Evaluation of the Efficacy and Safety of a 3D Navigation-Guided Transcatheter Aortic Valve Implantation Technique in Patients With Severe Aortic Stenosis and a High Risk of Atrioventricular Conduction Disorders: Results of a Pilot Randomized Study

Aim        To evaluate the efficacy and safety of a new 3D navigation-guided technique for transcatheter aortic valve implantation (TAVI) in patients with severe aortic stenosis (AS) and a high risk of atrioventricular (AV) conduction disorder.

Material and methods    The study presents the results of a single-center prospective randomized pilot study. Sixty patients meeting inclusion and exclusion criteria with at least one criterion of a high risk for AV conduction disorder were enrolled in the study. All included patients were randomized 1:1 into two groups. In Group 1, TAVI was performed using a 3D navigation-guided technique, while in Group 2, the classical TAVI technique was used. The primary endpoint was the composite incidence of permanent pacemaker (PP) implantation and new-onset complete left bundle branch block (LBBB) at 6 months.

Results  In the early postoperative period, the 3D navigation-guided TAVI group had a lower incidence of new-onset LBBB (10.3% vs. 33.3%; p=0.03), better parameters of intraventricular conduction according to electrophysiology study (EPS) (H-V interval 79.1±13.5 ms vs. 96.0±39.9 ms; p=0.03) and electrocardiography (QRS complex duration 108.0±16.3 ms vs. 119.0±22.6 ms; p=0.04). The incidence of PP implantation during the hospital stage, A-H interval duration, and Wenckebach point in the AV junction according to EPS did not differ significantly between the groups. The incidence of the primary endpoint (PP implantation + new-onset LBBB) during the 6-month follow-up period was 43.3% in the classical technique group and 16.7% in the 3D navigation-guided TAVI group (p=0.02). There were no statistically significant differences between the groups in the incidence of procedural complications or major adverse cardiovascular and cerebrovascular outcomes.

Conclusion         This study demonstrated the efficacy and safety of a new 3D navigation-guided TAVI technique in reducing the composite rate of implantation PP and LBBB at 6 months post-procedure, with comparable rates of procedural complications and major adverse cardiac and cerebrovascular events (MACCE) during long-term follow-up. Implementation of these findings into clinical practice will enable personalization and optimization of transcatheter treatment outcomes in patients with severe AS.

1. Otto CM, Nishimura RA, Bonow RO, Carabello BA, Erwin JP, Gentile F et al. 2020 ACC/AHA Guideline for the Management of Patients With Valvular Heart Disease: Executive Summary: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Circulation. 2021;143(5):e35–71. DOI: 10.1161/CIR.0000000000000932

2. Alekyan B.G., Ruchkin D.V., Karapetyan N.G., Irodova N.L., Meleshenko N.N., Geletsyan L.G. et al. Case report of a multidisciplinary approach to one-time treatment of a patient with critical aortic valve stenosis, lesion of the left main coronary artery and bleeding stomach cancer. Circulation Pathology and Cardiac Surgery. 2022;26(2):58–65. DOI: 10.21688/1681-3472-2022-2-58-65

3. Fujita B, Schmidt T, Bleiziffer S, Bauer T, Beckmann A, Bekeredjian R et al. Impact of new pacemaker implantation following surgical and transcatheter aortic valve replacement on 1-year outcome. European Journal of Cardio-Thoracic Surgery. 2020;57(1):151–9. DOI: 10.1093/ejcts/ezz168

4. Alekyan B.G., Titov N.S. Endovascular treatment of aortic valve stenosis in combination with coronary artery disease: a systematic review. Circulation Pathology and Cardiac Surgery. 2024;28(2):7–20. DOI: 10.21688/1681-3472-2024-2-7-20

5. Alperi Garcia A, Muntané-Carol G, Junquera L, Del Val D, Faroux L, Philippon F et al. Can we reduce conduction disturbances following transcatheter aortic valve replacement? Expert Review of Medical Devices. 2020;17(4):309–22. DOI: 10.1080/17434440.2020.1741349

6. Nuche J, Ellenbogen KA, Mittal S, Windecker S, Benavent C, Philippon F et al. Conduction Disturbances After Transcatheter Aortic Valve Replacement: An Update on Epidemiology, Preventive Strategies, and Management. JACC: Cardiovascular Interventions. 2024;17(22):2575–95. DOI: 10.1016/j.jcin.2024.07.032

