Heart Hospital to Implant Portico Transcatheter Aortic Valve System as Part of Clinical Trial
On Aug. 26, 2014, physicians at Heart Hospital of Austin became the first in Texas to implant the new Portico Re-sheathable Transcatheter Aortic Valve System—an innovative, repositionable aortic heart valve and delivery system. Heart Hospital of Austin is part of the PORTICO trial, a nationwide clinical study to examine the effectiveness of the new heart valve. The Portico valve was used during a catheter-based valve replacement procedure known as a transcatheter aortic valve replacement (TAVR), which is designed to treat patients with severe aortic stenosis who are not candidates for open-heart surgery due to advanced age, or because they are too ill or suffering from additional medical conditions. The TAVR procedure was first performed in Central Texas at Heart Hospital of Austin in February 2012.
Faraz Kerendi, M.D., a cardiothoracic surgeon at Cardiothoracic and Vascular Surgeons, and Frank Zidar, M.D., an interventional cardiologist at Heart Hospital of Austin and with Austin Heart, implanted the Portico valve. The patient, a 68-year-old man, was identified as a candidate for the new Portico valve by physicians at the Heart Valve Clinic at Heart Hospital of Austin, a clinic specifically designed to evaluate and treat patients with valvular disease and disorders. Drs. Kerendi and Zidar are principal investigators of the PORTICO trial at Heart Hospital of Austin.
"The procedure was very successful," Dr. Kerendi said. "The ability to fully resheath and precisely reposition the Portico valve prior to final valve deployment was very beneficial, as it helped achieve accurate placement and minimize procedural risk for the patient."
The Portico valve is the first fully repositionable transcatheter valve—allowing the physician to accurately place the valve at the implant site, via a catheter, or retrieve it before the valve is fully deployed and released from the delivery system. The ability to reposition the valve helps physicians place the valve more accurately, reducing the risk for patients. The self-expanding Portico valve was developed to maintain blood flow similar to that of a natural valve.
"We are excited to have the opportunity to participate in this trial, as this valve has the potential to greatly impact patients and improve their quality of life," Dr. Zidar said. "This unique valve design allows the device to be assessed after implantation and, if necessary, repositioned to optimize its function."
Artificial aortic heart valves are used to treat patients with symptomatic severe aortic stenosis, a condition in which the opening of the aortic valve becomes narrow, restricting blood flow from the heart to the body and causing the heart to work harder. Over time, the valve can become calcified, preventing it from opening and releasing blood properly. Symptoms of severe aortic stenosis include fatigue, dizziness or fainting, and chest pain or discomfort. It can also cause pressure to "back up" into the lungs, resulting in shortness of breath. Left untreated, this condition is often fatal.
Traditional heart valve replacement requires that patients undergo open-heart surgery—a more invasive approach that results in a longer recovery process. Because of this, some patients with aortic stenosis are not considered candidates for this type of treatment.
The TAVR procedure consists of inserting a valve—which is compressed down to the size of a pencil—through the groin via a catheter, up to the aorta. After the catheter is advanced through the aorta and aortic valve, the valve is positioned and then opened with a balloon. TAVR results in a shorter recovery time—one to two weeks, versus six to eight weeks for traditional surgery—and it prevents the need for physicians to utilize a heart bypass machine, allowing the patient's heart to beat on its own throughout the entire procedure.
The Portico transcatheter aortic heart valve system is limited to investigational use in the United States, and the PORTICO trial is being conducted under an Investigational Device Exemption from the U.S. Food and Drug Administration.
Heart Hospital of Austin is one of 40 sites in the United States participating in the PORTICO trial. Enrolled patients will undergo a TAVR procedure receiving either a Portico valve or another TAVR valve that is commercially available in the United States. Additionally, the trial will collect information on patients who are having a Portico valve placed inside an existing, degenerated surgical valve. This valve-in-valve registry will include patients in the trial who previously had valve replacement surgery and are now having a Portico valve placed inside an existing artificial valve without removing it.