Core Lab Adjudication of the ACURATE neo2 Hemodynamic Performance Using Computed-Tomography-Corrected Left Ventricular Outflow Tract Area

Ahmed Elkoumy; Andreas Rück; Won-Keun Kim; Mohamed Abdel-Wahab; Mahmoud Abdelshafy; Ole De Backer; Hesham Elzomor; Christian Hengstenberg; Sameh K Mohamed; Nawzad Saleh; Shahram Arsang-Jang; Henrik Bjursten; Andrew Simpkin; Christopher U Meduri; Osama Soliman

doi:10.3390/jcm11206103

Core Lab Adjudication of the ACURATE neo2 Hemodynamic Performance Using Computed-Tomography-Corrected Left Ventricular Outflow Tract Area

J Clin Med. 2022 Oct 17;11(20):6103. doi: 10.3390/jcm11206103.

Authors

Ahmed Elkoumy^{1

2}, Andreas Rück³, Won-Keun Kim⁴, Mohamed Abdel-Wahab⁵, Mahmoud Abdelshafy¹, Ole De Backer⁶, Hesham Elzomor¹, Christian Hengstenberg⁷, Sameh K Mohamed¹, Nawzad Saleh³, Shahram Arsang-Jang^{1

8}, Henrik Bjursten⁹, Andrew Simpkin¹⁰, Christopher U Meduri³, Osama Soliman^{1

8}

Affiliations

¹ Discipline of Cardiology, Saolta Group, Galway University Hospital, Health Service Executive and CORRIB Core Lab, University of Galway, H91 V4AY Galway, Ireland.
² Islamic Center of Cardiology, Al-Azhar University, Nasr City, Cairo 11651, Egypt.
³ Department of Cardiology, Karolinska University Hospital, 17176 Stockholm, Sweden.
⁴ Department of Cardiology and Cardiac Surgery, Kerckhoff Heart and Lung Centre, 61231 Bad Nauheim, Germany.
⁵ Department of Cardiology, Heart Center Leipzig at University of Leipzig, 04289 Leipzig, Germany.
⁶ The Heart Center-Rigshospitalet, 2100 Copenhagen, Denmark.
⁷ Division of Cardiology, Department of Internal Medicine II, Medical University of Vienna, 1090 Vienna, Austria.
⁸ CÚRAM, SFI Research Centre for Medical Devices, H91 W2TY Galway, Ireland.
⁹ Department of Cardiothoracic Surgery, Anesthesia and Intensive Care, Skane University Hospital, Lund University, 22185 Lund, Sweden.
¹⁰ Data Science Institute, University of Galway, H91 TK33 Galway, Ireland.

Abstract

(1) Background: Hemodynamic assessment of prosthetic heart valves using conventional 2D transthoracic Echocardiography-Doppler (2D-TTE) has limitations. Of those, left ventricular outflow tract (LVOT) area measurement is one of the major limitations of the continuity equation, which assumes a circular LVOT. (2) Methods: This study comprised 258 patients with severe aortic stenosis (AS), who were treated with the ACURATE neo2. The LVOT area and its dependent Doppler-derived parameters, including effective orifice area (EOA) and stroke volume (SV), in addition to their indexed values, were calculated from post-TAVI 2D-TTE. In addition, the 3D-LVOT area from pre-procedural MDCT scans was obtained and used to calculate corrected Doppler-derived parameters. The incidence rates of prosthesis patient mismatch (PPM) were compared between the 2D-TTE and MDCT-based methods (3) Results: The main results show that the 2D-TTE measured LVOT is significantly smaller than 3D-MDCT (350.4 ± 62.04 mm² vs. 405.22 ± 81.32 mm²) (95% Credible interval (CrI) of differences: -55.15, -36.09), which resulted in smaller EOA (2.25 ± 0.59 vs. 2.58 ± 0.63 cm²) (Beta = -0.642 (95%CrI of differences: -0.85, -0.43), and lower SV (73.88 ± 21.41 vs. 84.47 ± 22.66 mL), (Beta = -7.29 (95% CrI: -14.45, -0.14)), respectively. PPM incidence appears more frequent with 2D-TTE- than 3D-MDCT-corrected measurements (based on the EOAi) 8.52% vs. 2.32%, respectively. In addition, significant differences regarding the EOA among the three valve sizes (S, M and L) were seen only with the MDCT, but not on 2D-TTE. (4) Conclusions: The corrected continuity equation by combining the 3D-LVOT area from MDCT with the TTE Doppler parameters might provide a more accurate assessment of hemodynamic parameters and PPM diagnosis in patients treated with TAVI. The ACURATE neo2 THV has a large EOA and low incidence of PPM using the 3D-corrected LVOT area than on 2D-TTE. These findings need further confirmation on long-term follow-up and in other studies.

Keywords: ACURATE neo2; aortic stenosis; computed tomography; echocardiography; hemodynamic performance; left ventricular outflow tract; prosthesis patient mismatch.

Grants and funding

This research received support from Science Foundation of Ireland (Grant # 13/RC/2073_P2).