2024 ACC/AHA/AACVPR/APMA/ABC/SCAI/SVM/SVN/SVS/SIR/VESS Guideline for the Management of Lower Extremity Peripheral Artery Disease: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines.

AIM: The "2024 ACC/AHA/AACVPR/APMA/ABC/SCAI/SVM/SVN/SVS/SIR/VESS Guideline for the Management of Lower Extremity Peripheral Artery Disease" provides recommendations to guide clinicians in the treatment of patients with lower extremity peripheral artery disease across its multiple clinical presentation subsets (ie, asymptomatic, chronic symptomatic, chronic limb-threatening ischemia, and acute limb ischemia). METHODS: A comprehensive literature search was conducted from October 2020 to June 2022, encompassing studies, reviews, and other evidence conducted on human subjects that was published in English from PubMed, EMBASE, the Cochrane Library, CINHL Complete, and other selected databases relevant to this guideline. Additional relevant studies, published through May 2023 during the peer review process, were also considered by the writing committee and added to the evidence tables where appropriate. STRUCTURE: Recommendations from the "2016 AHA/ACC Guideline on the Management of Patients With Lower Extremity Peripheral Artery Disease" have been updated with new evidence to guide clinicians. In addition, new recommendations addressing comprehensive care for patients with peripheral artery disease have been developed.

The Diversity of Surgical Trainees Index identifies racial and ethnic disparities among surgical specialties.

OBJECTIVE: Racial and ethnic disparities have been well-described among surgical specialties; however, variations in underrepresented in medicine (URiM) representation between these specialties have not previously been quantified. METHODS: Data collected from Accreditation Council for Graduate Medical Education (ACGME) annual reports were used to derive the Diversity of Surgical Trainee Index (DoSTI), which was calculated as the proportion of URiM residents and fellow physicians within a given surgical specialty, relative to the overall proportion of URiM trainees within all surgical and non-surgical ACGME-accredited programs in the same academic year. RESULTS: From 2013 to 2022, a total of 108,193 ACGME-accredited residency programs trained 1,296,204 residents and fellows in the United States. Of these, 14.1% (n = 182,680) of trainees self-identified as URiM over the study period. The mean DoSTI among all surgical specialties was 0.80 (standard error, 0.01) compared with all ACGME-accredited programs. High DoSTI specialties incorporated significantly higher proportions of trainees who identify as Hispanic (8.7% vs 6.3%) and Black or African American (5.2% vs 2.5%) when compared with low DoSTI specialties (P < .0001 each). General surgery (1.06 ± 0.01), plastic surgery (traditional) (1.12 ± 0.06), vascular surgery (integrated) (0.96 ± 0.03), and vascular surgery (traditional) (0.94 ± 0.06) had the highest DoSTI (P < .05 each vs composite). On linear regression analysis, only ophthalmology (+0.01/year; R2 = 0.41; P = .019), orthopedic surgery (+0.01/year; R2 = 0.33; P = .047), otolaryngology (+0.02/year; R2 = 0.86; P < .001), and pediatric surgery (+0.06/year; R2 = 0.33; P = .048) demonstrated an annual increase in DoSTI. CONCLUSIONS: The DoSTI is a novel metric used to quantify the degree of URiM representation among surgical specialties. DoSTI has revealed specialty-specific variations in racial/ethnic minority representation among surgical training programs. This metric may be used to improve provider awareness and identify high performing DoSTI specialties to highlight best practices to ultimately recruit a more diverse surgical workforce.

Three-Year Outcomes of a US Pivotal Trial Substudy for Conformable Endoprosthesis in >=10 mm Non-Angulated Neck Anatomy.

OBJECTIVE: To report the midterm clinical outcomes from the GORE® EXCLUDER® Conformable AAA Endoprosthesis system (EXCC) pivotal regulatory trial in the United States (U.S.). METHODS: This is a prospective, multicenter, investigational device exemption clinical trial at 31 U.S. sites with Core Laboratory assessment of imaging and independent adjudication of safety. The study enrolled patients with abdominal aortic aneurysms (AAA) with a minimum proximal landing zone ≥ 10mm and proximal neck angulation of ≤ 60 degrees between December 2017 and February 2019 as part of a larger study to gain indications of the EXCC device. Endpoints included patient survival, freedom from secondary interventions, and stent-graft related outcomes. RESULTS: There were 80 patients enrolled (88.8% male, mean 73.5 ± 8.14 years-old). Mean maximum aortic diameter was 57.7±8.0 mm (range, 42.5-82.7). There was 100% freedom from type I and III endoleak and aneurysm-related mortality at 36-months. Freedom from secondary intervention was 91.9 ± (0.83, 0.96, 95% C.I.) at 36-months. There were no device fractures, migrations (>=10 mm), or aneurysm ruptures. At 36 months, thirteen patients (26.5%) had type 2 endoleak, 32 patients (58.2%) had AAA sac regression, 17 (30.9%) had no change in diameter, and 6 (10.9%) had sac enlargement. Seven patients (8.8%) through 36 months underwent reintervention. CONCLUSIONS: The 3-year outcomes have continued to show an adequate safety and efficacy profile of the EXCC device with no aneurysm related mortality or Type I/III endoleak. These results demonstrate durability for an EVAR device in US regulatory trials.

