PATHBREAKING MEDICAL TECHNOLOGY

World’s First Robotic Arm for Angioplasty Arrives in India at Dr L H Hiranandani Hospital


By Sudha Hariharan

The world’s first robotic arm for angioplasty arrived in India at the renowned Dr LH Hiranandani Hospital, Powai, Mumbai. With this Dr LH Hiranandani Hospital has become the country’s first and one of the world’s few centres of excellence to carry on research on this exciting international breakthrough. The robotic arm allows remote manipulation of Percutaneous Coronary Interventions (PCI).

For the first time in India, Dr L H Hiranandani Hospital conducted a live demonstration of angioplasty using this robotic arm.

As part of the multicentric clinical evaluation for US FDA approval Interventional Cardiologists Dr.Ganesh Kumar of Dr LH Hiranandani Hospital has been chosen as principal investigator and Dr. Ajay Chaurasia of Dr LH Hiranandani Hospital as co-investigator to conduct this study in India.

Earlier in December 2005, Dr. Ganesh Kumar teamed up with Rafael Beyar (considered the father of stents) and other eminent members including Tal Wenderow, Doron Lindner, and Rona Shofti, in Israel, to develop and test this equipment. The result of this path-breaking study was published in Europe’s EuroIntervention journal in November 2005. The study concluded that remote navigation system for coronary interventions including balloon angioplasty and stenting is feasible. The system was tested initially in a glass coronary model with visual feedback of the device movements through the transparent glass.

Later a normal coronary sheep model (animal model experiments) was employed to test the safety of the system. The third step was a pilot FIM (First in Man) clinical study, conducted on 15 patients with single coronary artery narrowing.

Dr. Ganesh Kumar was part of the first in man pilot study in Romania through which this system was evaluated on fifteen patients with stable angina pectoris and a typical risk of coronary heart disease with 100 percent clinical success and technical results in over 92 percent of cases. This study was a turning point in establishing the potential of such a system and was published in 2006 January in the Journal of American College of Cardiology.
Many advantages over traditional system

Percutaneous coronary intervention (PCI) is a major method of revascularization for coronary artery disease, with over 2 million coronary interventions performed annually. The majority of interventions (70-80%) are coronary dilatations using stents. Recently, drug-eluting stents (DES) have shown sustained advantage compared to bare metal stents, with a marked reduction of restenosis rates.

The catheterization laboratory personnel so far have been operating in an unfriendly environment subject to a continuous X-ray radiation throughout life. This has been unchanged since the beginning of the field of interventional cardiology more than 25 years ago. “Interventionalists’ disc disease” is a well confirmed entity with cardiologists reporting more neck and back pain, more subsequent time lost from work, and a higher incidence of cervical disc herniations, as well as multiple level disc disease owing to the tiresome standing procedure of angioplasty and the heavy weight of the anti -radiation gear that takes a toll on the operator.

This robotic remote control PCI system not only helps patients avail services of their preferred doctors over large distances, but also helps physicians operate in an X-ray free and relaxed environment with lesser chances of spinal risk thereby increasing the ability of the operator to deal with long procedural hours.

In contrast to the present angioplasty process that requires two cardiologists, the robotic remote control procedure can be conducted without need of assistants making the process more efficient and reproducible and reducing chances of operator-based error.

In this system motors and motion sensors are used to manipulate angioplasty wires, stents and balloons via a joystick and a computer touch screen, leading to enhanced precision of balloon and stent-positioning (which may be an extremely important feature in DES therapy). Semi-automatic procedures can also be robotically controlled by the system by obtaining continuous image base feedback data. On-line communication with the patient is obviously of value in generating trust and confidence of the lightly sedated patient and the medical team. The robotic remote-control system allows for doctor-patient interactions with voice and image technology. If for any reason the system malfunctions it can be switched to manual mode in a few seconds.

The current RNS (Remote Navigation System) is the first clinically oriented system for remote manipulation of PCI and allows full navigation of coronary wires and devices in parallel allowing operation in a standardized catheterization laboratory using standard wires and devices that are robotically manipulated and allow for transatlantic communication. This RNS is composed of a bedside unit and a remote manipulation unit. The bedside unit has individual wire and device manipulators capable of precise maneuvering and positioning of the wires and devices.

Hiranandani Hospital, Mumbai is considered as a centre for excellence in international quality healthcare and is well known for Primary Angioplasty in Myocardial Infarction (PAMI). Says Dr. Sujit Chatterjee, CEO of Dr LH Hiranandani Multispeciality Hospital, “We are proud that our hospital waschosen to conduct this pioneering study for the first time in India, and Dr Ganesh Kumar as the principal investigator of the world’s first team to have worked on creating such a system. We are very excited about a future possibility wherein our doctors can conduct angioplasties from our hospital when the patient is in another remote location and cannot be transported in time to our hospital due to any reason, through the help of precision controlled robots….such a process will indeed bring about a revolutionary era in cardiac interventions.”

Says Dr. Ganesh Kumar, “What was science fiction yesterday is fast becoming reality. With the positive results of the revolutionary studies, I am hopeful that the day is not far away when robotic remote control angioplasty will be the preferred procedure in coronary care bringing many far reaching advantages to the public.”