Patients with advanced heart disease and limited treatment options will soon have access to the most progressive cardiac care procedure in the world at Providence Heart and Vascular Institute.
Providence has been approved as one of the first 25 sites in the nation - and the only site in Oregon – to offer the newly FDA-approved Sapien valve to patients who are too sick to have traditional open-heart surgery.
Todd Caulfield, M.D. talks about Providence's selection and what it means for patients.
"The ability to provide access to this lifesaving technology is great for our patients and a privilege we have been working toward for years." said Todd Caulfield, M.D., interventional cardiologist and medical director of cardiovascular research for Providence Heart and Vascular Institute.
This procedure is approved for patients who have severe aortic stenosis, a condition in which the valve that allows blood to leave the heart does not fully open. This decreases blood flow to the brain and rest of the body. The condition is progressive and life-threatening. Nearly half of the patients with this condition do not survive more than two to three years without treatment.
Traditionally, aortic valve replacements required open-heart surgery, in which the chest is opened, the heart is stopped and a new valve is sewn into place. The Sapien valve is implanted in the heart in a minimally invasive procedure by way of a catheter threaded through the circulatory system from a groin artery incision. The FDA approved the commercial use of the Sapien valve after a successful multi-year clinical trial. The device has been approved for use in Europe since 2007. Physicians at Providence Heart and Vascular Institute expect to treat their first patient with this cutting edge technology as soon as this December.
In anticipation of bringing this treatment to its patients, Providence experts have been receiving specialized training. A team of seven physicians led by Dr. Caulfield and surgeon Jeffrey Swanson, M.D. just returned from studying with Canadian physician John Webb, M.D. Dr. Webb is an internationally known interventional cardiologist, and is the first in North America to perform a successful percutaneous aortic valve replacement. PHVI experts will use Dr. Webb's techniques in implanting the Sapien valve.
"Dr. Webb is the genius behind the development of techniques to safely position the Sapien valve without surgery and with minimal risk to the patient. Our team was very fortunate to learn these strategies directly from him," said Dr. Caulfield.
The other members of the PHVI Sapien valve team are surgeon Eric Kirker, M.D., cardiologists Robert Hodson, M.D., Aly Rahimtoola, M.D. and Craig Walsh, M.D., and anesthesiologist Steve Kelly, M.D. The entire team will work together to perform each valve replacement procedure.
The procedure will be performed in a hybrid surgical suite at Providence St. Vincent Medical Center. The hybrid surgical suite has been recently updated and includes the technology to perform open heart surgery and minimally invasive procedures.
The collapsible Sapien valve is made of cow tissue and polyester, and supported with a stainless steel mesh frame. It is designed and manufactured by Edwards Lifesciences Corporation.
Providence also has received an invitation to participate in clinical trials for the next version of the Sapien valve. Research on that device, also designed and manufactured by Edwards Lifesciences, will be open to a broader group of patients.
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