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