Stroke and Intracranial Hemorrhage in HeartMate II and HeartWare Left Ventricular Assist Devices: A Systematic Review

Background: Ischemic stroke and intracranial hemorrhage (ICH) following left ventricular assist device (LVAD) placement are major causes of morbidity. The incidence and mortality associated with these events stratified by device type have not been systematically explored. Methods: A systematic review of PubMed was conducted from January 2007 through June 2016 for all English-language articles involving HeartMate II (HMII) and HeartWare LVAD patients. Ischemic stroke and/or ICH incidence (events per patient-year) and associated mortality rates were abstracted for each device type. Results: Of 735 articles reviewed, 48 (11,310 patients) met inclusion criteria (33 HMII, six HeartWare, eight both devices, and one unspecified). The median duration of device support was 112 days (total 13,723 patient-years). Overall, ischemic stroke or ICH occurred in 9.8% (1110 persons and 0.08 events per patient year [EPPY]). Ischemic stroke occurred in a median of 6.0% or 0.06 EPPY (range 0–16% or 0–0.21 EPPY) of HMII patients versus 7.5% or 0.09 EPPY (range 4–17.1% or 0.01–0.94 EPPY) of HeartWare patients. ICH occurred in a median of 3.0% or 0.04 EPPY (range 0–13.5% or 0–0.13 EPPY) of HMII and 8.0% or 0.08 EPPY (range 3–23% or 0.01–0.56 EPPY) of HeartWare patients. The median mortality rate for LVAD-associated ischemic stroke was 31% (HMII: 33%, [range 2.4–75%] and HeartWare: 11.5% [range 3.9–40%]), and the median mortality rate following ICH was 71% (HMII: 75%, [range 3.9–100%] and HeartWare: 44%, [range 3.1–88%]). Conclusions: Ischemic stroke and ICH are common after LVAD placement, but heterogeneous event rates are reported in the literature. Given the high associated mortality, further prospective study is warranted.