Characterization of long-term survival in Medicare patients undergoing arteriovenous hemodialysis access.

BACKGROUND: Patients undergoing arteriovenous (AV) access creation for hemodialysis often have significant comorbidities. Our goal was to quantify the long-term survival and associated risks factors for long-term mortality in these patients to aid in optimization of goals and expectations. METHODS: The Vascular Implant Surveillance and Interventional Outcomes Network Vascular Quality Initiative Medicare linked data was used to assess long-term survival in the HD registry. Demographics, comorbidities, and interventions were recorded. Because the majority of hemodialysis patients are provided Medicare, Medicare linkage was used to obtain survival data. Multivariable analysis was used to identify independent associations with mortality. RESULTS: There were 13,945 AV access patients analyzed including 10,872 (78%) AV fistulas and 3073 (22%) AV grafts. The median age was 67 years and 56% of patients were male. Approximately one-third had a prior AV access and 44.7% had prior tunneled dialysis catheters. Patients receiving an AV fistula, compared with AV grafts, were more often younger, male, White, obese, independently ambulatory, preoperatively living at home, and less often have a prior AV access and tunneled dialysis catheters (P < .05 for all). The 5-year mortality overall was 62.9% with 61.2% for AV fistulas and 68.8% for AV grafts (P < .001). On multivariable analysis for 5 year mortality, nonambulatory status (hazard ratio [HR], 1.67; 95% confidence interval [CI], 1.53-1.83; P < .001), lower extremity access (HR, 1.67; 95% CI, 1.35-2.05; P < .001), human immunodeficiency virus or acquired immunodeficiency syndrome (HR, 1.44; 95% CI, 1.13-1.82; P < .001), White race (HR, 1.43; 95% CI, 1.35-1.51; P < .001), congestive heart failure (HR, 1.33; 95% CI, 1.26-1.41; P < .001), chronic obstructive pulmonary disease (HR, 1.23; 95% CI, 1.15-1.31; P < .001), and AV graft placement (HR, 1.12; 95% CI, 1.02-1.23, P = .016) were most associated with poor survival. Factors associated with improved survival were never smoking (HR, .73; 95% CI, 0.67-0.79; P < .001), prior/quit smoking (HR, .78; 95% CI, 0.72-0.84; P < .001), preoperative home living (HR, .75; 95% CI, 0.68-0.83; P < .001), and hypertension (HR, .89; 95% CI, 0.8-0.99; P = .03). CONCLUSIONS: Long-term survival in Medicare patients undergoing AV access creation is poor with nearly two-thirds of patients having died at 5 years. There are many modifiable risk factors that may improve survival in these patients and give an opportunity for transplantation.

A national census for the off-label treatment of complex aortic aneurysms.

