A Decade's Experience with Retrograde Open Mesenteric Stenting for Acute Mesenteric Ischemia.

OBJECTIVE: Retrograde open mesenteric stenting (ROMS) is an alternative to mesenteric bypass in patients with acute mesenteric ischemia (AMI) with variable reported 30-day mortality rates. Large studies evaluating patient outcomes following ROMS are scarce. Our study aims to assess the results of this approach among patients presenting with AMI. METHODS: We reviewed all the patients with AMI who were treated with ROMS (2011-2022). Patient demographics, presentation, operative details, and outcomes were analyzed. Primary endpoints were in-hospital, 30-day and 1-year mortality. Kaplan-Meier estimate for 1-year mortality and primary patency loss were generated. Secondary endpoints included postoperative 30-day complications. RESULTS: Between 2011 and 2022, ROMS was attempted on a total of 42 patients. The median age was 70 ±15 years and the majority of patients were female. Pain out of proportion to the physical exam was the most common presenting symptom (n=18 ,42.9%) followed by peritonitis (n= 14, 33.4%). All patients had pre-operative IV contrast computed tomography imaging. In-situ thrombosis was identified as the etiology of AMI in 36 (85.7%) patients. Technical success was achieved in 40 (95.2%) patients. Conventional, non-hybrid operating rooms were utilized for the majority of cases. Revascularization of all 40 patients involved angioplasty and stenting of superior mesenteric artery (SMA): A single stent was placed in 35 (87.5%) patients and the reminder had more than one stent. 80% of patients required bowel resection. A second-look laparotomy was required in 34 (85.0%) patients. The mean operative time, including both the general surgery and vascular surgery portions of the index procedure, was 192 ± 57 minutes. Sepsis was the most common complication observed within 30 days, occurring in 8 (20.0%) patients. In terms of mortality, 13 (32.5%) patients died during their index hospitalization, while 9 (22.5%) died within 30 days. On Kaplan-Meier analysis, the 1-year overall patient survival rate was 58.6%, and the primary patency rate for stents was 51.4%. CONCLUSION: ROMS has excellent technical success rate in management of AMI with lower than traditionally reported mortality rates for AMI. The dual benefits of rapid revascularization and bowel evaluation should make this surgical modality an alternative approach for treatment of AMI.

Midterm outcomes and predictors of failure of lower extremity bypass to para-malleolar and pedal targets.

OBJECTIVES: The frequency of distal lower extremity bypass (LEB) for infra-popliteal critical limb threatening ischemia (IP-CLTI) has significantly decreased. Our goal was to analyze the contemporary outcomes and factors associated with failure of LEB to para-malleolar and pedal targets. METHODS: We queried the VQI infra-inguinal database from 2003-2021 to identify LEB to para-malleolar or pedal/plantar targets. Primary outcomes were graft patency, major adverse limb events [vascular re-intervention, above ankle amputation] (MALE), and amputation-free survival at 2 years. Standard statistical methods were utilized. RESULTS: We identified 2331 LEB procedures (1265 anterior tibial at ankle/dorsalis pedis, 783 posterior tibial at ankle, 283 tarsal/plantar). The prevalence of LEB bypasses to distal targets has significantly decreased from 13.37% of all LEB procedures in 2003 to 3.51% in 2021 (p<0.001). The majority of cases presented with tissue loss (81.25. Common post-operative complications included major adverse cardiac events (8.9%) and surgical site infections (3.6%). Major amputations occurred in 16.8% of patients at 1 year. Post-operative mortality at 1 year was 10%. On unadjusted Kaplan-Meier survival analysis at 2 years, primary patency was 50.56%±3.6%, MALE was 63.49%±3.27%, and amputation-free survival was 71.71%±0.98%. In adjusted analyses [adjusted for comorbidities, indication, conduit type, urgency, prior vascular interventions, graft inflow vessel (femoral/popliteal), concomitant inflow procedures, surgeon and center volume] conduits other than GSV (p<0.001) were associated with loss of primary patency and increased MALE. High center volume (>5 procedures/year) was associated with improved primary patency (p=0.015), and lower MALE (p=0.021) at 2 years. CONCLUSIONS: Despite decreased utilization, open surgical bypass to distal targets at the ankle remains a viable option for treatment of IP-CLTI with acceptable patency and amputation-free survival rates at 2 years. Bypasses to distal targets should be performed at high volume centers to optimize graft patency and limb salvage and minimize re-interventions.

Aortobifemoral bypass vs covered endovascular reconstruction of aortic bifurcation.

