Zhou Ziqin, Tian Miao, Tu Jiazichao, Zhang Yong, Zhuang Jian, Wen Shusheng, Chen Jimei
Guangdong Cardiovascular Institute, Guangdong Provincial People's Hospital (Guangdong Academy of Medical Sciences), Southern Medical University, Guangzhou, China.
Catheter Cardiovasc Interv. 2025 Jun;105(7):1597-1607. doi: 10.1002/ccd.31471. Epub 2025 Mar 17.
Transcatheter pulmonary valve replacement (TPVR) has emerged as a valuable treatment for severe pulmonary regurgitation (PR). The Salus valve (Balance Medical Technology Co. Ltd., Beijing, China) represents a novel self-expanding valve stent designed for deployment through a transthoracic approach with a small subxiphoid incision.
The objective of this study was to evaluate the medium-term safety and efficacy of Salus valve stents in this patient population.
This prospective cohort study enrolled patients who underwent transthoracic pulmonary valve stenting at Guangdong Provincial People's Hospital from September 2021 to September 2024. Inclusion criteria included moderate-to-severe PR following RVOT reconstruction, age ≥ 14 years, and specific clinical/imaging parameters. Primary endpoints were pulmonary regurgitation fraction < 20%, freedom from reintervention at 12 months, and major adverse events (MAE). MAE were defined as death, reintervention, recurrent severe PR, worsening heart failure, cardiac arrest, new severe ventricular arrhythmias, and third-degree AV block.
Among 38 patients (mean age 24.08 ± 8.12 years), all procedures were successfully completed, although intraoperative valve displacement occurred in three cases. During a median follow-up period of 24 months, significant improvements were observed in right ventricular volumes: Right Ventricular End-Diastolic Volume Index (RVEDVI) decreased from 141.45 to 109.98 mL/m and Right Ventricular End-Systolic Volume Index (RVESVI) decreased from 74.27 to 56.62 mL/m (both p < 0.01). No mortality or need for reintervention was observed during the follow-up period. The estimated freedom from major adverse events at 36 months was 87.2%.
The Salus valve demonstrated safety and efficacy for severe PR treatment through its transthoracic approach, which offers unique advantages in terms of direct access and immediate complication management. Longer follow-up is needed to assess long-term durability.
经导管肺动脉瓣置换术（TPVR）已成为治疗严重肺动脉反流（PR）的一种有价值的方法。赛卢斯瓣膜（北京佰仁医疗科技有限公司）是一种新型的自膨胀瓣膜支架，设计用于通过剑突下小切口经胸途径进行植入。
本研究的目的是评估赛卢斯瓣膜支架在该患者群体中的中期安全性和有效性。
这项前瞻性队列研究纳入了2021年9月至2024年9月在广东省人民医院接受经胸肺动脉瓣支架植入术的患者。纳入标准包括右心室流出道重建术后中度至重度PR、年龄≥14岁以及特定的临床/影像学参数。主要终点为肺动脉反流分数<20%、12个月时无需再次干预以及主要不良事件（MAE）。MAE定义为死亡、再次干预、复发性严重PR、心力衰竭恶化、心脏骤停、新出现的严重室性心律失常和三度房室传导阻滞。
在38例患者（平均年龄24.08±8.12岁）中，所有手术均成功完成，尽管有3例术中出现瓣膜移位。在中位随访期24个月期间，右心室容积有显著改善：右心室舒张末期容积指数（RVEDVI）从141.45降至109.98 mL/m，右心室收缩末期容积指数（RVESVI）从74.27降至56.62 mL/m（均p<0.01）。随访期间未观察到死亡或再次干预的需求。36个月时估计无主要不良事件的发生率为87.2%。
赛卢斯瓣膜通过经胸途径治疗严重PR显示出安全性和有效性，在直接通路和即时并发症管理方面具有独特优势。需要更长时间的随访来评估长期耐久性。