OBJECTIVE: Despite regulatory challenges, device availability, and rapidly expanding techniques, off-label endovascular repair of complex aortic aneurysms (cAAs) has expanded in the past decade. Given the lack of United States Food and Drug Administration-approved endovascular technology to treat cAAs, we performed a national census to better understand volume and current practice patterns in the United States. METHODS: Targeted sampling identified vascular surgeons with experience in off-label endovascular repair of cAAs. An electronic survey was distributed with institutional review board approval from the University of Rochester to 261 individuals with a response rate of 38% (n = 98). RESULTS: A total of 93 respondents (95%) reported off-label endovascular repair of cAAs. Mean age was 45.7 ± 8.3 years, and 84% were male. Most respondents (59%) were within the first 10 years of practice, and 69% trained at institutions with a high-volume of off-label endovascular procedures for complex aortic aneurysms with or without a physician-sponsored investigational device exemption (PS-IDE). Twelve respondents from 11 institutions reported institutional PS-IDEs for physician-modified endografts (PMEGs), in-situ laser fenestration (ISLF), or parallel grafting technique (PGT), including sites with PS-IDEs for custom-manufactured devices. Eighty-nine unique institutions reported elective off-label endovascular repair with a mean of 20.2 ± 16.5 cases/year and ∼1757 total cases/year nationally. Eighty reported urgent/emergent off-label endovascular repair with a mean of 5.7 ± 5.4 cases/year and ∼499 total cases/year nationally. There was no correlation between high-volume endovascular institutions (>15 cases/year) and institutions with high volumes of open surgical repair for cAAs (>15 cases/year; odds ratio, 0.7; 95% confidence interval, 0.3-1.5; P = .34). Elective techniques included PMEG (70%), ISLF (30%), hybrid PMEG/ISLF (18%), and PGT (14%), with PMEG being the preferred technique for 63% of respondents. Techniques for emergent endovascular treatment of complex aortic disease included PMEG (52%), ISLF (40%), PGT (20%), and hybrid-PMEG/ISLF (14%), with PMEG being the preferred technique for 41% of respondents. Thirty-nine percent of respondents always or frequently offer referrals to institutions with PS-IDEs for custom-manufactured devices. The most common barrier for referral to PS-IDE centers included geographic distance (48%), longitudinal relationship with patient (45%), and costs associated with travel (33%). Only 61% of respondents participate in the Vascular Quality Initiative for complex endovascular aneurysm repair, and only 57% maintain a prospective institutional database. Eighty-six percent reported interest in a national collaborative database for off-label endovascular repair of cAA. CONCLUSIONS: Estimates of off-label endovascular repair of cAAs are likely underrepresented in the literature based on this national census. PMEG was the most common technique for elective and emergent procedures. Under-reported off-label endovascular repair of cAA outcomes data appears to be limited by non-standardized PS-IDE reporting to the United States Food and Drug Administration, and the lack of Vascular Quality Initiative participation and prospective institutional data collection. Most participants are interested in a national collaborative database for endovascular repair of cAAs.

Early survival benefit of a low-profile endograft in blunt traumatic aortic injury.

OBJECTIVE: The aim of this study was to demonstrate the safety and effectiveness of a low-profile thoracic endograft (19-23 French) in subjects with blunt traumatic aortic injury. METHODS: A prospective, multicenter study assessed the RelayPro thoracic endograft for the treatment of traumatic aortic injury. Fifty patients were enrolled at 16 centers in the United States between 2017 and 2021. The primary endpoint was 30-day all-cause mortality. RESULTS: The cohort was mostly male (74%), with a mean age of 42.4 ± 17.2 years, and treated for traumatic injuries (4% Grade 1, 8% Grade 2, 76% Grade 3, and 12% Grade 4) due to motor vehicle collision (80%). The proximal landing zone was proximal to the left subclavian artery in 42%, and access was primarily percutaneous (80%). Most (71%) were treated with a non-bare stent endograft. Technical success was 98% (one early type Ia endoleak). All-cause 30-day mortality was 2% (compared with an expected rate of 8%), with an exact two-sided 95% confidence interval [CI] of 0.1%, 10.6% below the performance goal upper limit of 25%. Kaplan-Meier analysis estimated freedom from all-cause mortality to be 98% at 30 days through 4 years (95% CI, 86.6%-99.7%). Kaplan-Meier estimated freedom from major adverse events, all-cause mortality, paralysis, and stroke, was 98.0% at 30 days and 95.8% from 6 months to 4 years (95% CI, 84.3%-98.9%). There were no strokes and one case of paraplegia (2%) during follow-up. CONCLUSIONS: RelayPro was safe and effective and may provide an early survival benefit in the treatment of blunt traumatic aortic injury.

A Bibliometric Analysis on Adherence to Reporting Standards for Endovascular Treatment of Chronic Lower Extremity Peripheral Artery Disease.

