Purpose: We sought to assess the safety & efficacy of the WiSE-CRT system during real world clinical use in an international registry.
Methods: Registry of centres implanting the WiSE-CRT system as part of the WiCS Post Market Surveillance Registry (Clinical trial study number NCT02610673)
Results: 89 patients across 14 centres underwent implantation with the WiSE-CRT system. Patients were predominantly male aged 68.1± 10.5 yrs, LVEF 30.3% ± 8.7 with a mean QRS duration 180.3 ± 26.8ms. Ischaemic aetiology was present in 40.4% of patients. 49.4% were classified as having previously experienced a failed attempt at CRT delivery, while 38.2% were deemed complex upgrades. The remaining 12.4% of patients were non-responders to prior CRT. Successful implantation and chronic delivery of BiV ENDO pacing via the WiSE-CRT system was achieved in 98% of patients. Acute (<24hrs) and 30 day complications rates (4.5% and 20.2% respectively) included one case of cardiac tamponade (1.1%) and four arterial access complications (5.6%). Six month follow-up data was analysed, see Table 1.
Conclusion: This is the largest analysis of leadless LV endocardial CRT to report so far. BiV ENDO pacing with the WiSE CRT system appears technically feasible with a high success rate and similar complication rate to that previously described. In addition, BiV ENDO pacing via the WiSE CRT system led to symptomatic improvements in 76% of patients. Significant LV remodelling was observed in over half of our cohort. BiV ENDO pacing using the WiSE CRT system is a safe and effective therapeutic option for patients who have either failed to improve following transvenous, epicardial CRT or who are unable to receive effective traditional resynchronisation pacing, whilst avoiding the need for long term anticoagulation.