The Science of Stapling: Staple Form.

Surgical stapling has evolved significantly over time, with the primary goal of improving patient outcomes. This study describes the technological advancements in surgical stapling from the perspective of staple and cartridge design, assessing the impact of staple design when it changes from the traditional B form (also known as 2D staple form) to a three-dimensional form (known as 3D staple form). The change in configuration helps compress a larger surface area of the tissue. The 3D configuration is designed to optimize compression not only underneath each staple but also across staples and multiple staple lines, including both stapled and unstapled regions of the tissue. By achieving more evenly distributed compression throughout the staple line, there is potential for reduced leak paths. The study demonstrates that the 3D staple form in surgical stapling results in more evenly distributed compression. In the future, this advanced technology should seamlessly integrate into emerging systems such as the surgical robot, enabling continued progress in surgical instrumentation and ultimately in surgical care.

A Comparison of the Preclinical Performance of the Echelon™+ Stapler with Thunderbird Reloads to Two Commercial Endoscopic Surgical Staplers.

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.

An umbrella review of the surgical performance of Harmonic ultrasonic devices and impact on patient outcomes.

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.

Improving Performance and Access to Difficult-to-Reach Anatomy with a Powered Articulating Stapler.

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.

The Viscoelastic Behavior of Soft Tissues Must be Accounted for in Stapler Design and Surgeon Technique.

BACKGROUND: Since its adoption as a surgical technique over a half-century ago, stapling has continually undergone improvements, both in the devices used and in our understanding of tissue mechanics. To best design and use stapling devices, it is beneficial to have an intimate knowledge of the response of tissue to compression and stapling dynamics. This paper provides the relevant background in the field of biomechanics, and in particular addresses the viscoelastic behavior of soft tissues under compression. Biomechanics of Stapling: The change in shape of a solid, or strain, is related to the load applied, or stress. Biological tissues are known to have non-linear relationships between stress and strain, and generally the relationships are anisotropic (dependent upon direction). Further complicating matters, there is typically a time-dependency to the relationship for compression and recovery, resulting in viscoelastic behavior. Hence both the amount and rate of compressive force applied can be expected to impact the outcome of stapling. DISCUSSION: The growth of the laparoscopic use of staples has increased the difficulty of device design, as precise control of compression is problematic in extended length staplers. Progressive firing along the cartridge and multi-stage compression have both been found to be beneficial in providing the uniform force needed to produce well-formed staples. Such technical advances can reduce stresses within the stapler, preventing deformation of the stapler arm and undesirable strain in the tissue. Current research includes understanding the effects of changing the rate of compression on staple formation with the hope that further improvements can be achieved in this ever-fruitful method of tissue apposition.

Intraoperative Measures to Reduce the Risk of COVID-19 Transmission During Minimally Invasive Procedures: A Systematic Review and Critical Appraisal of Societies' Recommendations.

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.

A Novel, Easy-to-Use Staple Line Reinforcement for Surgical Staplers.

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.

Microwave ablation compared with radiofrequency ablation for treatment of hepatocellular carcinoma and liver metastases: a systematic review and meta-analysis.

PURPOSE: 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. METHODS: 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. RESULTS: 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. CONCLUSION: 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.

Global hospital and operative costs associated with various ventral cavity procedures: a comprehensive literature review and analysis across regions.

Objectives: The aim of this literature review was to provide a comprehensive report on hospital costs, and cost components, for a range of ventral cavity surgical procedures across three regions of focus: (1) Americas, (2) Europe, Middle East and Africa (EMEA), and (3) Asia-Pacific. Methods: A structured search was performed and utilized a combination of controlled vocabulary (e.g., "Hepatectomy", "Colectomy", "Costs and Cost Analysis") and keywords (e.g. "liver resection", "bowel removal", "economics"). Studies were considered eligible for inclusion if they reported hospital-related costs associated with the procedures of interest. Cost outcomes included operating room (OR) time costs, total OR costs, ward stay costs, total admission costs, OR cost per minute and ward cost per day. All costs were converted to 2018 USD. Results: Total admission costs were observed to be highest in the Americas, with an average cost of $15,791. The average OR time cost per minute was found to vary by region: $24.83 (Americas), $14.29 (Asia-Pacific), and $13.90 (EMEA). A cost-breakdown demonstrated that OR costs typically comprised close to 50%, or more, of hospital admission costs. This review also demonstrates that decreasing OR time by 30 min provides cost savings approximately equivalent to a 1-day reduction in ward time. Conclusion: This literature review provided a comprehensive assessment of hospital costs across various surgical procedures, approaches, and geographical regions. Our findings indicate that novel processes and healthcare technologies that aim to reduce resources such as operating time and hospital stay, can potentially provide resource savings for hospital payers.