BACKGROUND: Covered endovascular reconstruction of aortic bifurcation (CERAB) is increasingly used as a first line-treatment in patients with aortoiliac occlusive disease (AIOD). We sought to compare the outcomes of patients who underwent CERAB compared with the gold standard of aortobifemoral bypass (ABF). METHODS: The Vascular Quality Initiative was queried for patients who underwent ABF or CERAB from 2009 to 2021. Propensity scores were generated using demographics, comorbidities, Rutherford class, and urgency. The two groups were matched using 5-to-1 nearest-neighbor match. Our primary outcomes were 1-year estimates of primary patency, major adverse limb events (MALEs), MALE-free survival, reintervention-free survival, and amputation-free survival. Standard statistical methods were used. RESULTS: A total of 3944 ABF and 281 CERAB cases were identified. Of all patients with AIOD, the proportion of CERAB increased from 0% to 17.9% between 2009 and 2021. Compared with ABF, patients who underwent CERAB were more likely to be older (64.7 vs 60.2; P < .001) and more often had diabetes (40.9% vs 24.1%; P < .001) and end-stage renal disease (1.1% vs 0.3%; P = .03). In the matched analysis (229 CERAB vs 929 ABF), ABF patients had improved MALE-free survival (93.2% [±0.9%] vs 83.2% [±3%]; P < .001) and lower rates of MALE (5.2% [±0.9%] vs 14.1% [±3%]; P < .001), with comparable primary patency rates (98.3% [±0.3%] vs 96.6% [±1%]; P = .6) and amputation-free survival (99.3% [±0.3%] vs 99.4% [±0.6%]; P = .9). Patients in the CERAB group had significantly lower reintervention-free survival (62.5% [±6%] vs 92.9% [±0.9%]; P < .001). Matched analysis also revealed shorter length of stay (1 vs 7 days; P < .001), as well as lower pulmonary (1.2% vs 6.6%; P = .01), renal (1.8% vs 10%; P < .001), and cardiac (1.8% vs 12.8%; P < .001) complications among CERAB patients. CONCLUSIONS: CERAB had lower perioperative morbidity compared with ABF with a similar primary patency 1-year estimates. However, patients who underwent CERAB experienced more major adverse limb events and reinterventions. Although CERAB is an effective treatment for patients with AIOD, further studies are needed to determine the long-term outcomes of CERAB compared with the established durability of ABF and further define the role of CEARB in the treatment of AIOD.

Incidental AVF creation during unrelated hospitalization is associated with worse outcomes compared with outpatient AVF creation.

INTRODUCTION: Arteriovenous fistula (AVF) creation during an inpatient hospitalization is often performed for patient convenience and to ensure compliance. We sought to evaluate whether this approach has comparable outcomes to outpatient AVF creation. METHODS: We identified patients undergoing index AVF creation from the United States Renal Data System dataset (2012-2017). Patients were grouped into outpatient and inpatient. Outpatient included patients that were operated in either an outpatient setting, ambulatory surgical center or were admitted inpatient on the day of AVF creation. Inpatient included only patients with claims for an inpatient visit before access creation. Multiple safety outcomes were compared between groups using unadjusted and adjusted logistic regression methods generating odds ratios and 95% confidence intervals (95% CI). One-year maturation rates were compared using competing-risks regression methods generating sub-hazard ratios (sHR) and 95% CI. Outcomes were also compared after 1:1 propensity score matching. RESULTS: We identified 68,872 patients undergoing AVF creation, 4855 (7.1%) of which were created during inpatient hospitalization. Patients in the inpatient group were older (65.8 ± 13.8 vs 65.2 ± 13.8, p = 0.002), more likely to be of Black race (28.1% vs 26.8%, p = 0.02), and have cardiovascular comorbidities (all p < 0.05). Patients in the inpatient groups were more likely to be dialyzed at for-profit (88.1% vs 85.9%, p < 0.01) and freestanding (94.8% vs 92.9%, p < 0.01) dialysis centers. On both unadjusted and adjusted analysis, inpatient group was more likely to experience 30-day adverse events (e.g. pneumonia, COPD exacerbation, stroke, myocardial infarction), any complication, and all-cause mortality. On competing risks analysis, successful two-needle cannulation at 1 year was significantly less likely in the inpatient group (68.1% vs 76.8%, p < 0.01; sHR = 0.68 [95% CI, 0.65-0.71], p < 0.01). These trends were robust on 1:1 propensity matching. CONCLUSION: Incidental AVF creation in hospitalized patients is associated with worse outcomes, ranging from mortality to postoperative complications to fistula maturation, compared with outpatient AVF creation.

A Comparison of Surgical Techniques and Outcomes for Primary Infected Abdominal Aortic Aneurysms.

BACKGROUND: Primary infected abdominal aortic aneurysms (PIAAAs) are associated with high morbidity and mortality. Three repair approaches include open in-situ repair (OIR), extra-anatomic repair (EAR), and endovascular abdominal aortic aneurysm repair (EVAR). This study is one of the largest single-center case series comparing the outcomes of the different surgical approaches for PIAAA. METHODS: This is a retrospective cohort study of all patients treated surgically for PIAAA between 2000 and 2021. PIAAA diagnosis was defined as the presence of an abdominal aortic aneurysm with evidence of infection on clinical presentation, laboratory markers, radiology, or surgically. Patients with prior aortic surgery were excluded from this study. Basic demographics were compared across the 3 surgical groups using standard statistical methods. Our primary outcomes included mortality at 1 and 5 years. Kaplan-Meier curves were generated and compared using log-rank testing. Multivariate Cox proportional hazards models were created to assess determinants of mortality. RESULTS: A total of 43 patients were included in the full cohort. Patients undergoing EVAR more often had diabetes, end-stage renal disease, and coronary artery disease. EVAR was also more often done in patients with a saccular aneurysm rather than fusiform. (93% vs. 70% in EAR and 42% in OIR; P = 0.015). All-cause mortality rates at 1 year were not significantly different between the 3 groups. Survival at 5 years did show a significant benefit of OIR over EVAR and EAR: OIR had an 8% mortality rate with EAR having a 53% rate and EVAR having the highest (72%) mortality rate at 5 years (P = 0.03). Multivariable Cox regression analysis showed that EVAR (aHR 12.1, (95% CI 1.42 to 103.9), P = 0.02) and EAR (aHR 15.1, (95% CI 1.59 to 143.3), P = 0.0.02) had an increased 5-year mortality risk when compared to OIR. CONCLUSIONS: Repair of primary infected aortic aneurysm is associated with high complication and mortality rates regardless of the approach. In our studied sample, OIR offered an improved long-term survival without added benefits in terms of complication rates. In infected AAA, EVAR should be considered bridging stage between the urgent situation and eventual open repair.

