Incidence of Postoperative Bleeding in Patients with a Heartmate II Left Ventricular Assist System with Sealed Grafts

Abstract

Introduction: The implantation of ventricular assist devices [VAD] is an effective and well recognized surgical treatment option for patients with terminal chronic or acute heart failure. However, the incidence of post-operative bleeding has remained high. Since the beginning of 2011 a sealed inflow graft was added to the HeartMate II LVAS (Thoratec) making both grafts (inflow and ouflow) sealed. Methods: The primary study objective was to compare the amount of chest tube drainage at 48 hours between two groups: 20 patients implanted with non-sealed inflow and outflow grafts (retrospective data) and 20 patients implanted with the sealed inflow and outflow grafts (prospective) while using our standard institutional anti-coagulation protocol in both groups. Patients were excluded from this study if they had known thrombophilia, a suboptimal pre-operative anticoagulation status, sepsis or infection before implantation. Additional secondary parameters included number of units of packed red blood cells and fresh-frozen plasma, days of ICU stay, and days to discharge. Results: A preliminary review and analysis was performed. The data of 20 HeartMate II patients with a non-sealed grafts (75% male, median age 57 years, median support time 12 months, 45% DCMP, 45% ICMP, 75% INTERMACS category 2 and 3) was compared to that of 12 HeartMate II patients implanted with sealed grafts (100% male, median age 58 years, median support time 3 months, 50% DCMP, 50% ICMP, 92% INTERMACS category 2 and 3). The chest tube drainage at 48 hours was lower in the sealed graft group: 1425 ml vs 1750 ml. Outcomes did not differ between the groups, with a 30 day survival of 100%. The additional secondary parameters will be reported after completion of study enrolment. Conclusion: This preliminary analysis indicates that introduction of the HeartMate II sealed grafts did lead to decreased postoperative bleeding at 48 hours.