Mechanical circulatory support devices for acute heart failure syndromes: Considerations for clinical trial design

John B. O'Connell; Patrick M. McCarthy; George Sopko; Gerasimos S. Filippatos; Ileana L. Pĩa; Marvin A. Konstam; James B. Young; Leslie W. Miller; Mandeep R. Mehra; Edmond Roland; John E.A. Blair; David J. Farrar; Mihai Gheorghiade

doi:10.1007/s10741-008-9097-7

Mechanical circulatory support devices for acute heart failure syndromes: Considerations for clinical trial design

John B. O'Connell, Patrick M. McCarthy, George Sopko, Gerasimos S. Filippatos, Ileana L. Pĩa, Marvin A. Konstam, James B. Young, Leslie W. Miller, Mandeep R. Mehra, Edmond Roland, John E.A. Blair, David J. Farrar, Mihai Gheorghiade

Medicine - Cardiology Division

Research output: Contribution to journal › Article › peer-review

6 Scopus citations

Abstract

Mechanical circulatory support (MCS) devices are a guideline-recommended treatment option for a small subset of advanced heart failure patients. MCS has the potential to become more prominent in the management of Acute Heart Failure Syndromes (AHFS) as device technology advances and as clinical trials consistently discover neutral or harmful effects with pharmacologic therapies hypothesized to be beneficial in this population. While it is now possible to identify AHFS patients who are at high risk of death, the therapeutic options available to improve their long-term outcomes are limited. MCS therapy in this population offers a "bridge to recovery" strategy; these patients may have viable myocardium that responds favorably to the influence of MCS on neurohormones, cytokines, and/or reverse remodeling. Patients at high risk for mortality who have a substantial likelihood of benefiting from MCS can be easily identified using standard clinical criteria developed from large observational databases. MCS technology is rapidly evolving, and risks related to implantation are declining. It is evident that rigorous clinical trial testing of the potential risks, benefits, and economic implications of MCS in patients with AHFS will need to be conducted before the "routine" application of this aggressive therapy. This paper examines the rationale for conducting trials of MCS devices in patients with AHFS, and it explores considerations for patient selection and appropriate endpoints. This manuscript was generated from discussions on this issue during the third international meeting of the International Working Group on AHFS held in Washington, DC, April 8-9, 2006.

Original language	English (US)
Pages (from-to)	101-112
Number of pages	12
Journal	Heart Failure Reviews
Volume	14
Issue number	2
DOIs	https://doi.org/10.1007/s10741-008-9097-7
State	Published - Jan 1 2009

Bibliographical note

Funding Information:
Research grant from NIH Intermacs Registry (significant); Leslie W. Miller: Pending; Mandeep R. Mehra: research grants from Scios (modest), Medtronic (modest), Guidant (modest), GlaxoSmithKline (modest), Roche (modest), and Orqis (modest); speakers bureau for and received honoraria from Scios (modest), Medtronic (modest), Guidant (modest), GlaxoSmithKline (modest), and AstraZeneca (modest); advisory boards for XDX (modest) and Scios (modest); Edmond Roland: none; John E. A. Blair: None; David J. Farrar: Stock owner of Thoratec Corporation (significant), employee of Thoratec Corporation (significant); Mihai Gheorghiade: Honoraria from GSK (modest), PDL (modest), Sigma Tau (modest), Medtronic (modest), Otsuka (modest).

Funding Information:
Funding sources The third international meeting of the International Working Group on AHFS was funded by: Sigma Tau, Abbott, Astellas, Scios, CV Therapeutics, Otsuka, Novartis, CHF Solutions, Protein Design Labs, CardioDynamics, RenaMedBio, Medtronic, Guidant, Thoratec, and Cytokinetics.

