Objective This prospective multicentre cohort study investigated patient-reported outcomes (PROM) in patients undergoing invasive revascularisation for intermittent claudication at 35 centres in Germany. Methods Patients were enrolled between 05/2018 and 03/2021 and followed for up to 12 months (NCT03098290). The Physical Component Summary score (PCS-12) of the SF-12 questionnaire, maximum pain-free walking distance, and frequency of leg pain at rest were collected as outcomes. Results A total of 963 (64% male, median age 68 years) provided sufficient data at follow-up (352 days in median). At index admission physical quality of life was substantially impaired at a median PCS-12 score of 35 (Q1: 28, Q3: 43). At follow-up, median PCS-12 improved to 45 (Q1: 39, Q3: 52) along with substantial improvement in maximum walking distance (+20 minutes) and lower leg pain (-10 points). Not working, retired job and obesity were associated with lack of improvements in PCS-12 during follow-up while obesity, and retired job seemed to particularly prevent improvements in maximum walking distance and reductions in leg pain. Conclusions Invasive revascularisation with either technical approach markedly improved patient-reported outcomes. Gains were smaller in obese and retired patients with similar trends in those not working and with high comorbidity burden.
BACKGROUND:Optimal antithrombotic therapy following infrapopliteal angioplasty for chronic limb-threatening ischemia (CLTI) remains uncertain. Dual pathway inhibition (DPI) with low-dose rivaroxaban plus aspirin has demonstrated benefit in broader peripheral arterial disease populations, including post lower extremity revascularization however evidence specific to isolated crural interventions is limited. Currently patients receive either DPI or DAPT based on surgeons' choice and this study will compare the outcomes of the 2 regimens from retrospective cohort analysis based on the hypothesis that DPI provides superior prevention of thromboembolic events post angioplasty. METHODS:A retrospective cohort study was conducted including patients undergoing isolated tibial balloon angioplasty for CLTI between January 2022 and July 2024. Patients receiving dual antiplatelet therapy (DAPT; aspirin plus clopidogrel) were compared with those receiving DPI (rivaroxaban 2.5 mg twice daily plus aspirin) lifelong. Patients undergoing multilevel interventions, stenting, drug-coated balloon angioplasty, thrombolysis, or treatment for claudication were excluded. Primary outcomes included major limb amputation and all-cause mortality. Secondary outcomes included target lesion revascularization (TLR), acute limb ischemia (ALI), and bleeding complications. RESULTS:A total of 199 patients met the inclusion criteria, including 102 treated with DAPT and 97 treated with DPI. Baseline demographic and clinical characteristics were broadly comparable between groups. At 12 months, major limb amputation occurred in 27 patients (26.5%) receiving DAPT and 17 patients (17.5%) receiving DPI (p=0.04), corresponding to an absolute risk reduction of 9.0% and a number needed to treat of 11. TLR was required in 14 patients (13.7%) in the DAPT group and 5 patients (5.2%) in the DPI group (p=0.04), corresponding to an absolute risk reduction of 8.5% and a number needed to treat of 12. ALI occurred in 4 patients (3.9%) receiving DAPT and 1 patient (1.0%) receiving DPI (p=0.40). One-year mortality was similar between groups (3.9% vs 3.1%; p=0.79). No major bleeding events occurred in either group, while minor bleeding rates were low and comparable. CONCLUSIONS:Among patients undergoing isolated tibial angioplasty for CLTI, dual pathway inhibition with low-dose rivaroxaban plus aspirin was associated with reduced major limb amputation and target lesion revascularization compared with dual antiplatelet therapy, without an increase in major bleeding. Larger prospective studies are warranted to confirm these findings and define the optimal antithrombotic strategy following infrapopliteal intervention.
