Transcatheter Arterialization of Deep Veins in Chronic Limb-Threatening Ischemia.

BACKGROUND: Approximately 20% of patients with chronic limb-threatening ischemia have no revascularization options, leading to above-ankle amputation. Transcatheter arterialization of the deep veins is a percutaneous approach that creates an artery-to-vein connection for delivery of oxygenated blood by means of the venous system to the ischemic foot to prevent amputation. METHODS: We conducted a prospective, single-group, multicenter study to evaluate the effect of transcatheter arterialization of the deep veins in patients with nonhealing ulcers and no surgical or endovascular revascularization treatment options. The composite primary end point was amputation-free survival (defined as freedom from above-ankle amputation or death from any cause) at 6 months, as compared with a performance goal of 54%. Secondary end points included limb salvage, wound healing, and technical success of the procedure. RESULTS: We enrolled 105 patients who had chronic limb-threatening ischemia and were of a median age of 70 years (interquartile range, 38 to 89). Of the patients enrolled, 33 (31.4%) were women and 45 (42.8%) were Black, Hispanic, or Latino. Transcatheter arterialization of the deep veins was performed successfully in 104 patients (99.0%). At 6 months, 66.1% of the patients had amputation-free survival. According to Bayesian analysis, the posterior probability that amputation-free survival at 6 months exceeded a performance goal of 54% was 0.993, which exceeded the prespecified threshold of 0.977. Limb salvage (avoidance of above-ankle amputation) was attained in 67 patients (76.0% by Kaplan-Meier analysis). Wounds were completely healed in 16 of 63 patients (25%) and were in the process of healing in 32 of 63 patients (51%). No unanticipated device-related adverse events were reported. CONCLUSIONS: We found that transcatheter arterialization of the deep veins was safe and could be performed successfully in patients with chronic limb-threatening ischemia and no conventional surgical or endovascular revascularization treatment options. (Funded by LimFlow; PROMISE II study ClinicalTrials.gov number, NCT03970538.).

Quality of Life in Patients With Chronic Limb-Threatening Ischemia Treated With Revascularization.

BACKGROUND: In the BEST-CLI trial (Best Endovascular Versus Best Surgical Therapy for Patients With Chronic Limb-Threatening Ischemia), a prespecified secondary objective was to assess the effects of revascularization strategy on health-related quality of life (HRQoL). METHODS: Patients with chronic limb-threatening ischemia were randomized to surgical bypass (Bypass) or endovascular intervention (Endo) in 2 parallel trials. Cohort 1 included patients with single-segment great saphenous vein; cohort 2 included those lacking suitable single-segment great saphenous vein. HRQoL was assessed over the trial duration using Vascular Quality-of-Life (VascuQoL), European Quality-of-Life-5D (EQ-5D), the Short Form-12 (SF-12) Physical Component Summary (SF-12 PCS), SF-12 Mental Component Summary (SF-12 MCS), Utility Index Score (SF-6D R2), and numeric rating scales of pain. HRQoL was summarized by cohort and compared within and between groups using mixed-model linear regression. RESULTS: A total of 1193 and 335 patients in cohorts 1 and 2 with a mean follow-up of 2.9 and 2.0 years, respectively, were analyzed. In cohort 1, HRQoL significantly improved from baseline to follow-up for both groups across all measures. For example, mean (SD) VascuQoL scores were 3.0 (1.3) and 3.0 (1.2) for Bypass and Endo at baseline and 4.7 (1.4) and 4.8 (1.5) over follow-up. There were significant group differences favoring Endo when assessed with VascuQoL (difference, -0.14 [95% CI, -0.25 to -0.02]; P=0.02), SF-12 MCS (difference, -1.03 [95% CI, -1.89 to -0.18]; P=0.02), SF-6D R2 (difference, -0.01 [95% CI, -0.02 to -0.001]; P=0.03), numeric rating scale pain at present (difference, 0.26 [95% CI, 0.03 to 0.49]; P=0.03), usual level during previous week (difference, 0.26 [95% CI, 0.04 to 0.48]; P=0.02), and worst level during previous week (difference, 0.29 [95% CI, 0.02 to 0.56]; P=0.04). There was no difference between treatment arms on the basis of EQ-5D (difference, -0.01 [95% CI, -0.03 to 0.004]; P=0.12) or SF-12 PCS (difference, -0.41 [95% CI, -1.2 to 0.37]; P=0.31). In cohort 2, HRQoL also significantly improved from baseline to the end of follow-up for both groups based on all measures, but there were no differences between Bypass and Endo on any measure. CONCLUSIONS: Among patients with chronic limb-threatening ischemia deemed eligible for either Bypass or Endo, revascularization resulted in significant and clinically meaningful improvements in HRQoL. In patients with an available single-segment great saphenous vein for bypass, but not among those without one, Endo was statistically superior on some HRQoL measures; however, these differences were below the threshold of clinically meaningful difference.

Surgery or Endovascular Therapy for Chronic Limb-Threatening Ischemia.

BACKGROUND: Patients with chronic limb-threatening ischemia (CLTI) require revascularization to improve limb perfusion and thereby limit the risk of amputation. It is uncertain whether an initial strategy of endovascular therapy or surgical revascularization for CLTI is superior for improving limb outcomes. METHODS: In this international, randomized trial, we enrolled 1830 patients with CLTI and infrainguinal peripheral artery disease in two parallel-cohort trials. Patients who had a single segment of great saphenous vein that could be used for surgery were assigned to cohort 1. Patients who needed an alternative bypass conduit were assigned to cohort 2. The primary outcome was a composite of a major adverse limb event - which was defined as amputation above the ankle or a major limb reintervention (a new bypass graft or graft revision, thrombectomy, or thrombolysis) - or death from any cause. RESULTS: In cohort 1, after a median follow-up of 2.7 years, a primary-outcome event occurred in 302 of 709 patients (42.6%) in the surgical group and in 408 of 711 patients (57.4%) in the endovascular group (hazard ratio, 0.68; 95% confidence interval [CI], 0.59 to 0.79; P<0.001). In cohort 2, a primary-outcome event occurred in 83 of 194 patients (42.8%) in the surgical group and in 95 of 199 patients (47.7%) in the endovascular group (hazard ratio, 0.79; 95% CI, 0.58 to 1.06; P = 0.12) after a median follow-up of 1.6 years. The incidence of adverse events was similar in the two groups in the two cohorts. CONCLUSIONS: Among patients with CLTI who had an adequate great saphenous vein for surgical revascularization (cohort 1), the incidence of a major adverse limb event or death was significantly lower in the surgical group than in the endovascular group. Among the patients who lacked an adequate saphenous vein conduit (cohort 2), the outcomes in the two groups were similar. (Funded by the National Heart, Lung, and Blood Institute; BEST-CLI ClinicalTrials.gov number, NCT02060630.).

