Six-month outcomes in postapproval HeartMate3 patients: A single-center US experience.
cardiovascular pathology
cardiovascular research
clinical review
transplant
Journal
Journal of cardiac surgery
ISSN: 1540-8191
Titre abrégé: J Card Surg
Pays: United States
ID NLM: 8908809
Informations de publication
Date de publication:
Jul 2022
Jul 2022
Historique:
revised:
21
02
2022
received:
10
11
2021
accepted:
22
02
2022
pubmed:
7
4
2022
medline:
7
6
2022
entrez:
6
4
2022
Statut:
ppublish
Résumé
The European CE Mark approval study and the MOMENTUM 3 trial demonstrated safety and a reduction in hemocompatibility-related adverse events with the use of HeartMate 3 (HM3) device. This single-center study investigated the real-world experience in HM3 patients since FDA approval. This retrospective, observational study included patients implanted with the HM3 LVAD as a primary implant between October 2017 and March 2020. Patients were divided into trial group and postapproval group. The primary endpoint was survival at 6 months. Secondary endpoints were adverse events including pump thrombosis (requiring pump exchange), stroke, renal failure, acute limb ischemia, re-exploratory for bleeding, gastrointestinal bleeding, right ventricular failure, and driveline infection. A total of 189 patients were implanted with HM3 device during the study period. 174 patients met the inclusion criteria: 82 patients in the trial group and 92 patients in the postapproval group. The postapproval group had younger patients, higher preoperative mean international normalized ratio, and greater numbers of patients with bridge to transplant (BTT) indications, IINTERMACS profile 1, and use of mechanical assist devices (other than IABP) than the trial group. Other characteristics between the two groups were comparable. Overall survival at 6 months in the postapproval group was 93.3% versus 93.8% (p = .88). The postapproval group demonstrated a statistically significant lower incidence of re-explorative surgery for bleeding (10.9% vs. 46.3, p = .01) than the trial group. In this single-center study, the real-world 6-month survival in the postapproval group was comparable to the trial results. Further studies are needed to monitor long-term outcomes.
Sections du résumé
BACKGROUND
BACKGROUND
The European CE Mark approval study and the MOMENTUM 3 trial demonstrated safety and a reduction in hemocompatibility-related adverse events with the use of HeartMate 3 (HM3) device. This single-center study investigated the real-world experience in HM3 patients since FDA approval.
METHODS
METHODS
This retrospective, observational study included patients implanted with the HM3 LVAD as a primary implant between October 2017 and March 2020. Patients were divided into trial group and postapproval group. The primary endpoint was survival at 6 months. Secondary endpoints were adverse events including pump thrombosis (requiring pump exchange), stroke, renal failure, acute limb ischemia, re-exploratory for bleeding, gastrointestinal bleeding, right ventricular failure, and driveline infection.
RESULTS
RESULTS
A total of 189 patients were implanted with HM3 device during the study period. 174 patients met the inclusion criteria: 82 patients in the trial group and 92 patients in the postapproval group. The postapproval group had younger patients, higher preoperative mean international normalized ratio, and greater numbers of patients with bridge to transplant (BTT) indications, IINTERMACS profile 1, and use of mechanical assist devices (other than IABP) than the trial group. Other characteristics between the two groups were comparable. Overall survival at 6 months in the postapproval group was 93.3% versus 93.8% (p = .88). The postapproval group demonstrated a statistically significant lower incidence of re-explorative surgery for bleeding (10.9% vs. 46.3, p = .01) than the trial group.
CONCLUSION
CONCLUSIONS
In this single-center study, the real-world 6-month survival in the postapproval group was comparable to the trial results. Further studies are needed to monitor long-term outcomes.
Identifiants
pubmed: 35385586
doi: 10.1111/jocs.16452
pmc: PMC9320844
doi:
Types de publication
Journal Article
Observational Study
Langues
eng
Sous-ensembles de citation
IM
Pagination
1907-1914Informations de copyright
© 2022 The Authors. Journal of Cardiac Surgery published by Wiley Periodicals LLC.
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