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

Surgery Clinical Trial

— ANDALVALVE  

Official 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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03239509
• Other study ID #: ANDALVALVE STUDY
• Status: Completed
• Start date: January 2017
• Est. completion date: April 2018

Study information

• Verified date: January 2018
• Source: Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1200
• Est. completion date: April 2018
• Est. primary completion date: April 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Heart Diseases
• Heart Valve Diseases
• Prosthesis Failure
• Surgery
• Survival, Prosthesis
• Valve Heart Disease

Intervention

Procedure:
• bioprosthesis implantation between 2000-2015
Implantation of a bioprosthesis in aortic position with cardiopulmonary bypass
• mechanical prosthesis implantation between 2000-2015
Implantation of a mechanical prosthesis in aortic position with cardiopulmonary bypass

Locations

Country	Name	City	State
Spain	Hospital Universitario Puerta Del Mar	Cadiz
Spain	Hospital Universitario Reina Sofia	Cordoba
Spain	Hospital Universitario Virgen de Las Nieves	Granada
Spain	Hospital Regional Universitario de Malaga	Malaga	Málaga
Spain	Hospital Universitario Virgen de La Victoria	Malaga
Spain	Hospital Universitario Virgen Del Rocio	Sevilla
Spain	Hospital Universitario Virgen Macarena	Sevilla

Sponsors (1)

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

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants alive	Survival since surgery	From date of surgery until the date of death from any cause, assessed up to 17 years
Primary	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	Total in-Hospital and Intensive Care Unit stay (in days)	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
Secondary	Cardiopulmonary bypass time in minutes needed in the surgery	Cardiopulmonary bypass time in minutes needed in the surgery	day 1 after surgery
Secondary	Cross-clamp ischemic heart time in minutes needed in the surgery	Cross-clamp ischemic heart time in minutes needed in the surgery	day 1 after surgery
Secondary	Transfusional requirements (number of red packed cells, fresh frozen plasma and platelets)	transfusional needs in long term follow up	rom date of surgery until the date of first documented transfusional requirement assessed up to 17 years
Secondary	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	From date of surgery until the date of first documented SVD assessed up to 17 years
Secondary	Cardiovascular cause of rehospitalization	any cardiovascular cause which need rehospitalization after surgery	f first documented Cardiovascular cause of rehospitalization assessed up to 17 years
Secondary	Postsurgery Mean transprosthetic gradients in mmHg	measured by the first echocardiography after surgery	From date of surgery until the date of Hospital Discharge, documented first Mean transprosthetic gradient in mmHg assessed by echocardiography after surgery.
Secondary	Late Mean transprosthetic gradients in mmHg	measured by the last echocardiography in follow up	From date of surgery until the date of last documented echocardiography assessed up to 17 years
Secondary	Any prosthetic infective endocarditis	definite diagnosis of early or late infective endocarditis	From date of surgery until the date of first documented prosthetic infective endocarditis, assessed up to 17 years