Venus-P in Large Right Ventricular Outflow Tracts: Procedural and Early Safety Profile

IF 2.2 3区医学 Q2 CARDIAC & CARDIOVASCULAR SYSTEMS

Archives of Cardiovascular Diseases Pub Date : 2025-09-01 DOI:10.1016/j.acvd.2025.06.044

Raymond Haddad , Grégoire Albenque , Cohen Sarah , Jelena Radojevic , Estíbaliz Valdeolmillos , Lisa Guirgis , Fournier Emmanuelle , Belli Emre , Jerome Petit , Magalie Ladouceur , clement Batteux , Sebastien Hascoet

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引用次数: 0

Abstract

Introduction

Self-expandable valves (SEVs) are emerging complements to balloon-expandable valves for transcatheter pulmonary valve replacement (TPVR) in large dysfunctional right ventricular outflow tracts (RVOTs), though their safety and efficacy remain underexplored. We aim to describe our experience with Venus-P SEVs in TPVR.

Method

Baseline and early follow-up data were prospectively analyzed for 52 patients who underwent TPVR with Venus-P SEVs (Jan 2022–Dec 2024).

Results

Cohort: 53.8% male; median age 43 years (IQR: 30.6–52.0); median weight 68 kg (IQR: 58.3–85.2). Tetralogy of Fallot was present in 63.5%. RVOTs were native in 30.8% and patched in 69.2%, all with severe pulmonary regurgitation. Multiplanar CT analysis classified RVOT anatomy as green in 17 (32.7%), Amber 1 in 17 (32.7%), Amber 2 in 12 (23.1%), and red in 6 (11.5%) cases. The median valve diameter was 36 mm (IQR: 32–36); valve length was 25 mm in 86.5%. All implantations were successful. Postoperative median RVOT velocity was 1.6 m/s (IQR: 1.1–1.8). Moderate procedural or vascular access AEs occurred in 4 patients. Non-sustained VT occurred in 5 patients (9.6%), all with negative preoperative EPS. One symptomatic case received IV amiodarone followed by beta-blockers; another symptomatic and two asymptomatic patients were treated with oral amiodarone; one was already on beta-blockers. Antiarrhythmic therapy was discontinued within 6 weeks in 4/5 patients, with no recurrence on follow-up Holter monitoring. Six patients (11.5%) had ventricular premature beats: five Grade II (one symptomatic) and one Grade IV (asymptomatic). Beta-blockers were initiated in four, and two were already on treatment. Hypoattenuated leaflet thickening (HALT) was detected in 7 patients on follow-up CT scans; 4 had impaired valve mobility without any echocardiographic gradient increase. One asymptomatic patient had the proximal stent part of the valve protruding at the level of the left PA without bleeding.

Conclusion

Venus-P SEVs are effective for TPVR but are associated with a high rate of early postoperative arrhythmic adverse events and HALT, both appearing to have no immediate clinical impact.

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大右心室流出道静脉- p：程序和早期安全性分析

自膨胀瓣膜（sev）是经导管肺瓣膜置换术（TPVR）中球囊膨胀瓣膜的新兴补充，尽管其安全性和有效性仍未得到充分研究。我们的目标是描述我们在TPVR中使用Venus-P sev的经验。方法前瞻性分析2022年1月至2024年12月期间52例接受TPVR合并Venus-P sev的患者的基线和早期随访数据。结果性别：男性53.8%；中位年龄43岁（IQR: 30.6-52.0）；中位体重68公斤（IQR: 58.3-85.2）。63.5%为法洛四联症。自发性rvot占30.8%，修补性rvot占69.2%，均伴有严重的肺反流。多平面CT分析RVOT解剖为绿色17例（32.7%），琥珀1型17例（32.7%），琥珀2型12例（23.1%），红色6例（11.5%）。中位瓣径36 mm (IQR: 32-36)；86.5%的阀门长度为25mm。所有移植均成功。术后中位RVOT速度为1.6 m/s （IQR: 1.1 ~ 1.8）。4例患者发生中度程序性或血管通路不良事件。5例（9.6%）患者发生非持续性室速，术前EPS均为阴性。1例有症状的患者静脉注射胺碘酮，随后服用β受体阻滞剂；1例有症状患者和2例无症状患者口服胺碘酮治疗；其中一人已经在服用-受体阻滞剂。4/5患者在6周内停止抗心律失常治疗，随访动态心电图监测无复发。6例患者（11.5%）室性早搏：5例II级（1例有症状）和1例IV级（无症状）。其中4人开始使用β受体阻滞剂，2人已经在接受治疗。随访CT扫描发现7例患者小叶减薄增厚（HALT）；4例瓣膜活动性受损，超声心动图梯度无升高。一名无症状的患者瓣膜近端支架部分在左PA水平突出，未出血。结论venus - p sev对TPVR有效，但与术后早期心律失常不良事件和HALT发生率高相关，两者似乎没有立即的临床影响。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Archives of Cardiovascular Diseases 医学-心血管系统

CiteScore

4.40

自引率

6.70%

发文量

审稿时长

34 days

期刊介绍： The Journal publishes original peer-reviewed clinical and research articles, epidemiological studies, new methodological clinical approaches, review articles and editorials. Topics covered include coronary artery and valve diseases, interventional and pediatric cardiology, cardiovascular surgery, cardiomyopathy and heart failure, arrhythmias and stimulation, cardiovascular imaging, vascular medicine and hypertension, epidemiology and risk factors, and large multicenter studies. Archives of Cardiovascular Diseases also publishes abstracts of papers presented at the annual sessions of the Journées Européennes de la Société Française de Cardiologie and the guidelines edited by the French Society of Cardiology.