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
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).
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 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.
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
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.
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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.