Long-term outcomes for hybrid aortic arch repair.

OBJECTIVE: Since its inception in the early 2000s, hybrid arch repair (HAR) has evolved from novel approach to well-established treatment modality for aortic arch pathology in appropriately selected patients. Despite this nearly 20-year history of use, long-term results of HAR remain to be determined. As such, objectives of this study are to detail the long-term outcomes for HAR within an expanded classification scheme. METHODS: From August 2005 to August 2022, 163 consecutive patients underwent HAR at a single referral institution. Operative approach was selected according to an institutional algorithm and included zone 0/1 HAR in 25% (n = 40), type I HAR in 34% (n = 56), and type II/III HAR in 41% (n = 67). Specific zone 0/1 technique was zone 1 HAR in 31 (78%), zone 0 with innominate snorkel (zone 0S HAR) in 7 (18%), and zone 0 with single side-branch endograft (zone 0B HAR) in 2 (5%). The 30-day and long-term outcomes, including overall and aortic-specific survival, as well as freedom from reintervention, were assessed. RESULTS: The mean age was 63 ± 13 years and almost one-half of patients (47% [n = 77]) had prior sternotomy. Presenting pathology included degenerative aneurysm in 44% (n = 71), residual dissection after prior type A repair in 38% (n = 62), chronic type B dissection in 12% (n = 20), and other indications in 6% (n = 10). Operative outcomes included 9% mortality (n = 14) at 30 days, 5% mortality (n = 8) in hospital, 4% stroke (n = 7), 2% new dialysis (n = 3), and 2% permanent paraparesis/plegia (n = 3). The median follow-up was 44 month (interquartile range, 12-84 months). Overall survival was 59% and 47% at 5 and 10 years, respectively, whereas aorta-specific survival was 86% and 84% at the same time points. At 5 and 10 years, freedom from major reintervention was 92% and 91%, respectively. Institutional experience had a significant impact on both early and late outcomes: comparing the first (2005-2012) and second (2013-2022) halves of the series, 30-day mortality decreased from 14% to 1% (P = .01) and stroke from 6% to 3% (P = .62). Improved operative outcomes were accompanied by improved late survival, with 78% of patients in the later era vs 45% in the earlier era surviving to 5 years. CONCLUSIONS: HAR is associated with excellent operative outcomes, as well as sustained protection from adverse aortic events as evidenced by high long-term aorta-specific survival and freedom from reintervention. However, surgeon and institutional experience appear to play a major role in achieving these superior outcomes, with a five-fold decrease in operative mortality and a two-fold decrease in stroke rate in the latter half of the series. These long-term results expand on prior midterm data and continue to support use of HAR for properly selected patients with arch disease.

Risk factors and consequences of wound complications following sartorius flap reconstruction.

OBJECTIVE: Groin wound complications are common following vascular surgery and can lead to significant patient morbidity. Sartorius muscle flap coverage may help to prevent vascular graft infection in the setting of wound dehiscence or infection. However, risk factors and consequences of wound complications following sartorius flap reconstruction remain incompletely investigated. METHODS: We retrospectively queried all patients who underwent sartorius flap reconstruction at a tertiary academic medical center. Data collected included patient demographics, medical comorbidities, surgical indication, index vascular procedure, and postoperative outcomes. The primary outcome was wound complication following sartorius flap procedure, which was defined as groin wound infection, dehiscence, or lymphocutaneous fistula. RESULTS: From 2012 to 2022, a total of 113 patients underwent sartorius flap reconstruction. Of these, 66 (58.4%) were performed after the development of a prior groin complication, and 47 (41.6%) were prophylactic. A total of 88 patients (77.9%) had a prosthetic bypass graft adjacent to the flap. Twenty-nine patients (25.7%) suffered a wound complication following sartorius flap reconstruction, including 14 (12.4%) with wound dehiscence, 13 (11.5%) with wound infection, and two (1.8%) with lymphocutaneous fistula. Patients with wound complications had a higher body mass index (28.8 vs 26.4 kg/m2; P =.03) and more frequently active smokers (86.2% vs 66.7%; P = .04). Additionally, patients with wound complications had a higher unplanned 30-day hospital readmission rates (72.4% vs 15.5%; P < .001), reintervention rates (75.9% vs 8.3%; P < .001), and re-do flap reconstruction rates (13.8% vs 2.4%; P = .02). On multivariable analysis, higher body mass index was independently associated with post-flap wound complications (adjusted odds ratio [aOR], 1.01; 95% confidence interval [CI], 1.001-1.03; P = .037). Consequently, wound complications were associated with both surgical reintervention (aOR, 35.4; 95% CI, 9.9-126.3; P < .001) and unplanned hospital readmission (aOR, 17.8; 95% CI, 5.9-54.1; P < .001). CONCLUSIONS: Sartorius flap reconstruction is an effective adjunct in facilitating wound healing of groin wounds. However, wound complications are common following sartorius flap reconstruction and may be associated with reintervention and unplanned hospital readmission. These data support the judicious and thoughtful utilization of sartorius flap procedures among high-risk patients.

