Initial Evaluation of the Safety and Performance of Single-Port Robotic-Assisted Thymectomy Via Subxiphoid Incision

M Blair Marshall; Jon O Wee; Harmik J Soukiasian; Matthew G Hartwig; Bernard J Park; Michael Zervos; David Rice

doi:10.1016/j.athoracsur.2024.11.022

Initial Evaluation of the Safety and Performance of Single-Port Robotic-Assisted Thymectomy Via Subxiphoid Incision

Ann Thorac Surg. 2024 Dec 10:S0003-4975(24)01043-9. doi: 10.1016/j.athoracsur.2024.11.022. Online ahead of print.

Authors

M Blair Marshall¹, Jon O Wee², Harmik J Soukiasian³, Matthew G Hartwig⁴, Bernard J Park⁵, Michael Zervos⁶, David Rice⁷

Affiliations

¹ First Physicians Group of Sarasota Memorial Health Care System, Thoracic Surgery, Sarasota, FL, USA; Brigham and Women's Hospital, Department of Surgery, Thoracic Surgery Division, Boston, MA, USA.
² Brigham and Women's Hospital, Department of Surgery, Thoracic Surgery Division, Boston, MA, USA.
³ Cedars-Sinai Medical Center, Department of Surgery, Division of Thoracic Surgery, Los Angeles, CA, USA.
⁴ Duke University Health System, Department of Surgery, Division of Cardiothoracic Surgery, Durham, NC, USA.
⁵ Memorial Sloan Kettering Cancer Center, Department of Surgery, Thoracic Service, New York, NY, USA.
⁶ NYU Langone Health, Department of Cardiothoracic Surgery, New York, NY, USA.
⁷ University of Texas MD Anderson Cancer Center, Department of Thoracic and Cardiovascular Surgery, Division of Surgery, Houston, TX, USA. Electronic address: [email protected].

PMID: 39667479
DOI: 10.1016/j.athoracsur.2024.11.022

Abstract

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 for thymectomy via a subxiphoid incision. Primary performance endpoints included ability to achieve R0 resection and completion of the procedure without conversion. The primary safety endpoint was all adverse events (AEs) up to 30-days postoperatively.

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

Conclusions: Thymectomy using the da Vinci SP Surgical System via 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 to multiport robotic thymectomy.