BIDMC receives FDA approval to use new medical device in patients with severely damaged aortic heart valves

Beth Israel Deaconess Medical Center (BIDMC) yesterday became the first institution in the United States to use a new minimally invasive medical device since it received FDA approval last week. The device treats patients with severely damaged aortic heart valves who are too ill or frail to have their aortic valves replaced through traditional open-heart surgery.

The first commercial implant of the CoreValve System was performed in an 84-year-old man by a multidisciplinary team of interventional cardiologists and cardiac surgeons from the CardioVascular Institute team at BIDMC. The team used a non-surgical, "transfemoral" technique to place the CoreValve in the man's heart through a catheter (tube) inserted in the femoral artery of his groin.

The CoreValve team includes interventional cardiologists Jeffrey Popma, MD, Roger Laham, MD, and Duane Pinto, MD; cardiac surgeons Kamal Khabbaz, MD, and David Liu, MD; and program coordinator Kim Guibone, NP. Dr. Popma is the co-principal investigator of the national CoreValve U.S. Pivotal Trial, the clinical study that led to its recent US Food and Drug Administration (FDA) approval.

Positive Clinical Performance

The FDA approved the device for use in patients with aortic stenosis based on its exceptionally positive clinical performance and its ability to lengthen life and reduce the rate of common complications - such as stroke and valve leakage - that have a dramatic impact on patients' quality of life.

Approximately one-third of severe aortic stenosis patients are not eligible for open-heart surgery because in their weak condition, their doctors deem the risk to be unacceptable. Unless these patients are treated, however, they have a 50 percent risk of death at one year. When calcium deposits cause the aortic valve to become stenotic, or narrowed, it cannot open and close properly, diminishing blood flow between the heart and the rest of the body. This causes the heart to weaken and function poorly. Symptoms of aortic stenosis include fatigue, dizziness, chest pain and pressure, shortness of breath during activity, heart palpitations and fainting.

Severe aortic stenosis primarily affects older people and typically develops when the patient is 50 to 70 years of age. Approximately 300,000 people worldwide, including 100,000 in the United States, suffer from severe aortic stenosis.

"This implant marks a significant milestone in our institution's history as we've been instrumental in confirming the safety and efficacy of this new device, and ultimately providing a viable new therapy to patients who otherwise have limited or no options," said Khabbaz, co-principal investigator for the local trial that took place at BIDMC.

Popma added, "Through the strength of our multi-disciplinary approach at the BIDMC, our patients will now have access to this life-saving therapy and the improved quality of life it allows."

Beth Israel Deaconess was one of 40 centers across the United States that participated in the clinical trial and continues to be involved in research on future improvements in this technology.

Beth Israel Deaconess is the only hospital in the Boston area currently offering CoreValve therapy. It also offers the Edwards Sapien valve, the first of the two devices (including the CoreValve) the FDA has approved for transfemoral aortic valve replacement. The program is part of the Structural Heart Center, a multidisciplinary initiative of the CardioVascular Institute and the Divisions of Cardiac Surgery and Cardiology that began in 2010.

Takes Over Valve Function

Most commonly, the Medtronic CoreValve System is inserted into a patient via an artery in the leg, and the physician then guides it through the arteries into the heart at the site of the original aortic valve. Once in place, it takes over the original valve's function and ensures that oxygen-rich blood flows out of the heart efficiently to circulate throughout the body.

The advanced design of the new device was developed to serve a broad spectrum of severe aortic stenosis patients. The CoreValve System is suitable for patients with native valves of nearly all sizes, and it is delivered via the smallest delivery system available (18 French, or approximately a quarter-inch), making it possible to treat patients with vascular systems that are small or difficult to navigate. Additionally, the CoreValve System enables physicians to deliver the device to the diseased valve in a controlled manner, allowing for accurate placement.