Learning curve of transfemoral carotid artery stenting in the Vascular Quality Initiative registry.

OBJECTIVE: With the recent expansion of the Centers for Medicare and Medicaid Services coverage, transfemoral carotid artery stenting (tfCAS) is expected to play a larger role in the management of carotid disease. Existing research on the tfCAS learning curve, primarily conducted over a decade ago, may not adequately describe the current effect of physician experience on outcomes. Because approximately 30% of perioperative strokes/deaths post-CAS occur after discharge, appropriate thresholds for in-hospital event rates have been suggested to be <4% for symptomatic and <2% for asymptomatic patients. This study evaluates the tfCAS learning curve using Vascular Quality Initiative (VQI) data. METHODS: We identified VQI patients who underwent tfCAS between 2005 and 2023. Each physician's procedures were chronologically grouped into 12 categories, from procedure counts 1-25 to 351+. The primary outcome was in-hospital stroke/death rate; secondary outcomes were in-hospital stroke/death/myocardial infarction (MI), 30-day mortality, in-hospital stroke/transient ischemic attack (stroke/TIA), and access site complications. The relationship between outcomes and procedure counts was analyzed using the Cochran-Armitage test and a generalized linear model with restricted cubic splines. Our results were then validated using a generalized estimating equations model to account for the variability between physicians. RESULTS: We analyzed 43,147 procedures by 2476 physicians. In symptomatic patients, there was a decrease in rates of in-hospital stroke/death (procedure counts 1-25 to 351+: 5.2%-1.7%), in-hospital stroke/death/MI (5.8%-1.7%), 30-day mortality (4.6%-2.8%), in-hospital stroke/TIA (5.0%-1.1%), and access site complications (4.1%-1.1%) as physician experience increased (all P values < .05). The in-hospital stroke/death rate remained above 4% until 235 procedures. Similarly, in asymptomatic patients, there was a decrease in rates of in-hospital stroke/death (2.1%-1.6%), in-hospital stroke/death/MI (2.6%-1.6%), 30-day mortality (1.7%-0.4%), and in-hospital stroke/TIA (2.8%-1.6%) with increasing physician experience (all P values <.05). The in-hospital stroke/death rate remained above 2% until 13 procedures. CONCLUSIONS: In-hospital stroke/death and 30-day mortality rates after tfCAS decreased with increasing physician experience, showing a lengthy learning curve consistent with previous reports. Given that physicians' early cases may not be included in the VQI, the learning curve was likely underestimated. Nevertheless, a substantially high rate of in-hospital stroke/death was found in physicians' first 25 procedures. With the recent Centers for Medicare and Medicaid Services coverage expansion for tfCAS, a significant number of physicians would enter the early stage of the learning curve, potentially leading to increased postoperative complications.

Investigator attitudes on equipoise and practice patterns in the BEST-CLI trial.

OBJECTIVES: There has been significant variability in practice patterns and equipoise regarding treatment approach for chronic limb-threatening ischemia (CLTI). We aimed to assess treatment preferences of Best Endovascular vs Best Surgical Therapy in Patients with CLTI (BEST-CLI) investigators prior to and following the trial. METHODS: An electronic 60-question survey was sent to 1180 BEST-CLI investigators in 2022, after trial conclusion and before announcement of results. Investigators' preferences were assessed across clinical scenarios for both open (OPEN) and endovascular (ENDO) revascularization strategies. Vascular surgeon (VS) surgical and ENDO preferences were compared with a 2010 survey administered to prospective investigators before trial funding. RESULTS: For the 2022 survey, the response rate was 20.2% and was comprised of VSs (76.3%), interventional cardiologists (11.4%) and interventional radiologists (11.6%). The majority (72.6%) were in academic practice and 39.1% were in practice for >20 years. During initial CLTI work-up, 65.8%, 42.6%, and 55.9% of respondents always or usually ordered an arterial duplex, computed tomography angiography, and vein mapping, respectively. The most common practice distribution between ENDO and OPEN procedures was 70/30. Postoperatively, a majority reported performing routine duplex surveillance of vein bypass (99%), prosthetic bypass (81.9%), and ENDO interventions (86%). A minority reported always or usually using the wound, ischemia, and foot infection (WIfI) criteria (25.8%), GLASS (8.3%), and a risk calculator (14.8%). More than one-half (52.9%) agreed that the statement "no bridges are burned with an ENDO-first approach" was false. Intervention choice was influenced by availability of the operating room or ENDO suite, personal schedule, and personal skill set in 30.1%, 18.0%, and 45.9% of respondents, respectively. Most respondents reported routinely using paclitaxel-coated balloons (88.1%) and stents (67.5%); however, 73.3% altered practice when safety concerns were raised. Among surgeons, 17.8%, 2.9%, and 10.3% reported performing >10 annual alternative autogenous vein bypasses, composite vein composite vein bypasses, and bypasses to pedal targets, respectively. Among all interventionalists, 8%, 24%, and 8% reported performing >10 annual radial access procedures, pedal or tibial access procedures, and pedal loop revascularizations. The majority (89.1%) of respondents felt that CLTI teams improved care; however, only 23.2% had a defined team. The effectiveness of the teamwork at institutions was characterized as highly effective in 42.5%. When comparing responses by VSs to the 2010 survey, there were no changes in preferred treatment based on Inter-Society Consensus for the Management of Peripheral Arterial Disease (TASC) II classification or conduit preference. In 2022, OPEN surgery was preferred more for a popliteal occlusion. For clinical scenarios, there were no differences except a decreased proportion of respondents who felt there was equipoise for major tissue loss for major tissue loss (43.8% vs 31.2%) and increased ENDO choice for minor tissue loss (17.6% vs 30.8%) (P < .05). CONCLUSIONS: There is a wide range of practice patterns among vascular specialists treating CLTI. The majority of investigators in BEST-CLI had experience in both advanced OPEN and ENDO techniques and represent a real-world sample of technical expertise. Over the course of the decade of the BEST-CLI trial, there was overall similar equipoise among VSs.

