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

*Corresponding author for this work

Research output: Contribution to journalArticle

4 Citations (Scopus)

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 languageEnglish (US)
Pages (from-to)101-112
Number of pages12
JournalHeart Failure Reviews
Volume14
Issue number2
DOIs
StatePublished - Jan 1 2009

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Heart Failure
Clinical Trials
Equipment and Supplies
Technology
Therapeutics
Patient Selection
Population
Neurotransmitter Agents
Myocardium
Economics
Databases
Guidelines
Cytokines
Mortality

Keywords

  • Devices
  • Heart failure
  • Trials

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

Cite this

O'Connell, John B. ; McCarthy, Patrick M ; Sopko, George ; Filippatos, Gerasimos S. ; Pĩa, Ileana L. ; Konstam, Marvin A. ; Young, James B. ; Miller, Leslie W. ; Mehra, Mandeep R. ; Roland, Edmond ; Blair, John E.A. ; Farrar, David J. ; Gheorghiade, Mihai. / Mechanical circulatory support devices for acute heart failure syndromes : Considerations for clinical trial design. In: Heart Failure Reviews. 2009 ; Vol. 14, No. 2. pp. 101-112.
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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

Mechanical circulatory support devices for acute heart failure syndromes : Considerations for clinical trial design. / O'Connell, John B.; McCarthy, Patrick M; Sopko, George; Filippatos, Gerasimos S.; Pĩa, Ileana L.; Konstam, Marvin A.; Young, James B.; Miller, Leslie W.; Mehra, Mandeep R.; Roland, Edmond; Blair, John E.A.; Farrar, David J.; Gheorghiade, Mihai.

In: Heart Failure Reviews, Vol. 14, No. 2, 01.01.2009, p. 101-112.

Research output: Contribution to journalArticle

TY - JOUR

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AU - O'Connell, John B.

AU - McCarthy, Patrick M

AU - Sopko, George

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

PY - 2009/1/1

Y1 - 2009/1/1

N2 - 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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