Background: Depression is a relevant co-morbidity in cardiovascular patients with crucial impact for outcome and survival. This could be proven also for aortic stenosis patients (AS) undergoing transcatheter aortic valve implantation (TAVI). The benefit of psychological interventions has been rarely studied in cardiovascular patients but there is evidence that expectation optimizing approaches can be beneficial for outcomes after cardiac surgery. Since there is no trial focusing on depressive TAVI patients, we aimed to assess the impact of a peri-procedural psychological intervention in these special patient group addressing the question, whether a persisting decrease in depression symptoms can be achieved. Methods: In total, 74 AS patients treated by transfemoral TAVI and presented with a baseline Hospital Anxiety and Depression Scale (HADS-D) score ≥ 8 points for depression underwent 1:1 randomization. 38 patients were assigned to the control group, which was treated as usual (CON) and 36 to the intervention group, in which an expectation optimizing short-term psychological intervention protocol was carried out (INT). Primary outcome measure was the HADS-D value for depression 180 days after TAVI that was compared to baseline between the two groups using analysis of covariance. Among others, depression scores and quality of life (QoL) using the EQ5D5L questionnaire were further recorded in all patients until 12 months after TAVI. Results: The mean age of patients in the entire study cohort (n=74) was 81 ± 6 years, 49% were female and the mean STS score was 5.6 ± 3.7%. In the CON group (treatment as usual), there was a mean HADS-D depression value of 10.76 ± 2.77 at baseline and 9.44 ± 4.56 at day 180. In the INT group (peri-interventional psychological short-term intervention), there was a mean HADS-D depression value of 9.86 ± 2.0 at baseline and 7.5 ± 3.15 at day 180. There was no significant effect of the psychological intervention on depression dynamics at 180 days (estimate = -1.67; 95% CI: -3.64; -0.29; p=0.094). The percentage of patients improving in HADS-D depression score 6 months after TAVI was significantly higher in the INT (77%) compared to the control (53%) group (p=0.045). When comparing HADS-D depression scores at the different follow-up time points, there was a significant decrease both, in the CON and the INT group at the time of hospital discharge as compared to baseline (p<0.05), which was much more pronounced in the INT group (p=0.026). In addition, at 12 months after TAVI, there was a further reduction in HADS-D depression scores in the INT (p=0.089) but not in the CON (p=0.456) group with significant differences between the groups at 12 months (p=0.002). Regarding QoL, there were significant improvements 12 months after TAVI as compared to baseline in the INT (p=0.008) but not in the CON (p=0.792) group again with significant differences between the groups (p=0.013). Conclusions: Although we could not demonstrate a significant effect of a short-term psychological intervention on depression dynamics after TAVI according to protocol analysis, a clinically relevant benefit regarding both, improvement of depression and QoL, can be supposed. Further studies should be initiated comparing or combining psychological interventions with pharmacological treatment.
