Topic: Interventional Cardiology
Presenter: James Hermiller
Author(s): Creighton Don
Summary
Patients with moderately severe to severe mitral regurgitation (MR) not due to structural valve defects who had percutaneous repair with the MitraClip had reduced regurgitation severity and left ventricular size at 12 month follow-up.
Background
This study evaluated the clinical and echocardiographic outcomes of patients from the EVEREST I pilot study and the “roll-in” phase of the ongoing EVEREST II study who have functional MR (MR not due to a structural mitral valve defect). Previous reports from the EVEREST I pilot study evaluated both those with functional MR and those with structurally abnormal valve leaflets.
Study Design
This is a non-controlled pilot study of 23 surgical candidates with functional MR who had percutaneous placement of the MitraClip device. Patients had moderate to severe MR and left ventricular dysfunction (ejection fraction ≤60% but >30%). Echocardiographic assessments of MR severity and left ventricular dimensions were obtained at baseline, 30 days, and 12 months. Clinical follow-up for major adverse events and need for mitral valve surgery was conducted over the 12 month period.
Results and Conclusions
At 30 days, 12 of the 19 who had the MitraClip placed had a reduction in MR grade to 1+, while 7 patients had grade 1-2+ MR. Four patients did not have any reduction in their MR, and 3 of these underwent subsequent surgical repair. The fourth patient had a cardiac perforation from the transseptal puncture that required emergency surgery. At the time of this presentation, only 12 of 19 patients who received the MitraClip had reached the one-year follow-up period. Among these 12 patients, average left ventricular dimensions decreased, MR remained moderate, and patients had a 1 class reduction in New York Heart Association (NYHA) symptoms. Event-free survival was 79%. Overall, there were 2 deaths, 3 patients who underwent open surgical repair, and one who had a mitral valve prosthetic placed.
Perspective
This non-controlled study is the first report of procedural and clinical outcomes in patients with functional MR treated with a MitraClip percutaneous device. While the authors report improvements in echocardiographic parameters and NYHA class among those with 12-month follow-up, this is a non-controlled study, and follow-up at one year is still ongoing (only 63% of patients who received the device had completed follow-up at the time of this ACC.08 report). Nearly 20% of patients required surgical repair, 3 of them early due to no improvement in MR. The authors did not report if there was specification for maximal medical management at baseline. Comparisons to surgical approaches for mitral valve repair are yet to be reported from the ongoing randomized phase 2 EVEREST II study. While there is some concern regarding alteration of normal valve tissue due to the MitraClip, which might limit options for subsequent surgical repair, 3 of 4 patients in this study who underwent surgery following device placement were able to undergo successful repair. The authors cite other data suggesting the MitraClip did reduce the chance for surgical repair in the first year.
Patients with moderately severe to severe mitral regurgitation (MR) not due to structural valve defects who had percutaneous repair with the MitraClip had reduced regurgitation severity and left ventricular size at 12 month follow-up.
Background
This study evaluated the clinical and echocardiographic outcomes of patients from the EVEREST I pilot study and the “roll-in” phase of the ongoing EVEREST II study who have functional MR (MR not due to a structural mitral valve defect). Previous reports from the EVEREST I pilot study evaluated both those with functional MR and those with structurally abnormal valve leaflets.
Study Design
This is a non-controlled pilot study of 23 surgical candidates with functional MR who had percutaneous placement of the MitraClip device. Patients had moderate to severe MR and left ventricular dysfunction (ejection fraction ≤60% but >30%). Echocardiographic assessments of MR severity and left ventricular dimensions were obtained at baseline, 30 days, and 12 months. Clinical follow-up for major adverse events and need for mitral valve surgery was conducted over the 12 month period.
Results and Conclusions
At 30 days, 12 of the 19 who had the MitraClip placed had a reduction in MR grade to 1+, while 7 patients had grade 1-2+ MR. Four patients did not have any reduction in their MR, and 3 of these underwent subsequent surgical repair. The fourth patient had a cardiac perforation from the transseptal puncture that required emergency surgery. At the time of this presentation, only 12 of 19 patients who received the MitraClip had reached the one-year follow-up period. Among these 12 patients, average left ventricular dimensions decreased, MR remained moderate, and patients had a 1 class reduction in New York Heart Association (NYHA) symptoms. Event-free survival was 79%. Overall, there were 2 deaths, 3 patients who underwent open surgical repair, and one who had a mitral valve prosthetic placed.
Perspective
This non-controlled study is the first report of procedural and clinical outcomes in patients with functional MR treated with a MitraClip percutaneous device. While the authors report improvements in echocardiographic parameters and NYHA class among those with 12-month follow-up, this is a non-controlled study, and follow-up at one year is still ongoing (only 63% of patients who received the device had completed follow-up at the time of this ACC.08 report). Nearly 20% of patients required surgical repair, 3 of them early due to no improvement in MR. The authors did not report if there was specification for maximal medical management at baseline. Comparisons to surgical approaches for mitral valve repair are yet to be reported from the ongoing randomized phase 2 EVEREST II study. While there is some concern regarding alteration of normal valve tissue due to the MitraClip, which might limit options for subsequent surgical repair, 3 of 4 patients in this study who underwent surgery following device placement were able to undergo successful repair. The authors cite other data suggesting the MitraClip did reduce the chance for surgical repair in the first year.
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