دورية أكاديمية
5-Year Outcomes of Anterior Mitral Leaflet Laceration to Prevent Outflow Obstruction.
| العنوان: | 5-Year Outcomes of Anterior Mitral Leaflet Laceration to Prevent Outflow Obstruction. |
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| المؤلفون: | Khan JM; Cardiovascular Branch, Division of Intramural Research, National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, Maryland, USA; St. Francis Hospital and Heart Center, Roslyn, New York, USA., Babaliaros VC; Structural Heart and Valve Center, Emory University Hospital, Atlanta, Georgia, USA. Electronic address: https://twitter.com/BabaliarosArgos., Greenbaum AB; Structural Heart and Valve Center, Emory University Hospital, Atlanta, Georgia, USA. Electronic address: https://twitter.com/AdamGreenbaumMD., McCabe JM; University of Washington, Seattle, Washington, USA. Electronic address: https://twitter.com/jamiemccabeMD., Rogers T; Cardiovascular Branch, Division of Intramural Research, National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, Maryland, USA; Medstar Washington Hospital Center, Washington, DC, USA., Eng MH; Center for Structural Heart Disease, Division of Cardiology, and Division of Cardiac Surgery, Henry Ford Health System, Detroit, Michigan, USA., Foerst JR; Carilion Roanoke Memorial Hospital, Roanoke, Virginia, USA., Yazdani S; Inova Fairfax Hospital, Fairfax, Virginia, USA., Paone G; Structural Heart and Valve Center, Emory University Hospital, Atlanta, Georgia, USA., Gleason PT; Structural Heart and Valve Center, Emory University Hospital, Atlanta, Georgia, USA., Halaby RN; Cardiovascular Branch, Division of Intramural Research, National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, Maryland, USA., Bruce CG; Cardiovascular Branch, Division of Intramural Research, National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, Maryland, USA., Tian X; Office of Biostatistics Research, Division of Intramural Research, National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, Maryland, USA., Stine AM; Cardiovascular Branch, Division of Intramural Research, National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, Maryland, USA., Lederman RJ; Cardiovascular Branch, Division of Intramural Research, National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, Maryland, USA. Electronic address: lederman@nih.gov. |
| المصدر: | JACC. Cardiovascular interventions [JACC Cardiovasc Interv] 2024 Sep 23; Vol. 17 (18), pp. 2157-2167. Date of Electronic Publication: 2024 Sep 04. |
| نوع المنشور: | Journal Article; Multicenter Study; Clinical Trial |
| اللغة: | English |
| بيانات الدورية: | Publisher: Elsevier Country of Publication: United States NLM ID: 101467004 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1876-7605 (Electronic) Linking ISSN: 19368798 NLM ISO Abbreviation: JACC Cardiovasc Interv Subsets: MEDLINE |
| أسماء مطبوعة: | Original Publication: New York : Elsevier |
| مواضيع طبية MeSH: | Mitral Valve*/surgery , Mitral Valve*/diagnostic imaging , Mitral Valve*/physiopathology , Ventricular Outflow Obstruction*/diagnostic imaging , Ventricular Outflow Obstruction*/etiology , Ventricular Outflow Obstruction*/prevention & control , Ventricular Outflow Obstruction*/surgery , Ventricular Outflow Obstruction*/physiopathology , Ventricular Outflow Obstruction*/mortality , Heart Valve Prosthesis Implantation*/adverse effects , Heart Valve Prosthesis Implantation*/instrumentation , Heart Valve Prosthesis Implantation*/mortality , Feasibility Studies* , Heart Valve Prosthesis* , Recovery of Function* , Cardiac Catheterization*/adverse effects , Cardiac Catheterization*/instrumentation , Mitral Valve Insufficiency*/surgery , Mitral Valve Insufficiency*/diagnostic imaging , Mitral Valve Insufficiency*/physiopathology , Mitral Valve Insufficiency*/mortality, Humans ; Male ; Female ; Time Factors ; Aged ; Prospective Studies ; Treatment Outcome ; Risk Factors ; United States ; Aged, 80 and over ; Ventricular Function, Left ; Mitral Valve Annuloplasty/adverse effects ; Mitral Valve Annuloplasty/instrumentation ; Mitral Valve Annuloplasty/mortality ; Middle Aged ; Hemodynamics |
