The use of robotics in peripheral artery disease interventions

Despite significant advances in pharmacotherapy and device technology for percutaneous cardiovascular interventions, the fundamental technique of manually advancing intravascular devices at the patient’s table side while wearing heavy lead aprons in relative close proximity to the X-ray radiation source remains largely unchanged. The heavy lead apron worn by cardiovascular interventionalists is associated with orthopaedic complications, and concerns also exist regarding radiation-associated occupational hazards of the profession.¹ Recently, write Ali Pourdjabbar and Ehtisham Mahmud, the introduction of robotic systems and the ability to perform robotically-assisted percutaneous interventions have offered a solution: a reduction in operator radiation exposure and the elimination of the need for prolonged use of lead aprons. In addition to operator radiation reduction, efficacy and safety of an interventional robotic approach for percutaneous coronary intervention (PCI) has been demonstrated.^2,3

Percutaneous peripheral arterial interventions are performed in the same manner as PCI and as such, operators are exposed to similar occupational hazards. The Corpath 200 system (Corindus Vascular Robotics) and the Hansen system (Hansen Medical) are the two robotic systems available for treating peripheral arterial disease (PAD) with endovascular interventions. The Corpath 200 system consists of an articulating arm, robotic-drive, single-use sterile cassette and a remote lead-lined workstation cockpit containing the control console. The system received US Food and Drug Administration (FDA) approval for peripheral vascular interventions in March 2016 based on the results of the RAPID (Robotic-assisted peripheral interventions for peripheral artery disease) clinical trial; a prospective single-centre, feasibility study which enrolled patients with symptomatic PAD, affecting the femoropopliteal arterial segment.⁴ The objective of the study was to examine the Corpath robotic system’s performance at delivering guide wires and balloons to the identified lesions. A total of 20 patients with 29 lesions were enrolled, with 89.7% of the lesions involving the superficial femoral artery and 10.3% involving the popliteal artery. Technical success was defined as successful cannulation of the target vessel and clinical success was defined as <50% residual stenosis without unplanned switch to manual procedure and device related serious adverse events in the peri-procedural period. The study reported 100% technical and clinical success with provisional stenting required in 34.5% of the lesions. No significant adverse events related to the device were reported and both total procedure and fluoroscopy time were comparable to other studies with similar patient cohorts.

The Hansen medical robotic vascular system uses the Hansen vascular control catheter—a remotely controllable proprietary delivery catheter—to gain access to the lesion of interest after which standard equipment can be used to percutaneously treat the lesion of interest. In the study by Bismuth et al,⁵ 15 patients with 20 iliofemoral lesions were enrolled and underwent successful cannulation and treatment of all attempted lesions with no significant adverse events. Both of the above two studies demonstrate the feasibility of robotically assisted peripheral interventions, while also improving physician ergonomics, reducing operator radiation exposure and potentially improving procedural accuracy.

Infrapopliteal lesions accounts for a significant number of PAD cases treated percutaneously but were excluded from the above study designs. However, these lesions are ideal targets for robotic interventions due to the ergonomic challenges faced by the operator working around the aortoiliac bifurcation, and the size of the target vessels which are frequently appropriate for coronary equipment. The Hansen system requires a proprietary catheter but the standard 0.014-inch guidewires, coronary balloons and stents are all compatible with the Corpath 200 system. However, clinical evidence for the robotic management of these lesions is scarce. Our group recently reported the first case of percutaneous robotic intervention for below-the-knee PAD using the Corpath 200 system.⁶ We performed successful robotic balloon angioplasty on a 56-year-old man with a tibioperoneal trunk stenosis and proximal peroneal artery demonstrating the feasibility of this approach. Further data are required to fully evaluate the safety and efficacy of this technique in a larger sample of patients.

In conclusion, the use of robotic coronary and peripheral interventions represents an exciting and growing field within interventional cardiology and helps address the issue of occupational hazards. Emerging clinical evidence shows that robotic peripheral vascular intervention can be safely performed for iliac and femoropopliteal lesions. Furthermore, improvements in the robotic platform and systems including compatibility with 0.018- and 0.035-inch guidewires, over-the-wire balloon catheters, drug coated balloons and atherectomy devices will further expand the use of robotic technology for treating patients with PAD.

References

1. Klein LW, Tra Y, Garratt KN et al., Catheter Cardiovasc Interv 2015;86:913-24.
2. Weisz G, et al., J Am Coll Cardiol 2013;61:1596-600.
3. Mahmud E, et al., Catheter Cardiovasc Intv 2016;87:S88.
4. Mahmud E, et al., J Am Coll Cardiol Intv 2016 (in press)
5. Bismuth J, et al., J Vasc Surg 2013;57:14S-9S.
6. Behnamfar et al., J Invasive Cardiol 2016 (in press)

Ali Pourdjabbar and Ehtisham Mahmud are at the University of California San Diego, USA