This section describes efficacy 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.
In a randomised controlled trial of 129 patients treated by pulsatile‑flow left ventricular assist device (LVAD) destination therapy (n=68) or optimal medical management (n=61), survival rates were 23% and 8% respectively at 2‑year follow‑up (p=0.09). At 4‑year follow‑up, survival rates were 16% in the pulsatile‑flow LVAD group and 8% in the optimal medical management group (no p value reported).
In a registry of 1,287 patients treated by continuous‑flow (n=1,160) or pulsatile‑flow (n=127) LVADs, survival rates were 76% and 68% respectively at 1‑year follow‑up (p<0.0001). At 2‑year follow‑up, survival rates were 67% in the continuous‑flow group and 45% in the pulsatile‑flow group (p<0.0001).
In a randomised controlled trial of 200 patients treated by continuous‑flow (n=134) or pulsatile‑flow LVADs (n=66), 6‑minute walking test distances improved from 182 m to 318 m (p<0.001) and 172 m to 306 m (p<0.001) respectively at 1‑year follow‑up (p value between groups=0.22).
In the randomised controlled trial of 200 patients treated by continuous‑flow or pulsatile‑flow LVADs, mean Minnesota Living with Heart Failure questionnaire scores (scores range from 0 to 105, with lower scores indicating better quality of life) improved from 75.4 to 34.1 (p<0.001) and 76.1 to 44.4 (p<0.001) respectively at 1‑year follow‑up (p value between groups=0.03). In the same study, mean overall Kansas City Cardiomyopathy questionnaire scores (scores range from 0 to 100, with higher scores indicating better quality of life) improved from 27.4 to 65.9 (p<0.001) in the continuous‑flow group and from 46.5 to 59.1 (p<0.001) in the pulsatile‑flow group at 1‑year follow‑up (p value between groups=0.06).
In the randomised controlled trial of 129 patients treated by pulsatile‑flow LVAD destination therapy or optimal medical management, mean SF‑36 emotional domain scores (scores range from 0 to 100, with higher scores indicating better emotional outcomes) changed from 33 to 64 and from 25 to 17 respectively at 1‑year follow‑up (p value between groups<0.05).
Specialist advisers listed key efficacy outcomes as: event‑free survival; cardiac output; exercise capacity; quality of life; and the 'potential for heart recovery'.