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
. 2021 Aug 4;6(9-10):772-795.
doi: 10.1016/j.jacbts.2021.06.002. eCollection 2021 Sep-Oct.

Device-Based Solutions to Improve Cardiac Physiology and Hemodynamics in Heart Failure With Preserved Ejection Fraction

Luca Rosalia  1   2 , Caglar Ozturk  2 , Saeed Shoar  3 , Yiling Fan  4 , Grainne Malone  5 , Faisal H Cheema  3   6 , Claire Conway  5 , Robert A Byrne  7   8 , Garry P Duffy  5   9   10   11   12 , Andrew Malone  5 , Ellen T Roche  1   2   4 , Aamir Hameed  5   12
Affiliations
Review

Device-Based Solutions to Improve Cardiac Physiology and Hemodynamics in Heart Failure With Preserved Ejection Fraction

Luca Rosalia et al. JACC Basic Transl Sci. .

Abstract

Characterized by a rapidly increasing prevalence, elevated mortality and rehospitalization rates, and inadequacy of pharmaceutical therapies, heart failure with preserved ejection fraction (HFpEF) has motivated the widespread development of device-based solutions. HFpEF is a multifactorial disease of various etiologies and phenotypes, distinguished by diminished ventricular compliance, diastolic dysfunction, and symptoms of heart failure despite a normal ejection performance; these symptoms include pulmonary hypertension, limited cardiac reserve, autonomic imbalance, and exercise intolerance. Several types of atrial shunts, left ventricular expanders, stimulation-based therapies, and mechanical circulatory support devices are currently under development aiming to target one or more of these symptoms by addressing the associated mechanical or hemodynamic hallmarks. Although the majority of these solutions have shown promising results in clinical or preclinical studies, no device-based therapy has yet been approved for the treatment of patients with HFpEF. The purpose of this review is to discuss the rationale behind each of these devices and the findings from the initial testing phases, as well as the limitations and challenges associated with their clinical translation.

Keywords: BAT, baroreceptor activation therapy; CCM, cardiac contractility modulation; CRT, cardiac resynchronization therapy; HF, heart failure; HFmEF, heart failure with mid-range ejection fraction; HFpEF; HFpEF, heart failure with preserved ejection fraction; HFrEF, heart failure with reduced ejection fraction; IASD, Interatrial Shunt Device; LAAD, left atrial assist device; LAP, left atrial pressure; LV, left ventricular; LVEF, left ventricular ejection fraction; MCS, mechanical circulatory support; NYHA, New York Heart Association; PCWP, pulmonary capillary wedge pressure; QoL, quality of life; TAA, transapical approach; atrial shunt devices; electrostimulation; heart failure devices; heart failure with preserved ejection fraction; left ventricular expanders; mechanical circulatory support; neuromodulation.

PubMed Disclaimer

Conflict of interest statement

Dr Hameed is leading a project to develop a novel device for HFpEF. The project is funded by the Enterprise Ireland through their Commercialization Fund (CF-2019-1136-P). This project is co-funded by the European Regional Development Fund under Ireland’s European Structural and Investment Funds Programme 2014-2020. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

Figures

None
Graphical abstract
Figure 1
Figure 1
HFpEF Pathophysiology Overview Overview of the structural, functional, and hemodynamic derangements associated with heart failure with preserved ejection fraction (HFpEF) as targeted by device-based solutions currently under development. The 4 main categories of medical devices for HFpEF are atrial shunts, left ventricular (LV) expanders, mechanical circulatory support (MCS) devices, and electrical and neurostimulators. EDPVR = end-diastolic pressure-volume relationship; ESPVR = end-systolic pressure-volume relationship; LA = left atrial; LAP = left atrial pressure; LAV = left atrial volume; LVP = left ventricular pressure; LVV = left ventricular volume.
Figure 2
Figure 2
Atrial Shunt Devices Under Development for the Treatment of HFpEF These devices include the Interatrial Shunt Device (IASD), the V-Wave Shunt, and the Atrial Flow Regulator (AFR) as left atrium (LA) to right atrium (RA) shunts and the Transcatheter Atrial Shunt System as a LA to coronary sinus (CS) shunt. HFpEF = heart failure with preserved ejection fraction.
Figure 3
Figure 3
LV Expander Devices Under Development for the Treatment of HFpEF These devices include the ImCardia and CORolla transapical approach (TAA) for epicardial and endocardial implantation, respectively. Other abbreviations as in Figure 1.
Figure 4
Figure 4
Stimulation Therapy Devices Under Development for the Treatment of HFpEF These devices include the BAROSTIM NEO for baroreceptor activation therapy and devices for cardiac contractility modulation and cardiac resynchronization therapy. RA = right atrial; RV = right ventricular; other abbreviations as in Figure 1.
Figure 5
Figure 5
MCS Devices Under Development for the Treatment of HFpEF These devices include the Synergy pump, the left atrial assist device (LAAD), and the CoPulse valveless design, including schematics of their rationale. Ao = aorta; LA = left atrium; LV = left ventricle; MCS = mechanical circulatory support.
Central Illustration
Central Illustration
Medical Devices for Heart Failure With Preserved Ejection Fraction Atrial shunts, left ventricular (LV) expanders, mechanical circulatory support (MCS) devices, and stimulation therapy are currently under development to improve the hemodynamics and symptomatology of patients with heart failure with preserved ejection fraction (HFpEF). EDPVR = end-diastolic pressure-volume relationship; ESPVR = end-systolic pressure-volume relationship; LVP = left ventricular pressure; LVV = left ventricular volume.
See this image and copyright information in PMC

References

    1. Yusuf S., Rangarajan S., Teo K. Cardiovascular risk and events in 17 low-, middle-, and high-income countries. N Engl J Med. 2014;371(9):818–827. - PubMed
    1. Roger V.L. Epidemiology of heart failure. Circ Res. 2013;113(6):646–659. - PMC - PubMed
    1. Yancy C.W., Jessup M., Bozkurt B. 2013 ACCF/AHA guideline for the management of heart failure: a report of the American College of Cardiology Foundation/American Heart Association Task Force on practice guidelines. J Am Coll Cardiol. 2013;62(16):e147–e239. - PubMed
    1. Yancy C.W., Jessup M., Bozkurt B. 2016 ACC/AHA/HFSA focused update on new pharmacological therapy for heart failure: an update of the 2013 ACCF/AHA guideline for the management of heart failure: a report of the American College of Cardiology/American Heart Association Task Force on Clinic. J Am Coll Cardiol. 2016;68(13):1476–1488. - PubMed
    1. Borlaug B.A. Evaluation and management of heart failure with preserved ejection fraction. Nat Rev Cardiol. 2020;17:559–573. - PubMed