An observational study in Surgery, Survival, Prosthesis and Valve Heart Disease, sponsored by Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud. Completed at 7 sites in Spain. Open to participants aged 50 Years to 65 Years. Per ClinicalTrials.gov, last updated 2018-07-26.
Sponsored by Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud · Observational
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)
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.
3,639 studies on the registry are indexed under Heart Diseases; 461 are open to participants now.
This study's enrollment of 1,200 is above the median of 294 across 1,241 observational studies indexed under Heart Diseases.
Browse Heart Diseases studies →Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud is the lead sponsor of 71 studies on the registry; 23 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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
Exclusion Criteria:
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
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
Implantation of a bioprosthesis in aortic position with cardiopulmonary bypass
Implantation of a mechanical prosthesis in aortic position with cardiopulmonary bypass
Number of participants alive
Survival since surgery
Time frame: 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)
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
Total in-Hospital and Intensive Care Unit stay (in days)
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
Cardiopulmonary bypass time in minutes needed in the surgery
Cardiopulmonary bypass time in minutes needed in the surgery
Time frame: day 1 after surgery
Cross-clamp ischemic heart time in minutes needed in the surgery
Cross-clamp ischemic heart time in minutes needed in the surgery
Time frame: day 1 after surgery
Transfusional requirements (number of red packed cells, fresh frozen plasma and platelets)
transfusional needs in long term follow up
Time frame: rom date of surgery until the date of first documented transfusional requirement assessed up to 17 years
Structural valve deterioration (SVD) in bioprosthesis
increase in 20 mmHg in transaortic gradient since discharge echocardiography, any aortic regurgitation greater than moderate or need for bioprosthesis reoperation
Time frame: From date of surgery until the date of first documented SVD assessed up to 17 years
Cardiovascular cause of rehospitalization
any cardiovascular cause which need rehospitalization after surgery
Time frame: f first documented Cardiovascular cause of rehospitalization assessed up to 17 years
Postsurgery Mean transprosthetic gradients in mmHg
measured by the first echocardiography after surgery
Time frame: From date of surgery until the date of Hospital Discharge, documented first Mean transprosthetic gradient in mmHg assessed by echocardiography after surgery.
Late Mean transprosthetic gradients in mmHg
measured by the last echocardiography in follow up
Time frame: From date of surgery until the date of last documented echocardiography assessed up to 17 years
Any prosthetic infective endocarditis
definite diagnosis of early or late infective endocarditis
Time frame: From date of surgery until the date of first documented prosthetic infective endocarditis, assessed up to 17 years
Plan to share: No
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Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud