subsequent data evaluation following the publication of the meta-analysis.

Methods: We review the published responses of physicians, regulatory agencies, and patient advocates during 15-month period after the meta-analysis. We present the additional data gathered from RCTs that comprised the meta-analysis and safety outcomes from large insurance databases in both the United States and Europe.

Results: Immediately after the publication of the meta-analysis, concern for patient safety resulted in less PCD use, the suspension of large RCTs evaluating their use, and the publication of a letter from the U.S. Food and Drug Administration informing physicians that there was uncertainty in the benefit-risk profile of these devices for indicated patients and that the potential risk should be assessed before the use of PCDs. Review of the meta-analysis found that a mortality signal was present, but criticisms included that the evaluation was performed on study-level, not patient-level data, and the studies in the analysis were heterogenous in device type, paclitaxel doses, and patient characteristics. Further, the studies were not designed to be pooled nor were they powered for evaluating long-term safety. Clinical characteristics associated with a drug effect or causal relationship were also absent. Specifically, there was no dose response, no clustering of causes of death, and a lack of signal consistency across geographic regions. As more long-term data became available in the RCTs the strength of the mortality signal diminished and analysis of real-world use in large insurance databases, showed that there was no significant increase in all-cause mortality associated with PCD use.

Conclusions: The available data do not provide definitive proof for increased mortality with PCD use. A key observation is that trial design improvements will be necessary to better evaluate the risk-benefit profile of PCDs.
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http://dx.doi.org/10.1016/j.jvs.2020.07.093DOI Listing
January 2021

The Long-Term Implications of Access Complications during EVAR.

J Vasc Surg 2020 Sep 1. Epub 2020 Sep 1.

Division of Cardiac, Thoracic, and Vascular Surgery, NewYork-Presbyterian / Columbia University Irving Medical Center / Columbia University Vagelos College of Physicians & Surgeons, New York, NY 10032. Electronic address:

Background: Access issues are one of the most common complications of endovascular aneurysm repair (EVAR). However, contemporary rates as well as risk factors for complications and the subsequent impact of access complications on mortality are poorly described.

Methods: We studied all EVAR for intact AAA without prior aortic surgery in the Vascular Quality Initiative between 2011 and 2018. We studied factors associated with access complications (thrombosis, embolus, wound infection, hematoma, conversion to cutdown), as well as the interaction with female sex and the impact on survival using multilevel logistic regression and propensity weighting. Multiple imputation was used for missing data.

Results: There were 33,951 EVAR during the study period (91% elective, 9% symptomatic); most cases (70%) involved an attempt at percutaneous access on at least one side, with 30% bilateral cutdowns and 0.1% iliac conduits. 1,553 patients (4.6%) experienced at least one access complication. Access complications were almost twice as common in female patients (7.5% vs 3.9%, P<.001). The factors associated with access complications included female sex (OR 2.7 [2.0-3.6], P<.001), age (OR 1.05 per 5 years [1.02-1.1], P<.01), aortouniiliac device (OR 1.6 [1.1-2.3], P<.01), smoking (OR 1.4 [1.1-1.7], P<.01), BMI < 16 (OR 1.8 [1.3-2.5], P=.001), dual antiplatelet therapy (1.3 [1.02-1.6], P=.03), prior infrainguinal bypass (OR 1.8 [1.3-2.7], P<.01), and beta blocker usage (OR 1.2 [1.03-1.4], P=.02). Conversion from percutaneous access to open cutdown was associated with higher rates of complications than planned open cutdown (8.6% vs 2.9%, P<.001). In propensity-weighted analysis, percutaneous access was associated with significantly lower odds of access complications in women (OR 0.6 [0.4-0.96], P=.03). Patients who experienced an access complication had over four times the odds of perioperative death (OR 4.2 [2.5-7.1], P<.001), and 60% higher risk of long-term mortality (HR 1.6 [1.2-2.1], P=.001). In addition to death, patients with access site complications had higher rates of other major complications, including reoperation during the index hospitalization (19% vs 1.2%, P < .001), myocardial infarction (3.5% vs 0.7%, P < .001), stroke (0.8% vs 0.2%, P < .001), acute kidney injury (12% vs 3%, P < .001), and reintubation (5.7% vs 0.8%).

