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Observational Study
. 2022 Oct;9(5):3469-3482.
doi: 10.1002/ehf2.13794. Epub 2022 Jul 26.

Third-generation continuous-flow left ventricular assist devices: a comparative outcome analysis by device type

Maks Mihalj  1 , Paul Philipp Heinisch  1 , Patrick Schober  2 , Monika Wieser  3 , Michele Martinelli  3 , Theo M M H de By  4 , Joerg C Schefold  5 , Markus M Luedi  6 , Alexander Kadner  1 , Thierry Carrel  1 , Paul Mohacsi  3 , Lukas Hunziker  3 , David Reineke  1
Affiliations
Observational Study

Third-generation continuous-flow left ventricular assist devices: a comparative outcome analysis by device type

Maks Mihalj et al. ESC Heart Fail. 2022 Oct.

Abstract

Aims: Continuous-flow left ventricular assist devices (CF-LVADs) have become a standard of care in end-stage heart failure. Limited data exist comparing outcomes of HeartMate3 (HM3) and HeartWare HVAD (HW). We aimed to compare midterm outcomes of these devices.

Methods and results: Investigator-initiated retrospective-observational comparative analysis of all patients who underwent primary LVAD implantation of either HM3 or HW at our centre between January 2010 and December 2020. Data were derived from a prospective registry. Primary endpoints were all-cause mortality and heart transplantation. Secondary endpoints included device-related major adverse cardiac and cerebrovascular events, which included major bleeding, major neurological dysfunction (defined as persisting neurological impairment for ≥24 h), device-related major infection (excluding driveline infections), major device malfunctions leading to re-intervention or partial device exchange (pump failure, outflow-graft twist or failure, controller failure, battery failure, patient cable failure, but excluding pump thrombosis), and pump thrombosis. Further secondary endpoints included right heart failure, gastrointestinal bleeding, driveline infections, and surgical re-interventions. The secondary outcomes were analysed not only for the first event but also for recurrent events. The analysis included competing risks analysis and recurrent event regression analysis, with adjustment for confounders age, gender, body mass index (BMI), and Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) level. Out of 106 primary CF-LVAD implantations, 36 (34%) received HM3 and 70 (66%) received HW. Median follow-up was 1.48 years [interquartile range 0.67, 2.41]. HM3 was more often implanted in men (91.7% vs. 72.9%, P = 0.024); patients were older (median 61 years [54, 66.5] vs. 52.5 years [43, 60], P < 0.001), had a higher BMI (median 26.7 kg/m2 [23.4, 29.0] vs. 24.3 kg/m2 [20.7, 27.4], P = 0.013), had more comorbidities, and were more likely targeted for destination therapy (36.1% vs. 14.3%, P = 0.010). Death occurred in 33.3% of HM3 patients, compared with 22.9% of HW patients, P = 0.247 (probability of survival at 4 years, 54.7% vs. 74.1%, P = 0.296). After adjustment for confounders, we observed a significant six-fold risk increase in device malfunctions for HW [hazard ratio (HR) 6.49, 95% confidence interval (CI) [1.89, 22.32], P = 0.003], but no significant differences in pump thrombosis (P = 0.173) or overall survival (P = 0.801).

Conclusions: Comparing midterm outcomes between HM3 and HW for LVAD support from a prospective registry, HW patients had a significantly higher risk of device malfunctions. No significant differences were evident between devices in overall survival and in respect to most outcomes.

Keywords: HeartMate3; HeartWare HVAD; LVAD; Left ventricular assist device; Outcome comparison.

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Conflict of interest statement

J.C.S. reports (full departmental disclosure) departmental grants outside of the submitted work from Orion Pharma, Abbott Nutrition International, Braun Medical AG, CSEM AG, Edwards Lifesciences Services GmbH, Kenta Biotech Ltd, Maquet Critical Care AB, Omnicare Clinical Research AG, Nestle, Pierre Fabre Pharma AG, Pfizer, Bard Medica S.A., Abbott AG, Anandic Medical Systems, Pan Gas AG Healthcare, Bracco, Hamilton Medical AG, Fresenius Kabi, Getinge Group Maquet AG, Dräger AG, Teleflex Medical GmbH, Glaxo Smith Kline, Merck Sharp and Dohme AG, Eli Lilly and Company, Baxter, Astellas, Astra Zeneca, CSL Behring, Novartis, Covidien, and Nycomed. The money was paid into departmental funds, and there was no personal financial gain. P.M. reports consulting for Abbott outside of the submitted work. D.R. reports proctoring for Abbott HM3, has previously received paid travel expenses by Edwards, Medtronic, and Abbott, and is the board member of Swiss Society of Cardiac Surgery. All authors report no conflicts of interest, and the presented study did not receive any funding support.

