Four-year outcomes with third-generation centrifugal left ventricular assist devices in an era of restricted transplantation

Abstract

OBJECTIVESThird-generation ventricular assist devices (VADs) are associated with improved outcomes, though in recent clinical trials bridge-to-transplant (BTT) rates are ∼30% at 6 months, so that transplantation can be used as a ‘bail out’ for serious complications. In the UK, there was a significant reduction in heart transplantation rates over the last decade, so that transplantation from VADs is much less frequent. The objective of this study was to determine outcomes and their predictors in this situation of low BTT rates, and as patients were exposed to long-term support, the incidence and outcomes of VAD thrombosis.METHODSWe analysed outcomes for 102 consecutive patients between 2009 and 2013 (mean age 47 ± 13; VentrAssist n = 6 and HeartWare n = 96). The median duration of support was 462 ± 426 days.RESULTSSurvival rates on the device were 75 and 66% at 1 and 2 years, respectively. Older age and more acute INTERMACS groups were significantly related to reduced survival within the first 90 days (P = 0.030 and 0.010, respectively). Poor preoperative right ventricular (RV) function had a negative effect on survival after 1 year (P = 0.009), though not earlier. VAD thrombosis (n = 24 HeartWare and n = 1 VentrAssist) occurred at 0.18 events per patient-year for HeartWare and 0.07 for VentrAssist devices at a median time of onset at 404 ± 281 days. There was no significant effect of VAD thrombosis on survival. Only 14 of 102 patients were transplanted at a median of 334 ± 347 days, and only 3 were transplanted within the first 6 months.CONCLUSIONSThird-generation left ventricular assist device implants with a low rate of transplantation have similar survival to destination therapy, and are susceptible to long-term complications of VAD thrombosis and right heart failure.

Initial 3‐year outcomes with left ventricular assist devices in a country with a nascent heart transplantation program

“…The percentage of patients with ICD/ cardiac resynchronization therapy in our population is lower than in some centres outside Kazakhstan, perhaps because of the fact that cardiac electrophysiology programmes in Kazakhstan began to develop recently. The mean age of our patients was similar to other recently published LVAD experience 11,12 The proportion of our patients with a DT indication was similar to the INTERMACS database. Fifty six percent of our patients received a VAD for the BTT indication; however, because of the lack of heart donors, transplantation is not common.…”

“…Notwithstanding, the differences in our study population compared with other centres, observed survival and adverse event rates are not dissimilar to those reported by other centres. [11][12][13] Our VAD programme was developed before any heart transplantation programme existed in our country. The existence of the VAD programme is now stimulating the growth of heart transplantation in Kazakhstan.…”

Impact of aortic valve closure on adverse events and outcomes with the HeartWare ventricular assist device

“…Compared with other series, the duration of support was longer, 2,11 which can at least partially explain the higher thrombotic event rates, because these are related to the duration of support. 4 This is also supported by the fact that our median time to PT is longer than in other series. 11 A unique aspect of our study population is the relatively low rates of transplantation in a group of patients in whom the indications were bridge to transplant or bridge to decision.…”

“…This is a retrospective analysis of patients aged older than 16 years who received a HeartWare HVAD as bridge to transplant or bridge to candidacy in the Freeman Hospital, between July 2009 and August 2015, following the standard technique previously described. 9 Anti-coagulation and anti-platelet regimens have previously been described, 4 and in brief, have been since 2011 a target international normalized ratio of 2.7 and aspirin at 300 mg daily. Before that, the standard dose of aspirin was 75 mg daily.…”

“…These discrepancies in mortality rates may be partly due to difficulties in diagnosing or defining PT, so there are concerns about some reports underestimating PT. 3,4 Ischemic stroke (IS) or transient ischemic attack (TIA), caused by cardioembolic events resulting from thrombus formation within the LV or the LVAD, are also important thrombotic complications of LVAD support. 5 The incidence was reported recently as 1.61 stroke events/100 patients within the first year after implantation.…”