Diversity in randomized clinical trials for peripheral artery disease: a systematic review.

BACKGROUND: Significant race and sex disparities exist in the prevalence, diagnosis, and outcomes of peripheral artery disease (PAD). However, clinical trials evaluating treatments for PAD often lack representative patient populations. This systematic review aims to summarize the demographic representation and enrollment strategies in clinical trials of lower-extremity endovascular interventions for PAD. METHODS: Following the 2020 Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines, we searched multiple sources (Medline, EMBASE, Cochrane, Clinicaltrials.gov, WHO clinical trial registry) for randomized controlled trials (RCTs), RCT protocols, and peer-reviewed journal publications of RCTs conducted between January 2012 and December 2022. Descriptive analysis was used to summarize trial characteristics, publication or study protocol characteristics, and the reporting of demographic characteristics. Meta-regression was used to explore associations between demographic characteristics and certain trial characteristics. RESULTS: A total of 2,374 records were identified. Of these, 59 met the inclusion criteria, consisting of 35 trials, 14 publications, and 10 protocols. Information regarding demographic representation was frequently missing. While all 14 trial publications reported age and sex, only 4 reported race/ethnicity, and none reported socioeconomic or marital status. Additionally, only 4 publications reported clinical outcomes by demographic characteristics. Meta-regression analysis revealed that 6% more women were enrolled in non-European trials (36%) than in European trials (30%). CONCLUSIONS: The findings of this review highlight potential issues that may compromise the reliability and external validity of study findings in lower-extremity PAD RCTs when applied to the real-world population. Addressing these issues is crucial to enhance the generalizability and impact of clinical trial results in the field of PAD, ultimately leading to improved clinical outcomes for patients in underrepresented populations. REGISTRATION: The systematic review methodology was published in the International Prospective Register of Systematic Reviews (PROSPERO: CRD42022378304).

Five-Year Results for Abdominal Aortic Aneurysm Repair with the GORE® EXCLUDER® Device: Insights from the Gore Global Registry for Endovascular Aortic Treatment (GREAT).

BACKGROUND: The early postoperative benefits of endovascular aneurysm repair (EVAR) have been well established but questions remain regarding its durability at mid-term and long-term time points. Long-term results in real-world use of EVAR outside of randomized trial data are limited. This study used the Global Registry for Endovascular Aortic Treatment registry to explore the 5-year outcomes with the GORE EXCLUDER device in real-world clinical circumstances. METHODS: All patients within the Global Registry for Endovascular Aortic Treatment registry who underwent an infrarenal abdominal aortic aneurysm repair with the GORE EXCLUDER device were included in this study. Baseline characteristics and demographic information of the cohort were collected. End points included mortality (all-cause and aneurysm-related), serious endoleaks, aneurysm sac diameter, endograft integrity (fracture, compression, migration), post-EVAR aortic rupture, device-related reintervention, conversion to open repair, graft explantation, and major adverse cardiovascular events. RESULTS: A total of 3,216 patients were included in this analysis. The cohort reflected a significantly comorbid population with 46% of patients reaching a Charlson Comorbidity Index score of ≥5. Follow-up at 5 years was 60% of eligible participants. The freedom from aortic-related mortality was at 98.8% and overall survival was 71.2%. Postoperative major adverse cardiovascular events occurred in 49 (1.5%) patients. Device-related intervention through 5 years was 7.2% and the overall serious endoleak rate was 6.8%. Less than 1% of patients required an open conversion/revision and aortic rupture following device placement occurred in 15 (0.5%) patients. Aneurysm sac regression was achieved in 58.1% of patients at 5 years, and stability/absence of growth was observed in 83.6% at 5 years. CONCLUSIONS: This study supports the durability of the GORE EXCLUDER device through 5 years with negligible incidence of graft integrity compromise and low aortic/device-related reintervention rates. Furthermore, the efficacy of the device is highlighted with low aortic-related mortality and high sac regression/stability diameter through 5 years.

Surgical Specialty Impacts Quality of Operative Training in Carotid Endarterectomy.

BACKGROUND: Carotid endarterectomy (CEA) is currently performed by multiple surgical specialties. The impact of surgical specialty and operative volume on post-CEA outcomes has been well described. However, it is unclear whether trainees of different surgical specialties have similar quality of operative training. METHODS: Data from Accreditation Council for Graduate Medical Education annual reports were collected and compared between graduating vascular surgery (VS) residents, VS fellows, and neurological surgery (NS) residents. Only cases reported as chief/senior/lead resident, surgeon junior, or surgeon fellow were included in analysis. Linear regression analysis was utilized to evaluate trends in case-mix and volume. RESULTS: From 2013 to 2022, total CEA case volume was higher among VS residents and fellows, compared to NS residents (52.8 ± 0.8 vs. 44.3 ± 1.4 vs. 12.9 ± 0.6, P < 0.0001). Additionally, VS residents and fellows performed other carotid operations including transfemoral or transcarotid artery stenting (11.1 ± 0.9 vs. 11.2 ± 0.8 vs. 0), carotid body tumor resection (0.7 ± 0.1 vs. 0.7 ± 0.0 vs. 0), and extracranial cervical bypass (6.7 ± 0.3 vs. 6.3 ± 0.3 vs. 0) that were not reported by the NS resident cohort (P < 0.0001 each). On linear regression analysis, total CEA procedures did not change for VS residents (R2 = 0.03, P = 0.62), decreased for VS fellows (-1.29 cases/yr, R2 = 0.75, P < 0.0001), and decreased among NS residents (-0.41 cases/yr, R2 = 0.44, P = 0.01) over the study period. CONCLUSIONS: Although residents of multiple surgical specialties are trained in CEA, vascular training offers significantly greater numbers and diversity of extracranial carotid cases. It also appears that CEA volume is decreasing among neurosurgical trainees. In light of recent reports on the volume-outcome effect in carotid surgery, these data may have implications for future practice patterns in the domain of extracranial carotid artery disease.

