13 May 2022
CoreValve™ and Evolut™ TAVI systems
The best TAVI vs SAVR durability data yet - The only platforms to demonstrate a durability benefit over SAVR at 5 years*1
Sponsored by Medtronic
Dr Michael Reardon (Huston, USA) presented at LBCT Scientific Sessions a pooled analysis of the CoreValve US Pivotal and SURTAVI trials looking at 5-year incidence, outcomes, and predictors of structural valve deterioration of transcatheter (N=1128) and surgical (N=971) aortic bioprostheses*1.
Main takeaways:
- Structural valve deterioration (SVD)2 at 5 years was significantly lower in patients treated with self-expanding, supra-annular TAVI* than surgery
5-year SVD adjusted for competing risk of mortality
- Significantly lower rate of SVD with TAVI vs Surgery through 5-year in small annuli. This difference in SVD was more profound in patients with smaller (≤ 23 mm) annuli (5.86% surgery vs 1.39% TAVI; P=0.049). A trend was also found in patients with larger (> 23 mm) annuli (3.96% surgery vs 2.48% TAVI; P=0.067)
5-year SVD in smaller (≤ 23 mm) annulus diameters
- Doppler assessments of post-AVR gradients demonstrating SVD were associated with a near 2-fold increase in 5-year all-cause mortality and hospitalization for aortic valve disease or worsening heart failure (HR 1.96; P < 0.001)
- Multivariate predictor analysis found a higher risk of developing SVD in patients with a higher body surface area, and a lower risk of SVD in men, older patients, those with prior PCI, and those with atrial fibrillation
Perspective
These data show that the CoreValveTM/EvolutTM platform is the only trancatheter aortic valve to demonstrate lower rates of SVD versus surgery at 5 years, with the most profound difference observed in patients with smaller (≤ 23 mm) annuli. Changes in Doppler TTE gradients were highly predictive of 5-year clinical outcomes.References
* In pooled analysis of intermediate and high-risk patients. Devices used: CoreValve™ 88%/Evolut™ R 12%.
1 Reardon MJ. 5-year Incidence, Timing and Predictors of Structural Valve Deterioration of Transcatheter and Surgical Aortic Bioprostheses: insights from the CoreValve US Pivotal and SURTAVI Trials. Presented at ACC 2022
2 Structural valve deterioration (SVD) was defined as an increase in mean gradient ≥ 10 mm Hg from discharge/30-day echo to last available echo AND mean gradient ≥ 20 mm Hg at last available echo OR new onset/increase of intra-prosthetic aortic regurgitation (AR) ≥ moderate.
Page published on June 2022
With an unrestricted educational grant from Medtronic
