无线循证前沿｜欧洲双腔无导线起搏真实世界研究：在高风险患者中的可行性与短期安全性表现优异
2026-06-06 17:43


关键图表


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研究背景


无导线心脏起搏器通过消除皮下囊袋和导线，可显著降低导线相关并发症（例如：脱位、断裂），囊袋相关问题（例如：感染、血肿），静脉通路并发症（例如：血栓或闭塞）等临床风险。


近年来，随着技术进展，双腔无导线起搏系统（如 AVEIR™ DR），实现了右房与右室模块间的无线通信，真正意义上使双腔无导线起搏成为可能。但现阶段多数研究集中于单腔无导线起搏器，双腔无导线起搏器与传统双腔经静脉起搏器的对照数据研究较少。因此，本研究旨在填补这一证据空白，开展首个真实世界中双腔无导线与经静脉起搏器的直接比较研究。


研究结论


在这一真实世界的初步比较研究中，双腔无导线起搏即使应用于临床情况更复杂、传统上被认为更高风险的患者人群中，仍表现出良好的短期安全性。因此，在特定高风险患者中可以考虑采用双腔无导线起搏策略。


研究方法


本研究采用非参数统计方法与Cox回归分析，重点评估组间差异及90天事件风险，纳入连续接受双腔起搏器植入的患者，无导线组患者基线风险高于经静脉组（Table 1）：

  • 经静脉双腔起搏器：178例（2023–2024年）

  • 双腔无导线起搏器：27例（2024–2025年）


Table 1.患者的临床特征


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本研究的主要终点包括：


  • 临床终点：器械或操作相关不良事件及植入后90天内任何原因导致的急性再住院

  • 电学参数终点：起搏阈值（pacing threshold）&电池电压（battery voltage）

电学参数分别在植入时，术后首次随访（约14天），术后90天门诊随访三个时间点进行评估。电学参数评估指标包括：


  • 感知

  • 起搏阈值（统一脉宽为0.4ms）

  • 阻抗

  • 电池寿命

在本中心的常规临床实践中，经静脉起搏器随访未系统记录感知和阻抗参数，因此组间比较主要聚焦于起搏阈值和电池寿命，所有起搏器均依据指南进行程控，原则包括为尽量减少不必要的右心室起搏及在有指征时启用频率应答功能。


由于波兰医保报销政策限制，无导线起搏器植入采取分阶段植入方式，暨先植入心室无导线，后二次住院植入心房无导线，二次植入间的间隔时间中位数（IQR）为 39天。因需进行两次植入，LPM组的手术时间，透视时间及辐射剂量均高于经静脉组。且因需建立两次大口径股静脉穿刺，累计的血管通路风险也可能更大。


研究结果


1.高风险下的更优结果：尽管无导线组患者基线风险较高（既往器械感染；恶性肿瘤；慢性肾病），AVEIR™ DR双腔无导线起搏器（LPM）组所有患者均成功完成手术植入，成功率100%，且所有装置均成功建立了稳定的器械间通信。在整个研究队列中，经静脉组并发症总体发生率为3.9%（导线脱位：4例；气胸：3例）。无导线组中有2例患者出现并发症

  • 心包积液1例，右房模块植入后12小时发生，后行心包穿刺引流，该患者因电学参数不理想，曾进行6次位置调整

  • 动静脉瘘1例

若按“手术次数”而非“患者人数”计算风险，双腔无导线起搏的并发症发生率为3.7%（2/54次手术）（Table 2）。因此，无导线患者组虽面临更高风险患者且需分期植入，但手术成功率100%，并发症率极低，且未观察到出院后的严重不良事件。


Table 2.研究人群围术期结果


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2.电学参数稳定：在植入时，心房无导线起搏器与心室无导线起搏器的电学参数存在差异：心房起搏器植入时候阈值初始较高，但在术后数天内通常会下降，由植入时阈值中位数2.0V下降至阈值中位数0.5V，特别是在术中获得理想的感知、阻抗及损伤电流指标的情况下(Table 3)。


Table 3. 随访期无导线起搏器电学参数：



心房感知

心房阈值

心房阻抗

3.电池寿命与长期管理：本研究中，无导线组电池寿命略短于经静脉组，其预测电池续航时间的中位数（IQR）为8.4（7.6–9.4）年，而经静脉装置为10（8.0–11.5）年（P = 0.002）。相信随着器械发展和新一代程控模式AAI (R) + VVI back up（本研究进行时该模式尚未在欧洲获批）的推出，预计未来无导线起搏器电池寿命将进一步改善。


总结


本研究结果更多体现了AVEIR™ DR无导线起搏器在高风险患者中的可行性与短期安全性。尽管双腔无导线组植入的患者具有更高的基线风险，其早期结局仍与传统经静脉起搏器相似。特别是两组在总体并发症发生率方面无显著差异，这一点尤为重要。因为双腔无导线起搏器均需分阶段植入（27例患者共进行54次手术）。这些结果提示，对于高风险患者，双腔无导线起搏可以在不影响短期手术安全性的前提下安全实施。


研究局限性


  • 为单中心的回顾性分析，且无导线组样本量相对较小

  • 无导线起搏器的电池寿命评估未考虑新获批的AAI(R)+VVI模式，已有研究显示该模式可延长心房及心室无导线起搏器的电池寿命

  • 患者分组并非随机分配，而是受到临床判断及报销标准的影响

  • 随访仅限于早期结局

  • 本研究未评估患者报告结局，包括生活质量指标。


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