Transcatheter Versus Standard Surgical Mitral Valve Operation for Secondary Mitral Regurgitation

Official title

Transcatheter Edge to Edge Mitral Valve Repair Versus Standard Surgical Mitral Valve Operation for Secondadry Mitral Regurgitation

Overview

The mechanical intervention is treating secondary mitral regurgitation (SMR) which may be performed using the standard open surgical approach or transcatheter edge to edge repair (TEER). The key question of this study is to establish the difference in left ventricular reverse remodeling after adjustment for death, as assessed by means of the left ventricular end-systolic dimension(LVESD), all-cause and cause-specific (cardiac vs noncardiac) mortality in patients who received the TEER vs the standard surgical procedure for SMR.

Detailed description

The target population enrolled in the registry includes patients with moderate to severe secondary mitral regurgitation due to cardiomyopathy of either ischemic or non-ischemic etiology who have had TEER or standard surgical procedure of their mitral valves with or without CABG. Individuals were adequately treated per applicable standards, including for coronary artery disease, LV dysfunction, mitral regurgitation, and heart failure. Patients enrolled in the studies were NYHA functional class II, III, or outpatient NYHA IV.

Four groups of patients are included in the study. Patients who were managed with TEER, patients who received mitral valve replacement and recipients of mitral valve repair who underwent surgery with the use of restrictive annuloplasty alone or combined with subvalvular repair. Four groups of patients are included in the study. Patients who were managed with TEER, patients who received mitral valve replacement, and those who received mitral valve repair who underwent surgery with the use of restrictive annuloplasty alone or combined with subvalvular repair

Interventions

• Device Trancatheter Edge to Edge Repair
  TEER is performed by apposing the edges of the anterior and posterior leaflet (edge-to-edge) of prolapsed MV. The patient may be under conscious sedation or general anesthesia, depending on hospital standard practice. The procedure is performed through femoral venous access and the inter-atrial septum is crossed using standard techniques. Trans-septal puncture allows MitraClip Steerable Guide Catheter (Guide) to advance so that the guide is positioned over the mitral valve. The MitraClip deliver
• Procedure Mitral Valve Replacement
  Mitral valve replacement is performed using mechanical or biological prosthesis while preserving the subvalvular apparatus to avoid dilation of the left ventricle over time.
• Procedure Restrictive Mitral Annuloplastie
  Mitral valve repair consists of a restrictive mitral annuloplasty (RMA) using a prosthetic ring
• Procedure Restrictive Mitral Annuloplastie/Subvalvular Repair
  RMA may be associated with the use of a subvalvular repair (SR). The SR permits the approximation or the relocation of papillary muscles which is displaced by post infarction scar formation.

Primary outcome measures

• Left Ventricular Reverse Remodelling [Time frame: 5 years]

Secondary outcome measures (10)

• Overall Mortality [Time frame: 5 years]
• Cardiac Death [Time frame: 5 years]
• Major Adverse Cardiac or Cerebrovascular Events (MACCE) [Time frame: 5 years]
• Echocardiographic Parameter Changes (LVEF) [Time frame: 5 years]
• Echocardiographic Parameter Changes (recurrence) [Time frame: 5 years]
• Echocardiographic Parameter Changes (LVEDD) [Time frame: 5 years]
• Echocardiographic Parameter Changes (Mitral Valve tenting area and height) [Time frame: 5 years]
• Echocardiographic Parameter Changes (Pulmonary artery systolic pressure) [Time frame: 5 years]
• Echocardiographic Parameter Changes (anteroposterior mitral valve annular diameter) [Time frame: 5 years]
• Echocardiographic Parameter Changes ( interpapillary distance) [Time frame: 5 years]

Eligibility criteria

Inclusion criteria

• Adult
• Ischemic NoIschemic cardiomyopathy
• EROA> 0,2 cm2 or Regurgitant Volume > 30 ml (ESC guidelines).
• EROA ≥ 0.4 cm2 with tethering (ACC/AHA)
• MR Grade 3/4
• Eligible for TEE, surgical repair and replacement of mitral valve
• Coronary artery disease with or without the need for coronary revascularization
• Average value LVEDD 62 mm LVEF 42%

Exclusion criteria

• Pediatric
• Any echocardiographic evidence of structural (chordal or leaflet) mitral-valve disease
• ruptured papillary

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

France · 2 centers

• Francesco Nappi — Saint-Denis
• Centre Cardiologique Du Nord — Saint-Denis

Publications

• Nappi F, Singh SSA, Salsano A, Spadaccio C, Shingu Y, Wakasa S, Fiore A. Study protocol for an international registry observational study evaluating clinical outcomes of transcatheter versus standard surgical mitral valve operation for secondary mitral regurgitation: the TEERMISO study. BMJ Open. 2025 Jan 8;15(1):e086888. doi: 10.1136/bmjopen-2024-086888. PMID 39779262
• Nappi F, Avtaar Singh SS, Salsano A, Nassif A, Shingu Y, Wakasa S, Fiore A, Spadaccio C, El-Dean Z. A Protocol Investigation Comparing Transcatheter Repair with the Standard Surgical Procedure for Secondary Mitral Regurgitation. J Clin Med. 2024 Dec 18;13(24):7742. doi: 10.3390/jcm13247742. PMID 39768667

Identifiers

NCT: NCT05090540 · CN-21-23 · CN-21-23

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