Cardio Trial Files: Self- or Balloon-Expandable TAVR in Aortic Stenosis, Dual-Energy Catheter in AFib, and DCCV in AFib
Self-Expanding or Balloon-Expandable TAVR in Patients with a Small Aortic Annulus
Herrmann HC et al. NEJM (April 2024)
Bottom Line: This randomized clinical trial compared the use of a self-expanding supraannular valve versus a balloon-expandable valve in patients with severe aortic stenosis and a small aortic annulus. A total of 716 patients were treated at 83 sites in 13 countries. The primary outcome, a composite of death, disabling stroke, or rehospitalization for heart failure, was assessed through 12 months and showed noninferiority in the self-expanding valve group. The secondary outcome, bioprosthetic-valve dysfunction, was found to be superior in the self-expanding valve group. The study also showed lower rates of hemodynamic structural valve dysfunction and prosthesis-patient mismatch in the self-expanding valve group. Major safety end points were similar in both groups. In conclusion, the use of a self-expanding supraannular valve was found to be noninferior to a balloon-expandable valve in patients with severe aortic stenosis and a small aortic annulus.
Dual-energy lattice-tip ablation system for persistent atrial fibrillation
Anter E et al. Nature Medicine (May 2024)
Bottom Line: This randomized, single-blind, non-inferiority trial compared the use of a large-tip catheter with dual pulsed field and radiofrequency energies to a conventional radiofrequency ablation system in 420 patients with persistent AF. The primary composite effectiveness endpoint was evaluated through 1 year and included freedom from acute procedural failure and repeat ablation at any time, plus arrhythmia recurrence, drug initiation or escalation or cardioversion after a 3-month blanking period. The primary safety endpoint was freedom from a composite of serious procedure-related or device-related adverse events. The primary effectiveness endpoint was observed for 73.8% and 65.8% of patients in the investigational and control arms, respectively (P < 0.0001 for non-inferiority). The dual-energy catheter was found to be non-inferior in safety and effectiveness compared to the conventional radiofrequency ablation system.
Dual vs Single Cardioversion of Atrial Fibrillation in Patients With Obesity
Aymond JD et al. JAMA Cardiology (May 2024)
Bottom Line: This prospective, investigator-initiated, patient-blinded, randomized clinical trial compared the efficacy and safety of dual direct-current cardioversion (DCCV) using 2 sets of pads, each delivering 200 J simultaneously, with traditional single 200-J DCCV using 1 set of pads in adult patients with obesity and atrial fibrillation. The study included 200 patients with a BMI of 35 or higher, and planned nonemergent electrical cardioversion for atrial fibrillation. Dual DCCV resulted in significantly higher success rates compared to single DCCV (97 of 99 patients [98%] vs 87 of 101 patients [86%]; P = .002), without any increase in complications or patient discomfort. There was no difference in the rating of postprocedure chest discomfort between the two groups. This study highlights the potential benefits of using dual DCCV in patients with obesity undergoing electrical cardioversion for atrial fibrillation.
Cardio Trial Files Issue #CRD-2024-16
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