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LAS VEGAS -- A remote controlled robotic system can safely and effectively guide implantation of coronary stents, a pivotal study found.

Of the 162 procedures, physicians needed to convert to manual implantation in only two instances, and the fault was not that of the robotic system, said Giora Weisz, MD, Columbia University Medical Center in New York City.

The remote interventional cockpit also reduced operator radiation exposure by 95% (P<0.0001), Weisz reported here at the Society for Cardiovascular Angiography and Interventions meeting during a late-breaking clinical trial session.

Weisz explained that the robotic device (CorPath 200) offered stability and accuracy, which he said improved patient safety, required less contrast, and used fewer stents.

"A second stent is required in 10% to 20% of patients because of inaccurate placement or size of the first stent," he said.

He cited a study that showed the increasing cases of neck and spine injuries to interventional cardiologists after wearing heavy lead aprons for 20-plus years. The robotic device allows them to shed the lead.

In addition, a study demonstrated that interventional cardiologists develop posterior lens cataracts at an earlier age and with higher frequency than the general population.

A report in the March issue of EuroIntervention detailed four new cases of left-sided brain malignancies in interventional clinicians. Previously, five cases of brain tumors had been documented in interventionalists, two of them on the left side. The location of the other three tumors was unconfirmed.

In the current study called PRECISE (CorPath Percutaneous Robotically-Enhance Coronary Intervention Study), researchers enrolled 164 patients at nine sites. Lesions had to be 24 mm or less in length, able to be covered by one stent with 2 mm margins, and with a reference vessel diameter of 2.5 to 4 mm.

The mean age of patients was 64 and three-quarters of them were men. Most of the patients had hypertension, hyperlipidemia, and a prior PCI. One-third had diabetes, half had a prior MI, and 17% had peripheral artery disease.

The primary endpoint was clinical procedural success defined as less than 30% residual stenosis in the target lesion at the completion of the procedure, and the absence of MACE at 48 hours post index procedure or at hospital discharge, whichever occurs first. The overall procedure success rate was 97.6 percent.

Technical success was defined as completing a procedure without the need to convert to manual operation. PCI was successfully completed without having to convert to manual PCI in 98.8% of patients, without device-related complications.

There were no inhospital deaths, Q-wave MIs, or revascularizations. However, there were four non-Q-wave MIs. At 30 days, there were no additional major adverse events.

The mean robotic procedure duration was 24 minutes, mean fluoroscopy duration was 11 minutes, and the mean contrast volume used was 144 mL.

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