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Format: 04/24/2014
Format: 04/24/2014

News

AGH Mechanical Heart Program Recertified By Joint Commission As Site for Advanced, Permanent Ventricular Assist Device Therapy

Friday, June 4th, 2010

Allegheny General Hospital (AGH) has once again earned the Joint Commission’s “seal of approval” as a site for permanent left ventricular assist device therapy. AGH physicians helped pioneer the treatment, referred to as destination therapy, for critically ill heart failure patients who are not suitable candidates for heart transplantation. The hospital became one of the country’s first medical centers to receive Joint Commission certification for destination therapy in 2008. 

A ventricular assist device is a mechanical pump that helps a failing heart circulate blood more effectively throughout the body. The technology consists of the surgically implanted pump, a control system and an energy supply. The latter two components are located outside of the body.

Originally intended to be used as a short-term bridge to heart transplantation, research over the past decade has shown the technology’s potential as a viable, long-term clinical option for advanced heart failure patients who do not qualify for transplant because of age or illness acuity.

In March of 2007, the Centers for Medicare and Medicaid Services (CMS) updated its National Coverage Determination for Artificial Hearts and Related Devices to closely regulate the specific, advanced utilization of VADs implanted as destination therapy for patients considered poor heart transplantation candidates.

The Joint Commission certification is now a requirement for any U.S. hospital seeking Medicare-approval for their VAD program. The new regulations are intended to meet additional, rigorous criteria established by CMS to demonstrate a program’s ability to safely and effectively manage the challenging life-long clinical care of patients who receive the technology as destination therapy.

CMS reimburses for VAD surgery as permanent therapy only when it is performed at a Joint Commission certified medical center.

“We are extremely gratified that the Joint Commission’s review of our mechanical heart assistance program once again confirmed the exceptional capabilities and expertise that it offers to patients with this difficult disease,” said George Magovern, M.D., Chairman of AGH’s Department of Thoracic and Cardiovascular Surgery.

“The development and use of state-of-the-art cardiovascular assist technologies has been a cornerstone of our program and its reputation as one of the country’s preeminent centers for the treatment of advanced heart disease.”

Dr. Magovern and his AGH colleagues participated in clinical studies that led to the Food and Drug Administration’s 2002 approval of VADs as destination therapy. Reporting in the New England Journal of Medicine, the study group showed the technology nearly doubled and tripled patient survival at one and two years respectively and significantly improved quality of life among recipients.

“The incidence of heart failure in the United States is staggering, with an estimated six million people afflicted and more than 500,000 new cases diagnosed every year. Although heart transplantation remains the best option for those who are terminally ill with this disease, a significant number of patients are not eligible for transplant surgery,” said Srinivas Murali, M.D., Director of AGH’s Division of Cardiovascular Medicine and medical director of the AGH Gerald McGinnis Cardiovascular Institute.

Dr. Murali said long-term VAD therapy provides critically ill, non-transplant candidates with a better option than any currently available heart failure medical therapy.

Currently directed by AGH cardiothoracic surgeon Stephen Bailey, MD, and cardiologist Raymond Benza, MD, AGH’s heart failure program has implanted more than 100 LVAD’s over the past three years including both “bridges to transplantation” and “destination therapy”.

Five VAD patients are presently being managed as destination recipients by the AGH VAD team.

“Ventricular assist devices are amazing pieces of technology that can make tremendous differences in the lives of people who need them. The associated possible risks and the challenges of supporting VAD patients over a lengthy period of time, however, are significant and successful programs require an experienced and highly skilled comprehensive medical team,” said Dr. Bailey.

Dr. Bailey said potential complications related to VAD therapy include infection, bleeding, development of blood clots, respiratory failure, kidney failure, stroke and device failure.

“With experience and a multi-disciplinary care approach, the risk of VAD related complications at specialized centers like AGH have declined in the recent years,” said Dr. Benza. “Our results with VAD therapy are among the best in the country,” said Dr. Benza.

Hospitals performing VAD destination therapy receive a certificate of distinction under the Joint Commission’s Disease Specific Care (DSC) Program for Ventricular Assist Devices. Medical centers are required to meet DSC standards relative to program management, delivering or facilitating care, performance measurement, supporting self management, clinical information systems and VAD-specific requirements.

“The VAD Certification Program standardizes the care provided for heart patients who are very sick and face limited treatment choices,” said Jean Range, executive director, Disease Specific Care Certification, the Joint Commission. “By focusing on quality and safety, VAD Certification will help patients and their families recognize which health care facilities are best equipped to perform this high risk surgical procedure.”

In addition to Drs. Magovern, Murali, Bailey and Benza, the other key members of the AGH VAD program include Lisa Hoff, RN, MSN, MBA , director, AGH Heart Transplant/VAD Program, Sherrie Stutz, RN, Manager, VAD Program, George Sokos, DO, cardiologist, Robert Moraca, MD, cardiothoracic surgeon, Amanda Hopwood, PA, William Gil, perfusionist, Peter Linden, MD, surgical critical care, Swami Nathan, M.D., psychiatry, Beth Burgess, MSW, social work, Julie Hughes, MS, cardiac rehab, Lisa Kernicky, RN, research coordinator, Ed Horn, PharmD, and Melinda Roedler, financial coordinator.

“Joint Commission certification is the gold seal of approval for many hospital clinical programs and it is no surprise that AGH has now been recognized by the Commission for its capabilities in the specialized field of VAD therapy. The level of care that our doctors, nurses and support staff afford patients in the VAD program is second to none,” said Greg Burfitt, AGH President and Chief Executive Officer.
 

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