Finnish Registry of Transcatheter and Surgical Aortic Valve Replacement for Aortic Valve Stenosis: FinnValve Registry

Study Overview
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Brief Summary
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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.

Detailed Description
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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: Inclusion criteria: 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. Exclusion criteria: 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. Definition criteria for baseline and operative variables as well as early and late outcomes will be according to the Valve Academic Research Consortium (VARC) 2 guidelines (Kappetein et al. Eur J Cardiothorac Surg 2012;42:S45-60). Prosthetic valve structural deterioration and failure will be reported according to the last specific guidelines on this topic (Capodanno et al. Eur J Cardiothorac Surg. 2017;52:408-417). However, because of the lack of complete echocardiographic follow-up in these patients, valve structural valve deterioration will be classified only according to the definition criteria of severe hemodynamic structural valve deterioration of these guidelines. The late events of interest are all-cause mortality, stroke, myocardial infarction, myocardial revascularization, structural deterioration, non-structural valve dysfunction, repeated procedures on the aortic valve and implantation of permanent pace-maker. Data on these late events will be collected at each participating center. These will be further checked and implemented for patients residing outside the catchment areas by interrogation of the Finnish National Health Institute for Health and Welfare database as well as Statistics Finland database. Planned studies The following is a tentatile of study projects which will be accomplished from the FinnValve registry: Late outcome of TAVI versus SAVR in intermediate risk patients Late outcome of TAVI versus SAVR in low risk patients Late outcome of TAVI and SAVR in high risk patients Futility of TAVI (3-month analysis) Mini- versus full-sternotomy SAVR Perceval sutureless bioprosthesis: 5-year outcome Late outcome of sutureless versus conventional stented bioprosthesis in isolated SAVR Late outcome of sutureless SAVR versus transfemoral TAVI in low- and intermediate risk patients Early and late outcome of TAVI versus SAVR in patients with recent acute heart failure Early and late outcome of TAVI versus SAVR in bicuspid AS Early and late outcome of TAVI versus SAVR in obese patients (BMI >29) at low- and intermediate risk Early and late outcome of isolated TAVI versus TAVI plus percutaneous coronary intervention (PCI) in patients with coronary artery disease Early and late outcome of TAVI plus PCI versus SAVR plus coornary artery bypass grafting (CABG) Prognostic impact of Syntax score on the early and late outcome after TAVI Early and late outcome of TAVI vs. SAVR in patients with prior CABG Early and late outcome of second versus third generation TAVI prostheses Early and late outcome of transfemoral versus transaortic TAVI Early and late outcome of trans-subclavian artery versus trans-aortic TAVI Early and late outcome of sutureless versus conventional stented bioprosthesis in SAVR plus CABG Early and late outcome of Trifecta versus Perimount bioprosthesis in isolated SAVR Thromboembolic events after TAVI and SAVR Early and late outcome of TAVI in nonagenarians Prognostic impact of permanent pace-maker implantation on the early and late outcome after TAVI and SAVR Prognostic impact of mild paravalvular leakage on the late outcome after SAVR Impact of preoperative atrial fibrillation on the late outcome of TAVI Impact of preoperative atrial fibrillation on the late outcome of SAVR Early and late outcome of TAVI vs. SAVR in patients aged 85 years or older Publications of results and PhD studies The results of these studies will be published in international, peer-reviewed journals in the fields of cardiology and cardiac surgery. Furthermore, data from this registry will be available for several doctoral study projects. At this stage, a proposal for PhD studies has been submitted by: Marko Virtanen, MD (Tampere University Hospital); Pasi Maaranen, MD (Tampere University Hospital) Maina Jalava, MD (Turku University Hospital); Tuomas Ahvenvaara (Oulu University Hospital); Teemu Laakso (Helsinki University Hospital). Time schedule of data collection, checking and analysis December 2017: start of data collection End of April 2018: deadline for data collection End of May 2018: data checking June 2018-December 2019: analyses and writing of the planned studies.