Microwave ablation compared with hepatic resection for the treatment of hepatocellular carcinoma and liver metastases: a systematic review and meta-analysis.

BACKGROUND: Hepatic resection (HR) is the gold standard liver cancer treatment, but few patients are eligible due to comorbidities or tumor location. Microwave ablation (MWA) is an important complementary liver cancer treatment to HR. This systematic review compared MWA with HR for liver cancer treatment. METHODS: A systematic search of MEDLINE, EMBASE, and CENTRAL was conducted for randomized and observational studies published from 2006 onwards. The primary outcome was local tumor recurrence (LTR), and a random effects model was used for meta-analyses. RESULTS: Of the 1845 studies identified, 1 randomized and 15 observational studies met the inclusion criteria. LTR was significantly increased with MWA versus HR (risk ratio (RR) = 2.49; P = 0.016). In secondary measures, HR provided significantly higher 3- and 5-year overall survival (RR = 0.94; P = 0.03 and RR = 0.88; P = 0.01, respectively) and 3-year disease-free survival (RR = 0.78; P = 0.009). MWA exhibited significantly shorter length of stay (weighted mean difference (WMD) = - 6.16 days; P < 0.001) and operative time (WMD = - 58.69 min; P < 0.001), less intraoperative blood loss (WMD = - 189.09 mL; P = 0.006), and fewer complications than HR (RR = 0.31; P < 0.001). When MWA was combined with HR and compared with either modality alone, complications and blood loss were significantly lower with the combination treatment; however, there were no differences in other outcomes. Subgroup and sensitivity analyses were generally aligned with the main results. CONCLUSIONS: MWA can be an effective and safe alternative to HR in patients/tumors that are not amenable to resection. More randomized and economic studies should be performed that compare the two treatments, especially to determine the target population that benefits most from MWA.

Comparative meta-analysis of feline leukemia virus and feline immunodeficiency virus seroprevalence correlated with GDP per capita around the globe.

Feline Leukemia Virus (FeLV) and Feline Immunodeficiency Virus (FIV) are two prevalent transmittable diseases for domestic cats. This paper reports the frequency of these two diseases compared globally across Gross Domestic Product (GDP) at purchasing power parity per capita (PPP). Information around FeLV and FIV rates of infection in specific locations around the world was analyzed from 47 published articles. Results show that based on the data available, the statistical model indicates that the highest percentage of FeLV or FIV infected cats live in areas of lower PPP (p ≤.001) with a decreasing rate of infection of FeLV and FIV with increasing income. Two theories for this could be that the lower PPP locations in this study were also in areas of greater feral cat and cat colony populations, as well as were areas with less emphasis on animal welfare and animal control programs. Additional research should be conducted to strengthen the study size in South America and Africa before further conclusions can be drawn.

Procedure costs associated with the use of Harmonic devices compared to conventional techniques in various surgeries: a systematic review and meta-analysis.

BACKGROUND: As compared to conventional techniques, recent meta-analyses have reported cost savings with Harmonic devices; however, only in thyroidectomy. Thus, the aim of this study was to evaluate the costs associated with Harmonic devices versus conventional techniques across a range of surgical procedures. METHODS: A systematic search of MEDLINE, EMBASE, and Cochrane Library was conducted from inception to October 01, 2016 without language restrictions to identify randomized controlled trials comparing Harmonic devices to conventional techniques and reporting procedure costs (operating time plus operating equipment/consumables/device costs). Costs were pooled using the ratio of geometric means, and a random effects model was applied. Sensitivity analyses varying statistical methods, number of included studies, and cost outcomes were completed to test the robustness of the results. RESULTS: Thirteen studies met the inclusion criteria. A total of 561 and 540 participants had procedures performed with Harmonic devices and conventional methods, respectively, with procedures including gastrectomy, thyroidectomy, colectomy, cholecystectomy, Nissen fundoplication, and pancreaticoduodenectomy. As compared to conventional methods, Harmonic devices reduced total procedure costs by 8.7% (p=0.029), resulting in an absolute reduction of US$227.77 from mean conventional technique costs, derived primarily from a reduction in operating time costs. When operating time costs, excluding operating equipment/consumables/device costs, were analyzed, costs were reduced by $544 per procedure with the use of Harmonic devices. The results from all sensitivity analyses demonstrated cost reductions with Harmonic devices. CONCLUSION: This systematic review and meta-analysis showed that despite a higher device cost, Harmonic devices provide a statistically significant reduction in procedure costs, derived primarily from a reduction in operating time costs, across surgical procedures. In addition to functionality benefits, Harmonic devices may represent a potentially cost saving method to reduce overall hospital resource use. Future research should focus on potential costs and benefits from use of Harmonic devices in procedures not covered here.

