Aortic Valve replAcement in eLective Patients From aOrtic Valve multiceNter Registry (AVALON)

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

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.

Study Overview

• Status: Completed
• Conditions: Aortic Valve Stenosis
• Intervention / Treatment: Procedure: Surgical Aortic Valve Replacement; Procedure: Transcutenous Aortic Valve Implantation

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.

• Study Type: Observational
• Enrollment (Actual): 2393

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients scheduled for elective aortic valve replacement (AVR) for severe AS, regardless of the aortic regurgitation (AR) severity.

Description

Inclusion Criteria:

• Age >18 years
• Elective procedure
• Aortic valve replacement with means of TAVI or SAVR

Exclusion Criteria:

• Concomitant procedures

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Surgical Aortic Valve Replacement; 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; Cardiac surgery under cardio-pulmonary bypass, via sternotomy or minimally invasive approach with the replacement of native valve with a biological or mechanic prosthesis.
Transcutaneous Aortic Valve Implantation; Transfemoral aortic valve implantation. Patients with a planned concomitant percutaneous coronary intervention were excluded	Procedure: Transcutenous Aortic Valve Implantation; Transfemoral implantation of aortic bioprosthesis with one of the devices available in Poland.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Nicolaus Copernicus University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2015
• Primary Completion (Actual): June 30, 2021
• Study Completion (Actual): June 30, 2021

Study Registration Dates

• First Submitted: March 20, 2022
• First Submitted That Met QC Criteria: March 31, 2022
• First Posted (Actual): April 1, 2022

Study Record Updates

• Last Update Posted (Actual): April 1, 2022
• Last Update Submitted That Met QC Criteria: March 31, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Pathological Conditions, Anatomical; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis; Constriction, Pathologic
• Other Study ID Numbers: AVALON

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No