Publications by authors named "Raghu Motaganahalli"

60 Publications

Acute effects of leg heat therapy on walking performance and cardiovascular and inflammatory responses to exercise in patients with peripheral artery disease.

Physiol Rep 2021 Jan;8(24):e14650

Department of Health and Kinesiology, Purdue University, West Lafayette, IN, USA.

Lower-extremity peripheral artery disease (PAD) is associated with increased risk of cardiovascular events and impaired exercise tolerance. We have previously reported that leg heat therapy (HT) applied using liquid-circulating trousers perfused with warm water increases leg blood flow and reduces blood pressure (BP) and the circulating levels of endothelin-1 (ET-1) in patients with symptomatic PAD. In this sham-controlled, randomized, crossover study, sixteen patients with symptomatic PAD (age 65 ± 5.7 years and ankle-brachial index: 0.69 ± 0.1) underwent a single 90-min session of HT or a sham treatment prior to a symptom-limited, graded cardiopulmonary exercise test on the treadmill. The primary outcome was the peak walking time (PWT) during the exercise test. Secondary outcomes included the claudication onset time (COT), resting and exercise BP, calf muscle oxygenation, pulmonary oxygen uptake (V̇O ), and plasma levels of ET-1, interleukin-6 (IL-6) and tumor necrosis factor-alpha (TNF-α). Systolic, but not diastolic BP, was significantly lower (~7 mmHg, p < .05) during HT when compared to the sham treatment. There was also a trend for lower SBP throughout the exercise and the recovery period following HT (p = .057). While COT did not differ between treatments (p = .77), PWT tended to increase following HT (CON: 911 ± 69 s, HT: 954 ± 77 s, p = .059). Post-exercise plasma levels of ET-1 were also lower in the HT session (CON: 2.0 ± 0.1, HT: 1.7 ± 0.1, p = .02). Calf muscle oxygenation, V̇O , COT, IL-6, and TNF-α did not differ between treatments. A single session of leg HT lowers BP and post-exercise circulating levels of ET-1 and may enhance treadmill walking performance in symptomatic PAD patients.
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http://dx.doi.org/10.14814/phy2.14650DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7758979PMC
January 2021

Anesthetic considerations in transcarotid artery revascularization.

Semin Vasc Surg 2020 Jun - Sep;33(1-2):10-15. Epub 2020 May 22.

Division of Vascular Surgery, Department of Surgery, Indiana University School of Medicine, 1801 N. Senate Boulevard, MPC2-3500, Indianapolis, IN 46202. Electronic address:

Transcarotid artery revascularization is a relatively new technology made available to vascular interventionalists within the last several years for patients with carotid artery stenosis. However, the intraoperative techniques and perioperative management of these patients continues to evolve as more experience is gained. Herein, we consider some important principles of anesthesia for patients undergoing this procedure.
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http://dx.doi.org/10.1053/j.semvascsurg.2020.05.005DOI Listing
December 2020

Clinical and laboratory characteristics of patients with novel coronavirus disease-2019 infection and deep venous thrombosis.

J Vasc Surg Venous Lymphat Disord 2020 Oct 22. Epub 2020 Oct 22.

Division of Vascular Surgery, Department of Surgery, Indiana University School of Medicine, Indianapolis, Ind.

Objective: Early reports suggest that patients with novel coronavirus disease-2019 (COVID-19) infection carry a significant risk of altered coagulation with an increased risk for venous thromboembolic events. This report investigates the relationship of significant COVID-19 infection and deep venous thrombosis (DVT) as reflected in the patient clinical and laboratory characteristics.

Methods: We reviewed the demographics, clinical presentation, laboratory and radiologic evaluations, results of venous duplex imaging and mortality of COVID-19-positive patients (18-89 years) admitted to the Indiana University Academic Health Center. Using oxygen saturation, radiologic findings, and need for advanced respiratory therapies, patients were classified into mild, moderate, or severe categories of COVID-19 infection. A descriptive analysis was performed using univariate and bivariate Fisher's exact and Wilcoxon rank-sum tests to examine the distribution of patient characteristics and compare the DVT outcomes. A multivariable logistic regression model was used to estimate the adjusted odds ratio of experiencing DVT and a receiver operating curve analysis to identify the optimal cutoff for d-dimer to predict DVT in this COVID-19 cohort. Time to the diagnosis of DVT from admission was analyzed using log-rank test and Kaplan-Meier plots.

Results: Our study included 71 unique COVID-19-positive patients (mean age, 61 years) categorized as having 3% mild, 14% moderate, and 83% severe infection and evaluated with 107 venous duplex studies. DVT was identified in 47.8% of patients (37% of examinations) at an average of 5.9 days after admission. Patients with DVT were predominantly male (67%; P = .032) with proximal venous involvement (29% upper and 39% in the lower extremities with 55% of the latter demonstrating bilateral involvement). Patients with DVT had a significantly higher mean d-dimer of 5447 ± 7032 ng/mL (P = .0101), and alkaline phosphatase of 110 IU/L (P = .0095) than those without DVT. On multivariable analysis, elevated d-dimer (P = .038) and alkaline phosphatase (P = .021) were associated with risk for DVT, whereas age, sex, elevated C-reactive protein, and ferritin levels were not. A receiver operating curve analysis suggests an optimal d-dimer value of 2450 ng/mL cutoff with 70% sensitivity, 59.5% specificity, and 61% positive predictive value, and 68.8% negative predictive value.

Conclusions: This study suggests that males with severe COVID-19 infection requiring hospitalization are at highest risk for developing DVT. Elevated d-dimers and alkaline phosphatase along with our multivariable model can alert the clinician to the increased risk of DVT requiring early evaluation and aggressive treatment.
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http://dx.doi.org/10.1016/j.jvsv.2020.10.006DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7581378PMC
October 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

Leg heat therapy improves perceived physical function but does not enhance walking capacity or vascular function in patients with peripheral artery disease.

J Appl Physiol (1985) 2020 12 1;129(6):1279-1289. Epub 2020 Oct 1.

Department of Health and Kinesiology, Purdue University, West Lafayette, Indiana.

