Publications

Background: The impact of significant tricuspid regurgitation (sTR) on healthcare costs and utilization in real-world populations remains understudied. Aim: Describe healthcare costs and utilization before and after development of sTR and describe differences by patient demographic characteristics. Materials & methods: We conducted a retrospective, longitudinal descriptive study using a large database containing electronic health record and insurance claims data for US patients. Healthcare costs and utilization are summarized for up to 3 years prior to sTR and for 1 year after sTR. Results: Costs and utilization increased in the 3 years leading up to and the year after sTR. Costs were higher for patients who were: aged 50-79 years, male, and Black or Hispanic (p < 0.01). Cardiovascular hospitalizations were an important driver of costs in all groups. Patients aged 80 years and over, women, and Black nonHispanic patients had fewer outpatient visits to cardiac specialists in the year following sTR (p < 0.01). Conclusion: Healthcare costs and utilization of patients with TR increase as clinical disease progresses, with important differences by age, sex and race. Increasing recognition of signs of TR progression and improved outpatient cardiac specialty access may be important means to reduce heart failure hospitalization duration as well as overall costs.

BACKGROUND: The dual use of intravascular imaging (IVI) and invasive physiology (IP) during percutaneous coronary intervention (PCI) is not well described in the United States.

OBJECTIVES: The aim of this study was to measure trends, clinical outcomes, and costs associated with the use of IVI and IP, alone and together, during PCI.

METHODS: Medicare fee-for-service claims were used to analyze trends in the use of IVI and/or IP during PCI from 2016 to 2023. Beneficiaries ≥65 years of age with a first PCI during the study period were included in the outcomes analysis. The primary outcome was major adverse cardiovascular events (MACE), defined as a composite of myocardial infarction, repeat revascularization, and all-cause death at 2 years. Multivariable Cox proportional regression was used to assess outcomes. Gamma regression was used to assess costs.

RESULTS: A total of 2,538,154 PCIs were performed in 1,958,990 patients from 2016 to 2023. After exclusion, a total of 1,587,532 patients were included in the analysis. Overall, IVI was used in about 15%, IP in 7%, and dual IVI and IP in 2.5% of all PCIs. By 2023, the use of IVI and dual IVI and IP increased to about 30% and 4.7%, respectively. Dual IVI and IP was associated with lower rates of MACE at 2 years compared with angiography alone (adjusted HR: 0.87; 95% CI: 0.85-0.89; P < 0.0001). The cost analysis showed higher upfront procedural costs but lower long-term costs associated with any use of IVI and/or IP.

CONCLUSIONS: The dual use of IVI and IP has marginally increased and was associated with lower MACE and long-term costs compared with angiography alone.

BACKGROUND: Racial and ethnic minority patients have higher rates of adverse ischemic events following percutaneous coronary intervention. The impact of these disparities on the efficacy of drug-coated balloon (DCB) angioplasty for in-stent restenosis is unclear. We aimed to evaluate the comparative efficacy of DCB angioplasty among racial and ethnic minority patients presenting with in-stent restenosis.

METHODS: This was a prespecified analysis of the AGENT IDE (A Clinical Trial to Assess the Agent Paclitaxel Coated PTCA [Percutaneous Transluminal Coronary Angioplasty] Balloon Catheter for the Treatment of Subjects With In-Stent Restenosis) trial which randomized patients with in-stent restenosis (2:1) to treatment with AGENT paclitaxel-coated balloon or conventional balloon angioplasty. The primary outcome was 1-year target lesion failure (composite of ischemia-driven target lesion revascularization, target vessel myocardial infarction, and cardiac death). Baseline clinical characteristics and outcomes were compared in minority patients versus non-Hispanic White patients and interaction terms used to determine if DCB efficacy was influenced by race or ethnicity.

RESULTS: Of the 406 patients treated with DCB, 103 (25%) self-identified as minority patients (30.1% Black, 25.2% Hispanic/Latino, 8.7% Asian), and 303 (75%) as non-Hispanic White patients. Minority patients were younger (66 versus 69 years, P=0.003). There were no differences in 1-year target lesion failure (15.0% versus 18.9%; hazard ratio [HR], 0.79 [95% CI, 0.44-1.39]; P=0.41) or target lesion revascularization (11.1% versus 13.7%; HR, 0.80 [95% CI, 0.41-1.56]; P=0.51) between subgroups, including after adjustment for imbalances in baseline characteristics (adjusted odds ratio for target lesion failure 0.71 [95% CI, 0.37-1.34]). Both groups derived similar DCB benefit, with no significant treatment by race and ethnicity interaction (P-interaction >0.30 for all end points).

