SHIELD I trial results confirm consistent cardiac support offered by St. Jude Medical HeartMate PHP cardiac assist device during high-risk PCI procedures

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The data show that the hemodynamics of severely ill patients undergoing complex revascularisation procedures can be maintaimed by use of the HeartMate PHP cardiac assist.

The benefits of the HeartMate PHP (Percutaneous Heart Pump) cardiac assist device for patients undergoing high-risk percutaneous coronary intervention (PCI) have been confirmed by the results from the SHIELD I (Coronary Interventions in High-Risk Patients Using a Novel Percutaneous Left Ventricular Support Device) study, St Jude Medical has announced. When assisted by the HeartMate PHP cardiac assist device, consistent, stable hemodynamics were maintained during the study.

SHIELD I is a prospective, nonrandomised, open-label, multicentre trial that evaluated the use of the HeartMate PHP cardiac assist device in patients who required hemodynamic (circulatory) support during complex PCI procedures. The study results from the first 46 patients were presented at the 27th Transcatheter Cardiovascular Therapeutics meeting.

“We are excited to share the results of SHIELD I, which support the safety and performance of the HeartMate PHP device,” said Dariusz Dudek, principal investigator of the SHIELD I study and physician in chief, Department of Cardiology and Cardiovascular Interventions at the University Hospital in Krakow, Poland. “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.”

Unlike traditional catheter-based support devices, the HeartMate PHP cardiac assist device can generate an average blood flow of four to five litres per minute.

Data from SHIELD I show the trial met both endpoints for primary performance (freedom from hemodynamic compromise during PCI) and safety (a composite of major adverse events). In addition, data from SHIELD I showed:

  • Low complication rates: researchers leading SHIELD I 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.
  • Ease of use: the research team highlighted the consistent and efficient implantation process offered by the HeartMate PHP device.

The HeartMate PHP device is CE mark approved and commercially available in Europe. In the USA, the HeartMate PHP cardiac assist device is currently being evaluated in the SHIELD II IDE clinical trial as an investigational device and limited by US law to investigational use.