Key result
Synchronized diaphragmatic stimulation safely increased 6-minute walk distance (315m to 340m; p=0.002) and decreased left ventricular end-systolic volume over 12 months in men with HFrEF.
Why the study?
Synchronized diaphragmatic stimulation transiently modulates intrathoracic pressures to impact cardiac function in HFrEF, but its safety and 1-year effectiveness across multiple implant methods required prospective evaluation.
Does synchronized diaphragmatic stimulation improve functional capacity, quality of life, and cardiac function safely in patients with HFrEF?
Cohort (n=19)
Does synchronized diaphragmatic stimulation improve functional capacity, quality of life, and cardiac function safely in patients with HFrEF?
Answers are grounded in this paper and cite their sources.
Synchronized diaphragmatic stimulation using the VisONE system appears safe and may improve functional capacity and quality of life in patients with HFrEF, warranting further randomized trials.
Background Synchronized diaphragmatic stimulation (SDS) produces localized contractions of the diaphragm gated to the cardiac cycle to transiently modulate intrathoracic pressures, thereby impacting cardiac function for heart failure patients with reduced ejection fraction (HFrEF). This study prospectively evaluated the safety and 1-year effectiveness of SDS in an expanded first-in-patient cohort using multiple implant methods. Methods Symptomatic patients with HFrEF despite guideline-directed therapy were enrolled. Patients were evaluated at 3, 6 and 12 months for adverse events, quality of life (SF-36 QOL), echocardiography and 6-minute hall walk distance. The SDS system consists of 2 bipolar, active-fixation leads, and an implantable pulse generator. Results Nineteen men were enrolled (age 63 [57, 67] years, New York Heart Association class II [53%]/III [47%], N-terminal pro B-type natriuretic peptide 1779 [886, 2309] pg/mL, left ventricular ejection fraction 27 [23, 33] %). Three implant techniques (abdominal laparoscopy: sensing and stimulating leads on the inferior diaphragm (n = 15); subxiphoid access for an epicardial sensing lead and abdominal laparoscopy for stimulation on the inferior diaphragm (n = 2); thoracoscopy to place an epicardial sensing lead and a stimulating lead on the superior diaphragm (n = 2)) were employed with 100% success. Patients were unaware of diaphragmatic stimulation. From discharge to 12 months, 6-minute hall walk distance increased (315 [296, 332]m to 340 [319, 384]m; p = 0.002), left ventricular end-systolic volume decreased (135 [114, 140]mL to 99 [90, 105]mL; p = 0.04), and SF-36 QOL improved (physical scale 0 [0, 0] to 25 [0, 50], p = 0.004; emotional scale 0 [0, 33] to 67 [33, 67], p = 0.001). N-terminal pro B-type natriuretic peptide was lower (1784 [944, 2659]pg/mL vs. 962 [671, 1960]pg/mL; p = ns) and left ventricular ejection fraction increased (28 [23, 38]% vs. 35 [31, 40]%; p = ns) although neither reached statistical significance. There were no procedure- or SDS-related adverse events. Conclusions These data demonstrate that SDS can be delivered using alternative implantation methods without raising safety concerns and suggest improved outcomes over 1 year of follow-up. Adequately powered randomized trials are now needed to confirm these findings.
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Jorbenadze et al. (2022) conducted a cohort in Heart failure with reduced ejection fraction (HFrEF) (n=19). Synchronized diaphragmatic stimulation (SDS) was evaluated on 6-minute hall walk distance at 12 months (p=0.002). Synchronized diaphragmatic stimulation safely increased 6-minute walk distance (315m to 340m; p=0.002) and decreased left ventricular end-systolic volume over 12 months in men with HFrEF.
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