Publications by authors named "Denis Rybin"

180 Publications

Detonation Spraying of Hydroxyapatite on a Titanium Alloy Implant.

Materials (Basel) 2021 Aug 26;14(17). Epub 2021 Aug 26.

Lavrentyev Institute of Hydrodynamics, Siberian Branch of the Russian Academy of Sciences, Lavrentyev Ave. 15, 630090 Novosibirsk, Russia.

Hydroxyapatite (HA), the major mineral component of tooth enamel and natural bones, is a good candidate for bone tissue engineering. Synthetic HA is used for making coatings on metallic implants intended for medical applications. A HA coating renders the implant biocompatible and osteoinductive. In addition, it improves fixation and the overall performance of the implanted object. In the present work, HA coatings were deposited on a medical titanium alloy implant with mesh geometry and a developed surface by detonation spraying. The feedstock powder was HA obtained by the dry mechanochemical method. Single-phase HA coatings were obtained. The coatings were formed not only on the surfaces normal to the particle flow direction, but also on the sides of the mesh elements. Despite partial melting of the powder, no decomposition of HA occurred. This work demonstrates the prospects of detonation spraying for the production of HA coatings on metallic implants with complex geometries.
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http://dx.doi.org/10.3390/ma14174852DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8432648PMC
August 2021

The Association of Body Mass Index with Outcomes after Carotid Endarterectomy.

Ann Vasc Surg 2021 Aug 23. Epub 2021 Aug 23.

Department of Biostatistics, Boston University School of Public Health, Boston, MA. Electronic address:

Background: Patients who are obese or underweight are traditionally at higher risk for perioperative morbidity and mortality. The effect of body mass index (BMI) on outcomes after carotid endarterectomy (CEA) is unclear. Our goal was to analyze the association of BMI with perioperative and long-term outcomes after elective CEA.

Methods: The Vascular Quality Initiative (VQI) database was queried from 2003-2018 for patients undergoing elective CEAs. Patients were categorized into 5 BMI cohorts - underweight (UW, BMI < 18.5 kg/m), normal weight (NW, BMI 18.5-24.9 kg/m), overweight (OW, BMI 25-29.9 kg/m), obese (OB, BMI 30-39.9 kg/m), and morbidly obese (MO, BMI ≥ 40 kg/m). Perioperative and long-term outcomes were assessed with univariable and multivariable analyses.

Results: There were 89,079 patients included: 2% UW, 26% NW, 38.4% OW, 29.9% OB, and 3.6% MO. Overall, the mean age was 70.6 years, 60% were male, and 91.8% were of white race. There were significant differences among the BMI cohorts in regards to age, sex, smoking status, and comorbidities (all P < 0.05). For perioperative outcomes, the BMI cohorts differed significantly in reoperation for bleeding and 30-day mortality. On multivariable analysis, BMI was not associated with stroke or perioperative mortality. MO was associated with perioperative cardiac complications (Odds Ratios [OR] 1.26, 95% CI 1-1.57, P = 0.05). UW status was associated with increased return to the operating room (OR 1.89, 95% confidence interval [95% CI] 1.28-2.78, P = 0.001), 30-day mortality (OR 1.68, 95% CI 1-2.86, P =0.05), 1-year mortality (Hazard ratio [HR] 1.37, 95% CI 1.08-1.74, P = 0.01), and 5-year mortality (HR 1.22, 95% CI 1.06-1.41, P =0.005).

Conclusions: BMI status was not associated with perioperative stroke, cranial nerve injury, or surgical site infections. Patients with MO had higher perioperative cardiac complications. UW patients have lower short and long-term survival and should be a focus for long-term targeted risk factor stratification and modification.
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http://dx.doi.org/10.1016/j.avsg.2021.05.046DOI Listing
August 2021

The trans-ancestral genomic architecture of glycemic traits.

Nat Genet 2021 06 31;53(6):840-860. Epub 2021 May 31.

Department of Epidemiology, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands.

Glycemic traits are used to diagnose and monitor type 2 diabetes and cardiometabolic health. To date, most genetic studies of glycemic traits have focused on individuals of European ancestry. Here we aggregated genome-wide association studies comprising up to 281,416 individuals without diabetes (30% non-European ancestry) for whom fasting glucose, 2-h glucose after an oral glucose challenge, glycated hemoglobin and fasting insulin data were available. Trans-ancestry and single-ancestry meta-analyses identified 242 loci (99 novel; P < 5 × 10), 80% of which had no significant evidence of between-ancestry heterogeneity. Analyses restricted to individuals of European ancestry with equivalent sample size would have led to 24 fewer new loci. Compared with single-ancestry analyses, equivalent-sized trans-ancestry fine-mapping reduced the number of estimated variants in 99% credible sets by a median of 37.5%. Genomic-feature, gene-expression and gene-set analyses revealed distinct biological signatures for each trait, highlighting different underlying biological pathways. Our results increase our understanding of diabetes pathophysiology by using trans-ancestry studies for improved power and resolution.
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http://dx.doi.org/10.1038/s41588-021-00852-9DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7610958PMC
June 2021

Perioperative Outcomes for Centers Routinely Admitting Postoperative Endovascular Aortic Aneurysm Repair to the ICU.

J Am Coll Surg 2021 06 19;232(6):856-863. Epub 2021 Apr 19.

Division of Vascular and Endovascular Surgery, Boston Medical Center, Boston University School of Medicine, Boston, MA. Electronic address:

Background: Intensive care unit (ICU) admission after endovascular aortic aneurysm repair (EVAR) varies across medical centers. We evaluated the association of postoperative ICU use with perioperative and long-term outcomes after EVAR.

Study Design: The Vascular Quality Initiative (2003-2019) was queried for index elective EVARs. Included centers were categorized by percentage of patients with EVARs postoperatively admitted to the ICU; routine ICU (rICU) centers as ≥80% ICU admissions and nonroutine ICU (nrICU) centers as ≤20% ICU admissions. Patients admitted preoperatively or with same day discharge were excluded. Perioperative outcomes and survival were compared between rICU and nrICU centers.

Results: Of 45,310 EVARs in the database, 35,617 were performed at rICU or nrICU centers - 5,443 (15.3%) at 71 rICU centers and 30,174 (84.7%) at 200 nrICU centers. Overall, mean age was 73.4 years and 81.6% were male. Postoperative myocardial infarction, pulmonary complications, stroke, leg ischemia, and in-hospital mortality were similar between rICU and nrICU centers (all p > 0.05). Postoperative length of stay (LOS) was prolonged at rICU centers (mean) (2.2 ± 3.6 vs 2 ± 4.2 days, p < 0.001). One-year survival was similar between rICU and nrICU centers, respectively, (94.9% vs 95.4%, p = 0.085). When compared with nrICU centers, rICU centers had similar 1-year mortality risk (hazard ratio [HR] 1.15, 95% CI 0.99-1.34, p = 0.076), but were associated with longer postoperative LOS (means ratio 1.1, 95% CI 1.08-1.13, p < 0.001).

Conclusions: Routine ICU use after EVAR was associated with prolonged postoperative LOS, without improved perioperative/long-term morbidity or mortality. Updated care pathways to include postoperative admission to lower acuity care units may reduce costs without compromising care.
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http://dx.doi.org/10.1016/j.jamcollsurg.2021.03.035DOI Listing
June 2021

Factor IX assay discrepancies in the setting of liver gene therapy using a hyperfunctional variant factor IX-Padua.

J Thromb Haemost 2021 05 28;19(5):1212-1218. Epub 2021 Mar 28.

Colorado Coagulation, Laboratory Corporation of America Holdings, Englewood, CO, USA.

Background: Limited information exists regarding the factor IX (FIX) coagulant activity (FIX:C) measured by different assays following FIX-Padua gene therapy.

Objective: Assess for the first time FIX:C in five commonly used coagulation assays in plasma samples from hemophilia B subjects receiving FIX-Padua gene transfer.

Methods: FIX:C was compared between central (n = 1) and local laboratories (n = 5) in the study, and across four commonly used FIX:C one-stage assays and one FIX:C chromogenic assay. For comparison, samples of pooled congenital FIX-deficient plasma spiked with purified recombinant human FIX (rHFIX)-Padua protein or rHFIX (nonacog alfa) to obtain FIX:C concentrations from ~20% to ~40% were tested.

Results: FIX:C results at local laboratories strongly correlated with central laboratory results. However, absolute values at the central laboratory were consistently lower than those at local laboratories. Across five different FIX:C assays, a consistent pattern of FIX:C was observed for subjects receiving fidanacogene elaparvovec-expressed gene transfer. Use of Actin FSL activated partial thromboplastin time (APTT) reagent in the central laboratory resulted in lower FIX:C values compared with other APTT reagents tested. The chromogenic assay determined lower FIX:C than any of the one-stage assays. The rHFIX-Padua protein-spiked samples showed similar results. In contrast, FIX:C results for rHFIX-nonacog alfa measured within 25% of expected for all one-stage assays and below 25% in the chromogenic assay.