CONCLUSIONS: In this prespecified analysis of the AGENT IDE trial, 1-year outcomes following DCB angioplasty were comparable between minority and non-Hispanic White patients. Although wide CIs limited the exclusion of clinically meaningful differences in outcomes between these groups, the relative efficacy of DCB versus balloon angioplasty was consistent across race and ethnicity. Registration: ClinicalTrials.gov; Identifier: NCT04647253. URL: https://www.clinicaltrials.gov/study/NCT04647253.

BACKGROUND AND AIMS: Radial access site for percutaneous coronary intervention (PCI) is recommended by clinical practice guidelines because of superior outcomes compared with femoral access site. Historically, the adoption of radial access site in the USA has lagged behind much of the rest of the world, but contemporary data on access site selection across the spectrum of clinical presentations and its association with outcomes are lacking.

METHODS: A retrospective cohort study from the National Cardiovascular Data Registry's CathPCI Registry was conducted including PCIs performed between 1 January 2013 and 30 June 2022. The comparative safety of radial vs femoral access site for PCI was evaluated with instrumental variable analysis, a technique that can be used to support causal inference, exploiting operator variation in access site preferences as the instrumental variable.

RESULTS: Overall, 6 658 479 PCI procedures were performed during the study period, of which 40.4% (n = 2 690 355) were performed via radial access site, increasing from 20.3% in 2013 to 57.5% in 2022. This increase was seen in all geographic regions and across the full spectrum of presentations, with the largest relative increase seen in patients with ST-elevation myocardial infarction. Overall, 2 420 805 PCIs met inclusion criteria for the comparative safety analysis. In instrumental variable analyses, radial access site was associated with lower in-hospital mortality [absolute risk difference (ARD) -.15%, 95% confidence interval (CI) -.20 to -.10], major access site bleeding (ARD -.64%, 95% CI -.68 to -.60), and other major vascular complications (ARD -.21%, 95% CI -.23 to -.18) but a higher risk of ischaemic stroke (ARD .05%, 95% CI .03-.08). There was no association with the falsification endpoint of gastrointestinal or genitourinary bleeding (ARD .00%, 95% CI -.03-.03).

CONCLUSIONS: Over the past decade, use of radial access site for PCI has increased 2.8-fold in the USA and now represents the dominant form of access site across all procedural indications. Based on instrumental variable analyses, PCI with radial access site had lower rates of in-hospital mortality, major access site bleeding, and other major vascular complications compared with femoral access site but a slightly higher risk of ischaemic stroke in contemporary practice.

BACKGROUND: Catheter-based interventions for acute pulmonary embolism (PE) have transformed the therapeutic landscape over the past decade despite a lack of high-quality, randomized data demonstrating clinical benefit. In addition, multicenter data describing their real-world diffusion, patient selection, and outcomes remain limited.

OBJECTIVES: This study sought to characterize national trends, patient and imaging characteristics, and institutional variation in the use of catheter-directed thrombolysis (CDT) and mechanical thrombectomy (MT) across the Pulmonary Embolism Response Team (PERT) Consortium Registry from 2016 to 2024.

METHODS: The authors analyzed 2,958 patients with intermediate- or high-risk PE treated with advanced therapies from 48 U.S. institutions in the prospective PERT registry. Temporal trends in use of systemic thrombolysis, CDT, and MT were evaluated using mixed-effects Poisson models; factors associated with MT vs CDT were identified using mixed-effects logistic regression with site-level random intercepts. Patients were stratified by the European Society of Cardiology 2019 risk categories. The Composite Pulmonary Embolism Score (CPES) was used to further assess patient acuity.

RESULTS: Of the 2,958 patients who received advanced therapies, 75.9% had intermediate-risk PE and 24.1% high-risk PE. The use of MT increased by 18% per year (incident rate ratio [IRR]: 1.18; 95% CI: 1.14-1.23), surpassing CDT use by 2021, whereas the use of CDT and systemic thrombolysis declined by 13% and 12% per year, respectively. MT was independently associated with older age (≥70 years; OR: 1.37; 95% CI: 1.04-1.81), male sex (OR: 1.54; 95% CI: 1.19-1.99), vasopressor use, extracorporeal membrane oxygenation support, and saddle embolus or clot in transit, whereas CDT was more often used in younger female patients and in the presence of cardiorespiratory symptoms. The proportion of high-risk patients treated increased as did the mean CPES over the study period, reflecting treatment of progressively higher-acuity patients with catheter-based intervention.