Prosthetic Conduit Use Does Not Adversely Impact Outcomes after Open Repair of Popliteal Artery Aneurysms.

BACKGROUND: Single segment, greater saphenous vein (GSV) conduit is considered the optimal bypass conduit among patients undergoing bypass surgery for peripheral artery disease (PAD). While this data has been extrapolated to patients undergoing bypass for popliteal artery aneurysms (PAAs), the pathophysiology of PAA is inherently different when compared to PAD, and the impact of conduit type on long-term outcomes after open repair of PAA remains unclear. METHODS: A multicenter database of five regional hospitals was retrospectively reviewed for all patients with PAA undergoing open surgical repair. Data were collected on demographic information, operative details, medications, and postoperative outcomes. Kaplan-Meier curves were used to compare freedom from major adverse limb events (MALE) following GSV versus prosthetic bypass. Cox proportional hazards model was used to identify patient-level characteristics associated with MALE, which was defined as major ipsilateral limb amputation or reintervention for graft patency. RESULTS: From 1999 to 2020, a total of 101 patients with PAA underwent open exclusion and bypass surgery. Median follow-up period was 4.2 years (interquartile range, 1.3-7.4 years), and complete data were available for 99 (98.0%) patients. The majority of patients were male (99.0%) and Caucasian (93.9%). Only 11.1% of procedures were emergent, with the remainder (88.9%) being elective. All patients underwent medial exposure with a below-knee popliteal bypass target (100%). Bypass conduits included GSV (69.7%), prosthetic conduit (28.3%), and 2 (2.0%) alternative conduits (one spliced arm vein, one cryopreserved vein). Patients undergoing prosthetic bypass were older (72 vs. 66 years, P = 0.001) and had similar rates of medical comorbidities. Compared with the GSV group, patients with prosthetic conduits were more frequently placed on postoperative anticoagulation (60.7% vs. 23.2%, P < 0.001). Conduit type did not impact postoperative complication rates (P = NS each). MALE rates were low overall (19.2% at 2 years), and similar when stratified by conduit type (log rank P = 0.47). On multivariable analysis, emergent bypass was associated with MALE (hazard ratio [HR] 5.73, 95% confidence interval [CI] 2.07-15.85, P < 0.001). Prosthetic conduit usage (HR 1.00, 95% CI, 0.40-2.51, P = 0.99) and postoperative anticoagulation (HR 1.02, 95% CI 0.42-2.50, P = 0.97) were not associated with MALE. CONCLUSIONS: Open repair of PAA is associated with excellent long-term outcomes. Prosthetic bypass is a comparable alternative to autogenous conduit for below-knee popliteal bypass targets, and lack of suitable GSV should not prohibit open surgical repair when indicated.

Understanding the Scope of Acute Care Vascular Surgery at a Tertiary Academic Medical System.

OBJECTIVE: The restructuring of non-elective general surgery and nationwide implementation of the acute care surgery paradigm has improved patient outcomes and healthcare resource utilization. Although vascular surgery maintains one of the highest acuity rates among surgical specialties, the acute care vascular surgery (ACVS) practice model has not been widely accepted. In the present study, we investigate the scope and burden of ACVS at a tertiary academic medical system. METHODS: All vascular surgical procedures performed at three hospitals comprising a large tertiary academic medical system were retrospectively queried through electronic medical records. Data were collected on procedure, acuity, timing of intervention, primary service, admission type, and total costs and charges. Patients were stratified by acuity of surgical intervention, with ACVS being defined as urgent or emergent operation. RESULTS: A total of 12,689 vascular surgeries were performed from 2018 to 2022. ACVS procedures comprised 22.1% this total (n=2,803; 12.5% urgent, 9.6% emergent), with an annual burden ranging from 19.1% to 28.3%. Vascular surgeons served as primary surgeon in 91.3% of ACVS and co-surgeon in 8.7%. Fourteen separate surgical specialties requested acute vascular assistance, with the most frequently consulting specialties including trauma/acute care surgery (n=109, 3.9%) and cardiac surgery (n=74, 2.6%). ACVS cases were more frequently performed after-hours (30.7% vs 11.6%) and on weekends (27.1% vs 2.0%) compared with elective vascular procedures (p<0.0001 each). The majority of ACVS cases originated from inpatient (n=2,353, 85.0%) and emergency department (n=379, 13.5%) consultations. Overall, ACVS generated $37.5 million in charges, accounting for 14% of total procedure-related charges over the study period. CONCLUSIONS: ACVS comprises a substantial portion of modern vascular practice, and is associated with significant human and healthcare resource expenditure. These data support the development of practice models dedicated to acute vascular surgical care.

