Enrico Giuseppe Ferro

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.

Cardiac implantable electronic devices (CIEDs) have increased the quality and duration of life for millions of patients. As their utilization continues to grow exponentially, clinicians need to diagnose and manage several device-associated complications that may arise during the CIED life cycle. This primer is tailored for the general internal medicine physician or hospitalist, who will inevitably take care of patients with CIEDs, to provide a contemporary update on the incidence and clinical manifestations of the 4 most common CIED complications, with the latest evidence to guide clinical management and expected outcomes. Specifically, this review focuses on: 1) generator/lead failure, which has decreased to less than 1% per year due to continuous advances in manufacturing and programming and is mostly managed conservatively with close monitoring; 2) CIED infections, which, while also rare at approximately 1% per year, carry a short-term mortality of 10% to 20%, thus requiring immediate diagnosis and often urgent treatment with lead extraction because antibiotic treatment is rarely effective; and 3) lead-related venous obstruction, which has highly variable incidence (5% to 30%) and manifestations, ranging from arm swelling to superior vena cava syndrome. Management options range from anticoagulation to balloon venoplasty, often with unsatisfying results. This review will also focus on 4) lead-related tricuspid regurgitation, which affects 20% to 30% of CIEDs and has become an area of intense interest with the development of percutaneous tricuspid treatments-where evidence is urgently needed to inform the need for lead extraction versus jailing during tricuspid interventions. The progressive adoption of leadless devices may significantly reduce many of these complications. Nonetheless, optimal management requires input from a multidisciplinary team of electrophysiologists and imaging, heart failure, and structural interventional specialists-who should be able to recognize and treat each complication promptly based on a rapidly evolving evidence base.

Cardiovascular diseases (CVDs) are the leading global cause of mortality, with treatment adherence posing a major barrier to effective prevention and control. Single pill combinations (SPCs), also known as fixed-dose combinations, simplify treatment by combining multiple agents into one pill, improving adherence and reducing cardiovascular risk. This World Heart Federation Roadmap synthesizes the latest clinical evidence and identifies key barriers to SPC implementation, including limited manufacturing, affordability, regulatory complexity, and inconsistent guideline inclusion. Drawing on global expert input and health systems analysis, the Roadmap outlines practical, context-specific solutions to improve access, scale-up, and integration of SPCs into national strategies, especially in low- and middle-income countries. It serves as a tool for policymakers, clinicians, and advocates to drive progress in aligning cardiovascular prevention efforts with evidence-based, people-centred care.

Background: Use of pulmonary vein isolation (PVI) to treat atrial fibrillation continues to increase. Despite great interest in leveraging administrative data for real‐world analyses, contemporary procedural codes for identifying PVI have not been evaluated. Methods and Results: In this observational retrospective cohort study, inpatient PVIs were identified among US Medicare fee‐for‐service beneficiaries using Current Procedural Terminology (CPT) code 93656 in Carrier Line Files. Each patient was matched with their claims from Medicare Provider Analysis and Review to compare CPT with International Classification of Diseases , Tenth Revision , Procedure Coding System ( ICD‐10‐PCS ) claims submitted by health care facilities to bill for PVIs. We performed the reverse for commonly matched ICD‐10‐PCS codes, to identify corresponding CPT‐billed procedures. Finally, we reviewed institutional cases for additional comparison of CPT and ICD‐10‐PCS assignation for PVI. We identified 25 617 inpatient PVIs from January 2017 to December 2021, of which 18 165 (71%) were linked to Medicare Provider Analysis and Review. Of these, 16 672 (92%) were billed as ICD‐10‐PCS 02583ZZ: “Destruction of Conduction Mechanism, Percutaneous Approach.” The reverse process yielded heterogeneous results: among 75 003 procedures billed as ICD‐10‐PCS 02583ZZ, only 15 691 (21%) matched with CPT 93656 (PVI), as several other unrelated procedures were billed under this ICD‐10‐PCS code. Institutional case review confirmed the greater specificity of CPT codes. Conclusions: The ICD‐10‐PCS code associated with CPT‐billed PVI procedures actually referred to ablation of the atrioventricular junction. Yet this ICD‐10‐PCS code also matched with a wide range of other procedures distinct from PVI. We conclude that ICD‐10‐PCS codes alone are not sensitive nor specific for identifying PVI in claims and cannot be reliably used in isolation for health services research on this important procedure.

Resumo Fundamento O tratamento da fibrilação atrial (FA) com ablação por cateter evoluiu significativamente. No entanto, dados do cenário clínico real em desfechos de longo prazo são limitados, particularmente em países de baixa e média renda. Objetivo Este estudo prospectivo, multicêntrico, do tipo coorte de pacientes consecutivos tem como objetivo avaliar a segurança da primeira ablação por cateter da FA na região sudeste do Brazil entre 2009 e 2024. Métodos O desfecho primário foi a recorrência de qualquer taquiarritmia atrial (TAA). O modelo de riscos proporcionais de Cox avaliou preditores independentes de recorrência. Resultados Entre 1043 pacientes (idade média 67,3 ± 11,3 anos, 27,9% mulheres), 75,5% apresentaram FA paroxística. Após um tempo mediano de acompanhamento de 1,4 (1,0 – 3,4) anos, 21,4% apresentaram recorrência de TAA. As taxas de recorrência foram de 18,6% para FA paroxística e de 29,8% para FA persistente; 67,3% dos eventos ocorreram no primeiro ano após a ablação por cateter. Preditores de recorrência foram FA persistente no basal [hazard ratio (HR) 1,57, Intervalo de Confiança (IC) 95% 1,15-2,13; p = 0,004), aumento do diâmetro atrial esquerdo (HR 1,03, IC95% 1,00-1,05; p = 0,033), e escore EHRA de sintomas de FA mais alto (HR 1,60, IC95% 1,18-2,18; p = 0,003). As taxas de recorrência diminuíram ao longo do tempo de acordo com o ano calendário do procedimento, com uma redução de 9% por ano consecutivo (HR 0,91; p < 0,001). Houve uma taxa de 2,1% de ocorrência de eventos adversos relacionados ao procedimento. Conclusão No maior estudo coorte de ablações consecutivas da FA da América Latina, preditores de recorrência de TAA se associaram com estágios mais avançados da FA. As taxas de complicação e de recorrência foram comparáveis às de países de alta renda, destacando a aplicabilidade global da ablação por cateter para o manejo da FA.