CONCLUSIONS: Over the past decade, MT has rapidly replaced CDT as predominant catheter-based therapy for acute PE, reflecting both technological innovation and evolving operator confidence. The PERT registry captures this diffusion of innovation across institutions and patient profiles, revealing a shift toward treating sicker patients and greater procedural integration across specialties. These findings highlight the need for randomized evidence to define optimal patient selection and comparative outcomes across device classes.

BACKGROUND: The mainstay of treatment for chronic limb-threatening ischemia (CLTI), late-stage peripheral artery disease, is prompt revascularization. However, contemporary data on sex differences in CLTI-related endovascular revascularization rates and outcomes remain limited.

METHODS: This retrospective cohort study used a 100% sample of Medicare fee-for-service claims from 2016 to 2023. We identified patients undergoing lower extremity endovascular revascularizations for CLTI. Male and female sex was the exposure. Population rates of CLTI-related endovascular revascularization were calculated by sex. Baseline characteristics were compared using standardized mean differences. The primary outcome, a composite of major amputation and death, was analyzed using Kaplan-Meier methods and multivariable Cox regression models adjusted for demographics, comorbidities, revascularization modality, disease severity, and other mediators. Nondeath outcomes included major amputation, minor amputation, repeat revascularization, and worsening of ambulatory status.

RESULTS: Among 333,173 patients undergoing endovascular revascularization for CLTI from 2016 to 2023, 146,644 (44.0%) were female. Females were older (75.7 years vs 73.3 years) and more likely to be Black and from socioeconomically distressed communities. Compared with males, female patients had a lower adjusted risk of mortality or major amputation (hazard ratio [HR], 0.91; 95% CI, 0.90-0.92; P < .0001), major amputation (HR, 0.82; 95% CI, 0.81-0.84; P < .0001), and mortality (HR, 0.93; 95% CI, 0.92-0.94; P < .0001). However, female patients were more likely to experience restriction in ambulatory function after revascularization (HR, 1.06; 95% CI, 1.05-1.08; P < .0001).

CONCLUSIONS: Females underwent CLTI endovascular revascularization at lower rates than males and experienced lower risks of mortality and major amputation, with higher rates of ambulatory decline. Continued investigation into modifiable drivers of sex differences can improve the quality of vascular care for both men and women with peripheral arterial disease.

IMPORTANCE: Recent evidence suggests that hospital-level associations between procedural volume and outcomes for transcatheter aortic valve replacement (TAVR) and mitral transcatheter edge-to-edge repair (MTEER) may be plateauing. Less is known about the operator volumes-outcomes association in the contemporary era.

OBJECTIVE: To determine whether an operator-level volume-outcomes association exists for TAVR and MTEER in the contemporary era.

DESIGN, SETTING, AND PARTICIPANTS: This cohort study examined data from patients undergoing TAVR or MTEER between January 2020 and December 2023 included in the Society of Thoracic Surgeons (STS)/American College of Cardiology (ACC) Transcatheter Valve Therapies (TVT) Registry, a national all-comers real-world registry. Consecutive patients undergoing TAVR for aortic stenosis or MTEER for mitral regurgitation were included. Data analysis was performed from October 2024 to December 2025.

EXPOSURE: TAVR or MTEER.

MAIN OUTCOMES AND MEASURES: The primary outcome measures were (1) 30-day all-cause mortality, (2) a 30-day composite outcome, and (3) in-hospital procedural complications following TAVR or MTEER. Data from the STS/ACC TVT Registry were analyzed for patients undergoing TAVR or MTEER between 2020 and 2023. The primary analysis assessed the association between operator volume and 30-day outcomes using a 2-level random-effects logistic regression model. The interaction between operator and hospital volumes and the association between TAVR and MTEER outcomes were also evaluated.

