BOSTON -- About 70 surgeons and engineers from across the country met at BIDMC recently to brainstorm on unmet clinical needs that could be tackled in an interdisciplinary $120 million
National Robotics Initiative proposed in President Barack Obama's 2012 budget and beyond.
In experienced hands, robotic devices can extend the benefits of minimally invasive surgery - less pain and bleeding, faster recovery and better outcomes - to more patients and procedures, but major challenges in training, tools, clinical evidence and cost have limited the successful widespread deployment of these devices and techniques, several surgeons said.
Even the most skilled robotic surgeons must cope with the existing disparities between 2-D video images and 3-D structures within the operative field, between distant tools and the inability of their own hands to feel delicate tissues, and between the limits of mechanical motions and their own ability to navigate around organs and tie off sutures.
"Solutions require collaborative problem-solving among creative thinkers from a diverse set of backgrounds," said
BIDMC Surgeon-In-Chief Elliot Chaikof, MD, PhD, who co-led and hosted the daylong workshop at the
Carl J. Shapiro Simulation and Skills Center. "We're all in our own silos. This is an opportunity to close the ingenuity gap by solving problems through teams of engineers and surgeons."
Recommendations from the workshop will go into a guidance document for the White Office of Science, Technology and Policy. Organizers hope it will help inform funding priorities going forward at the National Institutes of Health, National Science Foundation and other federal agencies, said Chaikof and workshop co-leader Henrik Christensen, PhD, Director of the Center for Robotics and Intelligent Machines at Georgia Tech.
"The workshop is a way to provide important input to the process by users of surgical robotic technology and to ensure that research and development efforts are well aligned with real needs," said Christensen. For the past two years, he and his colleagues have been working on the development of a roadmap for the U.S. robotics industry with the Congressional Robotics Caucus.
At BIDMC, the workshop was the first of many planned by the Department of Surgery as part of an ongoing initiative called the "IDEAS (Innovation, Design and Emerging Alliances in Surgery) Project." Chaikof and his colleagues seek to highlight opportunities for innovative problem solving at the interface of surgery and other disciplines, including engineering, and the physical, biological and social sciences. Surgical robotics led the series because it has recently emerged as a new enabling technology in surgery that holds significant promise despite existing limitations, Chaikof said.
In presentations, several videos showcased the "wow" factor of advances in robotic surgery. Robert Howe, PhD, the Lawrence Professor of Engineering at the Harvard School of Engineering and Applied Sciences, opened the day with an update on an experimental catheter based system he and colleagues have developed and tested on repairing a mitral valve in a beating heart. The one-way mitral valve opens so oxygenated blood can flow through the two left chambers of the heart en route from the lungs to the body. A faulty valve can allow blood to flow back into the lungs.
"We're careful to do only what the surgeon can't do," said Howe, which means making the surgical tools move fast and in sync with the motions of the opening and closing value in a beating heart. It took several years to figure out how to synchronize the three-dimensional imaging of the rapidly beating heart with the real-time robotic controls, he said. Next comes devising the hardware that can move in multiple dimensions.
"We have only hit the tip of the iceberg as to what minimally invasive surgery can do," said Howie Choset, PhD, a robotics researcher at Carnegie Mellon University. Working with surgeon collaborators, Choset has developed a "snake" robot with an outer diameter of 11 mm that can thread through compact and cluttered spaces in the body to reach anatomic targets inaccessible to conventional minimally invasive devices. He co-founded Cardiorobotics to develop a snake robot, whose prototype features three tool channels to provide lighting, visualization, ablation, suction and conventional forceps.
"The high point for me was our first-in-human operation," said Choset. The snake-like robot was able to maneuver around the heart and provide a diagnosis that would have otherwise required cracking open the chest of a patient.
Evolving Clinical Procedures
In the clinical session, Santiago Horgan, MD, Director of Minimally Invasive Surgery, at University of California, San Diego, showed video excerpts of robotic NOTES (Natural Orifice Translumenal Endoscopic Surgery), which eliminates minimally invasive scars on skin. In two examples, Horgan demonstrated the removal of an appendix through the mouth (transgastric appendectomy) and the removal of a gall bladder through the vagina (transvaginal cholestectomy).
"The outcome is very good, but there is a huge learning curve," Horgan said. "We're using devices that were not built for this application." Robotic technologies are needed to improve training and for developing NOTES- specific surgical devices, he said.
Some of most extensive clinical data in U.S. cardiovascular robotic surgery comes from the Brody School of Medicine at East Carolina University in Greenville, North Carolina, which conducted phase 1 and 2 clinical trials that led to federal approval of the da Vinci Surgical System for mitral valve repair. The da Vinci is the only federally approved robotic surgical system and is also used for robotic procedures in urology, gynecology, cardiology and general surgery.
In the last decade, "we've done 630 robotic mitral repairs, and they are successful in 92.5 percent of the patients," said Wiley Nifong, MD, Director of Cardiovascular Surgical Robotics at East Carolina University. More than half of the robotics cases come from out of state.
Efficacy, Evidence and Cost
The robotic surgery field needs more clinical trials showing solid evidence of efficacy and better surgical training, said Andrew Wagner, MD, Director of Minimally Invasive Urology at BIDMC. "We talk about cool instruments and neat new surgeries, but we haven't proven these are better." In fact, some studies evaluating patients after robotic prostate surgery performed by novice surgeons show worse outcomes and less patient satisfaction, including reduced sexual function.
The dissatisfaction may come from overselling the benefits and understating the risks of the robotic procedure, Wagner said. Outcomes data may be an artifact of comparing existing surgical procedures by highly experienced surgeons with less experienced robotic surgeons. In fact, BIDMC urologist Martin Sanda, MD, and colleagues are leading a prospective multicenter clinical trial comparing outcomes of robotic prostatectomy with standard open prostatectomy performed only by experienced surgeons.
The need to control costs of new robotic technology came up several times during the day. In the last 20 years, the cost of the fanciest new flat-screen TV dropped by two-thirds, while the price of a da Vinci almost tripled, said Horgan.
The gaming industry has provided cost-effective strategies that the military is adopting, advised Roger Dean Smith, who develops military simulators for the U.S. Department of Defense. "The gaming world created the market demand to draw in billions of dollars to do research to perfect the technology," said Smith, who champions simulator training whenever possible using a standard laptop and joystick.
Collaborating Across Disciplines
The workshop is one of a number of initiatives being taken to facilitate more effective communication and collaboration between surgeons and engineers, Chaikof said. Several participants of the workshop suggested that engineers spend as much time as possible in an operating room setting with surgeons and that surgical residents interested in robotics consider research fellowships in engineering lab groups.
During the day, surgeons talked about their wish lists, and engineers provided insights into likely short-term solutions. Certain tasks, although perceived as simple repetitive drudgery by a surgeon, are actually extravagantly complex to replicate in a safe and effective manner by a robotic device.
"We don't even have a robot that can autonomously unload a dishwasher," said Alison Okamura, PhD, an engineering professor at Johns Hopkins University, who studies how to relay force and touch sensations to the user of a teleoperated robot, such as to a surgeon in the OR. Okamura proposed a national "Haptic Human" project to provide data on the biomechanical properties of human tissues in much the same way that the Human Genome Project provided a shared resource on DNA sequencing. Such a project would help dictate force conditions needed to safely manipulate tissues by surgical robots.
On May 21, the next IDEAS workshop, "Re-engineering the Delivery of Surgical Care," is directed at examining strategies at the interface of surgery and public health, epidemiology, and healthcare economics to improve the delivery of high value surgical care, Chaikof said.