Official Title
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Nationwide Finnish Registry of Transcatheter and Surgical Aortic Valve Replacement for Aortic Valve Stenosis: FinnValve Registry

Conditions
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Aortic Valve Stenosis

Intervention / Treatment
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* Procedure: Aortic valve replacement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| TAVI cohort<br>Patients who underwent transcatheter aortic valve implantation for aortic valve stenosis | Procedure: Aortic valve replacement<br>* Transcatheter or surgical aortic valve replacement for severe aortic valve stenosis<br>|
| SAVR cohort<br>Patients who underwentsurgical aortic valve replacement for aortic valve stenosis | Procedure: Aortic valve replacement<br>* Transcatheter or surgical aortic valve replacement for severe aortic valve stenosis<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Death | All-cause death | From the index procedure till the end of the follow-up period (December 2017) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Atrial fibrillation | Any episode of atrial fibrillation | During the index hospital stay, an average of 7 days | 
| Permanent pace-maker implantation | Permanent pace-maker implantation | From the index procedure till the end of the follow-up period (December 2017) | 
| Stroke | Stroke | From the index procedure till the end of the follow-up period (December 2017) | 
| Infection | Deep sternal wound infection/mediastinitis, vascular access site infection, pneumonia, sepsis | During the index hospital stay, an average of 7 days | 
| Acute kidney injury | Postoperative acute kidney injury according to the Kidney Disease: Improving Global Outcomes (KDIGO) criteria | During the index hospital stay, an average of 7 days | 
| Bleeding | Minor, major, life-threatening or disabling bleeding according to the VARC 2 definition criteria | During the index hospital stay, an average of 7 days | 
| Reoperation for bleeding | Reoperation for bleeding | During the index hospital stay, an average of 7 days | 
| Postoperative intra-aortic balloon pump | Postoperative use of intra-aortic balloon pump | During the index hospital stay, an average of 7 days | 
| Venoarterial extracorporeal oxygenation | Postoperative use of venoarterial extracorporeal oxygenation | During the index hospital stay, an average of 7 days | 
| Intensive care unit stay | Length of stay in the intensive care unit | During the index hospital stay, an average of 7 days | 
| Structural valve deterioration | Mean transprosthetic gradient ≥40 mmHg Mean transprosthetic gradient ≥20 mmHg change from baseline Severe intraprosthetic regurgitation, new or worsening (>2+/4+) from baseline | From the index procedure till the end of the follow-up period (December 2017) | 
| Prosthesis thrombosis | Any thrombus attached to or near an implanted valve that occludes part of the blood flow path, interferes with valve function, or is sufficiently large to warrant treatment | From the index procedure till the end of the follow-up period (December 2017) | 
| Prosthesis endocarditis | Prosthesis endocarditis requiring medical or surgical treatment | From the index procedure till the end of the follow-up period (December 2017) | 
| Repeat procedure | Repeat procedure on the aortic valve | From the index procedure till the end of the follow-up period (December 2017) | 
| Myocardial infarction | Myocardial infarction occurring after discharge after the index procedure | From discharge after the index procedure till the end of the follow-up period (December 2017) | 
| Coronary revascularization | Coronary revascularization after discharge after the index procedure | From the index procedure till the end of the follow-up period (December 2017) | 
| Paravalvular regurgitation | Paravalvular regurgitation immediately after the index procedure | During the index hospital stay, an average of 7 days | 
| TAVI/SAVR prosthesis migration | TAVI/SAVR prosthesis migration | During the index hospital stay, an average of 7 days | 
| Annulus rupture | Rupture of the aortic annulus | During the index hospital stay, an average of 7 days | 
| Coronary artery ostium occlusion | Coronary artery ostium occlusion during the index procedure | During the index hospital stay, an average of 7 days | 
| Ventricular septal perforation | Ventricular septal perforation during the index procedure | During the index hospital stay, an average of 7 days | 
| Mitral valve apparatus damage or dysfunction | Mitral valve apparatus damage or dysfunction during the index procedure | During the index hospital stay, an average of 7 days | 
| Tamponade | Pericardial tamponade during or immediately after the index procedure | During the index hospital stay, an average of 7 days | 
| Vascular injury | Vascular injury during the index procedure | During the index hospital stay, an average of 7 days | 
| Injury of the left ventricle wall | Injury of the left ventricle wall during the index procedure | During the index hospital stay, an average of 7 days | 
| Need of emergency cardiac surgery | Need of emergency cardiac surgery | During the index hospital stay, an average of 7 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sutureless, Transcatheter aortic valve replacement, Transcatheter aortic valve implantation, TAVI, TAVR, Aortic valve replacement, Surgical aortic valve replacement