Two new studies by Edward Life Sciences and Medtronic Plc show that non-invasive heart valve replacement can be as good as, or even better than, open heart surgery in younger, more active patients for whom the surgical option was deemed low risk.
The two studies could be a game changer for heart surgery. The non-invasive surgery, known as transcatheter aortic valve replacement, or TAVR, has been in use for patients too old or frail to undergo open heart surgery, but the results of the study show that this method could be just as effective in younger people.
In a statement announcing the results, Edward Lifesciences announced that the results of the randomized PARTNER 3 trial demonstrated superiority of the SAPIEN 3 transcatheter aortic valve over surgery in a study published in the New England Journal of Medicine.
Edward Lifesciences explained that the PARTNER 3 Trial was an independently evaluated, randomized clinical trial comparing outcomes between TAVR and open-heart surgery.
Reuters reported that the Edwards Sapien 3 TAVR system proved superior to surgery for the main goal of trial, a composite of rate of stroke, death and rehospitalization one year after the procedure. The rate for TAVR was 8.5 percent versus 15.1 percent for surgery, as revealed in data unveiled at the American College of Cardiology scientific meeting in New Orleans. At 30 days, the Sapien also resulted in a lower rate of stroke — 0.6 percent versus 2.4 percent — which had been the primary safety concern when these systems were first introduced.
“In the PARTNER 3 Trial, TAVR with the SAPIEN 3 valve showed a remarkably low death and disabling stroke rate of 1 percent at one year versus 2.9 percent for surgery. Based upon these clinical trial findings at one year, TAVR should be considered the preferred therapy in low surgical risk aortic stenosis patients,” Martin Leon, Director of the Center for Interventional Vascular Therapy at NewYork-Presbyterian/Columbia University Medical Center and professor of medicine at Columbia University College of Physicians and Surgeons, said.
The trial, which was carried out between March 2016 and October 2017, studied 1,000 patients at 71 centers. The patients had a choice of either undergoing TAVR with the SAPIEN 3 valve or surgery with any commercially available surgical valve.
According to Larry Wood, Corporate Vice President, transcatheter aortic valve replacement, “These data demonstrate that TAVR with the SAPIEN 3 valve gives low surgical risk patients with severe AS a treatment with better outcomes, less time in the hospital and the ability to resume their everyday lives more quickly. It is also highly encouraging to see that 96 percent of TAVR patients were discharged to home as opposed to remaining in a hospital or specialized care setting,”
All patients were followed for at least one year, while a 10-year clinical and echocardiographic follow-up is planned for all patients.
On the other hand, Medtronic said its randomized trial had met its primary non-inferiority endpoint of all-cause mortality or disabling stroke at two years compared to surgery.
Michael Reardon, principal investigator and senior author of Medtronic’s Evolut Low Risk Trial said: “Low-risk aortic stenosis patients have unique characteristics due to their tendency to be younger and more active than their higher-risk counterparts. These data suggest that not only did TAVR match the gold standard of surgery, but it demonstrated statistical superiority across several key endpoints, including quality of life and hemodynamics – important considerations for severe aortic stenosis patients who may be more active.”
Medtronic said its Evolut TAVR system is not yet approved for use, but the company would need to submit its data to government regulators to support the safety and effectiveness of the device.
The results of Medtronic’s study, which had 1,400 patients, were also unveiled at the American College of Cardiology scientific meeting in New Orleans.
“These groundbreaking clinical trial results are positive for patients and heart teams alike and add to the growing body of clinical evidence that will help define the future of TAVR. We now have positive results from a wide range of patients with severe aortic stenosis across the surgical risk spectrum, and we hope to see that more patients will have the opportunity to receive this therapy option down the road,” Nina Goodheart, vice president and general manager of the Structural Heart business at Medtronic, said.
While both companies toasted to their groundbreaking results, the New York Times reported that patients in both studies suffered certain problems that were more common with surgery, such as major bleeding and development of a fluttering heartbeat called atrial fibrillation. In the Medtronic study, 17 percent of expandable valve recipients later required a pacemaker versus 6 percent of people who had surgery.
In terms of costs, TAVR systems can cost up to $30,000 compared to $5,000 for traditional replacement heart valves, but with the former, patients are guaranteed shorter hospital stays with fewer complications.
Medtronic estimates that up to 165,000 low risk patients suffer from severe aortic stenosis per year in the U.S., Western Europe and Japan. If left untreated, it can cause heart failure in as little as two years.
It is projected that the TAVR market is set for growth in both size and competition, with Boston Scientific’s Lotus system poised for potential U.S. approval this year.