Tjong Fleur V Y, Beurskens Niek E G, Neuzil Petr, Defaye Pascal, Delnoy Peter-Paul, Ip John, Guerrero Juan Jose Garcia, Rashtian Mayer, Banker Rajesh, Reddy Vivek, Exner Derek, Sperzel Johannes, Knops Reinoud E
Department of Clinical and Experimental Cardiology, Amsterdam UMC, location AMC, University of Amsterdam, Meibergdreef 9, 1105 AZ, Amsterdam, The Netherlands.
Na Homolce Hospital, Praha, Czech Republic.
J Interv Card Electrophysiol. 2018 Nov;53(2):239-247. doi: 10.1007/s10840-018-0438-8. Epub 2018 Aug 13.
Use of novel medical technologies, such as leadless pacemaker (LP) therapy, may be subjected to a learning curve effect. 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.
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 (> 10 implants) and patients in quartiles 1 through 3 (1-10 implants). Procedural efficiency was assessed based on procedure duration and repositioning attempts.
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 decreased from 30.9 ± 19.1 min in quartile 1 to 21.6 ± 13.2 min (p < 0.001) in quartile 4. The need for multiple repositionings during the LP procedure reduced in quartile 4 (14.8%), compared to quartiles 1 (26.8%; p < 0.001), 2 (26.6%; p < 0.001), and 3 (20.4%; p = 0.03).
Learning curves exist for Nanostim LP implantation. Procedure efficiency improved with increased operator experience, according to a decrease in the incidence of SADE, procedure duration, and repositioning attempts.
使用新型医疗技术，如无导线起搏器（LP）治疗，可能会受到学习曲线效应的影响。本研究的目的是评估操作者经验对严重不良器械效应（SADE）发生情况和手术效率的影响。
对两项前瞻性研究（即无导线II期器械临床试验和无导线观察性研究）中植入Nanostim LP（美国雅培公司）的患者进行评估。根据操作者经验将患者分为四分位数。学习曲线分析包括比较各四分位数植入后30天的SADE发生率，以及比较第四四分位数（>10例植入）患者与第一至第三四分位数（1-10例植入）患者之间的SADE发生率。根据手术时间和重新定位尝试次数评估手术效率。
171名植入者在10个国家的60个中心为1439名患者植入了Nanostim LP。共有91名（6.4%）患者在植入后的前30天内出现了SADE。每位操作者植入超过10例后，SADE发生率从7.4%降至4.5%（p = 0.038）。总手术时间从第一四分位数的30.9±19.1分钟降至第四四分位数的21.6±13.2分钟（p < 0.001）。与第一四分位数（26.8%；p < 0.001）、第二四分位数（26.6%；p < 0.001）和第三四分位数（20.4%；p = 0.03）相比，第四四分位数在LP手术期间需要多次重新定位的情况有所减少（14.8%）。
Nanostim LP植入存在学习曲线。随着操作者经验的增加，手术效率得到提高，SADE发生率、手术时间和重新定位尝试次数均有所降低。
