Registry for Cardiogenic Shock: Utility and Efficacy of Device Therapy

Cardiogenic shock (CS) develops in the end stage of various etiologies of heart failure and
continues to hold high mortality; ranging from 50 to 80%. Expert consensus recommends use of
more powerful mechanical circulatory support device (MCSD) in this patient population;
however, scientific evidence has been anecdotal relying on mostly single-center small case
series and, more fundamentally, because there is no unified definition to grade the severity
of the highly heterogeneous condition CS. Well-designed studies are warranted to precisely
characterize the various "phenotypes" of CS as well as the role of MCSD in this condition
with still excessive mortality.

This multicenter registry will be the first multicenter large-scale registry focused on
mechanical circulatory support (MCS) therapy for CS. The fundamental goal of RESCUE is to
advance the understanding and application of MCSD in order to improve the persistently
dismal survival of patients with CS with the following intents:

1. Elucidate current indication and outcomes of MCSD use in CS.

2. Redefine CS with better description of this disease entity, which will allow better
prediction of outcomes, selection of treatment strategy, and comparison and design of
studies.

3. Facilitate the refinement of patient selection to maximize outcomes with current and
new device options.

4. Improve and expedite new device clinical trials by providing historical control data.

5. Develop consensus "best practice" guidelines to improve clinical management by reducing
short and long-term complications of MCSD therapy.

Inclusion Criteria:

- Adult patients who receive any MCSD including Veno-Arterial Extracorporeal Membrane
Oxygenation (VA ECMO), surgical VAD, and percutaneous VAD, used to treat CS on or
after 9/30/10. Intraaortic balloon pumping (IABP) is not considered an MCSD in this
Registry.

- Adult patients who have signed informed consent. For patients who are too ill to give
informed consent the health care proxy of the patient or next of kin will be
approached for the informed consent.

Exclusion Criteria:

- patients younger than 18 years of age.