Vaidya Vaibhav R, Dai Mingyan, Asirvatham Samuel J, Rea Robert F, Thome Trena M, Srivathsan Komandoor, Mulpuru Siva K, Kusumoto Fred, Venkatachalam Kalpathi L, Ryan James D, Friedman Paul A, Cha Yong-Mei
Department of Cardiovascular Diseases, Mayo Clinic, Rochester, Minnesota.
Department of Pediatrics and Adolescent Medicine, Mayo Clinic, Rochester, Minnesota.
Pacing Clin Electrophysiol. 2019 Mar;42(3):366-373. doi: 10.1111/pace.13601. Epub 2019 Jan 30.
Leadless cardiac pacing (LCP) has emerged as a new modality for permanent pacing. We sought to describe comparative outcomes between LCP and transvenous pacemakers.
Patients receiving LCP (Micra [Medtronic, Minneapolis, MN, USA] and Nanostim [St. Jude Medical/Abbott Laboratories, Chicago, IL, USA]) between 2014 and 2017 at the Mayo Clinic Heart Rhythm Enterprise practice (Rochester, MN, USA; Jacksonville, FL, USA; and Scottsdale, AZ, USA) were identified. We identified 1:1 age- and sex-matched controls receiving single-chamber transvenous ventricular pacemakers (TVP). Statistical analyses were performed with JMP 13.0.0 (SAS, Institute Cary, NC, USA).
Ninety patients underwent LCP implantation (73 Micra and 17 Nanostim) with a median follow-up duration of 62 (interquartile range 28-169) days. Both groups had 100% successful device implant rates. There were no differences in procedure-related major (0% vs 1%) or minor complications (8% vs 3%) in the LCP versus TVP groups (P > 0.05). Excluding Nanostim patients, there was a lower rate of device-related revision or extraction in the Micra versus TVP groups (0% vs 5%, P = 0.028). Device endocarditis was more common in the TVP group (0% vs 3%, P = 0.04). Estimated longevity was greater for the LCP group (median 12.0 vs 10.0 years, P < 0.0001). An increase in severity of tricuspid valve regurgitation (TR) by ≥2 grades occurred in none of the LCP patients, and in 19% of the TVP patients (P = 0.017).
There are no significant differences in procedural complications among patients receiving LCP versus TVP. The Micra group had lower rates of device-related revision/extraction compared to the TVP group. Patients with leadless pacemaker were less likely to develop endocarditis or worsening TR.
无导线心脏起搏（LCP）已成为一种永久性起搏的新方式。我们试图描述LCP与经静脉起搏器之间的比较结果。
确定2014年至2017年在美国明尼苏达州罗切斯特市、佛罗里达州杰克逊维尔市和亚利桑那州斯科茨代尔市的梅奥诊所心律企业实践中接受LCP（美敦力公司的Micra和圣犹达医疗/雅培实验室的Nanostim）的患者。我们确定了1:1年龄和性别匹配的接受单腔经静脉心室起搏器（TVP）的对照。使用JMP 13.0.0（美国北卡罗来纳州卡里市SAS研究所）进行统计分析。
90例患者接受了LCP植入（73例Micra和17例Nanostim），中位随访时间为62（四分位间距28 - 169）天。两组的器械植入成功率均为100%。LCP组与TVP组在与手术相关的主要并发症（0%对1%）或次要并发症（8%对3%）方面无差异（P>0.05）。排除Nanostim患者后，Micra组与TVP组相比，与器械相关的翻修或取出率较低（0%对5%，P = 0.028）。器械性心内膜炎在TVP组更常见（0%对3%，P = 0.04）。LCP组的估计使用寿命更长（中位12.0年对10.0年，P<0.0001）。LCP患者中无一例三尖瓣反流（TR）严重程度增加≥2级，而TVP患者中有19%出现这种情况（P = 0.017）。
接受LCP与TVP的患者在手术并发症方面无显著差异。Micra组与TVP组相比，与器械相关的翻修/取出率较低。无导线起搏器患者发生心内膜炎或TR恶化的可能性较小。
