Contemporary Outcomes Following Transcatheter Edge-to-Edge Repair: 1-Year Results From the EXPAND Study.

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Citation: Jacc: Cardiovascular Interventions. 16(5):589-602, 2023 Mar 13.PMID: 36922046Institution: MedStar Health Research InstituteForm of publication: Journal ArticleMedline article type(s): Journal Article | Multicenter StudySubject headings: *Cardiomyopathies | *Heart Failure | *Heart Valve Prosthesis Implantation | *Mitral Valve Insufficiency | Cardiac Catheterization | Cardiomyopathies/co [Complications] | Heart Failure/co [Complications] | Heart Failure/dg [Diagnostic Imaging] | Heart Failure/th [Therapy] | Humans | Mitral Valve Insufficiency/dg [Diagnostic Imaging] | Mitral Valve Insufficiency/et [Etiology] | Mitral Valve Insufficiency/su [Surgery] | Mitral Valve/dg [Diagnostic Imaging] | Mitral Valve/su [Surgery] | Prospective Studies | Quality of Life | Treatment OutcomeYear: 2023Local holdings: Available online through MWHC library: 2008 - presentISSN:
  • 1936-8798
Name of journal: JACC. Cardiovascular interventionsAbstract: BACKGROUND: The third-generation MitraClip NTR/XTR transcatheter edge-to-edge repair system was introduced to assist in leaflet grasping with the longer clip arms of MitraClip XTR and to improve ease of use with the modified delivery catheter.CONCLUSIONS: The study demonstrates treatment with the third-generation system resulted in substantial reduction of MR in a contemporary real-world practice, compared with the results of earlier EVEREST and COAPT trials.(The MitraClip R EXPAND Study of the Next Generation of MitraClip R Devices [EXPAND]; NCT03502811). Copyright © 2023. Published by Elsevier Inc.METHODS: EXPAND is a prospective, multicenter, international, single-arm study that enrolled patients with primary MR and secondary MR at 57 centers. Follow-up was conducted through 12 months. Echocardiograms were analyzed by an echocardiographic core laboratories. Study outcomes included: MR severity, functional capacity measured by New York Heart Association functional class, quality of life measured by Kansas City Cardiomyopathy Questionnaire, heart failure hospitalizations, all-cause mortality.OBJECTIVES: The EXPAND study evaluated contemporary real-world outcomes in subjects with mitral regurgitation (MR) treated with the third-generation MitraClip NTR/XTR transcatheter edge-to-edge repair system.RESULTS: 1,041 patients were enrolled from April 2018 through March 2019, of which 50.5% had primary or mixed etiology. Implant success was 98.9%; 1.5 +/- 0.6 clips were implanted per subject. Significant MR reduction from baseline (>=MR 3+: 56.0%) to 30 days (<=MR 1+:88.8%) was maintained through 1 year (MR <=1+: 89.2%). A total of 84.5% and 93.0% of subjects in primary MR and secondary MR, respectively, had <=1+ MR at 1 year. Significant improvements were observed in clinical outcomes (New York Heart Association functional class I/II in 80.3%, +21.6 improvement in Kansas City Cardiomyopathy Questionnaire score) at 1 year. All-cause mortality and heart failure hospitalizations at 1 year were 14.9% and 18.9%, respectively, which was significantly lower than previous studies.All authors: Kar S, von Bardeleben RS, Rottbauer W, Mahoney P, Price MJ, Grasso C, Williams M, Lurz P, Ahmed M, Hausleiter J, Chehab B, Zamorano JL, Asch FM, Maisano FFiscal year: FY2023Digital Object Identifier: Date added to catalog: 2023-04-11
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Journal Article MedStar Authors Catalog Article Available

Available online through MWHC library: 2008 - present

BACKGROUND: The third-generation MitraClip NTR/XTR transcatheter edge-to-edge repair system was introduced to assist in leaflet grasping with the longer clip arms of MitraClip XTR and to improve ease of use with the modified delivery catheter.

CONCLUSIONS: The study demonstrates treatment with the third-generation system resulted in substantial reduction of MR in a contemporary real-world practice, compared with the results of earlier EVEREST and COAPT trials.(The MitraClip R EXPAND Study of the Next Generation of MitraClip R Devices [EXPAND]; NCT03502811). Copyright © 2023. Published by Elsevier Inc.

METHODS: EXPAND is a prospective, multicenter, international, single-arm study that enrolled patients with primary MR and secondary MR at 57 centers. Follow-up was conducted through 12 months. Echocardiograms were analyzed by an echocardiographic core laboratories. Study outcomes included: MR severity, functional capacity measured by New York Heart Association functional class, quality of life measured by Kansas City Cardiomyopathy Questionnaire, heart failure hospitalizations, all-cause mortality.

OBJECTIVES: The EXPAND study evaluated contemporary real-world outcomes in subjects with mitral regurgitation (MR) treated with the third-generation MitraClip NTR/XTR transcatheter edge-to-edge repair system.

RESULTS: 1,041 patients were enrolled from April 2018 through March 2019, of which 50.5% had primary or mixed etiology. Implant success was 98.9%; 1.5 +/- 0.6 clips were implanted per subject. Significant MR reduction from baseline (>=MR 3+: 56.0%) to 30 days (<=MR 1+:88.8%) was maintained through 1 year (MR <=1+: 89.2%). A total of 84.5% and 93.0% of subjects in primary MR and secondary MR, respectively, had <=1+ MR at 1 year. Significant improvements were observed in clinical outcomes (New York Heart Association functional class I/II in 80.3%, +21.6 improvement in Kansas City Cardiomyopathy Questionnaire score) at 1 year. All-cause mortality and heart failure hospitalizations at 1 year were 14.9% and 18.9%, respectively, which was significantly lower than previous studies.

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