Concerning Trends in Vascular Surgery Trainee Operative Experience in Venous Disease.

BACKGROUND: Comprehensive vascular care includes both arterial and venous disease management. However, operative training in venous disease is often significantly overshadowed by arterial procedures, despite the public health burden of acute and chronic venous disease. The purpose of this study is to evaluate the case-mix and volume of venous procedures performed by graduating integrated vascular surgery residents and fellows in the United States. METHODS: Accreditation Council for Graduate Medical Education national operative log reports were compiled for graduating integrated VSR (vascular surgery residency) and traditional vascular surgery fellowship (VSF) trainees from academic years 2013 to 2022. Only cases categorized as "surgeon fellow", "surgeon chief", or "surgeon junior" were included. Linear regression analysis was utilized to evaluate trends in case-mix and volume. RESULTS: Over the 10-year study period, total vascular cases increased for both VSR (mean 870.5 ± 9.3 cases, annual change +9.5 cases/year, R2 = 0.77, P < 0.001) and VSF (mean 682.1 ± 6.9 cases, annual change +6.7 cases/year, R2 = 0.85, P < 0.001) trainees. Concurrently, the proportion of venous cases in the VSR group decreased from 12.5% to 7.3% (annual change -3.7 cases/year, R2 = 0.72, P < 0.001). VSR trainees experienced an annual decrease in 4 of the top 5 venous case types performed, including venous angioplasty/stenting (-1.6 cases/year, P = 0.002), vena cava filter placement (-0.9 cases/year, P = 0.002), endoluminal ablation (-0.2 cases/year, P = 0.47), diagnostic venography (-1.7 cases/year, P < 0.001), and varicose vein treatment (-1.0 cases/year, P < 0.001). Venous cases proportions also decreased in the VSF group from 8.4% to 6.2% (annual change -2.2 cases/year, R2 = 0.54, P = 0.002). VSF trainees experienced an annual decrease in 4 of the top 5 venous case types, including venous angioplasty/stenting (-1.5 cases/year, P = 0.003), diagnostic venography (-1.2 cases/year, P < 0.001), vena cava filter placement (-0.2 cases/year, P = 0.44), endoluminal ablation (-0.6 cases/year, P < 0.001), and varicose vein treatment (-0.1 cases/year, P = 0.04). Both VSR and VSF trainee groups graduated with fewer than 5 cases for each of the following venous procedures-percutaneous mechanical thrombectomy, venous thrombolysis, open venous reconstruction, sclerotherapy, venous embolectomy, portal-systemic shunting, venous ulceration treatment, and arteriovenous malformation treatment. CONCLUSIONS: Current vascular residents and fellows have limited exposure to venous procedures, in part due to a proportional decline in venous cases. More robust venous operative experience is needed during surgical training. Further studies are needed to understand whether this discrepancy in venous and arterial training impacts career progression and patient outcomes.

A national analysis of vascular surgery resident operative experience in peripheral artery disease.

BACKGROUND: Endovascular and hybrid interventions have played an increasingly prominent role in the treatment of peripheral arterial disease (PAD) in the past decade. This shift has prompted concerns about the adequacy of open surgical training for current surgical residents. Moreover, the recent Best Surgical Therapy in Patients With Critical Limb Ischemia trial has further emphasized the importance of open surgical techniques in the treatment of peripheral arterial disease. The purpose of this study was to examine national temporal trends in peripheral operative volume among integrated vascular surgery residents. METHODS: Data was obtained from the Accreditation Council for Graduate Medical Education national data reports for integrated vascular surgery residents. Case volumes for surgeon chief or surgeon junior cases were collected from academic years 2012 to 2013 and 2021 to 2022. Trends in case-mix and volume were evaluated using linear regression analysis. RESULTS: The mean total vascular operative volume increased from 851.2 to 914.3 cases among graduating chief residents, with an annual growth of 8.5 ± 1.7 cases/year (R2 = 0.77; P < .0001). Major vascular case volume also increased at a rate of 5.7 ± 1.2 cases/year (R2 = 0.74; P < .001). Among operative categories, peripheral cases were the most frequent (n = 232.2 [26.6%]) and demonstrated the greatest annual growth (+8.0 ± 0.8 cases/year, R2 = 0.93; P < .001). No changes were seen in volume of open peripheral cases, including suprainguinal bypass (+0.1 ± 0.2 cases/year; R2 = 0.08; P = .40) or femoropopliteal bypass procedures (-0.1 ± 0.2 cases/year; R2 = 0.17; P = .20). Infrapopliteal bypass (+0.4 ± 0.1 cases/year; R2 = 0.48; P = .006), iliac/femoral endarterectomy (+1.3 ± 0.2 cases/year; R2 = 0.82; P < .001), and leg thromboembolectomy (+0.4 ± 0.1 cases/year; R2 = 0.64; P < .001) all demonstrated annual growth. For endovascular peripheral cases, aortoiliac revascularization (+3.4 ± 0.3 cases/year; R2 = 0.94; P < .001), femoropopliteal revascularization (+5.4 ± 0.2 cases/year; R2 = 0.98; P < .001), and tibioperoneal revascularization (+2.0 ± 0.2 cases/year; R2 = 0.92; P < .001) all increased in volume. Lower extremity amputations, including above-knee amputation (+0.6 ± 0.2 cases/year; R2 = 0.65; P < .001) and below-knee amputation (+0.9 ± 0.2 cases/year; R2 = 0.72; P < .001) also demonstrated an increase in volume. CONCLUSIONS: Current graduating residents have higher open and endovascular case volumes for peripheral artery disease on a national level, despite the increasing popularity of endovascular techniques. Further studies are needed to identify how these trends may impact current vascular surgery milestones. These trends may also influence the rising interest in competency-based training programs.

