Costs curbing the rise of robotics in spinal surgery

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Mazor X (Medtronic)

The era of routine robotic-assisted spinal surgery is on the horizon. Despite the hype, however, there remains little market penetration, with affordability and the degree of value-added by such technology representing significant barriers to complete disruption of standard practice.

In a recent literature review published in Spine, Srinivas Prasad (Thomas Jefferson University, Philadelphia, USA) concluded: “It is no longer a question of whether robotics has a role in spine surgery, but rather how and when.” Advantages of robotics include improved accuracy and consistency, and many have postulated that robotics could render complex spinal surgeries as easy as the simplest spine operations, reducing human error and surgical morbidity. However, many barriers remain before the use of robotics in spinal surgeries becomes routine.

Surgical applications for robotics truly emerged in the 1980s, with the adaptation and subsequent adoption of industrial robots. In 2001, Mazor Robotics (Caesarea, Israel) launched the first surgical robot specifically targeting applications in spinal surgery. The company released SpineAssist in 2004. Today, there are a limited number of spine robotic systems: Mazor X and Renaissance (both Medtronic, which acquired Mazor in Autumn 2018), Excelsius GPS (Globus Medical), ROSA (Zimmer biomet, which acquired the ROSA developers Medtech in 2017), and the recently introduced robotic offering from Chinese robots company Tinavi Medical Technology.

Speaking to Spinal News International, Vikas Patel (Spine Center, University of Colorado Hospital, Aurora, USA) hypothesises that the next technological leap for robotics in spinal surgery will potentially come from combining the capabilities of robots currently used in gynaecology, urology, and general surgery. He explains, “The next real leap will be in the ability of robots to safely handle soft tissues. In spine especially, we need them to be strong and stable when placing screws, but gentle enough to retract a nerve or work around the spinal cord. Some of this ability can come with ‘no fly zones’ to protect the nerves, but the real leap will be when they can gently handle the soft tissues the way a surgeon would. Then they might even be able to help suture the incision—that would be a huge benefit!”

Today’s robotic offerings in the spinal space function as guidance devices. They help line up channels and cannulas to correctly place pedicle screws or other instruments within the patient anatomy. Addressing assembled delegates at the North American Spine Society (NASS) annual meeting (26–29 September, Los Angeles, USA) concerning the integration of robotics into the operating room, Prasad explained how the machines work: “There are two principle modules, and of course navigated instruments as well. There is the platform with the robotic arm itself, with a screen that is sterilely wrapped that the surgeon can manipulate and plan on during the procedure. The other module is an optical camera that can be moved around the room.” Speaking specifically of the ExelsiusGPS robot (Globus), Prasad said, “One of the very interesting features about this is that it has an active and adaptable end effector. At the moment it is just a cannula for guidance, but you have to let your imagination run and think where all that can go.”

So where can robotics go? Imagining the future of robotic assisted spinal surgery, Patel elaborates to Spinal News International: “The next steps will be robots assisting with the entire surgery, from planning to postoperative care. This would include planning the surgery knowing there will be robotic assistance that allows for more complex procedures to be undertaken, and knowing that the robot can guide us [spine surgeons] to the optimal goal. For example, in planning an osteotomy, the robot could guide us intraoperatively to resecting the right amount of bone at the right angle to get the planned correction. Intraoperatively, it could help us with exposing the spine minimally invasively and precisely in the right spots while monitoring the movement of the patient and the relative movement of the spine. The robot could place cages in just the right locations and then bend the rods to the planned specifications. Even postoperatively, artificial intelligence could be used to monitor patients clinically by assimilating data from all kinds of health and activity monitors, and correlating these data with their X-ray findings to recommend the next steps in recovery. There is a huge opportunity, but it comes at significant cost and effort to get it up and running, and really needs teams of engineers and clinicians working closely together to make it happen.”

These barriers to the use of robots in spine surgery were the focus of several talks at the recent NASS annual meeting, with Andrew Fabiano, associate professor of Neurosurgery and director of Spinal Oncology at Roswell Park Comprehensive Cancer Center, Buffalo, USA, providing advice on how to make a financial case for acquiring new, expensive technology in hospitals, as cost is the biggest barrier to the more widespread use of robots in spinal operating theatres. Fabiano argued that in convincing hospital administrators to buy a robot, the goal was to demonstrate that spine operations are high margin procedures. He emphasised that the number one priority was the quality of the business plan. At its most basic, he explained, the business plan for new technology should prove five things: the device is for high margin cases; there are specific patient volume growth estimates; implementation of the device would establish the hospital’s position as a region leader; the device improves patient outcomes; and finally, that the hospital will be able to retrospectively demonstrate these improvements following the purchase.

In addition to the cost, the learning curve of clinicians represents a limitation to the accessibility of surgical robots. Patel explains, “It takes a real champion at an institution to encourage the purchase of a machine, and even greater effort to keep it utilised.”

