Nationwide Finnish Registry of Transcatheter and Surgical Aortic Valve Replacement for Aortic Valve Stenosis: FinnValve Registry
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 6,463
- 试验地点
- 1
- 主要终点
- Death
研究概览
简要总结
The FinnValve investigators planned a nationwide registry to investigate the early and late outcome of transcatheter aortic valve implantation (TAVI) compared to surgical aortic valve replacement (SAVR) in patients with aortic valve stenosis performed from 2008 to 2017 at five Finnish University Hospitals. Data will be collected in a dedicated electronic case report form.
详细描述
Rationale of the study Uncertainty regarding the potential benefits of transcatheter aortic valve implantation (TAVI) compared to surgical aortic valve replacement (SAVR) in patients with aortic valve stenosis (AS) requires well-designed studies with long-term data on the outcome of these patients. A Finnish nationwide registry would allow complementing of the knowledge gained from randomized trials by providing data on the outcome of a more inclusive patient population, within a Health Care System that reflects the actual clinical practice in Scandinavia. In fact, the internal validity attained in randomized trials is often achieved at the expense of uncertainty about generalizability, especially since the populations enrolled in such studies may differ in significant ways from those seen in practice.
The choice among different surgical aortic valve prostheses is based on solid data with 20-year follow-up, which have shown significant risk of structural valve deterioration of bioprosthesis on the second decade after implantation. However, much less is known about the structural durability of TAVI prostheses beyond 3 years of follow-up. This nationwide registry would provide data on the durability of surgical bioprostheses as well as second and third generation TAVI prostheses at 7 years . Continuous follow-up of these patients will allow monitoring of the durability of these prostheses on the long run.
Furthermore, the introduction of TAVI prompted a rapid development of minimally invasive surgical techniques and rapid deployment surgical bioprostheses in order to reduce the risk of early adverse events after SAVR. However, it is unclear whether these advances have a real clinical benefit on the early and late outcome of patients undergoing SAVR.
Patients and Methods
Patients operated on for AS at each Finnish University Hospitals from January 2008 to September 2017 will included in to this registry. The following inclusion and exclusion criteria will be considered:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who underwent transcatheter (TAVI) or surgical aortic valve replacement (SAVR) for severe aortic valve stenosis
- •Patients aged >18 years
- •Primary aortic valve procedure with a bioprosthesis for AS with or without associated regurgitation.
- •TAVI and SAVR with or without associated coronary revascularization
- •TAVI and SAVR for AS after any prior major cardiac surgery with exception of any maze procedure and/or closure of the left atrial appendage.
排除标准
- •Patients who underwent any prior SAVR or TAVI
- •Patients undergoing concomitant procedures on the mitral valve, tricuspid valve or the ascending aorta.
- •Patients operated on for aortic valve endocarditis
- •Patients operated for isolated aortic valve regurgitation.
结局指标
主要结局
Death
时间窗: From the index procedure till the end of the follow-up period (December 2017)
All-cause death
次要结局
- Vascular injury(During the index hospital stay, an average of 7 days)
- Injury of the left ventricle wall(During the index hospital stay, an average of 7 days)
- Tamponade(During the index hospital stay, an average of 7 days)
- Need of emergency cardiac surgery(During the index hospital stay, an average of 7 days)
- Atrial fibrillation(During the index hospital stay, an average of 7 days)
- Permanent pace-maker implantation(From the index procedure till the end of the follow-up period (December 2017))
- Stroke(From the index procedure till the end of the follow-up period (December 2017))
- Infection(During the index hospital stay, an average of 7 days)
- Acute kidney injury(During the index hospital stay, an average of 7 days)
- Bleeding(During the index hospital stay, an average of 7 days)
- Repeat procedure(From the index procedure till the end of the follow-up period (December 2017))
- TAVI/SAVR prosthesis migration(During the index hospital stay, an average of 7 days)
- Reoperation for bleeding(During the index hospital stay, an average of 7 days)
- Postoperative intra-aortic balloon pump(During the index hospital stay, an average of 7 days)
- Venoarterial extracorporeal oxygenation(During the index hospital stay, an average of 7 days)
- Intensive care unit stay(During the index hospital stay, an average of 7 days)
- Structural valve deterioration(From the index procedure till the end of the follow-up period (December 2017))
- Prosthesis thrombosis(From the index procedure till the end of the follow-up period (December 2017))
- Prosthesis endocarditis(From the index procedure till the end of the follow-up period (December 2017))
- Annulus rupture(During the index hospital stay, an average of 7 days)
- Myocardial infarction(From discharge after the index procedure till the end of the follow-up period (December 2017))
- Coronary revascularization(From the index procedure till the end of the follow-up period (December 2017))
- Paravalvular regurgitation(During the index hospital stay, an average of 7 days)
- Coronary artery ostium occlusion(During the index hospital stay, an average of 7 days)
- Ventricular septal perforation(During the index hospital stay, an average of 7 days)
- Mitral valve apparatus damage or dysfunction(During the index hospital stay, an average of 7 days)
研究者
Fausto Biancari
Professor
Turku University Hospital