Author + information
- 1University of California San Diego, La Jolla, California, United States
- 2University of California, San Diego, San Diego, California, United States
- 3UC San Diego School of Medicine, La Jolla, California, United States
- 4VA San Diego Healthcare System and University of California San Diego, La Jolla, California, United States
The first generation CorPath 200 robotic-assisted system for PCI is safe and effective but is limited by the lack of robotic guide catheter control. The second generation robotic-assisted system CorPath GRX (Corindus, Waltham, MA) enables robotic guide catheter manipulation in addition to guidewire control, and balloon/stent delivery. The goal of this study was to evaluate the safety and efficacy of this device for percutaneous coronary intervention (PCI).
Consecutive patients with demonstrated obstructive coronary artery disease (>70% stenosis) and clinical indications for PCI were treated with the CorPath GRX system and enrolled in the study. The two co-primary endpoints were clinical procedural success (final TIMI 3 flow, and <30% residual stenosis without in-hospital major adverse cardiac event) and device technical success (robotic clinical procedural success without the need for unplanned manual assistance/conversion).
The study enrolled 40 subjects (65.7 ±11.9 years; 72.5% male) with a high prevalence of hypertension (55%), diabetes (35%), dyslipidemia (82.5%), previous MI (47.5%) and history of PCI (52.5%). Subjects underwent robotic PCI for stable ischemic heart disease (70%), acute coronary syndrome (17.5%) or for LV dysfunction and complete revascularization (12.5%). A total of 53 lesions were treated robotically with the majority being complex (77.3% ACC/AHA type B2/C) (Table). Clinical procedural success and device technical success were 97.5 % (n=39 of 40) and 90.0 % (n= 36 of 40) respectively. The single clinical failure was a chronic total occlusion treated manually with antegrade wire escalation 2 weeks later. The three technical failures were due to bailout atherectomy (n=1), inadequate guidewire tip control to navigate a tortuous vessel (n=1), and an inability to advance a stent robotically through the side strut of a previously placed stent (n=1).
|ACC/AHA type A B1 B2 C||1 (1.9) 11 (20.8) 8 (15.1) 33 (62.2)|
|Primary lesion length (mm)||19.0±9.5|
|Primary lesion stenosis (%) Pre Post||82.7±9.9 0.6±4.1|
|Stents deployed per case (#)||1.57±0.90|
|Lesions treated per case (#)||1.32±0.65|
|Vessel treated LAD RCA LCx||26 (49.0) 10 (32.0) 17 (18.9)|
|Procedure time (min)||40.7 +/- 21.6|
|Procedural radiation exposure Fluoroscopy time (min): Dose area product time (cGy/cm2)||17.6 +/- 5.7 7162 +/- 5424|
|Contrast volume (mL)||172 +/- 65.1|
|Access site Radial Femoral||26 (65.0) 14 (35.0)|
The second generation CorPath GRX system for robotic-assisted PCI is safe, effective and achieves high rates of clinical and technical success in a cohort of patients with complex coronary disease.
OTHER: Pre-Clinical/First In-Human Studies