Performance of the ENSEAL X1 Curved Jaw Tissue Sealer in thoracic procedures in a Japanese cohort: a case series report.

BACKGROUND: Advanced vessel sealing electrosurgical systems have been widely adopted for grasping, cutting, and sealing vessels. Data remain sparse with regard to its use in thoracic procedures. Thus, a prospective case series, utilizing the ENSEAL X1 Curved Jaw Tissue Sealer (X1CJ) and its companion energy source, the Generator 11 (GEN11), in thoracic procedures was performed in a Japanese cohort. METHODS: Subjects were recruited at two Japanese surgical sites. The primary endpoint of this post-market study was the achievement of hemostasis (≤ Grade 3) for each thoracic vessel transection. Performance endpoints included scores for tasks completed with X1CJ (adhesiolysis, lymphatics or tissue bundles divided, tissue grasping, tissue cutting, or tissue dissection); hemostasis grading vessel transected; additional products required to achieve hemostasis for Grade 4 vessel transections. Safety was evaluated by evaluating device-related adverse events. All endpoint data were summarized. RESULTS: Forty subjects (50.0% female) of Asian ethnicity with a mean age of 67.6 ± 11.3 years underwent a lung resection. Estimated mean blood loss was 39.5 mL. Hemostasis was achieved in 97.5% of vessel transections. Thirty-seven vessel sealings resulted in a hemostatic Grade 1 (92.5%). All surgeons reported satisfaction/neutral in terms of tissue grasping (100.0%) while most reported satisfaction/neutral with tissue cutting (95.7%). One device-related serious adverse event was reported (2.5%), a chylothorax requiring an extension of hospitalization. There was no post-operative bleeding or deaths reported during the study period. CONCLUSION: The X1CJ demonstrated safe and effective performance without any reports of significant intra-operative or post-operative hemorrhage in thoracic vessel sealing.

Lipid deposition on contact lenses in symptomatic and asymptomatic contact lens wearers.

PURPOSE: Lipid deposition on contact lenses (CL) has traditionally been believed to reduce comfort during CL wear. The purpose of this study was to quantify lipid deposition on CL in a group of symptomatic and asymptomatic adapted CL wearers. METHODS: This was a single-masked, randomized clinical trial. Only confirmed symptomatic (comfortable lens wear time (CWT) < 8 h and a noticeable reduction in comfort over the course of the day) and asymptomatic (CWT > 10 h and minimal reduction in comfort over the course of the day) participants were recruited to participate in the study. Participants wore senofilcon A lenses in combination with a polyquaternium-based care solution (OPTI-FREE Replenish). Worn CL samples were collected on Day 14. Deposited lipid amounts from the lenses (including cholesteryl ester, cholesterol and triolein) were quantified using a liquid chromatography-mass spectrometry technique. RESULTS: Lipid deposition was significantly higher in CL extracts of asymptomatic wearers compared to the symptomatic wearers for all lipid types quantified, including cholesteryl ester (2.1 ± 0.6 vs 1.6 ± 0.5 log µg/lens), cholesterol (1.5 ± 0.3 vs 1.1 ± 0.3 log µg/lens) and triolein (0.3 ± 0.2 vs 0.1 ± 0.1 log µg/lens) (all p < 0.002). The amount of cholesteryl ester deposited was greatest (p = 0.0001), followed by cholesterol, then triolein, for both the asymptomatic and symptomatic groups (both p = 0.0001). CONCLUSION: This study demonstrated that the asymptomatic group deposited a significantly greater amount of lipid on their CL. Although lipid levels measured are considered low to trigger any observable clinical deposition, they may influence other clinical outcomes, particularly comfort.

Predisposing factors for solution-induced corneal staining.

PURPOSE: To evaluate predisposing factors in subjects susceptible to solution-induced corneal staining (SICS). METHODS: Four hundred forty-six existing soft contact lens wearers were randomly fitted with one of two study lenses (lotrafilcon B, CIBA Vision, or omafilcon A, CooperVision) and used a hydrogen peroxide care system (Clear Care, CIBAVision) for a 1-month period. Each subject was then challenged with the same lenses presoaked in a multipurpose solution (ReNu MultiPlus, Bausch & Lomb) and assessed after approximately 2 h to be categorized as either "stainers" or "non-stainers" based on whether they showed a classic SICS pattern (diffuse punctate corneal staining in three or more peripheral quadrants). RESULTS: Overall, 36% (155 of 425) of eligible subjects were classified as stainers and included a higher proportion of omafilcon wearers: 44% (91 of 205) vs. 29% (64 of 220). After using the peroxide system, the stainers were more likely to show poorer wetting (odds ratio [OR] = 1.76, p = 0.02) compared with the non-stainers. Lens wetting showed a significant negative correlation with film deposits (r = -0.63, p < 0.0001, n = 425). Furthermore, on slit lamp examination, the stainers were more likely to show higher levels of upper- and lower-palpebral hyperemia (OR = 2.18, p = 0.02; OR = 1.93, p = 0.04), tarsal roughness (OR = 1.71, p = 0.01), corneal staining (OR = 17.1, p < 0.0001), and conjunctival staining (OR = 1.94, p = 0.004). Although not exposed to preservatives, twice as many eyes in the stainers group had some level of corneal staining: 51% vs. 25%. There were no significant differences between the stainers and non-stainers with respect to age, sex, refraction, or keratometry (p > 0.05). CONCLUSIONS: This study highlighted some notable trends in patients susceptible to SICS. The findings point toward poor tear quality as a predisposing factor for SICS.