Surgery or endovascular therapy for patients with chronic limb-threatening ischemia requiring infrapopliteal interventions.

OBJECTIVE: The recent publication of randomized trials comparing open bypass surgery to endovascular therapy in patients with chronic limb-threatening ischemia, namely, Best Endovascular vs Best Surgical Therapy in Patients with Critical Limb Ischemia (BEST-CLI) and Bypass versus Angioplasty in Severe Ischaemia of the Leg-2 (BASIL-2), has resulted in potentially contradictory findings. The trials differed significantly with respect to anatomical disease patterns and primary end points. We performed an analysis of patients in BEST-CLI with significant infrapopliteal disease undergoing open tibial bypass or endovascular tibial interventions to formulate a relevant comparator with the outcomes reported from BASIL-2. METHODS: The study population consisted of patients in BEST-CLI with adequate single segment saphenous vein conduit randomized to open bypass or endovascular intervention (cohort 1) who additionally had significant infrapopliteal disease and underwent tibial level intervention. The primary outcome was major adverse limb event (MALE) or all-cause death. MALE included any major limb amputation or major reintervention. Outcomes were evaluated using Cox proportional regression models. RESULTS: The analyzed subgroup included a total of 665 patients with 326 in the open tibial bypass group and 339 in the tibial endovascular intervention group. The primary outcome of MALE or all-cause death at 3 years was significantly lower in the surgical group at 48.5% compared with 56.7% in the endovascular group (P = .0018). Mortality was similar between groups (35.5% open vs 35.8% endovascular; P = .94), whereas MALE events were lower in the surgical group (23.3% vs 35.0%; P<.0001). This difference included a lower rate of major reinterventions in the surgical group (10.9%) compared with the endovascular group (20.2%; P = .0006). Freedom from above ankle amputation or all-cause death was similar between treatment arms at 43.6% in the surgical group compared with 45.3% the endovascular group (P = .30); however, there were fewer above ankle amputations in the surgical group (13.5%) compared with the endovascular group (19.3%; P = .0205). Perioperative (30-day) death rates were similar between treatment groups (2.5% open vs 2.4% endovascular; P = .93), as was 30-day major adverse cardiovascular events (5.3% open vs 2.7% endovascular; P = .12). CONCLUSIONS: Among patients with suitable single segment great saphenous vein who underwent infrapopliteal revascularization for chronic limb-threatening ischemia, open bypass surgery was associated with a lower incidence of MALE or death and fewer major amputation compared with endovascular intervention. Amputation-free survival was similar between the groups. Further investigations into differences in comorbidities, anatomical extent, and lesion complexity are needed to explain differences between the BEST-CLI and BASIL-2 reported outcomes.

Prosthetic Conduits have Worse Outcomes compared to Great Saphenous Vein Conduits in Femoropopliteal and Infrapopliteal Bypass in Patients with Chronic Limb Threatening Ischemia.

OBJECTIVES: Single segment great saphenous vein (SSGSV) has traditionally been considered the gold standard conduit for infrainguinal bypass. There are data supporting similar outcomes with prosthetic femoral-popliteal bypass. Moreover, some have advocated for prosthetic conduit for femoral tibial bypass when GSV is inadequate or unavailable. We sought to evaluate long-term outcomes of infrainguinal bypass based on conduit type for treating chronic limb threatening ischemia (CLTI). METHODS: Data from the Best Endovascular versus Best Surgical Therapy of Patients with CLTI (BEST-CLI) multicenter, prospective, randomized controlled trial, comparing infrainguinal bypass with endovascular therapy in patients with CLTI, were evaluated. In this as-treated analysis, we compared outcomes of infrainguinal bypass using prosthetic, alternative autogenous vein (AAV), and cryopreserved vein (Cryo) with SSGSV bypass. Kaplan-Meier and multivariable analyses were performed to examine the associations of conduit type with major adverse limb event (MALE) events, reinterventions, above-ankle amputations, and all-cause death. RESULTS: In total, 784 bypasses were analyzed (120 prosthetic, 33 AAV, 21 Cryo, 610 SSGSV). For prosthetic and SSGSV, the distribution was 357 femoropopliteal (93 prosthetic and 264 GSV) and 373 infrapopliteal (27 prosthetic and 346 GSV). Mean age for the overall cohort was 67.1 years; 27.4% were female gender, 29.9% were non-White, and 11.5% were of Hispanic ethnicity. Patients undergoing prosthetic bypass were older (69.2 vs. 66.7 years), more likely to have chronic obstructive pulmonary disease (22.5% vs. 14%), prior coronary artery bypass grafting (88.9% vs. 66.5%), prior stroke (23.3% vs. 14%), but less often were of Hispanic ethnicity (5.8% vs. 12.6%) and had diabetes (59.2% vs. 71.3%) (P<.05 for all). For femoropopliteal bypass, use of prosthetic conduit was associated with increased major reinterventions at 3 years overall (19% vs. 11.5%, P=.06) and on risk adjusted analysis (HR 2.13, 95% CI 1.09 - 4.2, P=.028). No significant differences in MALE or death, above-ankle amputation, or death were observed. Outcomes were similar for bypasses to above knee popliteal targets and below knee popliteal targets. For infrapopliteal bypass, use of prosthetic conduit was associated with increased major reintervention (25.3% vs. 10.3%, P=.005), death (68.6% vs. 34.8%, P<.001), MALE or death (90% vs. 48.1%, P<.001) at 3 years. After risk adjustment, infrapopliteal bypass with prosthetic conduit was associated with higher major reintervention (HR 4.14, 95% CI 1.36 - 12.6, P=.012), above-ankle amputation (HR 4.64, 95% CI 1.59 - 13.5, P=.005), death (HR 2.96, 95% CI 1.4 - 6.2, P=.004), and MALE or death (HR 3.59, 95% CI 1.64 - 7.86, P=.001) compared to bypass with SSGSV. Overall, AAV had similar outcomes at 3 years to SSGSV, however Cryo had significantly higher above ankle amputation (50% vs 12.8%) (HR 4.2, 95% CI 1.68 - 10.5, P=.002), major reintervention (41.9% vs. 10.7%) (HR 3.12, 95% CI 1.18 - 8.22, P=.02), and MALE/death (88.8% vs. 37.8%) (HR 2.96, 95% CI 1.43-6.14, P=.004). CONCLUSIONS: Use of prosthetic conduit in infrainguinal bypass is associated with inferior outcomes compared to bypass using SSGSV, particularly for bypass to infrapopliteal targets. Cryo grafts were infrequent and also demonstrated inferior outcomes. SSGSV remains the preferred conduit of choice for infrainguinal bypass.