Conclusions: Assay-based differences in FIX:C were observed for fidanacogene elaparvovec transgene product and rHFIX-Padua protein, suggesting the variable FIX:C determined with different assay reagents is inherent to the FIX-Padua protein and is not specific to gene therapy-derived FIX-Padua.
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http://dx.doi.org/10.1111/jth.15281DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8130854PMC
May 2021

Sex-dimorphic genetic effects and novel loci for fasting glucose and insulin variability.

Nat Commun 2021 01 5;12(1):24. Epub 2021 Jan 5.

Department of Biostatistics and Data Science, Division of Public Health Sciences, Wake Forest University School of Medicine, Winston-Salem, NC, USA.

Differences between sexes contribute to variation in the levels of fasting glucose and insulin. Epidemiological studies established a higher prevalence of impaired fasting glucose in men and impaired glucose tolerance in women, however, the genetic component underlying this phenomenon is not established. We assess sex-dimorphic (73,089/50,404 women and 67,506/47,806 men) and sex-combined (151,188/105,056 individuals) fasting glucose/fasting insulin genetic effects via genome-wide association study meta-analyses in individuals of European descent without diabetes. Here we report sex dimorphism in allelic effects on fasting insulin at IRS1 and ZNF12 loci, the latter showing higher RNA expression in whole blood in women compared to men. We also observe sex-homogeneous effects on fasting glucose at seven novel loci. Fasting insulin in women shows stronger genetic correlations than in men with waist-to-hip ratio and anorexia nervosa. Furthermore, waist-to-hip ratio is causally related to insulin resistance in women, but not in men. These results position dissection of metabolic and glycemic health sex dimorphism as a steppingstone for understanding differences in genetic effects between women and men in related phenotypes.
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http://dx.doi.org/10.1038/s41467-020-19366-9DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7785747PMC
January 2021

The Association of the Day of the Week with Outcomes of Infrainguinal Lower Extremity Bypass.

Ann Vasc Surg 2021 May 25;73:43-50. Epub 2020 Dec 25.

Division of Vascular and Endovascular Surgery, Boston Medical Center, Boston University School of Medicine, Boston, MA. Electronic address:

Background: The day of the week (DOW) for performing procedures and operations has been shown to affect clinical and resource utilization outcomes. Limited published data are available on vascular surgery operations. Our primary objective was to assess outcomes by DOW for infrainguinal lower extremity bypass (LEB) performed for claudication or rest pain. The secondary objective was to assess outcomes by DOW for LEBs performed for tissue loss.

Methods: The Vascular Quality Initiative was queried from 2003 to 2018 for all elective index infrainguinal LEBs performed for claudication or rest pain. Cases performed for acute limb ischemia as well as concomitant peripheral vascular intervention, nonelective LEBs, sequential grafts, and weekend cases were excluded. LEBs were grouped by DOW: Monday-Tuesday (early weekdays) versus Wednesday-Friday (later weekdays). Baseline data, operative details, and outcomes were collected. Univariate and multivariable analyses were performed. LEBs performed for claudication/rest pain were analyzed together while tissue loss was assessed separately.

Results: There were 12,084 LEBs identified-44.5% performed on Monday-Tuesday and 55.5% on Wednesday-Friday. Overall, the mean age was 65.6 years, 68.6% were male, and 82.8% were Caucasian. LEBs were performed for claudication in 57.4% of cases. An autogenous great saphenous vein was used in 58.8% of cases, whereas a prosthetic graft was used in 35.1% of cases. The most common bypass origin was the femoral artery (94.1%), and target was the popliteal artery (70.1%). Significant differences between Monday-Tuesday versus Wednesday-Friday, respectively, were mean body mass index (27.8 kg/m vs. 28 kg/m), preoperative aspirin use (74.2% vs. 72.5%), continuous vein harvest technique (41.9% vs. 44%), and mean operative time (mins) (216.2 vs. 222.6) (all P < 0.05). Univariate postoperative outcomes were significantly different between Monday-Tuesday versus Wednesday-Friday, respectively, for mean length of stay (LOS) (days) (3.9 vs. 4.3), cardiac complications (myocardial infarction/dysrhythmia/congestive heart failure) (3.5% vs. 4.9%), stroke (0.3% vs. 0.6%), and respiratory complications (0.8% vs. 1.3%) (all P < 0.05). Multivariable analysis demonstrated that LEBs performed on Wednesday-Friday versus Monday-Tuesday for claudication/rest pain were independently associated with cardiac complications and prolonged LOS. There were also 8,491 LEBs performed for tissue loss which overall had similar findings to LEBs performed for claudication/rest pain such as increased LOS for LEBs performed for tissue loss on Wednesday-Friday (P < 0.001) and similar likeliness for respiratory complication, wound complication, return to the operating room, and mortality (all P > 0.05). However, LEBs performed for tissue loss on Wednesday-Friday versus Monday-Tuesday had similar cardiac complications (P > 0.05).

Conclusions: Elective LEBs performed on later weekdays for claudication/rest pain were associated with cardiac complications and prolonged LOS, whereas tissue loss confirmed association with prolonged LOS. Further investigations are needed to identify whether increased resources or allocation of resources should be focused on later weekdays to optimize patient outcomes.
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http://dx.doi.org/10.1016/j.avsg.2020.11.025DOI Listing
May 2021

Evaluation of Longitudinal Pain Study in Sickle Cell Disease (ELIPSIS) by patient-reported outcomes, actigraphy, and biomarkers.

Blood 2021 04;137(15):2010-2020

Central Michigan University, Children's Hospital of Michigan, Detroit, MI.

Clinical trials in sickle cell disease (SCD) often focus on health care utilization for painful vaso-occlusive crises (VOCs). However, no objective, quantifiable pain biomarkers exist, pain is not specific to VOCs, health care utilization varies between patients, unreported at-home VOCs likely contribute to long-term outcomes, and patient-reported outcomes are seldom considered. This noninterventional, longitudinal, 6-month study aimed to develop tools to identify VOCs in SCD patients with or without health care utilization. Participants wore an actigraph device, tracking sleep and activity. Patients with SCD used an electronic patient-reported outcome (ePRO) tool to collect data on pain, medication, fatigue, and daily function. Patients self-reported when they experienced VOC pain (VOC day). Biomarkers were collected every 3 weeks (non-VOC). Self-reported VOCs triggered at-home or in-hospital blood collection. The study enrolled 37 participants with SCD; 35 completed the study. Participants reported 114 VOC events and 346 VOC days, of which 62.3% and 78.3%, respectively, were self-treated at home. The ePRO and actigraphy captured end points of pain, functionality, fatigue, activity, and sleep; each was significantly altered on VOC days compared with non-VOC days. Biomarkers collected at home or in the hospital on VOC days were significantly altered compared with non-VOC baseline values, including leukocyte-platelet aggregates, microfluidic-based blood cell adhesion, interleukin-6, C-reactive protein, interleukin-10, tumor necrosis factor-α, and thrombin-antithrombin. The Evaluation of Longitudinal Pain Study in Sickle Cell Disease (ELIPSIS) trial shows the feasibility of accurately monitoring out-of-hospital pain by using patient-reported VOC days as potential end points for clinical trials in SCD; it describes the changes in biomarkers and activity measured by actigraphy that may enable improved identification and assessment of VOCs.
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http://dx.doi.org/10.1182/blood.2020006020DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8057263PMC
April 2021

Younger patients have worse outcomes after peripheral endovascular interventions for suprainguinal arterial occlusive disease.

J Vasc Surg 2021 05 26;73(5):1715-1722. Epub 2020 Sep 26.

Division of Vascular Surgery, Heart and Vascular Institute, University of Pittsburgh Medical School, Pittsburgh, Pa. Electronic address:

Objective: The choice of intervention for treating suprainguinal arterial disease, open bypass vs endovascular intervention, is often tempered by patient age and comorbidities. In the present study, we compared the association of patient age with 1-year major adverse limb events (MALE)-free survival and reintervention-free survival (RFS) rates among patients undergoing intervention for suprainguinal arterial disease.

Methods: The Vascular Quality Initiative datasets for bypass and peripheral endovascular intervention (PVI; aorta and iliac only) were queried from 2010 to 2017. The patients were divided into two age groups: <60 and ≥60 years at the procedure. Age-stratified propensity matching of patients in bypass and endovascular procedure groups by demographic characteristics, comorbidities, and disease severity was used to identify the analysis samples. The 1-year MALE-free survival and RFS rates were compared using the log-rank test and Kaplan-Meier plots. Proportional hazard Cox regression was used to perform propensity score-adjusted comparisons of MALE-free survival and RFS.