BACKGROUND: The treatment of chronic limb-threatening ischemia (CLTI) involves a broad spectrum of therapies including many new and emerging techniques. To standardize the results of studies examining this pathology and to allow critical analysis and comparison between studies, the Society for Vascular Surgery (SVS) recommended reporting standard guidelines for the endovascular management of CLTI in 2016. Research studies that do not adhere to complete reporting standards are often more ambiguous in impact and external validity, leading to bias and misinformation that has potentially damaging effects on clinical decision-making. We thus sought to examine adherence to and factors associated with noncompliance with these recommended guidelines. METHODS: A literature database search was conducted to include all clinical trials, randomized controlled trials, and retrospective comparative studies written in English examining the endovascular treatment of peripheral artery disease (PAD)/CLTI from January 2020 to August 2022. Systematic reviews, case reports, and meta-analysis were excluded. The manuscripts were reviewed for adherence with the SVS guidelines (overall and by guideline subcategories based on demographics, treatment methods, and outcomes), and factors associated with this adherence were determined. These data were used to calculate descriptive and comparative statistics. RESULTS: Fifty-four manuscripts were identified from this time frame. On average, articles reviewed reported on 42.0% of the SVS reporting standards (range, 25.0-65.2%, Fig 1) with 74.1% of articles (n = 40) not adhering to at least 50.0% of the standards. Manuscripts most completely followed guidelines regarding "patient factors" and were least likely to demonstrate adherence to the description of CLTI and study complications. Within the guideline subcategories, complete adherence to guidelines was not demonstrated in any manuscript in stent trials, disease outcome measures, technical outcome measures, patient factors and critical limb ischemia description, and complete adherence rates within the other subcategories was low (range, 5.6-18.6%). Studies conducted within the United States and those with industry sponsorship were more likely to adhere to >50% of the reporting standards (P < 0.05). Journal impact factor, year of publication, and number of authors had no correlation to the percent adherence to guidelines in specific categories or adherence overall. CONCLUSIONS: Adherence to reporting standard guidelines for endovascular treatment of lower extremity PAD specifically outlined by the SVS is suboptimal regardless of the quality of the journal the research is published in. Increasing adherence to reporting standards to provide a framework for comparison of studies across techniques used should be prioritized by authors, journal editors, and vascular societies.

Practice Patterns and Barriers to Vascular Genetic Testing Among Vascular Surgeons.

INTRODUCTION: Engaging patients living with or at risk of aortic dissection via the Aortic Dissection Collaborative, physician education in vascular genetics was identified as a research priority. We surveyed vascular surgeons to characterize practice patterns, motivations, and barriers regarding aortopathy genetic testing. METHODS: An anonymous 27-question survey was distributed on social media platforms between November and December 2022. Domains included demographics, vascular genetic education, testing attitudes and utilization, and experience in treating patients with genetic vascular aortopathies. The analysis included summary statistics and unpaired t-test to compare responses by interest in incorporating testing and practice type. RESULTS: A total of 171 vascular surgeons from 15 countries responded to the survey (23% trainees). Over half received vascular genetics education during training (59%), and most (86%) were interested in incorporating genetic testing into their practice. Academic surgeons were more likely to have cared for a patient with a known genetic aortopathy over the past year than surgeons in hospital-based and private practices (83% vs. 56% vs. 27%; P < 0.01), to have ever made a referral to a medical geneticist (78% vs. 51% vs. 9%; P < 0.01), and have access to genetic counselors or geneticists (66% vs. 46% vs. 0%; P < 0.01). Barriers to genetic testing were rated as more significant by surgeons in nonacademic practices, with top barriers being insurance coverage of testing, cost of genetic testing, and access to genetic counselors. Evidence-based professional society guidelines were the strongest rated motivating factor for testing incorporation among respondents. CONCLUSIONS: Vascular surgeon attitudes are not major barriers to incorporating genetic testing for patients with aortopathies; however, practical challenges regarding genetic testing and counseling are barriers to implementation especially for vascular surgeons in nonacademic practices. Future efforts should focus on evidence-based society guidelines, continuing medical education to increase adoption, and facilitating access to genetic counseling.

Treating deep venous insufficiency with a novel implantable device.

Chronic venous insufficiency (CVI) is increasing in prevalence on a global scale. Current treatment options are limited to improving venous return, ablation of refluxing veins, and reducing outflow obstruction. A new bioprosthetic device, the VenoValve, may bridge the gap of treatment for patients with chronic venous insufficiency who have failed prior treatment. We demonstrate the treatment of a 72-year-old man with bilateral venous insufficiency and leg wounds using this device in his left femoral vein via an open anterior surgical approach. The patient had no postoperative complications, and a patent valve at 6 months. The VenoValve may be a viable option for patients with advanced chronic venous insufficiency.

