Percutaneous implantation of self-expanding pulmonary valves: results from real-life experience of the Venus-P valve Registry of the Italian Society of Pediatric Cardiology (SICPED).

IF 1.2 Q4 CARDIAC & CARDIOVASCULAR SYSTEMS
M Pilati, F A D'Aiello, M Chessa, G Santoro, A Donti, E Mariucci, C Marrone, G Annoni, G Gaio, M Rebonato, E Piccinelli, M Cheli, R Formigari, G Butera
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引用次数: 0

Abstract

Background: Self-expandable valves may have a significant impact on the feasibility of transcatheter treatments of RVOT dysfunction. Venus P valve is the first autoexpadable Valve that received CE mark in 2022. Here, we are reporting on a multicenter data collection about patients undergoing Venus P valve implantation in Italy.

Materials: Seven italian centers were included in the study. Data were collected from patients treated with a venus P valve between July 2022 and May 2024. Indication for percutaneous valve implantation were in accordance with published guidelines.

Results: During the study period, a total of 65 patients were considered eligible to percutaneous implantation of a Venus P valve. Median age at procedure was 35 years (IQR 12-63 years) median weight 63 Kg (IQR 33-103 Kg). Indication for PPVI was severe regurgitation in all subjects but one where ventricular pressure was increased because of stenosis on a homograft conduit and pulmonary arteries which needed previous bilateral stenting. Venus P valve was implanted successfully in 61/65(94 %) patients. Four procedural complications occurred(6 %): 1 artero-venous fistula, 1 pulmonary bleeding, 1 hemothorax and a pulmonary oedema. During follow up (median 13 months,1-20months), all patients experienced a significant improvement of functional class. Neither deaths or re-intervention occurred. CT Scan showed hypoattenuating leaflet thickness (HALT) in 4 patients and one of them experienced endocarditis 12 months after the procedure.

Conclusions: Our study shows that Venus P valve implantation is safe and results are stable during a short-to-medium term follow-up. Endocarditis and HALT are inducing some concern and larger studies are needed.

经皮自扩张肺动脉瓣植入术:来自意大利儿科心脏病学会(SICPED)静脉- p瓣膜注册中心的实际经验。
背景:自膨胀瓣膜可能对经导管治疗RVOT功能障碍的可行性有重要影响。Venus P阀是第一个在2022年获得CE标志的自动膨胀阀。在这里,我们报告了意大利接受金星P瓣植入术患者的多中心数据收集。材料:七个意大利中心纳入研究。数据收集于2022年7月至2024年5月期间接受金星P瓣治疗的患者。经皮瓣膜植入术的适应症符合已出版的指南。结果:在研究期间,共有65例患者被认为符合经皮植入金星P瓣的条件。手术时中位年龄为35岁(IQR为12-63岁),中位体重为63公斤(IQR为33-103公斤)。PPVI的适应症是严重的反流,除了一例由于同种移植物导管和肺动脉狭窄而导致心室压力增加,这需要先前的双侧支架植入。65例患者中有61例(94%)成功植入金星P瓣。手术并发症4例(6%):动静脉瘘1例,肺出血1例,胸血1例,肺水肿1例。在随访期间(中位13个月,1-20个月),所有患者的功能分级均有显著改善。没有发生死亡或再干预。CT扫描显示4例患者小叶厚度减薄(HALT),其中1例患者术后12个月出现心内膜炎。结论:我们的研究表明,在中短期随访中,金星P瓣植入术是安全的,结果稳定。心内膜炎和HALT引起了一些关注,需要更大规模的研究。
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来源期刊
International journal of cardiology. Congenital heart disease
International journal of cardiology. Congenital heart disease Cardiology and Cardiovascular Medicine
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