One such champion is Andrew Cannestra (Baptist Memorial, Jacksonville, USA), head of one of the leading robotic spine surgery centres in the USA. Baptist purchased a Renaissance (Mazor) in 2013, and Cannestra has been an advocate ever since, with the centre purchasing a second robot a few years ago. Conceding there is a learning curve, Cannestra comments, “It is a great tool, but whether you are talking about a hammer or a complex robot, you have to go through the learning curve. That is the surgeon’s job.”

Patel continues: “We almost need a full-time engineer running the robot to get it to work at its real potential. For many clinicians, that learning curve is not worth the effort. I could foresee the possibility of robots being underutilised or sitting idle after purchase because of this. It happened with early navigation systems—many of them collected dust (even in the ‘clean’ operating rooms) because their use was not “worth the effort” after they were purchased. But in places where clinicians and technicians worked together, they were successful and improved both efficiency and outcomes of procedures. We need to try to avoid the risk of underutilisation with smart purchases and continual education.”

Corroborating Patel’s argument, Iain Kalfas (Cleveland Clinic, Cleveland, USA) describes how the belief that fluoroscopy-guided navigation is “good enough” may be holding surgeons back from using robotic guided navigation techniques. Indeed, Jang Yoon (Mayo Clinic, Florida, USA) explained the Peter Thiel rule in his NASS talk during a specialist symposium on robotics and navigation in spine surgery: according to venture capitalist, PayPal co-founder and early Facebook investor Peter Thiel in his book Zero to One: Notes on Start-ups, to achieve successful market penetration, a proprietary technology needs to be 10 times better than the current existing one.

Prasad hypothesises that actually, integrating emerging technologies into clinical practice starts with using robots to perform simple, low risk procedures frequently performed by surgeons, where the gains are less obvious. Writing in Spine earlier this year, he says, “The evolution of robotics in other surgical domains lends valuable insight into this vision [of robotic assisted spine surgeries]. The early applications of the da Vinci platform (Intuitive Surgical) targeted laparoscopic procedures that were widely accepted and performed. The challenge with this was that most surgeons did not feel there was value in bringing an expensive and complex device into the field to perform a procedure they could already perform efficiently and safely. At the same time, the long-term vision for the founders of Intuitive Surgical was to perform complex cardiac procedures using approaches that were as yet impossible. This required a tremendous amount of development and innovation on an engineering front and created the clinical challenge of securing confidence in a procedure that was neither established nor accepted.”

Calling for the same approach in the spinal arena, Prasad concludes, “Ideally, early applications in spine surgery must target applications that are established but not widely performed. This is, of course, a moving target, but there are ample such target applications in spine surgery. The robot must play a role in ‘levelling the playing field’ and enabling traditional surgeons to perform less invasive and/or more effective procedures that are emerging but getting early acceptance, and would be harder to perform without the robot. No doubt, success in establishing a secure early foothold will fuel continued evolution in this exciting space.”

This echoes Patel’s comments regarding learning from soft tissue surgery. Summarising the future direction of robot assisted spinal surgery by looking back at the past quarter of a century of progress, Patel says: “The field of robotics in spine surgery has changed surprisingly little over the last 25 years. When I started in orthopaedics 21 years ago, robotics was attempted in orthopaedic joint replacement surgery but failed due to high cost and increased time of surgery. Robotic technology itself has not advanced dramatically, but what has improved significantly is the integration with navigation and the efficiency of function that no longer means longer surgery. That has been the first real step forward and hopefully will lead to more and more applicability. On the other hand, with pure soft tissue surgery, robotics has had tremendous success in gynaecology, urology, and general surgery in navigating small spaces and allowing for very fine microsurgery. If we could combine some of their capabilities with spine robots and start to automate them, we would really have something!”

With the weight of large companies such as Medtronic, Globus Medical and Zimmer Biomet behind the robotics movement, many industry experts expect an increasing use of robotics in spinal surgery. Providing industry insight to the future of robotic-assisted surgeries, Geoff Martha, executive vice president and president of the Restorative Therapies Group at Medtronic told Spinal News International: “Medtronic is committed to transforming spine care through procedural solutions that integrate implants, biologics and enabling technologies. We believe robotic-assisted procedures have a role to play in spine surgery, enhancing surgeons’ abilities to perform procedures with greater precision, consistency and control.”

By guiding navigation, robots have the potential to help spine surgeons to be more precise in pedicle screw and device placement. Within the spine surgery discipline, there is mounting literature evidencing the improvements in accuracy and consistency robots provide. Outside of navigation, however, there is still little use for robots in spine operations, though with other areas of surgery showcasing the myriad opportunities in this dynamic space, there is much potential for a greater robotic role in spinal surgery.

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