Comparison of Transcatheter Arterialization of Deep Veins to Standard of Care in Patients with No-Option Chronic Limb Threatening Ischemia.

BACKGROUND: Patients with no-option chronic limb-threatening ischemia (no-option CLTI) have limited therapeutic options. The PROMISE II study evaluated, transcatheter arterialization of deep veins (TADV) as a treatment option for no-option CLTI. In the current study patients from PROMISE II were compared to patients from a registry of untreated no-option CLTI patients (CLariTI: Natural Progression of High-Risk Chronic Limb-Threatening Ischemia). METHODS: We used propensity matching to compare patients from the PROMISE II prospective study of the TADV intervention with simultaneously enrolled CLTI patients that were note candidates for PROMISE II but were enrolled in to CLariTI natural history registry. Untreated no-option CLTI (CLariTI) patients could either be no-option or patients who did not meet PROMISE II entry criteria. Risk difference between groups was calculated using common risk difference and P values were provided by propensity-score stratified Mantel-Haenszel test. The primary endpoint was amputation-free survival (AFS). RESULTS: Diabetes was present in over 75% of patients. All patients had tissue loss and 35-46% had extensive tissue loss (Rutherford 6). The unadjusted AFS at 6 months, was 66.1% by Kaplan-Meier estimate for PROMISE II patients (n = 105) compared to 39.1% in the no-option cohort of CLariTI (n = 121) and 44.0% in the full cohort (no-option and patients not meeting entry criteria combine, n = 180). The treatment group who underwent TADV for no-option CLTI had an absolute difference of 29% improved (P < 0.0001) propensity-adjusted risk difference in AFS and a relative event rate reduction of 45% compared to the no-option control patients. CONCLUSIONS: Transcatheter arterialization of deep veins (TADV) resulted in improved 6 month AFS in no-option CLTI patients and appears to be a promising therapy in patients with no-option CLTI.

Increased Preoperative Stress Test Utilization is Not Associated With Reduced Adverse Cardiac Events in Current US Surgical Practice.

OBJECTIVE: To measure the frequency of preoperative stress testing and its association with perioperative cardiac events. BACKGROUND: There is persistent variation in preoperative stress testing across the United States. It remains unclear whether more testing is associated with reduced perioperative cardiac events. METHODS: We used the Vizient Clinical Data Base to study patients who underwent 1 of 8 elective major surgical procedures (general, vascular, or oncologic) from 2015 to 2019. We grouped centers into quintiles by frequency of stress test use. We computed a modified revised cardiac risk index (mRCRI) score for included patients. Outcomes included in-hospital major adverse cardiac events (MACEs), myocardial infarction (MI), and cost, which we compared across quintiles of stress test use. RESULTS: We identified 185,612 patients from 133 centers. The mean age was 61.7 (±14.2) years, 47.5% were female, and 79.4% were White. Stress testing was performed in 9.2% of patients undergoing surgery, and varied from 1.7% at lowest quintile centers, to 22.5% at highest quintile centers, despite similar mRCRI comorbidity scores (mRCRI>1: 15.0% vs 15.8%; P =0.068). In-hospital MACE was less frequent among lowest versus highest quintile centers (8.2% vs 9.4%; P <0.001) despite a 13-fold difference in stress test use. Event rates were similar for MI (0.5% vs 0.5%; P =0.737). Mean added cost for stress testing per 1000 patients who underwent surgery was $26,996 at lowest quintile centers versus $357,300 at highest quintile centers. CONCLUSIONS: There is substantial variation in preoperative stress testing across the United States despite similar patient risk profiles. Increased testing was not associated with reduced perioperative MACE or MI. These data suggest that more selective stress testing may be an opportunity for cost savings through a reduction of unnecessary tests.

The financial burden associated with endovascular repair of thoracoabdominal and pararenal aortic aneurysms using physician-modified fenestrated-branched endografts.

OBJECTIVE/BACKGROUND: Endovascular thoracoabdominal and pararenal aortic aneurysm repair is more complex and requires more devices than infrarenal aneurysm repair. It is unclear if current reimbursement covers the cost of delivering this more advanced form of vascular care. The objective of this study was to evaluate the economics of fenestrated-branched (FB-EVAR) physician-modified endograft (PMEG) repairs. METHODS: We obtained technical and professional cost and revenue data for four consecutive fiscal years (July 1, 2017, to June 30, 2021) at our quaternary referral institution. Inclusion criteria were patients who underwent PMEG FB-EVAR in a uniform fashion by a single surgeon for thoracoabdominal/pararenal aortic aneurysms. Patients in industry-sponsored clinical trials or receiving Cook Zenith Fenestrated grafts were excluded. Financial data were analyzed for the index operation. Technical costs were divided into direct costs that included devices and billable supplies and indirect costs including overhead. RESULTS: 62 patients (79% male, mean age: 74 years, 66% thoracoabdominal aneurysms) met inclusion criteria. The mean aneurysm size was 6.0 cm, the mean total operating time was 219 minutes, and the median hospital length of stay was 2 days. PMEGs were created with a mean number of 3.7 fenestrations, using a mean of 8.6 implantable devices per case. The average technical cost per case was $71,198, and the average technical reimbursement was $57,642, providing a net negative technical margin of $13,556 per case. Of this cohort, 31 patients (50%) were insured by Medicare remunerated under diagnosis-related group code 268/269. Their respective average technical reimbursement was $41,293, with a mean negative margin of $22,989 per case, with similar findings for professional costs. The primary driver of technical cost was implantable devices, accounting for 77% of total technical cost per case over the study period. The total operating margin, including technical and professional cost and revenue, for the cohort during the study period was negative $1,560,422. CONCLUSIONS: PMEG FB-EVAR for pararenal/thoracoabdominal aortic aneurysms produces a substantially negative operating margin for the index operation driven largely by device costs. Device cost alone already exceeds total technical revenue and presents an opportunity for cost reduction. In addition, increased reimbursement for FB-EVAR, especially among Medicare beneficiaries, will be important to facilitate patient access to such innovative technology.

