Publications

OBJECTIVE: External saphenous vein graft stenting has been shown to reduce intimal hyperplasia, lumen irregularities, and flow disturbances after coronary artery bypass grafting (CABG). The objective of this study is to evaluate the effect of saphenous vein graft external stenting on clinical outcomes up to 5 years.

METHODS: Outcomes for patients who received external vein graft stenting in an international, real-world cohort were compared in a propensity matched analysis with patients from the Arterial Revascularization Trial (ISRCTN46552265). All eligible patients required an internal mammary artery graft to the left anterior descending coronary artery, received at least one vein graft, and survived to discharge. The primary end point was major adverse cardiovascular and cerebrovascular events at 1 year after surgery, consisting of all-cause mortality, myocardial infarction, repeat revascularization, and cerebrovascular accident. Secondary end points included 5-year major adverse cardiovascular and cerebrovascular events with and without stroke and annualized target vessel revascularization.

RESULTS: In total, 789 treated and 2205 control patients were included. At 1 year after CABG, the weighted hazard ratio comparing outcomes between treated and control patients was 0.60 (90% confidence interval, 0.38-0.94, P = .03). The benefits associated with external stenting for the composite outcome persisted through 5 years' post-CABG (hazard ratio, 0.70; 95% confidence interval, 0.51-0.98, P = .04). Annual target vessel revascularization rates in vein grafts were significantly lower in the venous external support cohort at 2 to 5 years after surgery (P = .009-.03).

CONCLUSIONS: The current study demonstrates that external vein graft stenting is associated with a significantly lower risk of experiencing adverse clinical outcomes up to 5 years after surgery compared with standard of care.

BACKGROUND: Although atherectomy for peripheral interventions has been studied for over 35 years, recent criticisms suggest it lacks supportive evidence. This analysis provides a comprehensive overview of the quality and outcomes in the published atherectomy literature.

METHODS: A systematic review of original research published in MEDLINE, Embase, and PubMed through November 2024 identified prospective and retrospective studies on atherectomy for infrainguinal peripheral artery interventions. Case studies and meta-analyses were included in the systematic review but excluded from the quantitative meta-analysis. Risk of bias was assessed using validated scales. Study design, device class, patient/lesion characteristics, provisional stenting, distal embolization, and 12-month outcomes (patency, major amputation, target lesion revascularization, and mortality) were captured.

RESULTS: The systematic review included 322 published atherectomy papers (121 directional, 44 laser, 30 orbital, 72 rotational, 55 mixed atherectomy classes). Designs were meta-analyses in 3.7% (12 papers), randomized controlled trials in 5.9% (19 papers), prospective observational studies in 29.8% (96 papers), retrospective observational studies in 45.7% (147 papers), and case studies in 14.9% (48 papers). Adjunctive therapies were used in 91.5%, and 29.2% included a comparator arm. Among 190 papers included in the meta-analysis, the 12-month patency, target lesion revascularization, major amputation, and mortality rates were 75.4% (51 studies), 15.6% (67 studies), 1.7% (71 studies), and 2.8% (63 studies), respectively. The distal embolization rate was 2.2% (159 studies), and the provisional stenting rate was 9.3% (131 studies). Considerable heterogeneity was observed.

CONCLUSIONS: Extensive published literature exists for peripheral atherectomy, including high levels of evidence. Clinical outcomes were overall favorable with low rates of amputation, mortality, provisional stenting, and distal embolization. This intentionally broad review was associated with considerable heterogeneity and should be confirmed with appropriate comparative studies.

BACKGROUND: Chronic limb-threatening ischemia (CLTI) affects over 2 million Americans and carries high risks of amputation and mortality. Use of ambulatory surgical centers (ASCs) and outpatient-based laboratories (OBLs) for revascularization has increased, but outcomes in these settings remain poorly characterized.

OBJECTIVES: The authors sought to evaluate national trends in CLTI revascularization from 2016 to 2023 across clinical settings (hospital-based inpatient, hospital-based outpatient, and ASC/OBL) and compare outcomes of peripheral vascular intervention (PVI) by setting.

