Mitral Valve Regurgitation, Structural Heart Disease
Conditions
Brief summary
A significant number of patients with severe mitral and tricuspid valve disease have been previously treated with either valve repair with annuloplasty rings or valve replacement with bioprosthetic/mechanical valves. Over time, these bioprosthetic valves and rings may fail resulting in recurrence of the valvular disease. The technical aspects of a re-do operation are complex and these patients are often times at high risk for repeat open surgery. The emergence of transcatheter options may provide a safer and less invasive alternative to open surgery. Majority of the data currently exist for Western cohorts with limited longer-term outcomes. Data on this therapy is particularly lacking in the Asia-Pacific region, especially important in the light of known differences in body habitus and size.
Interventions
None listed
Sponsors
National Heart Centre Singapore
Prince of Wales Hospital, Shatin, Hong Kong
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥ 21 2. Had at least one documented Mitral valve-in-valve/valve-in-ring procedure done during the period of 1 Jan 2023 to current date. (Retrospective) OR Planned to undergo a Mitral valve-in-valve/valve-in-ring procedure. (Prospective) OR Had at least one documented Tricuspid valve-in-valve/valve-in-ring procedure done during the period of 1 Jan 2023 to current date. (Retrospective) OR Planned to undergo a Tricuspid valve-in-valve/valve-in-ring procedure. (Prospective)
Exclusion criteria
1. Active endocarditis 2. Any other conditions which investigator deems unsuitable for participation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| All-cause mortality | 10 years | Rate of All-cause mortality in enrolled patients |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Procedural technical success rate | Immediately after operation | Rate of Procedural technical success (defined per Mitral Valve Academic Research Consortium (MVARC) criteria at exit from the hybrid suite as patient alive with successful access, delivery, and retrieval of the device delivery system, successful deployment and correct position of the first intended device, and freedom from emergency surgery or reintervention associated with the device or access procedure) |
| Procedural complication rate | Periprocedural | Rate of Procedural technical success (defined per Mitral Valve Academic Research Consortium (MVARC) criteria at exit from the hybrid suite as patient alive with successful access, delivery, and retrieval of the device delivery system, successful deployment and correct position of the first intended device, and freedom from emergency surgery or reintervention associated with the device or access procedure) |
| Major adverse cardiovascular events rate | 10 years | Rate of Major adverse cardiovascular events in enrolled patients |
| New York Heart Association (NYHA) classification | 10 years | NYHA class of enrolled patients |
| Echocardiographic result | 10 years | Rate of Major adverse cardiovascular events in enrolled patients |
Countries
Hong Kong
Contacts
Primary ContactChak Yu Kent So
Outcome results
None listed