This section describes safety outcomes from the published literature that the Committee considered as part of the evidence about this procedure. For more detailed information on the evidence, see the overview.
Death caused by device failure was reported in less than 1% (6 out of 1,160) of patients treated by continuous‑flow left ventricular assist devices (LVADs) and 2% (3 out of 127) of patients treated by pulsatile‑flow LVADs in a registry of 1,287 patients at 2‑year follow‑up. Death arising from loss of power to external components of LVADs was reported in 2% (9 out of 414) of patients in a case series of 414 patients treated by continuous‑flow LVADs, at a minimum follow‑up of 2 years.
Ischaemic stroke was reported in 8% (11 out of 133) of patients treated by continuous‑flow LVADs and 7% (4 out of 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 out of 133) of patients treated by continuous‑flow LVADs and 8% (5 out of 59) of patients treated by pulsatile‑flow LVADs at 2‑year follow‑up (p=0.33).
Right heart failure, managed by extended inotrope therapy, was reported in 20% (27 out of 133) of patients treated by continuous‑flow LVADs and 27% (16 out of 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 out of 133) of patients treated by continuous‑flow LVADs and 5% (3 out of 59) of patients treated by pulsatile‑flow LVADs at 2‑year follow‑up (p=0.12).
Respiratory failure was reported in 38% (50 out of 133) of patients treated by continuous‑flow LVADs and 41% (24 out of 59) of patients treated by pulsatile‑flow LVADs at 2‑year follow‑up in the randomised controlled trial of 200 patients (p<0.001).
Renal failure was reported in 16% (21 out of 133) of patients treated by continuous‑flow LVADs and 24% (14 out of 59) of patients treated by pulsatile‑flow LVADs at 2‑year follow‑up in the randomised controlled trial of 200 patients (p<0.001).
Cardiac arrhythmia was reported in 56% (75 out of 133) of patients treated by continuous‑flow LVADs and 59% (35 out of 59) of patients treated by pulsatile‑flow LVADs at 2‑year follow‑up in the randomised controlled trial of 200 patients (p=0.006).
LVAD-related infection was reported in 35% (47 out of 133) of patients treated by continuous‑flow LVADs and 36% (21 out of 59) of patients treated by pulsatile‑flow LVADs at 2‑year follow‑up in the randomised controlled trial of 200 patients (p=0.01).
Pump replacement was needed for 9% (12 out of 133) of patients treated by continuous‑flow LVADs and 34% (20 out of 59) of patients treated by pulsatile‑flow LVADs at 2‑year follow‑up in the randomised controlled trial of 200 patients (p<0.001).
Pump thrombosis was reported in 4% (5 out of 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).
Bleeding that needed blood transfusion was reported in 76% (315 out of 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 out of 414) of patients (no further details were provided).
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.