Excessive hemolysis is generally regarded as an adverse event when test results of plasma free hemoglobin >40 mg/dL are obtained after post surgical hemostasis has been acheived. During the clinical introduction of the AB5000 Ventricle, an early cluster of hemolysis events spurred a multi-faceted program which was successful in dramatically reducing event rates. This retrospective review describes the program and the resulting outcomes. Data voluntarily submitted to the ABIOMED Device registry by all US implanting institutions was used. All-cause, confirmed cases of hemolysis adverse events were grouped and analyzed. In the first six months of the clinical introduction (10/2003), hemolysis was reported in 10 of 63 patients (15.9%). A concerted effort to instruct clinicians on optimal implant techniques (eg. transesophagael echocardiography guidance), device management (eg. altering operation modes) and console upgrades (variable vacuum setting) was implemented. As a result, in the subsequent 251 patients over 21 months, there were only 14 confirmed reports of hemolysis (5.6%, p=0.01). Altogether, there were 15 biventricular and 9 univentricular hemolysis patients with an average support time of 36 days. Average pump flow index was 2.6 L/min/m2(n=19). Nine of 24 patients with observed hemolysis survived (37.5%). Hemolysis as a complication was identified early in the introduction of a new device and was greatly ameliorated by the combined efforts of both the device manufacturer and clinicians.
