Utah Woman Gets Second Lease on Life

MURRAY, UT (6/1/2009) - A Utah woman has received a second lease on life and in the process has become the first patient in the Intermountain West to have a heart valve replacement without having to undergo open heart surgery, the conventional method for valve replacement.

Instead, a cardiac team at the Heart Institute at Intermountain Medical Center in Murray replaced Rose Felice’s diseased aortic heart valve using a new catheter system that provides new hope for patients who are considered high risk or non-operable for conventional open-heart valve surgery. The new procedure is being studied as part of an international clinical trial to determine the effectiveness for patients.

Intermountain Medical Center is one of only 25 centers in the United States, Canada and Europe – and the only Utah hospital – participating in the study of more than 1,000 heart valve patients.

In the new procedure, the new valve is mounted and crimped onto a unique balloon delivery catheter. It is then inserted into the femoral artery in the leg or between the ribs through the apex of the heart. Once in the heart, the valve is positioned and deployed across the patient’s diseased aortic valve.

If the new system proves effective it could substantially reduce the risks, and costs, that are associated with open heart surgery for the nearly 250,000 people in the United States who need a new heart valve each year, says lead researcher Brian Whisenant, M.D., an interventional cardiologist at the Heart Institute at Intermountain Medical Center.

“This study represents new hope for a significant number of patients who may not be eligible for surgical replacement of their valves,” says Dr. Whisenant.
Doctors say open-heart surgery was not an option for Felice, who is from Helper, Utah. Her weak body could not endure the strain of opening the chest and placing the heart on a bypass machine while the valve was replaced.

Two years ago, Felice received a grim prognosis. Due to a condition called aortic stenosis, or a diseased aortic valve, she likely had just a couple of years left to live. The diseased valve was constricting the flow of blood from her heart, depleting the supply of oxygen to her body. She was weakening rapidly, growing unable to perform daily tasks, losing the strength to walk across the room; sometimes she hardly had the energy to speak. Traditionally, the only option to replace the valve in her heart would be through open-heart surgery.

Dr. Whisenant expects the procedure to have a marked improvement in Felice’s quality of life. “I anticipate this will markedly improve her ability to live an active life whereas now she can’t get across the room,” he says.

“I’m so grateful to have the opportunity to spend more time with my children and grandchildren and to actually have the energy and ability to enjoy quality time with them,” says Felice.

The PARTNER (Placement of Aortic Transcatheter Valve) clinical trial will determine whether delivery and placement of a replacement heart valve through a catheter, inserted into a blood vessel in the groin and snaked up into the heart, can serve as an alternative to open-heart surgery for patients at extremely high risk.

Designed for use through a catheter, the valve can be inserted and placed in a beating heart without surgery or reliance on cardiopulmonary bypass. The device integrates a balloon-expandable, wire-mesh, stainless-steel stent that serves to anchor it in place, with tissue leaflets, that ensure one-way blood flow.

The balloon-mounted valve is compressed to the diameter of a pencil, then inserted at the tip of a long thin plastic catheter through a small incision in the groin and delivered through the veins to the heart. The catheter is passed through the right atrium to the right ventricle, which pumps blood to the lung through the pulmonary valve.

Felice is one of 350 non-operative patients involved in this study nationwide. There are 690 high-risk patients who are also part of the PARTNER trial involved in the surgical arm of the study. They are candidates for conventional open-heart surgery. Those patients will be evaluated for femoral access to determine if they can receive the transcatheter valve through their femoral artery or if needs to be implanted through a small incision between the ribs.

Intermountain Medical Center is the premier cardiac center in the Intermountain West and serves as the flagship medical facility for Intermountain Healthcare, a nationally-recognized nonprofit system of hospitals, surgery centers, doctors, and clinics that serve the medical needs of patients in the Intermountain West.