Keywords

Devices
Heart failure
Trials

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O'Connell, J. B., McCarthy, P. M., Sopko, G., Filippatos, G. S., Pĩa, I. L., Konstam, M. A., Young, J. B., Miller, L. W., Mehra, M. R., Roland, E., Blair, J. E. A., Farrar, D. J., & Gheorghiade, M. (2009). Mechanical circulatory support devices for acute heart failure syndromes: Considerations for clinical trial design. Heart Failure Reviews, 14(2), 101-112. https://doi.org/10.1007/s10741-008-9097-7

O'Connell, JB, McCarthy, PM, Sopko, G, Filippatos, GS, Pĩa, IL, Konstam, MA, Young, JB, Miller, LW, Mehra, MR, Roland, E, Blair, JEA, Farrar, DJ & Gheorghiade, M 2009, 'Mechanical circulatory support devices for acute heart failure syndromes: Considerations for clinical trial design', Heart Failure Reviews, vol. 14, no. 2, pp. 101-112. https://doi.org/10.1007/s10741-008-9097-7

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abstract = "Mechanical circulatory support (MCS) devices are a guideline-recommended treatment option for a small subset of advanced heart failure patients. MCS has the potential to become more prominent in the management of Acute Heart Failure Syndromes (AHFS) as device technology advances and as clinical trials consistently discover neutral or harmful effects with pharmacologic therapies hypothesized to be beneficial in this population. While it is now possible to identify AHFS patients who are at high risk of death, the therapeutic options available to improve their long-term outcomes are limited. MCS therapy in this population offers a {"}bridge to recovery{"} strategy; these patients may have viable myocardium that responds favorably to the influence of MCS on neurohormones, cytokines, and/or reverse remodeling. Patients at high risk for mortality who have a substantial likelihood of benefiting from MCS can be easily identified using standard clinical criteria developed from large observational databases. MCS technology is rapidly evolving, and risks related to implantation are declining. It is evident that rigorous clinical trial testing of the potential risks, benefits, and economic implications of MCS in patients with AHFS will need to be conducted before the {"}routine{"} application of this aggressive therapy. This paper examines the rationale for conducting trials of MCS devices in patients with AHFS, and it explores considerations for patient selection and appropriate endpoints. This manuscript was generated from discussions on this issue during the third international meeting of the International Working Group on AHFS held in Washington, DC, April 8-9, 2006.",

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note = "Funding Information: Research grant from NIH Intermacs Registry (significant); Leslie W. Miller: Pending; Mandeep R. Mehra: research grants from Scios (modest), Medtronic (modest), Guidant (modest), GlaxoSmithKline (modest), Roche (modest), and Orqis (modest); speakers bureau for and received honoraria from Scios (modest), Medtronic (modest), Guidant (modest), GlaxoSmithKline (modest), and AstraZeneca (modest); advisory boards for XDX (modest) and Scios (modest); Edmond Roland: none; John E. A. Blair: None; David J. Farrar: Stock owner of Thoratec Corporation (significant), employee of Thoratec Corporation (significant); Mihai Gheorghiade: Honoraria from GSK (modest), PDL (modest), Sigma Tau (modest), Medtronic (modest), Otsuka (modest). Funding Information: Funding sources The third international meeting of the International Working Group on AHFS was funded by: Sigma Tau, Abbott, Astellas, Scios, CV Therapeutics, Otsuka, Novartis, CHF Solutions, Protein Design Labs, CardioDynamics, RenaMedBio, Medtronic, Guidant, Thoratec, and Cytokinetics.",

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AU - Filippatos, Gerasimos S.

AU - Pĩa, Ileana L.

AU - Konstam, Marvin A.

AU - Young, James B.

AU - Miller, Leslie W.

AU - Mehra, Mandeep R.

AU - Roland, Edmond

AU - Blair, John E.A.

AU - Farrar, David J.

AU - Gheorghiade, Mihai

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Mechanical circulatory support devices for acute heart failure syndromes: Considerations for clinical trial design

Abstract

Bibliographical note

Keywords

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