A single session of leg heat therapy (HT) has been shown to elicit increases in leg blood flow and reduce blood pressure (BP) and the circulating levels of endothelin-1 (ET-1) in patients with symptomatic peripheral artery disease (PAD). We assessed whether 6 wk of supervised leg HT (3 times/wk) with water-circulating trousers perfused with water at 48°C improved 6-min walk distance in individuals with PAD compared with a sham treatment. Secondary outcomes included the assessment of leg vascular function, BP, quality of life, and serum ET-1 and nitrite plus nitrate (NOx) levels. Of 32 PAD patients randomized, 30 [age: 68 ± 8 yr; ankle-brachial index (ABI): 0.6 ± 0.1] completed the 3- and 6-wk follow-ups. Participants completed 98.7% of the treatment sessions. Compared with the sham treatment, exposure to HT did not improve 6-min walk distance, BP, popliteal artery reactive hyperemia, cutaneous microvascular reactivity, resting ABI, or serum NOx levels. The change from baseline to 6 wk in scores of the physical functioning subscale of the 36-item Short Form Health Survey was significantly higher in the HT group (control -6.9 ± 10 vs. HT 6.8 ± 15; 95% confidence interval: 2.5-24.3, = 0.017). Similarly, the change in ET-1 levels after 6 wk was different between groups, with the HT group experiencing a 0.4 pg/mL decrease (95% confidence interval: -0.8-0.0, = 0.03). These preliminary results indicate that leg HT may improve perceived physical function in symptomatic PAD patients. Additional, larger studies are needed to confirm these findings and determine the optimal treatment regimen for symptomatic PAD patients. This is the first sham-controlled study to investigate the effects of leg heat therapy (HT) on walking performance, vascular function, and quality of life in patients with peripheral artery disease (PAD). Adherence to HT was high, and the treatment was well tolerated. Our findings revealed that HT applied with water-circulating trousers evokes a clinically meaningful increase in perceived physical function and reduces the serum concentration of the potent vasoconstrictor endothelin-1 in patients with PAD.
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http://dx.doi.org/10.1152/japplphysiol.00277.2020DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7792848PMC
December 2020

Left colic artery aneurysm.

J Vasc Surg 2020 10;72(4):1457-1458

Division of Vascular Surgery, Indiana University School of Medicine, Indianapolis, Ind. Electronic address:

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http://dx.doi.org/10.1016/j.jvs.2020.04.506DOI Listing
October 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

Early Outcomes in the ROADSTER 2 Study of Transcarotid Artery Revascularization in Patients With Significant Carotid Artery Disease.

Stroke 2020 09 19;51(9):2620-2629. Epub 2020 Aug 19.

St. Luke's University Hospital, Bethlehem, PA (T.O.).

Background And Purpose: Transcarotid artery revascularization (TCAR) is comprised of carotid artery stent placement with cerebral protection via proximal carotid artery clamping and reversal of cerebral arterial flow. The aim of the present study was to evaluate the safety and efficacy of TCAR performed by a broad group of physicians with variable TCAR experience.

Methods: The ROADSTER 2 study is a prospective, open label, single arm, multicenter, postapproval registry for patients undergoing TCAR. Patients considered at high risk for complications from carotid endarterectomy with symptomatic stenosis ≥50% or asymptomatic stenosis ≥80% were included. The primary end point was procedural success, which encompassed technical success plus the absence of stroke, myocardial infarction, or death within the 30-day postoperative period. Secondary end points included technical success and individual/composite rates of stroke, death, and myocardial infarction (MI). All patients underwent independent neurological assessments before the procedure, within 24 hours, and at 30 days after TCAR. An independent clinical events committee adjudicated all major adverse events.

Results: Between 2015 and 2019, 692 patients (Intent to Treat Population) were enrolled at 43 sites. Sixty cases had major protocol violations, leaving 632 patients adhering to the Food and Drug Administration-approved protocol (per-protocol population). The majority (81.2%) of operators were TCAR naïve before study initiation. Patients underwent TCAR for neurological symptoms in 26% of cases, and all patients had high-risk factors for carotid endarterectomy (anatomic-related 44%; physiological 32%; both 24%). Technical success occurred in 99.7% of all cases. The primary end point of procedural success rate in the Intent to Treat population was 96.5% (per-protocol 97.9%). The early postoperative outcomes in the Intent to Treat population included stroke in 13 patients (1.9%), death in 3 patients (0.4%), and MI in 6 patients (0.9%). The composite 30-day stroke/death rate was 2.3%, and stroke/death/MI rate was 3.2%. In the per-protocol population, there were strokes in 4 patients (0.6%), death in one patient (0.2%), and MI in 6 patients (0.9%) leading to a composite 30-day stroke/death rate of 0.8% and stroke/death/MI rate of 1.7%.

Conclusions: TCAR results in excellent early outcomes with high technical success combined with low rates of postprocedure stroke and death. These results were achieved by a majority of operators new to this technology at the start of the trial. Adherence to the study protocol and peri-procedural antiplatelet therapy optimizes outcomes. Longer-term follow-up data are needed to confirm these early outcomes. Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT02536378.
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http://dx.doi.org/10.1161/STROKEAHA.120.030550DOI Listing
September 2020

Urgent Endovascular Repair of an Anterior Tibial Artery Aneurysm: Case Report and Literature Review.

Vasc Endovascular Surg 2020 Nov 13;54(8):760-764. Epub 2020 Aug 13.

Division of Vascular Surgery, Department of Surgery, 12250Indiana University School of Medicine, Indianapolis, IN, USA.

True aneurysms of the anterior tibial artery are rare with less than 20 published reports in the literature. We report an urgent endovascular repair of a true anterior tibial artery aneurysm in a patient with Ehlers-Danlos type IV, vascular type. This approach resulted in an uneventful recovery without the elevated risks associated with open vascular repair in the setting of connective tissue disorder. Continuous follow-up in the subsequent 4 years has demonstrated durability and efficacy of the original intervention.
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http://dx.doi.org/10.1177/1538574420945073DOI Listing
November 2020

Treatment of a traumatic aortic bifurcation injury with an iliac branch endoprosthesis.

J Vasc Surg Cases Innov Tech 2020 Sep 23;6(3):317-319. Epub 2020 Apr 23.

Division of Vascular Surgery, Department of Surgery, Indiana University School of Medicine, Indianapolis, Ind.

We present the case of a 62-year-old man who sustained a traumatic distal aortic injury associated with an adjacent lumbar vertebral body fracture resulting from a 20-ft fall. Given the site of injury, an iliac artery branched endograft was deployed off-label to preserve the aortic bifurcation and cover a limited amount of healthy aorta to preserve the collaterals. The procedure was successful, with no intraoperative complications or evidence of an endoleak. The aortic bifurcation and distal iliac arteries remained widely patent by computed tomography angiography at the follow-up examination without evidence of sequelae.
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http://dx.doi.org/10.1016/j.jvscit.2020.04.002DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7355387PMC
September 2020

Managing central venous access during a health care crisis.

