Patients Benefit From New Way to Replace Heart Valves at The Christ Hospital

Two Local Seniors Share Their Story

CINCINNATI, June 26, 2012 /PRNewswire-USNewswire/ -- Nearly one in every eight Americans aged 75 and older will be diagnosed with valvular heart disease. Many of these patients suffer from a severe form of valve disease that requires their diseased aortic valve to be replaced. Transcatheter aortic valve replacement (TAVR) has been studied in clinical trials for patients whose heart valves need replacing, but are at increased risk for open-heart surgery because of reasons such as frailty, previous radiation to the chest or other pre-existing conditions. TAVR involves delivering a balloon-expandable valve to the heart via a small incision in the groin (transfemoral) or between the ribs (transapical). Patients with poor vascular access due to either small size vessels or severe peripheral vascular disease are often better candidates for the transapical approach. In these cases, the replacement valve can be delivered to the heart via a small incision between the ribs (left thoracotomy) below the left breast. These procedures are complex and require a highly integrated heart team approach consisting of interventional cardiologists, cardiac surgeons, cardiac imaging and cardiac anesthesiologists.

The transapical procedure is not yet U.S. FDA approved and is being studied in the nationwide Partner II Trial being conducted at The Carl and Edyth Lindner Center for Research and Education at The Christ Hospital. Gary Hamm, 61, of Goshen, OH, and Donald Grob, 82, of Florence, Kentucky, who could not have the valve inserted via the transfemoral approach, recently underwent the new transapical procedure.

"I feel better than I have in years, dare I say, as good as my old high school wrestling days," said Hamm, who had the transapical procedure late last month. "I'm looking forward to many more treasured moments with my family and grandchildren, fishing by the lake and playing with the kids at the beach."

Hamm had been living in North Carolina, and after contending with some serious cardiac medical issues, moved to the Cincinnati area specifically because of its reputation for offering some of the most outstanding and cutting edge cardiology research and treatment in the country. Hamm, who is a veteran, soon began treatment at The Christ Hospital, under the care of Dean Kereiakes, M.D., Medical Director of The Christ Hospital Heart and Vascular Center.

"Many patients are too frail to sustain open heart surgery, and even if they survive, they may experience stroke, multi-system failure or prolonged rehabilitation," said Dr. Kereiakes, lead investigator for the PARTNER II Trial at The Christ Hospital. "And now, delivering the valve via a small chest or groin incision provides yet another alternative to patients, who otherwise may not have any options."

Donald Grob, like Gary Hamm, is a fighter and a very persistent man. "I wanted to make sure that I had tried every option possible for my condition," said Grob. "I spoke with the Lindner Research Center weekly and they kept me informed on when the treatment for my specific condition was available."

Grob was diagnosed with a defective heart valve but, because of calcium build-up in the aorta, was not deemed an operative candidate. Like other inoperable patients, Grob had few options to address his severe symptomatic aortic stenosis. Grob had poor femoral vascular access so his procedure was also done via the transapical approach with great success

If you are interested in learning more about this procedure and clinical trial enrollment requirements, please contact The Carl and Edyth Lindner Center for Research and Education at The Christ Hospital at 513-585-1777.

About PARTNER II Trial: Placement of AoRTic TraNscathetER Valves

The purpose of this trial is to determine the safety and effectiveness of the Edwards SAPIEN XT transcatheter heart valve and delivery systems: NovaFlex (transfemoral access) and Ascendra2 (transapical access) in patients with symptomatic, calcific, severe aortic stenosis. The study is a prospective randomized, multi-center trial with two population cohorts: A) patients who are designated to have intermediate risk for surgical aortic valve replacement (operable) and B) patients who are not suitable for aortic valve surgery (inoperable). Enrollment consists of up to 2,000 patients in Cohort A and up to 500 patients in Cohort B, including up to 100 patients in nested registries. Study patients will undergo clinical follow-up at discharge, 30 days, six months, one year and then annually for a minimum of five years.

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.

About The Christ Hospital: The Christ Hospital offers a wide range of medical, surgical and testing services at its main campus just north of Downtown Cincinnati and at numerous outpatient and physician practice locations throughout Greater Cincinnati. Its mission is to provide the finest patient experience and improve the health of our community. For the past 12 years, The Christ Hospital has been recognized by U.S. News & World Report as one of the nation's top hospitals, and has been named Cincinnati's Most Preferred Hospital for 16 consecutive years by National Research Corporation (NRC). The Christ Hospital has been granted Magnet^® recognition from the American Nurses Credentialing Center for excellence in nursing care. For more information about the award-winning services of The Christ Hospital, visit www.TheChristHospital.com.

SOURCE The Christ Hospital