Results: A total of 14,301 cases from the Vascular Quality Initiative datasets were included in the present study. Propensity matching led to 3062 cases in the ≥60-year group (1021 bypass; 2041 PVI) and 2548 cases in the <60-year group (1697 bypass; 851 PVI). In the crude comparison of the matched samples, the older patients undergoing bypass had had significantly greater in-hospital (4.6% vs 0.9%; P < .001) and 1-year (10.5% vs 7.5%; P = .005) mortality compared with those who had undergone endovascular intervention. The rates of MALE (7.5% vs 14.3%; P < .001) and reintervention (6.7% vs 12.7%; P < .001) or death were significantly higher for the younger group undergoing PVI than bypass at 1 year. However, the rates of MALE (12.9% vs 14.3%; P = .298) and reintervention (12.7% vs 12.9%; P = .881) or death for were similar both procedures for the older group. Both log-rank analyses and the adjusted propensity score analyses of MALE-free survival and RFS in the two age groups confirmed these findings. The adjusted comparison of outcomes using propensity score matching favored PVI at 1-year survival (hazard ratio, 1.4; 95% confidence interval, 1.1-1.9; P = .003) for the older group but was not different for the younger group (hazard ratio, 0.6; 95% confidence interval, 0.3-1.0; P = .054).

Conclusions: Among the patients aged <60 years undergoing intervention for suprainguinal arterial disease, the choice of therapy should be open surgical intervention given the higher risk of reintervention and MALE with endovascular intervention. Endovascular intervention should be favored for patients aged ≥60 years because of reduced perioperative mortality.
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http://dx.doi.org/10.1016/j.jvs.2020.08.139DOI Listing
May 2021

Upper Arm Arteriovenous Grafts are Superior over Forearm Arteriovenous Grafts in Upper Extremity Dialysis Access.

Ann Vasc Surg 2021 Jan 29;70:131-136. Epub 2020 Jul 29.

Department of Surgery, University of Arizona, Tucson, AZ. Electronic address:

Background: In this study, we compared the outcomes of forearm arteriovenous grafts (AVGs) and upper arm AVGs in a large, prospectively collected data set, which represents real-world experience with upper extremity prosthetic dialysis access, to determine if there are clinically significant differences in the upper arm and forearm positions.

Methods: We identified 2,063 patients who received upper extremity AVGs within the Vascular Quality Initiative data set (2010-2018). Axillary to axillary upper arm AVGs were excluded (n = 394) from the analysis. The main outcome measures were primary and secondary patency rates at 12 months. Other outcomes were 6-month wound infection, steal syndrome, and arm swelling. The log-rank test was used to evaluate patency loss using a Kaplan-Meier analysis. Cox proportional hazards models were used to examine adjusted association between locations (forearm and upper arm) and outcomes.

Results: There were 1,160 forearm AVGs and 509 upper arm brachial artery AVGs in the study cohort. Patients with forearm AVGs were more likely to have a body mass index > 30 (45% vs. 38%, P = 0.013), no history of previous access (73% vs. 63%, P < 0.001), and underwent local-regional anesthesia (56% vs. 43%, P < 0.001). The 12-month primary patency (51.5% vs. 62.9%, P < 0.001) and secondary patency (76.4% vs. 89.1%, P < 0.001) were significantly lower for forearm AVGs. Wound infection, steal syndrome, and arm swelling were similar between forearm AVGs and upper arm AVGs at the 6-month follow-up. In multivariable analysis, the primary patency loss (adjusted hazard ratio (aHR) 1.66, 95% confidence interval (CI) 1.33-2.01, P < 0.001) and 12-month secondary patency loss (aHR 2.71, 95% CI 1.84-3.98, P < 0.001) were significantly higher for forearm AVGs at 12 months.

Conclusions: From this observational study of the Vascular Quality Initiative data set, the primary and secondary patency rates were superior for upper arm brachial artery AVGs compared with forearm AVGs.
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http://dx.doi.org/10.1016/j.avsg.2020.07.009DOI Listing
January 2021

The impact of hemoglobin A on outcomes after lower extremity bypass.

J Vasc Surg 2021 04 28;73(4):1332-1339.e5. Epub 2020 Jul 28.

Division of Vascular Surgery, Department of Surgery, University of Arizona College of Medicine, Tucson, Ariz. Electronic address:

Objective: Diabetes has been shown to be associated with increased risk of postoperative complications after lower extremity bypass (LEB), although it is unclear whether medium-term glucose control affects outcomes. This study aimed to assess the association of perioperative hemoglobin A (HbA) level on perioperative outcomes after LEB.

Methods: We examined consecutive infrainguinal LEBs for chronic limb-threatening ischemia (CLTI) using the Vascular Quality Initiative database (2007-2018). Perioperative HbA levels were stratified into <5.7%, 5.7% to 6.5%, and >6.5%. Propensity score matching on demographics, medical history, and procedural characteristics was used to select comparable patients across HbA groups. The primary outcome was postoperative wound infection. Multivariable analyses were performed for matched and unmatched groups using Cox proportional hazards models for survival outcomes and logistic regression for binary outcomes with association expressed by adjusted hazard ratio (aHR) or adjusted odds ratio (aOR) and corresponding 95% confidence intervals (CIs).

Results: The CLTI cohort included 8171 infrainguinal LEBs: 631 (7.7%) had HbA <5.7%; 1691 (20.6%), 5.7% to 6.5%; and 5849 (71.6%), >6.5%. There was no difference in rates of wound infection in the CLTI cohort (HbA ≤5.7%, 3.8%; HbA 5.7%-6.5%, 3.7%; HbA >6.5%, 3.2%; P = .53) or matched cohort (4.3%, 4.5%, 3.4%; P = .62). There were no differences in perioperative mortality in the CLTI cohort (2.5%, 1.7%, 1.5%; P = .16) or the matched cohort (2.7%, 2.3%, 2.2%; P = .84). In multivariable analysis, there was no significant association between HbA and wound infection in the CLTI cohort (HbA 5.7%-6.5% vs <5.7%: aOR, 0.91 [95% CI, 0.56-1.50; P = .72]; HbA >6.5% vs <5.7%: aOR, 0.81 [95% CI, 0.52-1.26; P = .35]). There was, however, a significant association between decreased HbA and mortality (HbA 5.7%-6.5% vs <5.7%: aHR, 0.77 [95% CI, 0.61-0.97; P = .03]; HbA >6.5% vs <5.7%: aHR, 0.75 [95% CI, 0.61-0.93; P = .01]).

Conclusions: Our study suggests no significant association of increased HbA level and perioperative complications. Additional investigation is required to further evaluate the impact of short-term glycemic control and long-term outcomes of patients undergoing LEB.
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http://dx.doi.org/10.1016/j.jvs.2020.05.036DOI Listing
April 2021

Tibial bypass in patients with intermittent claudication is associated with poor outcomes.

J Vasc Surg 2021 02 21;73(2):564-571.e1. Epub 2020 Jul 21.

Division of Vascular and Endovascular Surgery, Boston Medical Center, Boston University School of Medicine, Boston, Mass. Electronic address:

Objective: Given that intermittent claudication (IC) rarely progresses to chronic limb-threatening ischemia and limb loss, safety and durability of elective interventions for IC are essential. Whether patients with IC benefit from tibial intervention is controversial, and data supporting its utility are limited. Despite endovascular therapy expansion, surgical bypass is still commonly performed. We sought to assess outcomes of bypass to tibial arteries for IC.

Methods: The Vascular Quality Initiative (2003-2018) was queried for infrainguinal bypasses performed for IC. Perioperative and 1-year outcomes were compared between bypasses constructed to tibial and popliteal arteries.

Results: Of 5347 infrainguinal bypasses, 1173 (22%) and 4184 (78%) were tibial and popliteal bypasses, respectively. Overall, mean age was 65 ± 10 years, and patients were often men (72%) and current smokers (42%). Tibial bypasses commonly targeted posterior tibial (40%), tibioperoneal trunk (23%), and anterior tibial (19%) arteries. Great saphenous vein was more often used for tibial bypass than for popliteal bypass (78% vs 54%; P < .001). Patients undergoing tibial compared with popliteal bypass more often had impaired ambulation and prior ipsilateral bypasses and were less often taking antiplatelets and statins (all P < .05). In the perioperative period, tibial bypass patients had longer postoperative length of stay (4.5 ± 3.5 vs 3.5 ± 2.8 days), more pulmonary complications (1.3% vs 0.6%), and higher return to the operating room (7% vs 4%; all P < .05). Perioperative myocardial infarction (1.2% vs 0.8%; P = .19), stroke (0.4% vs 0.4%; P = .91), and mortality (0.3 vs 0.3%; P = .86) rates were similar between the cohorts. At 1 year, tibial compared with popliteal bypasses exhibited lower freedom from occlusion/death (81% vs 89%; P < .001), ipsilateral major amputation/death (90% vs 94%; P < .001), and reintervention/amputation/death (73% vs 80%; P < .001), but patient survival was similar (96% vs 97%; P = .07). On multivariable analysis, tibial compared with popliteal bypass was independently associated with increased occlusion/death (hazard ratio [HR], 1.65; 95% confidence interval [CI], 1.28-2.11; P < .001), major ipsilateral amputation/death (HR, 1.6; 95% CI, 1.12-2.19; P = .003), and ipsilateral reintervention/amputation/death (HR, 1.51; 95% CI, 1.28-1.79; P < .001), with similar patient survival.

