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First-in-human VisONE heart failure study implant experience and study design: asymptomatic diaphragmatic stimulation for chronic heart failure

Session Poster Session 4

Speaker Ana Jorbenadze

Event : Heart Failure 2019

  • Topic : heart failure
  • Sub-topic : Chronic Heart Failure: Multidisciplinary Interventions
  • Session type : Poster Session

Authors : M Zuber (Zurich,CH), R Young (Glasgow,GB), A Mcmonnachie (Glasgow,GB), T Shaburishvili (Tbilisi,GE), K Rudenko (Kiev,UA), V Demyanchuk (Kiev,UA), A Jorbenadze (Tbilisi,GE), R Buriak (Kiev,UA), B Todurov (Kiev,UA), M Mirro (Fort Wayne,US), N Nikitin (Douglas,GB), P Erne (Lugano,CH), J Cleland (Glasgow,GB)

Authors:
M Zuber1 , R Young2 , A Mcmonnachie2 , T Shaburishvili3 , K Rudenko4 , V Demyanchuk5 , A Jorbenadze3 , R Buriak4 , B Todurov5 , M Mirro6 , N Nikitin7 , P Erne8 , J Cleland2 , 1University Heart Center - Zurich - Switzerland , 2University of Glasgow, Robertson Centre for Biostatistics - Glasgow - United Kingdom of Great Britain & Northern Ireland , 3Heart and Vascular Clinic - Tbilisi - Georgia , 4Amosov Institute of Cardiovascular Surgery AMS of Ukraine - Kiev - Ukraine , 5Heart Institute of the Ministry of Healthcare of Ukraine - Kiev - Ukraine , 6Indiana University - Fort Wayne - United States of America , 7Clinical Accelerator - Douglas - United Kingdom of Great Britain & Northern Ireland , 8Universita della Svizzera Italiana, Faculty of Biomedical Sciences - Lugano - Switzerland ,

Citation:

Background
Asymptomatic Diaphragmatic Stimulation (ADS) is a novel device-based heart failure (HF) therapy under investigation.  Prior studies have shown that diaphragmatic contractions gaited to the cardiac cycle transiently lower intrathoracic pressure thereby affecting cardiovascular preload, venous return, right atrial pressure, right ventricular end diastolic volume, pulmonary artery flow and stroke volume. An early feasibility study to deliver ADS to the diaphragm via a superior thoracic approach in post-CABG patients demonstrated chronic ADS decreased LV volumes after 3 weeks in moderate symptomatic HF patients with reduced ejection fraction (HFrEF) incremental to optimal care.
Purpose
To prospectively evaluate the benefits and risks of chronically delivering ADS in patients with HFrEF and preserved ventricular synchrony, using a novel dedicated implantable system containing an algorithm for delivering ADS pulses gaited with sensed cardiac activity, via a new laparoscopic inferior approach, on chronic measures of HF function in an observational pilot study (NCT03484780).
Methods
Medical refractory patients with symptomatic HFrEF (EF = 35%) with no evidence of arrhythmias or ventricular dyssynchrony were screened to undergo laparoscopic implantation of the VisONE ADS system comprised of a pulse generator and two bipolar sutureless active fixation leads affixed to the inferior left and right hemispheres of the diaphragm. Exclusion criteria included severe primary pulmonary disease, known intra-abdominal infections and contraindications to laparoscopy. Therapy was programmed to deliver cardiac-gaited diaphragmatic stimulation at asymptomatic outputs. Patients will be followed at pre-specified times (1, 3, 6 and 12-months) using efficacy measures of haemodynamic, echocardiographic, HF status, and diaphragmatic function in conjunction with standard safety measures including adverse events.
Results
Nineteen patients were screened and 15 men (61 ± 7 years, EF 28 ± 5%, NYHA class II/III (2.5 ± 0.5), 87% prior myocardial infarction) were enrolled and successfully implanted with the VisONE system. The time from implant to hospital discharge was 3.3 ± 2.4 days. For all patients an effective asymptomatic diaphragmatic pacing threshold was confirmed using palpitation and patient perception. All patients were discharged with ADS therapy turned on without therapy-related complications.
Conclusions
Early pilot data suggests a dedicated ADS system implanted using a minimally invasive laparoscopic procedure can be performed successfully with short in-hospital stays. In addition, all implanted patients were free of device-related symptoms at discharge. Results from upcoming monitoring visits will further elucidate the risks and benefits of chronic ADS therapy.

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