Animal Instrumentation Model of Diaphragmatic Stimulation Effects on Cardiovascular Function

Bauer, Péter; Snell, J.A.; Wheeler, Tim; Chinchoy, Ed; Mirro, M J

doi:10.1016/j.cardfail.2017.07.352

Cited by 2 publications

(4 citation statements)

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“…Recently, a device for intrathoracic pressure regulation has been developed to decrease intrathoracic pressure to improve cardiac function in emergency situations. 13 The SDS therapy dose response is defined by the number of cardiac beats appropriately sensed (% SDS) so that diaphragmatic stimulation can be effectively delivered. For the results presented herein, the 80% SDS dose threshold was chosen, not pre-specified, after analysis of diagnostic data stored within the IPG (refer to Figure S1) because it appeared to identify responders.…”

Section: Discussionmentioning

confidence: 99%

“…found that increased intrathoracic pressure pulses during systole improved cardiac performance 11,12 due to changes in LV afterload and impedance and in venous return. Recently, a device for intrathoracic pressure regulation has been developed to decrease intrathoracic pressure to improve cardiac function in emergency situations 13 …”

Section: Discussionmentioning

confidence: 99%

“…Recently, a device for intrathoracic pressure regulation has been developed to decrease intrathoracic pressure to improve cardiac function in emergency situations. 13 …”

Section: Discussionmentioning

confidence: 99%

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

et al. 2022

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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 resultsThe 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.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

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

et al. 2022

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“… 10 SDS produced biphasic changes in intrathoracic pressure as shown in Figure 3 with data acquired from continuous ECG and intrathoracic pressure recordings in a porcine model. 11 Two research groups, Pinsky et al. and Peters et al., completed a series of canine and porcine model to determine the impact of transient changes of intrathoracic pressure relative to the cardiac cycle.…”

Section: Discussionmentioning

confidence: 99%

Synchronized Diaphragmatic Stimulation for Heart Failure With a Reduced Left Ventricular Ejection Fraction Using the VisONE System: A First-in-Patient Study With Extended Population

Jorbenadze¹,

Goldberg²,

Shaburishvili³

et al. 2022

Structural Heart

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Animal Instrumentation Model of Diaphragmatic Stimulation Effects on Cardiovascular Function

Cited by 2 publications

References 0 publications

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

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

Synchronized Diaphragmatic Stimulation for Heart Failure With a Reduced Left Ventricular Ejection Fraction Using the VisONE System: A First-in-Patient Study With Extended Population

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