OBJECTIVES:Patients undergoing vascular surgery have disproportionately high rates of limited health literacy, yet vascular disease-specific knowledge and digital health literacy remain poorly characterized in this population, particularly in a safety-net setting. We assessed both domains among vascular surgery patients at an urban safety-net hospital and examined their relationship. METHODS:We conducted a prospective, cross-sectional study of adult vascular surgery patients across three outpatient clinic sites within a single urban safety-net institution over an eight-week period. Participants completed the Vascular Surgery Literacy Assessment Tool (VSLAT), a 24-item assessment, and the eHealth Literacy Scale (eHEALS), an 8-item measure of perceived digital health proficiency. Demographic and clinical data were collected. Bivariate analyses and multivariable linear regression were used to identify factors associated with each literacy domain and to characterize the relationship between them. RESULTS:Among 84 patients (mean age 64 years; 57.1% female; 48.8% white, 35.7% Black), the mean VSLAT score was 11.3 of 24 (47.1%), with 62.9% scoring at or below 50%. The mean eHEALS score was 24.7 of 40, with fewer than half of patients (43.5%) expressing confidence in using online health information. Black patients scored significantly lower on both vascular literacy (8.8 vs 13.4, p<0.001) and eHEALS (18.0 vs 28.6, p<0.001) compared to their white counterparts. Low household income was independently associated with lower eHEALS scores (β = -7.9, p<0.001). Vascular and digital literacy were moderately correlated (r = 0.541, p<0.001). After adjusting for eHEALS in the regression model, Black race was no longer associated with a lower vascular literacy score (β = -0.4, p = 0.71), suggesting that digital health literacy influences the observed racial disparity in vascular knowledge. CONCLUSIONS:Vascular surgery patients at a safety-net hospital demonstrated significant deficits in both disease-specific knowledge and digital health literacy, with disparities linked to race and socioeconomic status. Digital literacy impacted the relationship between race and vascular disease knowledge, highlighting the compounding effect of the digital divide on health inequity. These findings highlight the need for multimodal, literacy-adapted educational interventions tailored to address these barriers in vulnerable patient populations.
OBJECTIVE:Real-world evidence comparing dual-pathway inhibition (DPI) with dual antiplatelet therapy (DAPT) after endovascular revascularization for acute or nonacute limb ischemia is limited. This study aims to compare the 24-month effectiveness and safety outcomes of DPI versus DAPT in this setting. METHODS:This prospective, multicenter observational study from the RESOLVE registry used propensity score matching (PSM) to analyze patients receiving DPI or DAPT after endovascular revascularization. The primary endpoint was 24-month major adverse events (MAE) including recurrent acute limb ischemia, major amputation, myocardial infarction, ischemic stroke, or cardiovascular death. Secondary endpoints included major adverse limb events (MALE), major adverse cardiovascular events (MACE), and all-cause death. RESULTS:After PSM, 109 matched pairs were analyzed. The DPI group had significantly lower 24-month MAE incidence than the DAPT group (11.47% vs 28.45%; HR = 2.83; P < .01), as well as lower MALE (16.83% vs 28.40%; HR = 1.83; P = .04) and all-cause death (2.94% vs 11.65%; HR = 4.28; P = .02). MACE showed a trend toward lower incidence with DPI (2.00% vs 7.77%; HR = 4.22; P = .07). No major bleeding events were observed in either group. Modified SVS run-off score >10 and chronic limb-threatening ischemia predicted greater DPI benefit (P for interaction=.020 and .031). CONCLUSIONS:In this PSM analysis, DPI was associated with significantly lower 24-month rates of MAE, MALE, and all-cause death compared with DAPT. No major bleeding events were observed in either group. These findings suggest a potentially favorable efficacy profile for DPI but warrant confirmation in further randomized controlled trials.
