Protected PCI Offers New Option for Patients Turned Down for CABG or Traditional PCI
Improving the health of patients and offering the best possible treatments is the primary ethos and goal of any medical professional. A new procedure called Protected PCI, with the Impella 2.5 pump, offers cardiologists the chance to reduce complications and improve outcomes for a wide range of high risk patients. These patients are severe heart disease patients who are characterized as being hemodynamically stable, but who have a depressed left ventricular ejection fraction (< 35%), complex coronary anatomy such as triple vessel disease or left main disease, and various comorbidities (such as heart failure, diabetes, advanced age, peripheral vascular disease, complex lesions, history of angina, prior surgeries).
These “high risk” patients often present to the cath lab as either a scheduled PCI case – they have been turned down for CABG or traditional PCI but have little to no options left to improve their heart failure symptoms, or, they present urgently with unstable angina and are in need of revascularization with hemodynamic support.
The Impella 2.5 is the only percutaneous hemodynamic support device proven safe and effective for treating these high risk patients with severe coronary artery disease and diminished (but stable) heart function. The Impella 2.5 is a miniature blood pump that reduces the strain on the heart during complex PCI procedures by maintaining mean arterial pressure and directly unloading the left ventricle -- allowing for a more complete revascularization.
After the recent FDA approval of the Impella 2.5 device in March 2015, the agency issued a press release, stating that the "use of the Impella 2.5 System is intended to prevent episodes of unstable heart function, including unstable blood pressure and poor circulation, in patients who are at high risk for its occurrence."
Clinical evidence has demonstrated that Impella 2.5 can reduce major adverse cardiac and cerebral events (MACCE) by 29% over the former standard of care, the intra-aortic balloon pump, in PCI procedures. Additionally, the data has shown that the Impella 2.5 can reduce hospital stays and repeat procedures, and improve the quality of life of patients with severe coronary artery disease.
The benefits of a Protected PCI with the Impella 2.5 could potentially improve patients outcomes when compared to traditional methods. On top of those benefits, a Protected PCI program with the Impella 2.5 also opens up the potential to treat more patients, whom in the past would not have been candidates for PCI.
To find out more about the Impella 2.5 FDA approval for high risk PCI, you can read the FDA article here.
To learn more about the Impella 2.5 approved indications for use, as well as important warning, safety, and contraindication information, visit abiomed.com/impella.
To learn more about the Impella® platform of heart pumps, including important risk and safety information associated with the use of the devices, please visit: www.protectedpci.com/indications-use-safety-information/