A registry-based study of paclitaxel drug-coated balloon angioplasty for the treatment of in-stent restenosis of the femoral-popliteal artery.

OBJECTIVE: The aim of this study was to report the results of a prospective, single-arm, registry-based study assessing the safety and performance of a paclitaxel drug-coated balloon (DCB) for the treatment of superficial femoral artery (SFA) or popliteal artery in-stent restenosis (ISR) in a United States population. METHODS: We conducted a prospective, non-randomized, multi-center, single-arm, post-market registry of the IN.PACT Admiral DCB for the treatment of ISR lesions in the SFA or popliteal artery at 43 sites within the Society for Vascular Surgery (SVS) Vascular Quality Initiative (VQI) Registry from December 2016 to January 2020. Clinical outcomes were assessed at 12, 24, and 36 months. The primary endpoint was target lesion revascularization at 12 months. Secondary endpoints included technical success, target vessel revascularization, major limb amputation, and all-cause mortality. Results are presented as survival probabilities based on Kaplan-Meier survival estimates. RESULTS: Patients (N = 300) were 58% male, with a mean age of 68 ± 10 years. Diabetes was present in 56%, 80% presented with claudication, and 20% with rest pain. Lesions included ISR of the SFA in 68%, SFA-popliteal in 26%, and popliteal arteries in 7%. The mean lesion length was 17.8 ± 11.8 cm. Lesions were categorized as occlusions in 43% (mean occluded length, 16 ± 10 cm). TASC type was A (17%), B (29%), C (38%), and D (15%). Technical success was 99%. Re-stenting was performed in 5% and thrombolysis in 0.6% of patients. Kaplan-Meier estimates for freedom from target lesion revascularization were 90%, 72%, and 62% at 12, 24, and 36 months. Freedom from target vessel revascularization was 88%, 68%, and 59% and freedom from major target limb amputation was 99.6%, 98.9%, and 98.9%, respectively, at 12, 24, and 36 months. Survival was 95%, 89%, and 85% at 12, 24, and 36 months. CONCLUSIONS: This post-market registry-based study shows promising results in treating femoral-popliteal ISR with paclitaxel DCB in comparison to the results of plain balloon angioplasty reported in the literature. These results demonstrate the ability of the SVS VQI to conduct post-market evaluation of peripheral devices in partnership with industry and federal regulators.

Socioeconomic factors predict successful supervised exercise therapy completion.

OBJECTIVE: Supervised exercise therapy (SET) for patients with intermittent claudication (IC) can lower the risk of progression to chronic limb-threatening ischemia and amputation, while preserving and restoring functional status. Despite supporting evidence, it remains underutilized, and among those who initiate programs, attrition rates are extremely high. We hypothesize that socioeconomic factors may represent significant barriers to SET completion. METHODS: Patients with IC referred to SET at a multi-hospital, single-institution health care system (2018-2022) from a prospectively maintained database were retrospectively analyzed. Our primary endpoint was SET program completion and graduation, defined as completion of 36 sessions. Our secondary endpoints were vascular intervention within 1 year of referral and change in ankle-brachial index (ABI). Baseline demographics were assessed using standard statistical methods. Predictors of SET graduation were analyzed using multivariable logistic regression generating adjusted odds ratios (aORs) with 95% confidence intervals (CIs). Change in ABI was analyzed using t-test between subgroups. Reasons for attrition were tabulated. Patient Health Questionnaire-9 (PHQ-9), metabolic equivalent level, Vascular QOL, Duke Activity Status, and ABI were analyzed using paired t-tests across the entire cohort. RESULTS: Fifty-two patients met inclusion criteria: mean age 67.85 ± 10.69 years, 19 females (36.54%), mean baseline ABI of 0.77 ± 0.16. The co-pays for 100% of patients were fully covered by primary and secondary insurance plans. Twenty-one patients (40.38%) completed SET. On multivariable analysis, residence in a ZIP code with median household income <$47,000 (aOR, 0.10; 95% CI, 0.01-0.76; P = .03) and higher body mass index (aOR, 0.81; 95% CI, 0.67-0.99; P = .04) were significant barriers to SET graduation. There were no differences in ABI change or vascular intervention within 1 year between graduates and non-graduates. Non-graduates reported transportation challenges (25.00%), lack of motivation (20.83%), and illness/functional limitation (20.83%) as primary reasons for SET attrition. Metabolic Equivalent Level (P ≤ .01) and Duke Activity Status scores (P = .04) were significantly greater after participating in a SET program. CONCLUSIONS: Although SET participation improves lower extremity and functionality outcomes, only 40% of referred patients completed therapy in our cohort. Our findings suggest that both socioeconomic and functional factors influence the odds of completing SET programs, indicating a need for holistic pre-referral assessment to facilitate enhanced program accessibility for these populations.

Carotid Endarterectomy Should Not Be Recommended to End-Stage Kidney Disease Patients with Asymptomatic Carotid Artery Disease.

