Cutting Edge

Robotic-assisted angioplasty: A new era in intervention

by Andrew Cassar, MD, MRCP, and Amir Lerman, MD, FACC

Several advances in interventional cardiology have been implemented since Andreas Gruentzig performed the first angioplasty in 1977. Despite this, current percutaneous coronary intervention still presents multiple potential hazards to patients as well as cardiac interventionalists, such as radiation exposure.

A remote-controlled, robotic-assisted angioplasty system (CorPath 200, Corindus) was developed to address some of the procedural challenges and occupational hazards associated with traditional PCI. The CorPath 200 system allows controlled, robotic-assisted placement of coronary guidewires and stent/balloon catheters from an ergonomically optimized interventional cockpit (Figure 1). System installation is easy and fast, taking about 10 minutes, and includes an articulating-arm that mounts on the patient’s bed rail, with a robotic drive and single-use sterile cassette that houses commercially available guidewire and stent/balloon catheters (Figures 1 and 2).

Andrew Cassar
Andrew Cassar

The robotic system is an open-architecture system compatible with standard catheterization laboratory hardware and imaging systems. The mobile lead-lined cockpit protects the operator from radiation exposure. The system has a short physician learning curve due to a simple touch screen interface; its designated joysticks at the control console allow for manipulation of the guidewire with the right hand and the balloon/stent catheter with the left hand. An automatic contrast media injector push button connected to the power injector may also be used from the cockpit.

Advantages in practice

The ultimate goal of this robotic-assisted PCI system is to benefit patients, interventional cardiologists and hospitals by improving standardization, reproducibility and precision. Procedural advantages include: high precision with discrete and controlled linear movements (in 1-mm increments) of the guidewire and balloon/stent and rotational movements (in 30 degree increments) of the guidewire; and improved stability of the Y-connector and guide catheter, as well as locking of the wire and balloon/stent during device deployment. Moreover, precise measurements of lesion length may be achieved that is unrelated to angiographic view and not affected by foreshortening.

Figure 1. The CorPath 200 system in the cath lab: the bedside unit mounted on a bedrail, and the interventional cockpit

Figure 1. The CorPath 200 system in the cath lab: the bedside unit mounted on a bedrail, and the interventional cockpit is positioned at the foot of the procedure table.

Images: Andrew Cassar, MD

In the first-in-human robotic-assisted angioplasty study on eight patients, which was recently published, the technical success of the robotic system for type A or B1 lesions was 97.9%. There were no device- or procedure-related complications and no in-hospital or 30-day major adverse cardiac events. The operators rated the robotic system performances as equal to or better than manual procedures in 97.5% of the cases.

Amir Lerman
Amir Lerman

Theoretical advantages to the patient include shorter procedure times with less radiation exposure and less use of contrast. Also, if precision and accuracy of stent placement decrease longitudinal geographic miss, which was reported in 47.6% of cases in one study, there may be improved long-term outcomes reguarding target vessel revascularization or MI. Similarly, the need to use a second stent may diminish. These hypothetical advantages, however, need to be confirmed in large controlled studies.

The advantage for the physician is the ability to work in an optimal ergonomic and safer environment. The comfortable seated position of the interventionalist in front of the “slaved” monitors provides enhanced visualization of the angiography screen while reducing fatigue and minimizing neck, back and leg strain since lead aprons do not need to be worn. Back injuries are extremely common among long-standing interventional cardiologists and prevention of work-related injury would be most welcome. Radiation exposure is of significant concern to interventional cardiologists and the supporting staff, as the prevalence of radiation-induced posterior-lens opacities was shown to be 52%, and cumulative radiation doses may increase the risk of stochastic cancer after many years in the catheterization laboratory. The operator radiation exposure was found to be 97% lower when using the robotic-assisted system compared with levels found at the standard table position.

Figure 2. Illustration of loading the single-use cassette with a guidewire.

Figure 2. Illustration of loading the single-use cassette with a guidewire.

Hospitals may also benefit from using robotic-assisted PCI. The novelty may attract both physicians and patients alike and, if large trials demonstrate increased efficiency, it may improve cost savings.

Future for robotic-assisted PCI

Potential future enhancements that come to mind for the CorPath system include manipulation of guide catheters; self-loading of wires and stents; increased tactile sense of guidewire tip (with a strain or pressure gauge); and adaptation to other interventions performed in the cath lab, such as structural heart disease cases.

The attractiveness to interventionalists is evident, but large studies are required to confirm the safety and efficacy of the CorPath in humans before it is ready for primetime. The CorPath Percutaneous Robotic-Enhanced Coronary Intervention Study (PRECISE) is designed to evaluate procedural success and major adverse cardiac events in a prospective, single arm, multicenter study, which is currently enrolling patients (100 enrolled with a plan for 175) and should be finalized by the end of 2011. Moreover, the concept and the ability to perform robotic-assisted procedures may be extended in the future to improve acute care for patients in remote sites and has the potential to revolutionize the way we perform PCI.

References:
  • Bashore TM. Am Heart J. 2004;147:375-378.

  • Ciraj-Bjelac O. Catheter Cardiovasc Interv. 2010;76:826-834.

  • Costa MA. Am J Cardiol. 2008;101:1704-1711.

  • Goldstein JA. Catheter Cardiovasc Interv. 2004;63:407-411.

  • Granada JF. J Am Coll Cardiol Cardiovasc Interv. 2011;4:460-465.

  • Klein LW. Catheter Cardiovasc Interv. 2009;73:432-438.

Andrew Cassar, MD, MRCP, is a third-year fellow of cardiovascular medicine at the Mayo Clinic, Rochester, Minn.; Amir Lerman MD, FACC, is a professor of medicine with the Division of Cardiovascular Diseases, Mayo Clinic.

