Nebraska Heart Institute First in the Nation to Implant Acorn(TM) Heart Failure Device Minimally Invasively

Lincoln, NE, February 20, 2009 – (HSMN NewsFeed) – Nebraska Heart Institute (NHI) physicians became the first site in the U.S. to perform an implantation of the Acorn Cardiac Support Device (CSD) using a minimally invasive approach. The “heart jacket” or CSD is designed to constrain and support the failing heart muscle.

“The CSD is used for the treatment of heart failure,” says James Wudel, MD, cardiothoracic surgeon with NHI. “It prevents further enlargement of the heart muscle while relieving the symptoms of heart failure, often in patients who have failed many other forms of therapy. Surgeons with NHI were part of the original trial involving this device in June of 2001, having been one of six clinic sites at that time.

During the current trial, the cardiac support device is being investigated as to the feasibility of implantation using a limited incision under the left breast.
Historically, the device was implanted through traditional open-heart surgery involving a lengthy surgery and recovery. The device being used today is the same as in 2001. What is new and being investigated is the delivery system.

With this new technology, surgeons with NHI implanted the device in one of the Cardiac Catheterization Labs at the Nebraska Heart Hospital (NHH). Only one incision, approximately 7 cm long, was used to place the device around the heart. “By utilizing this procedural approach, the team was able to take advantage of reduced anesthesia time, thus reducing the recovery time,” says Deepak Gangahar, MD, cardiothoracic surgeon with NHI.

Doctors Wudel and Gangahar along with a team of anesthesiology and technicians implanted the device; first, in a patient from Louisiana and following in a patient from Iowa. Both patients were referred to NHI due to the limited clinical sites in the U.S. involved in this FDA trial.

“These two procedures are exciting on two major ‘fronts,’” says Wudel. “First by utilizing a minimally invasive method, the patient undergoes far less stress and recovers dramatically sooner. Secondly, utilizing a cardiac catheterization suite provides optimal imaging and expedites device placement through this minimal approach.”

Dr. Gangahar further amplified this point. “In 2001 we utilized the heart-lung machine. The new implantation technique does not require the heart-lung machine or opening the breast bone.” “Additionally, the technique doesn’t require lifting of the heart nor suturing to the epicardium, which greatly simplifies the procedure,” says Wudel. Made from specifically designed polyester fabric, the CSD is strong enough to prevent the heart from getting larger and at the same time doesn’t interfere with the heart’s normal filling and emptying process. All of this contributes to the patient being dismissed much sooner.

Patients with advanced heart failure often have hearts that are larger than normal causing the muscle to become weak and not able to circulate blood, as it should. By implanting the CSD, the muscle is prevented from further expansion thus improving the heart’s already-compromised pumping efficiency.

It is the belief, based on extensive studies, that those patients in whom the CSD device is implanted will have improved heart function. “With this device, the heart will be prevented from further dilation and may gain improvement in pumping efficiency,” says Gangahar. “The CSD serves as a constant reminder to the heart of how it should perform and assists in the reduction of ‘over-stretch’ and wall stress.”

Five million Americans are living with congestive heat failure and, according to the American Heart Association, 400,000 new cases are diagnosed every year. If a patient’s heart continues to fail, there is still an option of transplantation or implementing a mechanical assist device. “There will never be enough human hearts for transplantation, therefore, it is imperative to improve upon and create new medications and devices for the treatment of heart failure,” says Gangahar. Further, the CSD is an investigational device and can be used only under the strict guidelines of the Food and Drug Administration’s protocol as its clinical benefit has not been yet established.

The NHI and NHH provide unparalleled cardiac, vascular and thoracic care services. These services include consultative cardiology; nuclear cardiology, electrophysiology, cardiac catheterization, coronary intervention, cardiothoracic and peripheral vascular surgery, heart and lung transplantation and cardiac mechanical assist devices. The Institute also provides services through its Heart Improvement Program, Women’s Heart Program, Arrhythmia and Syncope Clinic and the Lipid Clinic.

Source: Nebraska Heart Institute

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