Conclusion: Although access complications are infrequent in the current era, they are associated with both perioperative and long-term morbidity and mortality. Female patients in particular are at high risk of access complications but may benefit from percutaneous access.
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http://dx.doi.org/10.1016/j.jvs.2020.08.033DOI Listing
September 2020

Improved outcomes of endovascular repair of thoracic aortic injuries at higher volume institutions.

J Vasc Surg 2020 Sep 1. Epub 2020 Sep 1.

Division of Vascular Surgery, University of Pittsburgh Medical Center, Pittsburgh, Pa.

Background: The use of thoracic endovascular aortic repair (TEVAR) has significantly improved the ability to treat traumatic aortic injuries (tTEVAR). We sought to determine whether a greater center volume correlated with better outcomes.

Methods: Vascular Quality Initiative data of TEVAR (2011-2017) for trauma were used in the present analysis. Using the distribution of the annual case volume at the participating centers, the sample was stratified into three terciles. In-hospital mortality at high-volume centers (HVCs) and low-volume centers (LVCs) was compared after adjustment for risk factors established in our previous Vascular Quality Initiative-based risk model containing age, gender, renal impairment, left subclavian artery involvement, and select concomitant injuries.

Results: A total of 619 tTEVAR cases were studied across 74 centers. HVCs (n = 184 cases) had performed ≥4.9 cases annually and LVCs (n = 220 cases) had performed ≤2.4 cases annually. Both crude mortality (4.4% vs 8.6%; P = .22) and adjusted odds of mortality (odds ratio, 0.44; 95% confidence interval, 0.18-1.09; P = .08) showed a trend toward better outcomes for tTEVAR performed at HVCs than at LVCs. The addition of center volume to our previous multivariate model significantly improved its discriminative ability (C-statistic, 0.90 vs 0.88; P = .02). The overall TEVAR volume (for all indications) was not associated with increased odds of mortality for tTEVAR (odds ratio, 0.46; 95% confidence interval, 0.17-1.20; P = .11), nor did it improve the model's discriminative ability.

Conclusion: Higher volume centers showed improved perioperative mortality after tTEVAR. The thoracic aortic trauma volume was more predictive than the overall TEVAR volume, suggesting that technical expertise is not the driving factor. Stable patients might benefit from transfer to a higher volume center before repair.
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http://dx.doi.org/10.1016/j.jvs.2020.08.034DOI Listing
September 2020

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

J Vasc Surg 2020 Aug 29. Epub 2020 Aug 29.

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

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

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

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

Conclusions: Heel wounds confer considerably higher short- and long-term morbidity and mortality compared with midfoot or forefoot wounds in patients undergoing any first-time lower extremity revascularization.
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http://dx.doi.org/10.1016/j.jvs.2020.07.091DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7914284PMC
August 2020

Pregnancy-associated arterial dissections: a nationwide cohort study.

Eur Heart J 2020 Nov;41(44):4234-4242

Division of Cardiovascular Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, 185 Pilgrim Road, Palmer 4, Boston, MA 02215, USA.

Aims: Pregnancy is a known risk factor for arterial dissection, which can result in significant morbidity and mortality in the peripartum period. However, little is known about the risk factors, timing, distribution, and outcomes of arterial dissections associated with pregnancy.

Methods And Results: We included all women ≥12 years of age with hospitalizations associated with pregnancy and/or delivery in the Nationwide Readmissions Database between 2010 and 2015. The primary outcome was any dissection during pregnancy, delivery, or the postpartum period (42-days post-delivery). Secondary outcomes included timing of dissection, location of dissection, and in-hospital mortality. Among 18 151  897 pregnant patients, 993 (0.005%) patients were diagnosed with a pregnancy-related dissection. Risk factors included older age (32.8 vs. 28.0 years), multiple gestation (3.6% vs. 1.9%), gestational diabetes (14.3% vs. 0.2%), gestational hypertension (6.0% vs. 0.6%), and pre-eclampsia/eclampsia (2.7% vs. 0.4%), in addition to traditional cardiovascular risk factors. Of the 993 patients with dissection, 150 (15.1%) dissections occurred in the antepartum period, 232 (23.4%) were diagnosed during the admission for delivery, and 611 (61.5%) were diagnosed in the postpartum period. The most common locations for dissections were coronary (38.2%), vertebral (22.9%), aortic (19.8%), and carotid (19.5%). In-hospital mortality was 3.7% among pregnant patients with a dissection vs. <0.001% in patients without a dissection. Deaths were isolated to patients with an aortic (8.6%), coronary (4.2%), or supra-aortic (<2.5%) dissection.