Authors:
Tristen T Chun Dejah R Judelson David Rigberg Peter F Lawrence Robert Cuff Sherene Shalhub Max Wohlauer Christopher J Abularrage Papapetrou Anastasios Shipra Arya Bernadette Aulivola Melissa Baldwin Donald Baril Carlos F Bechara William E Beckerman Christian-Alexander Behrendt Filippo Benedetto Lisa F Bennett Kristofer M Charlton-Ouw Amit Chawla Matthew C Chia Sungsin Cho Andrew M T L Choong Elizabeth L Chou Anastasiadou Christiana Raphael Coscas Giovanni De Caridi Sharif Ellozy Yana Etkin Peter Faries Adrian T Fung Andrew Gonzalez Claire L Griffin London Guidry Nalaka Gunawansa Gary Gwertzman Daniel K Han Caitlin W Hicks Carlos A Hinojosa York Hsiang Nicole Ilonzo Lalithapriya Jayakumar Jin Hyun Joh Adam P Johnson Loay S Kabbani Melissa R Keller Manar Khashram Issam Koleilat Bernard Krueger Akshay Kumar Cheong Jun Lee Alice Lee Mark M Levy C Taylor Lewis Benjamin Lind Gabriel Lopez-Pena Jahan Mohebali Robert G Molnar Nicholas J Morrissey Raghu L Motaganahalli Nicolas J Mouawad Daniel H Newton Jun Jie Ng Leigh Ann O'Banion John Phair Zoran Rancic Ajit Rao Hunter M Ray Aksim G Rivera Limael Rodriguez Clifford M Sales Garrett Salzman Mark Sarfati Ajay Savlania Andres Schanzer Mel J Sharafuddin Malachi Sheahan Sammy Siada Jeffrey J Siracuse Brigitte K Smith Matthew Smith Ina Soh Rebecca Sorber Varuna Sundaram Scott Sundick Tadaki M Tomita Bradley Trinidad Shirling Tsai Ageliki G Vouyouka Gregory G Westin Michael S Williams Sherry M Wren Jane K Yang Jeniann Yi Wei Zhou Saqib Zia Karen Woo

J Vasc Surg 2020 Oct 15;72(4):1184-1195.e3. Epub 2020 Jul 15.

Division of Vascular Surgery, Department of Surgery, David Geffen School of Medicine at UCLA, Los Angeles, Calif. Electronic address:

Objective: During the COVID-19 pandemic, central venous access line teams were implemented at many hospitals throughout the world to provide access for critically ill patients. The objective of this study was to describe the structure, practice patterns, and outcomes of these vascular access teams during the COVID-19 pandemic.

Methods: We conducted a cross-sectional, self-reported study of central venous access line teams in hospitals afflicted with the COVID-19 pandemic. To participate in the study, hospitals were required to meet one of the following criteria: development of a formal plan for a central venous access line team during the pandemic; implementation of a central venous access line team during the pandemic; placement of central venous access by a designated practice group during the pandemic as part of routine clinical practice; or management of an iatrogenic complication related to central venous access in a patient with COVID-19.

Results: Participants from 60 hospitals in 13 countries contributed data to the study. Central venous line teams were most commonly composed of vascular surgery and general surgery attending physicians and trainees. Twenty sites had 2657 lines placed by their central venous access line team or designated practice group. During that time, there were 11 (0.4%) iatrogenic complications associated with central venous access procedures performed by the line team or group at those 20 sites. Triple lumen catheters, Cordis (Santa Clara, Calif) catheters, and nontunneled hemodialysis catheters were the most common types of central venous lines placed by the teams. Eight (14%) sites reported experience in placing central venous lines in prone, ventilated patients with COVID-19. A dedicated line cart was used by 35 (59%) of the hospitals. Less than 50% (24 [41%]) of the participating sites reported managing thrombosed central lines in COVID-19 patients. Twenty-three of the sites managed 48 iatrogenic complications in patients with COVID-19 (including complications caused by providers outside of the line team or designated practice group).

Conclusions: Implementation of a dedicated central venous access line team during a pandemic or other health care crisis is a way by which physicians trained in central venous access can contribute their expertise to a stressed health care system. A line team composed of physicians with vascular skill sets provides relief to resource-constrained intensive care unit, ward, and emergency medicine teams with a low rate of iatrogenic complications relative to historical reports. We recommend that a plan for central venous access line team implementation be in place for future health care crises.
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http://dx.doi.org/10.1016/j.jvs.2020.06.112DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7362805PMC
October 2020

Association Between Body Mass Index and Perioperative Mortality After Repair of Ruptured Abdominal Aortic Aneurysms.

Vasc Endovascular Surg 2020 Oct 9;54(7):573-578. Epub 2020 Jul 9.

Division of Vascular Surgery, 12250Indiana University School of Medicine, Indianapolis, IN, USA.

Objective: The attempt to repair a ruptured abdominal aortic aneurysm carries a significant risk of perioperative mortality. The relationship between body mass index (BMI) and outcomes after repair of ruptured abdominal aortic aneurysms (AAAs) has not been well defined. We report the association of BMI with outcomes after ruptured AAA repair.

Methods: Patients undergoing ruptured AAA repairs between 2008 and 2017 at 2 tertiary academic centers were included in this retrospective study. Demographics (including BMI), type of repair, length of stay, and admission mortality risk scores were gathered and analyzed using bivariate and multivariate logistic regressions. Adjusted odds ratio (AOR) was reported with 95% CIs and values from the multivariate analysis. The primary outcome was 30-day mortality. Akaike information criterion (AIC) and c-statistics were used to assess the predictive power of models including physiologic score with or without BMI.

Results: A total of 202 patients underwent repair of ruptured AAA. In bivariate relationship, increased BMI was significantly associated with 30-day mortality. With multivariate analysis, adjusting for demographics, type of procedure, and physiologic score, for each kg/m increase in BMI, an 8% increase in the likelihood of perioperative mortality (AOR = 1.08, 95% CI: 1.01-1.17; = .04) was observed.

Conclusion: When adjusted for admission risk score, type of procedure, and demographics, obesity was associated with increased 30-day mortality. With BMI as an additional data point, the c-statistics and AIC comparisons indicated that we would have a greater ability to preoperatively estimate mortality after ruptured AAA repair. Consideration could be made to include BMI in future mortality risk scoring systems for ruptured AAA.
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http://dx.doi.org/10.1177/1538574420939356DOI Listing
October 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

Perioperative and Long-term Results of Zenith Fenestrated Aortic Repair in Women.

Ann Vasc Surg 2020 Oct 29;68:44-49. Epub 2020 May 29.

