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      Association of Clinical Outcomes With Left Ventricular Assist Device Use by Bridge to Transplant or Destination Therapy Intent : The Multicenter Study of MagLev Technology in Patients Undergoing Mechanical Circulatory Support Therapy With HeartMate 3 (MOMENTUM 3) Randomized Clinical Trial

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          Key Points

          Question

          In patients with advanced heart failure, do outcomes with left ventricular assist device implantation differ by the initial intended goal of therapy as a bridge to transplant or destination therapy?

          Findings

          In this randomized clinical trial, the composite end point of survival free of disabling stroke or reoperation to remove or replace a malfunctioning device at 2 years was significantly better with the magnetically levitated centrifugal-flow HeartMate 3 than the mechanical-bearing axial-flow HeartMate II, irrespective of preimplant therapeutic intent. Event-free survival was not different between patients in the bridge to transplant or destination therapy groups treated with the HeartMate 3 pump.

          Meaning

          Per this randomized clinical trial, use of categorizations based on current or future transplant eligibility should be abandoned in favor of a single treatment indication for use of left ventricular assist devices.

          Abstract

          This prespecified secondary analysis of the MOMENTUM 3 randomized clinical trial aims to determine whether clinical outcomes of patients with 2 different left ventricular assist devices differed based on preoperative categories of bridge to transplant/bridge to candidacy vs destination therapy.

          Abstract

          Importance

          Left ventricular assist devices (LVADs) are well established in the treatment of advanced heart failure, but it is unclear whether outcomes are different based on the intended goal of therapy in patients who are eligible vs ineligible for heart transplant.

          Objective

          To determine whether clinical outcomes in the Multicenter Study of MagLev Technology in Patients Undergoing Mechanical Circulatory Support Therapy With HeartMate 3 (MOMENTUM 3) trial differed by preoperative categories of bridge to transplant (BTT) or bridge to transplant candidacy (BTC) vs destination therapy (DT).

          Design, Setting, and Participants

          This study was a prespecified secondary analysis of the MOMENTUM 3 trial, a multicenter randomized clinical trial comparing the magnetically levitated centrifugal-flow HeartMate 3 (HM3) LVAD to the axial-flow HeartMate II (HMII) pump. It was conducted in 69 centers with expertise in managing patients with advanced heart failure in the United States. Patients with advanced heart failure were randomized to an LVAD, irrespective of the intended goal of therapy (BTT/BTC or DT).

          Main Outcomes and Measures

          The primary end point was survival free of disabling stroke or reoperation to remove or replace a malfunctioning device at 2 years. Secondary end points included adverse events, functional status, and quality of life.

          Results

          Of the 1020 patients with implants (515 with HM3 devices [50.5%] and 505 with HMII devices [49.5%]), 396 (38.8%) were in the BTT/BTC group (mean [SD] age, 55 [12] years; 310 men [78.3%]) and 624 (61.2%) in the DT group (mean [SD] age, 63 [12] years; 513 men [82.2%]). Of the patients initially deemed as transplant ineligible, 84 of 624 patients (13.5%) underwent heart transplant within 2 years of LVAD implant. In the primary end point analysis, HM3 use was superior to HMII use in patients in the BTT/BTC group (76.8% vs 67.3% for survival free of disabling stroke and reoperation; hazard ratio, 0.62 [95% CI, 0.40-0.94]; log-rank P = .02) and patients in the DT group (73.2% vs 58.7%; hazard ratio, 0.61 [95% CI, 0.46-0.81]; log-rank P < .001). For patients in both BTT/BTC and DT groups, there were not significantly different reductions in rates of pump thrombosis, stroke, and gastrointestinal bleeding with HM3 use relative to HMII use. Improvements in quality of life and functional capacity for either pump were not significantly different regardless of preimplant strategy.

          Conclusions and Relevance

          In this trial, the superior treatment effect of HM3 over HMII was similar for patients in the BTT/BTC or DT groups. It is possible that use of arbitrary categorizations based on current or future transplant eligibility should be clinically abandoned in favor of a single preimplant strategy: to extend the survival and improve the quality of life of patients with medically refractory heart failure.

          Trial Registration

          ClinicalTrials.gov identifier: NCT02224755

          Related collections

          Most cited references19

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          A Fully Magnetically Levitated Left Ventricular Assist Device — Final Report

          In two interim analyses of this trial, patients with advanced heart failure who were treated with a fully magnetically levitated centrifugal-flow left ventricular assist device were less likely to have pump thrombosis or nondisabling stroke than were patients treated with a mechanical-bearing axial-flow left ventricular assist device.
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            Seventh INTERMACS annual report: 15,000 patients and counting.

