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N E G Beurskens, F V Y Tjong, P Neuzil, P Defaye, P P Delnoy, J Ip, J J Garcia Guerrero, M Rashtian, R Banker, V Reddy, D Exner, J Sperzel, R Knops, P3872
The learning curve associated with the implantation of the nanostim leadless cardiac pacemaker, European Heart Journal, Volume 39, Issue suppl_1, August 2018, ehy563.P3872, https://doi.org/10.1093/eurheartj/ehy563.P3872Close - Share Icon Share
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Background: The miniaturized Nanostim leadless pacemaker (LP) has become a well-accepted option for selected patients with a single-chamber pacing indication. Use of novel medical technologies, such as LP therapy, may be subjected to a learning curve effect.
Purpose: The objective of the current study was to assess the impact of operators' experience on the occurrence of serious adverse device effects (SADE) and procedural efficiency.
Methods: Patients implanted with a Nanostim LP (Abbott, USA) within two prospective studies (i.e. LEADLESS ll IDE and Leadless Observational Study) were assessed. Patients were categorized into quartiles based on operator experience. Learning curve analysis included the comparison of SADE rates at 30 days post-implant per quartile and between patients in quartile 4 (operators with most experience; >10 implants) and patients in quartile 1 through 3 (initial operators experience; 1–10 implants). Procedural efficiency was assessed based on procedure duration and repositioning attempts.
Results: Nanostim LP implant was performed in 1439 patients by 171 implanters, at 60 centers in 10 countries. A total of 91 (6.4%) patients experienced a SADE in the first 30 days. SADE rates dropped from 7.4% to 4.5% (p=0.038) after more than 10 implants per operator. Total procedure duration, which initially had a mean of 30.9±19.1 minutes in the first quartile, decreased across the procedure quartiles to 21.6±13.2 minutes (p<0.001) in quartile 4 (i.e. most experience). The need for multiple repositionings during the LP procedure reduced in quartile 4 (14.8%), compared to quartile 1 (26.8%; p<0.001), 2 (26.6%; p<0.001) and 3 (20.4%; p=0.03).