Division of Vascular Surgery, Department of Surgery, Indiana University School of Medicine, Indianapolis, IN. Electronic address:

Background: Inferior perioperative outcomes for women receiving major vascular surgery are well established in the literature in multiple arterial distributions. Therefore, this study was completed to determine the perioperative and durability results associated with women undergoing complex aortic reconstruction using the Zenith Fenestrated platform (ZFEN; Cook Medical, Bloomington, IN).

Methods: A retrospective review of a fenestrated endovascular aortic repair (FEVAR) database capturing all ZFENs performed at our institution between October 2012 and March 2019 was completed. Preoperative, intraoperative, perioperative, and follow-up outcomes were tabulated for females and compared with their male counterparts.

Results: Within our study period, 136 total ZFEN procedures were performed; of which, 20 devices (14.7%) were implanted in women. Intraoperatively, we observed a higher rate of estimated blood loss (660.0 mL vs. 311.6 mL, P < 0.01) and resultant need for transfusion (1.4 vs. 0.3 units, P < 0.01) in women despite a similar frequency of brachial (5.0% vs. 7.8%, P > 0.99) and femoral artery cutdowns (55.0% vs. 49.1%, P = 0.81). Operative (295.7 min vs. 215.7 mins, P < 0.01) and fluoroscopy (84.3 vs. 58.7 min, P < 0.01) times were also significantly higher in females than those in their male counterparts. In the perioperative (30-day) period, we observed significantly longer length of stay (5.6 days vs. 3.3 days, P = 0.03) and continued need for transfusion (50% vs. 9.5%, P < 0.01) in women. Statistical trends favoring men were also noted with respect to all-cause mortality, reintervention, visceral stent thrombosis, renal failure, acute kidney injury, and respiratory failure. After a mean follow-up of nearly 2 years, we found no differences in late all-cause or aneurysm-related mortality, major adverse cardiovascular events, or need for reinterventions.

Conclusions: The implantation of ZFEN in females is significantly more difficult than that in their male counterparts and may result in increased perioperative, but not necessarily long-term, complications.
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http://dx.doi.org/10.1016/j.avsg.2020.05.036DOI Listing
October 2020

Treatment of Carotid Restenosis Using Transcarotid Revascularization.

Vasc Endovascular Surg 2020 Jul 12;54(5):436-440. Epub 2020 May 12.

Division of Vascular Surgery, Department of Surgery, Indiana University School of Medicine, Indianapolis, IN, USA.

Objective: Transcarotid artery revascularization (TCAR) using the ENROUTE Neuroprotection System (Silk Road Medical) is a United States Food and Drug Administration-approved treatment modality for stroke risk reduction in the setting of carotid artery stenosis. The goal of this investigation was to define the real-world outcomes associated with the application of this technique to patients presenting with restenosis after previous carotid endarterectomy (CEA) or transfemoral carotid artery stenting (TF-CAS).

Methods: Retrospective review of prospectively maintained institutional databases capturing all nontrial TCARs performed between August 2013 and July 2018 using the ENROUTE Neuroprotection System was completed at 3 unaffiliated hospital systems and unified for descriptive outcomes analysis.

Results: During the study period, 237 combined TCARs were performed at our respective institutions. Of these procedures, 55 stents were implanted for the indication of restenosis after previous carotid revascularization (47 CEA, 8 TF-CAS). Within the 30-day perioperative period, we observed no ipsilateral strokes or deaths; one patient experienced perioperative myocardial infarction (MI; 1.8%). We noted a 4.8% incidence of postoperative hematoma, but none of these events were clinically significant as no reinterventions were performed in any of the 55 patients. Additionally, we did not observe any cases of stent thrombosis or pulmonary embolus. Mean length of stay was 2.2 ± 2.8 days. Our mean follow-up duration was 15.0 ± 9.2 months. Throughout the follow-up period, we did not observe any additional stroke or MI events. Additionally, there were no cases of in-stent restenosis, thrombosis, or reinterventions.

Conclusion: Transcarotid artery revascularization can be performed in patients with restenotic carotid arteries with acceptable rates of ipsilateral stroke, MI, and death as demonstrated in this small multi-institutional series.
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http://dx.doi.org/10.1177/1538574420923815DOI Listing
July 2020

Endovascular Therapy for Spontaneous Ilio-Iliac Arteriovenous Fistula Due To Iliac Artery Aneurysm Rupture With Multi-Organ Dysfunction.

Vasc Endovascular Surg 2020 Aug 6;54(6):519-524. Epub 2020 May 6.

Division of Vascular Surgery, Indiana University School of Medicine, Indianapolis, IN, USA.

Iliac artery aneurysms can rarely present with rupture into adjacent iliac vein resulting in arteriovenous fistula leading to acute cardiac failure or multi-organ failure. End-organ damage can be reversed with timely diagnosis and intervention. Endovascular therapy is an attractive option to treat this pathology besides allowing for a quick recovery and mitigating the risk of mortality associated with open surgical treatment options. We report treatment of this pathology with Endovascular repair with preservation of ipsilateral hypogastric artery flow using an iliac branch graft device. The postoperative course was complicated by type 3 endoleak due to the separation of components between iliac branch graft and aortic stent graft with resultant recurrence of the fistula. Additional endovascular techniques, including placement of a venous stent and stent grafts to bridge the components, was used to treat the endoleak. We present this report due to the unique nature of the recurrent arteriovenous fistula, technical complexity, and resultant multi-organ dysfunction.
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http://dx.doi.org/10.1177/1538574420923833DOI Listing
August 2020

Perioperative and 1-year transcarotid revascularization outcomes in symptomatic patients.

J Vasc Surg 2020 Dec 21;72(6):2047-2053. Epub 2020 Apr 21.

Division of Vascular Surgery, Department of Surgery, Indiana University School of Medicine, Indianapolis, Ind. Electronic address:

Objective: Previously published results of carotid revascularization with both transfemoral stenting and endarterectomy have demonstrated inferior perioperative stroke and death outcomes in neurologically symptomatic patients compared with those without symptoms. This study was completed to establish the real-world, symptom-based perioperative and follow-up outcomes for transcarotid artery revascularization (TCAR).

Methods: An institutional retrospective review of all TCARs performed outside of clinical trial regulations from 2016 to 2019 was completed. Eligible patients were classified as symptomatic or not based on a history of a unilateral neurologic deficit attributable to an extracranial carotid artery lesion within the previous 180 days. Univariate analysis consisting of Fisher's exact and Student t-tests, as appropriate, were performed between cohorts. Kaplan-Meier analysis was completed to estimate the stroke-free survival at 1 year postoperatively.