            The seventh annual report of the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) summarizes the first 9 years of patient enrollment. The Registry includes >15,000 patients from 158 participating hospitals. Trends in device strategy, patient profile at implant and survival are presented. Risk factors for mortality with continuous-flow pumps are updated, and the major causes/modes of death are presented. The adverse event burden is compared between eras, and health-related quality of life is reviewed. A detailed analysis of outcomes after mechanical circulatory support for ambulatory heart failure is presented. Recent summary data from PediMACS and MedaMACS is included. With the current continuous-flow devices, survival at 1 and 2 years is 80% and 70%, respectively.
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              • Article: not found

              Long-term use of a left ventricular assist device for end-stage heart failure.

              Implantable left ventricular assist devices have benefited patients with end-stage heart failure as a bridge to cardiac transplantation, but their long-term use for the purpose of enhancing survival and the quality of life has not been evaluated. We randomly assigned 129 patients with end-stage heart failure who were ineligible for cardiac transplantation to receive a left ventricular assist device (68 patients) or optimal medical management (61). All patients had symptoms of New York Heart Association class IV heart failure. Kaplan-Meier survival analysis showed a reduction of 48 percent in the risk of death from any cause in the group that received left ventricular assist devices as compared with the medical-therapy group (relative risk, 0.52; 95 percent confidence interval, 0.34 to 0.78; P=0.001). The rates of survival at one year were 52 percent in the device group and 25 percent in the medical-therapy group (P=0.002), and the rates at two years were 23 percent and 8 percent (P=0.09), respectively. The frequency of serious adverse events in the device group was 2.35 (95 percent confidence interval, 1.86 to 2.95) times that in the medical-therapy group, with a predominance of infection, bleeding, and malfunction of the device. The quality of life was significantly improved at one year in the device group. The use of a left ventricular assist device in patients with advanced heart failure resulted in a clinically meaningful survival benefit and an improved quality of life. A left ventricular assist device is an acceptable alternative therapy in selected patients who are not candidates for cardiac transplantation.
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                Author and article information

