Mitral Prosthetic Valve Stenosis and Regurgitation
Conditions
Keywords
Mitral Prosthetic valve dysfunction
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, acute, medium and long-term data on TsMViV as compared to redo surgical mitral valve replacement (rSMVR) is not yet established. 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 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, 3 months and annually through 10 years.
Interventions
PROCEDURETranscatheter Valve-in-Valve Intervention
Transcatheter mitral valve-in-valve implantation with SAPIEN 3
PROCEDURERedo Mitral valve surgery
Transcatheter Valve-in-Valve Intervention
Sponsors
Instituto Dante Pazzanese de Cardiologia
Edwards Lifesciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
No minimum to 80 Years
Healthy volunteers
No
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 severe 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Combined Major cardiovascular and Cerebrovascular events | 12 months | Death from any cause or Disabling Stroke |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Procedure-related complications | 30 days | * Death from any cause; * Disabling stroke * Major vascular complications; * Life-threatening, extensive or severe bleeding; * New-onset atrial fibrillation; * Acute renal failure (AKIN) stage 2 or 3; * Cardiovascular mortality; * Reoperation from any cause |
| Rate of Rehospitalization | 12 months | Rehospitalization from all-causes and cardiovascular causes at 12 months |
| Rate of Prosthetic Thrombosis | 3 and 12 months | Prosthetic thrombosis at 3- and 12 months (as assessed by transesophageal echocardiography and multi-slice tomography). |
| Rate of Structural Valve Dysfunction (as assessed by transthoracic echocardiography) | 10 years | Structural valve dysfunction assessed annually, up to 10-year follow-up. |
| Rate of Bioprosthetic Valve Failure (as assessed by clinical outcomes and echocardiographic evaluations) | 10 years | Bioprosthetic valve failure assessed annually, up to 10-year follow-up. |
| Change in Health Status | 3 and 12 months | New York Heart Association (NYHA) class and Quality-of-life measures (EuroQol 5D5L) |
Countries
Brazil
Contacts
PRINCIPAL_INVESTIGATORDimytri A Siqueira, MD, PhD
Instituto Dante Pazzanese de Cardiologia
Outcome results
None listed