Micra无导线起搏器植入的临床应用及疗效分析

Effi cacy and safety of Micra leadless pacemaker implantation

目的通过分析Micra无导线起搏器的应用和随访结果,探讨无导线起搏器在临床应用中的安全性和有效性。方法采用前瞻性队列研究,选取2019年12月至2021年1月于首都医科大学附属北京安贞医院行Micra无导线起搏器植入的患者,记录患者的临床基线资料、手术时间、放射线曝光时间、并发症、术后3个月内的随访情况、起搏参数以及生活质量评分。结果共入选65例Micra植入患者,平均年龄(73.6±9.5)岁,其中男45例(69.2%)。所有患者均成功植入Micra无导线起搏器,平均手术时间(42.56±5.83)min,放射线曝光时间(8.71±2.12)min,出院前和术后3个月的平均阈值分别为(0.51±0.29)V@0.24 ms和(0.48±0.16)V@0.24 ms,感知分别为(11.9±4.3)mV和(12.3±3.3)mV,阻抗分别为(815±212)Ω和(795±159)Ω;1例术后出现伤口愈合延迟,1例出现少量心包积液,1例阈值偏高,均未予特殊处理,预后良好;未见穿刺部位血肿、动静脉瘘、感染、器械移位和心脏压塞等发生;术后有8例进行了3.0 T核磁共振成像检查,无不良反应发生;术后3个月的健康调查简表心评分较术前明显升高,其中生理职能、精力、社会功能、情感职能方面差异均有统计学意义(均P<0.05)。结论Micra无导线起搏器植入手术操作相对简便、微创,手术成功率高、时间较短,安全性高,起搏参数稳定,提升了患者生活质量。

Objective To assess the efficacy and safety of Micra leadless pacemaker by analyzing the results of clinical application and follow up of Micra leadless pacemaker implantation.Methods A prospective observational cohort study was designed to select the patients who were implanted with Micra leadless pacemaker in Beijing Anzhen Hospital affiliated to Capital Medical University from December 2019 to January 2021.The clinical baseline data,operation time,X-ray exposure time and complications were recorded,pacing parameters and quality of life score were recorded within 3 months follow-up.Results A total of 65 patients with Micra leadless pacemaker were selected,with an average age of(73.6±9.5)years,including 45 males(69.2%).All cases were successfully implanted,the average procedural time was(42.56±5.83)min,X-ray exposure time was(8.71±2.12)min.The average thresholds before discharge and 3 months after procedure were(0.51±0.29)V@0.24 ms and(0.48±0.16)V@0.24 ms,respectively.R-Wave amplitude were(11.9±4.3)mV and(12.3±3.3)mV,impedance were(815±212)Ωand(795±159)Ω.Wound healing was delayed in 1 case,minimal pericardial eff usion was in 1 case,and high thresholds were observed in 1 case,while all 3 cases were with good prognosis without special treatment.There are no hematoma,arteriovenous fistula,infection,device displacement or cardiac tamponade during procedure or at follow up.After procedure,8 cases were examined by 3.0 T magnetic resonance imaging without adverse reactions.The SF-36 quality of life score after 3 months of procedure was signifi cantly higher than that before procedure,and there were statistical diff erences in physiological function,vitality,social function and emotional function(all P<0.05).Conclusions Micra leadless pacemaker implantation is relatively simple and minimally invasive,with high success rate,short operation time,high safety,stable pacing parameters and improved quality of life.