While minimally invasive procedures for replacing a heart valve have typically targeted patients considered too risky for open-heart surgery, the FDA now says that younger and potentially more active patients can take that route, too.
The agency broadened its premarket approvals of Medtronic’s Evolut and Edwards Lifesciences' Sapien transcatheter aortic valve replacements to include symptomatic patients with severe native stenosis who would have an otherwise low risk of complications from open heart surgery, the current standard-of-care.
Medtronic says this now allows its device to be used in all surgical risk categories. The company's clinical trial of more than 1,400 patients showed the TAVR procedure was safe and effective in low-risk patients across three device generations and was coupled with shorter hospital stays and improved quality of life.
“The majority of my patients want a replacement valve that’s going to minimize the risk of death, stroke and other cardiovascular events during the procedure and allow them to leave the hospital faster and recover sooner,” said co-principal investigator Michael Reardon, a surgeon at the Houston Methodist DeBakey Heart & Vascular Center. “In patients appropriate for a biologic valve, that option is going to be TAVR.”
In addition, patients showed a lower composite rate of all-cause mortality or disabling stroke at 30 days along with higher blood flow performance, though the rates of new pacemaker implantation and residual aortic regurgitation were higher in the TAVR group, according to Medtronic.
Likewise, a clinical trial of Edwards' Sapien system showed short lengths of hospital stays, with 96% of patients being discharged to home or self-care.
"This approval is a significant milestone and will allow all patients diagnosed with severe AS to be considered for TAVR based on their individual preferences and anatomical considerations versus traditional risk scoring," Larry Wood, Edwards' VP of its TAVR business, said in a statement.
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“With the low risk approval, risk stratification for TAVR treatment is becoming obsolete and heart teams will likely need to assess treatment options based on anatomical characteristics, concomitant risk factors, and also patient preference,” said Reardon.
The transcatheter Evolut valve is built with a self-expanding nitinol frame that conforms to the patient’s native opening, includes an external wrap and can be repositioned to better seal the valve to the surrounding heart tissue. In March 2017, it was approved to replace stiffened, narrowing aortic heart valves in patients considered too frail for open surgery. Medtronic estimates that severe aortic stenosis affects about 165,000 low-risk patients annually in the U.S., western Europe and Japan and if left untreated could lead to heart failure in about two years.
Meanwhile, Edwards' Sapien family of heart valves was first commercially approved in Europe in 2007. It picked up its first FDA approval in intermediate-risk patients in 2016, which covers a greater than 3% risk of death within 30 days of open-heart surgery.
“Low risk patients were younger and healthier than those patients enrolled in our prior studies, and were better able to weigh the risks and benefits of surgery or TAVR based on their value preferences,” said Jeffrey Popma, co-principal investigator of Medtronic's study and director of interventional cardiology at Beth Israel Deaconess Medical Center.
“It is our impression that patients will now be able to make a choice on the method of aortic valve replacement based on an informed risk-benefit discussion with their heart team,” Popma said.