Association Between Device Type and Type IIIb Endoleaks Following Thoracic Endovascular Aortic Repair.

OBJECTIVE: Endoleaks following thoracic endovascular aortic repair (TEVAR) can lead to the need for re-intervention and aortic rupture. Given the recent recall of a specific thoracic stent graft type due to concerns about type IIIb endoleak (T3bE), in which blood leaks through the stent graft fabric, the aim was to characterise patterns of T3bEs among available TEVAR devices. METHODS: Reports related to thoracic stent grafts in the Food and Drug Administration's (FDA) Manufacturer and User Facility Device Experience (MAUDE) database between 2010 and 2020 were reviewed. Proportional reporting ratios (PRRs) and chi squared tests were used to assess for the presence of a signal of association between device type and T3bE. A PRR > 2 and chi squared value > 4 with three or more reports overall constituted a signal of association. The institutional database of patients undergoing TEVAR for thoracic aneurysms since 2002 was also queried for T3bE. RESULTS: There were 7 328 MAUDE reports available for analysis. When analysing T3bEs in the MAUDE database, the lowest PRR was 0.36 (95% confidence interval [CI] 0 - 1.03 in Gore CTAG, nine T3bE among 1 328 reports) and the highest was 2.07 (95% CI 1.72 - 2.42 in Medtronic Valiant, 64 T3bE among 2 520 reports). The T3bE chi squared value for Medtronic Valiant was 17.3. The relationship between Medtronic Valiant and T3bE was ascertainable by MAUDE data as early as 2013. Among 542 TEVARs for an aneurysm indication at Duke University Hospital since 2002, there were eight T3bEs - all in devices with sutured on graft material. CONCLUSION: The Medtronic Valiant device met criteria for association with type IIIb endoleaks in the FDA's MAUDE database and met those criteria as early as 2013. A possible relationship between woven graft fabric and T3bEs is supported by the observation that all types of T3bE that occurred among a large number of TEVARs at the institution followed placement of grafts with sutured on woven fabric.

Preoperative Anemia is Associated with Poorer Postoperative Outcomes in Patients Undergoing Infrainguinal Bypass Surgery.

BACKGROUND: Preoperative anemia is an important, modifiable risk factor among surgical patients. However, data are scarce on the impact of preoperative anemia on postoperative outcomes after infrainguinal bypass. METHODS: In this multi-institutional analysis, data were retrospectively collected on all infrainguinal bypass procedures performed between 2010 and 2020. Patients were grouped by preoperative hemoglobin as per the National Cancer Institute anemia scale (mild, 10 g/dL-lower limit of normal; moderate, 8.0-9.9 g/dL; severe, 6.5-7.9 g/dL). Multivariable comparisons were performed using logistic regression analysis. RESULTS: A total of 492 patients underwent bypass for peripheral artery disease over the 10-year study period. Median preoperative hemoglobin was 11.0 g/dL (interquartile range 9.5-12.7) and median follow-up was 1.7 years. Preoperative anemia was prevalent among bypass patients (mild 52.4% [n = 258], moderate 26.4% [n = 130], and severe 5.1% [n = 25]). Women were more likely to have moderate (49.2% [women] vs. 50.8% [men]) or severe anemia (52.0% [women] vs. 48.0% [men]) compared with normal hemoglobin (17.7% [women] vs. 82.3% [men]) (P < 0.001). Patients with preoperative anemia were more likely to present with tissue loss (22.8% [normal] vs. 47.7% [moderate] vs. 52.0% [severe], P = 0.01). Bypass target and conduit types were similar between groups. Anemic patients had longer median hospital length of stay compared with nonanemic patients (4 days [normal] vs. 5 days [mild] vs. 6 days [moderate] vs. 7 days [severe], P < 0.001). Postoperative mortality at 30 days was similar across anemia groups (2.5% [normal] vs. 4.6% [moderate] vs. 8.0% [severe], P = 0.23). On multivariable analysis, however, postoperative mortality was independently associated with severe anemia (odds ratio 7.5 [1.2-48.8], P = 0.04) and male gender (odds ratio 7.5 [1.2-26.4], P = 0.03). CONCLUSIONS: Preoperative anemia is common among patients undergoing infrainguinal bypass surgery and is an independent risk factor for postoperative mortality. Future investigation is needed to determine whether correction of anemia improves postoperative outcomes in these high-risk patients.

