TAVI valve long-term durability

Equivalent with surgery at 5 years ^1*

When considering the use of TAVI in low-risk patients with a longer life expectancy, valve durability is of paramount importance²
5-year data from the PARTNER II Trial has shown similar rates of durability between SAPIEN 3 TAVI and surgery (sAVR)¹
The first real-world study with 10-year data has shown very low rates of structural valve deterioration (SVD) and bioprosthetic valve failure (BVF) after TAVI²

Sustained improvement of haemodynamic performance at 5 years¹

In a propensity-matched analysis of intermediate-risk patients with severe aortic stenosis, there was no difference in mean aortic valve gradient between the SAPIEN 3 TAVI group and the sAVR group at 5 years.¹

Similar rates of reintervention for TAVI vs sAVR¹

Durability data from the PARTNER II Trial found aortic valve reintervention was low in patients who had received SAPIEN 3 TAVI at 5 years. Only 1.3% of patients required reintervention versus 0.8% who had received sAVR (odds ratio 0.60 [95% CI, 0.22— 1.65; p=0.31]).¹

This evidence of durability at 5 years is further supported by the similar rates of haemodynamic valve deterioration (HVD) and bioprosthetic valve failure (BVF). ¹

Rate of HVD and BVF at 5 years ¹

Find out more about the PARTNER IIA Trial of TAVI in intermediate-risk patients.

Freedom from SVD and BVF at 10 years²

In a long-term, real-world follow up study (n=235^║), 93.5% of patients who had a TAVI were free from structural valve deterioration (SVD) and BVF at 10 years and only 2 required reintervention.²

Clinical implications

What could long-term durability with TAVI mean for your severe AS patients?

Engineered for the future

With the expansion of SAPIEN 3 TAVI to low-risk patients, long-term durability data is of paramount importance. Clinical and echocardiographic follow-up of patients from the PARTNER 3 Trial will continue for up to 10 years.³

Manufactured using the same tissue processing as the Perimount Magna Ease, the SAPIEN 3 valve was built on the proven SAPIEN platform and designed with patient needs in mind. More information can be accessed on the Edwards website.⁴

Manufactured using the same tissue processing as the Perimount Magna Ease, which is regarded as the most durable surgical bioprosthesis, the SAPIEN 3 valve was built on the proven SAPIEN platform and designed with patient needs in mind. More information can be accessed on the Edwards website.⁴

*Data from the PARTNER II Trial of TAVI in intermediate-risk severe aortic stenosis patients.¹

^†Violin plots have become the new standard for representing echocardiographic data. Like box plots they show the distribution of the data, with the addition of the density of the data at different values.⁵

^‡Stage 2 & 3 HVD defined as: + Δ mean gradient ≥ 10 mmHg and -Δ AVA ≥ 0.3 cm² or ≥ 25%, -Δ DVI ≥ 0.1 or ≥ 20%, AND/OR ≥ 1 grade Δ transvalvular AR with final grade ≥ moderate.

^$Bioprothetic valve failure defined as: Reintervention or death related to valve dysfunction, or severe (Stage 3) structural valve deterioration-related HVD.¹

^║77.4% of patients in the follow-up study had received Edwards SAPIEN.²

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References

1
Kodali SK, et al. Presentation at the Transcatheter Valve Therapies (TVT) Summit virtual event: TVT Connect 2020.
Available at: https://www.tctmd.com/slide/sapien-3-transcatheter-aortic-valve-replacement-compared-surgery-intermediate-risk-patients (accessed March 2021).
2Sathananthan J, et al. Catheter Cardiovasc Interv. 2021;97(3):E431--E437.
3Mack MJ. Two-year clinical and echocardiographic outcomes from the PARTNER 3 low-risk randomized trial. Presented at: ACC 2020, Chicago, March 29, 2020.
4Virtanen MPO, et al. J Cardiothorac Surg 2020;15(1):157.
5
Carron J. Violin Plots 101: Visualizing Distribution and Probability Density.
Available at: https://mode.com/blog/violin-plot-examples (accessed April 2021)

TAVI valve long-term durability

Equivalent with surgery at 5 years 1*

Sustained improvement of haemodynamic performance at 5 years1

Similar rates of reintervention for TAVI vs sAVR1

Freedom from SVD and BVF at 10 years2