OBJECTIVES:The 2018 MISSION ACT for expanding access for Veterans to receive care outside of the VA healthcare system has resulted in a significant increase in Vascular Surgery Community Care referrals and cost, especially for endovascular procedures, over time. We hypothesized that more endovascular procedures would be done over time and that this would contribute to increasing costs over the study period. METHODS:A retrospective analysis of the VA Community Care Referral (CCR) Dashboard and Integrated Informatics and Analytics was conducted for FY2020-FY2025. Referral volume and justification for Vascular Surgery consultation and Vascular Lab, and total paid claims were obtained for 40 Vascular Surgery-related CPT codes from all VA centers nationwide across four categories: endovascular arterial, open arterial, dialysis access, and vein procedures. All costs were inflation-adjusted to 2025 USD using the Consumer Price Index. RESULTS:Total Vascular Surgery Community Care paid claims increased from $72.7 million in FY2020 to $288.2 million in FY2025 (+296%). Number of referrals rose from 34,196 in FY2021 to 62,487 in FY2025 (+83%). Distance from a VA facility accounted for more than 70% of referral justifications. Endovascular arterial procedures represented the largest cost annually. Femoral-popliteal atherectomy (CPT 37225) was the highest-cost procedure in all years except 2022 with increasing cost from $2.2 million to $9.9 million (+348%). Infrainguinal endovascular paid claims increased from $8.8 million to $40.2 million, with atherectomy codes consistently comprised 60-67% of these charges. No open bypass or groin-level reconstruction appeared in the top 30 paid codes in any study year. Carotid endarterectomy was the highest-cost open procedure (increased from $611,984 to $1,151,122, +88%). Dialysis access costs increased substantially (+252%), led by fistulagram with PTA. Vein procedures had the largest percentage increase (+445%). CONCLUSIONS:VA Community Care Vascular Surgery paid claims increased nearly three-fold from FY2020 to FY2025. Infrainguinal endovascular procedures, particularly atherectomy, represented the largest cost category. All procedural groups demonstrated consistent growth, with vein procedures exhibiting the greatest relative increase. Open bypass procedures were absent from the highest-cost claims throughout the study. These findings characterize the trajectory of VA Community Care vascular expenditures and may inform future resource allocation and policy decisions.
OBJECTIVE:Laser in-situ fenestrated endovascular (LIFE) repair allows fenestrated endovascular aortic repair in complex and challenging cases, including urgent and emergency presentations and patients with prior aortic repairs. The real-world multicenter LIFE Registry reports the results of this unique approach for thoracoabdominal and pararenovisceral (TAAA/PAA) pathologies. METHODS:All patients (2017-2022) undergoing LIFE for TAAA/PAA were identified at nine high-volume institutions and collected in a retrospective multicenter registry database. Descriptive statistics and Kaplan-Meier analysis were used. The primary outcomes were technical success and target vessel instability. Secondary outcomes included mortality, stroke, paraplegia, and reinterventions. RESULTS:210 patients undergoing LIFE were included (mean age 72.3, 27% female, 83% white). Notable demographics included previous stroke in 14%, COPD in 26%, renal insufficiency in 27% (dialysis 3%) and previous aortic repair in 55% of patients. Indications for repair included fusiform aneurysm in 69%, Type Ia endoleak in 21%, saccular aneurysm in 10% and aortic dissection in 7%. Repair was performed for symptomatic/ruptured pathologies in 39%. Thirty-day deaths were seen in 17 patients overall (8%) with 15 deaths in symptomatic/ruptured patients and 2 deaths in asymptomatic patients (p<.0001). Proximal seal was achieved in Zone 2 (1%), Zone 3 (5%), Zone 4 (10%), Zone 5 (34%), Zone 6 (14%), Zone 7 (16%) and Zone 8 (17%). A total of 529 target vessels were incorporated (one vessel 18%, two vessel 26%, three vessel 29%, four vessel 24%, NR 3%) with a mean of 2.5 target vessels per patient. Technical success for LIFE repair was 95%. Fifteen of those deaths