دورية أكاديمية
1-Year Outcomes Following Transfemoral Transseptal Transcatheter Mitral Valve Replacement: Intrepid TMVR Early Feasibility Study Results.
| العنوان: | 1-Year Outcomes Following Transfemoral Transseptal Transcatheter Mitral Valve Replacement: Intrepid TMVR Early Feasibility Study Results. |
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| المؤلفون: | Zahr F; Oregon Health and Science University, Portland, Oregon, USA. Electronic address: zahr@ohsu.edu., Song HK; Oregon Health and Science University, Portland, Oregon, USA., Chadderdon S; Oregon Health and Science University, Portland, Oregon, USA., Gada H; UPMC Pinnacle Harrisburg Campus, Harrisburg, Pennsylvania, USA., Mumtaz M; UPMC Pinnacle Harrisburg Campus, Harrisburg, Pennsylvania, USA., Byrne T; Abrazo Arizona Heart Hospital, Phoenix, Arizona, USA., Kirshner M; Abrazo Arizona Heart Hospital, Phoenix, Arizona, USA., Sharma S; Mount Sinai Medical Center, New York, New York, USA., Kodali S; New York-Presbyterian Hospital/Columbia University Medical Center, New York, New York, USA., George I; New York-Presbyterian Hospital/Columbia University Medical Center, New York, New York, USA., Merhi W; Spectrum Health Hospitals, Grand Rapids, Michigan, USA., Yarboro L; University of Virginia Health System Hospital, Charlottesville, Virginia, USA., Sorajja P; Abbott Northwestern Hospital, Minneapolis, Minnesota, USA., Bapat V; Abbott Northwestern Hospital, Minneapolis, Minnesota, USA., Bajwa T; Aurora Saint Luke's Medical Center, Milwaukee, Wisconsin, USA., Weiss E; Aurora Saint Luke's Medical Center, Milwaukee, Wisconsin, USA., Thaden JJ; Mayo Clinic, Rochester, Minnesota, USA., Gearhart E; Medtronic PLC, Minneapolis, Minnesota, USA., Lim S; University of Virginia Health System Hospital, Charlottesville, Virginia, USA., Reardon M; Houston Methodist DeBakey Heart and Vascular Center, Houston, Texas, USA., Adams D; Mount Sinai Medical Center, New York, New York, USA., Mack M; Baylor Scott and White Heart Hospital, Plano, Texas, USA., Leon MB; New York-Presbyterian Hospital/Columbia University Medical Center, New York, New York, USA. |
| المصدر: | JACC. Cardiovascular interventions [JACC Cardiovasc Interv] 2023 Dec 11; Vol. 16 (23), pp. 2868-2879. Date of Electronic Publication: 2023 Oct 23. |
| نوع المنشور: | Multicenter Study; Journal Article; Research Support, Non-U.S. Gov't |
| 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: | Heart Valve Prosthesis* , Heart Valve Prosthesis Implantation* , Mitral Valve Insufficiency*/diagnostic imaging , Mitral Valve Insufficiency*/surgery , Mitral Valve Insufficiency*/etiology, Male ; Humans ; Aged, 80 and over ; Female ; Mitral Valve/diagnostic imaging ; Mitral Valve/surgery ; Feasibility Studies ; Prospective Studies ; Cardiac Catheterization/methods ; Treatment Outcome |
| مستخلص: | Background: High surgical risk may preclude mitral valve replacement in many patients. Transcatheter mitral valve replacement (TMVR) using transfemoral transseptal access is a novel technology for the treatment of mitral regurgitation (MR) in high-risk surgical patients. Objectives: This analysis evaluates 30-day and 1-year outcomes of the Intrepid TMVR Early Feasibility Study in patients with ≥moderate-severe MR. Methods: The Intrepid TMVR Early Feasibility Study is a multicenter, prospective, single-arm study. Clinical events were adjudicated by a clinical events committee; endpoints were defined according to Mitral Valve Academic Research Consortium criteria. Results: A total of 33 patients, enrolled at 9 U.S. sites between February 2020 and August 2022, were included. The median age was 80 years, 63.6% of patients were men, and mean Society of Thoracic Surgeons Predicted Risk of Mortality for mitral valve replacement was 5.3%. Thirty-one (93.9%) patients were successfully implanted. Median postprocedural hospitalization length of stay was 5 days, and 87.9% of patients were discharged to home. At 30 days, there were no deaths or strokes, 8 (24.2%) patients had major vascular complications and none required surgical intervention, there were 4 cases of venous thromboembolism all successfully treated without sequelae, and 1 patient had mitral valve reintervention for severe left ventricular outflow tract obstruction. At 1 year, the Kaplan-Meier all-cause mortality rate was 6.7%, echocardiography showed ≤mild valvular MR, there was no/trace paravalvular leak in all patients, median mitral valve mean gradient was 4.6 mm Hg (Q1-Q3: 3.9-5.3 mm Hg), and 91.7% of survivors