Introduction The National Institute for Clinical Excellence (NICE) define a population of patients that are most likely to respond to cardiac resynchronisation therapy (CRT) and have a favourable health economic profile. Current NICE criteria (technology appraisal; TA120) for CRT include: NYHA class III or IV symptoms despite optimal medical therapy, sinus rhythm, ejection fraction ≤35%, and either QRS duration >150 mS alone or 120–149 mS together with echocardiographic (echo) evidence of mechanical dyssynchrony. Several randomised clinical trials however have consistently reported beneficial effects of CRT in patients outside current NICE guidelines. In our centre, potential CRT patients are discussed at a multi-disciplinary team (MDT) meeting attended by a heart failure specialist, electrophysiologist, interventional cardiologist, cardiac surgeon and hospital manager. CRT is offered where there is consensus agreement that the individual patient is likely to benefit. This individualised and evidence based approach provides for a comparison of outcomes in NICE compliant (NICE:+ve) and NICE: −ve patients (patients with a clinical need and evidence base supporting CRT, but who do not meet NICE criteria).
Methods Our unit operates an integrated CRT service with pre-assessment, implantation, and follow-up components. Pre-assessment includes clinical evaluation and baseline echo (EF: ejection fraction, and ESV: left ventricular end-systolic volume) and functional characterisation: a) Minnesota quality of life score (QoL), b) 6 min walk test (6MWT), and c) peak oxygen consumption on cardiopulmonary exercise test (VO2). Follow-up at 3 and 6 months post CRT includes clinical evaluation, device/medical optimisation, and reassessment of echo and functional outcomes. This study involves a retrospective analysis of our CRT database and compares outcomes in NICE:+ve and NICE: −ve patients.
Results Between January 2007 and December 2009, 253 patients received CRT. Complete paired data comparing baseline and 6 month functional and echo data are available for 139 patients; 89 NICE:+ve and 50 NICE: −ve (Abstract 94 table 1). Exclusions for the NICE: −ve patients included: atrial fibrillation (n=19), QRS 120–149 mS without mechanical dyssynchrony (n=12); QRS <120 mS (n=5); pacemaker upgrades (n=9). An additional 5 patients with right bundle branch block and otherwise NICE CRT compliance are analysed as NICE: −ve in this study. Compared to baseline, 6-month outcomes were similar and significantly improved in both NICE:+ve and NICE: −ve groups (Abstract 94 table 2).
Conclusions We observed significantly favourable and similar functional and echocardiographic responses to CRT in patients meeting and not meeting current NICE criteria for CRT. Guidelines should guide therapy but ultimately each therapy should be individualised and evidence based.
- Biventricular pacing
- heart failure
- NICE guidelines