Key result
Two MitraClip devices were more frequently implanted in patients with thicker anterior leaflets and yielded similar 12-month mitral regurgitation reduction as one device.
Why the study?
What are the echocardiographic predictors of requiring two versus one MitraClip devices, and does the number of devices affect long-term mitral regurgitation reduction?
RCT (n=233)
What are the echocardiographic predictors of requiring two versus one MitraClip devices, and does the number of devices affect long-term mitral regurgitation reduction?
Thicker anterior mitral leaflets and more severe baseline mitral regurgitation predict the need for two MitraClip devices, but long-term MR reduction is similar whether one or two devices are used.
Answers are grounded in this paper and cite their sources.
Supports tailoring MitraClip number to anterior leaflet thickness; leaves open whether randomized data confirm similar long-term efficacy.
OBJECTIVES: To describe predictors of the number of MitraClip devices implanted during percutaneous repair of mitral regurgitation (MR), and the long-term reduction in MR. BACKGROUND: In the EVEREST trials, one or two MitraClip devices were implanted to reduce MR, as needed. METHODS: Preprocedural transthoracic echocardiograms (TTE) and transesophageal echocardiograms (TEE) of 233 subjects who received 1 or 2 MitraClip devices in the EVEREST II Randomized Trial and High-Risk Study were analyzed. TEEs were reviewed for etiology of MR and pathoanatomic features of the valve, valve apparatus, and the regurgitant jet. Follow-up MR was assessed by TTE postprocedure and at 12 months. RESULTS: Ninety-seven subjects (42%) had two MitraClip devices implanted. Subjects with quantitatively more severe MR were more likely to receive two devices [mean regurgitant volume (RV) 45.9 ± 21.9 vs. 36.3 ± 18.5 mL, P <0.001]. On multivariate analysis, increased anterior leaflet thickness (OR 1.7 per mm, P = 0.007) and greater baseline RV (OR 1.21 per 10 mL, P = 0.01) were associated with increased odds of implanting two devices. The frequency of 2+ MR or less at discharge was similar regardless of the number of devices implanted. After propensity matching, patients had quantitatively similar MR at twelve-month follow-up, regardless of whether one or two MitraClip devices were implanted (P = 0.6). CONCLUSIONS: Subjects with thicker anterior mitral leaflets and more severe MR were more likely to receive two MitraClip devices. Immediate and long-term reduction in MR was similar regardless of the number of devices implanted at the time of the procedure.
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Armstrong et al. (2012) conducted an RCT in mitral regurgitation (n=233). Two MitraClip devices vs. One MitraClip device was evaluated on Quantitative mitral regurgitation at 12-month follow-up (p=0.6). Two MitraClip devices were more frequently implanted in patients with thicker anterior leaflets and yielded similar 12-month mitral regurgitation reduction as one device.
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