Medtronic Inc.’s man-made aortic valve, inserted into the heart without cracking open the chest, reduced patient death rates more than open-heart surgery in the first study to ever record such a finding.
About 14 percent of patients in the 747-person trial died within a year of treatment with Medtronic’s CoreValve, while 19 percent of those who underwent open-heart surgery died, according to the research presented today at the American College of Cardiology meeting in Washington. The results were so robust that U.S. regulators said they won’t require the standard review by outside experts before approving the device.
“This is the type of evidence that changes guidelines and recommendations for care,” said David Adams, the chairmen of cardiothoracic surgery at Mount Sinai Hospital in New York and the study’s lead researcher.
The findings may bolster use of a new procedure in which man-made valves are inserted into the heart using a catheter through an artery to the heart, saving recovery time. Edwards Lifesciences Corp. began selling a similar valve in high-risk patients in 2012. While those sales haven’t met expectations, adding Medtronic’s CoreValve and others to follow may eventually create a $2.5 billion market, said Glenn Novarro, an analyst at RBC Capital Markets in New York.
The trial, funded by Minneapolis-based Medtronic, found patients did better with CoreValve than open-heart surgery in every comparison measured, including age, weight, the severity of their disease and other medical conditions.
There are about 300,000 people worldwide with severe aortic stenosis, a narrowing of the valve between the left ventricle and the aorta. In these patients, blood can back up in the heart, leading to chest pain, breathlessness and weakness. One in three can’t tolerate open-heart surgery, even though they carry a 50 percent mortality rate at one year without treatment.
Use of the new valves requires just a 1-inch cut, and can take as little as one week of recovery time, with less pain. Open-heart surgery, which pierces the breastbone with a slice that can run the length of the torso, takes as long as eight weeks for recovery.
There were no marked differences between the two approaches in the functioning of the valves or quality of life.
The rates of combined major heart and vascular complications such as stroke were lower with CoreValve than open surgery at one year, though not after a month. Patients on CoreValve were more likely to need a pacemaker, at 22 percent compared with 11 percent, and had more leakage around the device itself. Additionally, the hearts of five patients were perforated during a CoreValve implant.
CoreValve’s mortality rate looked better than earlier results weighed in Edwards’ Sapien valve in a similar group of patients earlier. That research, dubbed Partner, found a 24.3 percent mortality rate after a year with the catheter-based valve, compared with 26.8 percent in open surgery.
The valve used in that study was the first model from Irvine, California-based Edwards. This summer, the company is expecting U.S. Food and Drug Administration approval of its next-generation aortic valve. called Sapien XT. The first study directly comparing CoreValve and Sapien XT will be presented at the cardiology meeting tomorrow.
Medtronic rose 2.1 percent to $60.41 in New York trading yesterday on anticipation of today’s report, while Edwards fell less than 1 percent to $71.16.
It’s not clear if the survival benefit seen in the CoreValve study presented today would apply to similar devices that are also inserted with a catheter, Adams said. Other doctors disagreed, suggesting the better results with CoreValve reflect improvements with the technique and choosing patients.
“Research on CoreValve was conducted later in the learning curve, and maybe this shows that technique and patient selection is getting better,” said Michael Rinaldi, medical director of research at Carolinas HealthCare System’s Sanger Heart & Vascular Institute in Charlotte, North Carolina.
Open-heart “surgery is an established technique and we don’t expect that to get better over time, he said. ‘‘With new devices, clinicians get better over time.’’
The results show the transcatheter heart valve field is continuing to improve and bode well for future efforts to study the approach in other patients, said Sarah Huoh, an Edwards spokeswoman. The findings can’t be directly compared to the Edwards’ study of Sapien started years ago when it was the first research of its kind ever done, she said.
‘‘The PARTNER Trial studying the Sapien valve and the CoreValve trial are different studies at different points in time with different criteria,” with sicker patients in the Sapien study, she said. “Indirect comparisons between trials are always tempting, but ill-advised.”
The Medtronic device is already cleared for patients who can’t undergo open-heart surgery. Today’s results will likely be used by the company to seek approval for its use in all high-risk patients with faulty valves.
The procedure using the new-type valves is known as transcatheter aortic valve replacement, or TAVR. So far, the U.S. market for the new method hasn’t taken off as quickly as analysts and investors expected with the number of hospitals trained in the procedure lower than anticipated. Sales of Edwards’ Sapien 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,” Novarro said in a telephone interview before the study was presented.
“If the patients are there, we just aren’t doing a good enough job getting to them,” he said. “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.”
Now, TAVR 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, in an interview before the study was presented. “But we keep pushing that envelope.”
The CoreValve research was simultaneously published in the New England Journal of Medicine.