The Contemporary Impact of Body Mass Index on Open Aortic Aneurysm Repair.

INTRODUCTION: The Centers for Disease Control and Prevention (CDC) has deemed obesity a national epidemic and contributor to other leading causes of death including heart disease, stroke, and diabetes. Accordingly, the role of body mass index (BMI) and its impact on surgical outcomes has been a focus of persistent investigation. The purpose of this study was to quantify the effect of BMI on open abdominal aortic aneurysm repair (oAAA) outcomes in contemporary practice. METHODS: All elective oAAAs in the VQI (2010-2021) were identified. End-points included 30-day death, in-hospital complications and 1-year mortality. Patients were stratified into four BMI cohorts (BMI<18.5, 18.5≤BMI<25, 25≤BMI<30, BMI≥30). Spline interpolation was used to explore a potential non-linear association between BMI and perioperative mortality. Mixed-effects Cox regression was used to assess the association between BMI and 1-year survival. RESULTS: 9,479 patients underwent oAAA over the study interval (median age-70, 74%-male, BMI 27±6). Lower BMI patients(<18.5) compared to higher BMI(>30) patients were more likely to be women (53% vs. 32%;p<.0001), current smokers(65% vs. 50%;p<.0001), and have COPD(58% vs. 37%;p<.0001). In contrast, an increased BMI was associated with a greater prevalence of diabetes and CAD (DM-26% vs. 6%;p<.0001; CAD-27% vs. 20%;p=.01). There was no difference in cross-clamp position or visceral/renal bypass between groups, though low BMI patients necessitated more frequent infrainguinal bypass(5% vs. 2%;p=.0002). 30-day mortality and in-hospital complications were greater among low BMI patients(30-day mortality:12% vs. 4%;p<.0001;complications-47% vs. 37%;p<.0001). Interestingly, low BMI conferred a nearly 2-fold increase in observed pulmonary complications(18% vs. 11%;p<.0001). Surgical site infections were twice as common among the lowest and highest BMI groups(4% vs. 2%;p<.0001). 1-year mortality was greatest among low BMI patients(23% vs. 9%;p<.0001). Adjusted spline-fit analysis demonstrated increased mortality among patients with BMI<21 or >34(BMI<18.5-HR 2.1, 95%CI 1.6-2.8;p<.0001; BMI>34-HR 1.3, 95%CI 1.1-1.6;p=.009). CONCLUSION: Both low (<18.5) and high (>34) BMI were associated with increased oAAA mortality in current practice. Despite the perception that obesity confers substantial surgical risk during oAAA, diminished BMI was associated with a 3-fold increase in 30-day and 1-year mortality. It appears that BMI extremes are distinct proxies for differential clinical phenotypes and should inform risk stratification for oAAA repair.

Reduction in Acute Limb Ischemia With Rivaroxaban Versus Placebo in Peripheral Artery Disease After Lower Extremity Revascularization: Insights From VOYAGER PAD.

BACKGROUND: Patients with peripheral artery disease (PAD) are at heightened risk of acute limb ischemia (ALI), a thrombotic event associated with amputation, disability, and mortality. Previous lower extremity revascularization (LER) is associated with increased ALI risk in chronic PAD. However, the pattern of risk, clinical correlates, and outcomes after ALI early after LER are not well-studied, and effective therapies to reduce ALI post-LER are lacking. METHODS: The VOYAGER PAD trial (Vascular Outcomes Study of ASA [Acetylsalicylic Acid] Along With Rivaroxaban in Endovascular or Surgical Limb Revascularization for PAD; rNCT02504216) randomized patients with PAD undergoing LER to rivaroxaban 2.5 mg twice daily or placebo on a background of low-dose aspirin. The primary outcome was a composite of ALI, major amputation of vascular cause, myocardial infarction, ischemic stroke, or cardiovascular death. ALI was prospectively ascertained and adjudicated by a blinded committee. The cumulative incidence of ALI was calculated using Kaplan-Meier estimates, and Cox proportional hazards models were used to generate hazard ratios and associated CIs. Analyses were performed as intention-to-treat. RESULTS: Among 6564 patients followed for a median of 2.3 years, 382 (5.8%) had a total of 508 ALI events. In placebo patients, the 3-year cumulative incidence of ALI was 7.8%. After multivariable modeling, previous LER, baseline ankle-brachial index <0.50, surgical LER, and longer target lesion length were associated with increased risk of ALI. Incident ALI was associated with subsequent all-cause mortality (hazard ratio [HR], 2.59 [95% CI, 1.98-3.39]) and major amputation (HR, 24.87 [95% CI, 18.68-33.12]). Rivaroxaban reduced ALI relative to placebo by 33% (absolute risk reduction, 2.6% at 3 years; HR, 0.67 [95% CI, 0.55-0.82]; P=0.0001), with benefit starting early (HR, 0.45 [95% CI, 0.24-0.85]; P=0.0068 at 30 days). Benefit was present for severe ALI (associated with death, amputation, or prolonged hospitalization and intensive care unit stay, HR, 0.58 [95% CI, 0.40-0.83]; P=0.003) and regardless of LER type (surgical versus endovascular revascularization, P interaction=0.42) or clopidogrel use (P interaction=0.59). CONCLUSIONS: After LER for symptomatic PAD, ALI is frequent, particularly early after LER, and is associated with poor prognosis. Low-dose rivaroxaban plus aspirin reduces ALI after LER, including ALI events associated with the most severe outcomes. The benefit of rivaroxaban for ALI appears early, continues over time, and is consistent regardless of revascularization approach or clopidogrel use.