Intravascular Ultrasound May Not Impact Graft Sizing in Endovascular Repair of Blunt Thoracic Aortic Injury.

OBJECTIVES: Thoracic endovascular aortic repair (TEVAR) is the preferred treatment for severe blunt thoracic aortic injuries (BTAI). Successful outcomes rely on accurate endograft sizing, but initial imaging may underestimate aortic diameters. This study examines the impact of intravascular ultrasound (IVUS) on endograft sizing and clinical outcomes in BTAI patients. METHODS: A prospectively collected multi-institutional dataset from the Aortic Trauma Foundation was analyzed. Patients with BTAI undergoing TEVAR with IVUS were compared to patients who underwent TEVAR alone. Demographics and operative variables were compared, focusing on IVUS effects on endograft sizing by examining maximal proximal and distal aortic diameter on initial CT imaging compared to the graft diameters used during TEVAR. RESULTS: 293 patients underwent TEVAR for BTAI with IVUS utilized in 124 cases (42.3%). The average graft size in the IVUS and non-IVUS groups were similar proximally (26.91 ± 4.3 mm IVUS vs 27.77 ± 4.7 mm non-IVUS, P = 0.116) and distally (25.96 ± 4.7 mm IVUS vs 26.51 ± 4.7 mm non-IVUS). IVUS did not impact the difference between graft size and initial CT measurements proximally (4.32 ± 4.8 mm IVUS vs 4.23 ± 3.9 mm non-IVUS, P = 0.859) or distally (4.17 ± 5.9 mm IVUS vs 4.50 ± 4.3 mm non-IVUS, P = 0.606). Although delayed hemorrhagic and ischemic stroke occurred less frequently in IVUS patients (0.8% IVUS vs 7.1% non- IVUS, P = 0.024), in-hospital mortality was similar between groups (5.6% IVUS vs 7.7% non-IVUS, P = 0.581). CONCLUSIONS: IVUS is not associated with significant changes in endograft sizing compared to sizing based on CT scan alone in BTAI patients. IVUS was not associated with differences in mortality but was associated with a decrease in delayed hemorrhagic and ischemic stroke. Routine IVUS in BTAI patients may not be necessary for accurate sizing, but there may be a relationship between IVUS and stroke.

Factors Associated With Tobacco Cessation Advice Recall and Quit Rates in Vascular Surgery Patients. A Single Center Study.

OBJECTIVES: Smoking is an important modifiable risk factor in all vascular diseases and verbal advice from providers has been shown to increase rates of tobacco cessation. We sought to identify factors that will improve tobacco cessation and recall of receiving verbal cessation advice in vascular surgery patients at a single institution. METHODS: The study is a retrospective cohort study. Patients seen in outpatient vascular surgery clinic who triggered a tobacco Best Practice Advisory (BPA) during their office visits over a 10-month period were contacted post-clinic and administered surveys detailing smoking status, cessation advice recall, and validated scales for nicotine dependence and willingness to quit smoking. This BPA is a "hard stop" that requires providers to document actions taken. Charts were reviewed for tobacco cessation documentation. Nine-digit zip-codes identified the area deprivation index, a measure of socioeconomic status. Univariate analysis was used to identify factors associated with cessation and advice recall. RESULTS: One hundred out of 318 (31.4%) patients responded to the survey. Epic Slicer Dicer found 97 BPA responses. To dismiss the BPA, 89 providers (91.8%) selected "advised tobacco cessation" and "Unable to Advise" otherwise. Of the 318 patients, 115 (36.1%) had cessation intervention documented in their provider notes and 151 (47.5%) received written tobacco cessation advice. Of survey respondents, 70 recalled receiving verbal advice, 27 recalled receiving written advice, 28 reported receiving offers of medication/therapy for cessation. 55 patients reported having tobacco cessation plans, and among those 17 reported having quit tobacco. Recall of receiving written advice (P < .001) and recall of receiving medication/therapy (P = .008) were associated with recall of receiving verbal cessation advice. CONCLUSIONS: Providing patients with tobacco cessation medication/therapy and written tobacco cessation education during office visits is associated with increased patients' recall of tobacco cessation advice. Vascular surgeons should continue to provide directed tobacco cessation advice.