This Article Figures Only Full Text Full Text (PDF) View Related Cardiosource Journal Scan Alert me when this article is cited Alert me if a correction is posted Services Email this article to a friend Similar articles in this journal Alert me to new issues of the journal Download to citation manager Citing Articles Citing Articles via HighWire Citing Articles via Google Scholar Google Scholar Articles by Dixon, S. R. Articles by O'Neill, W. W. Search for Related Content PubMed Articles by Dixon, S. R. Articles by O'Neill, W. W.

A Prospective Feasibility Trial Investigating the Use of the Impella 2.5 System in Patients Undergoing High-Risk Percutaneous Coronary Intervention (The PROTECT I Trial)

Initial U.S. Experience

Simon R. Dixon, MB ChB^_*, José P.S. Henriques, MD, PhD, Laura Mauri, MD, MSc, Krischan Sjauw, MD, Andrew Civitello, MD, Biswajit Kar, MD, Pranav Loyalka, MD, Frederic S. Resnic, MD, Paul Teirstein, MD^||, Raj Makkar, MD^¶, Igor F. Palacios, MD^#, Michael Collins, MD^_**, Jeffrey Moses, MD^_**, Karim Benali, MD, MSc, William W. O'Neill, MD^,_*

^_* William Beaumont Hospital, Royal Oak, Michigan
Academic Medical Center, Amsterdam, the Netherlands
Brigham and Women's Hospital, Boston, Massachusetts
Texas Heart Institute, Houston, Texas
^|| Scripps Clinic, La Jolla, California
^¶ Cedars Sinai, Los Angeles, California
^# Massachusetts General Hospital, Boston, Massachusetts
^_** Columbia Presbyterian, New York, New York
Abiomed Inc., Danvers, Massachusetts
University of Miami, Miami, Florida

^_* Reprint requests and correspondence: Dr. William W. O'Neill, Leonard M. Miller School of Medicine, University of Miami, P.O. Box 016099 (R.699), Miami, Florida 33101 (Email: woneill{at}med.miami.edu).

Objectives: We sought to evaluate the safety and feasibility of the Impella 2.5 system (Abiomed Inc., Danvers, Massachusetts) in patients undergoing high-risk percutaneous coronary intervention (PCI).

Background: The Impella 2.5 is a miniaturized percutaneous cardiac assist device, which provides up to 2.5 l/min forward flow from the left ventricle into the systemic circulation.

Methods: In a prospective, multicenter study, 20 patients underwent high-risk PCI with minimally invasive circulatory support employing the Impella 2.5 system. All patients had poor left ventricular function (ejection fraction 35%) and underwent PCI on an unprotected left main coronary artery or last patent coronary conduit. Patients with recent ST-segment elevation myocardial infarction or cardiogenic shock were excluded. The primary safety end point was the incidence of major adverse cardiac events at 30 days. The primary efficacy end point was freedom from hemodynamic compromise during PCI (defined as a decrease in mean arterial pressure below 60 mm Hg for >10 min).

Results: The Impella 2.5 device was implanted successfully in all patients. The mean duration of circulatory support was 1.7 ± 0.6 h (range: 0.4 to 2.5 h). Mean pump flow during PCI was 2.2 ± 0.3 l/min. At 30 days, the incidence of major adverse cardiac events was 20% (2 patients had a periprocedural myocardial infarction; 2 patients died at days 12 and 14). There was no evidence of aortic valve injury, cardiac perforation, or limb ischemia. Two patients (10%) developed mild, transient hemolysis without clinical sequelae. None of the patients developed hemodynamic compromise during PCI.

Conclusions: The Impella 2.5 system is safe, easy to implant, and provides excellent hemodynamic support during high-risk PCI. (The PROTECT I Trial; NCT00534859)

Key Words: percutaneous coronary intervention • high risk • circulatory support

Abbreviations and Acronyms   EF = ejection fraction   INR = international normalized ratio   LV = left ventricle/ventricular   PCI = percutaneous coronary intervention

This article has been cited by other articles:

				K. D. Sjauw, T. Konorza, R. Erbel, P. L. Danna, M. Viecca, H.-H. Minden, C. Butter, T. Engstrom, C. Hassager, F. P. Machado, et al. Supported High-Risk Percutaneous Coronary Intervention With the Impella 2.5 Device: The Europella Registry J. Am. Coll. Cardiol., December 15, 2009; 54(25): 2430 - 2434. [Abstract] [Full Text] [PDF]

				N. R. Desai and D. L. Bhatt Evaluating percutaneous support for cardiogenic shock: data shock and sticker shock Eur. Heart J., September 1, 2009; 30(17): 2073 - 2075. [Full Text] [PDF]