Conclusion: Arterial dissections occurred in 5.5/100 000 hospitalized pregnant or postpartum women, most frequently in the postpartum period, and were associated with high mortality risk. The coronary arteries were most commonly involved. Pregnancy-related dissections were associated with traditional risk factors, as well as pregnancy-specific conditions.
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http://dx.doi.org/10.1093/eurheartj/ehaa497DOI Listing
November 2020

Risk factors and impact of postoperative hypotension after carotid artery stenting in the Vascular Quality Initiative.

J Vasc Surg 2021 Mar 21;73(3):975-982. Epub 2020 Jul 21.

Maine Medical Center (MMC), Portland, Me.

Objective: Hypotension is a frequent complication of carotid artery stenting (CAS). Although common, its occurrence is unpredictable, and association with adverse events has not been well defined. The aim of this study was to identify predictors of postoperative hypotension after CAS and the association with stroke/transient ischemic attack (TIA), major adverse cardiac events (MACEs), increased length of stay (LOS), and in-hospital mortality.

Methods: This is a retrospective analysis of all CAS procedures, including transfemoral CAS (TF-CAS) and transcarotid artery revascularization (TCAR), performed in the Vascular Quality Initiative between 2003 and 2018. The primary study end point was postoperative hypotension, defined as hypotension treated with continuous infusion of a vasoactive agent for ≥15 minutes. Secondary end points included any postoperative neurologic events (stroke/TIA), MACEs (myocardial infarction, congestive heart failure, and dysrhythmias), prolonged LOS (>1 day), and in-hospital mortality. Patients' demographics predictive of hypotension were determined by multivariable logistic regression, and a risk score was developed for correlation with outcomes.

Results: During the time period of study, 24,699 patients underwent CAS; 19,716 (80%) were TF-CAS, 3879 (16%) were TCAR, and 1104 (4%) were not defined. Fifty-six percent were for symptomatic disease, 75% were for a primary atherosclerotic lesion, and 72% were performed under local or regional anesthesia. Postoperative hypotension occurred in 15% of TF-CAS and 14% of TCAR patients (P = .50). Patients with hypotension (vs no hypotension) had higher rates of stroke/TIA (7.3% vs 2.6%; P < .001), MACEs (9.6% vs 2.1%; P < .001), prolonged LOS (65% vs 28%; P < .001), and in-hospital mortality (2.9% vs 0.7%; P < .001). By multivariable analysis, risk factors associated with hypotension included an atherosclerotic (vs restenotic) lesion (odds ratio, 2.2; 95% confidence interval, 2.0-2.4; P < .001), female sex (1.3 [1.2-1.4]; P < .001), positive stress test result (1.3 [1.2-1.4]; P < .001), age 70 to 79 years (1.1 [1.1-1.3]; P < .002), age >80 years (1.2 [1.1-1.4]; P < .001), history of myocardial infarction or angina (1.3 [1.2-1.4]; P < .001), and an urgent (vs elective) procedure (1.1 [1.0-1.2]; P < .01). A history of hypertension was protective (0.9 [0.8-0.9]; P < .02). A normalized risk score for hypotension was created from the multivariable model. Increasing risk scores correlated directly with rates of adverse events, including postoperative stroke/TIA, MACEs, increased LOS, and increased in-hospital mortality.

