Cincinnati (July 6, 2015) – A breakthrough heart valve that was pioneered in a clinical trial conducted by physicians at The Christ Hospital has been approved by the U.S. Food and Drug Administration (FDA).

The Christ Hospital is the only local hospital and one of the few research sites in the nation to participate in the clinical trial of the SAPIEN 3 Transcatheter Heart Valve, which has now been approved for use in patients who are inoperable or high risk for traditional open heart surgery. The new valve was developed by Edwards Lifesciences of Irvine, CA, and is designed to provide a simpler, easier procedure, with fewer post procedural complications and a faster recovery.

At The Christ Hospital, the trial was performed by a team of physicians led by Dean Kereiakes, MD, medical director of  The Christ Hospital Heart and Vascular Center and the Carl and Edyth Lindner Center for Research and Education at The Christ Hospital.

“The SAPIEN 3 Transcatheter Heart Valve is yet another example of The Christ Hospital participating in leading edge clinical trials and bringing new treatment options to our community while setting the bar for all other local providers,” Dr. Kereiakes said.

Through participation in the clinical trial, Christ Hospital is the only hospital in the region able to offer this minimally invasive procedure to patients at both high as well as intermediate risk for surgery.

“The Christ Hospital is the only hospital in the region able to offer this treatment to ‘intermediate’ risk patients (less ill with fewer co-existing medical problems) through the partner trial research study”, Dr. Kereiakes said. “Patients obviously prefer the less invasive surgery that we can offer because of our role in the Partner trial.”
In a statement the FDA said it based approval of the SAPIEN 3 on a clinical study involving 583 patients – including those at Christ Hospital - with aortic valve stenosis who were at high risk for open heart surgery or who could not undergo the surgery due to excess risk.

One of those patients was Susan Williams, a Cincinnati-area woman who was referred to Dr. Kereiakes after experiencing severe health problems related to a defective aortic valve. Williams said prior to receiving the SAPIEN 3, she was been bed-ridden for a month, in near constant need of oxygen and “really had no life.”
Williams said Dr. Kereiakes told her he that because of her age and condition, he wanted to use a new type of valve on her “but that it was part of a test.”

“I was never afraid of it,” Williams said. “I was never reluctant; it was whatever Dr. Kereiakes wanted. I never had a doubt. I couldn’t wait. I had a good strong heart. It was just this valve that was failing
.”
Williams’ husband Rick said he and his wife here hopeful the new valve would help her condition. “It was a brand new procedure,” he said. “But if it was going to save her life then we wanted to try it.” 

The valve is used in a procedure known as Transcatheter Aortic Valve Replacement, or TAVR. The procedure allows the native diseased heart valve to be replaced with a balloon expandable bioengineered valve without traditional open heart surgery and while the heart continues to beat, avoiding the need to stop the patient’s heart and connect them to a heart-lung machine that temporarily takes over the function of the heart and the patient’s breathing during surgery.

Williams said her life has changed since receiving the SAPIEN 3. Not only does she feel better but she is no longer in pain.

“We just couldn’t believe we were that blessed to get a second chance,” she said. “I came home on Monday and was back to work on Wednesday. The (SAPIEN 3) saved my life. I don’t think I would be here without it.”

“A year ago,” Rick Williams said, “I thought I was going to have to bury her. And now thanks to The Christ Hospital, she’s sitting here with me and she is so much better.” 

In 2011, The Christ Hospital was the first local hospital to adopt TAVR. The Lindner Research Center was one of a select number of research sites in the country to evaluate new technologies that have since transformed heart valve disease therapy. These innovations can be life saving for patients suffering from heart valve disease who are poor surgical candidates. The Christ Hospital has improved the lives of over 300 local patients using TAVR.

“At The Lindner Research Center at The Christ Hospital, we are both fortunate and proud to offer leading-edge technologies like the SAPIEN 3 transcatheter heart valve to patients in our community as part of a clinical trial years before they could otherwise get these treatments,” Dr. Kereiakes said.

To learn more about the heart valve program at The Christ Hospital, call 513-206-1179 or visit TheChristHospital.com/Heart.

About The Christ Hospital Health Network: The Christ Hospital Health Network is an acute care hospital located in Mt. Auburn with five ambulatory centers and 181 neighborhood offices conveniently located throughout the Greater Cincinnati area. Its mission is to improve the health of the community and to create patient value by providing exceptional outcomes, affordable care and the finest experiences. Led by the region’s Most Preferred Hospital (National Research Corporation) for 19 consecutive years, the network is dedicated to transforming care by delivering integrated, individualized healthcare and wellness services through its comprehensive physician network and advanced specialty service. The Christ Hospital is among only 6% of hospitals in the nation to be awarded Magnet recognition for nursing excellence and among the top 5% of hospitals in the country for patient satisfaction. For more than 125 years, The Christ Hospital has provided compassionate care to all those it serves.

About The Lindner Research Center: For the past 25 years, The Carl and Edyth Lindner Center for Research and Education (Lindner Research Center) has provided leading-edge medicines and medical technology research covering a broad spectrum of conditions from obesity, diabetes, coronary disease, hypertension and hyperlipidemia to new vascular interventional devices, adult stem cell therapies, structural heart disease, cardiovascular surgery, heart failure and electrophysiology. Physicians at the Lindner Research Center have conducted more than 1,200 clinical trials including multiple first-in-man and first-in-the-U.S procedures, which have contributed to best practice standards for the care of patients. For information on current trials, please call 513-585-1777.