von Zur Mühlen Constantin, Jeuck Marvin, Heidt Timo, Maulhardt Thomas, Hartikainen Tau, Supady Alexander, Hilgendorf Ingo, Wolf Dennis, Kaier Klaus, Westermann Dirk, Rilinger Jonathan
Department of Cardiology and Angiology, Faculty of Medicine, Heart Center Freiburg University, University of Freiburg, Hugstetterstr. 55, 79106, Freiburg, Germany.
Max Grundig Klinik, Bühl, Germany.
Clin Res Cardiol. 2024 Aug 21. doi: 10.1007/s00392-024-02524-0.
Robotic-assisted percutaneous coronary intervention (R-PCI) is a promising technology for optimizing the treatment of patients with coronary heart disease. For a better understanding of the potential of R-PCI in clinical routine compared to conventional manual PCI (M-PCI) both initial treatment success of the index procedure and long-term outcome have to be analysed.
Prospective evaluation from the FRiK (DRKS00023868) registry of all R-PCI cases with the CorPath GRX Cardiology by Siemens Healthineers and Corindus in the Freiburg University Heart Center between 04/2022 and 03/2023. Index procedure success and safety, radiation dose of patients and personnel, and 1-year outcome will be reported. Findings will be compared to a prospective control group of M-PCI patients treated by the same team of interventionalists during the same observation period.
Seventy patients received R-PCI and were included in the registry. PCI success rate was 100%, with 19% requiring manual assistance. No complications (MACE-major adverse cardiovascular events) occurred. Compared with 70 matched-pair M-PCI patients, there was a higher median procedural time (103 min vs. 67 min, p < 0.001) and fluoroscopy time (18 min vs. 15 min, p = 0.002), and more contrast volume was used (180 ml vs. 160 ml, p = 0.041) in R-PCI vs. M-PCI patients. However, there was no significant difference of the dose-area product (4062 vs. 3242 cGycm, p = 0.361). One year after the intervention, there was no difference in mortality, rehospitalisation, unscheduled PCI or target vessel failure. Health-related quality of life evaluation 6 and 12 months after the index procedure (NYHA, CCS, SAQ7 and EQ-5D-5L) was similar in both groups.
R-PCI is feasible and safe. Compared to M-PCI, index procedure success rate is high, safety profile is favourable, and manual assistance was required in only few cases. At 1-year follow-up results for R-PCI vs. M-PCI considering mortality, rehospitalisation, morbidity and target vessel failure were equal.
机器人辅助经皮冠状动脉介入治疗（R-PCI）是一种优化冠心病患者治疗的有前景的技术。为了更好地理解与传统手动PCI（M-PCI）相比，R-PCI在临床常规应用中的潜力，必须分析首次治疗的成功率和长期预后。
对2022年4月至2023年3月期间在弗莱堡大学心脏中心使用西门子医疗和Corindus公司的CorPath GRX心脏系统进行的所有R-PCI病例进行FRiK（DRKS00023868）注册研究的前瞻性评估。将报告首次治疗的成功率和安全性、患者及工作人员的辐射剂量以及1年的预后情况。研究结果将与同一介入治疗团队在同一观察期内治疗的M-PCI患者的前瞻性对照组进行比较。
70例患者接受了R-PCI并被纳入注册研究。PCI成功率为100%，其中19%需要手动辅助。未发生并发症（主要不良心血管事件，MACE）。与70例配对的M-PCI患者相比，R-PCI患者的手术时间中位数更长（103分钟对67分钟，p<0.001）、透视时间更长（18分钟对15分钟，p=0.002），使用的造影剂体积更多（180毫升对160毫升，p=0.041）。然而，剂量面积乘积无显著差异（4062对3242 cGycm，p=0.361）。干预1年后，两组在死亡率、再次住院、非计划PCI或靶血管失败方面无差异。两组在首次治疗后6个月和12个月的健康相关生活质量评估（纽约心脏协会分级、加拿大心血管学会分级、SAQ7和EQ-5D-5L）相似。
R-PCI是可行且安全的。与M-PCI相比，首次治疗成功率高，安全性良好，仅少数病例需要手动辅助。在1年随访中，考虑死亡率、再次住院、发病率和靶血管失败情况，R-PCI与M-PCI的结果相当。
