Outcomes of transfemoral TAVR using two new-generation devices in patients with horizontal aorta

Catheter Cardiovasc Interv. 2024 Sep;104(3):591-599. doi: 10.1002/ccd.31094. Epub 2024 Jun 11.

Abstract

Background: Challenging anatomies and comorbidities have impact on success in transcatheter aortic valve replacement (TAVR). There is controversy whether the extent of the aortic angle (AA) has an impact on procedural outcomes. Matched comparative outcome data of new generation transcatheter heart valves (THVs) in horizontal aorta (HA) are scarce.

Methods: A total of 1582 patients with severe native aortic stenosis (AS) treated with the SAPIEN3 Ultra (Ultra; n = 526) or ACURATE Neo2 (Neo2; n = 1056) THVs from January 2017 to January 2023 were analyzed. Patients with non-horizontal aortas (AA < 51.7°, n = 841) were excluded. The population was matched by 1-to-1 nearest-neighbor matching (Ultra, n = 246; Neo2, n = 246). Clinical and procedural outcome were evaluated according to VARC-3 recommendations.

Results: Technical success (93.1% vs. 94.7%, p = 0.572) was high after Ultra and Neo2. Device success (80.5% vs. 89.8%, p = 0.05) was inferior with Ultra. Neo2 reveals superior hemodynamic properties with lower rate of severe prosthesis patient mismatch (12.0% vs. 3.7%, p = 0.001) and elevated gradients ( ≥ $\ge $ 20 mmHg: 11.9% vs. 1.7%, p < 0.001). Ultra showed a lower rate of relevant paravalvular regurgitation ( > $\gt $ mild paravalvular regurgitation or Valve-in-Valve due to paravalvular regurgitation: 0.0% vs. 3.7%, p = 0.004). The rate of procedural bailout maneuvers (0.8% vs. 0.4%, p = 1.000) and thirty-day all-cause mortality (1.3% vs. 2.2%, p = 0.496) was similar.

Conclusion: Transfemoral TAVR in patients with severe aortic stenosis and HA, using the balloon expandable Sapien3 Ultra and self-expanding ACURATE Neo2 prosthesis, is feasible and safe. Therefore, valve selection between these platforms should be made irrespective of the aortic angle by a team experienced with both valves based on their specific advantages. Large, randomized trials in this sub-group of patients would be necessary to compare long term outcomes.

Keywords: Acurate; Neo2; Sapien; TAVR; horizontal aorta; ultra.

Publication types

  • Comparative Study

MeSH terms

  • Aged
  • Aged, 80 and over
  • Aortic Valve Stenosis* / diagnostic imaging
  • Aortic Valve Stenosis* / mortality
  • Aortic Valve Stenosis* / physiopathology
  • Aortic Valve Stenosis* / surgery
  • Aortic Valve* / diagnostic imaging
  • Aortic Valve* / physiopathology
  • Aortic Valve* / surgery
  • Catheterization, Peripheral / adverse effects
  • Catheterization, Peripheral / instrumentation
  • Female
  • Femoral Artery* / physiopathology
  • Heart Valve Prosthesis*
  • Hemodynamics*
  • Humans
  • Male
  • Prosthesis Design*
  • Punctures
  • Recovery of Function
  • Retrospective Studies
  • Risk Factors
  • Severity of Illness Index*
  • Time Factors
  • Transcatheter Aortic Valve Replacement* / adverse effects
  • Transcatheter Aortic Valve Replacement* / instrumentation
  • Transcatheter Aortic Valve Replacement* / mortality
  • Treatment Outcome