First New Jersey Patient Enrolled in PROTECT IV National Trial at Hackensack University Medical Center

Study Evaluating Long-Term Effectiveness of Impella Pump Support During Catheterization for High-Risk Patients

Protect IV

Interventional cardiologists at Hackensack University Medical Center recently treated the first patient in New Jersey enrolled in the multicenter national PROTECT IV clinical trial. The study will evaluate the effectiveness of the Impella pump offering support to high-risk patients with complex heart disease and reduced heart function during catheterization procedures.

The study is comparing cardiac catheterization with and without the addition of the Impella® to see if Impella support relieves heart disease symptoms and improves heart function and overall health better than catheterization alone.

If demonstrated successfully, the Impella may expand eligibility for catheter-based interventions to individuals with complex coronary artery disease and congestive heart failure deemed too severe to justify the risk of cardiac catheterization. For these patients, physicians recently began using the Impella device to support heart function during cardiac catheterization, inserting the device via the same catheter used during angioplasty to provide hemodynamic support to the patient during the procedure, ensuring that at no point is blood flow compromised.

While this alternative treatment for patients who are either not candidates for surgery or who have chosen not to have surgery is already applied in practice, there have not been scientifically rigorous data demonstrating that using Impella for hemodynamic support translates into long-term clinical benefit. This is the objective of the PROTECT IV trial.

"We are excited to participate in the PROTECT IV Trial and other investigation efforts that further improve our ability to care for patients with coronary artery disease. Taking the best advantage of mechanical circulatory support tools like the Impella allows our patients to have options when more traditional therapies like coronary bypass surgery are not ideal," said Michael Lim, M.D., FACC, FSCAI, Chief of the Cardiac Catheterization Lab at Hackensack University Medical Center.

Interventional cardiologists Ankitkumar Patel, M.D., and Pranaychandra Vaidya, M.D., treated the first patient in the PROTECT IV study at Hackensack University Medical Center. If the data show conclusively that the hemodynamic support provided by the Impella device is superior to catheterization alone, it could lead to a new standard of care for high-risk patients with complex coronary artery disease and impaired heart function, including new guidelines from the American Heart Association and American College of Cardiology.

Learn more about innovative cardiovascular treatments at Hackensack University Medical Center.

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