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

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.

Conclusions: 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.