Jeffrey Warren Clymer

Background: Electrosurgery has evolved significantly since its inception, with advancements in generator technology improving safety and efficacy. This study evaluates the performance and usability of the Dualto Energy System, a new multi-modal surgical energy platform combining core electrosurgery with enhanced monopolar, advanced bipolar, and ultrasonic capabilities. Methods: Benchtop testing assessed vessel sealing strength and thermal spread of Dualto compared to existing electrosurgical generators (GEN11 and MEGEN1) using various energy modalities and devices. Waveform and energy analysis was used to confirm electrical isolation of Dualto generators in expanded configuration. Preclinical studies evaluated hemostasis, thermal damage, and tissue healing in acute and chronic animal models. Surveys were conducted with surgeons, nurses, and biomedical technicians to assess usability and perceived benefits. An acquisition cost calculator was developed to estimate potential cost savings associated with Dualto implementation. Results: Benchtop testing demonstrated non-inferior vessel burst pressure for Dualto compared to GEN11. Thermal spread was comparable between generators, with slight increases observed in specific Dualto monopolar modes. Waveform analysis confirmed electrical isolation of Dualto generators. Dualto exhibited significantly faster frequency lock and transection speeds for ultrasonic devices. Preclinical studies demonstrated non-inferior hemostasis and thermal damage profiles for Dualto in both single and expanded configurations. Chronic preclinical studies met success criteria for hemostasis and tissue healing. HCP survey results indicated positive user perceptions regarding Dualto usability, efficiency, and potential cost savings. The cost calculator projected potential annual savings through reduced operating room time and maintenance. Conclusion: The Dualto Energy System demonstrates comparable or improved performance across multiple energy modalities compared to existing systems. Its modular design, combined with positive user feedback and potential cost savings, suggests that Dualto will be a useful addition to surgical energy technology in the operating room.

Background: Design of surgical staplers continues to advance with more consistent staple formation that can lead to higher leak pressures and lower rates of leak along the staple line. This study was performed to compare the Ethicon Echelon™+ Stapler with Thunderbird reloads to two other currently available commercial staplers, Reach Anzhi and Fulbright Lunar with corresponding reloads. Methods: The rate of malformed staples for three staplers was determined in porcine stomach (3.0– 3.3 mm thickness) via CT scanning. Staple line air leak pressures in bronchial tissue (3.0– 3.3 mm) and fluid leak pressures in colon (1.3– 1.7 mm) were measured and compared to a standard success criterion for both tissues. Results: The rate of malformed staples in gastric tissue for Echelon+ was more than 90% lower than for the two other commercial staplers (p < 0.001). In bronchus, Echelon+ had 56% higher air leak pressures than Reach Anzhi (p < 0.001) and was not significantly different from Fulbright Lunar. In colon, Echelon+ had over twice the fluid leak pressures of the comparators (p < 0.001). Conclusion: The Echelon+ Stapler with Thunderbird reloads exhibited a low rate of malformed staples, and its staple lines withstood high leak pressures in both thick and thin tissues. Clinical studies are needed to confirm that these observed benefits carry over into actual practice.

Background: For thirty years, the Harmonic scalpel has been used for precise dissection, sealing and transection. There are numerous meta-analyses on individual surgical procedures with Harmonic, but no overarching review covering all the areas. This umbrella review seeks to summarize the clinical results from the use of Harmonic across surgical fields and broadly quantify its effects on patient outcomes.Methods: MEDLINE, EMBASE, and Cochrane Databases were searched for meta-analyses (MAs) of randomized controlled trials (RCTs) comparing Harmonic devices to conventional techniques or advanced bipolar (ABP) devices. For each procedure type, the most comprehensive MAs were evaluated. RCTs not already analysed in a MA were also included. Operating time, length of stay, intraoperative blood loss, drainage volume, pain, and overall complications were evaluated, and the methodological quality and certainty of evidence were assessed.Results: Twenty-four systematic literature reviews were identified on colectomy, hemorrhoidectomy, gastrectomy, mastectomy, flap harvesting, cholecystectomy, thyroidectomy, tonsillectomy, and neck dissection. There were also 83 RCTs included. In every MA evaluated, Harmonic devices were associated with either statistically significant or numerical improvements in every outcome compared with conventional techniques; most MAs reported a reduction in operating time of ≥ 25 min. Harmonic versus ABP device MAs in colectomy and thyroidectomy showed no significant differences in outcomes.Conclusion: Across surgical procedures, Harmonic devices demonstrated improved patient outcomes for operating time, length of stay, intraoperative bleeding, drainage volume, pain, and overall complications compared to conventional techniques. Additional studies are required to assess differences between Harmonic and ABP devices.

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Background: Modern surgical staplers should provide precise placement and transection, especially in tight spaces and on thick tissue. Ideally, a stapler would move to accommodate variations in the tissue and anatomy instead of having to move the tissue around to fit the stapler. This study was undertaken to evaluate the performance characteristics of the new Echelon 3000 Stapler (ECH3). Use of the ECH3 was compared to another marketed stapler, including tests for access, seal strength, staple formation in thick tissue, and end effector stability. Methods: Pelvic anatomy measurements were used to construct a virtual model of a Low Anterior Resection (LAR). Monte Carlo simulations were performed on the staplers to compare the probability of completing a transection with one or two firings. Using water infusion of stapled porcine ileum, pressure at first leak and percentage of leaks at critical pressures were measured. Rate of malformed staples was measured in thick tissue. End effector stability while firing and under moderate pressure were compared between staplers. After use, surgeons were surveyed on the functionality of the device. Results: ECH3 had a markedly higher probability of completing an LAR transection in one or two firings than the comparator stapler. Median initial leak pressure of stapled ileum was significantly higher, and rate of leaks was lower at 40 and 50 mmHg. ECH3 had fewer malformed staples for both 3.3- and 4.0-mm thick tissue. The end effector exhibited less angular movement during firing, and less deflection under a moderate load. Surgeons agreed the ECH3 provided precise placement and easy one-handed operation. Conclusion: The Echelon 3000 Stapler demonstrated improved access capability, tighter seals, fewer malformed staples, and greater end effector stability. These advantages were recognized by surgeons who evaluated the use of the device preclinically.