Initial Assessment of Mucosal Capture and Leak Pressure After Gastrointestinal Stapling in a Porcine Model.

BACKGROUND: Anastomotic leak is a leading cause of morbidity and mortality in gastrointestinal surgery. The serosal aspect of staple lines is commonly observed for integrity, but the mucosal surface and state of mucosa after firing is less often inspected. We sought to assess the degree of mucosal capture when using stapling devices and determine whether incomplete capture influences staple line integrity. METHODS: Porcine ileum was transected in vivo and staple lines were collected and rated for degree of mucosal capture on a 5-point scale from 1 (mucosa mainly captured on both sides) to 5 (majority of mucosa not captured). Mucosal capture was also assessed in ex vivo staple lines, and fluid leakage pressure and location of first leak was assessed. Stapling devices studied were Echelon Flex GST with 60-mm blue (GST60B) and green (GST60G) cartridges, and Medtronic EndoGIA Universal with Tri-Staple Technology™ with 60 mm medium (EGIA60AMT) reloads (purple). RESULTS: GST60B and GST60G staple lines produced significantly better mucosal capture scores than the EGIA60AMT staple lines (p < 0.001, in all tests). Compared to EGIA60AMT, leak pressures were 39% higher for GST60B (p < 0.001) and 23% higher for GST60G (p = 0.022). Initial staple line leak site was associated with incomplete mucosal capture 78% of the time. CONCLUSIONS: There are differences in degree of mucosal capture between commercial staplers, and the devices that produce better mucosal capture had significantly higher leak pressures. Further research is needed to determine the significance of these findings on staple line healing throughout the postoperative period.

Prolonged operative duration is associated with complications: a systematic review and meta-analysis.

BACKGROUND: The aim of this study was to systematically synthesize the large volume of literature reporting on the association between operative duration and complications across various surgical specialties and procedure types. METHODS: An electronic search of PubMed, Cochrane Central Register of Controlled Trials, and Cochrane Database of Systematic Reviews from January 2005 to January 2015 was conducted. Sixty-six observational studies met the inclusion criteria. RESULTS: Pooled analyses showed that the likelihood of complications increased significantly with prolonged operative duration, approximately doubling with operative time thresholds exceeding 2 or more hours. Meta-analyses also demonstrated a 14% increase in the likelihood of complications for every 30 min of additional operating time. CONCLUSIONS: Prolonged operative time is associated with an increase in the risk of complications. Given the adverse consequences of complications, decreased operative times should be a universal goal for surgeons, hospitals, and policy-makers. Future study is recommended on the evaluation of interventions targeted to reducing operating time.

Performance of Harmonic devices in surgical oncology: an umbrella review of the evidence.

BACKGROUND: We performed an umbrella review of systematic reviews summarizing the evidence on the Harmonic scalpel (HS) compared with conventional techniques in surgical oncology (including lymph node dissection). METHODS: We searched MEDLINE, EMBASE, and the Cochrane Database of Systematic Reviews from inception to end of March of 2017 for meta-analyses or systematic reviews of randomized trials comparing HS to conventional techniques in surgical oncology. We assessed the quality of included systematic reviews with AMSTAR (A MeaSurement Tool to Assess systematic Reviews) and assessed the certainty in evidence for each pooled outcome using GRADE (Grading of Recommendations Assessment, Development, and Evaluation). RESULTS: We identified ten systematic reviews on breast cancer (n = 3), gastric cancers (n = 3), oral, head, and neck cancers (n = 1), and colon cancers (n = 3). Most reviews received a higher rating using AMSTAR. For operative time, systematic reviews reported a reduction of 25 to 29 min for HS compared with conventional methods across oncology types, with the exception of breast cancer where little differences were observed (very low to moderate quality of evidence (GRADE)). For blood loss and drainage volume, the majority of reviews reported statistically significant reductions with HS, and reductions ranged from 42 to 141 mL, and from 42 to 292 mL, respectively (very low to moderate quality of evidence). Hospitalization days were reported to decrease with use of HS by 0.2 to 3.2 days; however, reductions were only statistically significant for half of the included reviews (low to moderate quality of evidence). Regarding perioperative complications, two of six reviews reported a significantly reduced risk with HS use (breast cancer surgery) (moderate to high quality evidence)). CONCLUSION: Across surgical oncology types, the majority of included systematic reviews showed a statistically significant or numerical improvement in surgical outcomes with use of the HS compared with conventional methods. Well-designed randomized studies with large sample sizes will help to provide more precise estimates and reduce the risk of heterogeneity.

