Christina Lalani

Background: Extracorporeal membrane oxygenation (ECMO) provides bi‐ventricular support for patients with myocardial infarction–related cardiogenic shock (MI‐CS); comparative effectiveness data relative to other mechanical circulatory support remain limited. We characterize contemporary ECMO utilization for MI‐CS and compare short‐term mortality across ECMO and non‐ECMO treatment strategies. Methods: We compared baseline characteristics and temporal trends in mechanical circulatory support utilization among Medicare beneficiaries hospitalized with MI‐CS from 2016 to 2023 and treated with ECMO, Impella, intra‐aortic balloon pump, or medical management alone. Patient outcomes for each group were evaluated using inverse probability of treatment weighting, G‐formula approach, and grace period analysis. The primary endpoint was 30‐day all‐cause mortality. Results: The cohort included 102 718 patients: 1165 (1.1%) treated with ECMO, 10 064 (9.8%) Impella, 24 631 (24.0%) intra‐aortic balloon pump, and 66 858 (65.1%) medical management alone. From 2016 to 2023, ECMO use for MI‐CS increased from 0.8% to 1.8%. The percentage of hospitals using ECMO increased from 9.2% to 17.1%. Unadjusted 30‐day mortality was higher for ECMO (69%) compared with Impella (60%), intra‐aortic balloon pump (39%), and medical management (46%) (all P <0.0001). Adjusted inverse probability of treatment weighting and G‐formula analyses revealed a 30‐day mortality rate of 68%–70% for ECMO, which was higher than that for other therapies. The grace period analysis revealed similar mortality between patients treated with ECMO (54%) and Impella (54%). Conclusions: ECMO use in a contemporary Medicare cohort of patients with MI‐CS was infrequent (1.1%) and associated with high 30‐day mortality. Despite use of complementary causal inference methods, we were unable to establish valid causal inferences on ECMO use and patient survival.

BACKGROUND: Over half of Medicare beneficiaries are enrolled in privately administered Medicare Advantage (MA) plans, and aortic stenosis predominantly affects older patients. In this study, we evaluated whether differences in care delivery between MA and fee-for-service (FFS) Medicare contribute to cardiovascular outcomes after transcatheter aortic valve replacement (TAVR). METHODS: Medicare patients who underwent TAVR from January 1, 2018, to December 31, 2022, were eligible for cohort inclusion. TAVR utilization rates in MA and FFS were calculated as the age- and sex-standardized number of procedures per 10 000 person-years. Patient characteristics were compared between MA and FFS using standardized mean differences (SMDs), with an SMD ≥10 considered meaningful. The association of MA versus FFS enrollment with 30-day and 1-year outcomes was assessed using logistic and Cox regression models, respectively. RESULTS: Among the 317 630 patients (64.4% FFS, 35.6% MA) undergoing TAVR, the mean age was 80.6±7.0 years, and 55.1% were male. TAVR utilization rates were similar between MA and FFS, with 11.2 TAVRs/10 000 person-years in FFS compared with 11.7 TAVRs/10 000 person-years in MA by the end of the study. Compared with FFS patients, MA patients were more likely to be Black (5.4% versus 3.0%; SMD, −11.9) and dual-enrolled in Medicaid (13.7% versus 8.6%; SMD, −16.3). Comorbidity profiles were similar (SMD, < 10). In the comorbidity-adjusted model, MA patients had lower odds of 30-day death (adjusted odds ratio, 0.90 [95% CI, 0.86–0.95]). At 1 year, MA patients had a lower adjusted risk of death (hazard ratio, 0.94 [95% CI, 0.92–0.96]), all-cause readmission (hazard ratio, 0.86 [95% CI, 0.85–0.88]), stroke (hazard ratio, 0.90 [95% CI, 0.87–0.94]), and aortic valve reintervention (hazard ratio, 0.86 [95% CI, 0.76–0.96]). CONCLUSIONS: Despite similar clinical profiles and TAVR utilization, MA patients appeared to experience better 30-day and 1-year outcomes than FFS patients. Differences in care delivery may contribute, but future studies are needed to understand differences in outcomes.

BACKGROUND: AGENT is the only coronary drug-coated balloon (DCB) approved for treatment of in-stent restenosis (ISR) to date. In this study, we describe trends in DCB use and compare characteristics and in-hospital outcomes between patients who received DCB versus alternative treatments. METHODS: We included patients in the American College of Cardiology National Cardiovascular Disease Registry CathPCI Registry who underwent percutaneous coronary intervention between April 2024 and June 2025 and received DCB, drug-eluting stent (DES), or plain old balloon angioplasty. Treatment groups were compared using standard mean differences. RESULTS: Between April 2024 and June 2025, 14 946 DCBs were used in 12 337 patients across 704 CathPCI Registry sites. The monthly rate of DCB use for ISR percutaneous coronary intervention grew from <1% to 17.5% during the study period. Of 96 452 ISR procedures performed overall, 9269 (9.61%) involved the use of DCB. DCB procedures were more likely to involve the use of specialty balloons (DCB 45.3% versus DES 17.5% versus plain old balloon angioplasty 28.3%), intravascular imaging (DCB 54.5% versus DES 35.1% versus plain old balloon angioplasty 30.9%), and atherectomy (DCB 14.9% versus DES 6.0% versus plain old balloon angioplasty 7.3%). Among patients treated with DCB, 0.4% experienced myocardial infarction, 0.7% developed cardiogenic shock, 0.2% had an ischemic stroke, and 0.9% died. DCB was separately used in 3459 of 810 483 (0.43%) non-ISR percutaneous coronary interventions. Unadjusted rates of in-hospital adverse outcomes after ISR and non-ISR DCB use were like those for DES (standard mean difference <10%). CONCLUSIONS: Real-world DCB use is increasing rapidly in the United States, driven by use in ISR lesions but also with growth among non-ISR lesions.

BACKGROUND: Although Medicare Advantage (MA) plans provide coverage to >50% of Medicare beneficiaries, it is unclear whether MA claims can be used similarly to Medicare Fee-For-Service (FFS) claims for clinical outcomes assessment. In this study, we evaluate the accuracy of claims algorithms previously validated in FFS to assess comorbidities and outcomes in MA patients after aortic valve replacement. METHODS: We compared the concordance of 11 claims-based covariates (diabetes, hypertension, atrial flutter/fibrillation, myocardial infarction) and outcomes (stroke, disabling stroke, transient ischemic attack, major vascular complication, bleeding, permanent pacemaker implantation, death) among FFS and MA patients with the covariates and adjudicated outcomes in the multinational Evolut Low-Risk Trial (2016–2018). We used claims algorithms for 1-year outcomes and calculated sensitivity, specificity, positive predictive value, negative predictive value, and kappa, using adjudicated outcomes as the reference. We compared the kappa for MA versus FFS using the 2-sample z -test with a significance level of P P =0.03) and hypertension ( P =0.025) but was lower in myocardial infarction ( P <0.0001). There was no statistically significant difference in the kappa agreement between MA versus FFS for any of the selected outcomes. CONCLUSIONS: Medicare claims have a similar level of kappa agreement in MA versus FFS for most covariates and outcomes. As patients shift to MA, ascertainment of outcomes using Medicare claims in postapproval studies remains valid for select outcomes.