occurred in 77 symptomatic/ruptured patients (19%). There were six strokes (2.9%) and permanent paraplegia in four patients (2%). At mean follow-up of 9 months (range 1-35), there were twelve additional deaths (5.7%), four of which were aneurysm-related (2%). Kaplan-Meier survival for the overall cohort at 36 months was 70% with 80% freedom from bridging stent reintervention at 24 months (both SE < 10%) (Figure 1). By group, asymptomatic patients experienced higher overall survival (82% vs. 63%, p=.0007) at 20 months and freedom from bridging stent reintervention (88% vs. 77%; p=.0005) at 21 months than symptomatic/ruptured patients (SE < 10%). Overall reinterventions were performed in 45 patients (21%) with additional aortic stent graft in 21 patients (10%), bridging stent reintervention to 24 target vessels (4.5%), coil embolization in four patients for Type II endoleak and to the false lumen of a dissection (2%) and other surgical procedures in three patients (1.4%). CONCLUSIONS:The LIFE registry represents the largest multicenter experience with the laser in-situ fenestrated endovascular (LIFE) technique to date. Perioperative and mid-term outcomes are reasonable in a cohort with a significant proportion of symptomatic and ruptured patients. There was a higher-than-expected need for aortic stent graft reinterventions, which may be related to the learning curve with the technique and is higher than described for physician-modified endografts or fenestrated/branched EVAR. These data suggest that LIFE repair is a viable treatment option when no commercially-available solution exists, particularly among patients presenting with symptomatic or ruptured thoracoabdominal and pararenovisceral aortic pathologies. The need for longer-term evaluation of durability and reintervention rate is of paramount importance to fully assess the applicability of this technique.
OBJECTIVES:The provision of renal replacement therapy for the end stage kidney disease (ESKD) patient is lifesaving therapy. Surgically created arteriovenous access (SAA) is the most utilized modality. Positive remodeling may occur following SAA leading to high flow vascular access (HFVA). The impact of long-term exposure to HFVA on cardiovascular structural remodeling is not well understood. Accordingly, this study describes the echocardiographic changes observed in HFVA following SAA creation METHODS: This single-center retrospective study included all patients with HFVA, defined as volume flow (Qa) > 2000 ml/min, over a 10-year period. Electronic medical records were reviewed to extract demographic, clinical, and echocardiographic data before and after SAA creation at serial intervals. Changes in echocardiographic parameters were compared using paired analyses. Univariable and multivariable Cox regression models assessed mortality, ventricular dilatation, and dysfunction. RESULTS:201 patients were included, with an average age of 57 years and a median Qa of 2338 ml/min (2189, 2787). The cohort comprised of 31% females and 68% Black American patients. SAA were predominantly in the upper arm (87%), brachial-basilic (42%) and autogenous (89%). Significant echocardiographic changes were observed over time: Left atrial volume and left ventricular (LV) end-diastolic volume worsened after 6 months. At 1-3 years, most remaining parameters worsened significantly, and notably the right ventricle (RV) systolic pressure (. LV ejection fraction (LVEF) significantly decreased after 5 years (p<0.01), and LV mass index did not change significantly (p=0.34). RV and LV dilation and dysfunction were significant at 1-3 years. Most importantly, any degree of RV dilatation (HR 2.83; p 0.007) or RV systolic dysfunction (HR 2.36; p 0.017) was independently associated with early mortality. CONCLUSION:In patients with HFVA, cardiac remodeling was observed as early as 6 months. After 1-3 years' timeline, HFVA exposure was associated with progressive decline of key echocardiographic parameters related to heart failure. These findings underscore the importance of routine surveillance of the vascular access circuit and cardiac structures to detect early remodeling. Close monitoring of worsening RV parameters is essential, as it independently correlates with early mortality risk.