One-year results of the GORE EXCLUDER Conformable AAA Endoprosthesis system in the United States regulatory trial.

OBJECTIVE: To report the 1-year clinical outcomes from the GORE EXCLUDER Conformable AAA Endoprosthesis system in the US regulatory trial. METHODS: The study is a prospective, multicenter, investigational device exemption clinical trial at 31 US sites with core laboratory assessment of imaging and independent event adjudication. The primary safety (incidence of major adverse events at 30 days) and effectiveness end points (successful aneurysm treatment at 1 year) were assessed in a cohort of patients with abdominal aortic aneurysms (AAAs). RESULTS: We enrolled 80 patients between December 19, 2017, and February, 27, 2019. The mean maximum aortic diameter was 57.7 ± 7.95 mm (range, 42.5-82.7 mm) with an average patient age of 73.5 ± 8.14 years (range, 56-96 years). Overall technical success was 100% (80/80). The mean hospital length stay was 1.2 ± 0.6 days (range, 1-4 days). No primary safety end point events were observed, including no death, stroke, myocardial infarction, bowel ischemia, paraplegia, respiratory failure, renal failure, procedural blood loss of more than 1000 mL, or thromboembolic events including limb occlusion or distal emboli. There were no type I or III endoleaks detected on the 1-, 6-, or 12-month follow-up computed tomography scans. There were no stent fractures, device migrations (≥10 mm), AAA ruptures, or conversions to open surgical repair observed. Two patients had AAA sac growth of more than 5 mm at 1 year owing to type II endoleaks. There were no aneurysm-related deaths within the 12-month follow-up, and freedom from aneurysm-related mortality was 100% through 1 year. CONCLUSIONS: The safety and effectiveness of the GORE EXCLUDER Conformable AAA Endoprosthesis system has been demonstrated with 98.5% freedom from primary effectiveness end point events at 1 year and 100% freedom from primary safety end point events assessed through 30 days.

Etiology and outcomes of amputation in patients with peripheral artery disease in the EUCLID trial.

OBJECTIVE: Amputation remains a frequent and feared outcome in patients with peripheral artery disease (PAD). Although typically characterized as major or minor on the extent of tissue loss, the etiologies and outcomes after amputation by extent are not well-understood. In addition, emerging data suggest that the drivers and outcomes of amputation in patients with PAD may differ in those with and without diabetes mellitus (DM). METHODS: The EUCLID trial randomized 13,885 patients with symptomatic PAD, including 5345 with concomitant diabetes, to ticagrelor or clopidogrel and followed them for long-term outcomes. Amputations were prospectively reported by trial investigators. Their primary and contributing drivers were adjudicated using safety data, including infection, ischemia, or multifactorial etiologies. Outcomes following major and minor amputations were analyzed, including recurrent amputation, major adverse limb events, adverse cardiovascular events, and mortality. Multivariable logistic regression models were used to identify independent predictors of minor amputations. Analyses were performed overall and stratified by the presence or absence of DM at baseline. RESULTS: Of the patients randomized, 398 (2.9%) underwent at least one lower extremity nontraumatic amputation, for a total of 511 amputations (255 major and 256 minor) over a median of 30 months. A history of minor amputation was the strongest independent predictor for a subsequent minor amputation (odds ratio, 7.29; 95% confidence interval, 5.17-10.30; P < .001) followed by comorbid DM (odds ratio, 4.60; 95% confidence interval, 3.16-6.69; P < .001). Compared with patients who had a major amputation, those with a minor amputation had similar rates of subsequent major amputation (12.2% vs 13.6%), major adverse limb events (15.1% vs 14.9%), and major adverse cardiovascular events (17.6% vs 16.3%). Ischemia alone was the primary driver of amputation (51%), followed by infection alone (27%), and multifactorial etiologies (22%); however, infection was the most frequent driver in those with DM (58%) but not in those without DM (15%). CONCLUSIONS: Outcomes after amputation remain poor regardless of whether they are categorized as major or minor. The pattern of amputation drivers in PAD differs by history of DM, with infection being the dominant etiology in those with DM and ischemia in those without DM. Greater focus is needed on the prognostic importance of minor amputation and of the multifactorial etiologies of amputation in PAD. Nomenclature with anatomical description of amputations and eliminating terms "major" or "minor" would seem appropriate.

Impact of risk factor control on peripheral artery disease outcomes and health disparities.

