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NCT Number: NCT03239509

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

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)

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Key information

Conditions

Surgery Cardiovascular Diseases Heart Diseases Heart Valve Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Prosthesis Failure Survival, Prosthesis Valve Heart Disease

Age range

50 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Regional Universitario de Malaga, Málaga, Spain

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

bioprosthesis implantation between 2000-2015

Procedure

Implantation of a bioprosthesis in aortic position with cardiopulmonary bypass

mechanical prosthesis implantation between 2000-2015

Procedure

Implantation of a mechanical prosthesis in aortic position with cardiopulmonary bypass

Primary outcomes

  1. Number of participants alive

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

    Survival since surgery

  2. Late postoperative endpoint of 4 MACE complications

    Time frame: 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

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

Secondary outcomes

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

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

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

  2. Cardiopulmonary bypass time in minutes needed in the surgery

    Time frame: day 1 after surgery

    Cardiopulmonary bypass time in minutes needed in the surgery

  3. Cross-clamp ischemic heart time in minutes needed in the surgery

    Time frame: day 1 after surgery

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

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

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

    transfusional needs in long term follow up

  5. Structural valve deterioration (SVD) in bioprosthesis

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

    increase in 20 mmHg in transaortic gradient since discharge echocardiography, any aortic regurgitation greater than moderate or need for bioprosthesis reoperation

  6. Cardiovascular cause of rehospitalization

    Time frame: f first documented Cardiovascular cause of rehospitalization assessed up to 17 years

    any cardiovascular cause which need rehospitalization after surgery

  7. Postsurgery Mean transprosthetic gradients in mmHg

    Time frame: From date of surgery until the date of Hospital Discharge, documented first Mean transprosthetic gradient in mmHg assessed by echocardiography after surgery.

    measured by the first echocardiography after surgery

  8. Late Mean transprosthetic gradients in mmHg

    Time frame: From date of surgery until the date of last documented echocardiography assessed up to 17 years

    measured by the last echocardiography in follow up

  9. Any prosthetic infective endocarditis

    Time frame: From date of surgery until the date of first documented prosthetic infective endocarditis, assessed up to 17 years

    definite diagnosis of early or late infective endocarditis

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

15 Years Outcomes Following Bioprosthetic vs Mechanical Isolated Aortic Valve Replacement for Aortic Stenosis in Patients Aged 50 to 65 Years in South Spain. The Andalousian Aortic Valve Multicentric Study (ANDALVALVE)

Acronym: ANDALVALVE

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Aug 4, 2017
Registry last updated
Jul 26, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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