Synchronized diaphragmatic stimulation for heart failure using the VisONE system: a first‐in‐patient study

Jorbendaze, A. et al. (2022) Synchronized diaphragmatic stimulation for heart failure using the VisONE system: a first‐in‐patient study. ESC Heart Failure, 9(4), pp. 2207-2214. (doi: 10.1002/ehf2.13984) (PMID:35619238) (PMCID:PMC9288796)

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Abstract

Aims: Synchronized diaphragmatic stimulation (SDS) modulates intrathoracic and intra‐abdominal pressures with favourable effects on cardiac function for patients with a reduced left ventricular ejection fraction (LVEF) and heart failure (HFrEF). VisONE‐HF is a first‐in‐patient, observational study assessing the feasibility and 1 year effects of a novel, minimally invasive SDS device. Methods and results: The SDS system comprises a pulse generator and two laparoscopically delivered, bipolar, active‐fixation leads on the inferior diaphragmatic surface. Fifteen symptomatic men with HFrEF and ischaemic heart disease receiving guideline‐recommended therapy were enrolled (age 60 [56, 67] years, New York Heart Association class II [53%] /III [47%], LVEF 27 [23, 33] %, QRSd 117 [100, 125] ms, & N terminal pro brain natriuretic peptide [NT‐proBNP] 1779 [911, 2,072] pg/mL). Implant success was 100%. Patients were evaluated at 3, 6, and 12 months for device‐related or lead‐related complications, quality of life (SF‐36 QOL), 6 min hall walk distance (6MHWd), and by echocardiography. No implant procedure or SDS‐related adverse event occurred, and patients were unaware of diaphragmatic stimulation. By 12 months, left ventricular end‐systolic volume decreased (136 [123, 170] mL to 98 [89, 106] mL; P = 0.05), 6MHWd increased (315 [300, 330] m to 340 [315, 368] m; P = 0.004), and SF‐36 QOL improved (physical scale 0 [0, 0] to 25 [0, 50], P = 0.006; emotional scale 0 [0, 33] to 33 [33, 67], P = 0.001). Although neither reached statistical significance, LVEF decreased (28 [23, 40]% vs. 34 [29, 38]%; P = ns) and NT‐proBNP was lower (1784 [920, 2540] pg/mL vs. 1492 [879, 2028] pg/mL; P = ns). Conclusions: These data demonstrate the feasibility of laparoscopic implantation and delivery of SDS without raising safety concerns. These encouraging findings should be investigated further in adequately powered randomized trials.

Item Type:Articles
Additional Information:The work was supported by the Schweizerische Herz und Kreislauf-Stiftung (SHK), Switzerland, and VisCardia Inc., Portland, OR, USA.
Status:Published
Refereed:Yes
Glasgow Author(s) Enlighten ID:Young, Dr Robin and Cleland, Professor John
Authors: Jorbendaze, A., Young, R., Shaburishvili, T., Demyanchuk, V., Buriak, R., Todurov, B., Rudenko, K., Zuber, M., Stämpfli, S. F., Tanner, F. C., Erne, P., Mirro, M., Fudim, M., Goldberg, L. R., and Cleland, J. G.F.
College/School:College of Medical Veterinary and Life Sciences > School of Health & Wellbeing > Robertson Centre
Journal Name:ESC Heart Failure
Publisher:Wiley
ISSN:2055-5822
ISSN (Online):2055-5822
Published Online:26 May 2022
Copyright Holders:Copyright © 2022 The Authors
First Published:First published in ESC Heart Failure 9(4): 2207-2214
Publisher Policy:Reproduced under a Creative Commons License

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