AI News, Heart Surgeons Adapting to Robots

Heart Surgeons Adapting to Robots

What if you had a severely impaired heart, afflicted with an unpredictable rhythm, which could be treated only by lacing a catheter through the delicate avenues of your vasculature and up into the atria, where it would sear the tissue and leave a curative scar?

”You’re trying to drive the back end and steer the tip,” says Rick Green, vice president of marketing for Stereotaxis, a company that supplies cardiology labs with a robot called Niobe.

With the Stereotaxis device, surgeons must still manually guide the catheter through the arteries to the patient’s heart, but once the device is there, the Niobe system uses a set of external magnets to maneuver the metal tip of the catheter.

Each time it stops, the system records a point on the map, and every point that’s added enhances a topographical image of the heart on a computer screen.

Doctors who manually perform the operation without a robot’s help end up standing half bent over for long stretches, wearing a heavy lead smock.

For one thing, it is much less expensive to set up than Niobe, which requires that cardiology labs be fully renovated to shield the rest of the facility from the strong magnetic field that guides the robot.

Another cardiologist at the debate, Walid Saliba, from the Cleveland Clinic, explained that most of the complications in his own procedures were part of a natural learning curve and part of the process of figuring out how much force to use with a robotic system.

Judging by the vote, most doctors present were persuaded by Wazni’s request that we ”don’t blame the robot.” Although these systems could clearly be enhanced, he says, the human operators are the ones with the most to learn.

Reducing Physician Radiation Dose With Robotics

Operators already perform procedures manually without robotic assistance, but advocates for the technology point out these systems can greatly improve staff safety by reducing radiation dose and improve outcomes with more accurate procedural navigation.  “Gone are the days where you could spend money without thinking about the costs involved,” said Ehtisham Mahmud, M.D., FACC, chief of cardiovascular medicine, director, Sulpizio Cardiovascular Center-Medicine, director, interventional cardiology and cardiac cath lab, professor of medicine, UC San Diego Health System, La Jolla, Calif.

“I thought losing the tactile feel on the wires would be a problem, but I found the robotic system enhances wire manipulation and fine motor movements.”   While precision is a large part of why he wanted to adopt the system, it was the big reduction in radiation dose that really attracted him.

Robots in the Cath Lab, Robots in the EP Lab All robotic systems currently on the market (one system for PCI, one for peripheral vascular work and two for electrophysiology (EP) procedures) use a remote control console that allow a physician to be removed from the angiographic imaging system’s radiation field.

The CorPath system uses a lead lined booth that can be positioned anywhere in the cath lab and allows the operator to work in a seated position without the need to wear any lead.  Radiation dose in the cath lab has become a major concern in recent years and has become a big topic with the Society for Cardiac Angiography and Interventions (SCAI).

These aches and pains got him thinking about the longevity of his career and workplace safety in regard to unseen dangers of constant radiation exposure, and orthopedic issues common among interventionalists.  “You spend a lot of time in the cath lab with lead on and as the procedures become more complex, the procedure times are increasing,” Iyer said.

Improving Accuracy While the CorPath robotic system was designed to improve catheter guidance and measurements, users and skeptics of robotic systems say clinical data on its utility so far has been mainly limited to simple lesions, not in complex lesions or anatomy.

However, users of the system say the potential of the CorPath is not in the simple lesions used for clinical trials to gain U.S. Food and Drug Administration (FDA) approval, but in the much more complex interventions for which this system is destined to be used in the coming years.  “Part of our challenge is not that you can do a procedure with the robot, but finding the best cases where to use the system,” Iyer said.  The first CorPath case Iyer performed was a bifurcation lesion in a left anterior descending (LAD) diagonal branch.

Corindus said many of the centers with CorPath systems are routinely using the system for more complex cases and data is being gathered for publication.  Iyer said the robot might potentially lower healthcare costs by helping reduce the number of stents required.

Data from the PRECISE Trial showed the average procedure time was 24 minutes, plus or minus 14 minutes.  Iyer said during busy days and especially with cases involving very simple lesions, he will skip using the robot.

The system enables improved procedural predictability, control and catheter stability during navigation of the peripheral vasculature to provide a guide wire conduit for manual placement of therapeutic devices to treat vascular disease.

