One-Year Outcomes After MitraClip for Functional Mitral Regurgitation.

MedStar author(s):
Citation: Circulation. 139(1):37-47, 2019 Jan 02.PMID: 30586701Institution: MedStar Heart & Vascular InstituteForm of publication: Journal ArticleMedline article type(s): Journal ArticleSubject headings: *Cardiac Catheterization/is [Instrumentation] | *Heart Valve Prosthesis | *Heart Valve Prosthesis Implantation/is [Instrumentation] | *Mitral Valve Insufficiency/su [Surgery] | *Mitral Valve/su [Surgery] | Aged | Aged, 80 and over | Cardiac Catheterization/ae [Adverse Effects] | Cardiac Catheterization/mo [Mortality] | Echocardiography, Transesophageal | Female | Heart Valve Prosthesis Implantation/ae [Adverse Effects] | Heart Valve Prosthesis Implantation/mo [Mortality] | Hemodynamics | Humans | Male | Middle Aged | Mitral Valve Insufficiency/dg [Diagnostic Imaging] | Mitral Valve Insufficiency/mo [Mortality] | Mitral Valve Insufficiency/pp [Physiopathology] | Mitral Valve/dg [Diagnostic Imaging] | Mitral Valve/pp [Physiopathology] | Postoperative Complications/et [Etiology] | Prospective Studies | Prosthesis Design | Recovery of Function | Registries | Risk Assessment | Risk Factors | Severity of Illness Index | Time Factors | Treatment OutcomeYear: 2019Local holdings: Available online from MWHC library: 1950 - present, Available in print through MWHC library: 1999 - 2006ISSN:
  • 0009-7322
Name of journal: CirculationAbstract: BACKGROUND: Secondary mitral regurgitation (SMR) occurs in the absence of organic mitral valve disease and may develop as the left ventricle dilates or remodels or as a result of leaflet tethering with impaired coaptation, most commonly from apical and lateral distraction of the subvalvular apparatus, with late annular dilatation. The optimal therapy for SMR is unclear. This study sought to evaluate the 1-year adjudicated outcomes of all patients with SMR undergoing the MitraClip procedure in the EVEREST II (Endovascular Valve Edge-to-Edge Repair Study) Investigational Device Exemption program, which is comprised of the randomized clinical trial, the prospective High-Risk Registry, and the REALISM Continued Access Registry (Multicenter Study of the MitraClip System).CLINICAL TRIAL REGISTRATION: https://www.clinicaltrials.gov . Unique identifiers: NCT00209274, NCT01940120, and NCT01931956.CONCLUSIONS: Transcatheter mitral valve repair with the MitraClip in patients with secondary MR is associated with acceptable safety, reduction of MR severity, symptom improvement, and positive ventricular remodeling.METHODS: Patients with 3+/4+ SMR enrolled in EVEREST II were stratified by non-high surgical risk (non-HR) and high surgical risk (HR) status (defined as Society of Thoracic Surgeons risk of mortality >=12% or predefined risk factors). Clinical, echocardiographic, and functional outcomes at 1 year were evaluated.RESULTS: A total of 616 patients (482 HR, 134 non-HR; mean age, 73.3+/-10.5 years; Society of Thoracic Surgeons risk, 10.2+/- 6.9%) with SMR underwent the MitraClip procedure. At baseline, 80.5% of patients were in New York Heart Association class III/IV. Major adverse events at 30 days included death (3.6%), stroke (2.3%), and renal failure (1.5%). At discharge, 88.8% had MR <=2+. At 1 year, there were 139 deaths, and the Kaplan-Meier estimate of freedom from mortality was 76.8%. The majority of surviving patients (84.7%) remained with MR <=2+ and New York Heart Association class I/II (83.0%). Kaplan-Meier survival at 1 year was 74.1% in HR patients and 86.4% in non-HR patients ( P=0.0175). At 1 year, both groups achieved comparable MR reduction (MR <=2+, 84.0% versus 87.0%) and improvement in left ventricular end-diastolic volume (-8.0 mL versus -12.7 mL), whereas New York Heart Association class I/II was found in 80.1% versus 91.8% ( P=0.008) of HR and non-HR patients, respectively. In HR patients, the annualized rate of heart failure hospitalizations decreased from 0.68 to 0.46 in the 12 months before to 12 months after the procedure ( P<0.0001).All authors: Ailawadi G, Crosson L, Ellis J, EVEREST II Investigators, Fan F, Feldman T, Foster E, Glower DD, Grayburn PA, Kar S, Kron IL, Lim DS, Mack MJ, Pearson PJ, Qasim A, Trento A, Wang A, Weissman NJFiscal year: FY2019Digital Object Identifier: Date added to catalog: 2019-01-18
Holdings
Item type Current library Collection Call number Status Date due Barcode
Journal Article MedStar Authors Catalog Article 30586701 Available 30586701

Available online from MWHC library: 1950 - present, Available in print through MWHC library: 1999 - 2006

BACKGROUND: Secondary mitral regurgitation (SMR) occurs in the absence of organic mitral valve disease and may develop as the left ventricle dilates or remodels or as a result of leaflet tethering with impaired coaptation, most commonly from apical and lateral distraction of the subvalvular apparatus, with late annular dilatation. The optimal therapy for SMR is unclear. This study sought to evaluate the 1-year adjudicated outcomes of all patients with SMR undergoing the MitraClip procedure in the EVEREST II (Endovascular Valve Edge-to-Edge Repair Study) Investigational Device Exemption program, which is comprised of the randomized clinical trial, the prospective High-Risk Registry, and the REALISM Continued Access Registry (Multicenter Study of the MitraClip System).

CLINICAL TRIAL REGISTRATION: https://www.clinicaltrials.gov . Unique identifiers: NCT00209274, NCT01940120, and NCT01931956.

CONCLUSIONS: Transcatheter mitral valve repair with the MitraClip in patients with secondary MR is associated with acceptable safety, reduction of MR severity, symptom improvement, and positive ventricular remodeling.

METHODS: Patients with 3+/4+ SMR enrolled in EVEREST II were stratified by non-high surgical risk (non-HR) and high surgical risk (HR) status (defined as Society of Thoracic Surgeons risk of mortality >=12% or predefined risk factors). Clinical, echocardiographic, and functional outcomes at 1 year were evaluated.

RESULTS: A total of 616 patients (482 HR, 134 non-HR; mean age, 73.3+/-10.5 years; Society of Thoracic Surgeons risk, 10.2+/- 6.9%) with SMR underwent the MitraClip procedure. At baseline, 80.5% of patients were in New York Heart Association class III/IV. Major adverse events at 30 days included death (3.6%), stroke (2.3%), and renal failure (1.5%). At discharge, 88.8% had MR <=2+. At 1 year, there were 139 deaths, and the Kaplan-Meier estimate of freedom from mortality was 76.8%. The majority of surviving patients (84.7%) remained with MR <=2+ and New York Heart Association class I/II (83.0%). Kaplan-Meier survival at 1 year was 74.1% in HR patients and 86.4% in non-HR patients ( P=0.0175). At 1 year, both groups achieved comparable MR reduction (MR <=2+, 84.0% versus 87.0%) and improvement in left ventricular end-diastolic volume (-8.0 mL versus -12.7 mL), whereas New York Heart Association class I/II was found in 80.1% versus 91.8% ( P=0.008) of HR and non-HR patients, respectively. In HR patients, the annualized rate of heart failure hospitalizations decreased from 0.68 to 0.46 in the 12 months before to 12 months after the procedure ( P<0.0001).

English

Powered by Koha