Factors associated with lower preoperative quality of life in patients with chronic limb-threatening ischemia in the BEST-CLI trial.

OBJECTIVES: There are few contemporary data regarding health-related quality of life (HRQOL) measures in patients with chronic limb-threatening ischemia (CLI). METHODS: The Best Endovascular versus Best Surgical Therapy in Patients with CLI (BEST-CLI) trial is an ongoing, National Institutes of Health-sponsored, multicenter, randomized, controlled trial comparing revascularization strategies in patients with CLI. BEST-CLI baseline HRQOL measures were evaluated for patient-specific variables that were associated with poor HRQOL and then compared with published outcomes. The HRQOL measures Vascular Quality of Life Questionnaire (VascQOL), European Quality of Life 5D (EQ-5D), and the Short Form 12 (SF-12) Index score, physical component score (PCS) and mental component score (MCS) were aggregated from preoperative questionnaires completed by trial patients at baseline visits. Multivariable linear regression models were fit to determine which baseline characteristics were associated with poor HRQOL. RESULTS: We randomized 1830 patients into BEST-CLI. The majority (94.9%, 95.8%, and 95.8%) completed the VascQOL, EQ-5D, and SF-12 instruments at baseline, respectively. In the VascQOL, female sex, smoking history, opioid use, and nonindependent ambulation predicted lower HRQOL scores. Overall, VascuQOL scores were similar to those of participants in the Bypass versus Angioplasty in Severe Ischemia of the Leg (mean, 3.07 ± 1.2 vs mean, 2.9 ± 1.1; P = .07). In EQ-5D, nonindependent ambulation predicted lower HRQOL scores. In the SF-12, female sex, opioid use, nonindependent ambulation, and a history of smoking predicted lower HRQOL scores. The mean SF-12 PCS for all patients in the study was 33.0 ± 8.5 and for the MCS was 46.4 ± 12.0), significantly lower than the national SF-12 scores for US population ages more than 60 years, which is a PCS of 46.5 ± 11.4 and an MCS of 52.9 ± 8.7. CONCLUSIONS: Patients with CLI entering the BEST-CLI trial have very low HRQOL scores, comparable with patients suffering from other chronic conditions characterized by physical limitations and chronic pain. A history of smoking, impaired ambulation, opioid use, and female sex predicted lower HRQOL in patients with CLI, using multiple HRQOL measurement tools.

Center volume is associated with diminished failure to rescue and improved outcomes following elective open abdominal aortic aneurysm repair.

OBJECTIVE: Conflicting annual procedure volumes have been endorsed among different watchdog groups and professional societies, obscuring credentialing paradigms. There has been ample focus on surgeon volume to date but less attention on the effect of center volume. Specifically, whether center volume might be a better proxy for high-quality care. In the present study, we aimed to measure the association of center volume on open abdominal aortic aneurysm (AAA) repair (OAR) outcomes and failure to rescue (FTR). METHODS: All elective OARs (2003-2020) in the Society for Vascular Surgery Vascular Quality Initiative were reviewed (n = 9791). FTR was defined as in-hospital death after the occurrence of a complication (ie, cardiac, stroke, pulmonary, renal, colonic ischemia, return to the operating room for bleeding). The annual center volume for 218 hospitals was calculated, and the volume quartiles (quartile 1 [Q1], ≤3 procedures/y; quartile 2 [Q2], 4-6 procedures/y; quartile 3 [Q3], 7-10 procedures/y; quartile 4 [Q4], >10 procedures/y) were derived for comparison. Logistic regression was used to estimate the effect of center volume and determine the predictors of FTR. RESULTS: The center volume quartiles and incidence of FTR varied significantly (Q4, 2.5% vs Q1 and Q2, 4.9%; P < .0001; overall FTR, 3.1% [n = 302]). The patients were demographically similar among the quartiles. High-volume centers had used epidural anesthesia more often (Q4, 53%; vs Q1, 31%; P < .0001) but were less likely to use thrombectomy (Q4, 5%; vs Q1, 10%; P < .0001) or any concomitant procedure (Q4, 19%; vs Q1, 22%; P = .05). High-volume centers had had lower rates of pulmonary, renal, and overall complications (pulmonary: Q4, 7%; vs Q1-Q2, 8%-11%; renal: Q4, 16%; vs Q1-2, 19%-21%; P < .0001; overall mean number of complications: Q4, 0.46; vs Q1, 0.52; P = .0008). The crude 30-day and 1-year mortality rates were reduced at the higher volume centers (30 days: Q4, 3%; vs Q1-Q2, 6%; P < .0001; 1 year: Q4, 7%; vs Q1-Q2, 10%-11%; P < .0001). A strong inverse relationship between center volume and FTR was identified (P < .0001). In the adjusted analysis, OARs performed in high-volume centers (Q4 vs Q1) had a 50% risk reduction in FTR (odds ratio [OR], 0.48; 95% confidence interval [CI], 0.3-0.8; P = .004). Among the complications, a return to the operating room for bleeding was most likely to result in FTR (OR, 11.8; 95% CI, 4.3-33; P < .0001). A 24-fold increased risk of FTR was found for patients experiencing three or more complications vs one complication (OR, 24; 95% CI, 17-35; P < .0001). CONCLUSIONS: A greater center volume was strongly associated with significantly diminished FTR, reduced complications, and need for surgical adjuncts during OAR. These findings highlight the utility of center volume as an effective proxy to ensure high-quality aneurysm care.

A significant proportion of current endovascular aortic aneurysm repair practice fails to meet Society for Vascular Surgery clinical practice guideline recommended abdominal aortic aneurysm diameter treatment thresholds in the Vascular Quality Initiative.

