Martínez-Sande José Luis, García-Seara Javier, Rodríguez-Mañero Moisés, Fernández-López Xesús Alberte, González-Melchor Laila, Redondo-Diéguez Alfredo, González-Ferreiro Rocío, González-Juanatey José Ramón
Unidad de Arritmias y Electrofisiología Cardiaca, Servicio de Cardiología y Unidad Coronaria, Hospital Clínico Universitario de Santiago de Compostela, Santiago de Compostela, A Coruña, Spain.
Unidad de Arritmias y Electrofisiología Cardiaca, Servicio de Cardiología y Unidad Coronaria, Hospital Clínico Universitario de Santiago de Compostela, Santiago de Compostela, A Coruña, Spain.
Rev Esp Cardiol (Engl Ed). 2017 Apr;70(4):275-281. doi: 10.1016/j.rec.2016.11.027. Epub 2016 Dec 28.
Currently, studies on the leadless pacemaker (Micra) have mostly been limited to clinical trials with less than 6 months' follow-up and they often fail to reflect real population outcomes. We sought to evaluate electrical parameters at implantation and chronologically during follow-up, as well as the safety of this new technique.
This prospective, observational study included 30 consecutive patients, all ≥ 65 years, with an indication for single-chamber pacemaker implantation.
Successful implantation was accomplished in all patients referred for leadless implantation. The mean age was 79.4±6.4 years (range, 66-89 years); 20 (66.6%) were men and 28 had permanent atrial fibrillation (93.3%); 1 had atrial tachycardia and 1 had sinus rhythm. Concomitant atrioventricular node ablation was performed immediately after implantation in 5 patients (16.6%), and implantation was performed after transcatheter aortic valve implantation in 2. The procedure was performed under an uninterrupted anticoagulation regimen (maximum INR 2.4) in 23 patients (76.6%). With the exception of 1 moderate pericardial effusion without tamponade, there were no severe complications. The mean follow-up was 5.3±3.3 months and 4 patients had more than 1 year of follow-up. Sensing and pacing parameters were stable both at implantation and during the short- to mid-term follow-up.
Implantation of leadless pacemakers is feasible, safe and provides advantages over the conventional system. Further studies with longer follow-up periods will be needed before these devices become widely used in routine clinical practice.
目前，关于无导线起搏器（Micra）的研究大多局限于随访时间不足6个月的临床试验，且往往无法反映真实人群的结果。我们旨在评估植入时及随访过程中的电参数，以及这项新技术的安全性。
这项前瞻性观察性研究纳入了30例连续的患者，均为≥65岁，有单腔起搏器植入指征。
所有接受无导线植入的患者均成功植入。平均年龄为79.4±6.4岁（范围66 - 89岁）；20例（66.6%）为男性，28例有永久性心房颤动（93.3%）；1例有心房性心动过速，1例有窦性心律。5例患者（16.6%）在植入后立即进行了房室结消融，2例在经导管主动脉瓣植入术后进行了植入。23例患者（76.6%）在不间断抗凝方案（最大国际标准化比值2.4）下进行了该手术。除1例无心脏压塞的中度心包积液外，无严重并发症。平均随访时间为5.3±3.3个月，4例患者随访时间超过1年。感知和起搏参数在植入时及短期至中期随访期间均稳定。
无导线起搏器植入是可行、安全的，且比传统系统具有优势。在这些设备广泛应用于常规临床实践之前，还需要进行更长随访期的进一步研究。
