TY - JOUR
TI - Mechanical circulatory support devices for acute heart failure syndromes: Considerations for clinical trial design
AU - O'Connell, J.B.
AU - McCarthy, P.M.
AU - Sopko, G.
AU - Filippatos, G.S.
AU - Pĩa, I.L.
AU - Konstam, M.A.
AU - Young, J.B.
AU - Miller, L.W.
AU - Mehra, M.R.
AU - Roland, E.
AU - Blair, J.E.A.
AU - Farrar, D.J.
AU - Gheorghiade, M.
JO - Heart Failure Reviews
PY - 2009
VL - 14
TODO - 2
SP - 101-112
PB - 
SN - 1382-4147
TODO - 10.1007/s10741-008-9097-7
TODO - creatinine;  cytokine;  neurohormone;  nitrogen;  urea, acute heart failure;  article;  assisted circulation;  clinical study;  clinical trial;  economic aspect;  extracorporeal oxygenation;  health care cost;  heart assist device;  high risk patient;  human;  medical technology;  mortality;  patient selection;  practice guideline;  risk benefit analysis;  treatment outcome;  urea nitrogen blood level, Acute Disease;  Assisted Circulation;  Clinical Trials as Topic;  Heart Failure;  Heart, Artificial;  Heart-Assist Devices;  Humans;  Patient Selection;  Prognosis;  Ventricular Function
TODO - 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. © pringer Science+Business Media, LLC 2008.
ER -