Center Variability in Patient Outcomes Following HeartMate 3 Implantation : An Analysis of the MOMENTUM 3 Trial
Copyright © 2022 The Author(s). Published by Elsevier Inc. All rights reserved..
BACKGROUND: As left ventricular assist device (LVAD) survival rates continue to improve, evaluating site-specific variability in outcomes can facilitate identifying targets for quality-improvement initiative opportunities in the field.
METHODS: Deidentified center-specific outcomes were analyzed for HeartMate 3 (HM3) patients enrolled in the MOMENTUM 3 pivotal and continued access protocol trials. Centers < 25th percentile for HM3 volumes were excluded. Variability in risk-adjusted center mortality was assessed at 90 days and 2 years (conditional upon 90-day survival). Adverse event (AE) rates were compared across centers.
RESULTS: In the 48 included centers (1958 patients), study-implant volumes ranged between 17 and 106 HM3s. Despite similar trial-inclusion criteria, patient demographics varied across sites, including age quartile ((Q)1-Q3:57-62 years), sex (73%-85% male), destination therapy intent (60%-84%), and INTERMACS profile 1-2 (16%-48%). Center mortality was highly variable, nadiring at ≤ 3.6% (≤ 25th percentile) and peaking at ≥ 10.4% (≥ 75th percentile) at 90 days and ≤ 10.2% and ≥ 18.7%, respectively, at 2 years. Centers with low mortality rates tended to have lower 2-year AE rates, but no center was a top performer for all AEs studied.
CONCLUSIONS: Mortality and AEs were highly variable across MOMENTUM 3 centers. Studies are needed to improve our understanding of the drivers of outcome variability and to ascertain best practices associated with high-performing centers across the continuum of intraoperative to chronic stages of LVAD support.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2022 |
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| Erschienen: |
2022 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:28 |
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| Enthalten in: |
Journal of cardiac failure - 28(2022), 7 vom: 15. Juli, Seite 1158-1168 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Kanwar, Manreet K [VerfasserIn] |
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| Anmerkungen: |
Date Completed 19.07.2022 Date Revised 19.08.2022 published: Print-Electronic Citation Status MEDLINE |
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| doi: |
10.1016/j.cardfail.2022.04.006 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM340332174 |
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| 100 | 1 | |a Kanwar, Manreet K |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Center Variability in Patient Outcomes Following HeartMate 3 Implantation |b An Analysis of the MOMENTUM 3 Trial |
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| 500 | |a Date Revised 19.08.2022 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a Copyright © 2022 The Author(s). Published by Elsevier Inc. All rights reserved. | ||
| 520 | |a BACKGROUND: As left ventricular assist device (LVAD) survival rates continue to improve, evaluating site-specific variability in outcomes can facilitate identifying targets for quality-improvement initiative opportunities in the field | ||
| 520 | |a METHODS: Deidentified center-specific outcomes were analyzed for HeartMate 3 (HM3) patients enrolled in the MOMENTUM 3 pivotal and continued access protocol trials. Centers < 25th percentile for HM3 volumes were excluded. Variability in risk-adjusted center mortality was assessed at 90 days and 2 years (conditional upon 90-day survival). Adverse event (AE) rates were compared across centers | ||
| 520 | |a RESULTS: In the 48 included centers (1958 patients), study-implant volumes ranged between 17 and 106 HM3s. Despite similar trial-inclusion criteria, patient demographics varied across sites, including age quartile ((Q)1-Q3:57-62 years), sex (73%-85% male), destination therapy intent (60%-84%), and INTERMACS profile 1-2 (16%-48%). Center mortality was highly variable, nadiring at ≤ 3.6% (≤ 25th percentile) and peaking at ≥ 10.4% (≥ 75th percentile) at 90 days and ≤ 10.2% and ≥ 18.7%, respectively, at 2 years. Centers with low mortality rates tended to have lower 2-year AE rates, but no center was a top performer for all AEs studied | ||
| 520 | |a CONCLUSIONS: Mortality and AEs were highly variable across MOMENTUM 3 centers. Studies are needed to improve our understanding of the drivers of outcome variability and to ascertain best practices associated with high-performing centers across the continuum of intraoperative to chronic stages of LVAD support | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a HeartMate 3 | |
| 650 | 4 | |a LVAD | |
| 650 | 4 | |a outcomes | |
| 650 | 4 | |a site variability | |
| 700 | 1 | |a Pagani, Francis D |e verfasserin |4 aut | |
| 700 | 1 | |a Mehra, Mandeep R |e verfasserin |4 aut | |
| 700 | 1 | |a Estep, Jerry D |e verfasserin |4 aut | |
| 700 | 1 | |a Pinney, Sean P |e verfasserin |4 aut | |
| 700 | 1 | |a Silvestry, Scott C |e verfasserin |4 aut | |
| 700 | 1 | |a Uriel, Nir |e verfasserin |4 aut | |
| 700 | 1 | |a Goldstein, Daniel J |e verfasserin |4 aut | |
| 700 | 1 | |a Long, James |e verfasserin |4 aut | |
| 700 | 1 | |a Cleveland, Joseph C |c Jr |e verfasserin |4 aut | |
| 700 | 1 | |a Kormos, Robert L |e verfasserin |4 aut | |
| 700 | 1 | |a Wang, Aijia |e verfasserin |4 aut | |
| 700 | 1 | |a Chuang, Joyce |e verfasserin |4 aut | |
| 700 | 1 | |a Cowger, Jennifer A |e verfasserin |4 aut | |
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