Access to the widest range of possible treatments is of critical importance for patients with heart disease. When the arteries leading to the heart become blocked or narrowed, coronary artery bypass grafting (CABG), otherwise known as heart surgery, can be an effective treatment option. However, some patients with low heart function and other medical problems are not appropriate candidates for heart surgery. There is also a procedure called percutaneous coronary intervention (PCI), which can be performed in the cardiac catheterization lab to open narrowed or blocked arteries by performing balloon angioplasty to break away the plaque on the wall of the artery, or by placing a stent, which can open the narrowed artery. Patients who are also not candidates for this conventional PCI procedure may have no other viable options to help improve their heart disease symptoms.
Now, there is hope. A new procedure called Protected PCI is made possible through the support of a miniature heart pump called the Impella 2.5. The heart pump, which recently received FDA approval for elective and urgent high risk PCI procedures in hemodynamically stable patients with severe coronary artery disease and depressed left ventricular ejection fraction, has been shown to maintain stable heart function during the procedure, giving interventional cardiologists the opportunity to work on advanced heart disease patients who might otherwise, have no options.
The Impella 2.5 is so small that it does not require surgery. It is placed in the heart through a small hole in the leg and assists the heart, and allows it to the rest by pumping up to two-and-a-half liters of blood per minute while a PCI procedure is performed to open narrowed or blocked arteries. In a press release about the Food & Drug Administration (FDA) approval of the Impella 2.5, the FDA reports that the temporary circulatory support provided by the Impella 2.5 may allow physicians to perform a more thorough procedure by maintaining heart function. This can reduce the risk of certain additional medical problems during and after the procedure, lead to an improved quality of life, less days in the hospital and less repeat procedures in the future.
Patients deserve as many options as possible when dealing with something as serious as complex coronary artery disease. Using the Impella 2.5 pump to maintain heart function during PCI opens a new door of hope for people suffering from certain types of advanced heart disease, giving them the option to potentially improve their quality of life.
Read the entire FDA press release, discussing the Impella 2.5 approval here.
The Impella 2.5 system is a temporary (<6 hours) ventricular support device indicated for use during high risk percutaneous coronary interventions (PCI) performed in elective or urgent, hemodynamically stable patients with severe coronary artery disease and depressed left ventricular ejection fraction, when a heart team, including a cardiac surgeon, has determined high risk PCI is the appropriate therapeutic option. Use of the Impella 2.5 in these patients may prevent hemodynamic instability which can result from repeat episodes of reversible myocardial ischemia that occur during planned temporary coronary occlusions and may reduce peri- and post-procedural adverse events.
Protected PCI [or Impella 2.5, CP, etc.] is not right for everyone. You may not be able to be treated with Impella if you have certain pre-existing conditions, which a cardiologist will determine, such as: severe narrowing of the heart valve, severe peripheral artery disease, clots in your blood vessels, or a replacement heart valve or certain heart valve deficiencies. Additionally, use of Impella has been associated with risks, including, but not limited to valvular and vascular injury, bleeding, and limb ischemia in certain patients. Learn more about the Impella devices’ approved indications for use, as well as important safety and risk information at www.protectedpci.com/indications-use-safety-information/.