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The cVAD registry for percutaneous temporary hemodynamic support: A prospective registry of Impella mechanical circulatory support use in high-risk PCI, cardiogenic shock, and decompensated heart failure - 12/05/18

Doi : 10.1016/j.ahj.2017.09.007 
George W. Vetrovec, MD a, Mark Anderson, MD b, Theodore Schreiber, MD c, Jeffrey Popma, MD d, William Lombardi, MD e, Brijeshwar Maini, MD f, Jacob Eifer Moller, MD g, Andreas Schäfer, MD h, Simon R. Dixon, MBChB i, Shelley Hall, MD j, E. Magnus Ohman, MD k, Catalin Mindrescu, MD l, Jeffrey Moses, MD m, William O'Neill, MD n,
a Pauley Heart Center, VCU Medical Center, Richmond, VA 
b Einstein Medical Center, Philadelphia, PA 
c Detroit Medical Center Cardiovascular Institute, Detroit, MI 
d Beth Israel Deaconess Hospital, Boston, MA 
e University of Washington, Seattle, WA 
f Tenet Healthcare Corporation, Eastern Region - Coastal Division, Delray, FL 
g Odense University Hospital, Odense, Denmark 
h Medizinische Hochschule Hannover, Hanover, Germany 
i Beaumont Hospital Royal Oak, Royal Oak, MI 
j Baylor University Medical Center, Dallas, TX 
k Duke University, Durham, NC 
l Abiomed Inc., Danvers, MA 
m Columbia University Medical Center, New York, NY 
n Henry Ford Hospital/Wayne State University, Detroit, MI 

Reprint requests: William O'Neill, Henry Ford Hospital/Wayne State University, Division of Cardiology, 2799 W Grand Blvd, Detroit, MI 48202.Henry Ford Hospital/Wayne State UniversityDivision of Cardiology2799 W Grand BlvdDetroitMI48202

Abstract

Management of patients requiring temporary, mechanical hemodynamic support during high- risk percutaneous coronary intervention (PCI) or in cardiogenic shock is rapidly evolving. With the availability of the Impella 2.5, CP, 5.0, LD, and RP percutaneous mechanical circulatory support devices, there is a need for continued surveillance of outcomes.

Three factors underline the importance of a registry for these populations. First, large randomized trials of hemodynamic support, involving cardiogenic shock, are challenging to conduct. Second, there is increasing interest in the use of registries to provide “real-world” experience and to allow the flexibility to evaluate individual patient uses and outcomes. Third, current, large databases have not captured the specific impact of mechanical support treatment of cardiogenic shock.

The predecessor to the catheter-based ventricular assist devices registry, known as USpella, began in 2009 with paper data acquisition but beginning in 2011 transferred to electronic data capture, enrolling 3,339 patients through 2016. Throughout, registry data have been used to assess the outcomes of Impella therapy, leading to 8 publications and 4 Food and Drug Administration premarket approvals covering multiple indications and Impella devices.

Going forward, the registry will continue to assess not only in-hospital outcomes but long-term follow-up to 1 year. In addition, data management will be enhanced to assess quality and clinical experiences. The registry will also provide a mechanism for postmarketing surveillance.

This manuscript reviews the ongoing catheter-based ventricular assist devices registry design, management, and contributions of the registry data. The upgraded registry will provide a more robust opportunity to assess acute and late outcomes of current and future device use worldwide.

Condensed abstract

The current catheter-based ventricular assist devices registry is an international database documenting outcomes with temporary Impella hemodynamic support. The registry has supported 8 publications and 4 Food and Drug Administration premarket approvals since its inception in 2009. The current registry is more robust containing outcomes up to 1 year postprocedure.

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 Mauricio G. Cohen, MD, served as guest editor for this article.


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Vol 199

P. 115-121 - mai 2018 Retour au numéro
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