RESULTS: A total of 358 943 patients underwent TAVR at 827 hospitals (7524 operators; median [IQR] annual volume, 24 [11-47]), and 51 407 patients underwent MTEER at 493 hospitals (2483 operators; median [IQR] annual volume, 12 [7-19]). For TAVR, median (IQR) patient age was 79.0 (73.0-85.0) years, and 152 186 patients (42.4%) were female; for MTEER, median (IQR) patient age was 79.0 (71.0-84.0) years, and 23 402 patients (45.5%) were female. Low-volume operators demonstrated inferior process of care measures compared with high-volume operators. In adjusted analyses, a higher risk of 30-day mortality (odds ratio [OR], 1.13; 95% CI, 1.02-1.26; P = .02) and in-hospital complications (OR, 1.09; 95% CI, 1.03-1.16; P = .005) was observed for low-volume TAVR operators (<15/y) compared with high-volume operators (>37/y). For MTEER, in-hospital complications (OR, 1.31; 95% CI, 1.11-1.56; P = .002) were higher for low-volume operators (<8/y) compared with high-volume operators (>16/y), while 30-day mortality was not different (OR, 1.16; 95% CI, 0.96-1.41; P = .12). Associations were consistent across hospital volume strata. Operator-level outcomes for TAVR and MTEER were not correlated.

CONCLUSIONS AND RELEVANCE: In this cohort study, results from a large, contemporary US registry demonstrate a persistent inverse association between operator volume and patient outcomes for both TAVR and MTEER. These findings may help inform future policies aimed at ensuring optimal outcomes.

IMPORTANCE: The prevalence of obesity and cardiovascular-kidney-metabolic (CKM) syndrome continues to rise. Indications for novel CKM therapies, including glucagonlike peptide 1 receptor agonists (GLP-1RAs), sodium-glucose cotransporter-2 inhibitors (SGLT2is), and nonsteroidal mineralocorticoid antagonists (nsMRAs) continue to expand, yet the proportion of adults meeting expanded indications, including for multiple medications remains unclear.

OBJECTIVE: To examine proportion of adults meeting US Food and Drug Administration (FDA)-approved indications for GLP1-RAs, SGLT2is, and nsMRAs across national survey, community-based, and ambulatory health care samples.

DESIGN, SETTING, AND PARTICIPANTS: This study used a representative cross-sectional survey of US adults (National Health and Nutrition Examination Survey [NHANES], weighted 245 million; mean [SD] age, 47 [18] years; 126.8 million [52%] female), 5 pooled community-based cohort studies (the Framingham Heart Study, the Multi-Ethnic Study of Atherosclerosis, the Prevention of Renal and Vascular Endstage Disease Study, the Atherosclerosis Risk in Communities Study, and the Cardiovascular Health Study; n = 30 929; mean [SD] age, 63 [14] years; 16 749 [54%] female), and 2 ambulatory health care samples (the Beth Israel Deaconess Medical Center cohort [BIDMC], n = 84 714; mean [SD] age, 46 [17] years; 51 113 [60%] female] and the Mass General Brigham cohort [MGB], n = 362 485; mean [SD] age, 48 [17] years; 227 206 [61%] female). Data were analyzed from November 2024 to November 2025.

EXPOSURES: FDA-approved indications for GLP-1RAs, SGLT2is, and nsMRAs.

MAIN OUTCOMES AND MEASURES: Medication class eligibility within each study sample.

RESULTS: The proportion of individuals who met current FDA-approved indications for 1 or more CKM medication was 60% in NHANES (representing 148 million US adults), 61% in the pooled cohorts, 42% in the BIDMC ambulatory cohort, and 46% in the MGB ambulatory cohort. Eligibility for GLP-1RA therapy was most common, with 56% (representing 137.1 million US adults) in NHANES, 49% in the pooled cohorts, 41% in the BIDMC cohort, and 46% in the MGB cohort. This was followed by SGLT2i therapy (24% [57.9 million] in NHANES, 33% in the pooled cohorts, 14% for both BIDMC and MGB) and nsMRA (5% [11.7 million] in NHANES, 5% in the pooled cohorts, and 1% to 2% in ambulatory samples). Overlapping eligibility for multiple classes was common, with 12% to 17% for GLP1-RA and SGLT2i therapies and 1% to 5% for all 3 classes (an estimated 11.7 million US adults in NHANES).

CONCLUSIONS AND RELEVANCE: This study found that up to 61% of adults met FDA-approved indications for at least 1 of 3 novel CKM therapy classes. This represents an estimated 148 million US adults, including 11.7 million US adults with potential FDA indications for triple therapy, highlighting the urgent need to optimize implementation and utilization of CKM syndrome therapies.