Conclusions: In patients with IC, tibial bypass was associated with poor outcomes, including major amputation. Surgeons should exhaust nonoperative therapies and present realistic outcome expectations to their patients before offering such intervention.
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http://dx.doi.org/10.1016/j.jvs.2020.06.118DOI Listing
February 2021

Natural History of Non-operative Management in Asymptomatic Patients with 70%-80% Internal Carotid Artery Stenosis by Duplex Criteria.

Eur J Vasc Endovasc Surg 2020 Sep 11;60(3):339-346. Epub 2020 Jul 11.

Division of Vascular and Endovascular Surgery, Boston Medical Centre, Boston University School of Medicine, Boston, MA, USA. Electronic address:

Objective: Treatment of asymptomatic internal carotid artery (ICA) stenosis, particularly for moderate to severe (70%-80%) disease, is controversial. The goal was to assess the clinical course of patients with moderate to severe carotid stenosis.

Methods: A single institution retrospective analysis of patients with asymptomatic ICA stenosis identified on duplex ultrasound as moderate to severe (70%-80%) from 2003 to 2018 were analysed. Duplex criteria for 70%-80% stenosis was a systolic velocity of ≥325 cm/s or an ICA:common carotid artery ratio of ≥4, and an end diastolic velocity of <140 cm/s. Asymptomatic status was defined as no stroke/transient ischaemic attack (TIA) within six months of index duplex. Primary outcomes were progression of stenosis to >80%, ipsilateral stroke/TIA without documented progression, and death.

Results: In total, 206 carotid arteries were identified in 182 patients meeting the inclusion criteria. Mean patient age was 71.5 years, 57.7% were male, and 67% were white. There were 19 stenoses removed from analysis except for survival analysis as they initially underwent carotid endarterectomy or carotid artery stent based on surgeon/patient preference. Documented progression occurred in 24.1% of stenoses. There were 5.3% of stenoses associated with an ipsilateral stroke/TIA without documented progression, which occurred at a mean of 26.4 months. Kaplan-Meier analysis demonstrated a 60.3% five year freedom from stenosis progression, 92.5% five year freedom from stroke/TIA without documented progression, and 83.7% five year survival. Risk factors associated with stroke/TIA without documented progression at five years were atrial fibrillation (hazard ratio [HR] 14.87, 95% confidence interval [CI] 2.72-81.16; p = .002) and clopidogrel use at index duplex (HR 6.19, 95% CI 1.33-28.83; p = .020). Risk factors associated with death at five years were end stage renal disease (HR 9.67, 95% CI 2.05-45.6; p = .004), atrial fibrillation (HR 7.55, 95% CI 2.48-23; p < .001), prior head/neck radiation (HR 6.37, 95% CI 1.39-29.31; p = .017), non-obese patients (HR 5.49, 95% CI 1.52-20; p = .009), and non-aspirin use at index duplex (HR 3.05, 95% CI 1.12-8.33; p = .030).

Conclusion: Patients with asymptomatic moderate to severe carotid stenosis had a low rate of stroke/TIA without documented progression. However, there was a high rate of stenosis progression reinforcing the need to follow these patients closely.
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http://dx.doi.org/10.1016/j.ejvs.2020.05.039DOI Listing
September 2020

Access Type for Endovascular Repair in Ruptured Abdominal Aortic Aneurysms Does Not Affect Major Morbidity or Mortality.

Ann Vasc Surg 2021 Jan 10;70:181-189. Epub 2020 Jul 10.

Division of Vascular and Endovascular Surgery, Boston Medical Center, Boston University School of Medicine, Boston, MA. Electronic address:

Background: There are limited data on access type when treating ruptured abdominal aortic aneurysms (AAAs) with endovascular aneurysm repair (EVAR). Our study's objective was to evaluate if the type of access in ruptured AAAs affected outcomes.

Methods: The Vascular Quality Initiative was queried from 2009 to 2018 for all ruptured AAAs treated with an index EVAR. Procedures were grouped by access type: percutaneous, open, and failed percutaneous that converted to open access. Patients with iliac access, both percutaneous and open access, and concurrent bypass were excluded. Baseline characteristics, procedure details, and outcomes were collected. Univariable and multivariable analyses were performed.

Results: There were 1,206 ruptured AAAs identified-739 (61.3%) was performed by percutaneous access, 416 (34.5%) by open access, and 51 (4.2%) by failed percutaneous that converted to open access. Percutaneous access, compared with open access and failed percutaneous access, respectively, had the shortest operative time (min, median) (111 vs. 138 vs. 180, P < 0.001) and was most often performed under local anesthesia (16.7% vs. 5% vs. 9.8%, P < 0.001). The amount of contrast used was similar between the approaches. Univariable analysis comparing percutaneous access, open access, and failed percutaneous access showed differences in 30-day mortality (19.9% vs. 24.8% vs. 39.2%, P = 0.002), postoperative complications (33.7% vs. 40.2% vs. 54%, P = 0.003), and cardiac complications (18.2% vs. 19.8% vs. 34.7%, P = 0.018). However, multivariable analysis did not show access type to have a significant effect on cardiac complications, pulmonary complications, any complications, return to the operating room, or perioperative mortality. Open access was independently associated with a prolonged length of stay (means ratio 1.17, 95% confidence interval (CI) 1.04-1.33, P = 0.012). Factors independently associated with failed percutaneous were prior bypass (odds ratio (OR) 9.77, 95% CI 2.44-39.16, P = 0.001) and altered mental status (OR 2.45, 95% CI 1.17-5.15, P = 0.018).

Conclusions: Access type for ruptured AAAs was not independently associated with major morbidity or mortality but did have a differential effect on length of stay. Access during these emergent procedures should be based on surgeon preference and experience.
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http://dx.doi.org/10.1016/j.avsg.2020.07.004DOI Listing
January 2021

Nationwide patterns in industry payments to academic vascular surgeons.

J Vasc Surg 2021 02 11;73(2):675-681. Epub 2020 Jun 11.

Division of Vascular and Endovascular Surgery, UMass Memorial Medical Center, University of Massachusetts Medical School, Worcester, Mass. Electronic address:

Objective: Financial relationships between vascular surgeons and industry are essential to the development and adoption of innovative technology. However, these relationships may establish competing interests. Our objective was to describe publicly available financial transactions between industry and academic vascular surgeons.

Methods: Academic vascular surgeons were identified and characterized on the basis of publicly available data correlated with Accreditation Council for Graduate Medical Education and Association of American Medical Colleges data to identify academic practice settings. Vascular surgeons were linked to Open Payments data for 2017 as reported by the Centers for Medicare & Medicaid Services. Univariate and nonparametric tests were used for analysis.

Results: Of 1158 academic vascular surgeons identified, 997 (86%) received industry payments totaling $8,548,034. Overall, the median of total payments received was $814 (interquartile range [IQR], $124-$2863). The top paid decile of vascular surgeons received $29,645 (IQR, $16,128-$61,701). Payments to the top decile accounted for 81% of all payments. Payments did not vary by academic rank but did vary by sex, with male vascular surgeons (n = 954) receiving $889 (IQR, $146-$3217) vs female vascular surgeons (n = 204) receiving $467 (IQR, $87-$1533; P = .002). By leadership role, division chiefs received the highest median payment amount ($1571; IQR, $368-$11,281) compared with department chairs ($424; IQR, $56-$2698) and vascular surgeons without leadership role ($769; IQR, $117-$2592; P = .002). Differences in payments were also seen on the basis of U.S. census region: Northeast, $571 (IQR, $90-2462); Midwest, $590 (IQR, $75-$2364); South, $1085 (IQR, $241-$3405); and West, $1044 (IQR, $161-$4887; P = .001). The most common categories of payments were food and beverage (paid to 85% of all vascular surgeons), travel and lodging (35%), and consulting fees (13%). Among the top decile of vascular surgeons, median payments exceeded $10,000 for three categories: consulting fees, compensation, and honoraria. Payments were made by 178 distinct entities with median total payments of $286 (IQR, $70-$6285). The three top entities paid a total of $5,004,061, which accounted for 59% of all payments. Payments from at least one of the top three entities reached 76% of vascular surgeons.

