Predictors of 5-Year Mortality in Patients Managed With a Magnetically Levitated Left Ventricular Assist Device
Copyright © 2023 The Authors. Published by Elsevier Inc. All rights reserved..
BACKGROUND: In advanced heart failure patients implanted with a fully magnetically levitated HeartMate 3 (HM3, Abbott) left ventricular assist device (LVAD), it is unknown how preimplant factors and postimplant index hospitalization events influence 5-year mortality in those able to be discharged.
OBJECTIVES: The goal was to identify risk predictors of mortality through 5 years among HM3 LVAD recipients conditional on discharge from index hospitalization in the MOMENTUM 3 pivotal trial.
METHODS: This analysis evaluated 485 of 515 (94%) patients discharged after implantation of the HM3 LVAD. Preimplant (baseline), implant surgery, and index hospitalization characteristics were analyzed individually, and as multivariable predictors for mortality risk through 5 years.
RESULTS: Cumulative 5-year mortality in the cohort (median age: 62 years, 80% male, 65% White, 61% destination therapy due to transplant ineligibility) was 38%. Two preimplant characteristics (elevated blood urea nitrogen and prior coronary artery bypass graft or valve procedure) and 3 postimplant characteristics (hemocompatibility-related adverse events, ventricular arrhythmias, and estimated glomerular filtration rate <60 mL/min/1.73 m2 at discharge) were predictors of 5-year mortality. In 171 of 485 patients (35.3%) without any risk predictors, 5-year mortality was reduced to 22.6% (95% CI: 15.4%-32.7%). Even among those with 1 or more predictors, mortality was <50% at 5 years (45.7% [95% CI: 39.0%-52.8%]).
CONCLUSIONS: Long-term survival in successfully discharged HM3 LVAD recipients is largely influenced by clinical events experienced during the index surgical hospitalization in tandem with baseline factors, with mortality of <50% at 5 years. In patients without identified predictors of risk, long-term 5-year mortality is low and rivals that achieved with heart transplantation, even though most were implanted with destination therapy intent. (MOMENTUM 3 IDE Clinical Study Protocol, NCT02224755; MOMENTUM 3 Pivotal Cohort Extended Follow-up PAS, NCT03982979).
| Errataetall: |
CommentIn: J Am Coll Cardiol. 2023 Aug 29;82(9):782-784. - PMID 37612009 |
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| Medienart: |
E-Artikel |
| Erscheinungsjahr: |
2023 |
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| Erschienen: |
2023 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:82 |
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| Enthalten in: |
Journal of the American College of Cardiology - 82(2023), 9 vom: 29. Aug., Seite 771-781 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Nayak, Aditi [VerfasserIn] |
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| Links: |
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| Anmerkungen: |
Date Completed 25.08.2023 Date Revised 08.02.2024 published: Print ClinicalTrials.gov: NCT03982979, NCT02224755 CommentIn: J Am Coll Cardiol. 2023 Aug 29;82(9):782-784. - PMID 37612009 Citation Status MEDLINE |
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| doi: |
10.1016/j.jacc.2023.05.066 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM361104340 |
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| 245 | 1 | 0 | |a Predictors of 5-Year Mortality in Patients Managed With a Magnetically Levitated Left Ventricular Assist Device |
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| 500 | |a Date Completed 25.08.2023 | ||
| 500 | |a Date Revised 08.02.2024 | ||
| 500 | |a published: Print | ||
| 500 | |a ClinicalTrials.gov: NCT03982979, NCT02224755 | ||
| 500 | |a CommentIn: J Am Coll Cardiol. 2023 Aug 29;82(9):782-784. - PMID 37612009 | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a Copyright © 2023 The Authors. Published by Elsevier Inc. All rights reserved. | ||
| 520 | |a BACKGROUND: In advanced heart failure patients implanted with a fully magnetically levitated HeartMate 3 (HM3, Abbott) left ventricular assist device (LVAD), it is unknown how preimplant factors and postimplant index hospitalization events influence 5-year mortality in those able to be discharged | ||
| 520 | |a OBJECTIVES: The goal was to identify risk predictors of mortality through 5 years among HM3 LVAD recipients conditional on discharge from index hospitalization in the MOMENTUM 3 pivotal trial | ||
| 520 | |a METHODS: This analysis evaluated 485 of 515 (94%) patients discharged after implantation of the HM3 LVAD. Preimplant (baseline), implant surgery, and index hospitalization characteristics were analyzed individually, and as multivariable predictors for mortality risk through 5 years | ||
| 520 | |a RESULTS: Cumulative 5-year mortality in the cohort (median age: 62 years, 80% male, 65% White, 61% destination therapy due to transplant ineligibility) was 38%. Two preimplant characteristics (elevated blood urea nitrogen and prior coronary artery bypass graft or valve procedure) and 3 postimplant characteristics (hemocompatibility-related adverse events, ventricular arrhythmias, and estimated glomerular filtration rate <60 mL/min/1.73 m2 at discharge) were predictors of 5-year mortality. In 171 of 485 patients (35.3%) without any risk predictors, 5-year mortality was reduced to 22.6% (95% CI: 15.4%-32.7%). Even among those with 1 or more predictors, mortality was <50% at 5 years (45.7% [95% CI: 39.0%-52.8%]) | ||
| 520 | |a CONCLUSIONS: Long-term survival in successfully discharged HM3 LVAD recipients is largely influenced by clinical events experienced during the index surgical hospitalization in tandem with baseline factors, with mortality of <50% at 5 years. In patients without identified predictors of risk, long-term 5-year mortality is low and rivals that achieved with heart transplantation, even though most were implanted with destination therapy intent. (MOMENTUM 3 IDE Clinical Study Protocol, NCT02224755; MOMENTUM 3 Pivotal Cohort Extended Follow-up PAS, NCT03982979) | ||
| 650 | 4 | |a Clinical Trial | |
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Research Support, Non-U.S. Gov't | |
| 650 | 4 | |a MOMENTUM 3 | |
| 650 | 4 | |a advanced heart failure | |
| 650 | 4 | |a left ventricular assist device | |
| 650 | 4 | |a long-term survival | |
| 650 | 4 | |a mechanical circulatory support | |
| 650 | 4 | |a predictors of prognosis | |
| 700 | 1 | |a Hall, Shelley A |e verfasserin |4 aut | |
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| 700 | 1 | |a Goldstein, Daniel J |e verfasserin |4 aut | |
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| 700 | 1 | |a Cowger, Jennifer A |e verfasserin |4 aut | |
| 700 | 1 | |a Salerno, Christopher T |e verfasserin |4 aut | |
| 700 | 1 | |a Naka, Yoshifumi |e verfasserin |4 aut | |
| 700 | 1 | |a Horstmanshof, Douglas |e verfasserin |4 aut | |
| 700 | 1 | |a Crandall, Daniel |e verfasserin |4 aut | |
| 700 | 1 | |a Wang, AiJia |e verfasserin |4 aut | |
| 700 | 1 | |a Mehra, Mandeep R |e verfasserin |4 aut | |
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