Publications

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.

BACKGROUND: Cardiovascular disease (CVD) and cancer share multiple risk factors and are the leading causes of morbidity and death worldwide. This study aims to examine historical and projected trends of the combined CVD-cancer global estimates and their shared risk factors.

METHODS: Death and disability-adjusted life years (DALYs) associated with CVDs, cancers, and their risk factors were obtained from the GBD (Global Burden of Disease) 2021 study. Historical estimates from 1990 to 2021 and forecast data from 2025 to 2050 were examined across age groups, regions, sociodemographic index, and sex.

RESULTS: In 2021, CVD-cancer resulted in age-standardized DALY rates of 8009 per 100 000 population (63% contributed by CVD) and age-standardized mortality rates of 352 per 100 000 population (67% by CVD) globally. While age-standardized DALYs of the CVD-cancer burden declined by 30% (33% in CVD and 26% in cancer), crude DALYs increased by 46% from 1990 to 2021. CVD-cancer resulted in higher age-standardized DALY rates in men (9654 per 100 000 population) than women (6556 per 100 000 population). While low-middle sociodemographic index regions had the highest CVD-related age-standardized DALY rates (6744 per 100 000 population), high-middle sociodemographic index regions had the highest cancer-related rates (3388 per 100 000) in 2021. The top risk factors driving CVD-cancer morbidity burden in 2021 were high systolic blood pressure (largely CVD contribution), dietary risks (89% by CVD), and tobacco (60% by CVD), persisting to 2050.

CONCLUSIONS: Global improvements in CVD-cancer age-standardized morbidity will be offset by the ever-rising crude CVD-cancer morbidity burden. Preventive efforts should prioritize key shared risk factors of hypertension, dietary risks, and tobacco.

BACKGROUND: Lower-extremity peripheral vascular interventions (PVIs) are increasingly used for treatment of peripheral artery disease. However, the relationship between hospital and operator PVI volume with in-hospital major adverse limb events (MALEs) and major adverse cardiovascular events (MACEs) is not well established.

METHODS: We used the NCDR PVI (National Cardiovascular Data Registry) registry, including procedural data from April 1, 2014, to December 31, 2019, assessing in-hospital MALEs and MACEs during hospitalization for PVI. Annualized PVI volumes were categorized on the basis of operator or site volume. Generalized linear mixed models assessed volume-outcome relationships after adjustment of covariates.

RESULTS: Between 2014 and 2019, 55 785 PVI procedures were performed at 97 hospitals by 555 operators. Adjusted analysis showed no statistically significant association between hospital volume and MALEs (highest versus lowest volume: odds ratio, 0.91 [95% CI, 0.74-1.11]; P=0.35) or hospital volume and MACEs (highest versus lowest volume: odds ratio, 1.23 [95% CI, 0.95-1.16]; P=0.12). Notably, undergoing PVI with high-volume operators was associated with lower odds of in-hospital MALEs (odds ratio, 0.73 [95% CI, 0.55-0.97]; P=0.03) and MACEs (odds ratio, 0.64 [95% CI, 0.44-0.95]; P=0.03). Female sex and comorbidities including dyslipidemia, prior percutaneous coronary intervention, heart failure, and acute or chronic limb ischemia were associated with higher MALE risk. Older age and comorbidities including hypertension, dyslipidemia, end-stage renal disease requiring dialysis, severe lung disease, prior myocardial infarction, heart failure, and acute limb ischemia were associated with greater MACE risk.

CONCLUSIONS: In contemporary practice, a significant relationship was observed between operator volume and adjusted PVI outcomes. Highest-volume operators had lower rates of in-hospital MALEs and MACEs compared with lowest-volume operators.

BACKGROUND: It remains unclear whether drug-coated balloons (DCBs) and drug-eluting stents are comparable in the treatment of coronary artery disease (CAD) and whether limus versus paclitaxel DCBs yield similar clinical outcomes. We aimed to assess the clinical efficacy of limus and paclitaxel DCBs in patients with CAD through a network meta-analysis.

METHODS: We comprehensively searched multiple databases for randomized controlled trials comparing the following 4 strategies: limus DCB, paclitaxel DCB, second-generation or newer drug-eluting stent, and plain old balloon angioplasty. The primary outcome was trial-defined major adverse cardiovascular events (MACEs), typically a composite of death, myocardial infarction, and target lesion revascularization. Secondary outcomes included individual components of MACE. We performed subgroup analyses for in-stent restenosis, small-vessel (<3 mm) CAD, and other de novo CAD, such as large vessel and ST-segment-elevation myocardial infarction.

RESULTS: We identified 39 randomized controlled trials including 10 219 patients. There was no significant difference in MACE between limus and paclitaxel DCBs (relative risk, 1.22 [95% CI, 0.86-1.73]). There were no significant differences in MACE between limus or paclitaxel DCB and second-generation or newer drug-eluting stents. Plain old balloon angioplasty had an increased risk of MACE compared with others. These results were consistent across subgroup analyses for in-stent restenosis, small-vessel CAD, and other de novo CAD.

CONCLUSIONS: No significant differences were observed in MACE or its components between limus and paclitaxel DCBs, albeit with limited statistical power. Furthermore, DCB and second-generation or newer drug-eluting stents yielded similar outcomes though power was limited, especially for other de novo CAD.

REGISTRATION: URL: https://www.crd.york.ac.uk/PROSPERO/; Unique identifier: CRD420250654276.