Randomized Trial of Transcatheter Valve-in-Valve Intervention vs Redo Surgery for the Treatment of Structural Mitral Bioprosthetic Dysfunction
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Mitral Prosthetic Valve Stenosis and Regurgitation
- Sponsor
- Instituto Dante Pazzanese de Cardiologia
- Enrollment
- 150
- Locations
- 7
- Primary Endpoint
- Rate of Major cardiovascular and Cerebrovascular events
- Status
- Completed
- Last Updated
- 8 months ago
Overview
Brief Summary
Transcatheter valve-in-valve implantation has emerged as a valid alternative to redo surgery for patients with surgical bioprosthetic dysfunction. Nowadays, transcatheter, transeptal mitral valve-in-valve replacement (TsMViV) has been adopted in many centers worldwide. Some studies report low rates of periprocedural morbidity and mortality and favorable hemodynamic parameters of valve performance. However, medium and long-term data on TsMViV as compared to redo surgical mitral valve replacement (rSMVR) is not yet established. Studies of cost-effectiveness and cost-utility comparing both strategies were also not reported. In particular, late prosthesis durability and hemodynamic performance after TsMViV are largely unknown and need to be elucidated before widely indicated, especially among younger and low-risk surgical candidates with failed mitral bioprostheses.
Detailed Description
Prospective, randomized, controlled trial of transeptal, transcatheter mitral valve-in-valve versus redo surgical mitral valve replacement. After multidisciplinary, heart team discussion, patients meeting inclusion criteria will be randomized 1:1 to receive either transcatheter, transeptal mitral valve-in-valve replacement (TsMViV) with the SAPIEN 3 transcatheter heart valve (THV) or redo, mitral valve replacement with 3 commercially available surgical bioprosthetic valves. A sub-randomization in the surgical group will define which bioprosthetic valve will be used. Patients will be seen for follow-up visits at discharge, 30 days, 6 months and annually through 10 years.
Investigators
DIMYTRI ALEXANDRE DE ALVIM SIQUEIRA
Chief, Interventions in Acquired Valvular Heart Disease
Instituto Dante Pazzanese de Cardiologia
Eligibility Criteria
Inclusion Criteria
- •Age\>18 years;
- •Symptoms of heart failure NYHA class\>ll;
- •Severe mitral bioprosthetic dysfunction (stenosis, regurgitation, mixed) defined by echocardiography;
- •Heart team (including cardiac surgeon) agree on eligibility including assessment that transeptal, transcatheter mitral valve replacement (TsMVR) and redo surgical mitral valve replacement (rSMVR) are appropriate;
- •The study patient or the study patient's legal representative informed of the nature of the study, agreed to its provisions and provided written informed consent as approved by the Institutional Review Board (IRB) center;
- •The study patient agreed to comply with all required post- procedure follow-up visits including annual visits through 10 years and analysis close date visits, which was conducted as a phone follow-up;
- •Heart team agreed (a priori) on treatment strategy for concomitant coronary disease (if present);
- •Patient agreed to undergo redo surgical mitral valve replacement (rSMVR) if randomized to control treatment.
Exclusion Criteria
- •Heart Team assessment of inoperability (including examining cardiac surgeon);
- •Hostile chest;
- •Evidence of an acute myocardial infarction \< 1 month (30 days) before the intended treatment \[defined as: Q wave Ml, or non-Q wave Ml with total creatine kinase (CK), creatine kinase MB isoform (CK-MB) and/or cardiac troponin elevations (WHO definition)\];
- •Concomitant severe valvular disease (aortic, tricuspid or pulmonic) requiring surgical intervention;
- •Mitral mechanical prosthesis or mitral valve rings;
- •Preexisting mechanical or bioprosthetic valve in other position with dysfunction;
- •Complex coronary artery disease: unprotected left main coronary artery, Syntax score \> 32 (in the absence of prior revascularization);
- •Any therapeutic invasive cardiac procedure resulting in a permanent implant that is performed within 30 days of the index procedure (unless part of planned strategy for treatment of concomitant coronary artery disease). Implantation of a permanent pacemaker is not an exclusion criteria;
- •Patients with planned concomitant surgical or transcatheter ablation for atrial fibrillation;
- •Leukopenia (WBC \< 3000 cell/mL), acute anemia (Hgb\< 9 g/dL), thrombocytopenia (Pht\< 50,000 cell/mL);
Outcomes
Primary Outcomes
Rate of Major cardiovascular and Cerebrovascular events
Time Frame: 12 months
All-cause death; Cardiovascular death; Stroke
Secondary Outcomes
- Rate of Procedure-related complications(30 days)
- Rate of Rehospitalization(12 months)
- Rate of Prosthetic Thrombosis(3 and 12 months)
- Rate of Structural Valve dysfunction (as assessed by transthoracic echocardiography)(10 years)
- Rate of Bioprosthetic Valve Failure (as assessed by clinical outcomes and echocardiographic evaluations)(10 years)