Background: The coronavirus 2019 pandemic and the hypothetical risk of virus transmission through aerosolized CO₂ or surgical smoke produced during minimally invasive surgery (MIS) procedures have prompted societies to issue recommendations on measures to reduce this risk. The aim of this systematic review is to identify, summarize and critically appraise recommendations from surgical societies on intraoperative measures to reduce the risk of severe acute respiratory syndrome coronavirus 2 transmission to the operative room (OR) staff during MIS. Methods: Medline, Embase, and Google Scholar databases were searched using a search strategy or free terms. The search was supplemented with searches of additional relevant records on coronavirus 2019 resource websites from Surgical Associations and Societies. Recommendations published by surgical societies that reported on the intraoperative methods to reduce the risk of severe acute respiratory syndrome coronavirus 2 transmission to the OR staff during MIS were also reviewed for inclusion. Expert opinion articles were excluded. A preliminary synthesis was performed of the extracted data to categorize and itemize the different types of recommendations. The results were then summarized in a narrative synthesis. Results: Thirty-three recommendation were included in the study. Most recommendations were targeted to general surgery (13) and gynecology (8). Areas covered by the documents were recommendations on performance of laparoscopic/robotic surgery versus open approach (28 documents), selection of surgical staff (13), management of pneumoperitoneum (33), use of energy devices (20), and management of surgical smoke and pneumoperitoneum desufflation (33) with varying degree of consensus on the specific recommendations among the documents. Conclusions: While some of the early recommendations advised against the use of MIS, they were not strictly based on the available scientific evidence. After further consideration of the literature and of the well-known benefits of laparoscopy to the patient, later recommendations shifted to encouraging the use of MIS as long as adequate precautions could be taken to protect the safety of the OR staff. The release and implementation of recommendations should be based on evidence-based practices that allows health care systems to provide safe surgical and medical assistance.

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OA Text is an independent open-access scientific publisher showcases innovative research and ideas aimed at improving health by linking research and practice to the benefit of society.

Background: Staple line reinforcement (SLR) is a popular tool used by surgeons to increase staple line strength and improve peri-operative hemostasis. However, currently marketed buttress materials require special attention in attachment to the staple anvil and cartridge and may come loose during typical maneuvering of stapling procedures. We have evaluated a new SLR that has an attachment material that affixes buttress across the entire anvil and cartridge face to prevent slipping, twisting, sliding and/or bunching. Methods: In benchtop and preclinical testing, the new buttress material (ECHELON ENDOPATH™ Staple Line Reinforcement) was compared to a commercially available SLR for physical characteristics, including strength, absorption, security on the anvil and cartridge during stapler manipulation, impact on the tissue healing response and tissue abrasion. The two SLR’s were also compared to a staple line without buttress for hemostasis. Results: The new SLR was 180% stronger initially and maintained a greater strength for up to 14 days of exposure to an in vitro solution (p≤ 0.001), even though it was lighter and exhibited a faster rate of degradation. The new buttress material maintained complete adherence to the anvil and cartridge throughout tissue manipulation, whereas the commercial product lost substantial coverage in 72% of samples. Both SLR’s provided superior hemostasis to the non-buttress control, with minimal impact on tissue healing or abrasion. Conclusion: Because the new buttress material comes with attachment material affixed across the entire anvil and cartridge face of the stapler and maintains coverage during manipulations, it should be much easier to use. The physical characteristics of the new SLR were as good as or better than current product that requires the buttress to be applied to the cartridge and anvil. In addition, the new SLR is similar in hemostasis to standard products and superior to stapling without the use of buttress. Further research is needed to determine whether these preclinical benefits carry over into a clinical setting.

Percutaneous ablation techniques, including microwave ablation (MWA) and radiofrequency ablation (RFA), have become important minimally invasive treatment options for liver cancer. This systematic review compared MWA with RFA for treatment of liver cancer. The systematic review and meta-analysis followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. A systematic search of MEDLINE, EMBASE, and Cochrane Central Register of Controlled Trials was conducted for randomized and observational studies published from 2006 onwards. A random-effects model was used for meta-analyses and local tumor progression (LTP), technique efficacy, overall survival (OS), disease-free survival (DFS), intrahepatic de novo lesions (IDL), extrahepatic metastases (EHM), length of stay (LOS), and complications were analyzed. Subgroup and sensitivity analyses were also conducted. Of 1379 studies identified, 28 randomized and observational studies met inclusion criteria. The main analysis demonstrated that LTP was significantly reduced by 30% with MWA versus RFA (RR=0.70; P=0.02) (all studies) and by 45% with MWA versus RFA (RR=0.55; P=0.007) (randomized studies only). There were no significant differences between MWA and RFA for other efficacy and safety outcomes. Higher frequency (2450 MHz) and larger tumor size (≥2.5 cm) are amongst variables that may be associated with improved outcomes for MWA. Sensitivity analyses were generally congruent with the main results. MWA is at least as safe and effective as RFA for treating liver cancer and demonstrated significantly reduced LTP rates. Future studies should assess time and costs associated with these two treatment modalities.