Safety and Performance of Harmonic® HD 1000i Shears in Thoracoscopic Procedures: A Retrospective Study

Abstract

Background: Ultrasonic energy devices are utilized for transection, incision, and hemostasis in traditional open and laparoscopic procedures. The Harmonic HD 1000i Shears, designed to deliver a precise amount of thermal energy during tissue transection and vessel sealing, has been utilized in many specialties. This study aimed to confirm real-world safety and performance of the Harmonic device in two thoracoscopic procedures: lobectomy and segmentectomy. Methods: The primary endpoint of this retrospective, observational, single-arm study was rate of post-operative blood transfusions related to study device or procedure. Secondary endpoints included occurrence of intra- and post-operative adverse events (AEs) or complications device- or procedure-related, and rate of required additional hemostatic measures. Adults included those who underwent thoracoscopic lobectomy or segmentectomy where HD 1000i shears were used while excluding those where additional advanced energy devices were used. The study was conducted at Severance Hospital, Yonsei University Health System, South Korea from May 1, 2018, to November 30, 2020. Results: Subjects included n = 766 lobectomies (mean age 63.79, 52% male) and n = 215 segmentectomies (mean age 63.19, 54% male). Estimated blood loss was 50 mL (0 min, 3200 max) and 20 mL (0 min, 800 max), intraoperative transfusion rate 0.001% and 0%, intraoperative complication/AE rate 1% and 2%, and post-operative complication/AE rate 9% and 4% in the lobectomy and segmentectomy groups, respectively. Median operative times were 108 min. (35 min, 395 max) for lobectomies and 105 min. (32 min, 574 max) for segmentectomies. Conclusion: Given the low rate of blood loss and intra- and post-operative complication/AE rates, HD 1000i can be used confidently for thoracoscopic pulmonary resection in adults.