First Case of Robotic Percutaneous Vascular Intervention for Below-the-Knee Peripheral Arterial Disease

Abstract: Although the feasibility and safety of robotically assisted peripheral vascular intervention (PVI) for iliac and femoral peripheral arterial disease (PAD) have been demonstrated, robotic PVI for below-the-knee disease has never been reported. We present the first description of robotic PVI with the CorPath Vascular Robotic System (Corindus) for treating below-the-knee PAD. After contralateral sheath placement in the affected lower extremity, the entire procedure was performed robotically with remote control of the guidewire and angioplasty balloon. This feasibility report provides the opportunity to initiate further studies specifically focused on robotic PVI for below-the-knee PAD.

J INVASIVE CARDIOL 2016;28(11):E128-E131

Key words: peripheral vascular intervention, robotic intervention, below-the knee, peripheral arterial disease

Despite significant advances in pharmacotherapy and device technology for percutaneous cardiovascular interventions, the fundamental technique of performing the procedure at the tableside remains largely unchanged. Recent reports have highlighted a number of potential long-term complications for interventionalists due to both radiation exposure and ergonomically ill-designed interventional suites. Robotic-assisted percutaneous coronary intervention (PCI) is safe, with outcomes comparable to standard manual interventional techniques, and is associated with significant reduction in radiation exposure.^1,2 Furthermore, because the procedure is performed while the operator is seated without wearing a heavy lead apron, there is a reduction in the orthopedic hazard for the operator. More recently, robotic-assisted peripheral vascular intervention (PVI) has also been shown to be safe and feasible, with promising results for lower-extremity peripheral arterial disease (PAD).^3,4

The CorPath 200 Vascular Robotic System (Corindus Vascular Robotics) is designed for remotely delivering and manipulating 0.014˝ guidewires and rapid-exchange balloon/stent catheters during coronary interventional procedures.¹ It consists of a tableside unit with an articulating arm, robotic-drive, and single-use sterile cassette, as well as a remote lead-lined workstation cockpit containing the control console and imaging monitors (Figure 1).

The feasibility and safety of the CorPath 200 Vascular Robotic System in remotely controlling the guidewires, balloons, and stents for superficial femoral artery (SFA) and popliteal artery intervention was demonstrated in the RAPID (Robotic-Assisted Peripheral Intervention for peripheral arterial Disease) study.⁴ This prospective single-arm trial enrolled 20 patients with symptomatic PAD requiring percutaneous transluminal angioplasty (PTA) of femoropopliteal vessels and reported 100% device and clinical success using this robotic system. However, the utility of any remote robotic platform for the treatment of below-the-knee PAD has never been investigated. Here, we report the first case of successfully treating below-the-knee arterial disease using the CorPath 200 Vascular Robotic System.

Case Presentation

A 56-year-old man with a history of hypertension, hyperlipidemia, prior coronary bypass surgery, and PAD with a prior left SFA stent developed Rutherford class 3 lifestyle-limiting claudication affecting both lower extremities. Despite an exercise program and maximally tolerated medical therapy including cilostazol 100 mg twice daily, he had recalcitrant symptoms predominantly affecting his right leg. Prior right lower-extremity angiography demonstrated a 70%-80% stenosis in the right tibioperoneal trunk with a widely patent peroneal artery but 100% occluded anterior tibialis and posterior tibialis arteries. He was thus scheduled for revascularization of the right lower extremity.

Retrograde left common femoral arterial access was obtained and a 6 Fr arterial sheath was inserted. Contralateral right iliac catheter placement using a 5 Fr Omni Flush (Cook) and a soft angled Terumo Glidewire (Terumo) to traverse the iliac horn was successful. With the Glidewire positioned within the right SFA, the Omni flush catheter was exchanged for an end-hole Glide catheter (Terumo), which was easily advanced over the Glidewire into the right SFA. At this point, the soft angled Glidewire was exchanged for a stiff angled Glidewire (Terumo), which was positioned within the proximal right SFA. The glide catheter and the short 6 Fr sheath were then removed and a 6 Fr, 65 cm Destination sheath (Terumo) was advanced over the stiff Glidewire into the right SFA. At this point, the Glidewire was removed and the sheath was connected to the tableside robotic drive using a Tuohy Borst system (Copilot Bleedback Control Valve; Abbott Vascular).