                Journal
                JAMA Cardiol
                JAMA Cardiol
                JAMA Cardiology
                American Medical Association
                2380-6583
                2380-6591
                April 2020
                15 January 2020
                15 January 2020
                : 5
                : 4
                : 411-419
                Affiliations
                [1 ]Montefiore Einstein Center for Heart and Vascular Care, New York, New York
                [2 ]Columbia University College of Physicians and Surgeons, New York–Presbyterian Hospital, New York
                [3 ]INTEGRIS Baptist Medical Center, Oklahoma City, Oklahoma
                [4 ]St Vincent Heart Center, Indianapolis, Indiana
                [5 ]Duke University Medical Center, Durham, North Carolina
                [6 ]Baptist Health Medical Center, Little Rock, Arkansas
                [7 ]Washington University School of Medicine, St Louis, Missouri
                [8 ]University of Colorado School of Medicine, Aurora
                [9 ]Advent Health Transplant Institute, Orlando, Florida
                [10 ]University of Minnesota, Minneapolis
                [11 ]Houston Methodist Hospital, Houston, Texas
                [12 ]University of Nebraska Medical Center, Omaha
                [13 ]Pritzker School of Medicine, University of Chicago, Chicago, Illinois
                [14 ]University of Chicago Medical Center, Chicago, Illinois
                [15 ]Yale Medical School, New Haven, Connecticut
                [16 ]MedStar Washington Hospital Center, Washington, DC
                [17 ]Abbott Laboratories, Abbott Park, Illinois
                [18 ]Heart and Vascular Center, Center for Advanced Heart Disease, Brigham and Women’s Hospital, Harvard Medical School, Boston, Massachusetts
                Author notes
                Article Information
                Accepted for Publication: October 31, 2019.
                Corresponding Author: Mandeep R. Mehra, MD, MSc, Heart and Vascular Center, Center for Advanced Heart Disease, Brigham and Women’s Hospital, 75 Francis St, Boston, MA 02115 ( mmehra@ 123456bwh.harvard.edu ).
                Published Online: January 15, 2020. doi:10.1001/jamacardio.2019.5323
                Open Access: This is an open access article distributed under the terms of the CC-BY-NC-ND License. © 2020 Goldstein DJ et al. JAMA Cardiology.
                Author Contributions: Dr Mehra had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis. Drs Goldstein and Mehra contributed equally to this work.
                Concept and design: Goldstein, Naka, Ravichandran, Uriel, Lowes, Bonde, Sood, Farrar, Mehra.
                Acquisition, analysis, or interpretation of data: Goldstein, Naka, Horstmanshof, Schroder, Ransom, Itoh, Uriel, Cleveland, Raval, Cogswell, Suarez, Lowes, Kim, Bonde, Sheikh, Sood, Farrar, Mehra.
                Drafting of the manuscript: Goldstein, Schroder, Lowes, Sheikh, Farrar, Mehra.
                Critical revision of the manuscript for important intellectual content: All authors.
                Statistical analysis: Goldstein, Mehra.
                Administrative, technical, or material support: Cleveland, Raval, Cogswell, Suarez, Kim, Sood, Farrar.
                Supervision: Horstmanshof, Uriel, Lowes, Sood, Mehra.
                Conflict of Interest Disclosures: Dr Goldstein reported receiving travel support from Abbott Laboratories outside the submitted work. Dr Naka reported receiving consulting fees from Abbott Laboratories during the conduct of the study and personal fees from CryoLife and Zimmer Biomet outside the submitted work. Dr Horstmanshof reported receiving research support from Abbott Laboratories during the conduct of the study and personal fees for consulting and speaker’s bureau participation from Abbott Laboratories outside the submitted work. Dr Ravichandran reported receiving travel support from Abbott Laboratories and Medtronic. Dr Schroder reported receiving consulting fees from Abbott Laboratories outside the submitted work and Medtronic. Dr Itoh reported receiving consulting fees and honoraria from Abbott Laboratories during the conduct of the study and personal fees from Abiomed and Medtronic outside the submitted work. Dr Cogswell reported receiving fees for consulting and speaker’s bureau from Abbott Laboratories and Medtronic and served on the heart failure advisory board for Medtronic. Dr Suarez reported receiving speaker’s bureau fees from Abiomed and serving on advisory boards for Abbott Laboratories and Medtronic outside the submitted work. Dr Uriel reported receiving grant support, consulting fees, and honoraria from Abbott Laboratories and Medtronic and serving on advisory boards for Leviticus Cardio and Livemetric/Cormetric. Dr Cleveland reported receiving grant support from Abbott Laboratories during the conduct of the study. Dr Lowes reported grants from Abbott Laboratories during the conduct of the study and consulting fees from Abbott Laboratories outside the submitted work. Dr Sheikh reported receiving consulting or lecture fees from Abbott Laboratories, Alnylam, Pfizer, and Eidos and serving on advisory boards for Alnylam and Pfizer. Drs Sood and Farrar are employees of Abbott Laboratories, and Dr Farrar reports being a stockholder in Abbott Laboratories as well. Dr Mehra reported receiving travel support and consulting fees paid to Brigham and Women’s Hospital from Abbott Laboratories, fees for serving on a steering committee from Medtronic and Janssen (Johnson & Johnson), fees for serving on a data and safety monitoring board from Mesoblast, consulting fees from Portola, Bayer, Triple Gene, Baim Institute for Clinical Research, and Xogenex, and fees for serving as a scientific board member from NuPulseCV, Leviticus, and FineHeart outside the submitted work. Dr Bonde reported serving as a consultant for Thoratec and Abbott Laboratories. No other disclosures were reported.
                Funding/Support: This study was sponsored by Abbott Laboratories.
                Role of the Funder/Sponsor: The sponsor had a role in design and conduct of the study; collection, management, analysis, and interpretation of the data; and preparation, review, approval of the manuscript and the decision to submit the manuscript for publication.
                Additional Contributions: We thank the trial coordinators and clinical team coordinators for their dedication to the trial and patients. We also thank Ia Topuria, MPH, and John B. O’Connell, MD, from the biometrics and medical affairs team of Abbott Laboratories for their contributions to the trial conduct and completion. They were compensated (as employees) for their contributions.
                Article
                hoi190098
                10.1001/jamacardio.2019.5323
                6990746
                31939996
                8e3970e2-15dd-4ddb-be70-62454f32e468
                Copyright 2020 Goldstein DJ et al. JAMA Cardiology.

                This is an open access article distributed under the terms of the CC-BY-NC-ND License.

                History
                : 23 September 2019
                : 31 October 2019
                Categories
                Research
                Research
                Original Investigation
                Online First

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