BACKGROUND: There is mounting controversy surrounding the appropriate use of endovascular aortic aneurysm repair (EVAR) in contemporary practice. Persistent debate hinges on durability, cost, and survival. Accordingly, guidelines have attempted to clarify appropriate EVAR indications. The purpose of this analysis was to examine trends in EVAR practice throughout the United States and measure compliance with Society for Vascular Surgery (SVS) clinical practice diameter guidelines (CPGs). METHODS: We analyzed all elective repairs in the SVS Vascular Quality Initiative (VQI) EVAR registry from 2015 to 2019 (n = 25,112) and included patients with aneurysms confined to the infrarenal abdominal aorta. Center and surgeon variation with CPG diameter compliance was examined. Using a previously validated logistic regression model for risk adjustment, patients were stratified into predicted 1-year mortality risk tertiles and comparisons were made between patients meeting diameter guidelines (men ≥5.5;women ≥5.0 cm) and those who did not. RESULTS: Non-diameter-compliant EVAR occurred in 38.5% (n = 9675; diameter compliant, 61.5% [n = 15,437]). There was significant variation in CPG diameter compliance when stratified by VQI participating centers (range, 21%-95%; median, 61%; P < .001). This observation was amplified when categorized at the surgeon level (range, 0-100%; median, 63%; P < .0001). Notably, 82% of VQI surgeons (n = 852 of 1048) were non-diameter-compliant in more than 20% of their repairs. Moreover, among the 38.5% of patients failing to meet CPG diameter thresholds, 22.4% (n = 2171) were at high physiologic risk as determined by the validated SVS-VQI 1-year mortality calculator. Notably, the 1-year survival for the high-physiologic risk patients receiving non-guideline-compliant EVAR was worse compared with low- to intermediate-risk patients who were treated within recommended CPGs (92 ± 2% vs 97 ± 1%; log-rank P < .0001). CONCLUSIONS: A significant percentage of current US EVAR practice fails to adhere to the SVS diameter guidelines, as highlighted by the tremendous variation among VQI centers and surgeons. Furthermore, as noted by the 22% of patients undergoing noncompliant repair deemed to be at high physiologic risk, patient selection for EVAR seems to be suboptimal. Surprisingly, these findings are observed among the majority of VQI surgeons performing EVAR. In light of issues surrounding durability and cost, efforts to constrain observed deviation from recommended therapeutic size threshold guidelines would likely serve to improve abdominal aortic aneurysm care throughout the United States.

Society for Vascular Surgery clinical practice guidelines for management of extracranial cerebrovascular disease.

Management of carotid bifurcation stenosis in stroke prevention has been the subject of extensive investigations, including multiple randomized controlled trials. The proper treatment of patients with carotid bifurcation disease is of major interest to vascular surgeons and other vascular specialists. In 2011, the Society for Vascular Surgery published guidelines for the treatment of carotid artery disease. At the time, several randomized trials, comparing carotid endarterectomy (CEA) and carotid artery stenting (CAS), were reported. Since the 2011 guidelines, several studies and a few systematic reviews comparing CEA and CAS have been reported, and the role of medical management has been reemphasized. In the present publication, we have updated and expanded on the 2011 guidelines with specific emphasis on five areas: (1) is CEA recommended over maximal medical therapy for low-risk patients; (2) is CEA recommended over transfemoral CAS for low surgical risk patients with symptomatic carotid artery stenosis of >50%; (3) the timing of carotid intervention for patients presenting with acute stroke; (4) screening for carotid artery stenosis in asymptomatic patients; and (5) the optimal sequence of intervention for patients with combined carotid and coronary artery disease. A separate implementation document will address other important clinical issues in extracranial cerebrovascular disease. Recommendations are made using the GRADE (grades of recommendation assessment, development, and evaluation) approach, as was used for other Society for Vascular Surgery guidelines. The committee recommends CEA as the first-line treatment for symptomatic low-risk surgical patients with stenosis of 50% to 99% and asymptomatic patients with stenosis of 70% to 99%. The perioperative risk of stroke and death in asymptomatic patients must be <3% to ensure benefit for the patient. In patients with recent stable stroke (modified Rankin scale score, 0-2), carotid revascularization is considered appropriate for symptomatic patients with >50% stenosis and should be performed as soon as the patient is neurologically stable after 48 hours but definitely <14 days after symptom onset. In the general population, screening for clinically asymptomatic carotid artery stenosis in patients without cerebrovascular symptoms or significant risk factors for carotid artery disease is not recommended. In selected asymptomatic patients with an increased risk of carotid stenosis, we suggest screening for clinically asymptomatic carotid artery stenosis as long as the patients would potentially be fit for and willing to consider carotid intervention if significant stenosis is discovered. For patients with symptomatic carotid stenosis of 50% to 99%, who require both CEA and coronary artery bypass grafting, we suggest CEA before, or concomitant with, coronary artery bypass grafting to potentially reduce the risk of stroke and stroke/death. The sequencing of the intervention depends on the clinical presentation and institutional experience.

Risk factors and impact of postoperative hypotension after carotid artery stenting in the Vascular Quality Initiative.

OBJECTIVE: Hypotension is a frequent complication of carotid artery stenting (CAS). Although common, its occurrence is unpredictable, and association with adverse events has not been well defined. The aim of this study was to identify predictors of postoperative hypotension after CAS and the association with stroke/transient ischemic attack (TIA), major adverse cardiac events (MACEs), increased length of stay (LOS), and in-hospital mortality. METHODS: This is a retrospective analysis of all CAS procedures, including transfemoral CAS (TF-CAS) and transcarotid artery revascularization (TCAR), performed in the Vascular Quality Initiative between 2003 and 2018. The primary study end point was postoperative hypotension, defined as hypotension treated with continuous infusion of a vasoactive agent for ≥15 minutes. Secondary end points included any postoperative neurologic events (stroke/TIA), MACEs (myocardial infarction, congestive heart failure, and dysrhythmias), prolonged LOS (>1 day), and in-hospital mortality. Patients' demographics predictive of hypotension were determined by multivariable logistic regression, and a risk score was developed for correlation with outcomes. RESULTS: During the time period of study, 24,699 patients underwent CAS; 19,716 (80%) were TF-CAS, 3879 (16%) were TCAR, and 1104 (4%) were not defined. Fifty-six percent were for symptomatic disease, 75% were for a primary atherosclerotic lesion, and 72% were performed under local or regional anesthesia. Postoperative hypotension occurred in 15% of TF-CAS and 14% of TCAR patients (P = .50). Patients with hypotension (vs no hypotension) had higher rates of stroke/TIA (7.3% vs 2.6%; P < .001), MACEs (9.6% vs 2.1%; P < .001), prolonged LOS (65% vs 28%; P < .001), and in-hospital mortality (2.9% vs 0.7%; P < .001). By multivariable analysis, risk factors associated with hypotension included an atherosclerotic (vs restenotic) lesion (odds ratio, 2.2; 95% confidence interval, 2.0-2.4; P < .001), female sex (1.3 [1.2-1.4]; P < .001), positive stress test result (1.3 [1.2-1.4]; P < .001), age 70 to 79 years (1.1 [1.1-1.3]; P < .002), age >80 years (1.2 [1.1-1.4]; P < .001), history of myocardial infarction or angina (1.3 [1.2-1.4]; P < .001), and an urgent (vs elective) procedure (1.1 [1.0-1.2]; P < .01). A history of hypertension was protective (0.9 [0.8-0.9]; P < .02). A normalized risk score for hypotension was created from the multivariable model. Increasing risk scores correlated directly with rates of adverse events, including postoperative stroke/TIA, MACEs, increased LOS, and increased in-hospital mortality. CONCLUSIONS: Hypotension after CAS is associated with adverse neurologic and cardiac events as well as with prolonged LOS and in-hospital mortality. A scoring tool may be valuable in stratifying patients at risk. Interventions aimed at preventing postoperative hypotension may improve outcomes with CAS.

