Depending on whom you listen to, robotically assisted mitral valve repair is either still on the rise, already past its prime or currently plateauing as the very definition of a boutique medical procedure: an attractive option for high-end providers serving discerning niche markets. In reality, given the demographic variations driving regional market conditions across the U.S., it’s all three at once.
Approved for mitral valve surgery in 2002, Intuitive Surgical’s da Vinci system—the only player on the cardiac field so far, although competitors are expected—combines magnified 3D visualization with multi-arm instrument manipulation of micro instruments while also correcting for hand tremors. But its main selling point is that its use only requires three keyhole incisions. With far less cutting than traditional chest-cracking sternotomy, it decreases pain and scarring, lowers risk of infection and may reduce recovery time from 12 weeks to two.
Cardiac surgeons using the system also like its ergonomic position, which reduces physical fatigue.
Meanwhile, around 40,000 Americans undergo mitral valve surgery each year, and many are 50 or younger. Working-age patients prefer minimally invasive operations for obvious reasons, and both efficaciousness and costs per procedure have proven on par with traditional mitral valve surgeries for hospitals. For instance, Mayo Clinic researchers calculated that the median cost of robotic mitral valve repair was $700 less than open repair after they implemented their program (Mayo Clin Proc 2013;88:1075-1084).
But the system also comes with a hefty cost of entry—upwards of $1.5 million per unit, before service contracts—and it’s not a good fit for every cardiac surgery department. And the company has come under heat at times for high-profile patient injury cases from gynecological and other surgeries. Analyses show adverse event reports most commonly cite perforations, lacerations and tears due to operator error.
The Mayo Clinic’s Rakesh Suri, MD, DPhil, co-author of the Mayo Clinic article, also published research describing how robotic mitral valve repair can be performed safely and effectively for all categories of leaflet prolapse and sees vast potential in the technology (Ann Cardiothorac Surg 2013;2:841-845). He says the robot won’t eliminate nonrobotic minimally invasive options using thoracoscopes and conventional long instruments. Robotic telemanipulation may, however, become the preferred minimally invasive procedure for young, healthy patients requiring isolated mitral valve repair.
“Mitral valve repair is one of the most complex and technically sophisticated operations performed in cardiac surgery,” he explains. “Any technology that allows the surgeon enhanced visualization, increased technical precision and the ability to utilize more than two human arms is going to markedly enhance that process. That’s exactly what robotics does for our team.”
But there are caveats. Suri points out that in order to run a successful robotic mitral valve repair program, a structural heart team needs to have in place a highly specialized, deeply experienced mitral valve squad. He says all members must receive ample training in robotic procedures, and that includes not only the surgeons but also cardiologists, anesthesiologists, perfusionists, echocardiographers, operating room staff and nurses.
As for the surgeons themselves, after mastering the joystick-based controls and practicing the system in nonhuman settings, most will spend 20 to 25 cases supervised by a senior colleague before they’re ready to go it alone. Hospitals need to be prepared to deal with the scheduling and workflow ramifications of a potentially lengthy mentoring period.
Also essential, says Suri, is high enough volume for the team to have achieved and sustained a 99 percent first-time repair rate prior to launching into robotics. “The learning curve largely has to do with developing expertise for high quality, safety and efficacious mitral valve repair,” says Suri. “When the team is committed, introducing robotics as a tool to perform that operation with less physiologic burden to the patient really can proceed quickly.
“It just so happens,” he adds, “that those pieces are present only in a few high-volume places around the world.”
NewYork-Presbyterian Hospital/Columbia University Medical Center in New York City is one of those places, but it’s also a place where robotically assisted mitral valve repair is a thing of the past. Michael Argenziano, MD, chief of adult cardiac surgery, participant in the trial that led to the 2002 FDA approval and an enthusiastic early adopter, says that, for him, the technology turned into a stepping stone to nonrobotic minimally invasive procedures just two years after the FDA nod.
“There’s a decision point that you come to once you become proficient with the robot,” says Argenziano. “And that is: Do I consider the robot a temporary crutch to give me the courage to get in there through a five- or six-centimeter right-main thoracotomy, and do I now move on without the robot? Or, now that I’m proficient with the robot, do I try to make the robotic operation better? I made the former decision because I was trying to get to the best operation I could get to, and I felt like the robot had become superfluous.”
Argenziano is quick to add that he respects peers who choose to continue with the robot. “Both decisions are perfectly reasonable,” he says. “Neither is a bad decision and neither results in bad outcomes, as long as the surgeon has the skills. They just happen to be two different ways of doing things.”
He also says he won’t be surprised if the number of robotically assisted mitral valve operations dramatically increases over the next five to 10 years. “Worldwide, probably about 20 percent of mitral valve operations are done minimally invasively,” he says. “Most around the U.S. are still being done through a sternotomy. And of the 20 percent that are done minimally invasively, easily 95 percent are done without a robot. The potential market is quite large because the penetration level is so low.”
Cost may prove a barrier, though. By one account, minimally invasive mitral valve surgery offered more of a bargain than robotic surgery, with similar clinical benefits. In a poster at the 2014 American Association of Thoracic Surgeons, a team from the University of New Mexico placed a price tag on a robotic procedure that was $2,000 to $3,000 higher, depending on case volume.
Meanwhile, “a lot of surgeons are just coming out of robotics training and they’re going to follow the robotic path.” They certainly don’t want to waste their training and, Argenziano notes, the technology’s high-tech image is ideal for generating marketing buzz via “glitz, pizzazz, whatever you want to call it. There are always patients drawn in by the newest, the hottest, the most exciting.”
Robotically assisted persuasion
Buzz alone probably doesn’t explain so rapid an expansion, however. Cardiothoracic surgeon Danny Ramzy, MD, PhD, of Cedars-Sinai’s Heart Institute in Los Angeles, points to the robot’s utility for persuading asymptomatic and mildly symptomatic patients not to procrastinate.
“A lot of patients who have mitral regurgitation are young. They might have a murmur or a torn leaflet, stuff we know is not reversible and will get worse if left alone. But they’re not convinced,” says Ramzy, lead author of a study analyzing 300 cases at Cedars-Sinai (J Thorac Cardiovasc Surg 2014;147:228-235). They found that most complications and reoperations occurred early in the learning curve using a first generation device. “The minimally invasive robotic approach offers us a way to convince them that they need treatment before their ventricles deteriorate and they get arrhythmias.”
Ramzy is also sanguine about the potential depth and breadth of the technology’s contribution to cardiac care. “As this technology moves forward, there will be more than one company, and competition will eventually drive costs down,” he says. “The more costs go down, the more hospitals invest in the technology, the more costs are driven down throughout American healthcare.”