BACKGROUND: Carotid endarterectomy (CEA) for asymptomatic carotid artery disease is advised for patients with low perioperative stroke risk and life expectancy of 3-5 years. We sought to explore the role of risk stratification and postoperative medical management in identifying appropriate asymptomatic candidates for CEA in the end-stage kidney disease (ESKD) population. METHODS: We identified ESKD patients on dialysis from the United States Renal Data System that underwent CEA (2008-2014) for asymptomatic carotid artery disease. We used the Liu comorbidity index as well as a novel risk prediction model based on Cox proportional hazards model to stratify patients. The primary outcome evaluated was 3-year survival, and Kaplan-Meier methods were used to generate survival estimates. We further conducted a subanalysis of patients with Medicare part D data to determine postoperative usage of the following medications: statins, antiplatelets, and antihypertensives. We evaluated the association of medication utilization and 3-year survival using Kaplan-Meier methods and Cox proportional hazards modeling. RESULTS: We analyzed 1,813 patients meeting inclusion criteria. The population was predominantly older (mean age 70.2 ± 9.1), White (84.8%), and had a high prevalence of cardiovascular comorbidities, such as hypertension (90.7%), diabetes (62.5%), and congestive heart failure (35.4%). Among the entire cohort, 23.0% had a Liu comorbidity index ≤8, 35.0% had index 9-12, and 42.0% had index >12. Increasing Liu comorbidity index was associated with worse survival (P < 0.01); however, even the group with Liu index ≤8 had poor 3-year survival of 58.8% (53.9-63.4). The Cox proportional hazards model identified variables for inclusion in the risk model such as age >80 (adjusted hazard ratio [aHR] = 2.49, 95% confidence interval [CI] [1.87-3.33], P < 0.001), congestive heart failure (aHR = 1.31, 95% CI [1.14-1.51], P < 0.001), and Liu comorbidity index >12(aHR = 1.89, 95% CI [1.56-2.28], P < 0.001). The risk score generated ranged from 0 to 6.5, and patients were divided into 3 groups: score ≤2 (43.4%), 2-4 (41.2%), and >4 (15.4%). Increasing risk score was associated with worse survival (P < 0.01) but even the "low-risk" group had 3-year survival of 58.5% (54.9-61.9). Subanalysis of the 1,249 (68.8% of total) patients with part D data found that statins and calcium channel blocker use was associated with improved survival, although observed rates for patients on drug were still low. CONCLUSIONS: The overall long-term survival of ESKD patients undergoing CEA for asymptomatic carotid artery disease is low. Risk stratification and analysis of postoperative medical management did not identify a subgroup of patients with adequate 3-year survival. Hence, the preventive benefits of CEA are not realized in these patients.

Racial Disparities in Treatment Indications and Outcomes for Limb Ischemia.

BACKGROUND: Studies suggest that the Affordable Care Act (ACA) of 2014 has improved access to vascular care and vascular outcomes among patients suffering from peripheral arterial disease (PAD). We sought to examine the racial disparities that exist in patients with PAD who have undergone lower extremity bypass (LEB) or a peripheral vascular intervention (PVI) using the Vascular Quality initiative (VQI) database. METHODS: The VQI infrainguinal and PVI datasets were queried for patients receiving elective and urgent LEB or PVI between 2016, 2 years after ACA implementation, and in 2021. Patients undergoing interventions urgently/emergently or for aneurysm were excluded. The primary outcome was major adverse limb event (MALE-defined as any vascular reintervention or above-ankle amputation) free survival at 1 year. Standard statistical methods were utilized as appropriate. RESULTS: A total of 17,455 LEB and 87,475 PVIs were included in this analysis. Black persons present at a younger age when compared to non-Hispanic White persons (NHW) and are more likely to have diabetes, hypertension, end-stage renal disease (ESRD), and higher rates of prior amputation. Black persons are more likely to present with chronic limb-threatening ischemia (CLTI) rather than claudication, and in a more urgent setting. Postoperative outcomes show higher rates of major amputations among racial minorities, specifically Black persons for both LEB (1.8% vs. 0.8% P < 0.001) and PVI (20.8% vs. 16.8% P < 0.001). Black persons are at higher risk of 1-year MALE for LEB (36.7% vs. 29.9% P < 0.001) and PVI (31.0% vs. 21.7%; P < 0.001). Even after adjusting for confounding variables, Black persons have a higher risk of 1-year MALE for LEB, with an adjusted hazard ratio (aHR) of 1.15 (95% CI [1.05-1.26], P = 0.003) and PVI (aHR 1.18 95% CI [1.12-1.24], P < 0.001). Other major determinates of 1-year MALE on multivariate Cox regression included CLTI (LEB aHR 1.57 95% CI [1.43-1.72], P < 0.001; PVI aHR 2.29 95% CI [2.20-2.39], P < 0.001) and history of prior amputation (LEB aHR 1.35 95% CI [1.17-1.56], P < 0.001; PVI aHR 1.5 95% CI [1.4-1.6], P < 0.001). CONCLUSIONS: Compared to NHW persons, Black persons present with more advanced vascular disease regardless of the operative indication. Black persons are also at significantly higher risk of 1-year MALE. Despite some advances in more accessible care through the ACA of 2014, our observations suggest that Black persons still have significantly worse outcomes due to variety of variables that need further investigation.

Surgical and endovascular assisted maturation procedures improve cannulation after arteriovenous fistula creation, but not after arteriovenous graft placement.

