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 overview.

4.1 A randomised controlled trial (RCT) of 550 patients whose condition was managed by either pulmonary artery pressure monitoring or standard monitoring reported 84 and 120 heart failure-related hospitalisations respectively at 6-month follow-up (p<0.0001). By the end of the trial (mean follow-up 15 months) there were 158 heart failure-related hospitalisations in the pressure monitor group versus 254 in the control group (p<0.0001).

4.2 The RCT of 550 patients reported 174 and 172 mean days alive outside hospital in the pressure monitor and control groups respectively at 6-month follow-up (p=0.02).

4.3 The RCT of 550 patients reported mean scores of 45 and 51 on the Minnesota Living with Heart Failure Questionnaire (lower scores indicate a better quality of life, and a 5-point difference is considered clinically significant) in the pressure monitor and control groups respectively at 6-month follow-up (p=0.02).

4.4 The specialist advisers listed efficacy outcomes as reduction in heart failure-related hospitalisations, improved quality of life, and mortality.

  • National Institute for Health and Care Excellence (NICE)