17 De Novo Cardiac Rhythm Management Device Complications at 1-Year – Introducing Mortality Censoring

Introduction Cardiac rhythm device implantation rates continue to grow, yet procedure complications are inadequately reported. Accurate reporting is necessary to generate quality standards as a benchmark for consultant revalidation. We present complication rates within the first year following de novo pacemaker (PPM), defibrillator (ICD) and cardiac resynchronisation (CRT) implant procedures. Mortality censoring is introduced as a novel method for analysing such data. Methods Between April 2008–March 2011, consecutive virgin PPM, ICD and CRT device implants were prospectively followed for 1 year post implant for pre-defined complications. Results 2614 new devices were implanted. Mean patient follow-ups were 0.94, 0.98 and 0.95 years for PPM, ICD and CRT devices respectively. Abstract 17 Table 1 Complications according to device category PPM (n = 1224) ICD (n = 512) CRT (n = 878) Pneumothorax 7 (0.57%) 4 (0.78%) 4 (0.46%) Pericardial effusion 1 (0.08%) 0 (0.00%) 2 (0.23%) Haematoma surgical evacuation 0 (0.00%) 1 (0.20%) 0 (0.00%) Device pocket revision 4 (0.33%) 6 (1.17%) 3 (0.34%) Lead intervention 30 (2.45%) 10 (1.95%) 47 (5.35%) System explant 6 (0.49%) 1 (0.20%) 7 (0.80%) System re-implant 5 (0.41%) 0 (0.00%) 4 (0.46%) Device upgrade 11 (0.90%) 2 (0.39%) 0 (0.00%) Total 64 (5.23%) 24 (4.69%) 67 (7.64%) Mortality at 1 year after PPM, ICD or CRT implant was 9.43%, 4.40% and 10.38%. Abstract 17 Table 2 Mortality censored complications (CI; confidence intervals) PPM (CI) ICD (CI) CRT (CI) Pneumothorax 0.61 (0.24 – 1.25) 0.08 (0.22 – 2.05) 0.48 (0.13 – 1.23) Pericardial effusion 0.09 (0.00 – 0.48) 0.00 (0.00 – 0.74) 0.24 (0.03 – 0.87) Haematoma surgical evacuation 0.00 (0.00 – 0.32) 0.20 (0.01 – 1.11) 0.00 (0.00 – 0.44) Device pocket revision 0.35 (0.09 – 0.89) 1.20 (0.44 – 2.61) 0.36 (0.07 – 1.05)