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

NCT03239509 | Completed

• 1 other identifier: ANDALVALVE STUDY
• Study Type: observational
• Target: 1,200
• Locations: 1 country
• Sites: 7

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)

Conditions

Surgery; Survival, Prosthesis; Valve Heart Disease

Keywords

long-term survival; bioprosthesis; complications; anticoagulation; mechanichal prosthesis

Outcome Measures

Primary Outcomes (2)

• Number of participants alive

  Survival since surgery

  From date of surgery until the date of death from any cause, assessed up to 17 years

• Late postoperative endpoint of 4 MACE complications

  All cause Mortality, major bleeding, cerebrovascular or transient ischemic accident, and need of any prosthesis reintervention (Major Adverse Cardiovascular Events, MACE)

  From date of surgery until the date of first documented MACE (see description) or date of death from any cause, whichever came first, assessed up to 17 years

Secondary Outcomes (9)

• Total in-Hospital and Intensive Care Unit stay (in days)

  From date of surgery to discharge of the unit and Hospital, up to 6 months

• Cardiopulmonary bypass time in minutes needed in the surgery

  day 1 after surgery

• Cross-clamp ischemic heart time in minutes needed in the surgery

  day 1 after surgery

• Transfusional requirements (number of red packed cells, fresh frozen plasma and platelets)

  rom date of surgery until the date of first documented transfusional requirement assessed up to 17 years

• Structural valve deterioration (SVD) in bioprosthesis

  From date of surgery until the date of first documented SVD assessed up to 17 years

Study Arms (2)

Bioprosthesis

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

Procedure: bioprosthesis implantation between 2000-2015

Mechanical prosthesis

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

Procedure: mechanical prosthesis implantation between 2000-2015

Interventions

bioprosthesis implantation between 2000-2015 PROCEDURE

Implantation of a bioprosthesis in aortic position with cardiopulmonary bypass

Bioprosthesis

mechanical prosthesis implantation between 2000-2015 PROCEDURE

Implantation of a mechanical prosthesis in aortic position with cardiopulmonary bypass

Mechanical prosthesis

Eligibility Criteria

• Age: 50 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients aged 50-65 years who underwent isolated aortic valve replacement (AVR) for severe aortic stenosis from years 2000-2015 both inclusive, with bioprosthesis or mechanical prosthesis

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (7)

Hospital Regional Universitario de Malaga

Málaga, Málaga, Spain

Location

Hospital Universitario Puerta Del Mar

Cadiz, Spain

Location

Hospital Universitario Reina Sofia

Córdoba, Spain

Location

Hospital Universitario Virgen de Las Nieves

Granada, Spain

Location

Hospital Universitario Virgen de La Victoria

Málaga, Spain

Location

Hospital Universitario Virgen Del Rocio

Seville, Spain

Location

Hospital Universitario Virgen Macarena

Seville, Spain

Location

Related Publications (1)

• 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.

  PMID: 30608571 DERIVED

MeSH Terms

Conditions

Prosthesis Failure; Heart Valve Diseases

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Heart Diseases; Cardiovascular Diseases

Study Officials

• EMILIANO A RODRIGUEZ-CAULO, MD, PhD

  FIMABIS, HOSPITAL VIRGEN DE LA VICTORIA DE MÁLAGA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2017
• First Posted: August 4, 2017
• Study Start: January 1, 2017
• Primary Completion: April 1, 2018
• Study Completion: April 1, 2018
• Last Updated: July 26, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

ES (7)