The varying sizes of the CoreValve, which is being evaluated in people with damaged aortic valves who are at high-risk from open heart surgery to repair them.
New technology letting doctors insert man-made heart valves with a catheter instead of cracking open the chest is aiming to change the face of cardiac care for many aging baby boomers.
The procedure, requiring just a 1-inch cut, can take as little as one week of recovery time while open-heart surgery, which pierces the breastbone with a slice that can run the length of the torso, takes as long as eight weeks.
It’s a difference, doctors say, that can make aortic valves made by Edwards Lifesciences Corp. (EW) and Medtronic Inc. (MDT) -- designed to use the new procedure -- standard issue for heart patients. Medtronic wants to expand use of its valve based on data to be reported this weekend at the American College of Cardiology meeting in Washington. If the findings are positive, CoreValve may join Edwards’ Sapien valve in boosting the procedure’s popularity.
The procedure now is “generally used for people that have contraindications to surgery,” said Robert Siegel, director of the Cardiac Noninvasive Laboratory at Cedars-Sinai Medical Center in Los Angeles. “But we keep pushing that envelope.”
The Medtronic device is now cleared for patients who can’t undergo open-heart surgery. In the soon-to-be presented study, Minneapolis-based Medtronic tested its valve in almost 800 patients who were high-risk but who could have undergone the traditional rib-cracking operation.
If approved for that indication, the device may join Edwards’ Sapien in what may become a $2.5 billion market annually as other device makers present their similar products, saidGlenn Novarro, an RBC Capital Markets analyst in New York.
So far, the U.S. market hasn’t taken off as quickly as analysts and investors expected. The number of hospitals trained in the procedure is lower than originally anticipated. Sales of Sapien, approved in November 2011, have been flat for three quarters. It generated $350 million in the U.S. in 2013, $50 million less than expected, RBC’s Novarro said.
A second company, though, “especially the size of Medtronic with the ability to go out and educate the general cardiologists, should expand the marketplace,” he said. “If the patients are there, we just aren’t doing a good enough job getting to them. It’s about educating the cardiologists, who are the gatekeepers, and educating the consumer to let them know there is an alternative to open surgery.”
About 70,000 Americans undergo aortic valve operations yearly to relieve symptoms including chest pain and shortness of breath so severe it can limit everyday activities, according to the Society of Thoracic Surgeons. Doctors historically fixed the problem by opening the chest, cutting out the damaged valve and sewing in a replacement prosthesis.
Though traditional rib-cracking surgery may be daunting, the risk of death from it has fallen over the past decade to less than 1 percent for those younger than 70, creating a high hurdle for companies developing valves inserted via a catheter.
The Edwards valve was approved for use by all high-risk patients near the end of 2012. Both its valve and Medtronic’s are used in a process that’s considered minimally invasive, inserted mainly via the femoral artery through the groin area or through a small incision between the ribs.
Patients studied in a trial of Edwards’ Sapien had a mortality rate of 24.3 percent compared to 26.8 percent for those having open-heart surgery. The Sapien patients also spent just eight days in the hospital compared with 12 for the rib-cracking operation. While Sapien costs about $30,000, compared to $6,000 for older valves inserted in the traditional manner, patients save by spending less time in the operating room and the hospital, company officials have said.
In the Medtronic study, investors, regulators and doctors will be watching for side effects that may include a higher risk of stroke, an increased need for a pacemaker or high rates of leakage around the CoreValve itself.
If the side effects are acceptable compared with open-heart surgery, the added convenience of the newer procedure may be a big selling point for anyone with damaged aortic valves, said Prediman K. Shah, a cardiologist at Cedars Sinai Heart Institute in Los Angeles, during a conference call before the cardiology meeting.
“Cardiovascular surgeons should watch out,” said Shah, who is also the meeting’s co-chair. “In the next few years, it’s very likely it will be a relatively rare patient who will have a surgical valve replacement.”
The CoreValve is crimped, inserted into a catheter and snaked into the heart through an artery or an incision in the chest to replace a damaged aortic valve.
The Medtronic study is one of three focused on the approach at the cardiology conference. Another compares CoreValve to Edwards’ next-generation Sapien XT, while a registry of 7,000 patients examines how those outside of clinical trials fare a year after treatment.
“This is a unique meeting just because we have randomized trials on CoreValve, randomized trials comparing CoreValve to Sapien XT and a huge national registry,” said Cindy Grines, vice president of academic and clinical affairs at the Detroit Medical Center Cardiovascular Institute. “We’re going to walk away with an incredible body of evidence that could potentially be game-changing.”