Remote Magnetic Navigation for Accurate, Real-time Catheter Positioning and Ablation in Cardiac Electrophysiology Procedures

This new remote magnetic navigation system allows real-time remote catheter navigation inside the right and left atrial chambers, either in the operator or automated mode.

We considered nine targets in the right atrium (coronary sinus, 2 locations at the high right atrium, 3 locations at the tricuspid annulus, His, superior vena cava and inferior vena cava), nine targets in the left atrium (2 locations at the left atrial appendage, 3 locations at the mitral annulus and one location at each one of the pulmonary veins), six target sites in the right ventricle (2 locations at the right ventricular outflow tract, apex, right ventricle free wall, inferior wall and septum) and five more targets in the left ventricle (apex, anterior wall, lateral wall, septum and left ventricular outflow tract).

3D electro-anatomical mapping geometry of the left atrium and pulmonary veins.A, geometrical point acquisitions within the left atrium using the magnetized catheter, which is represented with the white tip and the overlaying yellow arrow.

Interruption of a left atrial flutter circuit around the right pulmonary veins after automatically guided radiofrequency energy delivered to specific sites in the posterior wall of the left atrium.A, voltage map shows a dense scar in the posterior wall of the left atrium (grey color).

Robots in the Cath Lab

Interest has exploded over the past year in robotic cath lab guidance technology since Corindus began its U.S. Food and Drug Administration (FDA) pivotal trial.

The Corindus CorPath 200 robotic-assisted percutaneous coronary intervention (PCI) system has been designed to provide precise, robotic-assisted placement of coronary guide wires and stent/balloon catheters in PCI procedures.

Drinking the Kool-AidIt is rare that a first-generation medical device is tested for the first time in patients and works exactly as planned.  All of the speakers at the TCT program have “drunk the Kool-Aid,” so to speak, and praised the system’s capabilities with no reservations.

The system just allows you to use these devices better.” “This first-generation device works amazingly well,” said Christopher Metzger, M.D., FACC, director of cardiac and peripheral vascular cath labs, Holston Valley Medical Center, Kingsport,  Tenn.

You always expect the worst whenever you begin testing a new technology.” “For the very first time in my career, I was able to perform a PCI procedure without wearing a lead apron,” said Jeffrey W.

“The CorPath System’s radiation-shielded cockpit provided an optimal view of the angiography screen and allowed me to easily manipulate the guide wire and accurately place the stent.

I was impressed — this trial has the potential to significantly impact how we care for patients in the cath lab.” Precision, Stability and ControlMoses said he was very skeptical about this and other robotic systems, because of the general feeling that a machine cannot replace the tactile skills of an experienced operator.

“You control fluoro, contrast media and balloon inflation.” Caputo said there is a high rate of longitudinal geographic miss with manual stent placement, as much as 47.6 percent, according to a recent study he cited.

While Metzger said he is comfortable with the robot in most cases, he still has reservations about using it with atherectomy procedures.All these operators said the system enabled easier catheter navigation because of more precise catheter manipulation and prevention of wire “slippage.” Easier vessel navigation also means less radiation for patients and operators.

  “We measured radiation exposure and there was a 97 percent reduction in exposure, without wearing a lead apron,” Weisz said.Weisz quoted a recent survey stating that nearly 38 percent of interventional cardiologists will get cataracts due to radiation exposure.

Metzger agreed, adding, “There is amazing potential for this with use in chronic total occlusions and structural heart cases.”Moses said future cath labs will include these, integrated with much more image navigation, including co-registered fluoro and 3-D computed tomography (CT) datasets.

The system is cleared in the United States for electrophysiology (EP) ablation, coronary, peripheral and neurovascular navigation.  It uses two large electromagnets on either side of the patient table to guide catheters remotely during complex procedures.

After an average followup of 15 months, the success rate (defined as freedom from atrial tachyarrhythmia off anti-arrhythmic drugs) of robotic procedures was slightly superior at 67 percent compared with that of manual procedures at 64 percent.

Review Article—Special issue: Atrial FibrillationRobot-assisted navigation in atrial fibrillation ablation—Of any benefits?

The most important potential advantages of robotic ablation include excellent catheter stability and accuracy of its movement, reduced fluoroscopic time, catheter contact monitoring, improved comfort of the operator during the procedure as they can sit most of the time unexposed to radiation and, last but not least, a very short learning curve potentially allowing for more complicated procedures (persistent forms of AF, structural ventricular tachycardias, congenital heart disease).

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