How can health care organizations balance physicians’ interests with patient safety in designing programs to ensure that cognitive and physical decline in older physicians doesn’t harm patients?
BACKGROUND: Pulsed field ablation (PFA) of atrial fibrillation has been rapidly adopted, partly because of safety expectations compared with thermal ablation. Comparative safety data between the 2 modalities remain limited.
METHODS: We conducted a prospective registry analyzing consecutive atrial fibrillation ablations at a high-volume US academic center between 2022 and 2026. The primary end point was stroke or transient ischemic attack (TIA) within 30 days, independently adjudicated by blinded neurologists. Secondary end points included death and other procedural complications. Propensity score methods with inverse probability of treatment weighting were used to balance differences in patient characteristics. Differences in the procedural workflow of PFA versus radiofrequency ablation (RFA) were evaluated with exploratory mediation analyses.
RESULTS: A total of 4221 ablation procedures (2077 RFA and 2144 PFA: 68.7% Farawave, 23.3% Sphere 9, 6.9% Varipulse, 0.7% PulseSelect) was performed by 12 operators. Patients receiving PFA and RFA had similar baseline characteristics (mean age, 67 years; 31% female; 47% persistent atrial fibrillation; 7% previous stroke/TIA), which were balanced after inverse probability of treatment weighting. Compared with RFA, PFA procedures were shorter (108 versus 144 minutes) and included more frequent posterior wall isolation (57% versus 31%). The 30-day rate of stroke/TIA was significantly higher for PFA cases (10 events; 0.47%) compared with RFA (2 events; 0.10%) in both unweighted and propensity score-weighted analyses (weighted risk difference, 0.36% [95% CI, 0.03%-0.70%]; P=0.03). Stroke/TIA events were evenly distributed throughout the study period with no clustering around the time of PFA adoption or operators (with no operator associated with ≥2 events). Exploratory mediation models were limited by the low event rates and did not identify more extensive ablation as an independent risk factor for stroke. Weighted rates of other procedural complications were low (<1%) and similar between PFA and RFA groups.
CONCLUSIONS: In a high-volume, single-center registry with high clinical granularity and systematic patient follow-up, PFA was associated with a significantly higher risk of stroke/TIA at 30 days compared with RFA. These results call for enhanced postmarket surveillance and dedicated prospective evaluation as the PFA procedural volume continues to exponentially increase.
BACKGROUND: Although the availability of electrophysiology technologies has expanded in the United States, little is known about how sociodemographic factors influence their use. This national study of the Medicare population aims to (1) examine trends in the use of contemporary electrophysiology procedures and (2) assess associations between sociodemographic factors and population-level use of these procedures.
METHODS: We identified Medicare beneficiaries who underwent pulmonary vein isolation, left atrial appendage occlusion, leadless pacemaker implantation, or subcutaneous implantable cardioverter-defibrillator implantation from 2018 to 2021 using Current Procedural Terminology codes. Procedural rates were calculated per 100 000 person-years among all eligible Medicare beneficiaries. We compared the rates of each procedure across sociodemographic characteristics (including sex, race, census region, and social vulnerability index) by reporting rate ratios adjusted for age and comorbidities.
RESULTS: A total of 425 242 electrophysiology procedures performed between 2018 and 2021 were included. During the study period, use rates of pulmonary vein isolation, left atrial appendage occlusion, and leadless pacemaker increased steadily, whereas subcutaneous implantable cardioverter-defibrillator use declined. In adjusted models, individuals identifying as Black or categorized as other race were less likely to undergo a pulmonary vein isolation, left atrial appendage occlusion, and leadless pacemaker procedure but were more likely to receive a subcutaneous implantable cardioverter-defibrillator. Beneficiaries in less socially vulnerable areas were more likely to receive pulmonary vein isolation, left atrial appendage occlusion, and leadless pacemaker but less likely to undergo subcutaneous implantable cardioverter-defibrillator implantation. Regional variation showed higher use rates in the South and West of the United States.
CONCLUSIONS: Significant sociodemographic differences in the use of contemporary electrophysiology procedures persist across communities in the United States. Targeted efforts are needed to ensure that use aligns with clinical need.
BACKGROUND: Despite ample evidence of the benefits of cardiac rehabilitation (CR), few transcatheter aortic valve replacement (TAVR) patients participate. Commercially available mobile health offers an opportunity to deliver activity-promotion content to populations that are challenged to participate in CR. This study aims to test the efficacy of clinically controlled, commercially available fitness programming for improving physical activity and cardiovascular health outcomes designed to be initiated while patients are on waitlists for traditional CR.
METHODS: The Cardio Heart Connect study is a hybrid type I effectiveness-implementation trial aiming to enroll N=200 patients who have been placed on a cardiac rehab waitlist following a TAVR procedure from the University of Colorado Hospital Heart and Vascular Center. Participants will be randomized 1:1 to the Cardio Heart Connect intervention with commercially available fitness or attention control, designed to control for technology access. At baseline, post-intervention (8 weeks), and follow-up (12 months), we will assess the primary outcome of participants' daily steps as measured by smartwatch accelerometer and secondary outcomes of interest including functional capacity (Duke Activity Status Index; VO2max), quality of life (Kansas City Cardiomyopathy Questionnaire), and cardiovascular health status (Life Essential 8). In addition, we will use mixed methodologies to evaluate the implementation of intervention using the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) Framework.
CONCLUSIONS: Commercially available fitness programs have the potential to provide more accessible opportunities for patients recovering from TAVR to engage in physical activity and may be preferred due to their customizability, convenience, and ease of scheduling. Overall, this study will provide insight into the use of commercial mHealth to promote activity following TAVR.
