Operator learning curve with a novel dual-energy lattice-tip ablation system
- PMID: 39922404
- DOI: 10.1016/j.hrthm.2025.02.006
Operator learning curve with a novel dual-energy lattice-tip ablation system
Abstract
Background: The SPHERE Per-AF trial demonstrated noninferiority for a primary composite effectiveness endpoint in patients with persistent atrial fibrillation (AF) treated with a 9-mm, lattice-tip, pulsed field (PF)/radiofrequency (RF) system (74%) vs conventional contact force-sensing RF (65%). Although operators were highly experienced with the control, the vast majority was new to the investigational system.
Objective: The aim of this study was to assess the learning curve using this novel system.
Methods: Patients were grouped based on the sequential procedures performed per operator. Operators who performed ≤2 investigational procedures were excluded. The composite effectiveness endpoint was freedom from acute procedural failure, repeat ablation at any time, recurrence of arrhythmia, drug initiation/escalation, or cardioversion each at 1 year excluding a 3-month blanking period. Efficiency endpoints included "skin-to-skin" procedure time.
Results: The total cohort included 443 patients (235 investigational [31 roll-in], 208 control). Primary effectiveness in the investigational cohort improved significantly with increased procedural order. Efficacy was 65% (74 of 114) for the first 5 patients per operator, 75% (33 of 44) for patients 6 to 10, and 80% (60 of 75) for patients >10. Kaplan-Meier effectiveness estimates at 1-year follow-up were significantly higher in the investigational cohort after 10 procedures performed, compared with control (80% vs 65%, P < .05). With the investigational system, total procedure time was reduced by 25 minutes (100 vs 125) within the first 5 procedures performed (P < .001).
Conclusion: AF ablation with a novel dual-energy, lattice-tip ablation system resulted in greater clinical efficacy compared with conventional RF after a rapid operator learning curve, with superior procedural efficiency noted from the initial procedures onward.
Clinical trial registration: NCT05120193.
Keywords: Affera; Atrial fibrillation; Catheter ablation; Lattice-tip catheter; Learning curve; Pulsed field ablation; Sphere-9.
Copyright © 2025. Published by Elsevier Inc.
Conflict of interest statement
Disclosures Dr Kiehl has served in consulting and advisory capacities for Biosense Webster, Medtronic, and Philips, unrelated to this manuscript or technology. Dr Mountantonakis has received Medtronic research grants and honoraria. Dr Mansour has served as a consultant for Boston Scientific, Biosense Webster, Abbott, Medtronic, Siemens, and Sentre Heart/Atricure and has equity in EPD-Philips (divested) and NewPace, Ltd. Dr Nair has served as consultant and on advisory boards and has received research grants from Abbott Medical, Boston Scientific, Medtronic, and Biosense Webster and has served as consultant and has received research grants from Adagio; he has received research grants from Laminar and has served as consultant for TerraRecon. Dr Sharma has received grant/research support from Medtronic and has served as consultant and advisory board participation for Biosense Webster, Medtronic, EBR Inc, AltaThera Pharmaceutical, and Attune Medical. Dr Taigen has served as a consultant for Biosense Webster and Medtronic. Dr Kautzner has received personal fees from Biosense Webster, Boston Scientific, GE Healthcare, Medtronic, and St Jude Medical (Abbott) for participation in scientific advisory boards and has received speaker honoraria from Biosense Webster, Biotronik, Boston Scientific, Medtronic, and St Jude Medical (Abbott). Dr Osorio has served as consultant for Medtronic; has received research grants, participated in consulting and advisory boards for Biosense Webster, Boston Scientific, and Abbott. Dr Natale has served as a consultant for iRhythm, Boston Scientific, Biosense Webster, Abbott, and Biotronik. Dr Hummel has served as consultant for Medtronic, Abbott, and Volta. Dr Amin has served in consulting and advisory capacities for Medtronic, Boston Scientific, and Biosense Webster and in medical education for Siemens, has has equity in Biostar Ventures, and has served in consulting and medical education for—and been supported by—research grants from Philips. Dr Siddiqui has served as a consultant for Medtronic. Dr Doshi has served as a consultant for Medtronic; unrelated to this article, he has provided consulting, received research grants, or served on advisory boards for Biosense Webster, Boston Scientific, Abbott, Philips, Cardiofocus, Lumavision, Cortex, Soundcath, Conformal, Atraverse, and Seimens. Dr Patel has served as a consultant and speaker for Boston Scientific. Dr Reddy has served as a consultant to and has received equity from Affera-Medtronic; unrelated to this article. Dr Reddy has served as a consultant for—and has equity in—Ablacon, Acutus Medical, Anumana, Apama Medical-Boston Scientific, APN Health, Aquaheart, Atacor, Autonomix, Axon Therapies, Backbeat, BioSig, SoundCath, and Valcare; unrelated to this work, he has served as a consultant for Abbott, Adagio Medical, Append Medical, AtriAN, Biosense Webster, BioTel Heart, Biotronik, Boston Scientific, Cairdac, Cardionomic, CoreMap, Fire1, Gore & Associates, Impulse Dynamics, Medtronic, Novartis, Novo Nordisk, Philips, and Pulse Biosciences. Unrelated to this work, Dr Reddy has equity in Atraverse, DRS Vascular, Manual Surgical Sciences, Newpace, Nyra Medical, Surecor and Vizaramed. Dr Anter is a consultant to and has received equity from Affera-Medtronic; unrelated to this article, he has served in consulting and advisory capacities for Biosense Webster, Boston Scientific, and Abbott Medical. He has received research grants from Biosense Webster and Medtronic. Doron Harlev, Paul Hultz, Sophia Rosen, Kelly van Bragt, and Khaldoun Tarakji are employees of Medtronic. The remaining authors have no conflicts of interest to disclose.
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