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'Cockpit'-Style Endovascular Tx OK for PAD

— Promising data from small, proof-of-concept study

Last Updated September 15, 2016
MedpageToday

Robotic assistance was safe and successful for percutaneous revascularization in patients with peripheral artery disease (PAD), the single-center RAPID (Robotic-Assisted Peripheral Intervention for peripheral arterial Disease) trial found.

All robotic-assisted peripheral vascular interventions were in the hands of three operators; , chief of cardiovascular medicine and director of the Interventional Cardiology and Cardiac Cath Lab at the University of California San Diego School of Medicine, and colleagues all achieved successful cannulation of the target vessel with less than 50% residual stenosis and no unplanned switching to manual intervention.

Action Points

  • Note that this small, single-center study demonstrated the safety and effectiveness of robot-assisted peripheral vascular interventions.
  • Be aware that there was no control group -- all patients studied had the robot-assisted intervention.

There were no device-related adverse events in the peri-procedural period, the team reported online in JACC: Cardiovascular Interventions.

"These data demonstrate the feasibility and safety of using a robotic-assisted platform for performing peripheral arterial revascularization," they wrote.

Provisional stenting was required in 34.5% of lesions, a figure comparable to that of manual revascularization procedures for the lower extremities, according to the authors' observations.

Fluoroscopy took 7.1 minutes on average with contrast use at 73.3 ml per session with their platform, the CorPath System (Corindus Vascular Robotics).

"Using the CorPath System for peripheral vascular intervention, the operator can perform the procedure in a seated position in a radiation-shielded cockpit," Mahmud and colleagues wrote. The "cockpit" houses two joysticks that the operator uses to control guidewires and catheters.

These features may be helpful for reducing the occupational hazards associated with interventional cardiology, such as radiation exposure as well as musculoskeletal pain/orthopedic injury from heavy lead aprons.

The PRECISE study previously showed similar high rates of technical and clinical success for the cockpit-style stenting of coronary lesions, noted , and , both of Brown University's Warren Alpert Medical School in Providence, R.I.

"Operator radiation exposure and orthopedic risk vary by procedure type and peripheral vascular intervention may pose even greater potential harm than percutaneous coronary intervention," they wrote in an .

"The authors are to be commended on the conduct of RAPID which serves as an important proof of concept study demonstrating the feasibility of robotically performed endovascular procedures. The view from 30,000 feet is favorable!"

Mahmud's group prospectively studied 20 patients with symptomatic PAD affecting the femoropopliteal artery (29 lesions in total). Rutherford class symptoms were class 2 or 3 in 90% of cases. The superficial femoral artery was the site of most targeted lesions (89.7%), which were 33.1 mm long on average.

The team commented that they did not assess operator radiation exposure in RAPID, although procedural and fluoroscopy times were comparable to historical controls.

Detailing the experience of a single high-volume tertiary care center, the report also begs the question of whether the results are applicable to other users. Furthermore, the authors acknowledged the small sample size and the participation of patients with relatively short lesions.

"It would be premature to extrapolate these findings to contemporary endovascular practice," wrote Aronow and Hyder. "Even upon demonstration of efficacy and safety in a broader cohort, questions will remain about the operator learning curve, and perhaps most importantly, cost-effectiveness."

In addition, the CorPath device was limited to commercially available rapid exchange balloon catheters. The investigators mentioned another robotic vascular system from Hansen Medical, one that has been successfully introduced in electrophysiology procedures to guide ablation -- albeit with a proprietary catheter that may have stunted its popularity.

Before CorPath can expand to more patients, it needs to become compatible with other devices -- namely, those used for atherectomy, reentry, and delivering drug-coated balloons and self-expanding stents, the researchers said.

"An iterative advance in the technology and future studies focusing on evaluating robotic-assisted peripheral vascular intervention outcomes in more complex patients and lesions are required. It is likely that a hybrid approach of manual and robotic-assisted peripheral vascular intervention could still result in substantive operator benefits with the current generation platform."

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    Nicole Lou is a reporter for ֱ, where she covers cardiology news and other developments in medicine.

Disclosures

The study was funded by Corindus Vascular Robotics.

Aronow and Hyder reported having no relevant relationships with industry.

Primary Source

JACC: Cardiovascular Interventions

Mahmud E, et al "Feasibility and safety of robotic peripheral vascular interventions: Results of the robotic-assisted peripheral intervention for peripheral artery disease (RAPID) trial" JACC Cardiovasc Interv 2016; DOI: 10.1016/j.jcin.2016.07.002.

Secondary Source

JACC: Cardiovascular Interventions

Aronow HD, Hyder ON "The future of endovascular therapy: A view from the cockpit" JACC Cardiovasc Interv 2016; DOI: 10.1016/j.jcin.2016.08.001.