Neurologic Events With a Totally Implantable Left Ventricular Assist Device: European LionHeart Clinical Utility Baseline Study (CUBS)

• Published in: The Journal of heart and lung transplantation Vol. 26; no. 1; pp. 1 - 8
• Main Authors: Pae, Walter E., MD, Connell, John M., MD, MPH, Boehmer, John P., MD, Korfer, Reiner, MD, El-Banayosy, Aly, MD, Hetzer, Roland, MD, Vigano, Mario, MD, Pavie, Alain, MD
• Format: Journal Article
• Language: English
• Published: New York, NY Elsevier Inc 2007; Elsevier Science
• Subjects: Aged; Anesthesia. Intensive care medicine. Transfusions. Cell therapy and gene therapy; Biological and medical sciences; Emergency and intensive cardiocirculatory care. Cardiogenic shock. Coronary intensive care; Follow-Up Studies; France - epidemiology; Heart Failure - therapy; Heart-Assist Devices - adverse effects; Humans; Incidence; Intensive care medicine; Male; Medical sciences; Middle Aged; Prognosis; Prospective Studies; Risk Factors; Stroke - epidemiology; Stroke - etiology; Surgery; Surgery (general aspects). Transplantations, organ and tissue grafts. Graft diseases; Surgery of the heart; Europe; France; Artificial heart; Intensive cardiocirculatory care; Respiratory disease; Artificial ventricle; Cardiocirculatory support; Cardiovascular disease; European; Symptomatology; Treatment; Implanted; Surgery; Auxiliary ventricule; Public health
• ISSN: 1053-2498; 1557-3117
• DOI: 10.1016/j.healun.2006.10.007

Background Neurologic events such as thromboembolic and hemorrhagic strokes are common complications of mechanical circulatory support. We report the neurologic events observed in patients treated for end-stage heart failure with the implantable, pulsatile LionHeart left ventricular assist device (LVAD). This sub-study was part of the LionHeart European Clinical Utility Baseline Study (CUBS). Methods Twenty-three male patients were implanted with the LionHeart LVAD in a non-randomized, observational study. Neurologic events were classified into three categories: (1) transient ischemic attacks (TIAs); (2) strokes, including cerebrovascular accidents (CVAs) and intracranial bleeding (ICB); and (3) “other,” including hypoperfusion, coma and brain death. Neurologic injuries were also categorized as transient/reversible or permanent/disabling. Results Thirteen of 23 patients (57%) had a total of 30 neurologic events. Eight patients (35%) had 18 TIAs. Eight patients (35%) also had a stroke, either CVA ( n = 5, 22%) or ICB ( n = 3, 13%), and 5 of these patients (22%) also had 12 TIAs. Three patients (13%) had 4 “other” neurologic events. Ten patients (43%) had transient/reversible neurologic deficits and 10 (43%) had permanent/disabling events. One patient (4%) had intracranial bleeding as a primary cause of death (anti-coagulation–related hemorrhage). The combined incidence of neurologic events was 1.37 events/patient-year. The incidences of transient and permanent events were 0.91 and 0.46 event/patient-year, respectively. Conclusions Neurologic events caused morbidity in the CUBS trial, with infrequent mortality. These results are similar to previous experiences with destination therapy and underscore the need for improvements in LVAD design, patient selection and patient management to reduce the incidence of neurologic events.