Division of Cardiology, Fondazione Cardiocentro Ticino, Via Tesserete 48, CH-6900 Lugano, Switzerland.
Europace. 2014 May;16(5):681-8. doi: 10.1093/europace/eut435. Epub 2014 Feb 4.
Left ventricular (LV) endocardial pacing may address the limitations in the selection of an LV pacing site and provide improvements in cardiac resynchronization therapy (CRT) effectiveness. We report on the feasibility, the safety, and the short-term outcome of a leadless ultrasound-based technology for LV endocardial resynchronization in heart failure (HF) patients enroled into the Wireless Stimulation Endocardially for CRT (WiSE-CRT) study.
Seventeen HF patients were enroled and categorized as: (i) patients in whom attempted coronary sinus lead implantation for CRT had failed (n = 7); (ii) patients with a previously implanted CRT device, not responding to CRT (n = 2); and (iii) patients with previously implanted pacemakers or implantable cardioverter-defibrillator and meeting the standard indications for CRT (n = 8). System implantation was achieved in 13 patients (76.5%); mean R-wave amplitude was 5.6 ± 3.2 mV and the mean pacing threshold was 1.6 ± 1.0 V, respectively. In one patient, no sufficient pacing thresholds were found; in three patients pericardial effusion occurred. Biventricular pacing was recorded in 83% and 92% of the patients at 1 month and 6 months, respectively. QRS duration was shorter during biventricular pacing compared with right ventricular pacing at 1 month (-41 ms; P = 0.0002) and 6 months (-42 ms; P = 0.0011), respectively. At the 6-month follow-up, two-thirds of the patients had at least one functional class change. Left ventricular ejection fraction significantly increased (P < 0.01) by 6 points at the 6-month follow-up.
The feasibility of providing an endocardial stimulation for CRT with a leadless technology was successfully demonstrated. Despite the promising results for a novel technology, further study is required to definitively conclude the safety and the performance of the system.
NCT01294527.
左心室（LV）心内膜起搏可以解决 LV 起搏部位选择的局限性，并提高心脏再同步治疗（CRT）的效果。我们报告了一项用于心力衰竭（HF）患者的无导线超声心内膜 LV 再同步治疗（WiSE-CRT）研究中，一种基于无导线技术的 LV 心内膜再同步的可行性、安全性和短期结果。
共纳入 17 例 HF 患者，并分为以下几类：（i）尝试进行 CRT 的冠状窦导线植入失败的患者（n=7）；（ii）对 CRT 无反应且已植入 CRT 设备的患者（n=2）；和（iii）已植入起搏器或植入式心脏除颤器且符合 CRT 标准适应证的患者（n=8）。在 13 例患者（76.5%）中实现了系统植入；平均 R 波振幅为 5.6±3.2 mV，平均起搏阈值为 1.6±1.0 V。在 1 例患者中未发现足够的起搏阈值，在 3 例患者中出现心包积液。1 个月和 6 个月时，分别有 83%和 92%的患者记录到双心室起搏。与右心室起搏相比，1 个月（-41 ms；P=0.0002）和 6 个月（-42 ms；P=0.0011）时双心室起搏时 QRS 持续时间更短。在 6 个月的随访中，三分之二的患者至少有一次功能分级变化。6 个月随访时，左心室射血分数显著增加（P<0.01），增加了 6 个百分点。
使用无导线技术提供 CRT 心内膜刺激的可行性已成功得到证实。尽管这项新技术有很有前景，但仍需要进一步的研究来确定该系统的安全性和性能。
NCT01294527。
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