OBJECTIVE: After creation, arteriovenous fistulae (AVF) and arteriovenous grafts (AVG) can undergo surgical or endovascular assisted maturation (AM) procedures to enable use for hemodialysis. We sought to explore the association of interventions with successful two-needle cannulation (TNC) using the United States Renal Data System (USRDS). METHODS: Using the 2012-2017 USRDS, we identified patients initiating hemodialysis with tunneled dialysis catheters (TDC). Successful AVF/G use was defined as two-needle cannulation (TNC). Our principal outcome was time to first TNC after AVF/G creation. Death and new access placement were competing events that precluded TNC. Competing-risks regression models were constructed to identify factors associated with cannulation. Logistic regression was used to assess the association between AM procedures and 1-year TNC and also to compare post-cannulation outcomes. RESULTS: Among 81,143 patients, 15,880 (19.6%) had AVG and 65,263 (80.4%) had AVF. AVG patients were more likely than AVF patients to achieve TNC at 1 year on unadjusted (77.4% vs 64.0%, p < 0.001) and on multivariate analysis (sHR = 2.56 (2.49-2.63), p < 0.001). For AVFs, one AM surgical procedure was associated with improved 1-year TNC rates, but further revisions were not helpful. Endovascular AM procedures were associated with increased AVF TNC rates. Any procedure, surgical or endovascular, was detrimental to achieving TNC for AVGs.Following initial TNC, those accesses that needed AM procedures were associated with higher rates of access failure (AVF: OR = 1.32 (1.21-1.45); AVG: OR = 1.77 (1.500-2.00); p < 0.001), catheter replacement (AVF: OR = 1.27 (1.20-1.34); AVG: OR = 1.56 (1.42-1.71), p < 0.001), and additional endovascular procedures (AVF: 0.75 ± 1.22 no AM vs 1.33 ± 1.62 any AM; AVG: 1.31 ± 1.77 no AM vs 1.96 ± 2.22 any AM; all p < 0.001). CONCLUSIONS: AVG achieved TNC after creation more reliably than AVF. A single surgery or endovascular procedures for AVFs is associated with greater rates of TNC. For AVGs, any AM procedure is associated with lower cannulation rates, and reinforces the need for careful operative technique.

Midterm Outcomes of Endovascular vs. Medical Therapy for Uncomplicated Type B Aortic Dissection: Meta-Analysis of Reconstructed Time to Event Data.

OBJECTIVE: To evaluate outcomes of thoracic endovascular aortic repair (TEVAR) vs. medical therapy in uncomplicated type B aortic dissections (TBAD). DATA SOURCES: PubMed/MEDLINE, EMBASE, SciELO, LILACS, CENTRAL/CCTR, Google Scholar, and reference lists of relevant articles. REVIEW METHODS: This was a pooled meta-analysis of time to event data extracted from studies published by December 2022 for the following outcomes: all cause mortality, aortic related mortality, and late aortic interventions. Certainty of evidence was evaluated through the Grading of Recommendations, Assessment, Development and Evaluations (GRADE) tool. RESULTS: Ten studies met the eligibility criteria (eight observational; two randomised trials), comprising 17 906 patients (2 332 patients in the TEVAR groups and 15 574 patients in the medical therapy group). Compared with patients who received medical therapy, patients who underwent TEVAR had a statistically significantly lower risk of all cause death (HR 0.79, 95% CI 0.72 - 0.87, p < .001; GRADE certainty: low) and lower risk of aortic related death (HR 0.43, 95% CI 0.30 - 0.62, p < .001; GRADE certainty: low) without statistically significant difference in the risk of late aortic interventions (HR 1.05, 95% CI 0.88 - 1.26, p = .56; GRADE certainty: low). In the subgroup analyses, TEVAR was associated with lower risk of all cause death when randomised controlled trials only were pooled (HR 0.44, 95% CI 0.23 - 0.83, p = .012; GRADE certainty: moderate), younger patients only (HR 0.56, 95% CI 0.47 - 0.67, p < .001; GRADE certainty: low), Western populations only (HR 0.85, 95% CI 0.77 - 0.93, p = .001; GRADE certainty: low) and non-Western populations only (HR 0.47, 95% CI 0.35 - 0.62, p < .001; GRADE certainty: low). For all cause mortality and aortic related mortality, restricted mean survival time was overall 396 days and 398 days longer with TEVAR (p < .001), respectively, which means that TEVAR was associated with lifetime gain. CONCLUSION: TEVAR may be associated with better midterm survival and lower risk of aortic related death in the follow up of patients treated for uncomplicated TBAD compared with medical therapy; however, randomised controlled trials with larger sample sizes and longer follow up are still warranted.

Selective Publication within Vascular Surgery: Characteristics of Discontinued and Unpublished Randomized Clinical Trials.

BACKGROUND: Discontinued and unpublished randomized clinical trials (RCTs) are common resulting in biased publication and loss of potential knowledge. The magnitude of selective publication within vascular surgery remains unknown. METHODS: RCT relevant to vascular surgery registered (01/01/2010-10/31/2019) on ClinicalTrials.gov were included. Trials ending normally with conclusion of participant treatment and examination were considered completed whereas discontinued trials stopped early. Publications were identified through automatically indexed PubMed citations on ClinicalTrials.gov or manually identified on PubMed or Google Scholar >30 months after the completion date, the date the final participant was examined, allowing time for publication. RESULTS: Of 108 RCT (n = 37, 837), 22.2% (24/108) were discontinued, including 16.7% (4/24) stopped prior to and 83.3% (20/24) after starting enrollment. Only 28.4% of estimated enrollment was achieved for all discontinued RCT. Nineteen (79.2%) investigators provided a reason for discontinuation, which most commonly included poor enrollment (45.8%), inadequate supplies or funding (12.5%), and trial design concerns (8.3%). Of the 20 trials terminated following enrollment, 20.0% (4/20) were published in peer-reviewed journals and 80.0% (16/20) failed to reach publication. Of the 77.8% trials completed, 75.0% (63/84) were published and 25.0% (21/84) remain unpublished. In a multivariate regression of completed trials, industry funding was significantly associated with decreased likelihood of peer-reviewed publication (OR = 0.18, (95% CI 0.05-0.71), P = 0.01). Of the discontinued and completed trials remaining unpublished, 62.5% and 61.9% failed to report results on ClinicalTrials.gov, respectively, encompassing a total of 4,788 enrollees without publicly available results. CONCLUSIONS: Nearly 25% of registered vascular RCT were discontinued. Of completed RCT, 25% remain unpublished with industry funding associated with decreased likelihood of publication. This study identifies opportunities to report all findings for completed and discontinued vascular surgery RCT, whether industry sponsored, or investigator initiated.

