Medical Devices-Evidence and Research最新文献

{"title":"Increasing Incremental Burden of Surgical Bleeding Associated with Multiple Comorbidities as Measured by the Elixhauser Comorbidity Index: A Retrospective Database Analysis.","authors":"Mosadoluwa Afolabi, Stephen S Johnston, Pranjal Tewari, Walter A Danker","doi":"10.2147/MDER.S434779","DOIUrl":"https://doi.org/10.2147/MDER.S434779","url":null,"abstract":"<p><strong>Purpose: </strong>Disruptive bleeding can complicate surgical procedures, increasing resource use, and impacting patients' well-being. This study aims to elucidate the impact of comorbidity on the risk of disruptive surgical-related bleeding and selected transfusion-associated complications, as well as the incremental cost of such bleeding.</p><p><strong>Patients and methods: </strong>This retrospective analysis of the Premier Healthcare Database included patients who were age ≥18 years and who had a procedure of interest between 1-Jan-2019-31-Dec-2019: cholecystectomy, coronary artery bypass grafting, cystectomy, hepatectomy, hysterectomy, pancreatectomy, peripheral vascular, thoracic, and valve procedures (first=index). The Elixhauser comorbidity index was assessed on index date and patients were grouped by cumulative comorbidity score (0, 1, 2, 3, 4, 5, ≥6). Outcomes, all measured as in-hospital during index, included bleeding (diagnosis and/or intervention for bleeding), transfusion-associated complications (diagnosis of infection, acute renal failure, or vascular events), and incremental total hospital costs associated with bleeding. Multivariable generalized linear models were used to examine the association of comorbidity/bleeding with outcomes.</p><p><strong>Results: </strong>Of the 304,074 patients included, 7% experienced bleeding. The Elixhauser scores were distributed as follows: 0=29%, 1=23%, 2=18%, 3=12%, 4=8%, 5=5%, ≥6=5%. Odds of bleeding significantly increased with Elixhauser score: 1 comorbidity vs 0 (odds ratio [OR] =1.30, 95% confidence interval [95% CI] =1.19-1.43), and this trend continued to surge (≥6 comorbidities [OR=3.22, 95% CI=2.94-3.53]). Similarly, the odds of transfusion-associated complications significantly increased with comorbidities score: 1 comorbidity vs 0 (OR=2.14, 95% CI=1.88-2.34), ≥6 comorbidities vs 0 (OR=12.37, 95% CI=10.80-14.16). The incremental cost of bleeding also increased with comorbidities score; per-patient costs with and without bleeding were $18,132 vs $13,190, p < 0.001 among patients with 0 comorbidities and $28,952 vs $19,623, p < 0.001 among patients with ≥6 comorbidities.</p><p><strong>Conclusion: </strong>Higher comorbidity burden was associated with significant increases in the risk of surgical bleeding, subsequent transfusion-related complications, and incremental cost burden of bleeding.</p>","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":"16 ","pages":"237-249"},"PeriodicalIF":1.3,"publicationDate":"2023-12-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10706582/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138804752","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Noninvasive Point of Care Device for Assessing Cardiac Response to Acute Volume Changes.","authors":"Harry A Silber,&nbsp;Nisha A Gilotra,&nbsp;Thomas L Miller","doi":"10.2147/MDER.S416845","DOIUrl":"https://doi.org/10.2147/MDER.S416845","url":null,"abstract":"<p><strong>Purpose: </strong>The change in the amplitude of a peripheral pulse in response to a Valsalva maneuver has diagnostic utility for assessing volume status at the bedside. We have developed a device to automatically quantify the Valsalva pulse response (VPR) to a standardized Valsalva maneuver that the device guides a user to perform. In this study, we sought to determine whether VPR by the device, Indicor, is sensitive enough to detect the acute increase in central pressure and volume load that occurs with a passive leg raise (PLR) in healthy volunteers.</p><p><strong>Methods: </strong>Healthy volunteers were tested semirecumbently at 45 degrees, then again after being leaned back on a pivoted wedge with legs raised at 45 degrees and torso and head flat, and then again in the semirecumbent position. The device recorded a finger photoplethysmography (PPG) signal during a 10-second expiratory effort of 20 mmHg as guided by the device. VPR was automatically calculated as the ratio of the end-Valsalva pulse amplitude to the baseline pulse amplitude.</p><p><strong>Results: </strong>In the 30 participants who completed testing, VPR increased from baseline to PLR in every participant, from 0.34 ± 0.13 to 0.60 ± 0.14 (p < 0.0001). Back upright, VPR decreased back to 0.33 ± 0.10 (p < 0.0001 versus PLR; NS versus baseline position).</p><p><strong>Conclusion: </strong>In this proof-of-concept study of healthy participants, the Indicor device, a noninvasive, convenient device that automatically calculates VPR from a finger photoplethysmography signal during a standardized Valsalva maneuver, was sensitive enough to detect the increase in VPR that occurred with an acute central volume load from a PLR. Future studies should examine whether VPR responds differently to a PLR in heart failure patients with abnormal cardiac performance and/or congestion.