Conclusions: Most academic vascular surgeons receive publicly reported industry payments that are paid by a limited number of entities, typically for food and beverage or travel and lodging. The top 10% of vascular surgeons received higher median payment amounts, totaling 81% of all industry payments. Vascular surgeons should be aware of publicly reported payment information and the potential for conflicts of interest.
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http://dx.doi.org/10.1016/j.jvs.2020.04.527DOI Listing
February 2021

Association of Anesthesia Type with Outcomes after Outpatient Brachiocephalic Arteriovenous Fistula Creation.

Ann Vasc Surg 2020 Oct 3;68:67-75. Epub 2020 Jun 3.

Division of Vascular and Endovascular Surgery, Boston Medical Center, Boston University School of Medicine, Boston, MA. Electronic address:

Background: Brachiocephalic arteriovenous fistulas (BCFs) are commonly placed in outpatient settings. The impact of general anesthesia (GA), regional anesthesia (RA), or local anesthesia (LA) on perioperative recovery and fistula maturation/patency after outpatient BCF creations is unknown. We evaluated whether outcomes of outpatient BCF creations vary based on anesthesia modality.

Methods: The Vascular Quality Initiative (2011-2018) national database was queried for outpatient BCF creations. Anesthesia modalities included GA, RA, and LA. Perioperative, 3-month, and 1-year outcomes were compared between GA versus RA/LA anesthesia types.

Results: Among 3,527 outpatient BCF creations, anesthesia types were GA in 1,043 (29.6%), RA in 1,150 (32.6%), and LA in 1,334 (37.8%). Patients receiving GA were more often younger, obese, Medicaid recipients, without coronary artery disease, and treated in non-office-based settings (P < 0.05 for all). GA compared with RA/LA cohorts were more often admitted postoperatively (5.3% vs. 2.4%, P < 0.001) but had similar rates of thirty-day mortality (0.9 vs. 0.6%, P = 0.39). 3-month access utilization for hemodialysis was lower in GA than in RA/LA cohorts (12.6% vs. 23.6%, P < 0.001). The Kaplan-Meier analysis showed that GA and RA/LA cohorts had similar 1-year primary access occlusion-free survival (43.6% vs. 47.1%, P = 0.24) and endovascular/open reintervention-free survival (57.2% vs. 57.6%, P = 0.98). On multivariable analysis, GA compared with RA/LA use was independently associated with increased postoperative admission (odds ratio [OR]: 1.7, 95% confidence interval [CI]: 1.08-2.67, P = 0.02) and decreased 3-month access utilization (OR: 0.39, 95% CI: 0.25-0.61, P < 0.001) but had similar 1-year access occlusion (hazard ratio [HR]: 1.09, 95% CI: 0.9-1.32, P = 0.36) and reintervention (HR: 1.02, 95% CI: 0.82-1.26, P = 0.88). On subgroup analysis of the RA/LA cohort, RA compared with LA was associated with increased 3-month access utilization (OR: 1.6, 95% CI: 1.01-2.5; P = 0.04) and 1-year access reintervention (HR: 1.46, 95% CI: 1.12-1.89), but had similar 1-year access occlusion (HR: 1.2, 95% CI: 0.95-1.51, P = 0.13).

Conclusions: Compared with RA/LA use, GA use in patients undergoing outpatient BCF creations was associated with increased hospital admissions, decreased access utilization at 3 months, and similar 1-year access occlusion and reintervention. RA/LA is preferable to expedite recovery and access utilization.
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http://dx.doi.org/10.1016/j.avsg.2020.05.067DOI Listing
October 2020

Intravenous drug use history is not associated with poorer outcomes after arteriovenous access creation.

J Vasc Surg 2021 01 20;73(1):291-300.e7. Epub 2020 May 20.

Division of Vascular and Endovascular Surgery, Boston Medical Center, Boston University School of Medicine, Boston, Mass. Electronic address:

Objective: Rising intravenous drug use (IVDU) paralleled with an increasing dialysis-dependent end-stage renal disease population may pose a challenge for creating and maintaining arteriovenous (AV) access for hemodialysis. We aimed to elucidate baseline characteristics and outcomes of AV access creation in the IVDU population.

Methods: The Vascular Quality Initiative (2011-2018) was queried for patients undergoing AV access placement. Univariable and multivariable analyses comparing outcomes of patients with and without IVDU history were performed.

Results: Of 33,404 patients undergoing AV access creation, 601 (1.8%) had IVDU history (21.8% current and 78.2% past users). IVDU patients receiving AV access were more often younger, male, nonwhite, smokers, homeless, Medicaid recipients, and hospitalized at the time of surgery (P < .001 for all). They exhibited higher rates of congestive heart failure, chronic obstructive pulmonary disease, and human immunodeficiency virus/acquired immunodeficiency syndrome (P < .05 for all). They more frequently had tunneled catheters at the time of access creation (53.6% vs 42%; P < .001) and had a previous AV access (25.3% vs 21.7%; P = .002). IVDU patients more often received prosthetic AV grafts (28.6% vs 18%; P < .001) and more often had anastomoses created to basilic veins (33.1% vs 23.2%; P < .001) but less often to cephalic veins (36.8% vs 57.7%; P < .001). IVDU patients had longer postoperative length of stay (2 ± 6 days vs 0.9 ± 5 days; P < .001) but no significant difference in 30-day mortality (1.7% vs 1.2%; P = .3). Comparing IVDU vs no IVDU cohorts, 1-year access infection-free survival (85.4% vs 86.6%; P = .382), primary patency loss-free survival (39.5% vs 37.9%; P = .335), endovascular/open reintervention-free survival (58% vs 57%; P = .705), and overall survival (89.7% vs 88.9%; P = .635) were similar. On multivariable analysis, IVDU was independently associated with postoperative length of stay (odds ratio, 1.64; 95% confidence interval, 1.35-2; P < .001) but not with 30-day mortality or 1-year infection-free survival, primary patency loss-free survival, reintervention-free survival, and all-cause mortality. The null results were confirmed in a propensity score-matched cohort.

Conclusions: IVDU history was uncommon among patients undergoing AV access creation at Vascular Quality Initiative centers and was not independently associated with major morbidity or mortality postoperatively. IVDU patients more often received grafts or autogenous access with anastomoses to basilic veins. Although these patients frequently have more comorbidities, IVDU should not deter AV access creation.
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http://dx.doi.org/10.1016/j.jvs.2020.04.521DOI Listing
January 2021

Smoking-by-genotype interaction in type 2 diabetes risk and fasting glucose.

PLoS One 2020 7;15(5):e0230815. Epub 2020 May 7.

Department of Epidemiology, School of Public Health, University of Michigan, Ann Arbor, MI, United States of America.

Smoking is a potentially causal behavioral risk factor for type 2 diabetes (T2D), but not all smokers develop T2D. It is unknown whether genetic factors partially explain this variation. We performed genome-environment-wide interaction studies to identify loci exhibiting potential interaction with baseline smoking status (ever vs. never) on incident T2D and fasting glucose (FG). Analyses were performed in participants of European (EA) and African ancestry (AA) separately. Discovery analyses were conducted using genotype data from the 50,000-single-nucleotide polymorphism (SNP) ITMAT-Broad-CARe (IBC) array in 5 cohorts from from the Candidate Gene Association Resource Consortium (n = 23,189). Replication was performed in up to 16 studies from the Cohorts for Heart Aging Research in Genomic Epidemiology Consortium (n = 74,584). In meta-analysis of discovery and replication estimates, 5 SNPs met at least one criterion for potential interaction with smoking on incident T2D at p<1x10-7 (adjusted for multiple hypothesis-testing with the IBC array). Two SNPs had significant joint effects in the overall model and significant main effects only in one smoking stratum: rs140637 (FBN1) in AA individuals had a significant main effect only among smokers, and rs1444261 (closest gene C2orf63) in EA individuals had a significant main effect only among nonsmokers. Three additional SNPs were identified as having potential interaction by exhibiting a significant main effects only in smokers: rs1801232 (CUBN) in AA individuals, rs12243326 (TCF7L2) in EA individuals, and rs4132670 (TCF7L2) in EA individuals. No SNP met significance for potential interaction with smoking on baseline FG. The identification of these loci provides evidence for genetic interactions with smoking exposure that may explain some of the heterogeneity in the association between smoking and T2D.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0230815PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7205201PMC
August 2020

Perioperative and long-term outcomes after percutaneous thrombectomy of arteriovenous dialysis access grafts.

J Vasc Surg 2020 12 11;72(6):2107-2112. Epub 2020 Apr 11.

Division of Vascular and Endovascular Surgery, Boston University, School of Medicine, Boston Medical Center, Boston, Mass. Electronic address:

Objective: Maintenance of functional arteriovenous grafts (AVGs) for dialysis is difficult secondary to low primary patency, need for reinterventions, and limited alternative dialysis access options. We assessed our experience with percutaneous thrombectomy for treatment of occluded AVGs.

