15 Years Outcomes Following Bioprosthetic vs Mechanical Aortic Valve Replacement Between 50-65 Years

NCT ID: NCT03239509

Last Updated: 2018-07-26

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-01-31
• Study Completion Date: 2018-04-30

Brief Summary

Currently there is an increase in the use of bioprosthesis worldwide (> 70% according to national data of the Spanish Society of Thoracic and Cardiovascular Surgery).

There is conflicting evidence regarding the long-term survival of patients aged 50-65 years with mechanical (M) or biological (B) aortic prostheses. General consensus of greater complications associated with the use of long-life anticoagulation in M and of reoperation in B.

Similar survival with lower MACCE complications in bioprosthesis could reconsider their choice in patients aged 50-65 years, specially in the current TAVI era.

The investigators are going to perform a multicentric retrospective observational study (Registry) about 15 year-outcomes Following Bioprosthetic vs Mechanical Isolated Aortic Valve Replacement for Aortic Stenosis in Patients Aged 50 to 65 Years in 5 Cardiovascular Surgery Centers in Andalousia (south Spain)

Detailed Description

Objectives The main objective is to analyze long-term survival (15 years) and major cardiovascular complications (MACE, (death of any cause, neurological events (TIA / stroke), any prosthesis reoperation, and major bleeding), in patients aged 50-65 years who underwent isolated aortic valve replacement (AVR) due to severe aortic stenosis . Secondary objectives were to analyze the evolution of transprosthetic gradients by echocardiography, type of INR control, and degree of significant structural degeneration in bioprostheses.

Material and Method: A retrospective analytical study of patients aged 50-65 years who underwent AVR surgery for stenosis between 2000-2015 in all centers with a Cardiovascular Surgery Dept. in Andalousia (SPAIN) as an inclusion criterion. As exclusion criteria, autonomic change of residence, need for concomitant surgery, previous cardiac interventions and endocarditis. Survival analysis and clinical data will be performed through the Diraya Health Care medical records (DAE), direct telephone contact with family and / or relatives, A crude analysis of the data and a posterior analysis by propensity score matching with the help of the Foundation for Biomedical Research of Malaga (IBIMA) with SPSS software will be carried out using a 1: 1 "nearest neighbour" matching protocol based on the Number of total bioprosthesis. A total sample of more than 1200 cases is expected, of which about 380 would be bioprostheses that would serve as a basis for the pairing. To find a 10% difference in the primary endpoint, two groups of 325 patients are required for a p = 0.05 and 80% for a bilateral contrast of two independent proportions. Sub-analysis will be performed by subgroups of age (50-59 vs. 60-65 years) and another according to the mark of the 2 prostheses of each type most used. All statistical analyzes will be two-tailed with an alpha error of 0.05 to consider statistically significant data, and will be reviewed by IBIMA biostatistics.

Conclusions: A positive result (similar survival and prosthetic durability in group B, with lower complications) could change the current indications of AVS in our environment, allowing the age of indication of bioprostheses to be reduced below 60 years.

Conditions

Surgery; Survival, Prosthesis; Valve Heart Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Bioprosthesis

All patients operated on of isolated AVR with a bioprosthesis implantation between 2000-2015 and age 50-65 years both inclusive.

bioprosthesis implantation between 2000-2015

Intervention Type: PROCEDURE

Implantation of a bioprosthesis in aortic position with cardiopulmonary bypass

Mechanical prosthesis

All patients operated on of isolated AVR with a Mechanical prosthesis implantation between 2000-2015 and age 50-65 years both inclusive.

mechanical prosthesis implantation between 2000-2015

Intervention Type: PROCEDURE

Implantation of a mechanical prosthesis in aortic position with cardiopulmonary bypass

Interventions

bioprosthesis implantation between 2000-2015

Implantation of a bioprosthesis in aortic position with cardiopulmonary bypass

Intervention Type: PROCEDURE

mechanical prosthesis implantation between 2000-2015

Implantation of a mechanical prosthesis in aortic position with cardiopulmonary bypass

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Patients aged 50-65 years who underwent isolated aortic valve replacement (AVR) for severe aortic stenosis from years 2000-2015 both inclusive

Exclusion Criteria

• Not reported Residency change (unreachable)
• Need of concomitant surgery
• Reoperations
• Infective endocarditis

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

EMILIANO A RODRIGUEZ-CAULO, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

FIMABIS, HOSPITAL VIRGEN DE LA VICTORIA DE MÁLAGA

Locations

Hospital Regional Universitario de Malaga

Málaga, Málaga, Spain

Hospital Universitario Puerta Del Mar

Cadiz, , Spain

Hospital Universitario Reina Sofia

Córdoba, , Spain

Hospital Universitario Virgen de Las Nieves

Granada, , Spain

Hospital Universitario Virgen de La Victoria

Málaga, , Spain

Hospital Universitario Virgen Del Rocio

Seville, , Spain

Hospital Universitario Virgen Macarena

Seville, , Spain

Countries

Spain

References

Rodriguez-Caulo EA, Macias D, Adsuar A, Ferreiro A, Arias-Dachary J, Parody G, Fernandez F, Daroca T, Rodriguez-Mora F, Garrido JM, Munoz-Carvajal I, Barquero JM, Valderrama JF, Melero JM. Biological or mechanical prostheses for isolated aortic valve replacement in patients aged 50-65 years: the ANDALVALVE study. Eur J Cardiothorac Surg. 2019 Jun 1;55(6):1160-1167. doi: 10.1093/ejcts/ezy459.

Reference Type: DERIVED

PMID: 30608571 (View on PubMed)

Other Identifiers

ANDALVALVE STUDY

Identifier Type: -

Identifier Source: org_study_id