Hoag Memorial Hospital Presbyterian in Newport Beach will be among one of the first U.S. hospitals to offer a much-touted medical device from a device maker here.
Irvine-based Edwards Lifesciences Corp.’s Edwards Sapien less-invasive heart valve will be available at Hoag starting in January. Ed-wards received Food and Drug Administraiton ap-proval for Sapien, which is inserted via catheter, in early November.
“We’re going to be one of the designated centers in order to bring that technology into the Uni-ted States,” said Richard Afable, Hoag’s chief executive.
Hoag will be the only hospital in Orange County that will offer Sapien as it enters the domestic market.
Edwards has said that between 150 and 200 centers in the U.S. will have access to the valve in the first year of commercialization.
Hoag has prepared for Sapien, and is expected to open a $6.6 million, 1,000-square-foot hybrid operating center for Sapien procedures next month.
“Multi-Disciplinary Approach”
Edwards picked Hoag as one of its centers for several reasons, including what Chief Executive Michael Mussallem called the hospital’s commitment to a “multi-disciplinary heart team approach,” as well as having a valve clinic and facilities with imaging equipment needed to perform Sapien procedures.
“We strongly believe that the heart team approach, which includes a strong partnership between the cardiothoracic surgeon and interventional cardiologist, is essential in ensuring optimal patient selection and outcomes,” Mussallem said (see related Year in Review, page 8).
Afable also cited a longstanding relationship between the hospital and the device maker.
“We have had a relationship with Edwards Lifesciences for many, many years, primarily because Hoag is one of the largest-volume users of Edwards’ valves,” Afable said.
Hoag wasn’t an official clinical trial site for Sapien as it went through the FDA’s approval process. The hospital’s heart surgeons still maintained a “very close relationship with Edwards in a developmental way,” Afable said.
Hoag doctors intensified their developmental relationship with the device maker as the potential of Sapien was “becoming apparent,” he said.
“Edwards knew that we were one of the leading hospitals and healthcare organizations for valve and valve care, especially valve surgery, so they wanted us to be intimately involved.”
Hoag began the planning for the Sapien operating center a year ago, aiming to dovetail with the likely timing of an approval for the device.
“Our intent when we created the plan and then began the construction and then received some community support for this whole process was all about ‘let’s time this out so that when the Edwards Sapien valve became available to us in the United States, we would then have our hybrid operating room with the latest technology available concurrent with that,” Afable said.
Afable said the use of Sapien “has to be very carefully controlled by Edwards as it’s brought forth—you just don’t want to sell the technology to anybody. You want to get the best outcomes.”
Sapien is expected to cost about $30,000.
Medicare Coverage
The Centers for Medicare & Medicaid Services has until next June to make a final decision on whether it will cover the cost of the valve. The federal agency is expected to cover the cost of the valve until a final decision is made.
Commercial healthcare insurance plans generally follow Medicare’s lead on payment decisions.
Afable said Hoag will leave the matter of coverage to Edwards and regulators.
“We as Hoag won’t be working with health plans or even the federal government to expedite payment methodologies,” he said.
Mussallem said that comprehensive Sapien training program under development by the device maker would include “case studies, lectures and hands-on simulator experience.”
Hoag anticipates that it will do around 30 Sapien implants in its first year.
The Hoag Heart and Vascular Institute does roughly 250 heart-valve procedures a year, according to Aiden Raney, director of cardiac surgery at Hoag.
The Sapien center was designed from top to bottom by the institute, which is made up of cardiologists and heart surgeons who practice at the hospital. The center will be equipped to handle procedures besides Sapien implants.
“It brings together the capability for highly sophisticated technical cardiac surgical procedures and merges that with very highly sophisticated, high-quality imaging,” Raney said.
The center includes imaging equipment that can look at various components of the aortic root, where Sapien will be implanted.
“Roadmap”
Raney said it has pre-programmed software that will “outline a roadmap that you can look at on a screen and know exactly what you can do, where you position the valve—it has to be just right. It can’t be too high, it can’t be too low.”
Sapien is approved only for patients who aren’t able to have traditional, open-heart surgical procedures where a patient is placed on a heart-lung machine to breathe.
“They would benefit from surgery but they’re too sick, we think, to survive it,” Raney said.
Hoag will be letting health plans and other doctors on its staff know that Sapien will be available at the hospital, Afable said.
The hospital could be the only Sapien implant center locally for some time, Afable said. He estimated that it could take 18 months to 36 months before other centers are ready to offer the device.
“We don’t think of that as a competitive advantage,” the chief executive said. “We think of that as a responsibility.”