were in NYHA functional class I/II with a median 11.4-point improvement in Kansas City Cardiomyopathy Questionnaire overall summary scores. Conclusions: The early benefits of the Intrepid transfemoral transseptal TMVR system were maintained up to 1 year with low mortality, low reintervention, and near complete elimination of MR, demonstrating a favorable safety profile and durable valve function. Competing Interests: Funding Support and Author Disclosures This work was funded by Medtronic. Dr Zahr has received institutional grant support from Edwards Lifesciences and Medtronic. Dr Song has received consulting fees from Medtronic and Edwards Lifesciences. Dr Chadderdon has received consulting fees from Medtronic and Edwards Lifesciences; and grant support from Medtronic and GE Healthcare. Dr Gada has received consulting fees from Medtronic, Boston Scientific, and Bard Medical. Dr Mumtaz has received consulting fees and grant support from Medtronic and Edwards Lifesciences; and consulting fees from Z Medica and from the Japanese Organization for Medical Device Development. Dr Byrne has received consulting fees from Medtronic and Abbott Vascular. Dr Kirshner has received consulting fees from Medtronic. Dr Sharma has served as a proctor for Medtronic; and received research grant support from the Norton Healthcare Foundation. Dr Kodali has received consultant fees from Admedus and Dura Biotech; holds equity in Dura Biotech, Microinterventional Devices, Thubrika Aortic Valve, Supira, Admedus, TriFlo, and Anona; and has received institutional grant support from Edwards Lifesciences, Medtronic, Abbott Vascular, Boston Scientific, and JenaValve. Dr George has received consulting fees from Cardiomech, Mitremedical, Atricure, Zimmer Biomet, Durvena, and Valcare Medical. Dr Sorrajja has received grant support from Medtronic for participation in the Steering Committee of the APOLLO trial; and consulting fees from 4C Medical, Abbott Structural, Anteris, BioSense Webseter, Edwards Lifesciences, Foldax, Medtronic, Phillips, Shifamed, Siemens, vDyne, W.L. Gore xDOT. Dr Bapat has received personal fees for consultancy and speaker service from Medtronic; and served as a consultant for Edwards Lifesciences, 4C, and Boston Scientific. Dr Bajwa has received personal and institutional consulting fees from Medtronic. Dr Weiss has received personal and institutional consulting fees from Medtronic and Baxter. Dr Thaden has received institutional consulting fees from Medtronic and speaker fees from Edwards Lifesciences. Ms. Gearhart is an employee of Medtronic. Dr Lim has received institutional grant support from Abbott Vascular, Boston Scientific, Edwards Lifesciences, and Medtronic; and consulting fees from Keystone, Pipeline, Valgen, and Venus. Dr Reardon has received institutional consulting fees from Medtronic, W.L. Gore & Associates, Boston Scientific, and Abbott Vascular. Dr Adams’s institution (Icahn School of Medicine at Mount Sinai) has received royalty payments from Edwards Lifesciences and Medtronic for intellectual property related to the development of valve repair rings; and he has served as the national co-principal investigator of the Medtronic APOLLO Food and Drug Administration pivotal trial, the NeoChord ReChord Food and Drug Administration pivotal trial, the Medtronic CoreValve US pivotal trial, and the Abbott TRILUMINATE pivotal trial. Dr Mack has served as a trial co-principal investigator for Abbott Vascular; as the study chair for Medtronic; and as a trial co–principal investigator for Edwards Lifesciences (both personal and institutional). Dr Leon has received personal and institutional grant support from Abbott Vascular, Boston Scientific, Edwards Lifesciences, and Medtronic. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose. (Copyright © 2023 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.) |
| التعليقات: | Comment in: JACC Cardiovasc Interv. 2023 Dec 11;16(23):2880-2883. doi: 10.1016/j.jcin.2023.11.009. (PMID: 38092494) |
| فهرسة مساهمة: | Keywords: TMVR; mitral regurgitation; trans-septal; transcatheter mitral valve replacement; transfemoral |
| تواريخ الأحداث: | Date Created: 20231030 Date Completed: 20231216 Latest Revision: 20240717 |
| رمز التحديث: | 20240717 |
| DOI: | 10.1016/j.jcin.2023.10.001 |
| PMID: | 37902145 |
| قاعدة البيانات: | MEDLINE |
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Full Text Finder | تدمد: | 1876-7605 |
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| DOI: | 10.1016/j.jcin.2023.10.001 |