Disclosure: Drs. Cassar and Lerman report no relevant financial disclosures.

Several advances in interventional cardiology have been implemented since Andreas Gruentzig performed the first angioplasty in 1977. Despite this, current percutaneous coronary intervention still presents multiple potential hazards to patients as well as cardiac interventionalists, such as radiation exposure.

A remote-controlled, robotic-assisted angioplasty system (CorPath 200, Corindus) was developed to address some of the procedural challenges and occupational hazards associated with traditional PCI. The CorPath 200 system allows controlled, robotic-assisted placement of coronary guidewires and stent/balloon catheters from an ergonomically optimized interventional cockpit (Figure 1). System installation is easy and fast, taking about 10 minutes, and includes an articulating-arm that mounts on the patient’s bed rail, with a robotic drive and single-use sterile cassette that houses commercially available guidewire and stent/balloon catheters (Figures 1 and 2).

Andrew Cassar
Andrew Cassar

The robotic system is an open-architecture system compatible with standard catheterization laboratory hardware and imaging systems. The mobile lead-lined cockpit protects the operator from radiation exposure. The system has a short physician learning curve due to a simple touch screen interface; its designated joysticks at the control console allow for manipulation of the guidewire with the right hand and the balloon/stent catheter with the left hand. An automatic contrast media injector push button connected to the power injector may also be used from the cockpit.

Advantages in practice

The ultimate goal of this robotic-assisted PCI system is to benefit patients, interventional cardiologists and hospitals by improving standardization, reproducibility and precision. Procedural advantages include: high precision with discrete and controlled linear movements (in 1-mm increments) of the guidewire and balloon/stent and rotational movements (in 30 degree increments) of the guidewire; and improved stability of the Y-connector and guide catheter, as well as locking of the wire and balloon/stent during device deployment. Moreover, precise measurements of lesion length may be achieved that is unrelated to angiographic view and not affected by foreshortening.

Figure 1. The CorPath 200 system in the cath lab: the bedside unit mounted on a bedrail, and the interventional cockpit

Figure 1. The CorPath 200 system in the cath lab: the bedside unit mounted on a bedrail, and the interventional cockpit is positioned at the foot of the procedure table.

Images: Andrew Cassar, MD

In the first-in-human robotic-assisted angioplasty study on eight patients, which was recently published, the technical success of the robotic system for type A or B1 lesions was 97.9%. There were no device- or procedure-related complications and no in-hospital or 30-day major adverse cardiac events. The operators rated the robotic system performances as equal to or better than manual procedures in 97.5% of the cases.

Amir Lerman
Amir Lerman

Theoretical advantages to the patient include shorter procedure times with less radiation exposure and less use of contrast. Also, if precision and accuracy of stent placement decrease longitudinal geographic miss, which was reported in 47.6% of cases in one study, there may be improved long-term outcomes reguarding target vessel revascularization or MI. Similarly, the need to use a second stent may diminish. These hypothetical advantages, however, need to be confirmed in large controlled studies.

The advantage for the physician is the ability to work in an optimal ergonomic and safer environment. The comfortable seated position of the interventionalist in front of the “slaved” monitors provides enhanced visualization of the angiography screen while reducing fatigue and minimizing neck, back and leg strain since lead aprons do not need to be worn. Back injuries are extremely common among long-standing interventional cardiologists and prevention of work-related injury would be most welcome. Radiation exposure is of significant concern to interventional cardiologists and the supporting staff, as the prevalence of radiation-induced posterior-lens opacities was shown to be 52%, and cumulative radiation doses may increase the risk of stochastic cancer after many years in the catheterization laboratory. The operator radiation exposure was found to be 97% lower when using the robotic-assisted system compared with levels found at the standard table position.

Figure 2. Illustration of loading the single-use cassette with a guidewire.

Figure 2. Illustration of loading the single-use cassette with a guidewire.

Hospitals may also benefit from using robotic-assisted PCI. The novelty may attract both physicians and patients alike and, if large trials demonstrate increased efficiency, it may improve cost savings.

Future for robotic-assisted PCI

Potential future enhancements that come to mind for the CorPath system include manipulation of guide catheters; self-loading of wires and stents; increased tactile sense of guidewire tip (with a strain or pressure gauge); and adaptation to other interventions performed in the cath lab, such as structural heart disease cases.

The attractiveness to interventionalists is evident, but large studies are required to confirm the safety and efficacy of the CorPath in humans before it is ready for primetime. The CorPath Percutaneous Robotic-Enhanced Coronary Intervention Study (PRECISE) is designed to evaluate procedural success and major adverse cardiac events in a prospective, single arm, multicenter study, which is currently enrolling patients (100 enrolled with a plan for 175) and should be finalized by the end of 2011. Moreover, the concept and the ability to perform robotic-assisted procedures may be extended in the future to improve acute care for patients in remote sites and has the potential to revolutionize the way we perform PCI.

References:
  • Bashore TM. Am Heart J. 2004;147:375-378.

  • Ciraj-Bjelac O. Catheter Cardiovasc Interv. 2010;76:826-834.

  • Costa MA. Am J Cardiol. 2008;101:1704-1711.

  • Goldstein JA. Catheter Cardiovasc Interv. 2004;63:407-411.

  • Granada JF. J Am Coll Cardiol Cardiovasc Interv. 2011;4:460-465.

  • Klein LW. Catheter Cardiovasc Interv. 2009;73:432-438.

Andrew Cassar, MD, MRCP, is a third-year fellow of cardiovascular medicine at the Mayo Clinic, Rochester, Minn.; Amir Lerman MD, FACC, is a professor of medicine with the Division of Cardiovascular Diseases, Mayo Clinic.

Disclosure: Drs. Cassar and Lerman report no relevant financial disclosures.