Results: Within the investigational period, 167 patients (85 symptomatic) qualified for study inclusion. Baseline demographics were roughly equivalent, although symptomatic patients were more likely to be female (28.0% vs 9.4%; P < .01). Procedures in symptomatic patients were associated with higher estimated blood loss (41 mL vs 58 mL; P = .04) and operative time (67 minutes vs 75 minutes; P = .06). We did not find an increased incidence of macroscopic debris in the filter of symptomatic patients after stent deployment. For symptomatic patients, we observed a perioperative (30-day) ipsilateral stroke risk of 1.2% (vs 2.4% in asymptomatic patients; P > .99), a myocardial infarction risk of 0% (vs 0%; P > .99), and a mortality risk of 4.9% (vs 0%; P = .06). Most deaths occurred after procedure-related discharge; as such, in-hospital (from index TCAR) mortality in symptomatic patients was 1.2%. The four perioperative deaths observed in our population were secondary to hemorrhagic stroke, acute on chronic congestive heart failure (n = 2), and unknown causes in the last patient. At 1 year after the procedure, 114 patients (54 symptomatic) had available data. In addition to the perioperative risks, in symptomatic patients we observed a rate of reintervention of 0% (vs 0%; P > .99), ipsilateral stroke of 3.7% (vs 0%; P = .22), >50% in-stent restenosis of 1.9% (vs 0%; P = .47), stent thrombosis of 3.7% (vs 0%; P = .22), and all-cause mortality of 13.0% (vs 10.0%; P = .77). Last, no difference was noted with respect to the 1-year stroke-free survival (P = .17) by Kaplan-Meier estimates.

Conclusions: In this institutional series of patients undergoing TCAR, we found that symptomatic patients have a similar perioperative risk of stroke and myocardial infarction as asymptomatic patients. However, we did observe a strong statistical trend suggesting a higher mortality risk in symptomatic patients. There was no difference between cohorts with respect to 1-year stroke-free survival.
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http://dx.doi.org/10.1016/j.jvs.2020.03.044DOI Listing
December 2020

Endovascular Treatment of a Persistent Traumatic Deep Femoral Arteriovenous Fistula After Gunshot Injury.

Vasc Endovascular Surg 2020 Jul 15;54(5):441-444. Epub 2020 Apr 15.

Division of Vascular Surgery, Department of Surgery, Indiana University School of Medicine, Indianapolis, IN, USA.

This article describes a deep femoral arteriovenous fistula (AVF) diagnosed over a decade after a small caliber gunshot injury to the groin. The fistula persisted following 2 previous attempts at endovascular exclusion and was referred to our institution for further care. We describe the successful exclusion of the AVF via a combination of endovascular techniques. Postoperatively, obliteration was noted to be durable for 4 additional years of follow-up.
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http://dx.doi.org/10.1177/1538574420918970DOI Listing
July 2020

Protamine use in transcarotid artery revascularization is associated with lower risk of bleeding complications without higher risk of thromboembolic events.

J Vasc Surg 2020 Dec 6;72(6):2079-2087. Epub 2020 Apr 6.

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

Objective: Recent studies have found that transcarotid artery revascularization (TCAR) is associated with lower risk of stroke or death compared with transfemoral carotid artery stenting but higher risk of bleeding complications, presumably associated with the need for an incision. Heparin anticoagulation is universally used during TCAR, so protamine use may reduce bleeding complications. However, the safety and effectiveness of protamine use in TCAR are unknown. We therefore evaluated the impact of protamine use on perioperative outcomes after TCAR in the Vascular Quality Initiative TCAR Surveillance Project.

Methods: We performed a retrospective review of patients undergoing TCAR in the Vascular Quality Initiative TCAR Surveillance Project from September 2016 to April 2019. We assessed in-hospital outcomes using propensity score-matched cohorts of patients who did and did not receive protamine. The primary efficacy end point was access site bleeding complications, and the primary safety end point was in-hospital stroke or death. Secondary end points included the individual end points of stroke, death, transient ischemic attack, myocardial infarction, congestive heart failure exacerbation, and hemodynamic instability.

Results: Of the 5144 patients undergoing TCAR, all patients received heparin and 4072 (79%) patients received protamine. We identified 944 matched pairs of patients who did and did not receive protamine. Protamine use was associated with a significantly lower risk of bleeding complications (2.8% vs 8.3%; relative risk [RR], 0.33; 95% confidence interval [CI], 0.21-0.52; P < .001), including bleeding that resulted in interventional treatment (1.0% vs 3.6%; RR, 0.26; 95% CI, 0.13-0.54; P < .001) and in blood transfusion (1.2% vs 3.9%; RR, 0.30; 95% CI, 0.15-0.58; P <.001). There were no statistically significant differences in in-hospital stroke or death for patients who received protamine and those who did not (1.6% vs 2.2%; RR, 0.71; 95% CI, 0.37-1.39; P = .32); however, there was a trend toward lower risk of stroke for patients who received protamine (1.1% vs 2.0%; RR, 0.53; 95% CI, 0.24-1.13; P = .09). There were also no statistically significant differences in the rates of transient ischemic attack (0.4% vs 1.1%; RR, 0.40; 95% CI, 0.13-1.28; P = .11), myocardial infarction (0.4% vs 0.8%; RR, 0.50; 95% CI, 0.15-1.66; P = .25), heart failure exacerbation (0.4% vs 0.3%; RR, 1.33; 95% CI, 0.30-5.96; P = .71), or postoperative hypotensive hemodynamic instability (16% vs 15%; RR, 1.06; 95% CI, 0.83-1.35; P = .50) with protamine use.

Conclusions: Protamine can be safely used in TCAR to reduce the risk of perioperative bleeding complications without increasing the risk of thrombotic events.
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http://dx.doi.org/10.1016/j.jvs.2020.02.019DOI Listing
December 2020

Propensity-Matched Outcomes of Transcarotid Artery Revascularization Versus Carotid Endarterectomy.

J Surg Res 2020 08 26;252:22-29. Epub 2020 Mar 26.

Division of Vascular Surgery, Department of Surgery, Indiana University School of Medicine, Indianapolis, Indiana. Electronic address:

Background: Transcarotid artery revascularization (TCAR) with cerebral flow reversal is an emerging treatment option for carotid artery stenosis in patients with high risk for traditional endarterectomy. The purpose of this study was to compare real-world, procedure-related outcomes in similarly comorbid patients undergoing TCAR or carotid endarterectomy (CEA).

