Onorato Eustaquio Maria, Alamanni Francesco, Muratori Manuela, Smolka Grzegorz, Wojakowski Wojtek, Pysz Piotr, Zorinas Aleksejus, Zakarkaite Diana, Eltchaninoff Hélène, Litzer Pierre-Yves, Godart François, Calvert Patrick, Christou Christos, Mussayev Abdurashid, Missiroli Bindo, Buzaev Igor, Curello Salvatore, Tesorio Tullio, Bartorelli Antonio Luca
Centro Cardiologico Monzino, IRCCS, 20138 Milan, Italy.
3rd Division of Cardiology, Medical University of Silesia, 40-055 Katowice, Poland.
J Clin Med. 2022 Apr 1;11(7):1978. doi: 10.3390/jcm11071978.
Between December 2014 and March 2021, 144 patients with aortic (Ao) or mitral (Mi) paravalvular leaks (PVLs) were enrolled at 21 sites in 10 countries. Safety data were available for 137 patients, who were included in the safety analysis fraction (SAF), 93 patients with Mi PVLs and 44 patients with Ao PVLs. The full analysis set (FAS) comprised 112 patients with available stratum (aortic/mitral leak) as well as baseline (BL), 180-day or later assessments (2 years). Procedural success (implantation of the device with a proper closure of the PVL, defined as reduction in paravalvular regurgitation of ≥one grade as assessed by echocardiography post implantation) was achieved in 91.3% of FAS patients with Mi PVLs and in 90.0% of those with Ao PVLs. The proportion of patients suffering from significant or severe heart failure (HF), classified as New York Heart Association (NYHA) class III/IV, decreased from 80% at baseline to 14.1% at 2-year follow-up (FAS). The proportion of FAS patients needing hemolysis-related blood transfusion decreased from 35.5% to 3.8% and from 8.1% to 0% in Mi patients and Ao patients, respectively. In total, 35 serious adverse events (SAEs) were reported in 27 patients (19.7%) of the SAF population. The SAEs considered possibly or probably related to the device included device embolization (three patients), residual leak (two patients) and vascular complication (one patient). During follow-up, 12/137 (8.8%) patients died, but none of the deaths was considered to be device-related. Patients implanted with the Occlutech Paravalvular Leak Device (PLD) showed long-lasting improvements in clinical parameters, including NYHA class and a reduced dependency on hemolysis-related blood transfusions.
2014年12月至2021年3月期间，10个国家的21个地点招募了144例患有主动脉瓣（Ao）或二尖瓣（Mi）瓣周漏（PVL）的患者。137例患者有安全数据，被纳入安全分析组（SAF），其中93例为二尖瓣瓣周漏患者，44例为主动脉瓣瓣周漏患者。完整分析集（FAS）包括112例有可用分层（主动脉瓣/二尖瓣漏）以及基线（BL）、180天或更晚评估（2年）的患者。在FAS组中，91.3%的二尖瓣瓣周漏患者和90.0%的主动脉瓣瓣周漏患者实现了手术成功（植入装置并适当闭合瓣周漏，定义为植入后经超声心动图评估瓣周反流减少≥一级）。患有严重或重度心力衰竭（HF）（纽约心脏协会（NYHA）III/IV级）的患者比例从基线时的80%降至2年随访时（FAS）的14.1%。FAS组中需要进行与溶血相关输血的患者比例在二尖瓣患者和主动脉瓣患者中分别从35.5%降至3.8%以及从8.1%降至0%。在SAF人群的27例患者（19.7%）中总共报告了35例严重不良事件（SAE）。被认为可能或很可能与装置相关的SAE包括装置栓塞（3例患者）、残余漏（2例患者）和血管并发症（1例患者）。在随访期间，12/137（8.8%）例患者死亡，但无一例死亡被认为与装置相关。植入Occlutech瓣周漏装置（PLD）的患者在临床参数方面显示出持久改善，包括NYHA分级以及对与溶血相关输血的依赖减少。