The financial evolution of endovascular aneurysm repair delivery in contemporary practice.

OBJECTIVE: The fiscal impact of endovascular repair (EVR) of aortic aneurysms and the requisite device costs have previously highlighted the tenuous long-term financial sustainability among Medicare beneficiaries. The Centers for Medicare & Medicaid Services have since reclassified EVR remuneration paradigms with new Medicare Severity Diagnosis-Related Groups (MS-DRGs) intended to better address the procedure's cost profile. The impact of this change remains unknown. The purpose of this analysis was to compare EVR-specific costs and revenue among Medicare beneficiaries both before and after this change. METHODS: All infrarenal EVRs performed in fiscal years (FYs) 2014 and 2015, before the MS-DRG change, and those performed in FYs 2017 and 2018, after the MS-DRG change, were identified using the DRG codes 238 (n = 108) and 269 (n = 84), respectively. We then identified those who were treated according to the instructions for use guidelines with a single manufacturer's device and billed to Medicare (n = 23 in FY14-15; n = 22 in FY17-18). From these cohorts, we determined total procedure technical costs, technical revenue, and net technical margin in conjunction with the hospital finance department. Results were then compared between these two groups. RESULTS: The two cohorts demonstrated similar demographic profiles (FY14-15 vs FY17-18 cohort: age, 78 years vs 74 years; median length of stay, 1.0 day vs 1.0 day). Mean total technical costs were slightly higher in the FY17-18 group ($24,511 in FY14-15 vs $26,445 in FY17-18). Graft implants continued to account for a significant portion of the total cost, with the device cost accounting for 56% of the total procedure costs in both cohorts. Net revenue was greater in the FY17-18 group by $5800 ($30,698 in FY14-15 vs $36,498 in FY17-18), resulting in an increased overall margin in the FY17-18 group compared with the FY14-15 group ($6188 in FY14-15 vs $10,053 in FY17-18). CONCLUSIONS: Device costs remain the single greatest cost driver associated with EVR delivery. DRG reclassification of EVR to address total procedure and implant costs appears to better address the requisite associated procedure costs and may thereby better support long-term fiscal sustainability of this procedure for hospitals and health systems alike.

Outcomes of rotational atherectomy in complex lesions of the superficial femoral artery.

BACKGROUND: The effectiveness of rotational atherectomy in the treatment of complex superficial femoral artery (SFA) lesions remains poorly defined. Outcomes of SFA lesions treated with rotational atherectomy were analyzed. METHODS: This retrospective review assessed all patients who underwent rotational atherectomy of the SFA at a single institution between 2015 and 2018. The data of all patients were deidentified, and the study was approved by the Institutional Review Board. Informed consent was not obtained for this retrospective analysis. Main outcomes were Kaplan-Meier primary patency rate, freedom from major amputation, and 2-year survival rate. The effect of drug-coated balloon angioplasty (DCBA) on patency and time to death was investigated with univariate regression. The safety profile for atherectomy and DCBA was assessed by the 30-day incidence of major amputation and all-cause mortality. RESULTS: Fifty-three patients (mean age, 70.2 ± 9.8 years; 73% male; 65% critical limb-threatening ischemia; 47 [90%] current or former smokers; seven [13%] with prior failed ipsilateral endovascular intervention) underwent rotational atherectomy (Jetstream; Boston Scientific, Marlborough, Mass) with mean follow-up of 543 days. Forty-six (87%) patients underwent DCBA (Lutonix; BD Bard, Covington, Ga) after atherectomy. Mean lesion length was 13.2 ± 9.0 cm. Thirty-one (58%) lesions were TransAtlantic Inter-Society Consensus C or D class. At 1-month follow-up, 39 of 45 (87%) patients experienced improvement in symptoms and Rutherford class. An improvement in ankle-brachial index was also noted in 13% of patients without improvement of symptoms, with no patients progressing to surgical bypass or major amputation. Mean ankle-brachial index increased from 0.54 ± 0.035 to 0.90 ± 0.031 at 1 month after intervention (P < .001) and remained constant out to 18 months. Mean toe pressure increased from 36 ± 3.8 mm Hg to 67 ± 4.5 mm Hg at 1 month after intervention (P < .001) and remained constant out to 18 months. Kaplan-Meier primary patency rate was 75% (95% confidence interval, 61%-85%) at 12 months and 65% (51%-77%) at 24 months. There was a trend toward improved primary patency after adjunctive DCBA compared with plain balloon angioplasty at 1 year (75% vs 43%; P = .1082). There was no significant difference in mortality between adjunctive DCBA and plain balloon angioplasty at 2 years (11% vs 0%). The 2-year incidence of major amputation in critical limb-threatening ischemia patients was 3.9% (1.2%-6.5%). One patient died and none underwent amputation within 30 days. CONCLUSIONS: Rotational atherectomy with adjunctive DCBA of long SFA lesions has excellent long-term patency. Two-year major amputation and mortality rates are low, and the technique has an exceptional safety profile.