Methods: A retrospective review of all patients receiving either TCAR or CEA outside of clinical trial regulations at our institution was performed. Participants were propensity-matched by age, gender, body mass index, smoking status, presence of restenosis, history of neck radiation, presence of contralateral carotid occlusion, history of previous neck dissection, and symptom status. Bivariate analysis was followed by a penalized Firth logistic regression to compare treatments.

Results: Between January 2011 and July 2018, 342 CEAs and 109 TCARs were captured for analysis. After matching, 87 distinct treatment pairs were created without evidence of variation in any of the prespecified variables. On multivariate analysis using maximum and penalized likelihood ratios, we found that TCAR was associated with an increased incidence of intraoperative hypertension (adjusted coefficient, 1.41; 95% confidence interval [0.53, 2.29], P < 0.01). TCAR was also associated with decreased reverse flow/clamp time (mins; -36.80; [-45.47, -27.93], P < 0.01) and estimated blood loss (mLs; -63.66; [-85.91, -41.42], P < 0.01). In the perioperative period, there were no differences between TCAR and CEA with respect to myocardial infarction (-0.04; [-3.68, 3.60], P = 0.98), stroke (-0.74; [-2.68, 1.19], P = 0.45), and all-cause mortality (1.09; [-1.76, 3.94], P = 0.11). Similarly, a composite incidence of stroke/death was the same between cohorts (2.42; [-0.57, 5.41], P = 0.11).

Conclusions: This propensity-matched analysis of carotid artery revascularization modalities suggests that TCAR is equivalent to CEA in the perioperative period while incurring shorter operative time and less blood loss.
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http://dx.doi.org/10.1016/j.jss.2019.12.003DOI Listing
August 2020

Treatment of superficial and perforator reflux and deep venous stenosis improves healing of chronic venous leg ulcers.

J Vasc Surg Venous Lymphat Disord 2020 07 21;8(4):601-609. Epub 2020 Feb 21.

Division of Vascular Surgery, Department of Surgery, Indiana University, Indianapolis, Ind.

Objective: To evaluate the impact of three treatment modalities, superficial truncal vein ablation, perforator vein ablation, and deep venous stenting on venous leg ulcer (VLU) healing, as well as their cumulative effect on ulcer healing, in an attempt to establish the best algorithm for the treatment of chronic and recalcitrant VLUs.

Methods: Multicenter retrospective cohort study using a standardized database to evaluate patients with chronic venous ulcers treated between January 2013 and December 2017.

Results: Eight-hundred thirty-two consecutive patients with VLU were identified at 11 centers in the United States. All patients were initially managed with wound care and compression for at least 2 months. Compression and wound care management alone, used in 187 patients, led to ulcer healing in 75% of patients by 36 months. Ulcer recurrence in patients managed without surgery at 6, 12, and 24 months was 3%, 5% and 15%, respectively. Five hundred twenty-eight patients underwent ablation of incompetent superficial veins, and 344 of those also underwent incompetent perforator ablation. Patients who underwent truncal vein ablation alone had an ulcer healing rate of 51% at 36 months. Patients who received both superficial and perforator ablation were significantly younger, and had a 17% improvement in healing at 36 months (68% vs 51%, respectively), but there was no impact of combined superficial and perforator ablations on ulcer recurrence rates. One hundred thirty-four patients had stenosis of one of more lower extremity deep veins and 95 (71%) underwent endovenous stenting. Ulcer healing and recurrence rates for those who underwent stent placement alone was 77% and 27%, respectively, at 36 months. Patients who underwent deep venous stenting and ablation of both incompetent truncal and perforator veins had an ulcer healing rate of 87% at 36 months and ulcer recurrence of 26% at 24 months.

Conclusions: This study demonstrates that correction of superficial truncal vein reflux, as well as deep vein stenosis, both contribute to healing of VLU. Patients who fail to heal their VLU after superficial and perforator ablation should have the iliocaval system imaged to identify hemodynamically significant stenoses or occlusions amenable to stenting, which facilitates venous ulcer healing even in patients with large ulcers.
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http://dx.doi.org/10.1016/j.jvsv.2019.09.016DOI Listing
July 2020

Duration of blood flow reversal during transcarotid artery revascularization does not affect outcome.

J Vasc Surg 2020 08 31;72(2):584-588. Epub 2019 Dec 31.

Harrington Heart & Vascular Institute, University Hospitals Cleveland Medical Center, Cleveland, Ohio.

Objective: Transcarotid artery revascularization (TCAR) has become an increasingly popular alternative for the treatment of carotid bifurcation stenosis. TCAR employs carotid blood flow reversal through an ex vivo common carotid artery to femoral vein shunt for neuroprotection during the placement and angioplasty of the carotid artery stent. There is a lack of data regarding an association between the duration of flow reversal and neurologic complications or other adverse events. We analyzed TCAR flow reversal time in relation to major adverse events.

Methods: There were 307 patients who underwent TCAR at four high-volume academic institutions. Patients were separated on the basis of the duration of carotid flow reversal as follows: group I, ≤8 minutes (n = 138); group II, 9-13 minutes (n = 105); group III, 14-20 minutes (n = 42); and group IV, >20 minutes (n = 22). Adverse events including stroke (assessed by a National Institute of Health Stroke Scale-certified examiner), myocardial infarction (MI), and death at discharge and 30 days were collected in all patients and were compared between groups using one-way analysis of variance and χ analysis.

Results: There were four strokes in the total cohort, yielding an overall stroke rate of 1.3%. All strokes were minor in nature; two were ipsilateral and two were contralateral. All patients demonstrated full recovery at 30 days. We found no significant difference in the stroke rate between any of the groups: I, 1.5% (2/138); II, 1.9% (2/105); III, 0% (0/42); and IV, 0% (0/22; P = .76). The four strokes occurred in patients with flow reversal time of 6, 7, 11, and 12 minutes. There was also no difference in the 30-day composite stroke/death or stroke/death/MI rates among the groups.

Conclusions: The length of flow reversal during TCAR does not affect rates of stroke, MI, or death. These data suggest that operators should focus on the technical aspects of the procedure during flow reversal rather than on its duration.
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http://dx.doi.org/10.1016/j.jvs.2019.10.092DOI Listing
August 2020

Association of Transcarotid Artery Revascularization vs Transfemoral Carotid Artery Stenting With Stroke or Death Among Patients With Carotid Artery Stenosis.

JAMA 2019 12;322(23):2313-2322

Division of Vascular and Endovascular Surgery, Department of Surgery, University of California San Diego Health System, San Diego.

