Initial Evaluation of the Safety and Performance of Single-Port Robotic-Assisted Thymectomy Through a Subxiphoid Incision.

Background: Sternotomy is the traditional approach for thymectomy. However, over the last 2 decades, minimally invasive surgical approaches (multiport thoracoscopic and robotic-assisted surgery) have proven feasible, offering similar survival, lower morbidity, and shorter length of stay. Single-port (SP) subxiphoid thymectomy potentially offers less pain and allows bilateral visualization of the mediastinum.

Methods: A prospective, multicenter, single-arm clinical study was conducted to evaluate the performance and safety of the da Vinci SP surgical system (Intuitive) for thymectomy through a subxiphoid incision. Primary performance end points included ability to achieve R0 resection and completion of the procedure without conversion. The primary safety end point was all adverse events up to 30 days postoperatively.

Results: The study enrolled 13 individuals (benign, n = 6; malignant, n = 7) at 6 centers in the United States. All SP thymectomy procedures were completed through a small (mean, 3.8 cm) subxiphoid incision without conversion to other minimally invasive or open approaches. For malignant cases, the rate of complete resection was 100%. No study participants experienced any intraoperative or serious adverse events. No unanticipated adverse device effects were reported.

Conclusions: Thymectomy using the da Vinci SP surgical system through a subxiphoid approach is feasible, and there are no early indications of safety or procedural concerns. Larger clinical studies are warranted to further evaluate the relative benefits and limitations of the SP system compared with multiport robotic thymectomy.