1Universitäts-Herzzentrum Freiburg - Bad Krozingen Klinik für Kardiologie und Angiologie Freiburg im Breisgau, Deutschland
Methods: We report twelve-month follow up data of our prospective FRiK registry, started in mid 2021. This registry focuses on success rates and safety, radiation dose of patients and personnel as well as long-term outcome (after 6, 12 and 24 months). Moreover, R-PCI is compared with M-PCI in these categories.
Results: 70 patients received R-PCI. PCI success rate was 100%, with 18.6% requiring manual assistance. Rate of complications (MACE - major adverse cardiovascular events) was 0%. Compared with 136 M-PCI patients, treated by the same interventionalists, there was a higher median procedural time (diagnostic and intervention) 102.5 (82.8-123.5) min vs. 74 (52.3-105.8) (p<0.001) and fluoroscopy time 18.3 (14.4-26.6) min vs. 16.4 (9.8-24.9) min (p=0.037) in R-PCI patients. However, there was no significant difference between the dose-area product 4061.9 (2336.7-5989.6) cGycm² vs. 3771 (2236.9-6184.7) cGycm² (p=0.878) and contrast volume use 180 (140-250) ml vs. 180 (130-230) ml (p=0.370).
Twelve months after the intervention, all patients in both groups were alive. R-PCI and M-PCI had comparable rates of rehospitalisation (14.9% vs. 14.1%, p=0.903) and repeat PCI (6.4% vs. 4.7%, p=0.932, figure 1). Target vessel failure occurred in both the R-PCI and M-PCI groups in one patient (2.1% vs. 1.2%, p=0.932).
Health-related quality of life evaluation 12 months after the primary PCI showed a comparable NYHA score (1 (1-2) vs. 1 (1-2), p=0.173) and no differences in the overall EuroQoL 5D (EQ-5D-5L), nor in the subcategories.
Conclusion: R-PCI showed a high success rate, low rates for need of manual assistance, and a very high safety profile without any complications. Also at 12-month follow-up, R-PCI was comparable to the M-PCI in all categories.
Figure 1. Comparison of twelve-month outcome of Robotic assisted PCI (R-PCI, n= 47) with manual PCI (M-PCI, n=85).