Text Size: A- A+ Facebook Twitter LinkedIn YouTube

Breaking News



Format: 04/16/2014
Format: 04/16/2014


HealthCanal.com: FDA Approves New Device Investigated at AGH for Patients With Advanced Heart Failure

Thursday, February 18th, 2010

A revolutionary heart assist technology investigated for several years at Allegheny General Hospital (AGH) has been approved by the FDA for patients with advanced heart failure who do not qualify for heart transplantation. Called the Thoratec® HeartMate II® Left Ventricular Assist System (LVAS), the device is now available as “destination therapy” – or long-term treatment for those patients.

Approximately six million Americans suffer from congestive heart failure and 600,000 new cases are diagnosed each year, according to the American Heart Association. The prognosis for patients with advanced heart failure is poor, with projected one-year mortality rates exceeding those of other terminal diseases such as AIDs, leukemia, and lung cancer.

Though transplantation offers hope for approximately 2,000 advanced heart failure patients each year, more than 250,000 patients have no viable treatment option and are considered at high risk for repeated hospitalizations, severely diminished quality of life and limited life expectancy.

For the 50,000-100,000 heart failure patients in the U.S. who do not qualify for a heart transplant, due to age or other extenuating circumstances, long-term therapy with HeartMate II may be a life-saving option, said Srinivas Murali, MD, director of AGH’s Division of Cardiovascular Medicine and Medical Director of AGH’s Gerald McGinnis Cardiovascular Institute.

HeartMate II is the first and only continuous flow chronic LVAS to receive FDA approval for both bridge-to-transplantation and destination therapy. AGH participated in the clinical trial of the device and is now one of a select number of advanced cardiac centers in the nation qualified to offer the state-of-the-art therapy on a routine basis.

“This technology is a breakthrough for a large group of patients whose therapeutic options until now have been severely limited. The HeartMate II provides cost-effective, long-term circulatory support in a manner that does not merely keep a person with end stage heart failure alive, but maximizes their quality of life. We are thrilled to have played a role in the development this exciting new treatment alternative,” said Raymond Benza, MD, medical director of AGH’s Advanced Heart Failure, Transplantation, Mechanical Circulatory Support and Pulmonary Hypertension Program

In 2009, AGH performed 36 successful implantations of ventricular assist devices and currently has three patients using the HeartMate II as destination therapy. The hospital is recognized regionally and nationally as a leading center for the treatment of heart failure, offering heart transplantation services as well as access to an array of cutting edge investigational heart assist devices. The mechanical circulatory support program at AGH has Joint Commission accreditation and was one of the first programs in the country to receive this distinction.

According to Stephen Bailey, MD, director of AGH’s Division of Cardiac Surgery and Surgical Director of Cardiac Transplantation and Mechanical Circulatory Support, LVADs take over the pumping ability of a weakened heart’s left ventricle, which pumps oxygen rich blood received from the lungs to the rest of the body.

 To read more, visit the HealthCanal website.

West Penn Allegheny Health System
Tell us who you are:

What areas do you use on our website?*
(select more than one if it applies)

Did you find what you were looking for?

Would you refer others to our website?

Can we contact you for future questions?

CAPTCHA math question:* 7 + 9 =

Thank you for completing the West Penn Allegheny Health System website survey.
We value your feedback and comments.