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TAVR for low-risk patients shines at 6 years in NOTION

 

Key clinical point: TAVR provided superior hemodynamic valve performance and less structural valve deterioration than SAVR in low-surgical-risk patients through 6 years of follow-up.

Major finding: The rate of moderate hemodynamic structural valve deterioration through 6 years was 3.6% with TAVR and 23.7% with SAVR.

Study details: An analysis of 6-year follow-up data from NOTION, a prospective, multicenter, randomized trial in 280 low-surgical-risk patients.

Disclosures: NOTION was funded by the Danish Heart Foundation. The presenter reported receiving research grants from and/or serving as a consultant to several medical device companies.


 

REPORTING FROM EUROPCR 2018

– Follow-up data from a randomized trial of transcatheter versus surgical aortic valve replacement in low-surgical-risk patients with symptomatic severe aortic stenosis showed sustained superior hemodynamic valve performance and less structural valve deterioration in the transcatheter group through 6 years, Lars Sondergaard, MD, reported at the annual meeting of the European Association of Percutaneous Cardiovascular Interventions.

Moreover, the rate of bioprosthetic valve failure as formally defined in a recent European consensus statement (Eur Heart J. 2017 Dec 1;38[45]:3382-90) was similarly low in the transcatheter aortic valve replacement (TAVR) and surgical aortic valve replacement (SAVR) arms at about 7%, in the randomized study known as NOTION (Nordic Aortic Valve Intervention), added Dr. Sondergaard, professor of cardiology at the University of Copenhagen, who was a coauthor of the consensus statement.

Dr. Lars Sondergaard Bruce Jancin/MDedge News

Dr. Lars Sondergaard

The absence of any concerning signal of limited TAVR valve durability after 6 years is encouraging news.

“As we look to expand TAVR to younger patients with longer life expectancy, durability, of course, becomes much more important,” the cardiologist observed.

NOTION was a pioneering prospective, multicenter, nonblinded, randomized trial of first-generation TAVR technology. The 280 participants, average age 79 years, were truly a low-surgical-risk population, with a mean Society of Thoracic Surgeons risk score of 3%.

NOTION is a small trial, but the results at 6 years of a planned 10-year follow-up augur well for TAVR success in the large, ongoing, definitive, randomized trials of TAVR versus SAVR in low-risk patients. That’s because NOTION participants were treated in 2009-2013, when the self-expanding TAVR CoreValve was implanted on the basis of aortic annulus measurements obtained via echocardiography, which is considerably less accurate than CT, the standard practice today. For this reason, it’s highly unlikely that the larger, ongoing trials, including PARTNER 3 and the Medtronic Evolut Transcatheter Aortic Valve Replacement in Low Risk Patients trial, will experience moderate paravalvular leak rates anything like the 20.9% rate seen in the TAVR group in NOTION, where the SAVR group’s rate was just 1.5%.

“I’m sure quite a few of the NOTION patients would have a larger TAVR valve prosthesis if they were treated today,” according to Dr. Sondergaard.

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