Authors: Liberman M, Markel T, Morgenthal C, Leung S, Nakeeb A, Shakir F, Yasafuku K, Curtis N, Sundaram CP, Canavan K, Veldhuis P, Atiyani O.
Background: As surgical procedures become more complex, ultrasonic energy devices, and specifically Harmonic technology, have become indispensable tools in providing precise sealing and transection of vessels demonstrating clinical utility and positive outcomes including reducing lateral thermal spread, intra-operative blood loss, and length of hospital stays. We present results from a real-world study evaluating the safety and usability of the Harmonic1100 Shears (H1100) and the accompanying Generator 11 (Gen11) across specialties in both adult and pediatric patients.
Methods: A prospective, multi-center observational trial was undertaken. Both pediatric (general) and adult subjects (general, gynecologic, urologic, thoracic) who presented for surgery where the device was slated to be used were included and clinical outcomes documented. The primary endpoint was the attainment of hemostasis for each vessel transected. Secondary endpoints to assess usability was measured by querying surgeons regarding specific tasks performed. Device-related adverse events (AEs) were recorded to evaluated safety.
Results: A total of 265 subjects comprised the final data set (40 pediatric general, 93 adult general, 32 adult gynecologic, 30 urologic, 61 thoracic). A total of 489 vessel transections occurred during the course of the study of which 99.0% of the vessel transections achieved hemostasis. Four subjects required an intra-operative transfusion (2 adult general, 2 gynecologic). Ninety-six (96) subjects had at least one vessel transected with a diameter greater than 5 mm (>5-7 mm) with 174 vessels transected. Hemostasis was achieved for 98.9% of >5 to 7 mm vessels transected (172/174). Five Grade 4 vessels transections occurred and all required additional measures to achieve hemostasis. Of the 104 cases in which the H1100 was used for sealing and transection of lymphatic vessels, surgeon satisfaction with the device, was high (97.1%). All surgeons indicated that the H1100 performed as well or better than their previous ultrasonic device of choice. Similarly, related queries were made regarding the Gen11’s use with surgeons reporting that the GEN11 touchscreen was easy-to-use (98.5%) and that it performed as intended (96.6%). Of the 183 AEs reported, 7 were deemed “possibly related” to the study device and included one subject with atrial fibrillation and pericardial effusion, and the others pleural effusion, anastomotic complications, and a gastrointestinal anastomotic leak.
Conclusion: The data from this real-world post-market study affirms the safety and efficacy of the H1100 across specialties, supporting its continued use in clinical practice.
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