7. Zaid S, Sengupta A, Okoli K, Tsoi M, Khan A, Ahmad H et al. Novel Anatomic Predictors of New Persistent Left Bundle Branch Block After Evolut Transcatheter Aortic Valve Implantation. The American Journal of Cardiology. 2020;125(8):1222–9. DOI: 10.1016/j.amjcard.2020.01.008

8. Wendler O, Schymik G, Treede H, Baumgartner H, Dumonteil N, Neumann F-J et al. SOURCE 3: 1-year outcomes post-transcatheter aortic valve implantation using the latest generation of the balloon-expandable transcatheter heart valve. European Heart Journal. 2017;38(36):2717–26. DOI: 10.1093/eurheartj/ehx294

9. Faroux L, Chen S, Muntané-Carol G, Regueiro A, Philippon F, Sondergaard L et al. Clinical impact of conduction disturbances in transcatheter aortic valve replacement recipients: a systematic review and meta-analysis. European Heart Journal. 2020;41(29):2771–81. DOI: 10.1093/eurheartj/ehz924

10. Sasaki K, Kuwata S, Izumo M, Koga M, Kai T, Sato Y et al. Three-Year Clinical Impacts of Permanence, Resolution, and Absence of NewlyDeveloped Left Bundle Branch Block After Transcatheter Aortic Valve Replacement. The American Journal of Cardiology. 2023;202:166–8. DOI: 10.1016/j.amjcard.2023.06.092

11. Maier O, Piayda K, Binnebößel S, Berisha N, Afzal S, Polzin A et al. Real-world experience with the cusp-overlap deployment technique in transcatheter aortic valve replacement: A propensity-matched analysis. Frontiers in Cardiovascular Medicine. 2022;9:847568. DOI: 10.3389/fcvm.2022.847568

12. Ochiai T, Yamanaka F, Shishido K, Moriyama N, Komatsu I, Yokoyama H et al. Impact of High Implantation of Transcatheter Aortic Valve on Subsequent Conduction Disturbances and Coronary Access. JACC: Cardiovascular Interventions. 2023;16(10):1192–204. DOI: 10.1016/j.jcin.2023.03.021

13. Gabbieri D, Ghidoni I, Mascheroni G, Chiarabelli M, D’Anniballe G, Pisi P et al. Pacemaker implantation after surgical aortic valve replacement and balloon-expandable transcatheter aortic valve implantation: Incidence, predictors, and prognosis. Heart Rhythm O2. 2025;6(3):259–72. DOI: 10.1016/j.hroo.2025.01.001

14. Junquera L, Freitas‐Ferraz AB, Padrón R, Silva I, Nunes Ferreira‐Neto A, Guimaraes L et al. Intraprocedural high‐degree atrioventricular block or complete heart block in transcatheter aortic valve replacement recipients with no prior intraventricular conduction disturbances. Catheterization and Cardiovascular Interventions. 2020;95(5):982–90. DOI: 10.1002/ccd.28323

15. Vahanian A, Urena M, Walther T, Treede H, Wendler O, Lefèvre T et al. Thirty-day outcomes in patients at intermediate risk for surgery from the SAPIEN 3 European approval trial. EuroIntervention. 2016;12(2):e235–43. DOI: 10.4244/EIJV12I2A37

16. Webb J, Gerosa G, Lefèvre T, Leipsic J, Spence M, Thomas M et al. Multicenter Evaluation of a Next-Generation Balloon-Expandable Transcatheter Aortic Valve. Journal of the American College of Cardiology. 2014;64(21):2235–43. DOI: 10.1016/j.jacc.2014.09.026

17. Rivard L, Schram G, Asgar A, Khairy P, Andrade JG, Bonan R et al. Electrocardiographic and electrophysiological predictors of atrioventricular block after transcatheter aortic valve replacement. Heart Rhythm. 2015;12(2):321–9. DOI: 10.1016/j.hrthm.2014.10.023

18. Tovia-Brodie O, Ben-Haim Y, Joffe E, Finkelstein A, Glick A, Rosso R et al. The value of electrophysiologic study in decision-making regarding the need for pacemaker implantation after TAVI. Journal of Interventional Cardiac Electrophysiology. 2017;48(2):121–30. DOI: 10.1007/s10840-016-0218-2

19. Rogers T, Devraj M, Thomaides A, Steinvil A, Lipinski MJ, Buchanan KD et al. Utility of Invasive Electrophysiology Studies in Patients With Severe Aortic Stenosis Undergoing Transcatheter Aortic Valve Implantation. The American Journal of Cardiology. 2018;121(11):1351–7. DOI: 10.1016/j.amjcard.2018.02.015