Conclusions: Hypotension after CAS is associated with adverse neurologic and cardiac events as well as with prolonged LOS and in-hospital mortality. A scoring tool may be valuable in stratifying patients at risk. Interventions aimed at preventing postoperative hypotension may improve outcomes with CAS.
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http://dx.doi.org/10.1016/j.jvs.2020.06.116DOI Listing
March 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

Outcomes of transcarotid artery revascularization with dynamic flow reversal in patients with contralateral carotid artery occlusion.

J Vasc Surg 2021 Feb 20;73(2):524-532.e1. Epub 2020 Jun 20.

Division of Vascular and Endovascular Surgery, Department of Surgery, University of California San Diego, San Diego, Calif. Electronic address:

Background: The outcomes of carotid revascularization in patients with contralateral carotid artery occlusion (CCO) are controversial. CCO has been defined by the Centers for Medicare and Medicaid Services as a high-risk criterion and is used as an indication for transfemoral carotid artery stenting. With the promising outcomes associated with transcarotid artery revascularization (TCAR), we aimed to study the perioperative outcomes of TCAR in patients with CCO and to assess the feasibility of TCAR in these high-risk patients.

Methods: All patients in the Vascular Quality Initiative database who underwent TCAR with flow reversal between September 2016 and May 2019 were included. Patients with trauma, dissection, or more than two treated lesions were excluded. Univariable and multivariable logistic analyses were used to compare the primary outcome of in-hospital stroke or death after TCAR in patients with CCO and those without CCO (patent and <99% stenosis). Secondary outcomes included intraoperative neurologic changes and the individual outcomes of in-hospital stroke, death, and myocardial infarction as well as 30-day mortality.

Results: A total of 5485 TCAR cases were included, of which 593 (10.8%) had CCO. In patients with CCO, mean flow reversal time was shorter (10.1 ± 6.7 minutes vs 11.1 ± 7.8 minutes; P < .01); intraoperative neurologic changes occurred in 1% of these patients compared with 0.7% of those with patent contralateral carotid arteries (P = .43). On univariable analysis, no significant difference in in-hospital stroke or death was shown between patients with and patients without CCO (1.7% vs 1.5%; P = .65). Similarly, no significant differences were noted between the groups in terms of in-hospital death (0.7% vs 0.4%; P = .27), stroke (1.7% vs 1.2%; P = .32), and stroke/death/myocardial infarction (2.2% vs 1.8%; P = .53) as well as 30-day mortality (0.8% vs 0.6%; P = .55). The results remained statistically nonsignificant after adjustment for baseline differences between the groups; the adjusted odds ratio (OR) of in-hospital stroke/death in patients with CCO compared with those with patent contralateral carotid arteries was not significant (OR, 1.39; 95% confidence interval, 0.65-3.0; P = .40). In symptomatic patients presenting with prior stroke, CCO was associated with significantly higher odds of stroke or death (OR, 4.63; 95% confidence interval, 1.39-15.4; P = .01) compared with no CCO. On the other hand, in asymptomatic patients, no significant difference in outcomes was observed between the groups.

Conclusions: In this analysis, TCAR seems to be safe in patients with CCO. Caution should be taken in symptomatic patients with CCO and a history of prior stroke as they might have worse outcomes compared with patients with patent contralateral carotid arteries. Studies with larger sample size and longer follow-up are needed to assess the perioperative and long-term outcomes of TCAR in patients with CCO in comparison to other procedures.
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http://dx.doi.org/10.1016/j.jvs.2020.04.529DOI Listing
February 2021

Clinical competence statement of the Society for Vascular Surgery on training and credentialing for transcarotid artery revascularization.

J Vasc Surg 2020 09 20;72(3):779-789. Epub 2020 Jun 20.

