Skip main navigation

Neo-Commissural Alignment Technique for Transcatheter Aortic Valve Replacement Using the ACURATE Neo Valve

Originally publishedhttps://doi.org/10.1161/CIRCINTERVENTIONS.122.011993Circulation: Cardiovascular Interventions. 2022;15

Neo-commissural alignment during transcatheter aortic valve replacement has been recently described to potentially facilitate coronary and valvular interventions post–transcatheter aortic valve replacement.1,2 The methods reported, however, may require significant manipulation of the device in some cases, and a detailed understanding of the anatomic relations involved.3,4

Thus, in an attempt to streamline the procedure, based on our clinical experience, we hypothesized that positioning the Luer port facing downwards facilitates optimal commissural alignment for the ACURATE Neo valve (Boston Scientific, Marlborough, MA), without a need for extensive manipulation. The aim of this study was to examine (1) whether optimal commissural alignment can be thus improved and (2) the degree of rotation required to obtain optimal commissural alignment in conventional port-up (Luer port facing upwards) and port-down (Luer port facing downwards) methods. The data that support the findings of this study are available from the corresponding author upon reasonable request.

The study consisted of an in vitro experimental model and an in vivo clinical study.

The experimental model consisted of an artificial aortic root with fluoroscopic markers for commissure positions and coronary ostia (Figure [A]), a pulsatile circulation system, and temperature and pressure transducers. The positions of the commissural posts were evaluated using a 3-cusp coplanar view on fluoroscopy. If the commissural posts were not optimally aligned, the delivery system was rotated to align them to the anatomic commissures (clockwise if the stent posts showed a II:I configuration, counter-clockwise if the stent posts showed a I:II configuration). Before transcatheter heart valve implantation, it was confirmed by C-arm rotation that the center post was at the back (rather than the front) on 3-cusp view (Figure [B]). The degree of deviation from ideal alignment of the commissural posts before optimization and the actual rotation angles of the transcatheter heart valve were recorded for each procedure (+clockwise/−counter-clockwise). Separately, after the procedures, the degree of deviation between commissure and neo-commissure was evaluated by an optical camera from the ascending aorta side. The experiment was repeated over 10 procedures for both conventional and port-down methods.

Figure.

Figure. Neo-commissural alignment technique for transcatheter aortic valve replacement using the ACURATE neo valve. A, Description of the experimental model. B, Fluoroscopic configuration of commissural posts of the ACURATE Neo valve during delivery. Note that rotation around the C-arm is required to distinguish the Center-Front and Center-Back configurations. C, Rotation angle of commissural posts of the ACURATE Neo Valve at the initial position after delivery. D, Final assessment of the commissure position using an optical camera. E, Commissure position by optical measurements after optimization and transcatheter heart valve implantation. F, Position of the Luer port during delivery of the ACURATE Neo system. G, Mean angle of commissure rotation on post-transcatheter aortic valve replacement computed tomography (CT). LCC indicates left coronary cusp; NCC, noncoronary cusp; and RCC, right coronary cusp.

All clinical procedures were enrolled in a prospective registry at the Heart Center Leipzig (https://www.clinicaltrials.gov; Unique identifier: NCT05015452). All participants provided informed consent, and the registry was approved by the Ethics Committee of the Medical Faculty of the University of Leipzig (102/20-ek). We compared 3 different patient groups: (1) a conventional historical control group (n=16); valve implantation with the Luer port of the delivery catheter positioned upward, (2) a prospective consecutive commissural alignment group (n=10); implantation after adjustment of commissural alignment based on fluoroscopic findings using the cusp-overlap view, and (3) a prospective consecutive port-down group (n=10); implantation with the Luer port positioned downward without further adjustment. In the cusp-overlap view, optimally aligned posts would correspond to a 90° angled post toward the intracoronary commissure and 2 overlapped 30° posts. Neo-commissural alignment and coronary overlap were evaluated on post–transcatheter aortic valve replacement computed tomography.