Importance: Several trials have observed higher rates of perioperative stroke following transfemoral carotid artery stenting compared with carotid endarterectomy. Transcarotid artery revascularization with flow reversal was recently introduced for carotid stenting. This technique was developed to decrease stroke risk seen with the transfemoral approach; however, its outcomes, compared with transfemoral carotid artery stenting, are not well characterized.

Objective: To compare outcomes associated with transcarotid artery revascularization and transfemoral carotid artery stenting.

Design, Setting, And Participants: Exploratory propensity score-matched analysis of prospectively collected data from the Vascular Quality Initiative Transcarotid Artery Surveillance Project and Carotid Stent Registry of asymptomatic and symptomatic patients in the United States and Canada undergoing transcarotid artery revascularization and transfemoral carotid artery stenting for carotid artery stenosis, from September 2016 to April 2019. The final date for follow-up was May 29, 2019.

Exposures: Transcarotid artery revascularization vs transfemoral carotid artery stenting.

Main Outcomes And Measures: Outcomes included a composite end point of in-hospital stroke or death, stroke, death, myocardial infarction, as well as ipsilateral stroke or death at 1 year. In-hospital stroke was defined as ipsilateral or contralateral, cortical or vertebrobasilar, and ischemic or hemorrhagic stroke. Death was all-cause mortality.

Results: During the study period, 5251 patients underwent transcarotid artery revascularization and 6640 patients underwent transfemoral carotid artery stenting. After matching, 3286 pairs of patients who underwent transcarotid artery revascularization or transfemoral carotid artery stenting were identified (transcarotid approach: mean [SD] age, 71.7 [9.8] years; 35.7% women; transfemoral approach: mean [SD] age, 71.6 [9.3] years; 35.1% women). Transcarotid artery revascularization was associated with a lower risk of in-hospital stroke or death (1.6% vs 3.1%; absolute difference, -1.52% [95% CI, -2.29% to -0.75%]; relative risk [RR], 0.51 [95% CI, 0.37 to 0.72]; P < .001), stroke (1.3% vs 2.4%; absolute difference, -1.10% [95% CI, -1.79% to -0.41%]; RR, 0.54 [95% CI, 0.38 to 0.79]; P = .001), and death (0.4% vs 1.0%; absolute difference, -0.55% [95% CI, -0.98% to -0.11%]; RR, 0.44 [95% CI, 0.23 to 0.82]; P = .008). There was no statistically significant difference in the risk of perioperative myocardial infarction between the 2 cohorts (0.2% for transcarotid vs 0.3% for the transfemoral approach; absolute difference, -0.09% [95% CI, -0.37% to 0.19%]; RR, 0.70 [95% CI, 0.27 to 1.84]; P = .47). At 1 year using Kaplan-Meier life-table estimation, the transcarotid approach was associated with a lower risk of ipsilateral stroke or death (5.1% vs 9.6%; hazard ratio, 0.52 [95% CI, 0.41 to 0.66]; P < .001). Transcarotid artery revascularization was associated with higher risk of access site complication resulting in interventional treatment (1.3% vs 0.8%; absolute difference, 0.52% [95% CI, -0.01% to 1.04%]; RR, 1.63 [95% CI, 1.02 to 2.61]; P = .04), whereas transfemoral carotid artery stenting was associated with more radiation (median fluoroscopy time, 5 minutes [interquartile range {IQR}, 3 to 7] vs 16 minutes [IQR, 11 to 23]; P < .001) and more contrast (median contrast used, 30 mL [IQR, 20 to 45] vs 80 mL [IQR, 55 to 122]; P < .001).

Conclusions And Relevance: Among patients undergoing treatment for carotid stenosis, transcarotid artery revascularization, compared with transfemoral carotid artery stenting, was significantly associated with a lower risk of stroke or death.
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http://dx.doi.org/10.1001/jama.2019.18441DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6990823PMC
December 2019

Novel Application of Transcarotid Artery Stenting With Dynamic Flow Reversal for Treatment of Symptomatic Tandem Carotid Artery Lesions Via an Ascending Aorta to Common Carotid Artery Bypass Graft.

Vasc Endovascular Surg 2019 Nov 15;53(8):665-669. Epub 2019 Aug 15.

Division of Vascular Surgery, Department of Surgery, Indiana University School of Medicine, Indianapolis, IN, USA.

The treatment of patients with symptomatic tandem lesions of their carotid artery is challenging. One solution is carotid endarterectomy with retrograde ipsilateral proximal endovascular intervention, but it is associated with a higher postoperative risk of stroke. Unfortunately, symptomatic patients with tandem lesions often present with stenotic, calcified supra-aortic arch vessels and require multiple modalities to adequately revascularize including staged approaches or hybrid procedures. Herein, we report the successful treatment of a symptomatic 76-year-old female with a calcific severe stenosis of her innominate artery treated by a prosthetic bypass graft from her ascending aorta to proximal common carotid artery, interval ligation, and use of TransCarotid artery revascularization with reverse-flow to treat her proximal internal carotid artery stenosis via this bypass graft.
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http://dx.doi.org/10.1177/1538574419869569DOI Listing
November 2019

Procedural Complexity of TransCarotid Artery Revascularization Is Not Increased in Irradiated and Reoperative Necks.

Ann Vasc Surg 2019 Nov 5;61:212-217. Epub 2019 Aug 5.

Division of Vascular Surgery, Department of Surgery, Indiana University School of Medicine, Indianapolis, IN. Electronic address:

Background: TransCarotid Revascularization (TCAR) with dynamic flow reversal using the ENROUTE Neuroprotection System (ENPS) is a Food and Drug Administration-approved alternative carotid revascularization modality. The purpose of this investigation was to determine whether TCAR in a hostile (fibrotic) surgical field increases procedural complexity and postoperative complications.

Methods: Perioperative variables for all institutional TCARs performed between December 2015 and April 2019 were prospectively captured. Procedures performed as part of the ongoing ROADSTER-2 registry were excluded. Univariate analysis, consisting of Student's T and Fisher's exact testing, comparing virgin and hostile neck TCAR, was performed at an alpha of 0.05.

