NOTION: TAVI with low risk at 4 year follow up

Courtesy of the SBHCI.

There is little data about the use of transcatheter aortic valve replacement (TAVR) to treat patients with severe aortic stenosis at low surgical risk. Many of the questions involve long term duration of valves (over 10 years) when treating younger patients with longer life expectancy.

The NOTION study aims at comparing TAVR (with the self-expandable CoreValve) vs. conventional valve replacement surgery in patients over 70 years old at low surgical risk. This article reports on its 4 year outcomes.

The NOTION (Nordic Aortic Valve Intervention) randomized 280 patients between 2009 and 2013 with a mean STS of around 3 (more than 80% had <4 STS).

Primary end point was a composite of death, infarction or stroke according to VARC II criteria, that resulted 30.2% at 4 year follow up for patients undergoing surgery vs. 29.1% for the TAVR group (p=0.76).

Global mortality was 23% for surgery vs. 20% for the TAVR group (p=0.56). Also the rate of stroke resulted similar (surgery 7.3% vs. TAVR 6.8%), as well as that of infarction.

When looking only at patients between 70 and 75 (all with STS ≤4), primary end point was 27.2% for surgery and 15.6% for TAVR (p=0.24).

The differences between methods were seen in atrial fibrillation, that was far more frequent in the surgery group (60.2% vs 24.5%; p<0.001), and in the need for pacemaker, far more frequent with TAVR (9% vs. 43.7%, p<0,001).

Conclusion

Patients with severe aortic stenosis at low risk randomized to surgery vs. transcatheter aortic valve replacement showed similar results at 4 years as regards primary end point.

Differences were seen basically in new atrial fibrillation rate, which favored TAVR and in the need of pacemaker, which favored surgery. 

Courtesy of SBHCI

Original Title: Clinical, safety and echocardiographic outcomes from NOTION trial: 4-year follow-up data in all-comer patients with severe aortic valve stenosis.

Presenter: Lars Sondergaard.

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