An in vivo comparison of the efficacy of hemostatic powders, using two porcine bleeding models.

BACKGROUND: Usage of topical hemostatic agents in surgery is increasing, including use during minimally invasive procedures, and even for surgeries that have a low risk of bleeding complications. A novel product, Surgicel® Powder - Absorbable Hemostatic Powder (SP), made from oxidized regenerated cellulose (ORC) fabric, has been developed for adjunctive use in surgical procedures to assist in control of oozing bleeding over broad areas and where access could be difficult with a fabric ORC product. This study compares the new SP to other commercially available hemostatic powder products in two in vivo models. METHODS: Hemostatic efficacy of SP was compared to two polysaccharide-based hemostats in a porcine liver punch biopsy model and to three polysaccharide-based hemostats and one non-regenerated oxidized cellulose hemostat in a porcine liver abrasion model. Primary outcomes measured were hemostatic efficacy, defined as hemostasis within 10 minutes of application, and time-to-hemostasis (TTH). RESULTS: In the punch biopsy model, SP displayed significantly higher effective hemostasis rates than one of the polysaccharide hemostats (p=0.047) and faster TTH than both (p<0.001). In the liver abrasion model, SP had significantly higher effective hemostasis rates (p≤0.002) and faster TTH (p<0.001) than the other four hemostatic agents. The amount of powder applied within the ranges used did not appear to affect hemostatic efficacy. CONCLUSION: In both the liver punch biopsy model of mild to moderate bleeding and the liver abrasion model of mild but diffuse oozing, SP provided more effective hemostasis and faster TTH than other marketed hemostatic powders. The results from this in vivo study suggest that Surgicel Powder may be useful in clinical applications where control of oozing capillary, mild venous, and small arterial hemorrhage is required including bleeding in difficult-to-access locations.

Healing comparison of porcine cutaneous incisions made with cold steel scalpel, standard electrosurgical blade, and a novel tissue dissector.

BACKGROUND: Standard electrosurgery provides superior hemostasis compared to a cold steel scalpel, but inferior tissue healing. A novel electrosurgical blade with an advanced waveform, the MEGADYNE ACE BLADE™ 700 Soft Tissue Dissector (ACE), was designed to provide both excellent hemostasis and wound healing. This study compared ACE to scalpel and standard electrosurgery in a porcine model of wound healing. METHODS: Skin incisions from six pigs were evaluated at time points of 0, 1, 2, 3 and 6 weeks after application of the three devices. Histopathology was performed on samples from each time point. For each non-initial time point, the healing incisions were photographed for later evaluation by expert graders, and excised for wound strength testing. RESULTS: Time 0 photomicrographs showed a gradient of thermal tissue damage by initial incision, ranging from no damage made by the scalpel, minimal damage made by ACE, and twice the ACE damage made by a nonstick PTFE-coated electrosurgical blade. Histopathologic analysis at 6 weeks showed comparable dermal scar width measurements for scalpel and ACE incisions. Scars were wider for incisions made by standard electrosurgical blade. Wound strength was greater for scalpel and ACE than for standard electrosurgery. Cosmetic results at 6 weeks were not significantly different between scalpel and ACE incisions, while standard electrosurgical blade incisions were significantly inferior to ACE (odds ratio: 53.4, p<0.001). CONCLUSION: The MEGADYNE ACE BLADE™ 700 Soft Tissue Dissector represents a significant improvement in electrosurgical technology for skin incisions and dispels the traditional concerns of delayed healing and poor cosmetic result that have been attributed to using conventional electrosurgical blades for skin incisions.

A systematic review and meta-analysis of Harmonic technology compared with conventional techniques in mastectomy and breast-conserving surgery with lymphadenectomy for breast cancer.