</p>","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":"16 ","pages":"219-227"},"PeriodicalIF":1.3,"publicationDate":"2023-10-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10614661/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"71427759","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"An Innovative Design for the Vaginal Speculum.","authors":"Jean M Bouquet,&nbsp;Rayyan Naji,&nbsp;Carlos A Armas,&nbsp;Valentina Roldan,&nbsp;Shadi Selkhi,&nbsp;Camille Z Bentley,&nbsp;Isain Zapata,&nbsp;Jensen Fisher","doi":"10.2147/MDER.S415558","DOIUrl":"https://doi.org/10.2147/MDER.S415558","url":null,"abstract":"<p><strong>Introduction: </strong>The main objective of this study is to evaluate the effectiveness of a newly designed vaginal speculum, the <i>Bouquet Speculum</i>, in-vitro. The setting of this study was at Florida International University and involved four senior students in the Department of Biomedical Engineering.</p><p><strong>Methods: </strong>A phantom vaginal model was used to test three variables of the <i>Bouquet Speculum</i> (Visibility, Pressure and Gynecologic Tools tests). As this was bench-lab testing with simulated models, no human participants were involved in this study.</p><p><strong>Results: </strong>The results of this in-vitro study are as follows: The <i>visibility test</i> demonstrated statistically better visualization of the cervix and the cervical os (sampling area for pap tests) with the <i>Bouquet Speculum</i> over the existing 2-bladed speculum at all intrapelvic pressures; The <i>pressure test</i> demonstrated an equal radial distribution of force, without breakage, across the <i>Bouquet Speculum</i>; The <i>gynecologic tools test</i> demonstrated that the <i>Bouquet Speculum</i> is compatible with the existing speculum and standard gynecologic tools in terms of retrieving samples and accessing the cervical os and entire cervix during gynecologic procedures and screening.</p><p><strong>Conclusion: </strong>The gynecologic screening and procedural value of this innovative change in the design of the vaginal speculum could save hundreds of thousands of lives every year, provide a more comfortable exam for the patient, and result in a more efficient and user-friendly provider experience.</p>","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":"16 ","pages":"211-218"},"PeriodicalIF":1.3,"publicationDate":"2023-09-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/c6/b5/mder-16-211.PMC10542509.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"41173421","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Incremental Healthcare Cost Implications of Retreatment Following Ureteroscopy or Percutaneous Nephrolithotomy for Upper Urinary Tract Stones: A Population-Based Study of Commercially-Insured US Adults.","authors":"Stephen S Johnston,&nbsp;Brian Po-Han Chen,&nbsp;Pragya Rai,&nbsp;Philippe Grange,&nbsp;Harikumaran R Dwarakanathan,&nbsp;Tony Amos,&nbsp;Barbara H Johnson,&nbsp;Sudip K Ghosh,&nbsp;Noor Buchholz","doi":"10.2147/MDER.S384823","DOIUrl":"https://doi.org/10.2147/MDER.S384823","url":null,"abstract":"<p><strong>Purpose: </strong>This study describes the incremental healthcare costs associated with retreatment among adults undergoing ureteroscopy (URS) or percutaneous nephrolithotomy (PCNL) for upper urinary tract stones (UUTS).</p><p><strong>Patients and methods: </strong>The IBM^® MarketScan^® Commercial Database was used to identify adults aged 18-64 years with UUTS treated with URS or PCNL between January 2010 and December 2019. Patients had 12 months of continuous insurance coverage before (baseline) and after (follow-up) the first (index) procedure. The primary outcome was total all-cause healthcare costs measured over the 365-day follow-up period, not inclusive of index costs. Generalized linear models were used to estimate the incremental costs associated with retreatment within 90 (early) or 91-365 days post-index (later) relative no retreatment. The models adjusted for demographics, comorbidities, stone(s) location, treatment setting, procedural characteristics (eg, 1-step vs 2-step PCNL) and index year.</p><p><strong>Results: </strong>Approximately 23% (27,402/119,800) of URS patients were retreated (82% had early retreatments). The adjusted mean total cost was $10,478 (95% CI: $10,281-$10,675) for patients with no retreatment, $25,476 (95% CI: $24,947-$26,004) for early retreatment ($14,998 incremental increase, p<0.01), and $32,868 [95% CI: $31,887-$33,850] for later retreatment ($22,391 incremental increase, p<0.01). Approximately 36% (1957/5516) of PCNL patients were retreated (78% had early retreatments). The adjusted mean total cost was $13,446 (95% CI: $12,659-$14,273) for patients with no retreatment, $37,036 [95% CI: $34,926-$39,145]) for early retreatment ($23,570 incremental increase, p<0.01), and $35,359 (95% CI: $32,234-$38,484) for later retreatment ($21,893 incremental increase, p<0.01).</p><p><strong>Conclusion: </strong>Retreatment during the first year following URS or PCNL was needed in 23% and 36% of patients, respectively, and was associated with an economic burden of up to $23,500 per patient. The high rate of retreatment and associated costs demonstrate there is an unmet need to improve mid- to long-term results in URS and PCNL.</p>","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":" ","pages":"371-384"},"PeriodicalIF":1.3,"publicationDate":"2022-11-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/01/6e/mder-15-371.PMC9662022.