Implantation of a left ventricular assist device for destination therapy in people ineligible for heart transplantation

5.1 Death caused by device failure was reported in less than 1% (6/1160) of patients treated by continuous‑flow left ventricular assist devices (LVADs) and 2% (3/127) of patients treated by pulsatile‑flow LVADs in a registry of 1287 patients at 2‑year follow‑up. Death arising from loss of power to external components of LVADs was reported in 2% (9/414) of patients in a case series of 414 patients treated by continuous‑flow LVADs, at a minimum follow‑up of 2 years.

5.2 Ischaemic stroke was reported in 8% (11/133) of patients treated by continuous‑flow LVADs and 7% (4/59) of patients treated by pulsatile‑flow LVADs at 2‑year follow‑up in a randomised controlled trial of 200 patients (p=0.38). In the same study, haemorrhagic stroke was reported in 11% (15/133) of patients treated by continuous‑flow LVADs and 8% (5/59) of patients treated by pulsatile‑flow LVADs at 2‑year follow‑up (p=0.33).

5.3 Right heart failure, managed by extended inotrope therapy, was reported in 20% (27/133) of patients treated by continuous‑flow LVADs and 27% (16/59) of patients treated by pulsatile‑flow LVADs at 2‑year follow‑up in the randomised controlled trial of 200 patients (p<0.001). In the same study, right heart failure, treated by right ventricular assist devices, was reported in 4% (5/133) of patients treated by continuous‑flow LVADs and 5% (3/59) of patients treated by pulsatile‑flow LVADs at 2‑year follow‑up (p=0.12).

5.4 Respiratory failure was reported in 38% (50/133) of patients treated by continuous‑flow LVADs and 41% (24/59) of patients treated by pulsatile‑flow LVADs at 2‑year follow‑up in the randomised controlled trial of 200 patients (p<0.001).

5.5 Renal failure was reported in 16% (21/133) of patients treated by continuous‑flow LVADs and 24% (14/59) of patients treated by pulsatile‑flow LVADs at 2‑year follow‑up in the randomised controlled trial of 200 patients (p<0.001).

5.6 Cardiac arrhythmia was reported in 56% (75/133) of patients treated by continuous‑flow LVADs and 59% (35/59) of patients treated by pulsatile‑flow LVADs at 2‑year follow‑up in the randomised controlled trial of 200 patients (p=0.006).

5.7 LVAD-related infection was reported in 35% (47/133) of patients treated by continuous‑flow LVADs and 36% (21/59) of patients treated by pulsatile‑flow LVADs at 2‑year follow‑up in the randomised controlled trial of 200 patients (p=0.01).

5.8 Pump replacement was needed for 9% (12/133) of patients treated by continuous‑flow LVADs and 34% (20/59) of patients treated by pulsatile‑flow LVADs at 2‑year follow‑up in the randomised controlled trial of 200 patients (p<0.001).

5.9 Pump thrombosis was reported in 4% (5/133) of patients treated by continuous‑flow LVADs and 0% of patients treated by pulsatile‑flow LVADs at 2‑year follow‑up in the randomised controlled trial of 200 patients (no p value reported).

5.10 Bleeding that needed blood transfusion was reported in 76% (315/414) of patients in the case series of 414 patients treated by continuous‑flow LVADs. In the same study, bleeding that needed surgical re‑exploration was reported in 23% (95/414) of patients (no further details were provided).

5.11 In addition to safety outcomes reported in the literature, specialist advisers are asked about anecdotal adverse events (events which they have heard about) and about theoretical adverse events (events which they think might possibly occur, even if they have never done so). For this procedure, specialist advisers did not list any anecdotal adverse events. They considered that aortic regurgitation was a theoretical adverse event.