Background: Anxiety is a certain co-morbidity of patients with severe symptomatic aortic stenosis (AS) undergoing transcatheter aortic valve implantation (TAVI). The reduction of pre-procedural anxiety is beneficial for patients’ well-being and potentially outcome. The COMTAVI study was aimed to answer the question, whether a medical graphic narrative as an additional component of the informed consent (IC) procedure is beneficial in TAVI patients showing pathologic levels for anxiety. Methods: A cohort of 95 anxious patients (defined by ≥ 8 points for anxiety in the Hospital Anxiety and Depression Scale, HADS-D) with severe AS undergoing transfemoral TAVI at the University Hospital Jena were included in this prospective randomized trial. Patients underwent randomization into a standard IC (control) and a standard IC plus comic (comic) group. The comic tells the journey of a TAVI patient from admission to discharge. The level of situational anxiety was assessed using the Short STAI-Y (state) Anxiety Scale (STAI-Y) at baseline (admission) and at the day prior to TAVI (before TAVI). Per protocol, the STAI-Y value for anxiety before TAVI was defined as primary outcome of the study and compared to admission between the control and the comic group by using analysis of covariance (ANCOVA). A p value < 0.05 was defined as statistically significant difference. Results: The mean age of patients in this anxious TAVI cohort (n=95) was 82 ± 6 years, 60% were female and the mean STS score was 5.1 ± 3.9%. 48 patients were randomized into the comic and 47 into the control group. The majority of clinical baseline characteristics did not show significant differences between the groups. Regarding primary outcome measure, situational anxiety revealed a mean STAI-Y score of 41.6 ± 12.1 at admission and 40.1 ± 12.1 before TAVI in the control group. In the comic group, mean STAI-Y was 40.21 ± 10.6 at admission and 37.3 ± 12.5 before TAVI. There was no significant effect of a standard IC plus comic on situational anxiety before TAVI compared to admission (estimate = -1.89; 95% CI: -5.77; 1.99; p=0.336). The percentage of patients that improved with respect to pre-procedural anxiety was 47% (n=22) in the control and 58% (n=28) in the comic group (p=0.263). When comparing the results of the randomized trial to a real-world collective (n=20), there were no significant differences in situational anxiety at admission. Interestingly, after the IC procedure, the real-word-group showed highest levels of anxiety (46.0 ± 13.1) with relevant differences to both, the control (p=0.084) and the comic group (p=0.011). Conclusions: In anxious TAVI patients, the addition of a medical graphic narrative to support understanding of the IC procedure did not lead to a significant reduction of pre-procedural (situational) anxiety. One could speculate, first, that TAVI patients, who are typically elderly and frail, are less accessible to a medical graphic narrative compared to younger patients; and second, that standard IC procedure in this randomized trial has been performed much more thorough compared to daily clinical practice.
