Destination Therapy in a Single European Country. Insights from the ITAMACS Registry

ITAMACS is a registry coordinated by the National Centre for Transplantations, an agency of the Italian Ministry of Health, reporting on long-term left ventricular assist device (LVAD) implants performed in 22 Italian centers. This paper is a retrospective analysis of prospectically collected data in LVAD implants performed as Destination Therapy (DT) in adult patients (pts) between January 2010 and December 2014. The records of 148 pts [(males 134, 91%; mean age 65 years (y)), age 50 to 64 y =58 pts (40%), 65 to 69 y=58 pts (40%), >70 y= 32 pts (20%); ischemic etiology 60%] were reviewed. Implanted devices were Incor BH (n=6, 4%), HeartAssist5 (n=2, 1%), Thoratec HM II (n=35, 23%), HeartWare HVAD (n=49, 33%), and Jarvik 2000 (n=56, 39%). INTERMACS level at implant was 1 in 16 pts (11%), 2 in 49 (33%), 3 in 44 (30%), 4 in 38 (26%). Level 1 pts did reduce through the years, from 18% in 2010 to 10% in 2014. In the 114 pts surviving the operation (77%), median duration of hospitalization was 29 days, not affected by etiology of the disease. Cumulative survival was 58%, 46%, 34% at 1, 2, and 3 years respectively. Survival at 1 year of INTERMACS level 1,2,3,4 pts was 19%, 56%, 63%, and 72% respectively (p<0.0001). Two-year survival was not influenced by age at implant, etiology of the disease, or re-do operation. Device malfunction, mainly due to pump thrombosis, occurred in 12% of the cases. Death occurred in 79 pts (53%): main causes of death were stroke (19%), infection (23%), right ventricular failure (12%), pump thrombosis (10%), other (36%). Pts operated after 2012 (n=76, 51%) had a significantly better 1-year survival with respect to those operated from 2010 to 2012 (60% vs 36%, p=0.008). ITAMACS depicts the actual scenario of DT in the most important Italian centers, in a relatively homogeneous cohort of eligible pts. Increasing usage of LVAD for DT is due to organ shortage. In keeping with international reports, INTERMACS level seems to be the most important factor affecting survival, partially regardless of age at implant, etiology of disease or previous surgery. A possible explanation of better survivals after 2012 can be found in centers’ learning curve and improved pts referral, with less INTERMACS level 1 pts trough the observation period.