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Multicenter Study
. 2023 Sep 4:36:11675.
doi: 10.3389/ti.2023.11675. eCollection 2023.

Five-Year Outcome After Continuous Flow LVAD With Full-Magnetic (HeartMate 3) Versus Hybrid Levitation System (HeartWare): A Propensity-Score Matched Study From an All-Comers Multicentre Registry

Alessandra Francica  1 , Antonio Loforte  2   3 , Matteo Attisani  3 , Massimo Maiani  4 , Attilio Iacovoni  5 , Teodora Nisi  6 , Marina Comisso  7 , Amedeo Terzi  5 , Michele De Bonis  6 , Igor Vendramin  4 , Massimo Boffini  3 , Francesco Musumeci  7 , Giovanni Battista Luciani  1 , Mauro Rinaldi  3 , Davide Pacini  2 , Francesco Onorati  1
Affiliations
Multicenter Study

Five-Year Outcome After Continuous Flow LVAD With Full-Magnetic (HeartMate 3) Versus Hybrid Levitation System (HeartWare): A Propensity-Score Matched Study From an All-Comers Multicentre Registry

Alessandra Francica et al. Transpl Int. .

Erratum in

Abstract

Despite the withdrawal of the HeartWare Ventricular Assist Device (HVAD), hundreds of patients are still supported with this continuous-flow pump, and the long-term management of these patients is still under debate. This study aims to analyse 5 years survival and freedom from major adverse events in patients supported by HVAD and HeartMate3 (HM3). From 2010 to 2022, the MIRAMACS Italian Registry enrolled all-comer patients receiving a LVAD support at seven Cardiac Surgery Centres. Out of 447 LVAD implantation, 214 (47.9%) received HM3 and 233 (52.1%) received HVAD. Cox-regression analysis adjusted for major confounders showed an increased risk for mortality (HR 1.5 [1.2-1.9]; p = 0.031), for both ischemic stroke (HR 2.08 [1.06-4.08]; p = 0.033) and haemorrhagic stroke (HR 2.6 [1.3-4.9]; p = 0.005), and for pump thrombosis (HR 25.7 [3.5-188.9]; p < 0.001) in HVAD patients. The propensity-score matching analysis (130 pairs of HVAD vs. HM3) confirmed a significantly lower 5 years survival (81.25% vs. 64.1%; p 0.02), freedom from haemorrhagic stroke (90.5% vs. 70.1%; p < 0.001) and from pump thrombosis (98.5% vs. 74.7%; p < 0.001) in HVAD cohort. Although similar perioperative outcome, patients implanted with HVAD developed a higher risk for mortality, haemorrhagic stroke and thrombosis during 5 years of follow-up compared to HM3 patients.

Keywords: HeartMate3; HeartWare; continuous-flow LVAD; full-magnetic levitation pump; hybrid levitation system pump.

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Conflict of interest statement

The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

Figures

FIGURE 1
FIGURE 1
Flowchart of the study population.
FIGURE 2
FIGURE 2
Overall (A) and PS-matched survival (B): HVAD patients had a significantly lower 5 years survival than HM3 patients in both unmatched and matched populations.
FIGURE 3
FIGURE 3
PS-matched population freedom from haemorrhagic stroke (A) and from pump thrombosis (B): HVAD patients had a significantly lower freedom from haemorrhagic stroke and from pump thrombosis.
FIGURE 4
FIGURE 4
PS-matched populations freedom from (A) ischaemic stroke, (B) gastrointestinal bleeding, (C) driveline infection, (D) right ventricular failure: no statistically significant differences at 5 years were found between HVAD and HM3 cohorts.
See this image and copyright information in PMC

References

    1. Ponikowski P, Voors AA, Anker SD, Bueno H, Cleland JGF, Coats AJS, et al. ESC Guidelines for the Diagnosis and Treatment of Acute and Chronic Heart Failure: The Task Force for the Diagnosis and Treatment of Acute and Chronic Heart Failure of the European Society of Cardiology (ESC)Developed With the Special Contribution of the Heart Failure Association (HFA) of the ESC. Eur Heart J (2016) 37(27):2129–200. 10.1093/eurheartj/ehw128 - DOI - PubMed
    1. Rogers JG, Pagani FD, Tatooles AJ, Bhat G, Slaughter MS, Birks EJ, et al. Intrapericardial Left Ventricular Assist Device for Advanced Heart Failure. N Engl Med (2017) 376:451–60. 10.1056/NEJMoa1602954 - DOI - PubMed
    1. Mehra MR, Goldstein DJ, Cleveland JC, Cowger JA, Hall S, Salerno CT, et al. Five-Year Outcomes in Patients With Fully Magnetically Levitated vs Axial-Flow Left Ventricular Assist Devices in the MOMENTUM 3 Randomized Trial. JAMA (2022) 328(12):1233–42. 10.1001/jama.2022.16197 - DOI - PMC - PubMed
    1. FDA Class Irecall for Medtronic HVAD system. Stop New Implants of the Medtronic HVAD System—Letter to Health Care Providers (2021). Available at: https://www.fda.gov/medical-evices/letters-health-care-providers/stop-ne... (Accessed October 16, 2021).
    1. Medtronic. Medtronic Press Release Urgent Medical Device Communication Notification Letter Medtronic HVAD™ System (2021). Available at: https://www.medtronic.com/content/dam/medtronic-com/global/HCP/Documents... (Accessed October 16, 2021).

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