Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Review
. 2025 Sep;30(5):1035-1043.
doi: 10.1007/s10741-025-10525-y. Epub 2025 May 28.

Synchronized diaphragmatic stimulation for the treatment of HFrEF-a review

L R Goldberg  1 , M Mirro  2 , G Becker  3 , T Shaburishvili  4 , M Fudim  5
Affiliations
Review

Synchronized diaphragmatic stimulation for the treatment of HFrEF-a review

L R Goldberg et al. Heart Fail Rev. 2025 Sep.

Abstract

The gap between maximally tolerated medical therapy and consideration for permanent mechanical circulatory support and/or cardiac transplant or palliative treatment of moderate to severe heart failure represents an underserved patient population. New therapies are evolving which may not only improve quality of life for these patients but also improve hemodynamics and potentially reverse the progression of the disease. This review is focused on one such therapy, synchronized diaphragmatic stimulation. Current clinical results suggest that patients experience improved exercise tolerance, quality of life, and hemodynamic function over 6-12 months of therapy which can be safely implemented through a minimally invasive laparoscopic procedure, often as an outpatient. This technology has been granted breakthrough device designation and is being evaluated for a double-blinded, randomized controlled trial by the US FDA.

Keywords: GDMT; HFrEF; Heart failure; Intrathoracic pressure; Minimally invasive; Synchronized diaphragmatic stimulation.

PubMed Disclaimer

Conflict of interest statement

Declarations. Ethics approval: All human studies have been approved by the appropriate ethics committee and have been performed in accordance with the ethical standards laid down in the 1964 Declaration of Helsinki and its later amendments. All persons gave their informed consent prior to their inclusion in all studies. Competing interests: Lee Goldberg, MD, MPH, FACC is a member of the Scientific Advisory Board of VisCardia, Inc. Michael Mirro MD, FACC, FACP is the Director of Medical Affairs and a member of the Scientific Advisory Board of VisCardia, Inc. Georg Becker is an investigator for the first-in-human and RECOVER-HF Pilot study. Tamaz Shaburishvili, MD is the principal investigator for the first-in-human and RECOVER-HF Pilot study. Marat Fudim, MD, MHS is a member of the Scientific Advisory Board of VisCardia, Inc.

Figures

Fig. 1
Fig. 1
Illustration of intrathoracic pressure with SDS OFF and ON
Fig. 2
Fig. 2
Position of implanted SDS system
Fig. 3
Fig. 3
Procedure and recovery times from operating room start [8]
Fig. 4
Fig. 4
Improved exercise tolerance with early feasibility study (data on file at VisCardia, Inc.)
Fig. 5
Fig. 5
QOL improvement based on synchronized diaphragmatic pacing dose. First-in-human study (N = 15)
Fig. 6
Fig. 6
Physical activity as measured by an on-board diagnostic monitor. Total N = 19. Data on file at VisCardia, Inc
Fig. 7
Fig. 7
LVEF during 1-year follow-up. Total N = 19. Data on file at VisCardia, Inc
Fig. 8
Fig. 8
LVESV and NT-proBNP during 1-year follow-up. Total N = 19. Data on file at VisCardia, Inc
See this image and copyright information in PMC

References

    1. Heidenreich PA, Bozkurt B, Aguilar D, Allen LA, Byun JJ, Colvin MM, Deswal A, Drazner MH, Dunlay SM, Evers LR, Fang JC, Fedson SE, Fonarow GC, Hayek SS, Hernandez AF, Khazanie P, Kittleson MM, Lee CS, Link MS, Milano CA, Nnacheta LC, Sandhu AT, Stevenson LW, Vardeny O, Vest AR, Yancy CW (2022) 2022 AHA/ACC/HFSA guideline for the management of heart failure: a report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. J Am Coll Cardiol. 79(17):e263–e421. 10.1016/j.jacc.2021.12.012 - PubMed
    1. Allen LA, Stevenson LW, Grady KL, Goldstein NE, Matlock DD, Arnold RM, Cook NR, Felker GM, Francis GS, Hauptman PJ, Havranek EP, Krumholz HM, Mancini D, Riegel B, Spertus JA; American Heart Association; Council on Quality of Care and Outcomes Research; Council on Cardiovascular Nursing; Council on Clinical Cardiology; Council on Cardiovascular Radiology and Intervention; Council on Cardiovascular Surgery and Anesthesia (2012) Decision making in advanced heart failure: a scientific statement from the American Heart Association. Circulation. 125(15):1928-52. 10.1161/CIR.0b013e31824f2173 - PMC - PubMed
    1. Hawkins NM, Bennett MT, Andrade JG, Virani SA, Krahn AD, Ignaszewski A, Toma M (2015) Review of eligibility for cardiac resynchronization therapy. Am J Cardiol. 116(2):318–24. 10.1016/j.amjcard.2015.04.026 - PubMed
    1. Salah HM, Goldberg LR, Molinger J, Felker GM, Applefeld W, Rassaf T, Tedford RJ, Mirro M, Cleland JGF, Fudim M (2022) Diaphragmatic function in cardiovascular disease JACC Review Topic of the Week. J Am Coll Cardiol. 80(17):1647–1659 - PubMed
    1. Fudim M, Mirro M, Goldberg LR (2022) Synchronized diaphragmatic stimulation for the treatment of symptomatic heart failure: a novel implantable therapy concept. JACC BTS 7(3):322–323 - PMC - PubMed

LinkOut - more resources