July 24, 2009
Sorin ClearGlide® Endoscopic Vessel Harvesting, “The Vessel Without the Trauma”
On July 16, 2009, The New England Journal of Medicine (Vol. 361, No. 3), published a paper entitled, “Endoscopic versus Open Vein-Graft Harvesting in Coronary-Artery Bypass Surgery” 1 authored by Dr. Renato D. Lopes, et al. Dr. Lopes and colleagues analyzed the impact of vein-graft harvesting techniques and patient outcomes of 3,014 patients undergoing coronary-artery bypass grafting. The Lopes paper is based on a retrospective cohort study using data from the PREVENT IV study reported in 2005. They concluded that “endoscopic vein-graft harvesting is independently associated with vein-graft failure and adverse clinical outcomes” while noting that randomized trials are needed. The paper also stated: “At the time of the PREVENT IV trial, at least two different endoscopic devices for harvesting the vein were commercially available. These devices use different techniques to harvest the vein, and these differences could have played a role in our findings.”
Open CO2 vs. Closed CO2 EVH systems
The Sorin ClearGlide is an open CO2 EVH system. It is not dependent on gas insufflation to maintain tissue separation and/or the tunnel. With no reliance on closed gas insufflation, as there is with other systems, ClearGlide has little to no risk of CO2 embolism. Also, our patented, offset bipolar electrode provides the only lockable jaw in the market, and operates at only 28˚ C compared to double the temperatures seen with other devices.
In addition to embolism, intraluminal clot formation is another concern with EVH. Emile Brown et al hypothesized that sealed carbon dioxide insufflation causes stagnation of blood within the saphenous vein in the paper entitled, “Strategies to reduce intraluminal clot formation in endoscopically harvested saphenous veins.”2 Brown concluded that “an open carbon dioxide endoscopic vein harvest system can significantly lessen the complication of clot formation.” With the Sorin ClearGlide system, a more consistent flow of blood occurs during the procedure without the use of heparin as proven in the study via CT angiography post surgery.
Event-Free Survival Study
The Sorin ClearGlide was also the sole EVH system used in a study on event-free survival vs. traditional vein harvesting techniques. The paper titled, “Influence of Endoscopic versus Traditional Saphenectomy on Event-Free Survival: Five-Year Follow-up of a Prospective Randomized Trial” 3 written by Dr. Keith Allen et al, addressed whether graft patency and event-free survival are influenced by the harvest method. Their method was prospectively randomized comparing the Sorin ClearGlide system versus a traditional longitudinal, open harvest incision without skin bridges.
The follow up was 100% at five years and concluded that the two methods yielded similar event-free survival. Additionally, Dr. Allen stated that leg wound complications were reduced from 19% to 4% while the number of outpatient visits required to manage each wound complication to complete resolution was significantly less following endoscopic vein harvest using Sorin ClearGlide.
Sorin ClearGlide Precision Bipolar
The bipolar device within an EVH system is used to cauterize and divide tissue. When cauterizing, the temperature at the point of tissue contact can have an impact on the quality of the harvested vessel. The ClearGlide Precision Bipolar cauterizes at much lower temperatures than other EVH devices. The collateral thermal spread is also significant reducing the risk of intimal hyperplasia of the harvested vessel graft.4 Due to our flexibility with our instruments, there is no need of a vein manipulation or locking system that tends to strain the venous intima and the branches. Therefore, there is less intimal trauma to the veins harvested with our ClearGlide system.
Sorin Group contends that the ClearGlide Endoscopic Vessel Harvesting System provides a better quality conduit through minimal vein manipulation, open CO2 harvest, and less thermal damage with our offset patented bipolar electrodes resulting in better patient outcomes. We encourage you to consider the methodology of where and how the data was collected as well as the fundamental differences in the design of the EVH systems in the market place. Finally, please consult with your local Sorin Group Procedural Specialist, Account Executive or visit our website at www.soringroup-usa.com/EVH for additional information.
Regards,
Jim Trevor
U.S. Country Leader
SVP Cardiopulmonary Business Unit
References:
1 Lopes et al. Endoscopic versus Open Vein-Graft Harvesting in Coronary-Artery Bypass Surgery,
The New England Journal of Medicine 2009; 361:235-244.
2 Brown et al. Strategies to reduce intraluminal clot formation in endoscopically harvested saphenous veins,
The Journal of Thoracic and Cardiovascular Surgery;134(5):1259-1265.
3 Allen et al. Influence of Endoscopic versus Traditional Saphenectomy on Event-Free Survival:
Five Year Follow- up of a Prospective Randomized Trial, The Heart Surgery Forum; 2003; (6), (6), E143-E145.
4 Allen. A Comparison of Endoscopic Thermal Dissectors Regarding Vascular and
Thermal Injury, Surgical Physician Assistant; January 2003.