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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
150
Transcatheter mitral valve-in-valve implantation with SAPIEN 3
Transcatheter Valve-in-Valve Intervention
Hospital de Messejana Dr. Carlos Alberto Studart Gomes
Fortaleza, Ceará, Brazil
Hospital Ana Nery
Salvador, Estado de Bahia, Brazil
Instituto Nacional de Cardiologia
Rio de Janeiro, Rio de Janeiro, Brazil
Instituto de Cardiologia de Santa Catarina
São José, Santa Catarina, Brazil
Instituto Dante Pazzanese de Cardiologia
São Paulo, São Paulo, Brazil
UNIFESP
São Paulo, São Paulo, Brazil
Instituto do Coração (INCOR)
São Paulo, São Paulo, Brazil
Rate of Major cardiovascular and Cerebrovascular events
All-cause death; Cardiovascular death; Stroke
Time frame: 12 months
Rate of Procedure-related complications
Major vascular complications; * Bleeding and transfusions; * Atrial fibrillation; * Acute renal failure; * Left-ventricular outflow obstruction; * Reoperation
Time frame: 30 days
Rate of Rehospitalization
Rehospitalization at 12 months
Time frame: 12 months
Rate of Prosthetic Thrombosis
Prosthetic thrombosis at 3- and 12 months (as assessed by transesophageal echocardiography and multi-slice tomography).
Time frame: 3 and 12 months
Rate of Structural Valve dysfunction (as assessed by transthoracic echocardiography)
Structural valve dysfunction assessed annually, up to 10-year follow-up.
Time frame: 10 years
Rate of Bioprosthetic Valve Failure (as assessed by clinical outcomes and echocardiographic evaluations)
Bioprosthetic valve failure assessed annually, up to 10-year follow-up.
Time frame: 10 years
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