BACKGROUND: Catheter ablation of ventricular arrhythmias, one of the most rapidly growing procedures in cardiac electrophysiology, is associated with magnetic resonance imaging–detected brain lesions in more than half of cases. Although a retrograde aortic approach is conventional, modern tools enable entry through a transseptal approach that may avoid embolization of debris from the arterial system. We sought to test the hypothesis that a transseptal puncture would mitigate brain injury compared with a retrograde aortic approach. METHODS: The TRAVERSE trial (Transseptal Versus Retrograde Aortic Ventricular Entry to Reduce Systemic Emboli) was a multicenter randomized controlled comparative effectiveness trial. Patients with left ventricular arrhythmias undergoing catheter ablation procedures were randomly assigned to a transseptal puncture approach compared (1:1) with a retrograde aortic approach. The primary outcome was the presence of an acute brain lesion detected by magnetic resonance imaging. Secondary outcomes included clinically manifest complications, procedural efficacy, and 6-month neurocognitive assessments. RESULTS: Among the 62 patients randomly assigned to a retrograde aortic approach with postoperative brain magnetic resonance imaging, 28 (45%) exhibited an acute brain lesion compared with 19 of the 69 (28%) of those randomized to a transseptal puncture ( P =0.036). No differences in clinically manifest complications or procedural efficacy were observed. More patients in the retrograde aortic arm were categorized as having a high likelihood of cognitive impairment at 6 months (33% compared with 19% of those in the transseptal arm), but substantial loss to follow-up was present. CONCLUSIONS: Among patients undergoing left ventricular catheter ablation procedures, a transseptal approach reduced the risk of acute brain lesions by nearly half compared with a retrograde aortic approach without sacrificing safety or efficacy. Given a likely embolic pathogenesis, the brain magnetic resonance imaging findings may reflect a propensity to other organ damage; these findings may extend to other procedures requiring left ventricular entry. REGISTRATION: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT03946072.
Anatomical location of leadless pacemaker and the risk of pacing‐induced cardiomyopathy
Abstract Background It is unclear if the location of implantation of the leadless pacemaker (LP) makes a difference in the incidence of pacing‐induced cardiomyopathy (PICM). Aim The aim of this study was to compare the incidence of PICM based on the location of implantation of LP. Methods A total of 358 consecutive patients [women: 171 (48%), mean age: 73 ± 15 years] with left ventricular ejection fraction (EF) > 50%, who received an LP (Micra) between January 2017 and June 2022, formed the study cohort. Micra‐AV and Micra‐VR were implanted in 122 (34%) and 236 (66%) patients, respectively. Fluoroscopically, the location of implantation of LP in the interventricular septum (IS) was divided into two equal halves (apex/apical septum [AS] and mid/high septum [HS]). During follow‐up, PICM was defined as an EF drop of ≥10%. Results LP was implanted in 109 (34%) and 249 (66%) patients at AS and HS locations, respectively. During a mean 18 ± 8 months follow‐up, 28 patients (7.8%) developed PICM. Among the 249 patients with HS placement of LP, 10 (4%) developed PICM, whereas among the 109 patients with AS placement of LP, 18 (16.5%) developed PICM ( p = .002). AS location was associated with a higher risk of PICM compared to HS locations (adjusted hazard ratio: 4.42, p < .001). Conclusion AS location of LP was associated with a higher risk of PICM compared to HS placement. Larger randomized studies are needed to confirm our findings.
Sex‐Specific Associations of Oral Anticoagulant Use and Cardiovascular Outcomes in Patients With Atrial Fibrillation
Background Sex‐specific effectiveness of rivaroxaban ( RIVA ), dabigatran ( DABI ), and warfarin in reducing myocardial infarction ( MI ), heart failure ( HF ), and all‐cause mortality among patients with atrial fibrillation are not known. We assessed sex‐specific associations of RIVA , DABI , or warfarin use with the risk of MI , HF , and all‐cause mortality among patients with atrial fibrillation. Methods and Results Medicare beneficiaries (men: 65 734 [44.8%], women: 81 135 [55.2%]) with atrial fibrillation who initiated oral anticoagulants formed the study cohort. Inpatient admissions for MI , HF , and all‐cause mortality were compared between the 3 drugs separately for men and women using 3‐way propensity‐matched samples. In men, RIVA use was associated with a reduced risk of MI admissions compared with warfarin use (hazard ratio [95% confidence interval ( CI ): 0.59 [0.38–0.91]), with a trend towards reduced risk compared with DABI use (0.67 [0.44–1.01]). In women, there were no significant differences in the risk of MI admissions across all 3 anticoagulants. In both sexes, RIVA use and DABI use were associated with reduced risk of HF admissions (men: RIVA ; 0.75 [0.63–0.89], DABI ; 0.81 [0.69–0.96]) (women: RIVA ; 0.64 [0.56–0.74], DABI ; 0.73 [0.63–0.83]) and all‐cause mortality (men: RIVA ; 0.66 [0.53–0.81], DABI ; 0.75 [0.61–0.93]) (women: RIVA ; 0.76 [0.63–0.91], DABI ; 0.77 [0.64–0.93]) compared with warfarin use. Conclusions RIVA use and DABI use when compared with warfarin use was associated with a reduced risk of HF admissions and all‐cause mortality in both sexes. However, reduced risk of MI admissions noted with RIVA use appears to be limited to men.