A First in Human Multi-center, Open Label, Prospective Study to Evaluate Safety, Usability and Performance of the VisONE System for Heart Failure with a Reduced Left Ventricular Ejection Fraction

Cleland, John G.F.; Young, Robin; Jorbenadze, Ana; Shaburishvili, Tamaz; Demyanchuk, Vitaly; Тодуров, Б.М.; Rudenko, K. V.; Züber, Michel; Stämpfli, Simon F.; Tanner, Felix C.; Erné, Paul; Mirro, Michael J.; Goldberg, Lee R.

doi:10.1016/j.cardfail.2020.09.188

Cited by 8 publications

(4 citation statements)

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“…The study revealed tangible improvements in both functional measures, such as the 6-min walk distance, and physiological parameters, including cardiac output and LVEF [32]. Importantly, the study and its subsequent 12-month follow-up period did not report any serious device-related events [33]. Building upon these encouraging findings, the FDA granted breakthrough device status to the VisONE system.…”

Section: Asymptomatic Diaphragmatic Stimulationmentioning

confidence: 80%

Device therapy for heart failure management

Chouairi,

Levin,

Fudim

2024

Current Opinion in Cardiology

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Purpose of review Given the prevalence of heart failure (HF) and the interdisciplinary nature of device therapy, it is paramount that cardiologists not only understand the current landscape of goal-directed medical therapy, but also the ongoing efforts in device development. Thus, we aim to provide a practical overview of the broad approaches being utilized in the burgeoning field of device-based therapies for heart failure. Recent Findings Currently, a diverse array of devices for HF treatment is being developed and tested, each targeting distinct aspects of HF pathophysiology. These innovative solutions encompass a wide spectrum, ranging from devices enabling remote monitoring of HF associated physiological parameters, to those focused on creating interatrial shunts and effecting structural modifications of the left ventricle, as well as to those designed to modulate the autonomic nervous system and diaphragm. Notably, a subset of these emerging devices is directed towards treating patients with heart failure with preserved ejection fraction, a population that has traditionally not been served by device-based therapies. Summary In recent decades, there has been a remarkable surge in the development and utilization of device-based treatments for managing HF. It is important for physicians to be familiar with these devices, their mechanisms of action, and their applications.

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Section: Asymptomatic Diaphragmatic Stimulationmentioning

confidence: 80%

Device therapy for heart failure management

Chouairi,

Levin,

Fudim

2024

Current Opinion in Cardiology

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“…In the Stimulation of the Diaphragm in Patients with Severe Heart Failure Following Heart Surgery randomized trial including 33 subjects, an improvement in LVEF and HF symptoms, and an elevation in maximal power and oxygen consumption during exercise testing was noticed, with no considerable improvement in the six MWT, nor the BNP levels [146]. At the 1-year follow-up of the non-randomized VisOne Heart Failure trial, improvements in LVEF, QOL, and 6MWT were reported [147]. Although both trials included a limited number of patients, because of the encouraging outcomes, it might be beneficial to conduct additional research on a larger scale.…”

Section: Respiratory Disorders Implicated In Heart Failurementioning

confidence: 96%

Modern Approaches for the Treatment of Heart Failure: Recent Advances and Future Perspectives

et al. 2022

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Heart failure (HF) is a progressively deteriorating medical condition that significantly reduces both the patients’ life expectancy and quality of life. Even though real progress was made in the past decades in the discovery of novel pharmacological treatments for HF, the prevention of premature deaths has only been marginally alleviated. Despite the availability of a plethora of pharmaceutical approaches, proper management of HF is still challenging. Thus, a myriad of experimental and clinical studies focusing on the discovery of new and provocative underlying mechanisms of HF physiopathology pave the way for the development of novel HF therapeutic approaches. Furthermore, recent technological advances made possible the development of various interventional techniques and device-based approaches for the treatment of HF. Since many of these modern approaches interfere with various well-known pathological mechanisms in HF, they have a real ability to complement and or increase the efficiency of existing medications and thus improve the prognosis and survival rate of HF patients. Their promising and encouraging results reported to date compel the extension of heart failure treatment beyond the classical view. The aim of this review was to summarize modern approaches, new perspectives, and future directions for the treatment of HF.

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“…Best results were achieved in patients with over 80% diaphragm pacing synchronized to the heart cycle. No AE were observed at 12-month follow-up (primary and secondary endpoint) [ 12 , 13 ].…”

Section: Respiratory Disturbances In Heart Failurementioning

confidence: 99%

Novel Therapeutic Devices in Heart Failure

Guzik

Urban

Iwanek

et al. 2022

JCM

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Heart failure (HF) constitutes a significant clinical problem and is associated with a sizeable burden for the healthcare system. Numerous novel techniques, including device interventions, are investigated to improve clinical outcome. A review of the most notable currently studied devices targeting pathophysiological processes in HF was performed. Interventions regarding autonomic nervous system imbalance, i.e., baroreflex activation therapy; vagus, splanchnic and cardiopulmonary nerves modulation; respiratory disturbances, i.e., phrenic nerve stimulation and synchronized diaphragmatic therapy; decongestion management, i.e., the Reprieve system, transcatheter renal venous decongestion system, Doraya, preCardia, WhiteSwell and Aquapass, are presented. Each segment is divided into subsections: potential pathophysiological target, existing evidence and weaknesses or unexplained issues. Novel therapeutic devices represent great potential in HF therapy management; however, further evidence is necessary to fully evaluate their utility.

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A First in Human Multi-center, Open Label, Prospective Study to Evaluate Safety, Usability and Performance of the VisONE System for Heart Failure with a Reduced Left Ventricular Ejection Fraction

Cited by 8 publications

References 0 publications

Device therapy for heart failure management

Device therapy for heart failure management

Modern Approaches for the Treatment of Heart Failure: Recent Advances and Future Perspectives

Novel Therapeutic Devices in Heart Failure

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