Methods: We performed a retrospective analysis of all percutaneous thrombectomies for AVGs from 2015 to 2017. These were generally performed using mechanical thrombectomy and occasional chemical tissue plasminogen activator thrombolysis, over-the-wire balloon embolectomy for inflow, and adjunctive inflow and outflow interventions as necessary. Perioperative outcomes, long-term patency, reinterventions, and need for new permanent access placement were analyzed.

Results: There were 218 percutaneous thrombectomies performed on 86 AVGs in 77 patients. Approximately half (53.2%) of the patients were male and 68.8% were black. Mean age was 61.1 ± 13.0 years. At the time of thrombectomy, 73.8% underwent venous outflow interventions and 4.5% underwent arterial inflow interventions. Within 30 days, 24.8% of declotted grafts underwent repeated percutaneous thrombectomy, 14.3% required tunneled dialysis catheter placement, 4% developed minor access site or graft infections, and one patient underwent surgical arterial thrombectomy for arm ischemia. There were no venous thromboembolic, cardiopulmonary, or cerebrovascular complications or clinically significant pulmonary embolism. At 1 year and 3 years after percutaneous thrombectomy, freedom from repeated thrombosis was 37% and 18%, respectively, and freedom from new dialysis access placement was 66% and 51%, respectively. Overall patient survival was 82% at 3 years.

Conclusions: Percutaneous thrombectomy of AVGs is safe and is associated with acceptable patency rates. This minimally invasive method extends AVG use for these high-risk patients with limited dialysis access options.
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http://dx.doi.org/10.1016/j.jvs.2020.03.032DOI Listing
December 2020

Patients with human immunodeficiency virus infection do not have inferior outcomes after dialysis access creation.

J Vasc Surg 2020 12 8;72(6):2113-2119. Epub 2020 Apr 8.

Division of Vascular and Endovascular Surgery, Boston Medical Center, Boston University School of Medicine, Boston, Mass. Electronic address:

Objective: Despite improvements in treating human immunodeficiency virus (HIV) infection and acquired immunodeficiency syndrome (AIDS), the risk of end-stage renal disease and need for long-term arteriovenous (AV) access for hemodialysis remain high in HIV-infected patients. Associations of HIV/AIDS with AV access creation complications have been conflicting. Our goal was to clarify short- and long-term outcomes of patients with HIV/AIDS undergoing AV access creation.

Methods: The Vascular Quality Initiative registry was queried from 2011 to 2018 for all patients undergoing AV access creation. Documentation of HIV infection status with or without AIDS was recorded. Data were propensity score matched (4:1) between non-HIV-infected patients and HIV/AIDS patients. Subsequent multivariable analysis and Kaplan-Meier analysis were performed for short- and long-term outcomes.

Results: There were 25,711 upper extremity AV access creations identified: 25,186 without HIV infection (98%), 424 (1.6%) with HIV infection, and 101 (.4%) with AIDS. Mean age was 61.8 years, and 55.8% were male. Patients with HIV/AIDS were more often younger, male, nonwhite, nonobese, and current smokers; they were more often on Medicaid and more likely to have a history of intravenous drug use, and they were less often diabetic and less likely to have cardiac comorbidities (P < .05 for all). There was no significant difference in autogenous or prosthetic access used in these cohorts. Wound infection requiring incision and drainage or explantation within 90 days was low for all groups (0.6% vs 1.9 vs 0%; P = .11) of non-HIV-infected patients vs HIV-infected patients vs AIDS patients. Kaplan-Meier analysis showed no significant difference in 1-year freedom from primary patency loss (43.9% vs 46.3%; P =.6), 1-year freedom from reintervention (61% vs 60.7%,; P = .81), or 3-year survival (83% vs 83.8%; P = .57) for those with and without HIV/AIDS, respectively. Multivariable analysis demonstrated that patients with HIV/AIDS were not at significantly higher risk for access reintervention (hazard ratio [HR], 0.97; 95% confidence interval [CI], 0.76-1.24; P = .81), occlusion (HR, 1.06; 95% CI, 0.86-1.29; P = .6), or mortality (HR, 1.08; 95% CI, 0.83-1.43; P = .57).

Conclusions: Patients with HIV/AIDS undergoing AV access creation have outcomes similar to those of patients without HIV infection, including long-term survival. Patients with HIV/AIDS had fewer traditional end-stage renal disease risk factors compared with non-HIV-infected patients. Our findings show that the contemporary approach for creation and management of AV access in patients with HIV/AIDS should be continued; however, further research is needed to identify risk factors in this population.
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http://dx.doi.org/10.1016/j.jvs.2020.03.030DOI Listing
December 2020

Shunt intention during carotid endarterectomy in the early symptomatic period and perioperative stroke risk.

J Vasc Surg 2020 10 5;72(4):1385-1394.e2. Epub 2020 Feb 5.

Division of Vascular and Endovascular Surgery, Boston Medical Center, Boston University School of Medicine, Boston, Mass. Electronic address:

Objective: Whether recent stroke mandates planned shunting during carotid endarterectomy (CEA) is controversial. Our goal was to determine associations of various shunting practices with postoperative outcomes of CEAs performed after acute stroke.

Methods: The Vascular Quality Initiative database (2010-2018) was queried for CEAs performed within 14 days of an ipsilateral stroke. Surgeons who prospectively planned to shunt either shunted routinely per their usual practice or shunted selectively for preoperative indications. Surgeons who prospectively planned not to shunt either shunted selectively for intraoperative indications or did not shunt. Univariable and multivariable analyses compared shunting approaches.

Results: There were 5683 CEAs performed after acute ipsilateral stroke. Surgeons planned to shunt in 56.1% of cases. Patients whose surgeons planned to shunt vs planned not to shunt were more likely to have severe contralateral stenosis (8.8% vs 6.9%; P = .008), to receive general anesthesia (97.5% vs 89.1%; P < .001), and to undergo conventional CEA (94% vs 81.8%; P < .001). Unadjusted outcomes were similar between the cohorts for operative duration (124.3 ± 48.1 minutes vs 123.6 ± 47 minutes; P = .572) and 30-day stroke (3.4% vs 3%; P = .457), myocardial infarction (1.1% vs 0.8%; P = .16), and mortality (1.6% vs 1.3%; P = .28). On multivariable analysis, planning to shunt vs planning not to shunt was associated with similar risk of 30-day stroke (odds ratio [OR], 1.17; 95% confidence interval [CI], 0.82-1.67; P = .402). On subgroup analysis, in 38.4% patients, no shunt was placed, whereas the remainder received routine shunts (44.4%), preoperatively indicated shunts (11.6%), and intraoperatively indicated shunts (5.5%). Compared with no shunting, shunting by surgeons who routinely shunt was associated with a similar stroke risk (OR, 1.39; 95% CI, 0.91-2.13; P = .129), but shunting by surgeons who selectively shunt on the basis of preoperative indications (OR, 2.11; 95% CI, 1.22-3.63; P = .007) or intraoperative indications (OR, 3.34; 95% CI, 1.86-6.01; P < .001) was associated with increased stroke risk. Prior coronary revascularization independently predicted increased intraoperatively indicated shunting (OR, 1.37; 95% CI, 1.05-1.8; P = .022).

Conclusions: In CEAs performed after acute ipsilateral stroke, there is no difference in postoperative stroke risk when surgeons prospectively plan to shunt or not to shunt. Shunting is often not necessary; however, when shunting is performed, routine shunters achieve better outcomes.
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http://dx.doi.org/10.1016/j.jvs.2019.11.047DOI Listing
October 2020

Patients undergoing interventions for claudication experience low perioperative morbidity but are at risk for worsening functional status and limb loss.

J Vasc Surg 2020 07 12;72(1):241-249. Epub 2019 Dec 12.

Division of Vascular and Endovascular Surgery, Boston Medical Center, Boston University School of Medicine, Boston, Mass. Electronic address:

Objective: Interventional approaches to managing intermittent claudication vary widely. According to Society for Vascular Surgery guidelines, any invasive treatment of claudication must offer long-term benefit at low risk of complications. Our aim was to evaluate contemporary claudication intervention patterns and functional outcomes.

Methods: The Vascular Study Group of New England database (2003-2018) was queried for peripheral vascular interventions (PVIs), infrainguinal bypasses, and suprainguinal bypasses for claudication. Perioperative and 1-year outcomes were evaluated.

