Real World Experience of Leadless LV Endocardial CRT with the WiSE CRT Pacing System; An International Study

Abstract

IntroductionBiventricular endocardial pacing (BiV ENDO) is a potential therapy for heart failure patients who either cannot receive transvenous, epicardial CRT (BiV EPI) or who have failed to respond. BiV ENDO is traditionally delivered via trans-septal pacing leads, mandating lifelong anti-coagulation due to thromboembolic complications. The introduction of a new wireless LV endocardial pacing system (WiSE-CRT System, EBR Systems, Sunnyvale, California) avoids the need for long-term anticoagulation.ObjectiveWe sought to assess the safety & efficacy of the WiSE-CRT system during real world clinical use in an international registry.MethodsRegistry of centres implanting the WiSE-CRT system as part of the WICS Post Market Surveillance Registry (Clinical trial study number NCT02610673)ResultsA total of 68 patients across the 12 centers underwent implantation with the WiSE-CRT system, the largest series of leadless LV endocardial CRT yet reported. Patients were predominantly male with a mean age of 68.3± 10.4 years, a mean LVEF of 31% ± 9.1 and a mean QRS duration of 195.8 ± 120.0ms. Ischemic etiology was present in 37.5% of patients. Successful implantation and chronic delivery of BiV ENDO pacing via the WiSE-CRT system was achieved in 97% of patients. Acute (<24hrs) and 30 day complications rates were 5.9% and 23.5% respectively.ConclusionThis is the largest international series of the WiSE-CRT pacing system to date. In a real-world setting, leadless LV endocardial CRT proved technically feasible with a high success rate and similar complication rate to that previously described. BiV ENDO is a safe and effective therapeutic option for patients who fail to improve following transvenous, epicardial CRT. Biventricular endocardial pacing (BiV ENDO) is a potential therapy for heart failure patients who either cannot receive transvenous, epicardial CRT (BiV EPI) or who have failed to respond. BiV ENDO is traditionally delivered via trans-septal pacing leads, mandating lifelong anti-coagulation due to thromboembolic complications. The introduction of a new wireless LV endocardial pacing system (WiSE-CRT System, EBR Systems, Sunnyvale, California) avoids the need for long-term anticoagulation. We sought to assess the safety & efficacy of the WiSE-CRT system during real world clinical use in an international registry. Registry of centres implanting the WiSE-CRT system as part of the WICS Post Market Surveillance Registry (Clinical trial study number NCT02610673) A total of 68 patients across the 12 centers underwent implantation with the WiSE-CRT system, the largest series of leadless LV endocardial CRT yet reported. Patients were predominantly male with a mean age of 68.3± 10.4 years, a mean LVEF of 31% ± 9.1 and a mean QRS duration of 195.8 ± 120.0ms. Ischemic etiology was present in 37.5% of patients. Successful implantation and chronic delivery of BiV ENDO pacing via the WiSE-CRT system was achieved in 97% of patients. Acute (<24hrs) and 30 day complications rates were 5.9% and 23.5% respectively. This is the largest international series of the WiSE-CRT pacing system to date. In a real-world setting, leadless LV endocardial CRT proved technically feasible with a high success rate and similar complication rate to that previously described. BiV ENDO is a safe and effective therapeutic option for patients who fail to improve following transvenous, epicardial CRT.