INTERMACS Analysis of Stroke During Support With Continuous-Flow Left Ventricular Assist Devices

Abstract

Objectives We sought to evaluate predictors of stroke on LVAD from data available prior to implantation, and quantify stroke-related morbidity and mortality Background Stroke is a major complication after LVAD. Pre-implant factors that influence stroke are not well understood. Methods We evaluated all patients in the INTERMACS registry who were implanted with continuous-flow LVADs from May 1, 2012 to March 31, 2015. Preoperative risk factors for stroke, and stroke incidence, morbidity, and mortality were analyzed. Results During the study period, 7112 patients underwent CF LVAD placement. Median follow-up was 9.79 months (range 0.02–34.96 months). Of all patients, 752 (10.57%) had at least one stroke, with an incidence rate of 0.123 strokes per patient-year. 447 (51.38%) strokes were ischemic and 423 (48.62%) were hemorrhagic. Patients with hemorrhagic stroke had worse survival than those with ischemic strokes (30-day survival 45.3% vs. 80.7, p <0.001). Of patients with a first stroke, 13% had a second stroke. Pre-implant predictors of stroke were female gender (HR 1.51, 95% CI 1.25–1.82, p <0.001), pre-implant systolic blood pressure (HR 1.01, 95% CI 1.00–1.01, p = 0.002), heparin-induced thrombocytopenia (HIT) (HR 3.68, 95% CI 1.60–8.47, p = 0.002), intra-aortic balloon pump (IABP) (HR 1.21, 95% CI 1.01–1.46, p = 0.043), and primary cardiac diagnosis (ischemic/other/unknown) (p = 0.040). Conclusion Despite improvements in LVAD technology, stroke-related morbidity and mortality is substantial. Further investigation is necessary to decrease the risk of this devastating complication.

Stroke after implantation of continuous flow left ventricular assist devices

“…It is a leading cause of death that not only affects outcomes, but also the quality of life and transplantation candidacy. [8][9][10][11][12][13][14] The high incidence of stroke is mainly caused by an extremely delicate balance that exists between thrombosis and bleeding in patients receiving LVAD therapy. There is an intrinsic thrombogenicity associated with the device.…”

“…The reported incidences of post-LVAD stroke across a variety of studies range from 10%-40%. [8][9][10][11][12][13][14] The cause of this common complication is multifactorial. LVAD therapy significantly alters a patient's coagulation profile.…”

Reducing regional flow stasis and improving intraventricular hemodynamics with a tipless inflow cannula design: An in vitro flow visualization study using the EVAHEART LVAD

“…Hypertension, diabetes, and thrombocytopenia are all risk factors for thrombus formation in heart failure patients, which are not accounted for in the mock circulatory loop studies. Long‐term remodeling is another significant challenge for predicting outcomes from in vitro studies, including the formation of pannus at the inflow cannula and LV volume reduction due to reverse remodeling . Thus, any trends indicated by experimental measurements must be validated with clinical outcomes.…”

“…In addition to the high incidence of stroke events, there is a high risk associated with stroke. In the third quarter of 2017, INTERMACS identified neurological dysfunction as the primary cause of death in 18.8% of reported deaths . Previous studies have identified the LVAD inflow cannula as a nidus for thrombus formation.…”

“…In the third quarter of 2017, INTERMACS identified neurological dysfunction as the primary cause of death in 18.8% of reported deaths. 2 Previous studies have identified the LVAD inflow cannula as a nidus for thrombus formation. In particular, the outer aspect of the LVAD inflow cannula that protrudes into the LV has shown a high incidence of thrombi, sometimes accompanied by pannus formation, that is considered a high risk for complications.…”