Results: There were 7051 PVIs, 2527 infrainguinal bypasses, and 849 suprainguinal bypasses performed for claudication. Treatment levels were iliac (52.2%), femoral-popliteal (54%), and tibial (5.7%). Isolated tibial interventions were completed in 1.7% of patients. Infrainguinal bypasses were most often to the popliteal artery (81.2%); however, in 18.8% of cases, bypasses were to tibial targets. Suprainguinal bypasses originated primarily from the abdominal aorta (88.6%) but also from the axillary artery (10.6%) and thoracic aorta (0.8%). Common perioperative complications were access site hematoma in 4.9% of PVIs and cardiac complications in 3.7% of infrainguinal bypasses and 11.3% of suprainguinal bypasses. Overall, 30-day mortality was 0.4% to 2%. After 1 year, of patients initially ambulating without assistance, 2.4% to 3.6% required assistance and 0.3% to 1.3% were nonambulatory. Ipsilateral reintervention/amputation-free survival, major amputation-free survival, and survival at 1 year were 81.4% to 90.6%, 92.9% to 94.1%, and 95.3% to 97%, respectively.

Conclusions: Multisegment PVI was the most commonly performed intervention for claudication; however, a subset of patients received treatments supported by limited evidence, including isolated tibial PVI and bypasses with axillary inflow and tibial outflow. Interventions had low perioperative morbidity and mortality, yet patients were still at risk for worse functional status and limb loss at 1 year, emphasizing the importance of careful patient selection, medical optimization, and informed consent.
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http://dx.doi.org/10.1016/j.jvs.2019.08.278DOI Listing
July 2020

The impact of the housing status on clinical outcomes and health care utilization among individuals living with HIV.

AIDS Care 2021 01 25;33(1):1-9. Epub 2019 Nov 25.

Boston Health Care for the Homeless Program, Boston, MA, USA.

The lack of stable housing can impair access and continuity of care for patients living with human immunodeficiency virus (HIV). This study investigated the relationship between housing status assessed at multiple time points and several core HIV-related outcomes within the same group of HIV patients experiencing homelessness. Patients with consistently stable housing (CSH) during the year were compared to patients who lacked CSH (non-CSH group). The study outcomes included HIV viral load (VL), CD4 counts, and health care utilization. Multivariable and propensity weighted analyses were used to assess outcomes adjusting for potential group differences. Of 208 patients, 88 (42%) had CSH and 120 (58%) were non-CSH. Patients with CSH had significantly higher proportion of VL suppression and higher mean CD4 counts. The frequency of nurse visits in the CSH group was less than a half of that in the non-CSH group. Patients with CSH were less likely to be admitted to the medical respite facility, and if admitted, their length of stay was about a half of that for the non-CSH group. Our study findings show that patients with CSH had significantly better HIV virologic control and immune status as well as improved health care utilization.
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http://dx.doi.org/10.1080/09540121.2019.1695728DOI Listing
January 2021

Perioperative outcomes after lower extremity bypass and peripheral vascular interventions in patients with morbid obesity and superobesity.

J Vasc Surg 2020 02 20;71(2):567-574.e4. Epub 2019 Aug 20.

Division of Vascular and Endovascular Surgery, Boston University School of Medicine, Boston Medical Center, Boston, Mass. Electronic address:

Objective: Although the effect of body mass index (BMI) on the treatment of infrainguinal peripheral artery disease has been reported, outcomes of patients on the upper end of the obesity spectrum, including morbid obesity (MO) and superobesity (SO), are unclear. Our goal was to analyze perioperative outcomes after lower extremity bypass (LEB) and peripheral vascular interventions (PVIs) in this population of patients.

Methods: The Vascular Quality Initiative was reviewed for all infrainguinal peripheral artery disease interventions from 2010 to 2017. All patients were categorized into four groups: nonobese (BMI 18.5-29.9 kg/m), obese (BMI 30-39.9 kg/m), morbidly obese (BMI 40-49.9 kg/m), and superobese (BMI ≥50 kg/m). Patient and case details were recorded. Multivariable analysis was used to analyze outcomes. For statistical analysis, MO and SO groups were combined.

Results: We identified 29,138 LEB cases (68.5% nonobese, 28.3% obese, 2.9% morbidly obese, 0.3% superobese) and 81,405 PVI cases (66.6% nonobese, 29.2% obese, 3.6% morbidly obese, 0.5% superobese). For both LEB and PVI, patients with MO and SO were more likely to be younger, female, nonsmokers, and ambulatory (P < .05). They also more often had diabetes, end-stage renal disease, congestive heart failure, and fewer previous inflow procedures (P < .05). LEB and PVI interventions in patients with MO and SO were less often elective and more often performed for tissue loss. Multivariable analysis showed that LEB in patients with MO and SO was not significantly associated with increased perioperative cardiac complications, return to the operating room, or mortality. Patients with MO and SO were significantly associated with increased surgical site infection (odds ratio, 1.43; 95% confidence interval, 1.02-1.98; P = .03) and increased respiratory complications (odds ratio, 1.6; 95% confidence interval, 1.11-2.31; P = .01). Multivariable analysis showed that MO and SO were not significantly associated with periprocedural access site hematoma, access site stenosis or occlusion, or mortality after PVI.

Conclusions: MO and SO were significantly associated with increased incidence of wound infections and respiratory complications after LEB but were not significantly associated with increased incidence after PVI. Overall, patients with MO and SO have more comorbidities and more advanced presentation of vascular disease at the time of intervention, but MO and SO alone should not deter necessary and appropriate revascularization.
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http://dx.doi.org/10.1016/j.jvs.2019.05.039DOI Listing
February 2020

Comparison of Early and Late Post-operative Outcomes after Supra-inguinal Bypass for Aortoiliac Occlusive Disease.

Eur J Vasc Endovasc Surg 2019 Oct 19;58(4):529-537. Epub 2019 Aug 19.

Division of Vascular Surgery, University of Pittsburgh Medical Centre, Pittsburgh, PA, USA. Electronic address:

Objective: The choice for surgical revascularisation for aortoiliac occlusive disease is often tempered by patient comorbidities. This study compares peri-operative outcomes and the association between choice of operation and one year major adverse limb event (MALE) free survival and five year mortality.

Methods: The Vascular Study Group of New England (VSGNE) dataset for supra-inguinal bypass operations from 2009 to 2015 was queried. This study excluded cases with bypass other than aortofemoral (AFB), axillofemoral (AXB), and femorofemoral (FFB), and those with endovascular interventions or femoral endarterectomy. Cases combined with other procedures, indications other than occlusive disease, and missing pathology were also excluded. Patients were divided into three groups: AFB, AXB, and FFB. Thirty day post-operative death (POD) and adverse events were compared using univariable and multivariable analyses. One year MALE free survival was compared between groups with log rank test and Kaplan-Meier plot. Proportional hazard Cox regression was used for adjusted comparison of MALE free and five year survival.

Results: In total, 1,602 cases were included: 207 (12.9%) AXB; 872 (54.4%) AFB; 523 (32.6%) FFB. AXB patients were older with more comorbidities. Post-operative complications and POD rates were significantly higher for AXB (p < .05). On adjusted analyses, AXB increased the hazard of one year MALE (hazard ratio [HR] 1.76, 95% confidence interval [CI] 1.12-2.78; p = .014) and five year mortality (HR 1.54; 95% CI 1.11-2.41; p = .009). Both FFB and AFB had similar one year MALE free survival but significantly better one year MALE free survival than AXB.

Conclusion: After adjusting for confounding variables, and while acknowledging limitations related to the VSGNE data set, FFB led to significantly lower rates of post-operative complications than AXB. FFB may serve as the extra-anatomical operation of choice in high risk patients with extensive disease, who cannot undergo AFB, provided that anatomy permits. AFB should be performed preferentially in low risk patients with appropriate anatomy. Owing to its higher complications rates, the study suggests that AXB should be limited to patients with no other option for revascularisation.
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http://dx.doi.org/10.1016/j.ejvs.2019.02.010DOI Listing
October 2019

Hypoalbuminemia Predicts Increased Readmission and Emergency Department Visits After Lower Extremity Bypass.

Vasc Endovascular Surg 2019 Nov 15;53(8):629-635. Epub 2019 Aug 15.

Division of Vascular and Endovascular Surgery, Boston Medical Center, Boston University School of Medicine, Boston, MA, USA.

Introduction: Preoperative hypoalbuminemia is associated with poor outcomes across many surgical fields. However, the effects on outcomes after lower extremity bypass (LEB), particularly over the 90-day global surgical period, are unclear. Our goal was to analyze the effect of hypoalbuminemia within 90 days after LE bypass.

Methods: We performed a single-center retrospective review of all infrainguinal LEBs from 2007 to 2017. Patients were categorized into 3 preoperative albumin groups: severe hypoalbuminemia (SH; albumin ≤2.8g/dL), mild-moderate hypoalbuminemia (MH; albumin >2.8-3.5g/dL), and normal albumin (albumin >3.5g/dL). Patient and procedural details were recorded. Outcomes analyzed included wound infection, myocardial infarction (MI), pulmonary complications, early graft occlusion (≤30 days), mortality, and emergency department (ED) presentation and readmissions within 30 and 90 days. Multivariable analysis was performed.