BACKGROUND: Mastectomy and breast-conserving surgery (BCS) are important treatment options for breast cancer patients. A previous meta-analysis demonstrated that the risk of certain complications can be reduced with the Harmonic technology compared with conventional methods in mastectomy. However, the meta-analysis did not include studies of BCS patients and focused on a subset of surgical complications. The objective of this study was to compare Harmonic technology and conventional techniques for a range of clinical outcomes and complications in both mastectomy and BCS patients, including axillary lymph node dissection. METHODS: A comprehensive literature search was performed for randomized controlled trials comparing Harmonic technology and conventional methods in breast cancer surgery. Outcome measures included blood loss, drainage volume, total complications, seroma, necrosis, wound infections, ecchymosis, hematoma, hospital length of stay, and operating time. Risk of bias was analyzed for all studies. Meta-analysis was performed using random-effects models for mean differences of continuous variables and a fixed-effects model for risk ratios of dichotomous variables. RESULTS: Twelve studies met the inclusion criteria. Across surgery types, compared to conventional techniques, Harmonic technology reduced total complications by 52% (P=0.002), seroma by 46% (P<0.0001), necrosis by 49% (P=0.04), postoperative chest wall drainage by 46% (P=0.0005), blood loss by 38% (P=0.0005), and length of stay by 22% (P=0.007). Although benefits generally appeared greatest in mastectomy patients with lymph node dissection, Harmonic technology showed significant reductions in complications in the BCS study subgroup. CONCLUSION: In this meta-analysis of both mastectomy and BCS procedures, the use of Harmonic technology reduced the risk of most complications by about half across breast cancer surgery patients. These benefits may be due to superior hemostatic capabilities of Harmonic technology and better dissection, particularly lymph node dissection. Reduction in complications and other resource outcomes may engender lower downstream health care costs.

Thickness of Cadaveric Human Lung Tissue.

BACKGROUND: Choosing the correct surgical staple height is dependent on knowledge of specific tissue thickness and compressibility. The purpose of this study was to measure the thickness of cadaveric human lung tissue. MATERIALS AND METHODS: Between December 2012 and February 2013, whole lungs were procured from 12 donors. Inclusion criteria included negative serology, no prior thoracic surgery, and completion of measurements within 72 hours of death. Tissue thickness was measured in the anterior-to-posterior direction using a tissue measuring device (TMD) at 41 lung locations. The tissue measuring device applied a constant pressure (8 g/mm2) via a plunger for 15 seconds before reading the thickness. RESULTS: Cadaveric lung tissue thickness displayed a large variation by location and within each location. Mean thickness in the anterior-to-posterior direction ranged from 1.5 mm (right middle lobe [inferior peripheral] location) to 9.0 mm (right inferior lobe [mid-central] location). In general, the periphery of the lung lobes was thinner than the central locations (e.g., mean peripheral location thickness: 4.1 mm; mean central location thickness: 5.9 mm). The thinnest tissues among the 12 donor cadaveric lung specimens were found in the one donor with a history of severe emphysema/chronic bronchitis. Height (P = 0.012) and weight (P = 0.036) were positively correlated with tissue thickness. Additionally, after adjusting for height, cadaveric lung tissue was 3.0 mm thicker for females than males. CONCLUSIONS: Large variations of lung tissue thickness were demonstrated throughout the lung as well as within each measured location across different cadaveric specimens. Generally, peripheral locations were thinner than the central locations of the lobes. There was a strong positive correlation between thickness and height, and females had slightly thicker lung tissue than males of the same height.

Hospital costs associated with thyroidectomy performed with a Harmonic device compared to conventional techniques: a systematic review and meta-analysis.

OBJECTIVES: Harmonic devices have become a world-wide standard for dissection and hemostasis in thyroidectomy. Numerous systematic reviews have reported superior operating times, blood loss, post-operative pain, length of stay, and overall safety outcomes. What has not been extensively evaluated in a robust manner is their economic impact. The purpose of this study is to evaluate the hospital costs associated with open thyroidectomy using Harmonic devices compared with conventional techniques for hemostasis. METHODS: A systematic review of Medline, Scopus, and CENTRAL was performed from January 1, 2000 to May 23, 2014 without language restrictions for randomized clinical trials comparing Harmonic surgical devices to conventional methods in thyroidectomy. The main outcome measure was total reported costs. Costs were pooled using the ratio of means and a random effects model. Sensitivity analyses assessed whether differences in patient and trial characteristics, healthcare setting, or choice of statistical model affected outcomes. RESULTS: Seven studies met the inclusion criteria. A total of 476 participants had procedures performed with Harmonic devices and 478 with conventional monopolar electrosurgery and clamp, cut and tie techniques. Compared with conventional techniques, Harmonic devices reduced total reported costs by 10% (p = 0.007), resulting in a $229 US dollars (USD) absolute reduction from mean baseline costs. Results remained relatively robust to additional sensitivity analyses. CONCLUSIONS: This systematic review and meta-analysis demonstrates that the Harmonic family of surgical devices is associated with a reduction in total reported costs in thyroidectomy compared with conventional techniques. A large portion of the overall savings derives from a reduction in operative costs.