Informed consent procedure supplemented by a medical graphic narrative in anxious TAVI patients: unexpected effects at follow-up

Background and aims:Anxiety as relevant mental comorbidity in cardiovascular diseases was supposed to have a negative impact on patients’ well-being and peri-procedural outcomes. In aortic stenosis patients undergoing transcatheter aortic valve implantation (TAVI) and preexisting anxiety measured by the Hospital Anxiety and Depression Scale (HADS-D), the COMTAVI study aimed to elucidate the impact of a medical graphic narrative, which is telling the journey of a TAVI patient, in addition to the standard informed consent (IC) procedure. While the primary endpoint was the level of situational anxiety prior to TAVI, the reassessment of persisting anxiety at mid-term follow-up as secondary endpoint was the aim of this sub-study.

Methods: In the prospective randomized COMTAVI study, 95 patients with preexisting anxiety as defined by ≥ 8 points in the Hospital Anxiety and Depression Scale (HADS-D), were included. All patients suffered from severe AS and underwent transfemoral TAVI at the University Hospital Jena. Patients were randomized at baseline into a standard IC (control) and a standard IC plus comic (comic) group. Important secondary endpoints were persisting relevant anxiety and its dynamics 6 weeks after TAVI measured by HADS-D.

Results: The majority of baseline characteristics of the patients (mean age: 82 ± 6 years, 60% female and mean STS score 5.1 ± 3.9%) did not differ significantly between control group (n=47) and comic group (n=48). HADS-D for anxiety was 9.7 ± 2.0 at baseline in the entire collective (n=95) without significant differences between the study groups (p=0.691). There was a significant decrease in anxiety 6 weeks after TAVI (7.2 ± 3.6, p<0.001) in all patients. When comparing the level of anxiety 6 weeks after TAVI between the two study groups, HADS-D anxiety was significantly lower in the control group (6.5 ± 4.4) compared to the comic group (7.8 ± 2.7, p=0.039). With respect to anxiety dynamics, there was a significant decline 6 weeks after TAVI in both, the control group (9.7 ± 1.9 versus 6.5 ± 4.4, p<0.001) and the comic group (9.7 ± 2.1 versus 7.8 ± 2.7, p<0.001).  

Conclusions: As already known from recent studies, anxiety as relevant comorbidity in AS patients significantly improves 6 weeks after TAVI. There were no additional effects in anxiety reduction as measured by HADS-D when adding a medical graphic narrative to the IC procedure. Although there was a significant reduction of anxiety in both study groups at follow-up compared to baseline, surprisingly, the absolute levels of anxiety were even lower in control patients not receiving the comic.