| مستخلص: | Background: Left ventricular outflow tract (LVOT) obstruction is a common, often fatal complication of transcatheter mitral valve replacement (TMVR). Laceration of the anterior mitral leaflet to prevent outflow obstruction (LAMPOON) was safe and effective at preventing LVOT obstruction at 30 days in the National Heart, Lung, and Blood Institute LAMPOON trial. Objectives: The authors report the 5-year outcomes of intentional anterior mitral leaflet laceration before SAPIEN 3 TMVR, in patients at risk of LVOT obstruction. Methods: The National Heart, Lung, and Blood Institute LAMPOON trial was a prospective, multicenter, single-arm safety and feasibility study of LAMPOON and transseptal SAPIEN 3 TMVR in annuloplasty rings (valve-in-ring) or native mitral annular calcification (MAC) (valve-in-MAC). All subjects had high predicted risk for LVOT obstruction. Subjects were not excluded for excessive frailty or comorbidity. The primary endpoints were technical success and safety at 30 days. Secondary clinical and echocardiographic endpoints were assessed at 1 year and clinical follow-up at 5 years. Results: Thirty subjects were enrolled between June 2017 and June 2018, equally between the valve-in-MAC and valve-in-ring arms. At 30 days, LAMPOON was successful in all 30 subjects, with no strokes, 1 (3%) death, and 1 (3%) moderate LVOT obstruction. Eighteen (65%) survived to 1 year, and 7 (25%) survived to 5 years. Six (20%) were hospitalized for heart failure in the first year. From baseline to 1 year, there was a 24-point improvement in Kansas City Cardiomyopathy Questionnaire score and a 60-m improvement in 6-minute walk distance. There was no significant change in N-terminal pro-brain natriuretic peptide. At 1 year, LVOT gradients remained low. Conclusions: LAMPOON enabled TMVR despite the risk for LVOT obstruction. There were no long-term complications associated with LAMPOON. The selection of inoperable patients limited assessment of long-term survival following TMVR. (NHLBI DIR LAMPOON Study: Intentional Laceration of the Anterior Mitral Leaflet to Prevent Left Ventricular Outflow Tract Obstruction During Transcatheter Mitral Valve Implantation; NCT03015194). Competing Interests: Funding Support and Author Disclosures This work was supported by the Division of Intramural Research, NHLBI, National Institutes of Health (Z01-HL006040), and by the intramural programs of the participating centers. The NHLBI and Edwards Lifesciences have a collaborative research and development agreement on transcatheter modification of mitral valve leaflets, including joint financial support of this study. Drs Khan, Rogers, and Lederman are coinventors on patents, assigned to the National Institutes of Health, for catheter devices to lacerate valve leaflets. Dr Khan is a proctor for Edwards Lifesciences and Medtronic; and has equity in Transmural Systems. Dr Greenbaum is a proctor for Edwards Lifesciences, Medtronic, and Abbott Vascular; and has equity in Transmural Systems and Excision Medical. Dr Babaliaros is a consultant for Edwards Lifesciences, Abbott Vascular, and Transmural Systems; and his employer has research contracts for clinical investigation of transcatheter aortic and mitral devices from Edwards Lifesciences, Abbott Vascular, Medtronic, St. Jude Medical, and Boston Scientific. Dr Rogers is a consultant for Edwards Lifesciences, Boston Scientific, Abbott, Anteris, and Medtronic; serves on advisory boards for Medtronic and Boston Scientific; and has equity in Transmural Systems. Dr Eng is on the Speakers Bureau for Edwards Lifesciences and Medtronic. Dr Foerst is a proctor for Edwards Lifesciences and Medtronic. Dr Paone is proctor for Edwards Lifesciences and has equity in Medtronic. Dr Lederman is the principal investigator on a cooperative research and development agreement between the National Institutes of Health and Edwards Lifesciences for transcatheter modification of the mitral valve. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose. (Published by Elsevier Inc.) |
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| معلومات مُعتمدة: | ZIA HL006040 United States ImNIH Intramural NIH HHS |
| فهرسة مساهمة: | Keywords: LAMPOON; left ventricular outflow tract obstruction; mitral annular calcification; mitral valve disease; transcatheter electrosurgery; transcatheter mitral valve replacement |
| سلسلة جزيئية: | ClinicalTrials.gov NCT03015194 |
| تواريخ الأحداث: | Date Created: 20240907 Date Completed: 20240925 Latest Revision: 20240927 |
| رمز التحديث: | 20240927 |
| مُعرف محوري في PubMed: | PMC11424260 |
| DOI: | 10.1016/j.jcin.2024.05.041 |
| PMID: | 39243268 |
| قاعدة البيانات: | MEDLINE |
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Full Text Finder | تدمد: | 1876-7605 |
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| DOI: | 10.1016/j.jcin.2024.05.041 |