Dataset Information

Percutaneous treatment of mitral regurgitation with MitraClip device.

ABSTRACT: The percutaneous edge-to-edge repair of mitral regurgitation with a MitraClip device has been recently approved in Europe. The results of the randomized EVEREST II study showed a favourable safety profile of the technique. However, the efficacy in terms of regurgitation reduction in a population with predominantly degenerative mitral disease was inferior as compared to the results of conventional open heart surgery. Nevertheless, up to 50% of symptomatic heart failure patients with severe mainly functional mitral regurgitation are not treated surgically because of very high procedural risk. The registry data suggest that the minimally invasive and generally well-tolerated MitraClip procedure reduces symptoms and need for recurrent hospitalization and improves left ventricular function in inoperable subjects. The ongoing randomized clinical trials with clinical endpoints will further define the current role of percutaneous edge-to-edge repair in heart failure patients with mitral regurgitation.

SUBMITTER: Pregowski J

PROVIDER: S-EPMC3927113 | biostudies-literature | 2013

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Percutaneous treatment of mitral regurgitation with MitraClip device.

Pregowski Jerzy J Witkowski Adam A

Postepy w kardiologii interwencyjnej = Advances in interventional cardiology 20131118 4

The percutaneous edge-to-edge repair of mitral regurgitation with a MitraClip device has been recently approved in Europe. The results of the randomized EVEREST II study showed a favourable safety profile of the technique. However, the efficacy in terms of regurgitation reduction in a population with predominantly degenerative mitral disease was inferior as compared to the results of conventional open heart surgery. Nevertheless, up to 50% of symptomatic heart failure patients with severe mainly ...[more]

PMID: 24570757

Similar Datasets

Project description:BackgroundFunctional mitral regurgitation (FMR) is a bad prognosis condition despite optimal medical treatment. Nowadays there is an open debate about the surgical versus percutaneous treatment. The main objective of this study is to evaluate the mid-term follow up clinical outcomes of patients with FMR treated with MitraClip® system, according to their left ventricular ejection fraction (LVEF).MethodsData was obtained from two experienced centers in transcatheter mitral valve repair (TMVR). All consecutive cases of severe FMR undergoing TMVR in both centers with the same inclusion criteria were included prospectively in this study and followed-up. Periodical follow-ups with clinical and echocardiographic evaluation were scheduled from the baseline procedure, at 3 months and then yearly.ResultsFrom October 2015 to October 2019, a total of 119 patients with FMR at 2 centers in Spain underwent TMVR with the MitraClip® procedure and were included in this study. The mean age was 73.8±8.9 years old and 32 patients (26.9%) were female. A 39.5% of cases [47] had a LVEF ≤30% (group 1) and 60.5% (72 cases) had a LVEF >30% (group 2). There was a similar distribution in cardiovascular risk factors, age and other diseases. All MitraClip® implantations were elective and procedural success was achieved in 110 patients (92.4%) with a similar distribution between the groups. There were no differences in procedural time and the number of implanted clips. The median follow-up was 22.6 months (IQR, 11.43-34.98 months). The primary combined endpoint occurred in the 41.6% of the global cohort, 57.5% in group 1 and 30.99% in group 2 (P=0.036). LVEF was associated to the main event in the multivariate analysis (HR 2.09, 95% CI: 1.12-3.89; P=0.02).ConclusionsThe MitraClip edge-to-edge technique is a safe and effective procedure for the treatment of FMR. In this study, patients with LVEF >30% treated with Mitraclip presented better clinical cardiovascular outcomes than those with a LVEF ≤30%. Regardless clinical outcomes, at the end of the follow-up, there was a sustained reduction in MR grades and an important improvement in NYHA functional class.

Project description:Background The current standard of care for the treatment of patients with primary mitral regurgitation (MR) is surgical mitral valve repair. Transcatheter edge-to-edge repair with the MitraClip device provides a less invasive treatment option for patients with both primary and secondary MR. Worldwide, >150 000 patients have been treated with the MitraClip device. However, in the United States, MitraClip is approved for use only in primary patients with MR who are at high or prohibitive risk for mitral valve surgery. The REPAIR MR (Percutaneous MitraClip Device or Surgical Mitral Valve Repair in Patients With Primary Mitral Regurgitation Who Are Candidates for Surgery) trial is designed to compare early and late outcomes associated with transcatheter edge-to-edge repair with the MitraClip and surgical repair of primary MR in older or moderate surgical risk patients. Methods and Results The REPAIR MR trial is a prospective, randomized, parallel-controlled, open-label multicenter, noninferiority trial for the treatment of severe primary MR (verified by an independent echocardiographic core laboratory). Patients with severe MR and indications for surgery because of symptoms (New York Heart Association class II-IV), or without symptoms with left ventricular ejection fraction ≤60%, pulmonary artery systolic pressure >50 mm Hg, or left ventricular end-systolic diameter ≥40 mm are eligible for the trial provided they meet the moderate surgical risk criteria as follows: (1) ≥75 years of age, or (2) if <75 years of age, then the subject has a Society of Thoracic Surgeons Predicted Risk Of Mortality score of ≥2% for mitral repair (or Society of Thoracic Surgeons replacement score of ≥4%), or the presence of a comorbidity that may introduce a surgery-specific risk. The local surgeon must determine that the mitral valve can be surgically repaired. Additionally, an independent eligibility committee will confirm that the MR can be reduced to mild or less with both the MitraClip and surgical mitral valve repair with a high degree of certainty. A total of 500 eligible subjects will be randomized in a 1:1 ratio to receive the MitraClip device or to undergo surgical mitral valve repair (control group). There are 2 co-primary end points for the trial, both of which will be evaluated at 2 years. Each subject will be followed for 10 years after enrollment. The study has received approval from both the Food and Drug Administration and the Centers for Medicare and Medicaid Services, and enrolled its first subject in July 2020. Conclusions The REPAIR MR trial will determine the safety and effectiveness of transcatheter edge-to-edge repair with the MitraClip in patients with primary MR who are at moderate surgical risk and are candidates for surgical MV repair. The trial will generate contemporary comparative clinical evidence for the MitraClip device and surgical MV repair. Registration https://clinicaltrials.gov/ct2/show/NCT04198870; NCT04198870.

Dataset Information

Percutaneous treatment of mitral regurgitation with MitraClip device.

Publications

Percutaneous treatment of mitral regurgitation with MitraClip device.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets