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Randomized Controlled Trial
. 2025 Oct:79:71-77.
doi: 10.1016/j.carrev.2025.05.015. Epub 2025 May 15.

Anxiety during transcatheter aortic valve replacement under local anesthesia - the ART-VR trial

Sraman Chatterjee  1 , Joris Ooms  1 , Marjo de Ronde  1 , Stefan van Gorsel  1 , Antonio Maarten Mattace-Raso  1 , Jeannette Goudzwaard  2 , Francesco Mattace-Raso  2 , Isabella Kardys  1 , Rutger-Jan Nuis  1 , Joost Daemen  1 , Nicolas Van Mieghem  3
Affiliations
Free article
Randomized Controlled Trial

Anxiety during transcatheter aortic valve replacement under local anesthesia - the ART-VR trial

Sraman Chatterjee et al. Cardiovasc Revasc Med. 2025 Oct.
Free article

Abstract

Background: The use of local anesthesia during transcatheter aortic valve replacement (TAVR) could result in patient discomfort. Application of immersive virtual reality (VR) during TAVR might distract the patient and enhance the overall experience.

Objective: To evaluate the effect of an immersive VR environment on periprocedural anxiety and patient discomfort, compared to standard of care in patients undergoing transfemoral (TF) TAVR under local anesthesia.

Methods: In this single-center, randomized controlled pilot study, patients were randomized to either VR immersion during TAVR or standard of care. The intervention was a VR headset to create 3D experiences during percutaneous transfemoral TAVR. The main outcome was patient-reported procedural anxiety assessed directly after the procedure on a visual analog scale (VAS). Secondary outcomes were procedural satisfaction, pain, and change in anxiety. Personality scores were obtained at baseline to explore associations between personality types and relevant outcomes.

Results: A total of 75 patients (VR = 37, control = 38) were included between September 2021 and January 2023. The median age was 79 (25th-75th: 75-84) years and 32 patients (43 %) were female. Overall procedural anxiety VAS was 1.0 (0.0-3.0) and satisfaction was 9.0 (8.0-10.0). There was no difference in procedural anxiety between VR and control (VAS: 1.0 [25th-75th: 0.0-3.0] versus 1.0 [25th-75th: 0.0-3.0], p = 0.59). Procedural satisfaction, pain perception and change in anxiety were not affected by VR use.

Conclusion: Patients undergoing TF-TAVR under local anesthesia experienced mild procedural anxiety and high satisfaction levels. Procedural VR use did not affect procedural anxiety or pain perception.

Keywords: Anesthesia; Anxiety; Pain; TAVR; VR.

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Conflict of interest statement

Declaration of competing interest Rutger-Jan Nuis received research grant support from Vifor Pharma and Merill, and consulting fees from Edwards Lifesciences, Abbott, Boston Scientific. Marjo de Ronde received honoraria or consultation fees by Edwards Lifesciences: Edwards Valve Nurse Leadership program, Edwards Benchmark Program. This program aims to streamline TAVI pathways through implementation of nurse-led best practices, leading to better patient outcomes and experience. Joost Daemen received institutional grant/research support from Abbott Vascular, Boston Scientific, ACIST Medical, Medtronic, Pie Medical, and ReCor medical, and consultancy and speaker fees from Abbott Vascular, Abiomed, ACIST medical, Boston Scientific, Cardialysis BV, CardiacBooster, Kaminari Medical, ReCor Medical, PulseCath, Pie Medical, Sanofi, Siemens Health Care and Medtronic. Nicolas van Mieghem has received grant support/research contracts from Abbott Vascular, Boston Scientific, Medtronic, Edwards Lifesciences, Daiichi Sankyo, Astra Zeneca and PulseCath BV and has received consulting/speaker fees from Abbot Vascular, Boston Scientific Corporation, Medtronic, Daiichi Sankyo, PulseCath BV, JenaValve, and Amgen. All other authors declare to have no conflicts of interest.

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