SHIELD I Confirms Benefit of St. Jude Medical's HeartMate PHP During High-Risk PCI Procedures

October 16, 2015—St. Jude Medical, Inc. announced results from the SHIELD I study that confirm the benefits of using the company’s HeartMate PHP (percutaneous heart pump) for left ventricular support in high-risk patients undergoing percutaneous coronary intervention (PCI). Data from the first 46 patients in SHIELD I were presented at TCT 2015, the 27th Transcatheter Cardiovascular Therapeutics scientific symposium of the Cardiovascular Research Foundation in San Francisco, California.

The study demonstrated that consistent, stable hemodynamics were maintained during revascularization when assisted by the HeartMate PHP cardiac assist device, which can generate an average blood flow of 4 to 5 L/min, which is the normal amount of blood pumped out by the left ventricle.

According to the company, SHIELD I is a prospective, nonrandomized, open-label, multicenter trial that evaluated the use of the HeartMate PHP cardiac assist device in patients who required hemodynamic support during complex PCI procedures. Data from SHIELD I show that the trial met both endpoints for primary performance (freedom from hemodynamic compromise during PCI) and safety (a composite of major adverse events).

Additionally, data from SHIELD I showed low complication rates. SHIELD investigators did not observe any cases of device-related cardiac death or myocardial infarction, no intraprocedural hypotension, and the overall incidence of complications related to the HeartMate PHP device was low. The trial also demonstrated the device’s ease of use with a consistent and efficient implantation process.

In the company’s press release, SHIELD I Principal Investigator Dariusz Dudek, MD, commented, “We are excited to share the results of SHIELD I, which support the safety and performance of the HeartMate PHP device. The data from SHIELD I demonstrate that the HeartMate PHP device is a highly promising technology that should be considered for high-risk patients, such as those with advanced heart failure or who may be at risk of cardiogenic shock, undergoing PCI procedures.” Dr. Dudek is Physician in Chief, Department of Cardiology and Cardiovascular Interventions at the University Hospital in Krakow, Poland.

St. Jude Medical advised that the HeartMate PHP device has received CE Mark approval and is commercially available in Europe. Approval was based on data from the first 30 patients enrolled in the HeartMate PHP SHIELD I CE Mark trial. In the United States, where it is limited to investigational use only, the HeartMate PHP cardiac assist device is currently being evaluated in the SHIELD II investigational device exemption clinical trial.