Early real-world implant experience with a helix-fixation ventricular leadless pacemaker. 

 -  2024 
<br/><br/> BACKGROUND: Roughly one in six patients receiving conventional transvenous pacemaker systems experience significant complications within 1 year of implant, mainly due to the transvenous lead and subcutaneous pocket. A new helix-fixation single-chamber ventricular leadless pacemaker (LP) system capable of pre-deployment exploratory electrical mapping is commercially available. Such an LP may mitigate complications while streamlining the implantation. In this study, the initial real-world implant experience of the helix-fixation LP was evaluated following its commercial release.  CONCLUSIONS: The initial, real-world experience of the helix-fixation ventricular leadless pacemaker demonstrated safe and efficient implantation with minimal repositioning, viable electrical metrics, and limited acute complications. Copyright © 2024. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.  METHODS: In patients indicated for single-chamber right ventricular pacing, helix-fixation Aveir VR LPs (Abbott, Abbott Park, IL) were implanted using the dedicated loading tool, introducer, and delivery catheter. Implant procedural characteristics, electrical parameters, and any 30-day procedure-related adverse events of consecutive implant attempts were retrospectively evaluated.  RESULTS: A total of 167 patients with Class I indication for permanent pacing received implants in four North American centers (57% male, 70 years old). Pre-fixation electrical mapping of potential sites allowed repositioning to be avoided in 95.7% of patients. Median [interquartile range] LP procedure and fluoroscopy durations were 25.5 min [20.0, 35.0] and 5.7 min [4.0, 9.2], respectively. Pacing capture threshold, sensed R-wave amplitude, and impedance were 0.8 V [0.5, 1.3], 9.0 mV [6.0, 12.0], and 705 OMEGA [550, 910], respectively. Implantation was successful in 98.8% of patients, with 98.2% free from acute adverse events. 
<br/><br/><br/>English 
<br/><br/><label>ISSN: </label>1383-875X 
<br/><br/><label>Standard No.: </label>10.1007/s10840-024-01791-1 [pii] 
<br/><br/><label>Subjects--Topical Terms: </label>--Automated<br/>IN PROCESS -- NOT YET INDEXED
<br/><br/><label>Subjects--Geographic Terms: </label><br/>MedStar Heart & Vascular Institute<br/>MedStar Washington Hospital Center
<br/><br/><label>Index Terms--Occupation: </label><br/>Electrophysiology
<br/><br/><label>Index Terms--Function: </label><br/>Journal Article