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摘要: 目的 初步探讨高龄患者无导线起搏器植入后电学参数的稳定性, 分析无导线起搏器在临床应用中的有效性及安全性。方法 本研究为回顾性、观察性研究。选取2021年8月-2023年2月于上海市奉贤区中心医院和上海市普陀区利群医院接受单、双腔无导线起搏器植入的52例年龄≥70岁患者。收集患者的基本特征以及围术期相关信息。术后随访程控参数(感知、阈值、阻抗)、超声心动图、B型利钠肽(BNP)、肌酐。收集并发症及严重不良事件发生情况。结果 52例患者均完成起搏器植入, 成功率为100%。术中阈值(0.53±0.24) V/0.24 ms, 感知(11.67±4.65) mV, 阻抗(831.88±194.82)Ω, 手术时间(39.41±19.54) min, 住院时间(9.25±3.72) d。围手术期均未发生空气血栓栓塞、心脏穿孔、心包填塞等严重并发症, 均未发生起搏器脱落或移位。术后1个月超声心动图显示三尖瓣功能无明显变化。术后6个月随访时, 阈值(0.48±0.10) V/0.24 ms, 感知(13.38±3.89) mV, 阻抗(716.88±141.23)Ω, 心室起搏比例为54.1%。与术中相比, 术后6个月起搏感知及阈值无显著改变, 阻抗则呈下降趋势(P < 0.05)。结论 对于高龄患者, 植入无导线起搏器术中与术后电学参数稳定, 并发症发生率低, 在临床应用中安全有效。Abstract: Objective To preliminarily explore the stability of electrical parameters after leadless pacemaker implantation in elderly patients and evaluate the efficacy and safety of leadless pacemakers in clinical application.Methods This study was a retrospective and observational research.Fifty-two patients aged≥70 years who received single or dual chamber leadless pacemaker implantation in Shanghai Fengxian District Central Hospital and Shanghai Putuo District Liqun Hospital from August 2021 to February 2023 were selected.The basic characteristics and perioperative data were collected.The parameters of leadless pacemaker (R-wave, threshold, impedance), echocardiography, brain natriuretic peptide (BNP), and creatinine were followed up after implantation.The complications and serious adverse events were also recorded.Results Fifty-two patients completed pacemaker implantation with a success rate of 100%.The intraoperative mean ventricular pacing threshold was (0.53±0.24) V at 0.24 ms, the leadless pacemaker R-wave was (11.67±4.65) mV, impedance was (831.88±194.82)Ω, operation time was (39.41±19.54) min, and hospital stay was (9.25±3.72) d.There was no perioperative air thromboembolism, cardiac perforation, pericardial tamponade, pacemaker falling off, or shifts.The tricuspid valve function showed no significant change under echocardiography one month after implantation.The electrical parameters 6 months after implantation: mean ventricular pacing threshold was (0.48±0.10) V at 0.24 ms, leadless pacemaker R-wave was (13.38±3.89) mV, impedance was (716.88±141.23)Ω, and ventricular pacing was 54.1%.Compared with intraoperative values, there was no significant change in the leadless pacemaker R-wave or threshold, while the impedance showed a decreasing trend (P < 0.05).Conclusion For elderly patients, leadless pacemaker implantation has stable electrical parameters during and after the implantation, with the low incidence of complications.It is safe and effective in clinical applications.
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Key words:
- leadless pacemaker /
- electrical parameters /
- elderly /
- complications
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表 1 患者的临床基线资料
Table 1. Baseline characteristics
例(%), X±S 项目 数据 年龄/岁 77.38±8.10 住院时长/d 9.25±3.72 男性 28(53.8) 起搏器植入适应证 SSS 23(44.2) AVB 21(40.4) 房颤伴长R-R间歇 8(15.4) 合并症 冠心病 36(69.2) 高血压 10(19.2) 糖尿病 2(3.85) 肥厚型心肌病 2(3.85) 主动脉瓣置换 1(1.9) 肺气肿 1(1.9) 术前应用抗血小板药物 未应用 37(71.1) 单联抗血小板 8(15.4) 双联抗血小板 7(13.5) 术前应用抗凝药物情况 未应用 41(78.8) 华法林 3(5.8) 新型口服抗凝药 8(15.4) 起搏器类型 AV 26(50.0) VR 26(50.0) 表 2 无导线起搏器植入术中各项指标
Table 2. Indicators of leadless pacemaker procedure
例(%), X±S 项目 数据 手术时长/min 39.41±19.54 X线曝光量/mGy 459.09±299.77 植入位置 低位间隔 25(48.1) 中位间隔 19(36.5) 高位间隔 8(15.4) 左前斜/° 32.07±5.21 右前斜/° 29.94±4.12 表 3 手术前后超声心动图参数比较
Table 3. Echocardiographic parameters before and after operation
X±S 项目 基线 术后1个月 P值 LVEF/% 63.20±6.89 64.16±5.82 0.398 LVEDD/mm 47.56±4.81 48.28±4.90 0.192 LVESD/mm 31.19±3.52 31.56±3.92 0.562 LVEF:左心室射血分数;LVEDD:左心室舒张末期内径;LVESD:左心室收缩末期内径。 表 4 手术前后BNP与肌酐水平比较
Table 4. BNP and creatinine before and after operation
M(P25, P75) 项目 基线 术后 1个月 3个月 6个月 BNP/(pg/mL) 175.85(102.72,203.55) 132.00(89.85, 292.50) 111.00(71.25,236.00)1) 88.00(63.75,144.31)1) 肌酐/(μmol/L) 74.50(65.75,100.75) 74.50(69.00,93.25) 81.00(69.25,104.75) 78.50(67.25,111.50) 与基线比较,1)P < 0.05。 表 5 术中与术后电学参数比较
Table 5. Intraoperative and postoperative electrical parameters
