Long Term Results of Physician Modified Endografts for the Treatment of Elective, Symptomatic and Ruptured Juxtarenal Abdominal Aortic Aneurysms.

OBJECTIVE: The objective of this study was to report long term results of an ongoing physician-sponsored, investigational device exemption (IDE) pivotal clinical trial using physician-modified endovascular grafts (PMEGs) for the treatment of patients with juxtarenal aortic aneurysms. METHODS: Data from a nonrandomized, prospective, consecutively enrolling IDE clinical trial were used. Data collection began on April 1, 2011, and data lock occurred on January 2, 2024, with outcomes analysis through December 31, 2023. Primary safety and effectiveness end points were used to measure treatment success. The safety end point was defined as the proportion of subjects who experienced a major adverse event within 30 days of the procedure. The effectiveness end point was the proportion of subjects who achieved treatment success. Treatment success required the following at 12 months: technical success, defined as successful delivery and deployment of a PMEG with preservation of intended branch vessels; and freedom from: type I and III endoleak, stent graft migration >10 mm, aortic aneurysm sack enlargement >5 mm, and aortic aneurysm rupture or open conversion. RESULTS: Over the 12-year study period, 228 patients were enrolled; 205 began the implant procedure and 203 received PMEG. Thirteen patients withdrew prior to PMEG. Two withdrew (<1.0%) after failure to deploy due to tortuous iliac anatomy and are tracked as intent to treat and a total of 24 withdrew after receiving the PMEG implant. 44 patients died during the study period. A total of 14 were deemed lost to follow up. Fifty-nine completed the five-year follow-up period and 62 remain active in follow-up visits.Aneurysm anatomy, operative details, and lengths of stay were recorded and included: aneurysm diameter (mean, 67.5 mm; range, 49-124 mm), proximal seal zone length (mean, 41.6 mm; range, 18.9-92.9 mm), graft modification time (mean, 48.7 min), procedure time (mean, 137.7 min), fluoroscopy time (mean, 33.8 min), contrast material use (mean, 93.0 mL), estimated blood loss (mean, 118.8 mL), length of hospital stay (mean, 3.7 d) and ICU length of stay (mean, 1.6 d).A total of 575 fenestrations were created for 387 renal arteries, 181 superior mesenteric arteries (SMAs), and 7 celiac arteries. Renal arteries were in 96% of patients and included 410 renal artery stents in 203 patients. The SMA was stented as needed and included one patient with an SMA stent placed before the procedure, 19 during the procedure, and 2 patients underwent stent placement after the procedure. There were no open conversions or device migrations and one partial explant due to late distal graft occlusion. Three ruptures (1.4%) were recorded on days 830, 1346 and 1460. There was one presumed graft infection at 750 days (<0.5%) treated with? Thirty-day all-cause mortality was 2.9% (6/204). One type Ia, one type Ib, and seven type III endoleaks were identified during follow-up and treated with successful reintervention at the one year period. The overall rate of major adverse events at 30 days was 15% (29/194). Technical success was 93.7% and overall treatment success 82.6%. CONCLUSIONS: PMEG can be performed with low rates of long term morbidity and mortality, confirming our early and midterm reports that endovascular repair with PMEG is safe, durable and effective for managing patients with juxtarenal aortic aneurysms. While historically considered experimental, these results suggest that PMEG is a safe and durable option and should be considered for patients where off-the-shelf devices are not available.

Using Multidisciplinary Teams to Improve Outcomes for Treating Chronic-Limb Threatening Ischemia.

Multidisciplinary teams are necessary to treat complex patients with chronic limb-threatening ischemia (CLTI). The need for adequate wound care and control of comorbid conditions cannot be accomplished by the vascular specialist alone. Numerous specialties have a role in this group to include surgical podiatrists, orthopedic surgery, plastic and reconstructive surgery endocrinology, and wound care. However, the vascular specialist must drive this team as the patients are usually referred to them and numerous studies have shown a direct correlation between major amputations and the lack of vascular involvement. Creating these teams is unique in each community and must consider practice patterns that are relevant in the local region. CLTI is a challenging disease to manage, and multidisciplinary teams have demonstrated an ability to improve outcomes and deliver superior care to this patient population.

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.

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.

Surgical release of anterior tibial artery entrapment with associated popliteal artery entrapment.

Popliteal artery entrapment syndrome (PAES) is compression of the popliteal artery from embryologic myotendinous variation or calf muscle hypertrophy. PAES necessitates prompt diagnosis and complete release of the entrapped vasculature for symptom relief and to prevent chronic cumulative vascular damage. Our patient is a 27-year-old female referred for progressive bilateral claudication. Workup was consistent with bilateral PAES with preoperative imaging notable for an atypically proximal origin of the anterior tibial artery, which was also encased anterior to the popliteus muscle. Preoperative angiogram confirmed the diagnosis, and complete surgical release resolved symptoms by 4 months postoperatively.

Patterns in Complex Aortic Vascular Surgery Training and Early Career Practice.

BACKGROUND: Recent literature has suggested a decreasing experience with open aortic surgery among recent vascular surgery graduates. While trainees have a wide exposure to endovascular aortic repair, experience with both endovascular and open management of thoracoabdominal aneurysms, as well as the early career surgeon comfort with these procedures, remains unknown. Thus, we sought to evaluate early practice patterns in the surgical treatment of complex aortic surgery among recent US vascular surgery graduates. METHODS: An anonymous survey was distributed among all vascular surgeons who completed vascular surgery residency or fellowship in 2020. Self-reported data assessed the number and type of cases performed in training, surgeon experience in early practice, and surgeon desire for additional training in these areas. RESULTS: A total of 62 surgeons completed the survey with a response rate of 35%. Seventy-nine percent of respondents completed fellowship training (as compared to integrated residency), and 87% self-described as training in an academic environment. Sixty-six percent performed less than 5 open thoracoabdominal aortic surgeries and 58% performed less than 5 4-vessel branched/fenestrated aortic repairs (F/BEVARs), including 56% who completed less than 5 physician modified endovascular grafts repairs. Only 11% of respondents felt adequately prepared to perform open thoracoabdominal operations following training. For both open and F/BEVAR procedures, more than 80% respondents plan to perform such procedures with a partner in their current practice, and the majority desired additional open (61%) and endovascular (59%) training for the treatment of thoracoabdominal aneurysms. CONCLUSIONS: The reported infrequency in open thoracoabdominal and multivessel F/BEVAR training highlights a desire and utility for an advanced aortic training paradigm for surgeons wishing to focus on this area of vascular surgery. Further research is warranted to determine the optimal way to provide such training, whether through advanced fellowships, junior faculty apprenticeship models, or regionalization of this highly complex patient care. The creation of these programs may provide pivotal opportunity, as vascular surgery and the management of complex aortic pathology continues to evolve.