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MitraClip After Failed Surgical Mitral Valve Repair-An International Multicenter Study.

ABSTRACT: Background Recurrence of mitral regurgitation (MR) after surgical mitral valve repair (SMVR) varies and may require reoperation. Redo mitral valve surgery can be technically challenging and is associated with increased risk of mortality and morbidity. We aimed to assess the feasibility and safety of MitraClip as a treatment strategy after failed SMVR and identify procedure modifications to overcome technical challenges. Methods and Results This international multicenter observational retrospective study collected information for all patients from 16 high-volume hospitals who were treated with MitraClip after failed SMVR from October 29, 2009, until August 1, 2017. Data were anonymously collected. Technical and device success were recorded per modified Mitral Valve Academic Research Consortium criteria. Overall, 104 consecutive patients were included. Median Society of Thoracic Surgeons score was 4.5% and median age was 73 years. At baseline, the majority of patients (82%) were in New York Heart Association class ≥III and MR was moderate or higher in 86% of patients. The cause of MR pre-SMVR was degenerative in 50%, functional in 35%, mixed in 8%, and missing/unknown in 8% of patients. The median time between SMVR and MitraClip was 5.3 (1.9-9.7) years. Technical and device success were 90% and 89%, respectively. Additional/modified imaging was applied in 21% of cases. An MR reduction of ≥1 grade was achieved in 94% of patients and residual MR was moderate or less in 90% of patients. In-hospital all-cause mortality was 2%, and 86% of patients were in New York Heart Association class ≤II. Conclusions MitraClip is a safe and less invasive treatment option for patients with recurrent MR after failed SMVR. Additional/modified imaging may help overcome technical challenges during leaflet grasping.

SUBMITTER: Rahhab Z

PROVIDER: S-EPMC8174343 | biostudies-literature |

REPOSITORIES: biostudies-literature

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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.

Project description:ObjectiveIn the current study, we present our mid-term experience with modified edge-to-edge repair technique through a transventricular and transaortic route in patients requiring left ventricular remodeling or aortic root/valve surgery.MethodsFrom December 2006 through April 2015, 49 high-risk patients (median age: 69 years; median European System for Cardiac Operative Risk Evaluation II: 11.4 [6.54-14.9]) underwent transventricular (N = 7; 14%) or transaortic (N = 42; 86%) edge-to-edge mitral valve repair. The Alfieri stitch technique was modified by MitraClip type overcorrection and solid buttressing behind the posterior leaflet. Indication was grade 2+ functional mitral valve incompetence and dilated or impaired left ventricle (N = 25; 52%), or grade 3+ (N = 22; 45%) and grade 4+ functional mitral valve regurgitation (N = 2; 4%). Surgical procedure included aortic root surgery in 65%, aortic valve replacement with surgical revascularization in 18%, and Dor-plasty with surgical revascularization in 14%.ResultsIntraoperative mortality and early neurologic complications were absent in our series. Ninety-day mortality was 12.2% (N = 6). Median clinical and echocardiographic follow-up-time was 50.7 (21.5-44.1) and 39.2 (33.7-44.1) months, respectively. Median postoperative transvalvular gradient was low (2.72 [1.91-4.22] mm Hg) and did not increase during follow-up (P = .268), although peak gradient rose slightly from 7.41 to 8.12 mm Hg (P = .071). The actuarial reoperation free rate at the index valve was 96.8%.ConclusionsTransventricular or transaortic Alfieri mitral repair mimicking mitral clip overcorrection represents a quick and safe technique in the setting of high-risk patients undergoing left ventricular remodeling or aortic root/valve surgery and can be performed with low risk of creating mitral stenosis at midterm. The technique is straightforward, with reliable identification of the center of the valve leaflets being the limitation.

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MitraClip After Failed Surgical Mitral Valve Repair-An International Multicenter Study.

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