Robotic mitral valve surgery: A United States multicenter trial

Objective: In a prospective phase 11 Food and Drug Administration trial, robotic mitral valve repairs were performed in 112 patients at 10 centers by using the da Vinci surgical system. The safety of performing valve repairs with computerized telemanipulation was studied. Methods: After institutional review board approval, informed consent was obtained. Patients had moderate to severe mitral regurgitation. Operative technique included peripheral cardiopulmonary bypass, a 4- to 5-cm right minithoracotomy, a transthoracic aortic crossclamp, and antegrade cardioplegia. The successful study end point was grade 0 or 1 mitral regurgitation by transthoracic echocardiography at 1 month after surgery. Results: Valve repairs included quadrangular resections, sliding plasties, edge-to-edge approximations, and both chordal transfers and replacements. The average age was 56.4 +/- 0.09 years (mean +/- SEM). There were 77 (68.8%) men and 35 (31.2%) women. Valve pathology was myxomatous degeneration in 105 (91.1%), and 103 (92.0%) had type II leaflet prolapse. Leaflet repair times averaged 36.7 +/- 0.2 minutes, with annuloplasty times of 39.6 +/- 0.1 minutes. Total robot, aortic crossclamp, and cardiopulmonary bypass times were 77.9 +/- 0.3 minutes, 2.1 +/- 0.1 hours, and 2.8 +/- 0.1 hours, respectively. On 1-month transthoracic echocardiography, 9 (8.0%) had grade 2 mitral regurgitation, and 6 (5.4%) of these had reoperations (5 replacements and 1 repair). There were no deaths, strokes, or device-related complications. Conclusions: Multiple surgical teams performed robotic mitral valve repairs safely early in development of this procedure, with a reoperation rate of 5.4%. Advancements in robotic design and adjunctive technologies may help in the evolution of this minimally invasive technique by decreasing operative times.