Predictors of chronic thromboembolic pulmonary hypertension in patients with submassive pulmonary embolism treated with catheter-directed thrombolysis versus anticoagulation alone: A secondary analysis of the SUNSET sPE trial.

OBJECTIVE: Chronic thromboembolic pulmonary hypertension (CTEPH) after pulmonary embolism (PE) is a morbid complication with suboptimal treatment. We aimed to evaluate the biomarker profile and functional outcomes in patients with submassive PE (sPE) treated with catheter-directed thrombolysis (CDT) compared with anticoagulation alone (ACA). We performed a secondary biomarker and survey analysis of the SUNSET sPE (standard vs ultrasound-assisted catheter thrombolysis for submassive pulmonary embolism) randomized trial comparing standard CDT to ultrasound-assisted thrombolysis in patients with sPE. METHODS: As a part of the SUNSET sPE study, patients who did not receive an intervention were enrolled in the medical (ACA) arm. The biomarkers associated with CTEPH in the literature (ie, CCL2, CXCL10, PTX3, GDF-15, RAGE, BCA-1, TFPI) were collected and measured using a multiplex assay at diagnosis, discharge, and 3-month follow-up. Patients underwent a 6-minute walk test and answered quality-of-life questionnaires (pulmonary embolism quality of life; University of California, San Diego, shortness of breath questionnaire; 36-item short-form survey) at 3 months after diagnosis. Comparisons were made using the Student t test. Nonparametric tests were used when the distributions were not normal. Significance was set at P ≤ .05. RESULTS: A total of 72 patients (age, 56 ± 15 years; 40.3% women) were included in the present analysis. Of these 72 patients, 53 underwent CDT and 19 were included in the ACA arm. The baseline right ventricle/left ventricle ratios were similar between the two groups (CST, 1.8; ACA, 1.7). The survival and complication rates were similar between the two groups. At discharge, CXCL10 (768.9 ± 148.6 pg/mL vs 3032.0 ± 1201.0 pg/mL; P = .018) and PTX3 (3203.5 ± 1298.0 pg/mL vs 12,716.2 ± 6961.5 pg/mL; P = .029) were lower in the CDT group and displayed a quicker return to baseline than in the ACA group. This trend, although not significant, was also seen with the other biomarkers. At 3 months, the 6-minute walking distance and quality-of-life scores were similar between both groups. CONCLUSIONS: In patients with sPE, the biomarkers of CTEPH were lower with CDT compared with ACA. At 3 months, both groups demonstrated similar biomarker levels, 6-minute walking distances, and quality-of-life scores.

Pulmonary embolism response team for hospitalized patients with submassive and massive pulmonary embolism: A single-center experience.

BACKGROUND: Pulmonary embolism (PE) is a major cause of mortality with presentation varying between few or no symptoms to sudden death. This makes timely and appropriate treatment extremely important. Multidisciplinary PE response teams (PERT) have emerged to improve the management of acute PE. This study aims to describe the experience of a large multihospital single-network institution with PERT. METHODS: A retrospective cohort study of patients admitted for submassive and massive PE between 2012 and 2019 was conducted. The cohort was divided based on time of diagnosis and hospital into two groups: non-PERT included patients treated at hospitals that did not initiate PERT and patients diagnosed before the introduction of PERT (June 1, 2014); and the PERT group included those admitted after June 1, 2014, to a hospital with PERT. Patients with low-risk PE and those who had admissions in both time periods were excluded. Primary outcomes included all-cause mortality at 30, 60, and 90 days. Secondary outcomes included causes of death, intensive care unit (ICU) admission, ICU length of stay (LOS), total hospital LOS, type of treatment, and specialty consultations. RESULTS: We analyzed 5190 patients, with 819 (15.8%) being in the PERT group. Patients in the PERT group were more likely to receive extensive workup that included troponin-I (66.3% vs 42.3%; P < .001) and brain natriuretic peptide (50.4% vs 20.3%; P < .001). They also more often received catheter-directed interventions (12% vs 6.2%; P < .001) rather than anticoagulation monotherapy. Mortality outcomes were similar between both groups at all measured timepoints. Rates of ICU admission (65.2% vs 29.7%; P < .001), ICU LOS (median, 64.7 hours; interquartile range [IQR], 41.9-89.1 hours vs median, 38 hours; IQR, 22-66.4 hours; P < .001), and total hospital LOS (median, 5 days; IQR, 3-8 days vs median, 4 days; IQR, 2-6 days; P < .001) were all higher among the PERT group. Patients in the PERT group were more likely to receive vascular surgery consultation (5.3% vs 0.8%; P < .001) and the consultation occurred earlier in the admission when compared with the non-PERT group (median, 0 days; IQR, 0-1 days vs median, 1 day; IQR, 0-1; P = .04). CONCLUSIONS: The data presented here showed that there was no difference in mortality after PERT implementation. These results suggest that the presence of PERT increases the number of patients receiving a full PE workup with cardiac biomarkers. PERT also leads to more specialty consultations and more advanced therapies such as catheter-directed interventions. Further research is needed to assess the effect of PERT on long-term survival of patients with massive and submassive PE.

Comparing post-maturation outcomes of arteriovenous grafts and fistulae.

