Randomized Trial of Transcatheter Valve-in-Valve vs Redo Surgery for Bioprosthetic Mitral Dysfunction
Randomized Trial of Transcatheter Valve-in-Valve vs Redo Surgery for Bioprosthetic Mitral Dysfunction
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.
Inclusion Criteria:

 -  Age<70 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);

 -  Hypertrophic cardiomyopathy with or without obstruction (HOCM);

 -  Severe ventricular dysfunction with left-ventricular ejection fraction (LVEF) < 20%;

 -  Echocardiographic evidence of intracardiac mass, thrombus or vegetation;

 -  Active upper gastrointestinal (GI) bleeding within 3 months (90 days) prior to
 procedure;

 -  A known contraindication or hypersensitivity to all anticoagulation regimens, or
 inability to be anticoagulated for the study procedure;

 -  Clinically (by neurologist) or neuroimaging confirmed stroke or transient ischemic
 attack (TIA) within 3 months (90 days) of the procedure;

 -  Renal insufficiency (creatinine > 3.0 mg/dL) and/or renal replacement therapy at the
 time of screening;

 -  Estimated life expectancy < 24 months (730 days) due to carcinomas, chronic liver
 disease, chronic renal disease or chronic end stage pulmonary disease;

 -  Currently participating in an investigational drug or another device study;

 -  Active bacterial endocarditis within 6 months (180 days) of procedure;

 -  Patient refuses redo mitral valve replacement surgery.