May 11, 2012 (Las Vegas, Nevada) — A new robotic-enhanced coronary intervention system could make coronary interventions safer and less taxing on interventionalists while improving the precision of the procedures, according to the lead investigator of the system's pivotal trial[1,2].

Here at the Society for Cardiovascular Angiography and Intervention (SCAI) 2012 Scientific Sessions, Dr Giora Weisz (Columbia University Medical Center, New York) presented results of the CorPath Percutaneous Robotically Enhanced Coronary Intervention Study (PRECISE), a 164-patient multicenter pivotal trial of the CorPath system (Corindus Vascular Robotics, Natick, MA).

Dr. Giora Weisz

CorPath includes a remote interventional cockpit from which the interventionalist controls a bedside disposable cassette holding all of the devices typically used in a coronary intervention. The operator can precisely advance, retract, and rotate guidewires and rapid-exchange catheters with two joysticks, as if the operator were using three hands, Weisz said. The operator monitors the procedure on three high-definition screens in the shielded cockpit. In a standard procedure, the monitors are on the other side of the operating table and are sometimes hard to watch from that distance, Weisz told heartwire .

In PRECISE, PCI was successfully completed in 162 of the 164 cases. In the other two cases, the operator had to finish the procedure manually, but Weisz told heartwire that this switch only took 30 seconds and did not cause any problems. There were no device-related complications, and clinical procedural success was achieved in 160/164 patients (97.6%). Four patients had had a periprocedural non-Q-wave MI, but there was no death, stroke, Q-wave MI, or need for revascularization within 30 days postprocedure.

Importantly, the median radiation exposure to the operator was 94.8% lower than the levels recorded during the standard procedures, where the operator stands next to the operating table.

CorPath system [Source: Corindus]

Weisz cited data showing that standing so long wearing lead shielding increases interventionalists' risk of spine problems, while the fatigue may compromise their decision-making ability. Also, the radiation exposure puts them at increased risk of cataracts and, perhaps, brain cancer.

"This is not just about the convenience of the operator, it is also for the patients. This [robotic system] is important because it brings a lot of stabilization and standardization to the procedure," Weisz told heartwire . He pointed out that longitudinal geographic miss with stents was near 50% in the 1500-patient STLLR study, and 10% to 20% of patients required a second stent because the first stent was inaccurately sized or placed. Wires and devices may slip, which prolongs procedures, leading to greater doses of radiation and contrast media.

Weisz said he and Corindus hope to eventually conduct a cost-effectiveness study showing that avoiding these additional procedures justifies the cost of the CorPath system. The company hasn't revealed the price yet because it is still waiting for the FDA to clear a 510(k) to allow it to be sold commercially in the US.

PRECISE enrolled relatively simple cases--patients with de novo stenosis ≥50% by visual estimate, under 25 mm long, in vessels 2.5 to 4 mm in diameter. Weisz said that "the next stage is for us to try this for 'all-comers,' not just those meeting these tight inclusion criteria. The more we do, the more we get better at it and can improve the system." He also suggested that this system could eventually be used for other percutaneous procedures such as transcatheter valve repair or replacement.

Interventionalists welcome robot help

Weisz said that the feedback he has received from interventionalists who have tried the CorPath system has been universally positive. "The learning curve is very short, about 45 minutes. Interventionalists already know how the devices behave and what to expect. Within two or three cases, they're experts."

SCAI 2012 program chair Dr Kenneth Rosenfield (Massachusetts General Hospital, Boston) asked Weisz, "How much do you think the absence of the tactile sensation will impact more complex cases [with this system]?" Weisz answered that his own experience shows that more complex procedures are possible with the CorPath and pointed out, "You actually do that every day, because when you work with your fellow and you don't touch the devices, you know when he's not doing well."

PRECISE is funded by Corindus. Weisz has no conflicts of interest.


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