Aortic Valve replAcement in eLective Patients From aOrtic Valve multiceNter Registry

Study Overview
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Brief Summary
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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
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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.

Official Title
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Surgical and Transcatheter Aortic Valve Replacement for Aortic Stenosis in Low-risk Elective Patients. Data From Multicenter Registry.

Conditions
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Aortic Valve Stenosis

Intervention / Treatment
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* Procedure: Surgical Aortic Valve Replacement
* Procedure: Transcutenous Aortic Valve Implantation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age >18 years Elective procedure Aortic valve replacement with means of TAVI or SAVR Exclusion Criteria: Concomitant procedures

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 |
| --- | --- |
| Surgical Aortic Valve Replacement<br>Surgically replaced aortic valve. Patients with planned concomitant bypass grafting other valvular interventions, arrhythmia ablation, or left atrial appendage occlusion were excluded. Any tissue or mechanical valve implantation in an aortic position with sternotomy or minimal access was included. | Procedure: Surgical Aortic Valve Replacement<br>* Cardiac surgery under cardio-pulmonary bypass, via sternotomy or minimally invasive approach with the replacement of native valve with a biological or mechanic prosthesis.<br>|
| Transcutaneous Aortic Valve Implantation<br>Transfemoral aortic valve implantation. Patients with a planned concomitant percutaneous coronary intervention were excluded | Procedure: Transcutenous Aortic Valve Implantation<br>* Transfemoral implantation of aortic bioprosthesis with one of the devices available in Poland.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| all-cause death | death resulting from cardiovascular and non-cardiovascular causes | up to 6 years |