Figures

Figure 1
Figure 1
Kaplan–Meier plots and adjusted cumulative incidence functions (considering heart transplantation as competing risk for death and vice versa) for primary outcomes. Kaplan–Meier survival probability of primary outcomes of overall survival (A) and heart transplantation (C), and correlating competing risk analysis after adjusting for confounders, respectively (B, D). No significant difference was observed in overall survival between devices. Significant difference in transplant probability was observed in HeartWare HVAD in the adjusted and unadjusted model. The cumulative incidence functions for death (B) and heart transplantation (D) are typically displayed.
Figure 2
Figure 2
Forest plot analysis of primary and secondary outcomes by device type. Time‐to‐event analysis for primary and secondary outcomes. Primary outcomes were analysed by Cox proportional hazards regression. Secondary outcomes can recur and were analysed with a modification of Cox proportional hazards regression suggested by Andersen and Gill. All analyses were adjusted for patient age and body mass index at the time of device implantation, gender, and Interagency Registry for Mechanically Assisted Circulatory Support score 1–3 versus 4–7. CI, confidence interval; HR, hazard ratio; MACCE, major device‐related adverse cardiac and cerebrovascular events.
Figure 3
Figure 3
Kaplan–Meier plots for secondary outcomes and adjusted cumulative incidence functions for secondary outcomes. Kaplan–Meier freedom‐from‐event analysis for secondary outcomes: composite of MACCE (A), major device malfunction excluding pump thrombosis (C), and pump thrombosis (D). Competing risk analysis for composite of MACCE after adjusting for confounders is displayed in Panel (B). The cumulative incidence functions for MACCE are typically displayed. MACCE, major device‐related adverse cardiac and cerebrovascular events.
See this image and copyright information in PMC

References

    1. Kormos RL, Cowger J, Pagani FD, Teuteberg JJ, Goldstein DJ, Jacobs JP, Higgins RS, Stevenson LW, Stehlik J, Atluri P, Grady KL, Kirklin JK. The Society of Thoracic Surgeons Intermacs database annual report: evolving indications, outcomes, and scientific partnerships. J Heart Lung Transplant 2019; 38: 114–126. - PubMed
    1. Teuteberg JJ, Cleveland JC Jr, Cowger J, Higgins RS, Goldstein DJ, Keebler M, Kirklin JK, Myers SL, Salerno CT, Stehlik J, Fernandez F, Badhwar V, Pagani FD, Atluri P. The Society of Thoracic Surgeons Intermacs 2019 annual report: the changing landscape of devices and indications. Ann Thorac Surg 2020; 109: 649–660. - PubMed
    1. Molina EJ, Shah P, Kiernan MS, Cornwell WK 3rd, Copeland H, Takeda K, Fernandez FG, Badhwar V, Habib RH, Jacobs JP, Koehl D, Kirklin JK, Pagani FD, Cowger JA. The Society of Thoracic Surgeons Intermacs 2020 annual report. Ann Thorac Surg 2021; 111: 778–792. - PubMed
    1. Zimpfer D, Gustafsson F, Potapov E, Pya Y, Schmitto J, Berchtold‐Herz M, Morshuis M, Shaw SM, Saeed D, Lavee J, Heatley G, Gazzola C, Garbade J. Two‐year outcome after implantation of a full magnetically levitated left ventricular assist device: results from the ELEVATE registry. Eur Heart J 2020; 41: 3801–3809. - PubMed
    1. Goldstein DJ, Naka Y, Horstmanshof D, Ravichandran AK, Schroder J, Ransom J, Itoh A, Uriel N, Cleveland JC Jr, Raval NY, Cogswell R, Suarez EE, Lowes BD, Kim G, Bonde P, Sheikh FH, Sood P, Farrar DJ, Mehra MR. 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. JAMA Cardiol 2020; 5: 411–419. - PMC - PubMed

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