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Wireless LV endocardial cardiac resynchronisation therapy is safe & effective; results from a multicentre international study

Session Rapid Fire 5: improving the response to cardiac resynchronization therapy: emerging technologies

Speaker Benjamin Sieniewicz

Congress : EHRA 2019

  • Topic : arrhythmias and device therapy
  • Sub-topic : Cardiac Resynchronization Therapy
  • Session type : Rapid Fire Abstracts
  • FP Number : 926

Authors : B Sieniewicz (London,GB), TR Betts (Oxford,GB), S James (Middlesbrough,GB), A Turley (Middlesbrough,GB), M Seifert (Bernau bei Berlin,DE), LVA Boersma (Nieuwegein,NL), S Riaha (Aalborg,DK), M Arnold (Erlangen,DE), M Biffi (Bologna,IT), I Diemberger (Bologna,IT), P Defaye (Grenoble,FR), JC Deharo (Marseille,FR), A Chow (London,GB), R Schilling (London,GB), CA Rinaldi (London,GB)

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Authors:
B Sieniewicz1 , TR Betts2 , S James3 , A Turley3 , M Seifert4 , LVA Boersma5 , S Riaha6 , M Arnold7 , M Biffi8 , I Diemberger8 , P Defaye9 , JC Deharo10 , A Chow11 , R Schilling11 , CA Rinaldi1 , 1King's College London, Division of Imaging Sciences and Biomedical Engineering - London - United Kingdom , 2Oxford University Hospitals NHS Trust - Oxford - United Kingdom , 3James Cook University Hospital - Middlesborough - United Kingdom , 4Brandenburg Klinik, Immanuel Klinikum Bernau Herzzentrum Brandenburg and Medical School Brandenburg, Bernau, Germany - Bernau bei Berlin - Germany , 5St Antonius Hospital - Nieuwegein - Netherlands , 6Aalborg University Hospital - Aalborg - Denmark , 7University Hospital Erlangen - Erlangen - Germany , 8Policlinico S. Orsola "L. e A. Seragnoli" - Bologna - Italy , 9University Hospital of Grenoble - Grenoble - France , 10Hospital La Timone of Marseille - Marseille - France , 11Barts Health NHS Trust - London - United Kingdom ,

Citation:

Background: Biventricular endocardial pacing (BiV ENDO) is a potential therapy for heart failure patients who either cannot receive transvenous epicardial CRT or who have failed to adequately respond. BiV ENDO CRT delivered by a new wireless LV ENDO pacing system (WiSE-CRT System, EBR Systems, Sunnyvale, California) avoids the need for lifelong anti-coagulation associated with lead based LV endocardial systems. 

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.

Parameter Baseline ± SD 6 Months ± SD P value Response Definition Response Rate
NYHA 2.6 ± 0.5 2.1 ± 0.7 <0.0001
LEVEF (%) 30.3 ± 8.7 36.9 ± 12.0 <0.0001
LVESV (ml) 128.9 ± 75.4 110.8 ± 75.4 <0.0001 > 15% relative reduction 55.4%
LVEDV (ml) 181.4 ± 91.0 166.2 ± 85.5 <0.0001
6 Month Outcome Data Post Implant


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