METHODS: This retrospective cohort study used Medicare fee-for-service claims data from January 1, 2016, to December 31, 2023, including 925,905 beneficiaries aged ≥66 years undergoing lower extremity PVI for CLTI. Clinical setting of the index procedure was the primary exposure. The primary outcome was a composite of all-cause mortality or major amputation. Secondary outcomes included components of the primary outcome, repeat revascularization, and changes in ambulatory status. Outcomes were analyzed via Kaplan-Meier methods via multivariable Cox regression, adjusting for clinical, sociodemographic, and hospital-level factors.

RESULTS: Of 820,381 total revascularizations, the proportion performed in ASC/OBLs increased to 46.72% by 2023. ASC/OBLs treated a higher proportion of Black patients (18.25%) and dual-eligible beneficiaries (29.94%), whereas hospital inpatient settings treated more patients with gangrene and complex comorbidities. Over a median follow-up of 657 days (Q1-Q3: 204-1,378 days), 188,033 patients (56.4%) experienced the composite of death or major amputation, including 176,140 deaths (52.9%) and 36,743 major amputations (11.0%). Median follow-up for the composite outcome was 413 days (Q1-Q3: 95-1,093 days) after inpatient, 840 days (Q1-Q3: 307-1,579 days) after hospital-based outpatient, and 745 days (Q1-Q3: 285-1,417 days) after ASC/OBL procedures. After multivariable adjustment, ASC/OBLs were associated with lower risk of the primary outcome compared with hospital-based outpatient (HR: 0.93; 95% CI: 0.92-0.94) and inpatient settings (HR: 0.47; 95% CI: 0.45-0.49). However, ASC/OBLs had higher rates of repeat revascularization and similar changes in ambulatory status.

CONCLUSIONS: By 2023, ASC/OBLs emerged as the dominant setting for CLTI revascularization among Medicare beneficiaries. Although ASC/OBLs were associated with improved outcomes, the observational nature of this analysis and residual confounding limit causal conclusions. Rather, the improved outcomes suggest appropriate patient selection has supported the migration of PVI to ambulatory environments.

BACKGROUND: Given recent approval of percutaneous tricuspid valve devices, clinical evidence is needed to guide lead management (extraction vs "jailing" [ie, entrapping]) for patients with preexisting cardiac implantable electronic devices (CIEDs).

OBJECTIVES: The goal of this study was to describe nationwide trends in both surgical and percutaneous tricuspid interventions and resulting clinical outcomes, particularly for patients with CIEDs.

METHODS: Tricuspid interventions were identified among Medicare beneficiaries with and without CIEDs. In-hospital and 30-day procedural complications were compared with propensity score models. Predictors of CIED extraction were identified with Cox regression.

RESULTS: From 2016 to 2023, a total of 25,910 patients underwent tricuspid interventions, 2,355 (9.2%) of whom had CIEDs. The volume of percutaneous tricuspid interventions increased from <1% in 2016 to 28% in 2023, and patients with CIEDs underwent significantly more percutaneous interventions than patients without CIEDs (17.2% vs 7.9%). Among patients with CIEDs, tricuspid intervention plus extraction was performed in 18.9% of cases. CIED infection was the most common predictor of extraction (35.8%). Overall, patients undergoing tricuspid interventions (with or without CIEDs) had high rates of death (1.1%), shock (14.1%), and bleeding requiring transfusion (8.7%). For patients with CIEDs, concomitant extraction was not associated with more complications compared with no extraction, except for more in-hospital acute kidney injury (adjusted OR: 1.61; 95% CI: 1.31-1.98).

CONCLUSIONS: The nationwide volume of percutaneous tricuspid interventions is increasing, driven primarily by patients with CIEDs, who represent approximately 10% of the tricuspid procedural volume. Concomitant lead extraction was frequently used when clinically indicated and was not associated with higher complications. The high complication rate for all tricuspid interventions suggests that extraction procedures should be deployed cautiously in this population.

OBJECTIVE: Chronic limb threatening ischaemia (CLTI) requires timely and comprehensive management to improve limb salvage and survival rates. Socioeconomic disparities, including individual wealth, are critical determinants of healthcare access and outcomes.

