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

4.1 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).

4.2 In a registry of 1287 patients treated by continuous‑flow (n=1160) 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).

4.3 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).

4.4 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).

4.5 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).

4.6 Specialist advisers listed key efficacy outcomes as: event‑free survival; cardiac output; exercise capacity; quality of life; and the 'potential for heart recovery'.