OBJECTIVE:Transcatheter arterialization of the deep veins (TADV) is a novel therapy for no-option chronic limb-threatening ischemia (CLTI) that delivers oxygenated blood to the foot via the venous system and has demonstrated favorable limb salvage outcomes in several studies, including the Pivotal Revascularization or Limb Restoration in Patients With Chronic Limb-Threatening Ischemia (PROMISE) II trial. The present study characterizes circuit maturation in the PROMISE II cohort by examining its longitudinal hemodynamic development and associated wound healing, with the goal of better defining the mechanism of action of TADV. METHODS:PROMISE II (NCT03970538) was a prospective, multicenter study on TADV in patients with no-option CLTI due to "desert foot" arterial anatomy. The objective was to evaluate longitudinal changes following TADV including hemodynamics from duplex ultrasound, distal perfusion, and wound healing over time. Clinical outcomes, perfusion metrics, and serial duplex ultrasound data were collected through 1 year using standardized protocols. Duplex studies evaluated volume flow and spectral Doppler parameters across the TADV circuit. Distal perfusion was assessed using toe-brachial index and toe pressures. Duplex-derived waveforms were categorized as low resistance or high resistance, and longitudinal hemodynamic changes were analyzed. Circuit maturation was assessed using characteristics such as waveform achieving high-resistance configuration and decreased acceleration time indicating vascular remodeling. RESULTS:A total of 105 patients from PROMISE II were included in the analysis. Limb salvage was 68.7% at 1 year. Among patients with adjudicated wound data, 75.5% were healed/healing at 1 year; patients with worsening status decreased from 52.6% to 14.3%, whereas complete healing increased to 46.9%. Circuits transitioned from low- to high-resistance waveforms (7.9% at baseline; 24.6% at 3 months; 37.7% at 6 months; 81.1% at 1 year; P < .0001). At 1 year, in patients with high-resistance circuits, healed/healing wound status was 86.7%, toe-brachial index ≥ 0.3 was 57.1%, and toe pressure ≥40 mmHg was 78.3% indicating greater distal perfusion. CONCLUSIONS:TADV promotes limb salvage through staged hemodynamic maturation demonstrated by duplex ultrasound, microvascular remodeling, sustaining perfusion, and supporting its durable benefit in no-option CLTI.
OBJECTIVE:Depression affects 20% to 37% of patients with peripheral artery disease, frequently requiring serotonergic antidepressants while receiving antiplatelet therapy concomitantly after vascular intervention. As platelets depend entirely on the serotonin transporter for serotonin uptake, serotonergic agents may alter platelet function in this setting. Hence, we aimed to determine whether serotonergic antidepressant exposure is associated with longitudinal instability in adenosine diphosphate (ADP)-mediated platelet inhibition. METHODS:In this retrospective cohort study of prospectively enrolled patients with peripheral artery disease undergoing lower-extremity revascularization (December 2020-2025) at a single US tertiary care center, serial thromboelastography with platelet mapping data (December 2020-2025) were used to construct consecutive-visit pairs. The primary outcome was visit-to-visit variability in ADP-mediated platelet inhibition, defined as log-transformed absolute change between consecutive measurements, capturing larger visit-to-visit change regardless of direction. Serotonergic antidepressant exposure (such as selective serotonin reuptake inhibitors, serotonin-norepinephrine reuptake inhibitors, or trazodone) was evaluated both as active exposure at the current assessment within each consecutive measurement pair and as a four-level transition variable: stable nonexposure ((0→0), reference), initiation (0→1, exposure onset between two sequential assessments), discontinuation (1→0), and stable exposure (1→1). Associations were estimated using adjusted linear mixed-effects model. Prespecified exploratory analyses were performed in the chronic limb-threatening ischemia subgroup. RESULTS:Among 514 enrolled cases, 330 contributing 896 consecutive-visit pairs were included; 307 patients contributed 838 consecutive-visit pairs in the complete case-adjusted analysis. Active serotonergic exposure was not independently