BACKGROUND: Peripheral artery disease (PAD) is associated with modifiable atherosclerotic risk factors like hypertension, diabetes, hyperlipidemia, and smoking. However, the effect of risk factor control on outcomes and disparities in achieving control is less well understood. METHODS: All patients in an integrated, regional health system with PAD-related encounters, fee-for-service Medicare, and clinical risk factor control data were identified. Component risk factors were dichotomized into controlled and uncontrolled categories (control defined as low-density lipoprotein < 100 mg/dL, hemoglobin A1c < 7.0%, SBP < 140 mmHg, and current nonsmoker) and composite categories (none, 1, ⩾ 2 uncontrolled RFs) created. The primary outcome was major adverse vascular events (MAVE, a composite of all-cause mortality, myocardial infarction, stroke, and lower-extremity revascularization and amputation). RESULTS: The cohort included 781 patients with PAD, average age 72.5 ± 9.8 years, of whom 30.1% were Black, and 19.1% were Medicaid dual-enrolled. In this cohort, 260 (33.3%) had no uncontrolled risk factors and 200 (25.6%) had two or more uncontrolled risk factors. Patients with the poorest risk factor control were more likely to be Black (p < 0.001), Medicaid dual-enrolled (p < 0.001), and have chronic limb-threatening ischemia (p = 0.009). Significant differences in MAVE by degree of risk factor control were observed at 30 days (none uncontrolled: 5.8%, 1 uncontrolled: 11.5%, ⩾ 2 uncontrolled: 13.6%; p = 0.01) but not at 1 year (p = 0.08). risk factor control was not associated with outcomes at 1 year after adjustment for patient and PAD-specific characteristics. CONCLUSIONS: risk factor control is poor among patients with PAD. Significant disparities in achieving optimal risk factor control represent a potential target for reducing inequities in outcomes.

Contemporary Management of Abdominal Aortic Aneurysms.

PURPOSE OF REVIEW: Abdominal aortic aneurysms (AAA) can carry extremely high mortality rates and most will only present with symptoms with impending rupture. We present an overview of management of this disease process starting with screening, to medical management, surveillance and treatment options currently available, as well as those being studied for future use. RECENT FINDINGS: Screening has been proven to reduce the mortality rate. There still remains a paucity of data to support medical therapies to help mitigate the rate of aneurysm growth and prevent rupture. However, on the topic of repair, there have been advancements in endovascular devices which have broadened the scope of treatment for patients with anatomy not amenable to standard endovascular repair or those who are not suitable candidates for open surgical repair. Appropriate surveillance, risk factor modification, and operative repair, when indicated, are the cornerstones of contemporary management of AAAs. Advancements in endovascular technologies have allowed us to treat more patients. Further research is warranted on non-operative medical therapies.

Younger patients with chronic limb threatening ischemia face more frequent amputations.

INTRODUCTION: Amputations among younger patients with chronic limb threatening ischemia (CLTI) may carry higher personal and societal costs, but younger patients are often not included in CLTI research because of dataset limitations. We aimed to characterize and compare outcomes between younger (<65 years old) and older patients with CLTI. METHODS: This retrospective cohort study identified patients with CLTI between July 1, 2014 and December 31, 2017 in the MarketScan commercial claims database, a proprietary set of claims for over 50 million patients with private insurance in the United States. The primary outcome was major adverse limb events (MALE); secondary outcomes included amputations, major adverse cardiovascular events, and statin prescription fills. RESULTS: The study cohort included 64,663 people with CLTI, of whom 25,595 (39.6%) were <65 years old. Younger patients were more likely to have diabetes mellitus (54.1% versus 49.9%, P<.001) but less likely to have other comorbidities. A higher proportion of younger patients suffered MALE (31.7% versus 30.2%, P=.002), specifically amputation (11.5% versus 9.3%, P<.001). After adjustment, age <65 years old was associated with a 24% increased risk of amputation (HRadj 1.24, 95%CI 1.18-1.32, P<.001) and a 10% increased risk of MALE (HRadj 1.10, 95%CI 1.07-1.14, P<.001). CONCLUSIONS: A significant proportion of commercially insured patients with CLTI are under the age of 65, and younger patients have worse limb-related outcomes. These findings highlight the importance of aggressively treating risk factors for atherosclerosis and intentionally including younger patients with CLTI in future analyses to better understand their disease patterns and outcomes.

The association of healthcare disparities and patient-specific factors on clinical outcomes in peripheral artery disease.

BACKGROUND: PAD increases the risk of cardiovascular mortality and limb loss, and disparities in treatment and outcomes have been described. However, the association of patient-specific characteristics with variation in outcomes is less well known. METHODS: Patients with PAD from Duke University Health System (DUHS) between January 1, 2015 and March 31, 2016 were identified. PAD status was confirmed through ground truth adjudication and predictive modeling using diagnosis codes, procedure codes, and other administrative data. Symptom severity, lower extremity imaging, and ankle-brachial index (ABI) were manually abstracted from the electronic health record (EHR). Data was linked to Centers for Medicare and Medicaid Services data to provide longitudinal follow up. Primary outcome was major adverse vascular events (MAVE), a composite of all-cause mortality, myocardial infarction (MI), stroke, lower extremity revascularization and amputation. RESULTS: Of 1,768 patients with PAD, 31.6% were asymptomatic, 41.2% had intermittent claudication (IC), and 27.3% had chronic limb-threatening ischemia (CLTI). At 1 year, patients with CLTI had higher rates of MAVE compared with asymptomatic or IC patients. CLTI and Medicaid dual eligibility were independent predictors of mortality. CLTI and Black race were associated with amputation. CONCLUSIONS: Rates of MAVE were highest in patients with CLTI, but patients with IC or asymptomatic disease also had high rates of adverse events. Black and Medicaid dual-eligible patients were disproportionately present in the CLTI subgroup and were at higher risk of amputation and mortality, respectively. Future studies must focus on early identification of high-risk patient groups to improve outcomes in patients with PAD.