PURPOSE: The LATERAL Trial demonstrated safety and efficacy of the thoracotomy approach in implanting the HVAD™ System as a bridge to transplant (BTT). The purpose of this analysis is to evaluate pre-discharge (DC) adverse event burden for bleeding as compared to the historical BTT/CAP Trial. METHODS: A post-hoc comparative analysis was performed on the ADVANCE BTT/Continued Access Protocol (BTT/CAP) (N=382) and LATERAL Trials (N=144) to identify patients who experienced a bleeding event prior to hospital DC following VAD implant. Per INTERMACS definitions, bleeding events included those that required reoperation, blood transfusions, and gastrointestinal bleeding (GIB). Events per patient year (EPPY) between the LATERAL and BTT-CAP cohorts were compared. RESULTS: There were 10 patients in the LATERAL Trial who experienced pre-discharge bleeding events, of which 5 required re-operation, 10 blood transfusions, and 3 GIBs (1.62, 0.74, 1.62, 0.59 EPPY respectively). In patients enrolled in BTT-CAP, 107 experienced pre-discharge bleeding events, 40 requiring re-operation, 50 blood transfusions, and 15 GIBs (6.21, 1.68, 2.11, 0.57 EPPY respectively). The overall pre-discharge bleeding rate was significantly lower in the Lateral Trial compared to BTT-CAP (p<0.001), with a trend toward lower reoperations for bleeding (Table 1). Transfusion rates were numerically improved in patients in the Lateral Trial with similar rates of GIB between groups. CONCLUSION: This post-hoc comparison of the Lateral and BTT/CAP trials reveals a significant reduction in overall pre-discharge bleeding events and a trend toward reduction in events requiring reoperations following thoracotomy HVAD implant. These findings continue to support the potential benefits of the thoracotomy approach for implantation of the HVAD System.
|Original language||English (US)|
|Journal||The Journal of heart and lung transplantation : the official publication of the International Society for Heart Transplantation|
|State||Published - Apr 1 2020|
ASJC Scopus subject areas
- Pulmonary and Respiratory Medicine
- Cardiology and Cardiovascular Medicine