Nonsurgical Heart Valve Replacement Clinical Trial Begins at Scripps
LA JOLLA – Interventional cardiologists and a cardiothoracic surgeon at Scripps have embarked on a clinical trial of an investigational transcatheter aortic heart valve replacement procedure for patients at high risk or nonoperable for conventional open-heart valve surgery. The PARTNER (Placement of AoRtic traNscathetER valves) trial may represent a new treatment option for heart valve replacement that is less invasive, safer and more cost-effective compared to open heart surgery.
Scripps Clinic interventional cardiologist Dr. Paul Teirstein and cardiothoracic surgeon Dr. Scot Brewster have already performed percutaneous heart valve replacements on two patients who were considered too “high risk” for open heart surgery.
The SAPIEN transcatheter heart valve developed by Edwards Lifesciences integrates balloon-expandable stent technology with a bovine pericardial bioprosthetic tissue valve. The valve is mounted and crimped onto the balloon delivery catheter to the approximate diameter of a pencil and threaded through the patient’s circulatory system from the leg (transfemoral) or inserted between the ribs (transapical) and deployed across the patient’s diseased aortic valve, providing physicians with two options for treating patients based on their individual anatomies. Drs. Teirstein and Brewster anticipate the technology will offer a tremendous alternative to valve-needy patients, many of whom have no other option today except open-heart surgery.
With shortness of breath and severe chest pain, Poway, Calif. resident Robert Hylton, 88, was in need of valve replacement surgery. He previously suffered a stroke and had already undergone bypass surgery. His health history combined with his age made traditional open heart surgery significantly more risky. He underwent percutaneous heart valve replacement at Scripps Green Hospital and is recovering well.
“Catheter-based heart valve replacement is the next technology revolution in cardiology,” says Teirstein. “Percutaneous heart valve technology will redefine heart valve replacement from a complex operation to a more simple, much less invasive procedure.”
Both procedures are performed on a “beating heart,” without the need for cardiopulmonary bypass and its associated risks. Annually, some 200,000 people in the U.S. need a new heart valve, but nearly half of them do not receive a new valve for a variety of reasons. Some 110,000 aortic valves are replaced annually via open-heart surgery in the United States. While some patients qualify for biological valve replacements taken from cows and pigs, the majority of patients get a mechanical heart valve, which then requires them to take blood-thinners for the rest of their lives.
“Percutaneous heart valve placement is a promising alternative to conventional open heart surgery for many patients who have no other option today.” says Brewster. “The hope of this trial is to demonstrate faster recovery times and less surgical trauma to the patient.”
The PARTNER trial is a prospective randomized study with two separate treatment arms. The surgical arm of the trial will focus on patients who are at high risk but still candidates for conventional open-heart surgery. Patients will be evenly randomized – essentially like the flip of a coin – to receive either the transcatheter heart valve or a valve implanted using traditional surgery. Patients randomized to the new catheter based procedure will be evaluated for femoral access to determine if they can receive a transcatheter valve via their femoral artery or if it needs to be implanted via a small incision between the ribs. The clinical results of this arm will be used to determine if the new, transcatheter heart valve is not statistically inferior to conventional surgery.
The nonsurgical, medical management arm of the trial will focus on patients who are considered to be nonoperative using traditional surgical valve replacement techniques. These patients will be evenly randomized to receive either the transcatheter heart valve or appropriate medical therapy. The clinical results of this arm will need to demonstrate that the transcatheter heart valve is statistically superior to medical management.
The region’s largest provider of cardiac services, in 2006 Scripps announced it will build a comprehensive cardiovascular institute which will integrate the cardiac programs of Scripps Clinic/Scripps Green Hospital and Scripps Memorial Hospital La Jolla. It will be a center for the most advanced diagnostic and treatment options for patients with cardiovascular diseases, as well as serve as a center for medical research, clinical trials and graduate medical education.
“Drs. Teirstein and Brewster’s participation in the PARTNER trial is a powerful example of the innovative research protocols that can result from collaboration across the Scripps system,” says Chris Van Gorder, president and CEO of Scripps Health.
ABOUT SCRIPPS HEALTH
Founded in 1924 by philanthropist Ellen Browning Scripps, Scripps Health is a $2 billion nonprofit community health system based in San Diego, Calif. Scripps treats a half-million patients annually through the dedication of 2,600 affiliated physicians and 12,300 employees among its five acute-care hospital campuses, home health care services, and an ambulatory care network of clinics, physician offices and outpatient centers.
Recognized as a leader in the prevention, diagnosis, and treatment of disease, Scripps is also at the forefront of clinical research and graduate medical education. In 2007, Scripps committed more than $150 million in capital and facility improvements across the San Diego region while providing significant charity care to the community – more than $236 million in uncompensated care in 2007. Scripps Health Foundation generated $74 million in charitable donations in 2007 to support the Scripps mission.
Contact: Johnny Hagerman