New Study Confirms TAVR Durability at 5 Years

The ADVANCE study was designed to evaluate the safety and effectiveness of transcatheter aortic valve replacement (TAVR) with self-expanding prosthesis CoreValve in “real world” patients with symptomatic, severe aortic stenosis at high surgical risk.

Patients were enrolled from 44 experimental centers in 12 countries; treatment approach and choice of anaesthesia were determined by the local Heart Team.

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In total, there were 1015 patients; the mean age was 81 years old and the logistic EuroSCORE was 19.3 ± 12.3%. Five-year follow-up was available on 465 of these patients, whose rate of mortality for that period was 50.7%.

Haemodynamic measures remained consistent over time with a mean gradient of 8.8 ± 4.4 mmHg and an effective area of 1.7 ± 0.4 cm².

Moderate to severe paravalvular aortic regurgitation decreased from 12.8% at the time of implantation to 8.0% at 5 years.

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Of the 860 patients with echocardiographic data, there were 22 (2.6%) patients who met the VARC-2 criteria for valve dysfunction and 10 (1.2%) patients who required a reintervention.

Conclusion

The 5-year follow-up of a “real-world” high-risk population who underwent transcatheter aortic valve replacement with self-expanding prosthesis CoreValve provided clear evidence for valve durability with low rates of reintervention and prosthesis dysfunction.

Editorial

The 5-year results from ADVANCE continue to demonstrate the haemodynamic performance of the CoreValve bioprosthesis, as well as low rates of stroke, paravalvular aortic regurgitation, and a high mortality rate that is still within the expected range for this population.

All-cause mortality for patients in the CoreValve ADVANCE study was 50.7% at 5 years vs. 67.8% for patients in the PARTNER 1 trial over the same time period. While both populations presented high surgical risk, it was even higher for PARTNER 1 patients (Society of Thoracic Surgeons [STS] score of 10.7 ± 3.5% for PARTNER 1 vs. 6.4 ± 4.4% for ADVANCE), which might explain the difference in mortality.

Original title: Final 5-Year Clinical and Echocardiographic Results for Treatment of Severe Aortic Stenosis with a Self-Expanding Bioprosthesis from the ADVANCE Study.

Reference: Ulrich Gerckens et al. Eur Heart J. 2017 Sep 21;38(36):2729-2738.

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