Feasibility and safety of robotic PCI in China: first in man experience in Asia.

ABSTRACT

OBJECTIVES: To evaluate the feasibility and safety of a second generation robotic percutaneous coronary intervention (R-PCI) system in China. BACKGROUND: Robotic PCI has been shown to be an effective method for conducting coronary interventions. It has further benefits of more accurate lesion measurement, improved stent deployment, reduced incidence of geographic miss and reduction of operator radiation exposure. METHODS: This single center evaluation enrolled 10 consecutive patients who had been selected for PCI. Clinical success was defined as residual stenosis < 30% and no in-hospital major adverse cardiovascular events. Learning curve effect was assessed by comparing efficiency metrics of early vs. later cases. RESULTS: Eleven lesions were treated all successfully without manual interruption or MACE events. Most lesions (63%) were ACC/AHA class B2 and C. Mean procedure time was 57.7 ± 26.4 min, however two procedures were part of live demonstrations. Excluding the two live cases, the mean procedure time was 51.8 ± 23.7 min. Procedural efficiency tended to improve from early cases to later cases based on PCI time (48.3 ± 32.9 vs. 25.5 ± 13.0 min, P = 0.27), fluoroscopy time (20.3 ± 8.2 vs. 12.5 ± 4.6 min, P = 0.16), contrast volume (145.0 ± 28.9 vs. 102.5 ± 17.1 mL, P = 0.05) and Air Kerma dose (1932 ± 978 vs. 1007 ± 70 mGy, P = 0.31). CONCLUSIONS: Second generation robotic PCI was safe, effective and there were trends toward improvements in procedural efficiency during this early experience in China.