X±S 项目 术中 术后 1个月 3个月 6个月 感知/mV 11.67±4.65 13.03±3.11 12.86±3.06 13.38±3.89 阈值V/0.24 ms 0.53±0.24 0.54±0.16 0.57±0.14 0.48±0.10 阻抗/Ω 831.88±194.82 781.25±133.821) 750.31±114.141) 716.88±141.231) 与术中比较,1)P < 0.05。 -
[1] 李燕玲, 王博雯, 张天成, 等. 起搏器术后发生上腔静脉阻塞综合征和起搏功能障碍介入治疗1例[J]. 临床心血管病杂志, 2023, 39(4): 324-326. https://lcxxg.whuhzzs.com/article/doi/10.13201/j.issn.1001-1439.2023.04.017
[2] Bencardino G, Scacciavillani R, Narducci ML. Leadless pacemaker technology: clinical evidence of new paradigm of pacing[J]. Rev Cardiovasc Med, 2022, 23(2): 43. doi: 10.31083/j.rcm2302043
[3] Roberts PR, Clementy N, Al Samadi F, et al. A leadless pacemaker in the real-world setting: The Micra Transcatheter Pacing System Post-Approval Registry[J]. Heart Rhythm, 2017, 14(9): 1375-1379. doi: 10.1016/j.hrthm.2017.05.017
[4] Xu F, Meng L, Lin H, et al. Systematic review of leadless pacemaker[J]. Acta Cardiol, 2024, 79(3): 284-294. doi: 10.1080/00015385.2023.2276537
[5] Schiavone M, Filtz A, Gasperetti A, et al. Leadless pacemaker implantation in the emergency bradyarrhythmia setting: results from a multicenter European registry[J]. Medicina, 2022, 59(1): 67. doi: 10.3390/medicina59010067
[6] Udo EO, Zuithoff NPA, van Hemel NM, et al. Incidence and predictors of short-and long-term complications in pacemaker therapy: The FOLLOWPACE study[J]. Heart Rhythm, 2012, 9(5): 728-735. doi: 10.1016/j.hrthm.2011.12.014
[7] Ranasinghe I, Labrosciano C, Horton D, et al. Institutional variation in quality of cardiovascular implantable electronic device implantation: a cohort study[J]. Ann Intern Med, 2019, 171(5): 309-317. doi: 10.7326/M18-2810
[8] Cantillon DJ, Exner DV, Badie NM, et al. Complications and health care costs associated with transvenous cardiac pacemakers in a nationwide assessment[J]. JACC Clin Electrophysiol, 2017, 3(11): 1296-1305. doi: 10.1016/j.jacep.2017.05.007
[9] 中国医师协会心律学专业委员会, 中华医学会心电生理和起搏分会. 无导线起搏器临床应用中国专家共识(2022)[J]. 中华心律失常学杂志, 2022, 26(3): 263-271.
[10] Ngo L, Nour D, Denman RA, et al. Safety and efficacy of leadless pacemakers: a systematic review and meta-analysis[J]. J Am Heart Assoc, 2021, 10(13): e019212. doi: 10.1161/JAHA.120.019212
[11] Lakkireddy D, Knops R, Atwater B, et al. A worldwide experience of the management of battery failures and chronic device retrieval of the Nanostim leadless pacemaker[J]. Heart Rhythm, 2017, 14(12): 1756-1763. doi: 10.1016/j.hrthm.2017.07.004
[12] El-Chami MF, Al-Samadi F, Clementy N, et al. Updated performance of the Micra transcatheter pacemaker in the real-world setting: a comparison to the investigational study and a transvenous historical control[J]. Heart Rhythm, 2018, 15(12): 1800-1807. doi: 10.1016/j.hrthm.2018.08.005
[13] Cabanas-Grandío P, García Campo E, Bisbal F, et al. Quality of life of patients undergoing conventional vs leadless pacemaker implantation: a multicenter observational study[J]. J Cardiovasc Electrophysiol, 2020, 31(1): 330-336. doi: 10.1111/jce.14322
[14] Tjong FVY, Beurskens NEG, de Groot JR, et al. Health-related quality of life impact of a transcatheter pacing system[J]. J Cardiovasc Electrophysiol, 2018, 29(12): 1697-1704. doi: 10.1111/jce.13726
[15] Beurskens NEG, Tjong FVY, de Bruin-Bon RHA, et al. Impact of leadless pacemaker therapy on cardiac and atrioventricular valve function through 12 months of follow-up[J]. Circ Arrhythm Electrophysiol, 2019, 12(5): e007124. doi: 10.1161/CIRCEP.118.007124
[16] Hai JJ, Mao YK, Zhen Z, et al. Close proximity of leadless pacemaker to tricuspid annulus predicts worse tricuspid regurgitation following septal implantation[J]. Circ Arrhythm Electrophysiol, 2021, 14(5): e009530. doi: 10.1161/CIRCEP.120.009530
[17] Carabelli A, Jabeur M, Jacon P, et al. European experience with a first totally leadless cardiac resynchronization therapy pacemaker system[J]. Europace, 2021, 23(5): 740-747. doi: 10.1093/europace/euaa342
[18] Steinwender C, Khelae SK, Garweg C, et al. Atrioventricular synchronous pacing using a leadless ventricular pacemaker: results from the MARVEL 2 study[J]. JACC Clin Electrophysiol, 2020, 6(1): 94-106. doi: 10.1016/j.jacep.2019.10.017
[19] Strik M, Clementy N, Mondoly P, et al. Implantation of a leadless pacemaker in young adults[J]. J Cardiovasc Electrophysiol, 2023, 34(2): 412-417. doi: 10.1111/jce.15796