Identification of characteristics, risk factors, and predictors of recurrent LVAD thrombosis: conditions in HeartWare de

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ORIGINAL ARTICLE Artificial Heart (Clinical)

Identification of characteristics, risk factors, and predictors of recurrent LVAD thrombosis: conditions in HeartWare devices Takayuki Gyoten1   · Michiel Morshuis1 · Sebastian V. Rojas1 · Marcus‑André Deutsch1 · René Schramm1 · Jan F. Gummert1 · Henrik Fox1 Received: 26 August 2020 / Accepted: 4 November 2020 © The Author(s) 2020

Abstract Background  Redictors of repetitive left-ventricular assist device (LVAD)-thrombosis have not been studied yet. Methods  We identified predictors of recurrent LVAD thrombosis in HeartWare (HVAD) patients in a long-term study from 2010 until 2020. We included all patients with two or more thrombolysis treatments for repetitive HVAD thrombosis and effectiveness of thrombolytic therapy was defined as freedom from stroke, death, another HVAD thrombosis, or surgical device exchange within 30 days after the event. Study endpoints also include all-cause mortality and heart transplantation. Results  A total of 534 HVAD implantations have been screened, and 73 patients (13.7%) developed first HVAD thrombosis after a median of 10 months (IQR; 6–21 months). 46 of these patients had effective thrombolysis in 71.7% (n = 33/46). After a median of 14 months (IQR 4–32 months) follow-up, 17 patients (51.5%) had developed a second HVAD thrombosis and all were treated with t-PA therapy again, resulting in effectiveness in 76.5% (n = 13/17). The four patients with ineffective t-PA therapy underwent subsequent surgical HVAD exchange. Multiple Cox regression model analysis revealed time interval between HVAD implantation and first thrombosis as an independent risk factor of recurrent thrombosis (HR, 0.93, 95% CI 0.87–0.99, p = 0.031). Kaplan–Meier analysis at 3 year follow-up showed no significant difference in overall survival for recurrent vs non-recurrent thrombosis groups (log-rank test, p = 0.959). Conclusion  Recurrent HVAD thrombosis mostly appears within 12 months after first thrombosis. Systemic t-PA therapy for recurrent pump thrombosis seems safe, achieving comparable effectiveness rates to initial t-PA therapy. Survival does not differ between patients with or without recurrent HVAD thrombosis. Keywords  LVAD · Thrombolysis · Pump thrombosis · t-PA · Surgical pump exchange · HeartWare

Introduction Long-term mechanical circulatory support with left-ventricular assist devices (LVAD) has increasingly become an established treatment option in advanced heart failure with improving outcomes during the past 2 decades [1, 2]. In clinical routine, indication for LVAD implantation is provided by progressive heart failure (HF) often but not exclusively with severely impaired left-ventricular function in * Takayuki Gyoten [email protected] 1



Clinic for Thoracic and Cardiovascular Surgery, Herz‑ und Diabeteszentrum Nordrhein‑Westfalen, Universitätsklinik der Ruhr-Universität Bochum, Georgstrasse 11, 32503 Bad Oeynhausen, Germany

the context of exhausted medical therapy [1, 2]. However, LVAD thrombus formation either in the inflow cannula, in the d