March 26, 2013
Lula Veronie’s greatest pleasure was working in her garden. But, shortness of breath from critical aortic stenosis made it nearly impossible for her to do any activity without effort. At age 84, she was not a candidate for open-heart surgery. So, her interventional cardiologist, Dr. Raghotham Patlola with Cardiovascular Institute of the South, recommended a new procedure just approved for The Heart Institute at Regional Medical Center of Acadiana – transcatheter aortic valve replacement.
On Jan. 21, 2013, a team of surgeons and cardiologists performed Acadiana’s first TAVR procedure on Veronie. TAVR is a less-invasive approach to aortic valve implantation indicated for patients considered high-risk or inoperable for traditional open-heart valve surgery because of advanced age, extreme frailty or comorbid conditions. Now, instead of opening the chest, the entire valve can be replaced through a catheter placed in the groin or alternatively, through a small incision on the left side of the chest. “It is such a fantastic offering to these patients who are at the end of the road,” explained Dr. Charles Wyatt, Surgical Director of Regional Medical Center of Acadiana’s TAVR program. “Fifty percent of the time these patients are likely to die within one year after they first start getting symptoms for this problem. Now, we have a solution.”
During the procedure, physicians navigate an Edwards SAPIEN transcatheter heart valve, which is mounted onto a balloon delivery catheter, from a small incision in the groin. Cardiac surgeons make an incision in the groin for insertion of this 18-27 FR catheter into the aorta. Two small catheters in the opposite groin are placed percutaneously and are used as a temporary pacemaker and for angiography. After dilating the aortic valve, the physicians insert a sheath to deliver the artificial valve across the natural valve. Once in place, the doctor deploys the artificial valve. “What we are trying to do is crush the native valve with this new valve,” Dr. Patlola explained. “Once we do this, the native valve is stuck behind the stainless steel frame on the balloon, and the artificial valve takes over immediately.”
While TAVR itself can take only about 15 minutes, the entire process is highly regulated and is quite intensive, requiring a large multidisciplinary team consisting of cardiovascular surgeons, Drs. Mitchell Lirtzman and Wyatt of Louisiana Heart, Lung & Vascular at Regional; interventional cardiologists, Drs. Patlola, John Patterson and Louis Salvaggio of CIS; echocardiologist Dr. Wade May of CIS, an anesthesiologist, heart-lung perfusion team and several technicians and nurses, to coordinate care. “It’s actually required by law that a patient be seen in advance by one of the cardiologists and two surgeons prior to proceeding with the surgery,” Wyatt observed. “Additionally, in the actual procedure, it’s required governmentally for reimbursement that both a surgeon and a cardiologist be present for the entire procedure and participating equally.”
For the first two cases, The Heart Institute had about 50 participants and observers. Since then, the number dropped to about 22 participants. “It takes a complete team effort,” Lirtzman said. “Every step of the way, every team member is aware of the steps that we are doing, every team member is ready to do his or her job and we all agree. And, at any point during the surgery, if anybody sees something that is questionable, any team member can say ‘Stop.’ And we stop.”
At press time, The Heart Institute had performed four TAVR procedures and has several more scheduled. “The patients all did very well,” Patlola reported. “It’s a very smooth procedure. Most of these patients go home within about two to three days, and they are perfectly back to normal. This is one of those procedures where the patients feel better almost immediately. It’s a really neat, state-of-the-art procedure. It really saves lives and improves the quality of life, and maybe the longevity of these patients.”
Following surgery, Veronie felt better almost immediately. Already, she is back to doing yard work, cooking and taking care of her family. “I’m feeling very good,” she said. “Now, I go walk on the road probably pretty close to a mile.”
Regional’s Heart Institute is the third facility in Louisiana chosen by Edwards Lifesciences for use of the SAPIEN transcatheter heart valve along with Ochsner Medical Center in New Orleans and Willis-Knighton Medical Center in Shreveport. The procedure has been available in Europe for about five years, and was FDA-approved in the U.S. about four months ago.
In order to be approved, cardiac surgeons must do 50 aortic valve replacements a year, and hospital cardiologists have to do at least 400 coronary stents annually, as well as more than 1000 percutaneous coronary interventions. Also mandatory is cardiologist left side structural heart experience. Additionally, teams are highly advised to have access to a hybrid operating room. An intensive two-day training period with Edwards Lifesciences is required. A heart valve multidisciplinary clinic coordinates the heart team’s activities. “For Regional Medical Center of Acadiana to be selected as a provider for southwest Louisiana is really quite an honor and attests to our longstanding team approach to cardiovascular disease,” Wyatt said.
Results from PARTNER 1 and 2 trials showed comparable mortality and durability rates and treatment benefit between surgical aortic valve replacement and transcatheter aortic valve replacement. “For safety, efficacy, economic costs, complications and longevity, TAVR was equivalent to the conventional open heart surgery,” Patlola said.
These results give patients who cannot undergo surgery a viable option. Lirtzman encourages physicians from across the state to contact The Heart Institute to see if their patients qualify for TAVR. “The whole idea is offering hope and care to these folks who otherwise would have none,” he said.
For more information on TAVR, contact Cindy Langley, RN, The Heart Institute Director at (337) 406-4127 or visit www.RegionalHeartValve.com.