Marlene Busko

May 09, 2016

ORLANDO, FL — In a single-center, single-operator study in 315 patients with mainly complex coronary lesions, robot-assisted PCI procedures using the CorPath 200 robotic device (Corindus, Waltham, MA) appeared as clinically and technically successful as manual PCI procedures[1]. Extending the use of this robotic procedure beyond simple cases to a broader range of more challenging ones could help limit radiation exposure and the orthopedic problems that affect PCI operators.

Dr Ehtisham Mahmud (University of California, San Diego School of Medicine) presented these findings from the Complex Robotically Assisted Percutaneous Coronary Intervention (CORA-PCI) trial in a late-breaking clinical-trial session and in a press briefing here at the Society for Cardiac Angiography and Interventions (SCAI) 2016 Scientific Sessions.

As previously reported, in 2012 the US Food and Drug Administration approved the use of this robotic device to assist interventional cardiologists in performing PCI, based on the PRECISE study. However, in that study, few lesions were complex ones, whereas the current study included all comers.

Dr Ehtisham Mahmud

"This trial definitively establishes [robot-assisted PCI] as an alternative to manual PCI and importantly now represents a viable option to arrest the orthopedic and radiation risks" for interventional cardiologists, Mahmud told the press.

In the robot-assisted procedure, operators sit in a lead-lined "cockpit" away from the radiation zone on the patient's bedside and use joysticks to control a robotic arm to place guidewires, stents, and balloons. "The primary advantages are for the operator, essentially eliminating not only the radiation risk but the potential for orthopedic injuries because you don't have to wear a lead vest and you're not standing up all day—those are clear advantages," Mahmud told heartwire from Medscape. Moreover, clinical outcomes are not compromised and the procedure is safe, he added.

This study showed that robot-assisted PCI is safe and effective "even in our most complex patients," session comoderator Dr Steven R Bailey (University of Texas Health Science Center, San Antonio) agreed, speaking with heartwire . Thus, the findings "set the stage for further development" of this first-generation device.

Can Robot Arms Be Used for Complex Cases?

"Anybody who is working in a cath lab for more than 15 years has fairly dramatic risks" of occupational hazards, including orthopedic illness (which is also common much earlier) as well as skin lesions, cataracts, and cancer, according to a recent study[2], Mahmud noted.

The PRECISE trial showed that robot-assisted PCI was successful and radiation to operators was reduced by 95%, but the lesions were relatively short and most were not type C[3].

The CORA-PCI trial hypothesized that robotic PCI could be performed safely and successfully in patients with complex coronary artery disease.

Over an 18-month period, 413 PCI procedures were performed at the researchers' center.

A total of 79 cases were excluded from the study since they were not technically possible with the robot-assisted procedure (eg, atherectomy, chronic total occlusion, or a planned two-stent strategy for a bifurcation lesion).

Mahmud performed 108 robotic-assisted PCI procedures where 157 lesions were treated, and 226 manual procedures where 336 lesions were treated.

The patients in both groups had similar baseline demographics; they had a mean age of 68, and 78% were men.

In 3% of patients, the target artery was the left main artery. Femoral access was used in 88% of patients.

On average, compared with patients in the manual–PCI group, those in the robotic-assisted-PCI group were more likely to have type B2 or type C lesions (81% vs 69%; P=0.02) and their primary lesions were longer (22.2 mm vs 19.4 mm; P=0.02)

The robotic-assisted procedure was clinically successful—that is, there was stent implantation with <30% stenosis, TIMI 3 flow, and no in-hospital major adverse cardiac events (MACE)—in patients who had robot-assisted or manual PCI (99.1% vs 99.6% of patients, respectively; P=0.64).

The rate of freedom from periprocedural MI was similar in the robotic-PCI and manual-PCI groups (94.4% vs 91.6%, respectively; P=0.32)

The robotic arm was temporarily disengaged in 11% of cases and permanently disengaged in 7.4% of cases, resulting in a technical success rate (where the procedure was completed robotically or with planned manual assistance) of 91.7%.

The procedure took longer in the robot-assisted group (44 min vs 36 min; P<0.01), which remained significant after adjustment for SYNTAX score, primary lesion length, and complexity (P=0.026). Both types of procedure used a similar number of stents (an average of 1.5), and fluoroscopy time, a surrogate for patient radiation exposure, was similar in both groups. Overall, the robotic procedure used less contrast media (183 mL vs 202 mL; P=0.03), but this difference disappeared in a propensity-matched analysis with 94 patients in each group.

The robot-assisted system and the visual screens provide very precise measurement of lesion length, Mahmud told heartwire .

The group is now conducting a detailed cost analysis. Apart from the cost of the equipment, the disposable cartridges used in each case cost about $600.

Mahmud is a consultant for and receives research support from Corindus, but the company did not fund this study.

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