Robotic-assisted PCI – insights from a monocenter registry

Abstract

Abstract 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. Purpose To investigate the success rate as well as the safety profile of robotic-assisted percutaneous coronary intervention (R-PCI) and compare it with manual PCI (M-PCI). Methods We report preliminary 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, long-term outcome (after 6, 12 and 24 months), as well as on economic aspects and the learning curve of the interventionalists. Moreover, the R-PCI is compared with the M-PCI in these categories. Results So far, 51 patients (age 69 (62–80) years, BMI 28.4 (25.2–32) kg/m2, 74.5% male), received R-PCI. PCI success rate was 100%, with 15% requiring manual assistance (Figure 1). Rate of complications (myocardial infarction after PCI, dissection, stent thrombosis, pericardial effusion, target lesion revascularization and MACE (major adverse cardiovascular events) was 0%. Compared with 41 M-PCI patients (Table 1), treated by the same interventionalists, there was a higher median procedural time (diagnostic and intervention) 106 (82–127) min vs. 71 (54–93) min (p<0.001) and fluoroscopy time 20.3 (14.8–28.5) min vs. 14.8 (10.4–22.4) min (p=0.012) in R-PCI patients. However, there was no significant difference between the dose-area product 4662.4 (3019.4–6399.2) cGy cm2 vs. 4193.9 (2759.9–6254.3) cGy cm2 (p=0.487) and contrast volume use 200 (150–280) ml vs. 180 (145–255) ml (p=0.587). 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. The dose-area product and contrast volume use were comparable between R-PCI and M-PCI, whereas R-PCI showed a longer procedural and fluoroscopy time. Future steps will include a larger number of cases and definitions of patient cases with optimal eligibility for R-PCI. Funding Acknowledgement Type of funding sources: None.