Safety and effectiveness of introducing a robotic-assisted percutaneous coronary intervention program in a tertiary center: a prospective study

Abstract

Background: Robotic-assisted percutaneous coronary intervention (PCI) is a novel technology that permits remote operation of interventional devices. However, little is known about the safety and effectiveness of introducing a robotic PCI program in a hospital already experienced in traditional coronary angioplasty.

Methods: Prospective single-arm survey to assess the safety and effectiveness of robotic-assisted PCI in comparison to pre-defined performance goals. The study cohort comprised all consecutive cases treated with robotic PCI since its introduction. The safety primary endpoint was a composite of (I) overall death or (II) non-fatal adverse events related to target vessel complications (stent thrombosis, myocardial infarction, vessel perforation or cardiac tamponade, or repeat invasive treatment) during the index hospitalization. The efficacy primary endpoint was robotic-assisted procedural success, a composite of (I) successful dilatation of the target lesion and (II) successful robotic assistance, defined as absent non-planned manual conversion.

Results: A total of 83 patients and 112 lesions were prospectively enrolled. The rate of angiographic success was 99.1%. From these, 97 lesions (86.6%) were treated with only robotic PCI or with hybrid according to the pre-interventional plan. The rates of efficacy and safety primary endpoints were 85.7% and 2.4% respectively (P<0.01 for non-inferior to the pre-defined performance threshold).

Conclusions: Introduction of robotic-assisted PCI in a tertiary center was associated with safe and effective results, comparable to pre-defined goals of optimal performance.

Keywords: Coronary; angioplasty; noninferiority; robotics; stent.

Figure 1

Overview of the two modules of the CorPath GRX Robotic System (Corindus, A Siemens Healthineers Company, Waltham, MA, USA). (A) Control cockpit, from which the interventionalist operates the interventional devices through joysticks and a computerized touchscreen. Note that the operator performs the procedure sitting and unscrubbed outside of the suite, while having full view of the navigation, imaging, and other important patient, as well as maintaining visual contact with the inside space, through the cath lab leaded glass window. (B) The robotic arm itself, located at tableside, which houses a sterile single-use cassette that provides the interface for insertion of the interventional devices.

Figure 2

Safety and efficacy primary endpoints. Observed rates of efficacy (A) and safety (B) primary endpoints are represented by the black horizontal bars. Error bars (red) represent 95% confidence limits, and the dotted black line indicates the pre-defined performance goals (12% for the safety and 70% for the efficacy primary endpoints respectively). Note that error bars of safety and efficacy do not cross the dotted black lines indicating the performance goals (P<0.01 for noninferiority, for both endpoints).