Abstract 424 Six-month outcome of Robotic assisted PCI – the Freiburg Robotics in Interventional Cardiology (FRiK) Registry

Clin Res Cardiol (2023). https://doi.org/10.1007/s00392-023-02180-w
Six-month outcome of Robotic assisted PCI – the Freiburg Robotics in Interventional Cardiology (FRiK) Registry
J. Rilinger¹, M. Jeuck¹, T. Heidt¹, D. Westermann², C. von zur Mühlen³
¹Klinik für Kardiologie und Angiologie I, Universitäts-Herzzentrum Freiburg - Bad Krozingen, Freiburg im Breisgau; ²Innere Medizin III, Kardiologie und Angiologie, Universitäts-Herzzentrum Freiburg - Bad Krozingen, Freiburg im Breisgau; ³Innere Medizin III, Kardiologie und Angiologie, Albert- Ludwigs-Universität Freiburg, Freiburg im Breisgau;
Background: Robotics in interventional cardiology is a rapidly evolving technique, which is still in an early phase of development and clinical application. Beside the pivotal studies, there is limited real world data on success rates and safety of this new technology, especially in the post-inpatient follow up. Methods: We report six-month follow up data of our ongoing, 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, the Robotic assisted PCI (R-PCI) is compared with the manual PCI (M-PCI) in these categories. Results: So far, 65 patients received R-PCI. PCI success rate was 100%, with 18.5% requiring manual assistance. Rate of complications (MACE - major adverse cardiovascular events) was 0%. Compared with 118 M-PCI patients, treated by the same interventionalists, there was a higher median procedural time (diagnostic and intervention) 104 (82.5-125) min vs. 74 (53.8-101.3) min (p<0.001) and fluoroscopy time 18.8 (14.5-28.5) min vs. 16.2 (10.2-23.8) min (p=0.030) in R-PCI patients. However, there was no significant difference between the dose-area product 4106.1 (2405-6001.5) cGycm² vs. 3789.3 (2254-6327.2) cGycm² (p=0.974) and contrast volume use 180 (150-250) ml vs. 180 (140-240) ml (p=0.475). Six months after the intervention, all patients in both groups were alive. R-PCI and M-PCI had comparable rates of rehospitalisation (29.5% vs. 35.4%, p=0.506) and unscheduled repeat coronary angiography (4.5% vs. 6.3%, p=0.483, figure 1). Target vessel failure occurred in both the R-PCI and M-PCI groups in one patient (2.8% vs. 1.2%, p=0.853). Health-related quality of life evaluation 6 months after the primary PCI showed a comparable NYHA score (1.5 (1-2) vs. 1 (1-2), p=0.083) and no differences in the overall EuroQoL 5D (EQ-5D-5L), nor in the subcategories. Conclusion: Preliminary results of R-PCI showed a high success rate, low rates for need of manual assistance, and a very high safety profile without any complications. These positive periprocedural results continued in the 6-month follow-up. Figure 1. Comparison of six-month outcome of Robotic assisted PCI (R-PCI, n= 44) with manual PCI (M-PCI, n=79).
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