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Background <p>Comparative data on safety and efficacy of intra- and supra-annular self-expanding heart valves (THV) for transcatheter aortic valve implantation (TAVI) in patients with severe aortic stenosis (AS) is scarce. The FIRE TAVI study compared procedural in-hospital and mid-term outcomes of the intra-annular Navitor THV and the supra-annular Evolut PRO THV.</p> Methods <p>The retrospective, multicenter study enrolled patients with severe AS who underwent TAVI using Navitor or Evolut PRO. The primary composite safety endpoint included all-cause mortality, myocardial infarction, disabling stroke, life-threatening bleeding, major vascular complication, or acute kidney injury requiring dialysis until discharge. Secondary endpoints comprised pacemaker implantation, paravalvular leakage (PVL), and mean transvalvular gradient. Mortality was assessed 381 ± 308&#xa0;days after TAVI. Multivariable regression analysis was used for endpoint comparison of both THVs.</p> Results <p>Then, 269 patients after Navitor and 272 patients after Evolut PRO implantation were enrolled. There was no significant risk difference regarding the adjusted primary safety endpoint (OR 0.97 [95% CI 0.50–1.89]) and rate of pacemaker implantation (OR 1.13 [95% CI 0.67–1.90]). The pressure gradient was comparable between both groups (Navitor 7.0 [4.0–10.0] mmHg vs. Evolut PRO 6.0 [2.0–10.0] mmHg, mean difference − 0.32 [95% CI -0.97–0.32]). Navitor showed a lower frequency of more than mild PVL (0.8% vs. 3.5%, <i>p</i> = 0.032). Mortality was similar (HR 1.04 [95% CI 0.66–1.63]).</p> Conclusion <p>The implantation of the intra-annular Navitor and the supra-annular Evolut PRO was safe, with severe adverse events occurring at similar rates until discharge. The risk of moderate or severe PVL was lower with Navitor; mid-term mortality was comparable in both groups.</p> Graphical Abstract <p>The FIRE TAVI study compared patients with Navitor and Evolut platforms and showed that the implantation of the intra-annular self-expanding Navitor THV and the supra-annular self-expanding Evolut THV was safe and severe adverse events occurred with comparable frequency until discharge. Navitor patients presented a lower risk of moderate or severe PVL at discharge. The adjusted analysis included the following parameters: center, sex, age, BMI, Society of Thoracic Surgeons (STS) score, New York Heart Association (NYHA) class, left ventricular ejection fraction (LVEF), mitral and tricuspid regurgitation, estimated glomerular filtration rate (eGFR), right bundle branch block (RBBB), coronary artery disease, prior stroke, chronic obstructive pulmonary disease, atrial fibrillation or flutter, peripheral artery disease, pulmonary hypertension, and transfemoral access. CI, confidence interval; HR, hazard ratio; OR, odds ratio; SEV, self-expanding valve; TAVI, transcatheter aortic valve implantation; THV, transcatheter heart valve; PVL, paravalvular leakage. Illustration of the Evolut THV provided by Medtronic</p> <p></p>

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Early safety and efficacy of intra-annular versus supra-annular self-expanding transcatheter heart valves

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年4月8日

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  • Isabel Mattig,
  • Elena Romero Dorta,
  • Lorenz Kösters,
  • Anne-Katrin Fietz,
  • Daniel Schulze,
  • Simon H. Sündermann,
  • Anna Brand,
  • Axel Unbehaun,
  • Sebastian Spethmann,
  • Karl Stangl,
  • Gerhard Hindricks,
  • Lenard Conradi,
  • Andreas Schäfer,
  • Henryk Dreger

摘要

Background

Comparative data on safety and efficacy of intra- and supra-annular self-expanding heart valves (THV) for transcatheter aortic valve implantation (TAVI) in patients with severe aortic stenosis (AS) is scarce. The FIRE TAVI study compared procedural in-hospital and mid-term outcomes of the intra-annular Navitor THV and the supra-annular Evolut PRO THV.

Methods

The retrospective, multicenter study enrolled patients with severe AS who underwent TAVI using Navitor or Evolut PRO. The primary composite safety endpoint included all-cause mortality, myocardial infarction, disabling stroke, life-threatening bleeding, major vascular complication, or acute kidney injury requiring dialysis until discharge. Secondary endpoints comprised pacemaker implantation, paravalvular leakage (PVL), and mean transvalvular gradient. Mortality was assessed 381 ± 308 days after TAVI. Multivariable regression analysis was used for endpoint comparison of both THVs.

Results

Then, 269 patients after Navitor and 272 patients after Evolut PRO implantation were enrolled. There was no significant risk difference regarding the adjusted primary safety endpoint (OR 0.97 [95% CI 0.50–1.89]) and rate of pacemaker implantation (OR 1.13 [95% CI 0.67–1.90]). The pressure gradient was comparable between both groups (Navitor 7.0 [4.0–10.0] mmHg vs. Evolut PRO 6.0 [2.0–10.0] mmHg, mean difference − 0.32 [95% CI -0.97–0.32]). Navitor showed a lower frequency of more than mild PVL (0.8% vs. 3.5%, p = 0.032). Mortality was similar (HR 1.04 [95% CI 0.66–1.63]).

Conclusion

The implantation of the intra-annular Navitor and the supra-annular Evolut PRO was safe, with severe adverse events occurring at similar rates until discharge. The risk of moderate or severe PVL was lower with Navitor; mid-term mortality was comparable in both groups.

Graphical Abstract

The FIRE TAVI study compared patients with Navitor and Evolut platforms and showed that the implantation of the intra-annular self-expanding Navitor THV and the supra-annular self-expanding Evolut THV was safe and severe adverse events occurred with comparable frequency until discharge. Navitor patients presented a lower risk of moderate or severe PVL at discharge. The adjusted analysis included the following parameters: center, sex, age, BMI, Society of Thoracic Surgeons (STS) score, New York Heart Association (NYHA) class, left ventricular ejection fraction (LVEF), mitral and tricuspid regurgitation, estimated glomerular filtration rate (eGFR), right bundle branch block (RBBB), coronary artery disease, prior stroke, chronic obstructive pulmonary disease, atrial fibrillation or flutter, peripheral artery disease, pulmonary hypertension, and transfemoral access. CI, confidence interval; HR, hazard ratio; OR, odds ratio; SEV, self-expanding valve; TAVI, transcatheter aortic valve implantation; THV, transcatheter heart valve; PVL, paravalvular leakage. Illustration of the Evolut THV provided by Medtronic