In the in vitro procedures, an optimal postconfiguration was achieved at initial device position in 50% with port-down method but none with port-up method. Well-aligned commissures (defined as a mean rotation angle <30 degrees) were achieved without manipulation in 90% of the port-down group (versus 60% of the port-up group, P=0.019; Figure [C]). The device rotation angle required for optimal positioning of the commissural posts was significantly lower in the port-down group than the port-up group (321±117 versus 488±99 degrees, P=0.003; >1 full turn of the device handle in many cases, due to the limited efficiency in transmitting torque from over 1 m away). The rotation was predominantly counter-clockwise in the port-up group (90% versus 30%, P=0.020). After implantation, the final commissure position (Figure [D]) did not significantly differ between both groups, and all achieved well-aligned commissures (Figure [E]).

In the in vivo population, optimal alignment (defined as a mean rotation angle <15 degrees) was obtained in 8 of 10 patients (80%) treated with port-down method (Figure [F]) compared to 10 of 10 patients (100%) treated with commissural alignment method. No patient in either of these groups had mal-aligned neo-commissures (defined as a mean rotation angle of 45 to 60 degrees). In post-transcatheter aortic valve replacement computed tomography, the port-down group showed comparable commissure rotation to the commissural alignment group, with a mean commissure rotation of 10±5 degrees compared to 8±2 degrees (Figure [G]). In comparison, the conventional port-up method (n=16) achieved optimal alignment in only 31% of cases, and 50% of cases had mal-aligned commissures, with a mean commissure rotation of 35±20 degrees.

In conclusion, in vitro and in vivo experimental data show that commissural alignment with the ACURATE Neo is possible in transfemoral TAVI and the port-down method facilitates this in the majority of cases.

Article Information

Disclosures Dr Abdel-Wahab reports that his hospital received speakers’ honoraria and/or consulting fees on his behalf from Medtronic and Boston Scientific. C. Frawley and K. Ward are both Boston Scientific Corporation employees. The other authors report no conflicts.

Footnotes

*M. Abdel-Wahab and M. Kitamura contributed equally.

For Sources of Funding and Disclosures, see page 634.

Correspondence to: Mohamed Abdel-Wahab, MD, Department of Structural Heart Disease/Cardiology, Heart Center Leipzig at University of Leipzig, Strümpellstraße 39, 04289 Leipzig, Germany. Email

References

  • 1. Fuchs A, Kofoed KF, Yoon SH, Schaffner Y, Bieliauskas G, Thyregod HG, Makkar R, Søndergaard L, De Backer O, Bapat V. Commissural alignment of bioprosthetic aortic valve and native aortic valve following surgical and transcatheter aortic valve replacement and its impact on valvular function and coronary filling.JACC Cardiovasc Interv. 2018; 11:1733–1743. doi: 10.1016/j.jcin.2018.05.043CrossrefMedlineGoogle Scholar
  • 2. Abdelghani M, Landt M, Traboulsi H, Becker B, Richardt G. Coronary access after TAVR with a self-expanding bioprosthesis: insights from computed tomography.JACC Cardiovasc Interv. 2020; 13:709–722. doi: 10.1016/j.jcin.2020.01.229CrossrefMedlineGoogle Scholar
  • 3. Bieliauskas G, Wong I, Bajoras V, Wang X, Kofoed KF, De Backer O, Søndergaard L. Patient-specific implantation technique to obtain neo-commissural alignment with self-expanding transcatheter aortic valves.JACC Cardiovasc Interv. 2021; 14:2097–2108. doi: 10.1016/j.jcin.2021.06.033CrossrefMedlineGoogle Scholar
  • 4. Kitamura M, Wilde J, Gohmann R, Majunke N, Gutberlet M, Shibata M, Kiefer P, Desch S, Thiele H, Holzhey D, et al. Commissural alignment of the ACURATE neo valve in transcatheter aortic valve replacement.JACC Cardiovasc Interv. 2021; 14:1740–1742. doi: 10.1016/j.jcin.2021.05.037CrossrefMedlineGoogle Scholar