Results: During the study period, 149 total procedures (n = 30, hostile ipsilateral necks) qualified for inclusion. Both hostile and virgin neck groups were comparable with respect to preoperative comorbidities and medication profiles. The ipsilateral hostile neck cohort consisted of ten patients who underwent previous ipsilateral neck radiation and 23 who were status after neck dissection (3 had both). Intraoperatively, there were no differences with respect to estimated blood loss (47.2 vs. 44.8 mL, P = 0.81), operative time (69.5 vs. 74.5 min, P = 0.38), reverse flow time (12.4 vs. 10.4 min, P = 0.34), radiation exposure (217.7 vs. 226.2 mGy, P = 0.88), fluoroscopy time (5.4 vs. 5.0 min, P = 0.65), contrast usage (23.5 vs. 25.0 mL, P = 0.55), and ability to achieve technical success (96.7% vs. 100%, P = 0.58) between virgin and hostile necks, respectively. Perioperative (30-day) ipsilateral stroke and death rate was 2.5% vs. 0% (P = 1.0) and 2.5% vs. 0% (P = 1.0), respectively, between virgin and hostile necks. We observed one postoperative cranial nerve injury in any of our TCAR patients (hostile neck, P = 0.20). Finally, a total of 3 hematomas (requiring washout) occurred in our (2 in virgin necks and one in a hostile neck) surgical cohort (P = 0.49).

Conclusions: Based on this limited, small series, TCAR in hostile surgical fields is not associated with an increase in case complexity and maintains a similar perioperative risk to virgin field procedures.
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http://dx.doi.org/10.1016/j.avsg.2019.05.063DOI Listing
November 2019

Combined transbrachial and transfemoral strategy to deploy an iliac branch endoprosthesis in the setting of a pre-existing endovascular aortic aneurysm repair.

J Vasc Surg Cases Innov Tech 2019 Sep 29;5(3):305-309. Epub 2019 Jun 29.

Division of Vascular Surgery, Department of Surgery, Indiana University School of Medicine, Indianapolis, Ind.

This article describes brachial access to position a long sheath in the abdominal aorta in conjunction with a large caliber sheath via the femoral artery ipsilateral to the target site to deliver a 0.018 bodyfloss wire. This bodyfloss wire is inserted into the precannulation port of the iliac branch endoprosthesis (W. L. Gore and Associates, Flagstaff, Ariz), which is then advanced from the groin. Once the bifurcated device is deployed, hypogastric access and stenting is achieved from the upper extremity. This technique is an alternative to safely extend the distal seal while preserving the hypogastric artery and has the advantage of limited iliac bifurcation manipulation.
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http://dx.doi.org/10.1016/j.jvscit.2019.03.007DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6614596PMC
September 2019

Management of Unusual Proximal Radial Artery Aneurysm.

Vasc Endovascular Surg 2019 Jul 26;53(5):411-414. Epub 2019 Mar 26.

1 Division of Vascular Surgery, Indiana University School of Medicine, Indianapolis, IN, USA.

Distal upper extremity arterial aneurysms are rare with only a few case reports and small retrospective studies described. Most aneurysms are secondary to trauma making idiopathic aneurysms an especially rare disease process. An 83-year-old male presented with a painful pulsatile mass that was confirmed with ultrasound and computed tomography angiogram as a 2.0 × 1.5 cm radial artery aneurysm. He had successful aneurysm resection and primary repair. Histopathology confirmed a true aneurysm. This case report demonstrates successful excision and repair of this rare pathology. This case is been reported more for its rarity than complexity of the treatment.
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http://dx.doi.org/10.1177/1538574419839261DOI Listing
July 2019

Use of PET-CT Imaging to Identify Femoral-Popliteal Stent Infection .

Vasc Endovascular Surg 2019 05 5;53(4):341-342. Epub 2019 Mar 5.

1 Indiana University School of Medicine, Indianapolis, IN, USA   .

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http://dx.doi.org/10.1177/1538574419831479DOI Listing
May 2019

Spontaneous Iliac Vein Rupture Due to May-Thurner Syndrome and Its Staged Management.

Vasc Endovascular Surg 2019 May 19;53(4):348-350. Epub 2019 Feb 19.

1 Division of Vascular Surgery, Indiana University School of Medicine, Indianapolis, IN, USA.

We present a case of a 58-year-old otherwise healthy women who presented with left lower extremity deep venous thrombosis and was found to have pulmonary embolism along with a ruptured left internal iliac vein. Our patient was hemodynamically stable upon presentation; therefore, a staged approach was undertaken. Initially, an inferior vena cava filter was placed and the patient was slowly advanced to therapeutic anticoagulation and subsequently discharged. She then returned 2 weeks after discharge for venogram, mechanical thrombectomy, and stenting. At 1-year follow-up in clinic, she was found to have patent stents and resolution of symptoms.
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http://dx.doi.org/10.1177/1538574419831488DOI Listing
May 2019

Aggressive Surveillance Is Needed to Detect Endoleaks and Junctional Separation between Device Components after Zenith Fenestrated Aortic Reconstruction.

Ann Vasc Surg 2019 May 24;57:129-136. Epub 2019 Jan 24.

Department of Surgery, Division of Vascular Surgery, Indiana University School of Medicine, Indianapolis, IN. Electronic address:

Background: Junctional separation and resulting type IIIa endoleak is a well-known problem after EVAR (endovascular aneurysm repair). This complication results in sac pressurization, enlargement, and eventual rupture. In this manuscript, we review the incidence of this late finding in our experience with the Cook Zenith fenestrated endoprosthesis (ZFEN, Bloomington, IN).

Methods: A retrospective review was performed of a prospectively maintained institutional ZFEN fenestrated EVAR database capturing all ZFENs implanted at a large-volume, academic hospital system. Patients who experienced junctional separation between the fenestrated main body and distal bifurcated graft (with or without type IIIa endoleak) at any time after initial endoprosthesis implantation were subject to further evaluation of imaging and medical records to abstract clinical courses.

Results: In 110 ZFENs implanted from October 2012 to December 2017 followed for a mean of 1.5 years, we observed a 4.5% and 2.7% incidence of clinically significant junctional separation and type IIIa endoleak, respectively. Junctional separation was directly related to concurrent type Ib endoleak in all 5 patients. Three patients presented with sac enlargement. One patient did not demonstrate any evidence of clinically significant endoleak and had a decreasing sac size during follow-up imaging. The mean time to diagnosis of modular separation in these patients was 40 months. Junctional separation was captured in surveillance in 2 patients and reintervened upon before manifestation of endoleak. However, the remaining 3 patients completed modular separation resulting in rupture and emergent intervention in 2 and an aortic-related mortality in the other.

Conclusions: Junctional separation between the fenestrated main and distal bifurcated body with the potential for type IIIa endoleak is an established complication associated with the ZFEN platform. Therefore, we advocate for maximizing aortic overlap during the index procedure followed by aggressive surveillance and treatment of stent overlap loss captured on imaging.
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http://dx.doi.org/10.1016/j.avsg.2018.09.038DOI Listing
May 2019