Background

Left ventricular (LV) endocardial pacing is a promising method to deliver cardiac resynchronization therapy (CRT). WiSE-CRT is a wireless LV endocardial pacing system, and delivers ultrasonic energy to an LV electrode.

Objective

The purpose of this study was to present short-term outcomes with the WiSE-CRT system in centers with no prior implanting experience.

Methods

Data were prospectively collected from 19 centers where WiSE-CRT systems were implanted during the roll-in phase of the SOLVE-CRT trial. Patients were followed at 1, 3, and 6 months, including transthoracic echo (TTE) at 6 months.

Results

The WiSE-CRT was successfully implanted in all 31 attempted cases, and 30 patients completed the 6-month follow-up. One patient underwent heart transplantation 1 month after implantation, and was excluded. Fourteen (46.7%) patients demonstrated ≥1 NYHA class improvement. TTE data were available in 29 patients. LV ejection fraction, LV end-systolic volume, and LV end-diastolic volume improved from 28.3% ± 6.7% to 33.5% ± 6.9% (P < .001), 134.9 ± 51.3 mL to 111.1 ± 40.3 mL (P = .0004), and 185.4 ± 58.8 mL to 164.9 ± 50.6 mL (P = .0017), respectively. There were 3 (9.7%) device-related type 1 complications: 1 insufficient LV pacing, 1 embolization of an unanchored LV electrode, and 1 skin infection.

Conclusions

We demonstrated a high success rate of LV endocardial electrode placement in centers with no prior implanting experience. Favorable clinical responses in heart failure symptoms and significant LV reverse remodeling were noted.

中文翻译：

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使用 WiSE-CRT 系统进行无引线左心室刺激 - SOLVE-CRT 研究 I 期的初步经验和结果（非随机、滚动阶段）

背景

左心室 (LV) 心内膜起搏是一种很有前途的心脏再同步化治疗 (CRT) 方法。WiSE-CRT 是一种无线 LV 心内膜起搏系统，可将超声波能量传送到 LV 电极。

客观的

本研究的目的是在没有植入经验的中心展示 WiSE-CRT 系统的短期结果。

方法

数据是从 19 个在 SOLVE-CRT 试验的滚动阶段植入 WiSE-CRT 系统的中心前瞻性收集的。在 1、3 和 6 个月时对患者进行了随访，包括第 6 个月时的经胸回声 (TTE)。

结果

WiSE-CRT 在所有 31 例尝试病例中均成功植入，30 例患者完成了 6 个月的随访。一名患者在植入后 1 个月接受了心脏移植，被排除在外。十四名 (46.7%) 患者表现出≥1 NYHA 等级改善。29 名患者可获得 TTE 数据。LV 射血分数、LV 收缩末期容积和 LV 舒张末期容积从 28.3% ± 6.7% 提高到 33.5% ± 6.9% ( P < .001)、134.9 ± 51.3 mL 到 111.1 ± 40.3 mL ( P  = .0004 ) 和 185.4 ± 58.8 mL 至 164.9 ± 50.6 mL ( P  = .0017)。有 3 例 (9.7%) 与装置相关的 1 型并发症：1 例 LV 起搏不足，1 例未锚定 LV 电极栓塞，1 例皮肤感染。

结论

我们展示了在没有先前植入经验的中心放置 LV 心内膜电极的高成功率。注意到心力衰竭症状和显着的 LV 反向重构的良好临床反应。