Influence of Original Native Mitral Valve Lesion (Stenosis or Steno-insufficiency vs. Insufficiency) on Post-implant Structural Bioprosthetic Degeneration After Mitral Valve Replacement
Trial Snapshot
- Phase
- Not Applicable
- Status
- Enrolling By Invitation
- Enrollment
- 3,500
- Locations
- 1
- Primary Endpoint
- Prosthesis degeneration due to physiological deterioration
Study Overview
Brief Summary
It aims to perform a retrospective, multi-center, observational study. All patients undergoing elective mitral valve replacement from 2012 to 2021 who met the inclusion criteria for the study (described in the dedicated section) will be enrolled in the study. These patients will be followed-up as part of routine care, and information about the clinical status, NYHA functional class, possible rehospitalization, possible cardiovascular events and postoperative echocardiography will be available for analysis. Once consent is given, and if required by local governance, pre-, intra- and post-operative data will be collected in a dedicated, structured, database.
Detailed Description
It aims to perform a retrospective, multi-center, observational study. All patients undergoing elective mitral valve replacement from 2012 to 2021 who met the inclusion criteria for the study (described in the dedicated section) will be enrolled in the study. These patients will be followed-up as part of routine care, and information about the clinical status, NYHA functional class, possible rehospitalization, possible cardiovascular events and postoperative echocardiography will be available for analysis. Once consent is given, and if required by local governance, pre-, intra- and post-operative data will be collected in a dedicated, structured, database.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Other
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age ≥ 18 years;
- •Patients who underwent isolated mitral valve replacement for stenosis or regurgitation
- •Signed informed consent, inclusive of release of medical information where required by local governance.
Exclusion Criteria
- •- Aortic and mitral valve replacement associated with surgery of ascending aorta/aortic root;
- •Aortic and mitral valve replacement associated with other cardiac valve surgery (apart from arrythmia-related ablation or procedures);
- •Previous cardiac surgery of any kind;
- •Surgery for acute endocarditis
- •Surgery for Type A aortic dissection
- •Participation in another clinical trial that could interfere with the endpoints of this study.
- •Pregnant or breastfeeding at time of screening.
Outcomes
Primary Outcomes
Prosthesis degeneration due to physiological deterioration
Time Frame: 20 years
Echocardiographic paramters will be used. Quantitative and qualitative measurments swill be implied. The measurment used are listed below: 1. Morphological Assessment (2D / 3D TTE \& TEE) Leaflet morphology: thickness, mobility, calcification, pannus, tears, perforations. Bioprosthetic ring/annulus: dehiscence, rocking motion, paravalvular defects. Presence of thrombus, pannus, or vegetation. Structural valve deterioration (SVD) features: leaflet thickening, restricted opening, abnormal motion. 2. Hemodynamic Assessment (Doppler Echocardiography) Mitral inflow pattern (continuous-wave Doppler across prosthesis): Peak velocity (m/s) Mean transprosthetic gradient (mmHg) - heart-rate dependent Pressure half-time (PHT, ms) - limited use in prosthetic valves, but can suggest stenosis Effective orifice area (EOA) (via continuity equation or PHT-derived, cautiously interpreted). Doppler Velocity Index (DVI) = LVOT VTI / Prosthetic MV VTI (helps detect obstruction independent of fl
Secondary Outcomes
- Long term survival(20 years)
Investigators
Roberto Lorusso
Prof. MD PhD
Maastricht University Medical Center