BACKGROUND: Though arteriovenous grafts (AVG) mature more reliably than arteriovenous fistulae (AVF) and require fewer maturation procedures (MP) to obtain functional patency, AVG are thought to have worse function after maturation. We explored differences in post-maturation outcomes between the following groups: AVF patients who did (AS-AVF) and did not (unAS-AVF) require assisted maturation and AVG patients who did (AS-AVG) and did not (unAS-AVG) require assisted maturation. METHODS: Using the US Renal Data System (2012-2017), we retrospectively identified patients who initiated dialysis with a central venous catheter, underwent AVF or AVG placement and achieved successful two-needle cannulation. Primary patency and access abandonment after maturation were compared across groups using competing risks regression methods, generating sub-hazards ratios (sHR). RESULTS: We identified 42,664 AVF and 12,335 AVG that met inclusion criteria. A larger proportion of AVFs required interventions: 18,408 AVF (43.2%) versus 2594 AVG (21.0%; p < 0.01). Both AS-AVG and AS-AVF patients experienced patency loss at 1 year more frequently compared with unAS-AVG (67.5% & 57.5% vs 55.2% respectively). Patency loss was lowest in unAS-AVF (38.9%). These trends were robust on adjusted analysis (unAS-AVG reference, AS-AVG sHR = 1.44, p < 0.01; AS-AVF sHR = 1.08, p < 0.01, unAS-AVF sHR = 0.67, p < 0.01). AS-AVGs were more likely to be abandoned than unAS-AVGs (11.7% unAS-AVG vs 17.2% AS-AVG). Fistulae, assisted or not, had lower unadjusted rates of 1-year abandonment than grafts (8.9% AS-AVF vs 7.3% unAS-AVF). On adjusted analysis, AVF usage was protective against abandonment (unAS-AVG, reference; AS-AVF sHR = 0.67, p < 0.01; unAS-AVF sHR = 0.59, p < 0.01) while AS-AVG was not (AS-AVG sHR = 1.32, p < 0.01). CONCLUSIONS: unAS-AVF have the best long-term outcomes. AS-AVF lose primary patency at a higher rate than unAS-AVG. AVGs may be a better choice than AVFs if veins are marginal and likely to require assisted maturation. Further research is needed to identify anatomic and physiologic factors that affect long-term performance and influence conduit choice.

Five-year outcomes from a prospective, multicenter study of endovascular repair of iliac artery aneurysms using an iliac branch device.

OBJECTIVE: We have reported the 5-year results of a pivotal prospective, multicenter study conducted in the United States of a specifically designed iliac branch endoprosthesis (IBE; W.L. Gore & Associates, Flagstaff, AZ) for endovascular repair of aortoiliac aneurysms and common iliac artery aneurysms. METHODS: A total of 63 patients (98.4% male; mean age, 70 years) with aortoiliac or common iliac artery aneurysms had undergone implantation of a single IBE device and a bifurcated aortoiliac stent graft. Patients with bilateral common iliac artery aneurysms (n = 22; 34.9%) had undergone either staged occlusion or surgical revascularization of the contralateral internal iliac artery before study enrollment. At 5 years, 36 of the 63 patients had completed the final study follow-up examinations, including clinical examinations (n = 35) and computed tomography (n = 32), with the results evaluated by an independent core laboratory and adverse events adjudicated by a clinical events committee. RESULTS: At 5 years, freedom from all-cause mortality was 85.7% and freedom from aneurysm-related mortality was 100%. The nine deaths that had occurred (range, 132-1898 days) were adjudicated as unrelated to the aneurysm or procedure. Primary patency of the internal and external iliac artery IBE limbs was 95.1% and 100%, respectively. No patients had experienced new-onset buttock claudication on the IBE side or self-reported new-onset erectile dysfunction. The common iliac artery diameter on the IBE side was either unchanged or had decreased by ≥5 mm in 30 of the 31 patients (96.8%) with a baseline (1 month) and 5-year (range, 1641-2006 days) computed tomography scan available. Of the 31 evaluable patients, 9 (29.0%) had had an increase of ≥5 mm in the aortic diameter, 5 of whom had had a concurrent type II endoleak. No type I or type III endoleaks or device migration were identified by the core laboratory. Six patients had undergone eight secondary interventions, including five interventions for a type II endoleak. The freedom from secondary intervention was 90.5%. CONCLUSIONS: The 5-year results of our prospective, multicenter study have confirmed the safety, efficacy, and durability of the IBE device for the treatment of aortoiliac and iliac artery aneurysms. The device effectively prevented common iliac artery aneurysm rupture, maintained the patency of the internal iliac artery, and avoided the complications associated with internal iliac artery sacrifice. Although common iliac artery aneurysm enlargement was rare, abdominal aortic enlargement was more common, suggesting that the outcomes of endovascular aneurysm repair might be different for patients with or without associated common iliac artery aneurysms.

COVID-associated acute limb ischemia during the Delta surge and the effect of vaccines.