Results: We identified 313 patients undergoing LEB-45 (14.4%) with SH, 133 (42.5%) with MH, and 135 (43.1%) with normal albumin. Overall, the mean age was 65.7 years, and 63.3% were male. The SH group more frequently had tissue loss, diabetes, hypertension, end-stage renal disease, preoperative hematocrit <30%, and patients admitted preoperatively (all < .05). There were no significant differences in wound complications, MI, pulmonary complications, early graft occlusion, 30-day or 90-day mortality, and 30-day ED presentation. Severe hypoalbuminemia compared to MH and normal albumin, respectively, had significantly higher rates of 30-day readmission (40% vs 30.8% vs 17.8%, = .005), 90-day ED presentation (55.6% vs 33.8% vs 29.6%, = .006), and 90-day readmission (66.7% vs 48.9% vs 35.6%, = .001). Multivariable analysis showed that SH was independently associated with 90-day ED presentation (odds ratio [OR]: 2.8, 95% confidence interval [CI]: 1.23-6.36, = .014) and 90-day readmission (OR: 2.63, 95% CI: 1.21-5.71, = .015).

Conclusion: Our study suggests that patients with SH undergoing LEB had similar perioperative complication rates compared to normal albumin and MH groups, and SH was independently associated with 90-day ED presentation and readmission. Further studies are needed to assess other factors associated with ED visits and readmission.
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http://dx.doi.org/10.1177/1538574419868869DOI Listing
November 2019

Axillary-bifemoral and axillary-unifemoral artery grafts have similar perioperative outcomes and patency.

J Vasc Surg 2020 03 5;71(3):862-868. Epub 2019 Aug 5.

Division of Vascular and Endovascular Surgery, Boston University, School of Medicine, Boston, Mass. Electronic address:

Objective: It has been suggested that more bypass outflow targets for bypass grafts improve patency and outcomes. Our objective was to examine this in a multicenter contemporary series of axillary to femoral artery grafts.

Methods: The Vascular Quality Initiative database was queried for all axillary-unifemoral (AxUF) and axillary-bifemoral (AxBF) bypass grafts performed between 2010 and 2017 for claudication, rest pain, and tissue loss. Patients with acute limb ischemia were excluded. Patients' demographics and comorbidities as well as operative details and outcomes were recorded. Univariable, multivariable, and Kaplan-Meier analyses were used to assess long-term outcomes.

Results: There were 412 (32.9%) AxUF grafts and 839 (67.1%) AxBF grafts identified. Overall, the mean age of the patients was 68.3 years, 51.1% were male, and 84.7% were white. Compared with AxBF grafts, AxUF grafts were more often performed for urgent cases; in patients who were younger, male, nonambulatory, and diabetic; and in those with preoperative anticoagulation, critical limb ischemia, prior bypass, aneurysm repair, peripheral vascular intervention, and major amputation (P < .05 for all). There were no significant differences between AxUF and AxBF grafts in perioperative wound complications (4.2% vs 2.9%; P = .23), cardiac complications (7.3% vs 10.4%; P = .08), pulmonary complications (4.1% vs 6%, P = .18), early stenosis/occlusion (0.2% vs 0.8%; P = .22), perioperative mortality (2.9% vs 3.2%; P = .77), and length of stay (6.4 ± 5.6 days vs 6.7 ± 8 days; P = .29). The mean estimated blood loss (268.1 mL vs 348.6 mL; P < .001) and mean operative time (201 minutes vs 224.1 minutes; P < .001) were significantly lower for AxUF grafts. Kaplan-Meier analysis showed that AxUF and AxBF grafts had similar freedom from graft occlusion (62.6% vs 71.8%; P = .074), major adverse limb event-free survival (57.1% vs 66.6%; P = .052), and survival (86% vs 86%; P = .897) at 1 year. Major amputation-free survival was lower for AxUF grafts (63.7% vs 73%; P = .028). Multivariable analysis also showed that the type of graft configuration did not independently predict occlusion/death (hazard ratio [HR], 1.06; 95% confidence interval [CI], 0.77-1.46; P = .72), amputation/death (HR, 1.12; 95% CI, 0.83-1.51; P = .45), major adverse limb event/death (HR, 0.97; 95% CI, 0.73-1.3; P = .85), or mortality (HR, 0.91; 95% CI, 0.65-1.26; P = .55). Three-year survival after placement of AxUF and AxBF grafts was similar (75.1% vs 78.2%; P = .414).

Conclusions: AxUF and AxBF grafts have similar perioperative and 1-year outcomes. Graft patency was not significantly different between an AxBF graft and an AxUF graft at 1 year. Overall, patients treated with these reconstructions have many comorbidities and low long-term survival.
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http://dx.doi.org/10.1016/j.jvs.2019.05.038DOI Listing
March 2020

Factors Associated with Wound Complications after Open Femoral Artery Exposure for Elective Endovascular Abdominal Aortic Aneurysm Repair.

Int J Angiol 2019 Jun 28;28(2):124-129. Epub 2019 Mar 28.

Division of Vascular and Endovascular Surgery, University of Arizona Department of Surgery, Banner University Medical Center Tucson, Tucson, Arizona.

We identified factors that would lead to wound complications after open femoral exposure for endovascular abdominal aortic aneurysm repair (oEVAR). Using the National Surgical Quality Improvement Program dataset (2005-2014), we examined the patients who underwent oEVAR. Patients were stratified on whether they developed postoperative wound complications. Comparisons were made between group with wound complications and those without and adjusted analyses performed to identify variables that independently increased the risk of wound complications. There were 14,868 patients in the study cohort and 2.6% (384 patients) developed wound complications after EVAR. Among those with wound complications, 94% (360 patients) of patients had superficial and deep surgical site infection. Patients who had wound complication were likely to be younger (72.6 vs. 73.7 years old (  = 0.02), functionally dependent (5.4 vs. 2.5%) (  < 0.05), smoker (3 vs. 2.4%, =0.03), female (4 vs. 2.2%), with significantly higher body mass index (31 vs. 28), and more commonly had diabetes (4 vs. 2.4%,  < 0.001) or renal failure (12 vs. 3%,  < 0.001). Although perioperative survival was similar, patients who had wound complications had significantly longer hospital length of stay (LOS) (7.3 ± 12 vs. 3.4 ± 5 days,  < 0.001). Up to 3% patients developed wound complications after open femoral exposure during EVAR with significantly higher LOS and therefore cost utilization.
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http://dx.doi.org/10.1055/s-0039-1683898DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6679999PMC
June 2019

Risk assessment of significant upper extremity arteriovenous graft infection in the Vascular Quality Initiative.

J Vasc Surg 2020 03 18;71(3):913-919. Epub 2019 Jul 18.

Division of Vascular and Endovascular Surgery, Boston Medical Center, Boston University School of Medicine, Boston, Mass. Electronic address:

Objective: Infectious complications of arteriovenous grafts (AVGs) are a major source of morbidity. Our aim was to characterize contemporary risk factors for upper extremity AVG infection.

Methods: The Vascular Quality Initiative (2011-2018) was queried for all patients undergoing upper extremity AVG creation. AVG infection was classified as an infection treated with antibiotics, incision and drainage, or graft removal. Multivariable analyses were used to evaluate risk factors for short- and long-term AVG infection.

Results: Of 1758 upper extremity AVGs, 49 (2.8%) developed significant infection within 3 months, resulting in incision and drainage in 24% and graft removal in 76% of cases. None were managed with antibiotics alone in the study sample. Patients with significant AVG infection were more likely to be white, to be insured, to have a history of coronary artery bypass graft and intravenous (IV) drug use, to be undergoing a concomitant vascular procedure, and to be discharged on an anticoagulant. In multivariable analysis, significant AVG infection within 3 months was associated with IV drug use history (odds ratio [OR], 5; 95% confidence interval [CI], 1.75-14.3; P = .003), discharge to a health care facility (OR, 2.66; 95% CI, 1.07-6.63; P = .035), discharge on an anticoagulant (OR, 2.31; 95% CI, 1.13-4.72; P = .021), white race (OR, 2.3; 95% CI, 1.21-4.34; P = .011), and female sex (OR, 2.02; 95% CI, 1.06-3.85; P = .033). Kaplan-Meier analysis showed that freedom from graft site infection at 1 year was 96.4%. Longer term graft infection at 1 year was independently associated with IV drug use history (hazard ratio [HR], 1.98; 95% CI, 1.06-3.68; P = .032), initial discharge to a health care facility (HR, 1.88; 95% CI, 1.19-2.97; P = .007), and white race (HR, 1.64; 95% CI, 1.23-2.19; P = .001).

Conclusions: Although significant AVG infection was uncommon in the Vascular Quality Initiative, the majority were treated with graft removal. In select high-risk patients, extra care should be taken and alternative forms of arteriovenous access may be considered.
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http://dx.doi.org/10.1016/j.jvs.2019.04.491DOI Listing
March 2020
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