FDA News

TAVR systems approved for low-risk patients

Mathew R. Williams

Edwards Lifesciences and Medtronic announced that their transcatheter aortic valve replacement systems have been approved by the FDA for use in patients with severe symptomatic aortic stenosis at low surgical risk.

“It’s remarkable the recovery advantage these patients get from this procedure,” Mathew R. Williams, MD, director of the Heart Valve Center at NYU Langone Health, told Healio. “They go from a debilitating disease where they can’t walk to the bathroom without getting out of breath to literally walking 2.5 hours after the procedure and going home the next day.”

As Healio previously reported, in the PARTNER 3 and Evolut Low Risk trials, TAVR (Sapien 3, Edwards Lifesciences; Evolut, Medtronic) was associated with favorable results compared with surgical AVR in patients at low risk for surgical mortality.

Martin B. Leon
 

“The PARTNER 3 trial demonstrated that low-risk patients treated with the Sapien 3 TAVR experienced extraordinary outcomes with 1% rates of death or disabling stroke at 1 year, a short length of stay and 96% discharged to home or self-care. Sapien 3 is the only valve to achieve superiority over surgery based on the prespecified primary endpoint,” Martin B. Leon, MD, director of the Center for Interventional Vascular Therapy at NewYork-Presbyterian/Columbia University Medical Center, professor of medicine at the Columbia University College of Physicians and Surgeons and the national co-principal investigator of PARTNER 3, said in a press release from Edwards. “Today’s FDA approval of Sapien 3 TAVR will expand access to this proven therapy, which should be considered the preferred treatment for the majority of low-risk severe [aortic stenosis] patients.”

In the Evolut Low Risk trial, the self-expanding TAVR system (Evolut, Medtronic) was noninferior to surgical AVR for all-cause mortality or disabling stroke at 2 years and was superior to surgery for those outcomes at 30 days.

In addition, the TAVR system yielded better hemodynamic performance than surgery in terms of lower mean aortic valve gradients and larger effective orifice areas, although TAVR was associated with higher rates of permanent pacemaker implantation and residual aortic regurgitation, according to a press release from Medtronic.

Michael Reardon

Not every low-risk patient is going to be appropriate for TAVR, but right now, as far as I’m concerned, every patient who has symptomatic severe aortic stenosis that is a candidate for a biologic valve should at least have TAVR included in the conversation or else they’re not getting a fully informed consent and they’re not really getting shared decision-making,” Michael Reardon, MD, cardiothoracic surgeon at Houston Methodist DeBakey Heart & Vascular Center, and principal investigator and senior author of the Evolut Low Risk trial, told Healio.

The results of both trials were presented in March at the American College of Cardiology Scientific Session and published in The New England Journal of Medicine.

“Today’s approval marks a significant treatment paradigm for low-risk patients, who are often younger and healthier, in need of a better option than surgery,” Larry L. Wood, corporate vice president of transcatheter aortic valve replacement at Edwards Lifesciences, told Healio. “It is a landmark achievement for patients who suffer from aortic stenosis to have expanded access to a less-invasive therapy that, in the case of Sapien 3, has proven to be better than surgery in the PARTNER 3 trial.”

Disclosures: PARTNER 3 was funded by Edwards Lifesciences. The Evolut Low Risk trial was funded by Medtronic. Leon reports he has received research support from Abbott, Boston Scientific, Edwards Lifesciences and Medtronic and has received consultant fees from Abbott, Boston Scientific, Gore, Medtronic and Meril Life Sciences. Reardon reports he has received consultant fees paid to his institution from Medtronic. Wood is an employee of Edwards Lifesciences. Williams reports he received research funding from Edwards Lifesciences and Medtronic.

 

 

Mathew R. Williams

Edwards Lifesciences and Medtronic announced that their transcatheter aortic valve replacement systems have been approved by the FDA for use in patients with severe symptomatic aortic stenosis at low surgical risk.

“It’s remarkable the recovery advantage these patients get from this procedure,” Mathew R. Williams, MD, director of the Heart Valve Center at NYU Langone Health, told Healio. “They go from a debilitating disease where they can’t walk to the bathroom without getting out of breath to literally walking 2.5 hours after the procedure and going home the next day.”

As Healio previously reported, in the PARTNER 3 and Evolut Low Risk trials, TAVR (Sapien 3, Edwards Lifesciences; Evolut, Medtronic) was associated with favorable results compared with surgical AVR in patients at low risk for surgical mortality.

Martin B. Leon
 

“The PARTNER 3 trial demonstrated that low-risk patients treated with the Sapien 3 TAVR experienced extraordinary outcomes with 1% rates of death or disabling stroke at 1 year, a short length of stay and 96% discharged to home or self-care. Sapien 3 is the only valve to achieve superiority over surgery based on the prespecified primary endpoint,” Martin B. Leon, MD, director of the Center for Interventional Vascular Therapy at NewYork-Presbyterian/Columbia University Medical Center, professor of medicine at the Columbia University College of Physicians and Surgeons and the national co-principal investigator of PARTNER 3, said in a press release from Edwards. “Today’s FDA approval of Sapien 3 TAVR will expand access to this proven therapy, which should be considered the preferred treatment for the majority of low-risk severe [aortic stenosis] patients.”

In the Evolut Low Risk trial, the self-expanding TAVR system (Evolut, Medtronic) was noninferior to surgical AVR for all-cause mortality or disabling stroke at 2 years and was superior to surgery for those outcomes at 30 days.

In addition, the TAVR system yielded better hemodynamic performance than surgery in terms of lower mean aortic valve gradients and larger effective orifice areas, although TAVR was associated with higher rates of permanent pacemaker implantation and residual aortic regurgitation, according to a press release from Medtronic.

Michael Reardon

Not every low-risk patient is going to be appropriate for TAVR, but right now, as far as I’m concerned, every patient who has symptomatic severe aortic stenosis that is a candidate for a biologic valve should at least have TAVR included in the conversation or else they’re not getting a fully informed consent and they’re not really getting shared decision-making,” Michael Reardon, MD, cardiothoracic surgeon at Houston Methodist DeBakey Heart & Vascular Center, and principal investigator and senior author of the Evolut Low Risk trial, told Healio.

The results of both trials were presented in March at the American College of Cardiology Scientific Session and published in The New England Journal of Medicine.

“Today’s approval marks a significant treatment paradigm for low-risk patients, who are often younger and healthier, in need of a better option than surgery,” Larry L. Wood, corporate vice president of transcatheter aortic valve replacement at Edwards Lifesciences, told Healio. “It is a landmark achievement for patients who suffer from aortic stenosis to have expanded access to a less-invasive therapy that, in the case of Sapien 3, has proven to be better than surgery in the PARTNER 3 trial.”

Disclosures: PARTNER 3 was funded by Edwards Lifesciences. The Evolut Low Risk trial was funded by Medtronic. Leon reports he has received research support from Abbott, Boston Scientific, Edwards Lifesciences and Medtronic and has received consultant fees from Abbott, Boston Scientific, Gore, Medtronic and Meril Life Sciences. Reardon reports he has received consultant fees paid to his institution from Medtronic. Wood is an employee of Edwards Lifesciences. Williams reports he received research funding from Edwards Lifesciences and Medtronic.