Numan, Lieke; Zimpfer, Daniel; Ben Zadok, Osnat Itzhaki; Aarts, Emmeke; Morshuis, Michiel; Guenther, Sabina PW; Riebandt, Julia; ... Van Laake, Linda W; + view all Numan, Lieke; Zimpfer, Daniel; Ben Zadok, Osnat Itzhaki; Aarts, Emmeke; Morshuis, Michiel; Guenther, Sabina PW; Riebandt, Julia; Wiedemann, Dominik; Ramjankhan, Faiz Z; Oppelaar, Anne-Marie; Ben-Gal, Tuvia; Ben-Avraham, Binyamin; Asselbergs, Folkert W; Schramm, Rene; Van Laake, Linda W; - view fewer (2023) Identifying patients at risk: multi-centre comparison of HeartMate 3 and HeartWare left ventricular assist devices. ESC Heart Failure 10.1002/ehf2.14308. (In press).

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Abstract

Aims: Since the withdrawal of HeartWare (HVAD) from the global market, there is an ongoing discussion if and which patients require prophylactically exchange for a HeartMate 3 (HM3). Therefore, it is important to study outcome differences between HVAD and HM3 patients. Because centres differ in patient selection and standard of care, we performed a propensity score (PS)-based study including centres that implanted both devices and aimed to identify which HVAD patients are at highest risk. Methods and results: We performed an international multi-centre study (n = 1021) including centres that implanted HVAD and HM3. PS-matching was performed using clinical variables and the implanting centre. Survival and complications were compared. As a sensitivity analysis, PS-adjusted Cox regression was performed. Landmark analysis with conditional survival >2 years was conducted to evaluate long-term survival differences. To identify which HVAD patients may benefit from a HM3 upgrade, Cox regression using pre-operative variables and their interaction with device type was performed. Survival was significantly better for HM3 patients (P < 0.01) in 458 matched patients, with a median follow-up of 23 months. Within the matched cohort, HM3 patients had a median age of 58 years, and 83% were male, 80% of the HVAD patients were male, with a median age of 59 years. PS-adjusted Cox regression confirmed a significantly better survival for HM3 patients when compared with HVAD, with a HR of 1.46 (95% confidence interval 1.14–1.85, P < 0.01). Pump thrombosis (P < 0.01) and ischaemic stroke (P < 0.01) occurred less in HM3 patients. No difference was found for haemorrhagic stroke, right heart failure, driveline infection, and major bleeding. Landmark-analysis confirmed a significant difference in conditional survival >2 years after implantation (P = 0.03). None of the pre-operative variable interactions in the Cox regression were significant. Conclusions: HM3 patients have a significantly better survival and a lower incidence of ischaemic strokes and pump thrombosis than HVAD patients. This survival difference persisted after 2 years of implantation. Additional research using post-operative variables is warranted to identify which HVAD patients need an upgrade to HM3 or expedited transplantation.

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