OBJECTIVE: Hypercoagulability is common in severe acute respiratory syndrome coronavirus 2 and has been associated with arterial thrombosis leading to acute limb ischemia (ALI). Our objective was to determine the outcomes of concurrent coronavirus disease 2019 (COVID-19) infection and ALI, particularly during the Delta variant surge and the impact of vaccination status. METHODS: A retrospective review was performed of patients treated at a single health care system between March 2020 and December 2021 for ALI and recent (<14 days) COVID-19 infection or who developed ALI during hospitalization for the same disease. Patients were grouped by year as well as by pre and post Delta variant emergence in 2021 based on the World Health Organization timeline (January to May vs June to December). Baseline demographics, imaging, interventions, and outcomes were evaluated. A control cohort of all patients with ALI requiring surgical intervention for a 2-year period prior to the pandemic was used for comparison. Primary outcomes were in-hospital mortality and amputation-free survival. Kaplan-Meier survival and Cox proportional hazards analysis were performed. RESULTS: Forty acutely ischemic limbs were identified in 36 patients with COVID-19, the majority during the Delta surge (52.8%) and after the wide availability of vaccines. The rate of COVID-19-associated ALI, although low overall, nearly doubled during the Delta surge (0.37% vs 0.20%; P = .09). Intervention (open or endovascular revascularization vs primary amputation) was performed on 31 limbs in 28 individuals, with the remaining eight treated with systemic anti-coagulation. Postoperative mortality was 48%, and overall mortality was 50%. Major amputation following revascularization was significantly higher with COVID-19 ALI (25% vs 3%; P = .006) compared with the pre-pandemic group. Thirty-day amputation-free survival was significantly lower (log-rank P < .001). COVID-19 infection (adjusted hazard ratio, 6.2; P < .001) and age (hazard ratio, 1.1; P = .006) were associated with 30-day amputation in multivariate analysis. Severity of COVID-19 infection, defined as vasopressor usage, was not associated with post-revascularization amputation. There was a higher incidence of re-thrombosis in the latter half of 2021 with the Delta surge, as reintervention for recurrent ischemia of the same limb was more common than our previous experience (21% vs 0%; P = .55). COVID-19-associated limb ischemia occurred almost exclusively in non-vaccinated patients (92%). CONCLUSIONS: ALI observed with Delta appears more resistant to standard therapy. Unvaccinated status correlated highly with ALI occurrence in the setting of COVID-19 infection. Information of limb loss as a COVID-19 complication among non-vaccinated patients may help to increase compliance.

Stenting across inferior vena cava filters can be a safe and effective alternative to complex retrieval.

OBJECTIVE: Venous stenting for acute and chronic venous disease has been increasingly used as more evidence has accumulated on the efficacy and durability of these interventions for symptomatic patients. Inferior vena cava (IVC) filters that could have been present for years will often be implicated in the obstructive pathology and removal can be challenging. The purpose of the present study was to evaluate whether stenting across an indwelling IVC filter is a safe and effective alternative to removal. METHODS: Consecutive patients who had undergone iliocaval stenting at our institution from 2007 to 2020 were identified and divided into groups stratified by the presence of an IVC filter. The operative notes, venography findings, and the electronic health records were queried to obtain the operative details, patient characteristics, postoperative outcomes, stent patency, and survival outcomes. The primary end point was iliocaval stent patency. The patients were divided into two groups according to the presence of an IVC filter with or without overstenting. We used the χ2 test and survival analysis as appropriate. RESULTS: A total of 224 consecutive patients were identified, of whom 71 were found to have undergone iliocaval stenting (age, 48 ± 18 years; 47.9% male; body mass index, 31 ± 9 kg/m2). Of the 71 patients, 15 had had stents placed across an indwelling IVC filter (overstented group) and 56 had not had an IVC filter present (non-overstented group). No differences were found in presentation between the overstented group (acute occlusion, 4 of 15 [26.7%]; chronic occlusion, 8 of 15 [53.3%]; and nonocclusive lesions, 3 of 15 [20%]) and the non-overstented group (acute occlusion, 29 of 56 [52%]; chronic occlusion, 18 of 56 [32%]; nonocclusive lesions, 9 of 56 [16%]; P = .2). Comparisons between the two groups revealed no differences in the baseline characteristics except for age (overstented, 57 ± 15 years; non-overstented, 46 ± 18 years; P = 0.03), preoperative anticoagulation therapy (overstented, 66.6%; non-overstented, 26.9%; P = .01), and bilateral leg symptoms (overstented, 86.7%; non-overstented, 23.2%; P < .001). Primary patency at 30 months was 85.6% in the overstented group and 86.1% in the non-overstented group (P = .78). At follow-up, no adverse events related to filter crushing were reported, and no differences were found in 30-month survival. CONCLUSIONS: In our single-center, retrospective study of iliocaval stenting, patients who had undergone overstenting across an indwelling IVC filter had had patency rates similar to those whose stents had been placed with no IVC filter in place. Thus, complex IVC filter removal, when not possible or when the risk of operative complications is too high, can be forgone in favor of stenting across the IVC filter, with no implications on midterm patency or adverse events.

Abdominal aortic aneurysm monitoring via arterial waveform analysis: towards a convenient point-of-care device.

Abdominal aortic aneurysms (AAAs) are lethal but treatable yet substantially under-diagnosed and under-monitored. Hence, new AAA monitoring devices that are convenient in use and cost are needed. Our hypothesis is that analysis of arterial waveforms, which could be obtained with such a device, can provide information about AAA size. We aim to initially test this hypothesis via tonometric waveforms. We study noninvasive carotid and femoral blood pressure (BP) waveforms and reference image-based maximal aortic diameter measurements from 50 AAA patients as well as the two noninvasive BP waveforms from these patients after endovascular repair (EVAR) and from 50 comparable control patients. We develop linear regression models for predicting the maximal aortic diameter from waveform or non-waveform features. We evaluate the models in out-of-training data in terms of predicting the maximal aortic diameter value and changes induced by EVAR. The best model includes the carotid area ratio (diastolic area divided by systolic area) and normalized carotid-femoral pulse transit time ((age·diastolic BP)/(height/PTT)) as input features with positive model coefficients. This model is explainable based on the early, negative wave reflection in AAA and the Moens-Korteweg equation for relating PTT to vessel diameter. The predicted maximal aortic diameters yield receiver operating characteristic area under the curves of 0.83 ± 0.04 in classifying AAA versus control patients and 0.72 ± 0.04 in classifying AAA patients before versus after EVAR. These results are significantly better than a baseline model excluding waveform features as input. Our findings could potentially translate to convenient devices that serve as an adjunct to imaging.