METHODS: In this study, 333 173 Medicare beneficiaries who underwent CLTI revascularisation from 2016 - 2023 were analysed. Patients were stratified by dual enrolment in Medicaid, a marker of socioeconomic disadvantage, and outcomes were assessed using Kaplan-Meier methods and multivariable Cox proportional hazards models. The primary endpoint was a composite of major amputation or death. The study period was divided into pre-COVID-19 (January 2016 - March 2020), during COVID-19 (March 2020 - December 2021), and post-COVID-19 (December 2021 - December 2023) phases to evaluate pandemic related impacts on outcomes. Healthcare utilisation was compared between groups.

RESULTS: Among 333 173 Medicare beneficiaries who underwent endovascular revascularisation for CLTI, 26.2% were dual eligible (DE) patients. DE patients were younger, more often female, and had a higher burden of comorbidities compared with Medicare only beneficiaries. The crude cumulative incidence of the primary composite outcome was 80.1% for DE patients and 79.7% for Medicare only beneficiaries (unadjusted hazard ratio [HR] 1.07, 95% confidence interval [CI] 1.06 - 1.08; p < .001), but this difference was not statistically significant after adjustment (adjusted HR 1.00, 95% CI 0.99 - 1.01; p = .98). DE patients experienced higher rates of major amputation (17.8% vs. 12.7%; adjusted HR 1.10, 95% CI 1.07 - 1.12; p < .001), but no statistically significant differences in adjusted rates of repeat revascularisation (adjusted HR 1.00, 95% CI 0.99 - 1.01; p = .99) or all cause mortality (adjusted HR 0.99, 95% CI 0.98 - 1.00; p = .067). During the COVID-19 period, the adjusted HR for the primary outcome was statistically significantly elevated among DE vs. non-DE patients (adjusted HR 1.05, 95% CI 1.02 - 1.08; p < .001), while risks were similar pre-COVID (adjusted HR 1.00, 95% CI 0.98 - 1.02; p = .88) and post-COVID (adjusted HR 1.01, 95% CI 0.97 - 1.04; p = .67).

CONCLUSION: DE patients represent a socioeconomically disadvantaged group with higher baseline comorbidity burdens and slightly higher unadjusted risks of adverse outcomes.

BACKGROUND: The dissemination of novel procedures should attempt to strike a balance between access and procedure quality. This study aimed to evaluate the temporal trends and geographic dispersion of mitral transcatheter edge-to-edge repair (M-TEER) sites and to examine the associations of site volume and site-to-population density with patient outcomes.

METHODS: We used the Medicare administrative databases in the United States to identify sites performing M-TEER in patients aged 65 to 99 years from 2017 to 2020 and examined the annualized volume and site-to-population density (per million beneficiaries in each corresponding hospital referral region). A hierarchical Cox regression analysis accounting for site-level clustering was performed to assess the association of site volume and density with 30-day and 1-year all-cause mortality.

RESULTS: We identified 456 sites performing M-TEER in 16 810 patients (median [interquartile range] age, 81 [75-86] years; female, 47%). The case number of M-TEER increased by 54% from 3125 in 2017 to 4820 in 2020, while sites performing M-TEER increased by 71% from 252 in 2017 to 432 in 2020, corresponding to a decline in the median patient-to-site distances from 37.1 kilometers (interquartile range, 14.4-105.0) to 28.6 kilometers (interquartile range, 12.8-74.9). Higher site volume (every 10 cases/y) was associated with lower 30-day (adjusted hazard ratio, 0.94 [95% CI, 0.91-0.99]) and 1 year (adjusted hazard ratio, 0.98 [95% CI, 0.96-1.00]) mortality, while there was insufficient evidence to determine the association between higher site density (every 1 site/million-beneficiaries) and 30-day (adjusted hazard ratio, 1.00 [95% CI, 0.99-1.02]) and 1-year (adjusted hazard ratio, 1.00 [95% CI, 0.99-1.01]) mortality.

CONCLUSIONS: Although sites performing M-TEER have been rapidly expanding, we did not find associations between higher regional site density and patient mortality. Continuous careful planning in disseminating M-TEER while ensuring adequate procedure volume per site may optimize patient outcomes.