Robotic PCI Remotely?

8.2 / IAGS 2019
Session 8: Emerging Therapies Session 1
Robotic PCI Remotely?
Problem Presenter: Amir Lerman, MD

 

Statement of the problem or issue

It is apparent there is a lack and a gap in the standardization and equalization of access to medical care. This is specifically true for more specialized medical care such as access to various procedures. Examining the access to medical care and the physician shortage throughout the world reveals that there are several major areas, such as in Africa and Asia, where there are fewer than 5 physicians per 10,000 population, in some cases less than 1 per 10,000. This imbalance creates an uneven access to lifesaving procedures worldwide. It is anticipated that by the year 2025, there will be a shortage of 90,000 physicians in the United States, specifically in the area of coronary intervention. A recent study demonstrated that from the year 2001 to 2006, the hospitals capability to perform percutaneous coronary intervention grew by 44%, whereas the access to the procedure grew by only 1%. Thus, the growth to perform PCI was actually in places which already had the facilities and capability, and this growth did not distribute equally and evenly throughout the United States. Thus, the capability to perform primary PCI in a timely manner and reduce even the door-to-balloon time and the distribution gap remains a major challenge. In order to bridge this gap, it has become apparent that if we cannot bring all the patients to the cath lab, we need to think about a creative and novel method to bring facilities and cath labs to the patients.

The idea to be able to perform coronary intervention safely and accurately by using remote robotic procedures is currently being assessed.

Gaps in knowledge

In order to build a system that will enable us to safely perform coronary intervention using robotic arms remotely from a distance, several gaps in knowledge need to be filled. The first one is the ability to safely perform PCI using a robotic arm, rather than the traditional method that has been done so far using operator tactile sensation for the procedure. The second gap in knowledge that needs to be filled is the ability to operate this robotic arm safely and with acceptable reaction time. Thirdly, other obstacles need to be overcome such as the training and reimbursement for this procedure.

Possible solutions and future directions

Operating robotic arms to perform PCI became available in the past several years. The introduction of the CorPath device from Corindus allows the operator to safely perform interventional procedures situated in a cockpit in the same room where the patient is having the procedure. This ‘robot’ is composed of a bedside unit optimized for radial access, easy and simple setup within the procedure workflow, and during intervention, and with imaging and device handling capability. The operating physician is situated in a protected cockpit in the same procedure room. The rational in building this robotic assist device stems from the growing body of evidence demonstrating health hazards to the operator during coronary intervention. More specifically, accumulated evidence demonstrates increased risk of spine injury, head radiation exposure that may lead to cataracts, as well as several reports of brain and neck tumors among physicians performing interventional procedures. To address the feasibility and safety robotic PCI, several studies were performed demonstrating that the procedure is safe, and there is significant reduction in contrast media volume as well as fluoroscopy time and radiation dose. Other studies have demonstrated the feasibility of robotically assisted PCI in complex lesions and with low levels of adverse events. These were completely robotic procedures in more than 80% of the cases. Robotic procedures also have expanded to the peripheral vascular intervention, with potential for neurovascular procedures very soon. The safety of using a robotic arm to perform PCI is now well established.

The second challenge is with the ability to operate this robotic arm from a distance with acceptable reaction time and safely. There is both increasing interest and data in using robotics in multiple areas, and not only in medicine. NASA is operating a vehicle on Mars more than 50 million kilometers away, however, the reaction time is about 20 minutes, which is unacceptable for coronary procedures. Several years ago, a laparoscopic cholecystectomy was performed between New York and Germany, more than 14,000 kilometers with a reaction time of 155 milliseconds. This reaction time is acceptable and safe.

Recent studies by Dr. Madder et al demonstrated the feasibility of using and operating the robotic arm remotely from a separate operating room. The success of this remotely operated procedure was 95%. We have launched a multi-stage protocol in collaboration with the Helmsley Foundation as well as Corindus Vascular Robotics to assess the feasibility and safety of performing remote robotic procedures. We previously demonstrated the safety of performing this procedure with a reaction time of less than 30 seconds in several animal models. Recently, the first in-man procedures were done in India operating the remote PCI arm 22 miles away in five patients.

There are still challenges coming before the procedure will be clinically available, including safety of the procedure, reduction and stabilization of the reaction time, and other legal issues such as reimbursement and malpractice concerns.

This new technology allows us to integrate the robotics with wireless capability in order to perform procedures remotely, and thus, bridging the gap of the lack of distribution of specialized physicians throughout the world.