associated with greater longitudinal variability in platelet inhibition [β = .135; 95% confidence interval (CI), -0.901 to 0.360; P = .240]. However, serotonergic initiation was associated with increased variability compared with stable nonexposure (β = .571, 95% CI, 0.144-0.998; P = .009), persisting after adjustment for psychiatric diagnosis burden. Discontinuation showed a borderline association (β = .405; P = .05); stable exposure was not associated with greater variability (β = .105; P = .40). Ticagrelor use was independently associated with lower variability in primary adjusted models (β = -.521; 95% CI, -0.901 to -0.141; P = .008). In exploratory chronic climb-threatening ischemia analyses, initiation was associated with a 19.7 percentage point mean upward shift in ADP-mediated platelet inhibition (95% CI, 3.9-35.6; P = .015) and higher odds of entering a high-inhibition range previously linked to bleeding risk (odds ratio, 7.61; 95% CI, 1.32-43.96; P = .023). CONCLUSIONS:Serotonergic antidepressant initiation, rather than stable ongoing therapy, was associated with increased instability in ADP-mediated platelet inhibition after lower-extremity revascularization. These findings identify the peri-initiation window with implications for medication reconciliation in vascular surgery patients and raise the hypothesis that background P2Y12 regimen consistency may modulate the magnitude of serotonergic medication-induced platelet instability.
BACKGROUND:Single-segment great saphenous vein (GSV) grafts are the conduits of choice for infrainguinal bypass (IIB) performed for chronic limb-threatening ischemia. GSV has been used in three configurations: reversed, in situ, and nonreversed. In this large multi-institutional study, we aimed to compare the outcomes of IIB performed utilizing different GSV configurations in a real-world experience. METHODS:We queried the Vascular Quality Initiative-Medicare-linked database for all IIB procedures performed for occlusive disease accompanied by chronic limb-threatening ischemia between 2011 and 2019. All bypass procedures were performed with single-segment GSV. The primary outcome was amputation-free survival. The secondary outcomes included overall survival, limb salvage, and freedom from reintervention. Limb salvage was defined as freedom from major amputation. All the outcomes were analyzed at 1 and 5 years. Kaplan-Meier survival estimates and Cox regression were used for analyses. RESULTS:This study included three cohorts of IIB, namely reversed (N = 3003, 53.0%), in situ (N = 1344, 23.7%), and nonreversed (N = 1322, 23.3%) GSV configurations. The 5-year amputation-free survival rates were 39.8%, 39.5%, and 42.4% in the reversed, in situ, and nonreversed cohorts, respectively (P = .126). After adjustment for potential confounders, the analysis revealed that the in situ and nonreversed configurations were not associated with increased hazards of major amputation/death at 1 year compared with the reversed configuration (adjusted hazards ratio [aHR], 0.96; 95% confidence interval [CI], 0.83-1.13; P = .652 and aHR, 0.94; 95% CI, 0.81-1.08; P = .375, respectively). Additionally, the in situ and nonreversed configurations were not associated with increased hazards of major amputation/death at 5 years compared with the reversed configuration (aHR, 1.06; 95% CI, 0.96-1.17; P = .255 and aHR, 0.93; 95% CI, 0.84-1.02; P = .129, respectively). The nonreversed configuration was associated with decreased hazards of death (aHR, 0.82; 95% CI, 0.73-0.93; P = .002) and major amputation/death (aHR, 0.87; 95% CI, 0.78-0.97; P = .016) at 5 years compared with the in situ configuration. GSV configurations were not associated with reintervention. CONCLUSIONS:In this large multi-institutional study comparing three GSV configurations for lower extremity bypass, long-term limb-related outcomes were mainly comparable across the configurations. Although the nonreversed configuration was associated with lower hazards of death and major amputation/death at 5 years compared with the in situ configuration, this difference was primarily due to mortality and may reflect differences in patient selection. Overall, all the three GSV configurations represent acceptable and durable options for IIB, with conduit selection guided by surgeon preference, conduit availability, and patient anatomy.
