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
TAVI valve long-term durability
Equivalent with surgery at 5 years1*
- 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
.svg "Durability_mean-aortic-valve-gradient")
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
.svg "Durability_rate-of-HVD-BVF-5-years")
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 reintervention2
.svg "Durability_freedom-from-SVD-BVF-10-years-1")
Clinical implications
What could long-term durability with TAVI mean for your severe AS patients?
- A promising outlook for the future1,2
- Equivalent haemodynamic performance to sAVR at 5 years1
- Low rate of valve deterioration or failure at 10 years2
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
* 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 o ≥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
Related resources
Edwards TAVI study compendium
In-depth summary of the key Edwards Lifescience TAVI studies.
References:
1 Kodali SK, et al. Presentación en el evento virtual Transcatheter Valve Therapies (TVT) Summit: TVT Connect 2020. Disponible en: https://www.tctmd.com/slide/sapien-3-transcatheter-aortic-valve-replacement-compared-surgery-intermediate-risk-patients (consultado en marzo de 2021).
2 Sathananthan J, et al. Catheter Cardiovasc Interv. 2021;97(3):E431--E437.
3 Mack MJ. Two-year clinical and echocardiographic outcomes from the PARTNER 3 low-risk randomized trial. Presentado en: ACC 2020, Chicago, 29 de marzo de 2020.
4 Virtanen MPO, et al. J Cardiothorac Surg 2020;15(1):157.
5 Carron J. Violin Plots 101: Visualizing Distribution and Probability Density. Disponible en: https://mode.com/blog/violin-plot-examples (consultado en abril de 2021).
Medical device for professional use. For a listing of indications, contraindications, precautions, warnings, and potential adverse events, please refer to the Instructions for Use (consult eifu.edwards.com where applicable). Edwards devices placed on the European market meeting the essential requirements referred to in Article 3 of the Medical Device Directive 93/42/EEC bear the CE marking of conformity.
PP--EU-1855 v2.0