Key result
MitraClip yields ~66% freedom from death, surgery, or MR >2+ at 12 months post-successful repair.
Why the study?
Percutaneous mitral valve repair based on surgical double-orifice repair was developed using the MitraClip device, requiring evaluation of its feasibility, safety, and efficacy.
Does percutaneous mitral repair with the MitraClip system improve freedom from death, mitral valve surgery, or MR >2+ in patients with 3 to 4+ mitral regurgitation?
Does percutaneous mitral repair with the MitraClip system improve freedom from death, mitral valve surgery, or MR >2+ in patients with 3 to 4+ mitral regurgitation?
Percutaneous mitral repair with the MitraClip system is feasible and safe, achieving acute MR reduction and sustained freedom from death, surgery, or recurrent MR in a substantial proportion of patients.
Captured external expert commentary on this paper, strongest first. Original sources are linked where available.
“Current procedures target leaflet modification; various percutaneous annuloplasty approaches are under investigation, but most are in early stages of development. Treatment of MR with percutaneous coronary sinus annuloplasty is intuitively attractive, but there are technical limitations.”
“Successful clip placement occurred in 90% of patients; two clips were required in 32%. All echocardiograms were evaluated by a core laboratory before patient enrollment. This was the first trial of an MR device therapy to utilize both an echo core lab and also prospective qualification of patients.”
“The Achilles heel of MitraClip is that it cannot completely eliminate the regurgitation. In another words, some leakage is likely to continue even after the clip is placed. For those with severe MR who can withstand surgery, surgical repair or replacement is still the preferred treatment.”
May support percutaneous edge-to-edge repair in selected MR patients; leaves open durability and efficacy versus surgery in randomized trials.
OBJECTIVES: We undertook a prospective multicenter single-arm study to evaluate the feasibility, safety, and efficacy of the MitraClip system (Evalve Inc., Menlo Park, California). BACKGROUND: Mitral valve repair for mitral regurgitation (MR) has been performed by the use of a surgically created double orifice. Percutaneous repair based on this surgical approach has been developed by use of the Evalve MitraClip device to secure the mitral leaflets. METHODS: Patients with 3 to 4+ MR were selected in accordance with the American Heart Association/American College of Cardiology guidelines for intervention and a core echocardiographic laboratory. RESULTS: A total of 107 patients were treated. Ten (9%) had a major adverse event, including 1 nonprocedural death. Freedom from clip embolization was 100%. Partial clip detachment occurred in 10 (9%) patients. Overall, 79 of 107 (74%) patients achieved acute procedural success, and 51 (64%) were discharged with MR of < or =1+. Thirty-two patients (30%) had mitral valve surgery during the 3.2 years after clip procedures. When repair was planned, 84% (21 of 25) were successful. Thus, surgical options were preserved. A total of 50 of 76 (66%) successfully treated patients were free from death, mitral valve surgery, or MR >2+ at 12 months (primary efficacy end point). Kaplan-Meier freedom from death was 95.9%, 94.0%, and 90.1%, and Kaplan-Meier freedom from surgery was 88.5%, 83.2%, and 76.3% at 1, 2, and 3 years, respectively. The 23 patients with functional MR had similar acute results and durability. CONCLUSIONS: Percutaneous repair with the MitraClip system can be accomplished with low rates of morbidity and mortality and with acute MR reduction to < 2+ in the majority of patients, and with sustained freedom from death, surgery, or recurrent MR in a substantial proportion (EVEREST I; NCT00209339. EVEREST II; NCT00209274).
No takes yet. Share an insight, caveat, or question.
Feldman et al. (2009) studied Mitral regurgitation (n=107). MitraClip system was evaluated on Freedom from death, mitral valve surgery, or MR >2+ at 12 months. Percutaneous mitral repair with the MitraClip system achieved acute procedural success in 74% of patients, with 66% of successfully treated patients free from death, surgery, or MR >2+ at 12 months.
Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context: