4 Efficacy

4 Efficacy

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 interventional procedure overview.

4.1 A register including 3065 adult cardiac failure and cardiopulmonary resuscitation (CPR) patients reported survival to discharge or transfer in 39% (891/2312) of cardiac failure patients and in 27% (207/753) of CPR patients. A non-randomised comparative study of 79 patients (61 treated by extracorporeal membrane oxygenation [ECMO] compared with 18 treated by miniaturised percutaneous ventricular assist device [mp-VAD]) reported in-hospital survival in 49% (30/61) of ECMO patients and 50% (9/18, p>0.999) of mp-VAD patients.Three case series of 81 patients (with acute refractory cardiogenic shock), 295 patients (treated by ECMO-supported CPR), 219 patients (with refractory postcardiotomy cardiogenic shock) and 1 systematic review of case series of 1150 patients (with cardiogenic shock postcardiotomy) reported survival to discharge in 42% (34/81), 27% (79/295), 24% (52/219) and 34% (386/1150) of patients respectively.

4.2 A case series of 47 patients with refractory postcardiotomy cardiogenic shock who were discharged from hospital after ECMO reported an overall survival rate of 59% at 10 years.

4.3 A non-randomised comparative study of 79 patients (61 ECMO compared with 18 mp-VAD) reported 31% (19/61) of the ECMO group and 28% (5/18, p>0.999) of the mp-VAD group were successfully bridged to long-term support or transplant. A systematic review of case series of 800 patients reported that 4% (29/800) were bridged to transplant. Seventy-six per cent (22/29) of these patients survived to discharge. The case series of 219 patients reported that 4% (8/219) of patients were bridged to a long-term ventricular assist device. Five patients subsequently died, 2 had a successful transplant and 1 was successfully weaned from ECMO.

4.4 The case series of 81 patients (28 patients available for quality of life evaluation) reported significantly better scores in physical component (p=0.0001), general health (p=0.01) and vitality (p=0.02) domains of SF-36 quality of life scores in 14 patients who were followed up for 325 days or more than 14 patients who were followed up for fewer than 325 days.

4.5 The specialist advisers listed key efficacy outcomes as survival (to discharge from hospital, at 28 days, at 6 months, to definitive therapy, and long term), successful bridge to recovery, functional capacity and quality of life in the long term.

  • National Institute for Health and Care Excellence (NICE)