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

As the practice of medicine grows in complexity, the process of defining the expertise required for the competent execution of specific procedures has also become complex. The Society for Vascular Surgery therefore constituted a task force to provide informed recommendations on the knowledge, technical skills, resources, and infrastructure required to obtain and to maintain privileges for the safe and effective performance of transcarotid artery revascularization (TCAR). The TCAR procedure is being adopted rapidly, and it is therefore important that informed guidance be available expeditiously. Formal training in the pathophysiology and diagnosis of carotid occlusive disease and all management options is essential. Appropriate diagnostic, imaging, endovascular, surgical, and monitoring infrastructure is required, as are resources to maintain quality control. Credentialing and privileging require a combination of both open surgical and endovascular skills. As such, physicians must have hospital privileges to perform carotid endarterectomy. They should attend an appropriate program for education and simulated training in TCAR. In addition, physicians must have performed ≥25 endovascular procedures as the primary operator using low-profile rapid-exchange platforms plus ≥5 TCAR procedures as the primary operator (pathway 1); or they may have acquired ≥25 endovascular procedures as the primary operator using low-profile rapid-exchange platforms and a supplement of 5 TCAR procedures under proctored guidance if they have not performed sufficient TCAR procedures (pathway 2); or a team of two physicians can collaborate, combining the endovascular and surgical requirements plus at least 5 TCAR procedures under proctored guidance (pathway 3).
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http://dx.doi.org/10.1016/j.jvs.2020.05.053DOI Listing
September 2020

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

A Systematic Review and Meta-Analysis of Transcarotid Artery Revascularization with Dynamic Flow Reversal Versus Transfemoral Carotid Artery Stenting and Carotid Endarterectomy.

Ann Vasc Surg 2020 Nov 4;69:426-436. Epub 2020 Jun 4.

Division of Vascular and Endovascular Surgery, Department of Surgery, University of California San Diego Health System, San Diego, CA. Electronic address:

Background: Transfemoral carotid artery stenting (TFCAS) was introduced as a less invasive option for carotid revascularization in patients at high risk for complications from carotid endarterectomy (CEA). The increased perioperative stroke and death risk of TFCAS has however prevented TFCAS from widespread acceptance as an alternative to CEA in high-risk patients. Recent research suggests that transcarotid artery revascularization (TCAR) may be associated with a low stroke and death risk and potentially meet the needs of patients at high surgical risk. We aimed to estimate the 30-day risk of stroke or death of TCAR and compare it to TFCAS and CEA.

Methods: We searched PubMed, Cochrane, Embase, and Scopus for studies of patients treated with TCAR. Meta-analysis was conducted when appropriate. A logistic-normal random-effects model with logit transformation was used to estimate the pooled event rates after TCAR. Pooled Mantel-Haenszel odds ratios (ORs) of events comparing TCAR to TFCAS and CEA were calculated using a fixed-effects model. Heterogeneity among studies was quantified with the chi-squared statistic of the likelihood ratio (LR) test that compares the random-effects and fixed-effects models.

Results: Nine nonrandomized studies evaluating 4012 patients who underwent TCAR were included. The overall 30-day risks after TCAR were stroke/death, 1.89% (95% confidence interval [CI]: 1.50, 2.37); stroke, 1.34% (95% CI: 1.02,1.75); death, 0.76% (95% CI: 0.56, 1.08); myocardial infarction (MI), 0.60% (95% CI: 0.23, 1.59); stroke/death/MI, 2.20% (95% CI: 1.31, 3.69); cranial nerve injury (CNI), 0.31% (95% CI: 0.12, 0.83). The failure rate of TCAR was 1.27% (95% CI: 0.32, 4.92). Two nonrandomized studies suggested that TCAR was associated with lower risk of stroke and death as compared with TFCAS (1.33% vs. 2.55%, OR: 0.52, 95% CI: 0.36, 0.74 and 0.76% vs. 1.46%, OR: 0.52, 95% CI: 0.32, 0.84, respectively). Four nonrandomized studies suggested that TCAR was associated with a lower risk of CNI (0.54% and 1.84%, OR: 0.52, 95% CI: 0.36, 0.74) than CEA, but no statistically significant difference in the 30-day risk of stroke, stroke/death, or stroke/death/MI.

Conclusions: Among patients undergoing TCAR with dynamic flow reversal for carotid stenosis the 30-day risk of stroke or death was low. The perioperative stroke/death rate of TCAR was similar to that of CEA while CNI risk was lower. Larger prospective studies are needed to account for confounding factors and provide higher certainty.
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http://dx.doi.org/10.1016/j.avsg.2020.05.070DOI Listing
November 2020