Background: Periprocedural anxiety and reduced patient comprehension of Informed Consent (IC)-related aspects may pose significant obstacles to the shared decision process when preparing patients for transcatheter aortic valve implantation (TAVI), especially in elderly patients suffering from impaired cognitive function.

Purpose: To evaluate the effects of the current standard patient IC practice and potential benefits of additionally using an information brochure containing medical graphic narratives to inform patients about the planned TAVI procedure.

Methods: In this prospective, randomized, controlled, multicenter study, 303 patients scheduled for TAVI were randomized to the usual IC procedure (written IC sheet and conversation with a physician) + placebo (hospital information brochure; Control group) or to a group that received medical graphics in addition to standard care (Comic group). The information brochure was designed in collaboration with scientific illustrators; it narratively illustrates important procedural details, risks, treatment alternatives and behavioural measures in close reference to the official written patient information sheet. Cognitive function was assessed using the Montreal Cognitive Assessment (MoCA). Patient comprehension was tested using a self-designed questionnaire consisting of 14 simple questions covering central IC-related aspects. Differences between groups were analyzed using the Welch two sample t-test. The effect of cognitive status on patient comprehension was assessed using Analysis of Variance (ANOVA). Peri-procedural anxiety was tested before and after the IC using the validated Spielberger State Trait Anxiety Inventory (STAI). A mixed ANOVA with time point as within subject factor including IC method and sex, or cognitive status, respectively, as fixed between factors and trait anxiety as a covariate was used to analyze state anxiety across time points. Patient satisfaction was assessed by using the validated Client Satisfaction Questionnaire-8 (CSQ-8).

Results: 138 (45.5%) of patients showed mild, 28 (9.3%) moderate or severe cognitive dysfunction according to the MoCA classification. Patient understanding markedly decreased with declining cognitive function in the Control group while this effect was significantly mitigated in patients of the Comic group (correct answers in 92.9% vs. 85.6%; 90.1% vs. 79.7%; and 88.9% vs. 69.3% in no; mild; and ≥moderate cognitive dysfunction in the Comic vs. Control group, respectively; p<0.001). Compared to baseline state anxiety, patient anxiety after the IC procedure significantly decreased in the Comic group but not in the Control group [mean baseline STAI 41.1 (±5.0) in Comic vs. 40.3 (±5.8) in Comic (p=n.s.); mean STAI decline -5.75 vs. -0.75 in the Comic and Control group, respectively (p<0.001)]; this effect was exclusively attributable to the IC method applied, and not to sex or cognitive status. Patient satisfaction with the IC procedure was significantly higher in the Comic group [CSQ-8 score 28.5 vs. 25.2 (95% CI 2.8 to 3.7); p<0.001].

Conclusions: Patient comprehension of important IC-related aspects was significantly improved by using medical graphic narratives to assist the IC procedure, especially in patients with cognitive dysfunction. Integrating medical graphics into the IC procedure entails significant beneficial effects on periprocedural anxiety and patient satisfaction, independent of cognitive status or patient sex.