Second-order angiography of the right below-the-knee vessels confirmed that both the anterior tibialis and posterior tibialis were 100% occluded, while the tibioperoneal trunk had a 90% focal stenosis and the peroneal artery had an 80% proximal stenosis (Figure 2A). Bivalirudin was used as the anticoagulant, with a peak activated clotting time >300 seconds. The remaining aspects of the procedure were performed entirely robotically without manual sheath, balloon, or guidewire manipulation. Once connected to the robotic drive, a 300 cm, 0.014˝ BMW wire (Abbott Vascular) was advanced with the back-up support of a 3.0 x 20 mm Maverick rapid exchange (Rx) balloon (Boston Scientific) through the SFA and into the right peroneal artery. After fluoroscopic positioning, balloon angioplasty of the peroneal artery was performed with the balloon inflated to moderate pressure. The balloon was then pulled back into the tibioperoneal trunk, where additional balloon angioplasty was performed.

Follow-up angiography revealed a good angioplasty result, but with significant elastic recoil (Figure 2B). Therefore, additional balloon angioplasty using a 3.5 x 20 mm Maverick Rx balloon was performed robotically (Figure 2C). Final angiography was then performed, revealing angiographic improvement with <30% residual stenosis at both lesions without a flow-limiting dissection (Figure 2D). The BMW wire was then removed while the Destination sheath was disconnected from the robot and exchanged over a standard 0.035˝ J-wire for a short 6 Fr sheath. This was then removed with hemostasis achieved after deployment of a 6 Fr AngioSeal closure device (St. Jude Medical).

Discussion

This is the first reported case of successful percutaneous management of below-the-knee PAD using robotic-assisted balloon angioplasty. Using the CorPath Robotic System, this case demonstrates the ability to remotely cannulate and treat below-the-knee atherosclerotic disease with balloon angioplasty.

Vascular interventions in the catheterization laboratory are associated with occupational health hazards for the physician and the support staff, including radiation exposure and orthopedic complications such as neck and spine injuries resulting from wearing a heavy lead apron in non-ergonomic positions for long hours.^5-9 Robotic-assisted PVI allows lengthy interventional procedures to be performed remotely from a radiation-shielded work space where the operator is able to perform the procedure in a seated position without the need for a lead apron and free from radiation exposure. In addition to the aforementioned benefits, the use of robotics has the potential to improve the accuracy of lesion measurements and device selection for peripheral procedures compared with manual interventions in a similar manner to that demonstrated for PCI.^10-12

The evidence demonstrating the efficacy of robotically assisted revascularization is growing for PCI. Our group has recently reported on robotically assisted left main intervention and more recently we reported on the use of robotic intervention in complex PCI with similar clinical outcomes to manual PCI without any adverse effects.^13,14 The use of robotics in peripheral intervention is an emerging field, with recent reports demonstrating efficacy and safety of robotic PVI in the femoropopliteal and iliac vessels.^3,4 However, robotic PVI has never been reported for below-the-knee intervention.

The robotic system used in the current report is compatible with all commercially available 0.014˝ guidewires, rapid-exchange balloon catheters, and stent delivery systems.¹ Similar to coronary interventions, the same sized guidewires and angioplasty balloons/stents are commonly used in infrapopliteal intervention. Although below-the-knee PTA was successful in the current report, in a case with a flow-limiting dissection, a coronary drug-eluting stent could easily have been placed robotically as well.¹⁵ The use of robotic PVI should continue to increase, especially in below-the-knee intervention for which no additional iteration of the system is required. Further improvements in the robotic platform and system, including compatibility with 0.018˝ and 0.035˝ guidewires, over-the-wire balloon catheters, drug-coated balloons, and atherectomy devices, will only further expand the use of this technology for PVI. The PVI procedures are typically prolonged and associated with higher radiation exposure, with the operator frequently in ergonomically challenging positions especially when working around the iliac horn. Therefore, the potential benefit for robotically enhanced and facilitated PVI is greatest for the operator and warrants further investigation.

Conclusion

This is the first report demonstrating that robotic PVI can be safely and successfully performed for below-the-knee interventions. However, further clinical data are required to fully examine the safety and effectiveness of this technique in a larger sample of patients.

References

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From the Division of Cardiovascular Medicine, Sulpizio Cardiovascular Center, University of California, San Diego, California.

Disclosure: The authors have completed and returned the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr Mahmud reports consulting fees and research grant support from Corindus. The remaining authors report no conflicts of interest regarding the content herein.

Manuscript submitted June 22, 2016, and accepted July 1, 2016.

Address for correspondence: Ehtisham Mahmud, MD, FACC, FSCAI, Professor of Medicine/Cardiology, Chief, Cardiovascular Medicine, Director, Sulpizio Cardiovascular Center, University of California, 200 West Arbor Dr, San Diego, CA 92103. Email: emahmud@ucsd.edu