与手术相比，使用70-100mm长部分覆盖的Optimus-CVS®XXL支架经导管矫正静脉窦缺损的安全性和有效性：OPTIVENOSUS研究设计

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.2025.05.003

Clément Batteux , Vlad Ciobotaru , Raymond N. Haddad , Ali Houeijeh , Clément Karsenty , Ivan Bouzguenda , Régine Roussin , Nicolas Combes , Mohamed Bakloul , Philippe Aldebert , Fanny Dion , Bruno Lefort , Gilles Bosser , Damien Bonnet , Alain Fraisse , Hélène Bouvaist , Jurgen Hoerer , Pamela Moceri , François Godart , Marien Lenoir , Sébastien Hascoët

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引用次数: 0

摘要

背景：经导管矫正静脉窦缺损是一种微创的心脏直视手术。目的：评价70-100mm长部分覆盖球囊可扩张的Optimus-CVS®XXL支架（AndraTec, Koblenz, Germany）用于静脉窦缺损修复的安全性和有效性，并与手术干预进行比较。方法：OPTIVENOSUS是一项法国全国性的多中心前瞻性比较队列研究，研究对象是有静脉窦缺损矫正指征的患者（2023年5月至2031年2月）。该研究包括两部分，全面转变患者分配到导管组。第一部分将招募30名被多学科团队认为不适合手术的成年患者（年龄在100 - 18岁），他们将接受导管矫正的可行性评估，包括虚拟模拟和三维打印台架测试。第2部分将增加30名具有良好解剖结构的成年患者，直接考虑支架治疗，而三维打印台架测试将保留给复杂的病例。手术患者（年龄≥12岁）将在整个研究期间连续入组，无入组上限。所有患者将接受长达5年的标准化随访。结果：主要终点是6个月的安全性和有效性的综合测量，由轻微或无残留分流和无主要不良事件（死亡或手术转换）定义。如果没有发现显著差异，疗效（舒张末期右心室容积减少）和安全性（无再干预、卒中、起搏器植入或严重心律失常）将采用分层分析进一步评估。结论：OPTIVENOSUS研究评估了Optimus-CVS®XXL支架与手术（NCT05865119）相比经导管窦静脉缺损矫正的安全性和有效性。

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Safety and efficacy of transcatheter correction of sinus venosus defect using 70–100 mm-long partially covered Optimus-CVS® XXL stents compared with surgery: The OPTIVENOSUS study design

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Safety and efficacy of transcatheter correction of sinus venosus defect using 70–100 mm-long partially covered Optimus-CVS® XXL stents compared with surgery: The OPTIVENOSUS study design

Background

Transcatheter correction of sinus venosus defect provides a less invasive alternative to open-heart surgery.

Aim

To evaluate the safety and efficacy of 70–100 mm-long partially covered balloon-expandable Optimus-CVS® XXL stents (AndraTec, Koblenz, Germany), specifically designed for sinus venosus defect repair, compared with surgical intervention.

Methods

OPTIVENOSUS is a French nationwide multicentre prospective comparative cohort study of patients with indications for sinus venosus defect correction (May 2023 to February 2031). The study comprises two parts, with a comprehensive shift in patient assignment to the catheter group. Part 1 will enrol 30 adult patients (aged > 18 years) deemed ineligible for surgery by a multidisciplinary team, who will undergo feasibility assessment for catheter correction, including virtual simulations and three-dimensional-printed bench testing. Part 2 will add 30 adult patients with favourable anatomy, considered directly for stent therapy, whereas three-dimensional-printed bench testing will be reserved for complex cases. Surgical patients (aged ≥ 12 years) will be enrolled continuously throughout the study, with no enrolment cap. All patients will receive standardized follow-up for up to 5 years.

Results

The primary endpoint is a 6-month composite measure of safety and efficacy, defined by trivial or absent residual shunt and the absence of major adverse events (death or surgical conversion). If no significant difference is found, efficacy (end-diastolic right ventricular volume reduction) and safety (absence of reintervention, stroke, pacemaker implantation or severe arrhythmia) will be further evaluated using hierarchical analysis.

Conclusion

The OPTIVENOSUS study evaluates the safety and effectiveness of transcatheter sinus venosus defect correction with Optimus-CVS® XXL stents versus surgery (NCT05865119).

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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.