Surgical and Transcatheter Aortic Valve Replacement for Aortic Stenosis in Low-risk Elective Patients. Data From Multicenter Registry.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Aortic Valve Stenosis
- Sponsor
- Nicolaus Copernicus University
- Enrollment
- 2393
- Primary Endpoint
- all-cause death
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
Multicenter registry data analysis of aortic valve stenosis patients that underwent elective, isolated transcutaneous aortic valve implantation (TAVI) or surgical aortic valve replacement between 2015 and 2019. In TAVI group only transfemoral access was considered.
Detailed Description
A retrospective analysis of the Multicenter Aortic Valve Registry patients operated between 2015 and 2019 in the three departments of cardiac surgery in Poland: the Medical University of Silesia in Katowice, Medical University in Gdańsk, and Poznań, University of Medical Science. Baseline clinical, procedural, and outcome data at follow-up were entered into prespecified electronic case report forms. Follow-up status was validated by personal contact or access to Polish National Health Fund. Patients with planned concomitant intervention on coronary arteries (by bypass grafting or percutaneous intervention), other valvular interventions, arrhythmia ablation, or left atrial appendage occlusion were excluded too. In TAVI group only femoral access was considered. For SAVR any tissue or mechanical valve implantation in an aortic position with sternotomy or minimal access was included.
Investigators
Mariusz Kowalewski
PhD, M.D.
Nicolaus Copernicus University
Eligibility Criteria
Inclusion Criteria
- •Age \>18 years
- •Elective procedure
- •Aortic valve replacement with means of TAVI or SAVR
Exclusion Criteria
- •Concomitant procedures
Outcomes
Primary Outcomes
all-cause death
Time Frame: up to 6 years
death resulting from cardiovascular and non-cardiovascular causes