Plenary: Next Frontier, Sunday, Afternoon Session
Presentation Authors: Jorge Diaz, Alvaro Vidal, Camilo Sandoval, Pedro Recabal, Jaime Altamirano, Santiago, Chile, Matthew Gettman*, Rochester, MN
Introduction:Urological surgery is constantly searching for ways to improve outcomes in order to increase patient quality of life. Magnetic retraction has the potential to increase the benefits of minimally invasive surgery, as this innovative technology enhances exposure, meanwhile reducing invasiveness. The system allows for un-constrained, shaft-less magnetic retraction, overcoming the limitations of conventional surgical instruments. Early clinical results showed reduced pain, less complications, less scars and shorter length of hospital stay in general surgical procedures. This is the first prospective clinical trial that combines magnetic retraction in urological procedures. The purpose of this study was to evaluate the safety and effectiveness of the Levita Magnetic Surgical System (LMSS) in patients undergoing prostatectomy surgery.
Methods: A prospective single-arm study was designed to assess the safety and effectiveness of the LMSS (Levita Magnetics, San Mateo CA) for prostatectomy. All adverse events (AE) were captured and summarized by relatedness to the device and/or procedure, seriousness and level of severity. The primary effectiveness endpoint was the ability to adequately retract the prostate to achieve an effective exposure of the target tissue. Adequate retraction was deemed to be achieved if it was not necessary to replace the LMSS with another instrument to perform the procedure.
Results: The study was conducted following Good Clinical Practices and ISO 14155:2011(E). Local IRB approval was obtained and 30 subjects underwent surgery with the LMSS. All the cases were performed with 5 ports. The average procedure time was 3:23 (hours: minutes) and the average amount of time that the device was in the abdomen was 1:47. In all of the 30 cases, the LMSS was able to adequately retract the prostate (and/or peri-prostatic tissue) to achieve an effective exposure of the target tissue. 28 of 30 cases had organ-confined disease, and a nerve sparing technique was effectively performed. Eleven AE were reported (ten mild and one moderate) and all resolved with no clinical sequelae. No AE was reported as device-related.
Conclusions: The study results demonstrate that the Magnetic Surgical System can be used in reduced port robotic-assisted laparoscopic prostatectomy surgery in a safe and effective manner. It is interesting to highlight that this new technology might provide assistance in preserving the nerve bundles in order to reduce incontinence and sexual dysfunction in prostatectomy patients.
Source of Funding: None