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"40692739","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Revision of Failed Sacroiliac Joint Posterior Interpositional Structural Allograft Stabilization with Lateral Porous Titanium Implants: A Multicenter Case Series [Response to Letter].","authors":"Andy Kranenburg,&nbsp;Gabriel Garcia-Diaz,&nbsp;Judson H Cook,&nbsp;Michael Thambuswamy,&nbsp;Whitney James,&nbsp;David Stevens,&nbsp;Adam Bruggeman,&nbsp;Ying Chen,&nbsp;Robyn Capobianco,&nbsp;W Carlton Reckling,&nbsp;Joel D Siegal","doi":"10.2147/MDER.S388473","DOIUrl":"https://doi.org/10.2147/MDER.S388473","url":null,"abstract":"1Southern Oregon Orthopedics, Medford, OR, USA; 2OrthoSpine Advance Health, Inc, Merced, CA, USA; 3Central Texas Brain and Spine, Austin, TX, USA; 4Oklahoma Spine & Brain Institute, Tulsa, OK, USA; 5James Marco Health, Prescott, AZ, USA; 6Utah Spine Specialists, Bountiful, UT, USA; 7Texas Spine Care Center, San Antonio, TX, USA; 8OrthoNeuro Inc, New Albany, OH, USA; 9SI-BONE Inc, Santa Clara, CA, USA; 10Key Clinics LLC, Mayfield Heights, OH, USA","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":" ","pages":"367-369"},"PeriodicalIF":1.3,"publicationDate":"2022-10-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/bd/24/mder-15-367.PMC9587730.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"40568923","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Revision of Failed Sacroiliac Joint Posterior Interpositional Structural Allograft Stabilization with Lateral Porous Titanium Implants: A Multicenter Case Series [Letter].","authors":"Timothy R Deer,&nbsp;Douglas P Beall,&nbsp;Steven M Falowski","doi":"10.2147/MDER.S385627","DOIUrl":"https://doi.org/10.2147/MDER.S385627","url":null,"abstract":"","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":" ","pages":"365-366"},"PeriodicalIF":1.3,"publicationDate":"2022-10-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/80/f0/mder-15-365.PMC9586172.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"40675605","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Risk Identification and Analysis in the Development of Medical Devices Among Start-Ups: Towards a Broader Risk Management Framework.","authors":"Omar Kheir,&nbsp;Alexis Jacoby,&nbsp;Stijn Verwulgen","doi":"10.2147/MDER.S375977","DOIUrl":"https://doi.org/10.2147/MDER.S375977","url":null,"abstract":"<p><strong>Introduction: </strong>Whilst risk management has become fundamental in the development of medical devices, enforced by regulations and international standards, there is still no comprehensive model that explains how risk management in medical devices' development should be tackled, especially with regard to the type of risks that should be addressed. Risk management in the medical devices' development field is currently focused on technical risks, comprising product, usability, and development process risks, in alignment with standards' requirements and regulations, without giving enough attention to non-technical risks, which include business and project risks. Start-ups within this heavily regulated domain have a key role in the innovation process, yet they suffer a structural lack of tangible, such as financial capacity, and intangible resources such as development, risk management, and regulations' compliance. Nonetheless, they can still optimize their risk identification coverage beyond the enforced requirements to increase their products' chances of success.</p><p><strong>Methods: </strong>A set of qualitative interviews, serving the adopted grounded theory building research method, with seven start-ups who are involved in the development, commercialization, and quality control of medical devices was accomplished. The purpose was to determine the applied risk management practices and most importantly identify the risk types covered by them. Since every start-up is a project by itself, a sample of project risks, as identified by the project management institute, was utilized to scope the risk coverage and flag missing non-technical risks by the participating start-ups.</p><p><strong>Results: </strong>Un-identified risk types, lack of involvement of the right teams, and other related loopholes were presented.</p><p><strong>Discussion: </strong>A list of requirements was developed and sketched in a user-friendly risk management framework, which is believed to be crucial in helping start-ups attain successful, safe, and regulatory compliant medical devices production, is shared in the discussion and proposed framework section of this paper.</p>","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":" ","pages":"349-363"},"PeriodicalIF":1.3,"publicationDate":"2022-09-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/9f/3b/mder-15-349.PMC9507292.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"33484276","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Lens Autofluorescence Based Advanced Glycation End Products (AGEs) Measurement to Assess Risk of Osteopenia Among Individuals Under the Age of 50.","authors":"Shaoyun Li,&nbsp;Yuefei Li,&nbsp;Xiyan Xu,&nbsp;Jian Shao,&nbsp;Ruifeng Xie,&nbsp;Sheng Liu,&nbsp;Li Peng,&nbsp;Jin Wang,&nbsp;Kaixin Zhou,&nbsp;Huyi Feng","doi":"10.2147/MDER.S381115","DOIUrl":"https://doi.org/10.2147/MDER.S381115","url":null,"abstract":"<p><strong>Introduction: </strong>Simple non-invasive biomarker is urgently needed to detect the largely silent osteopenia in order to prevent osteoporosis-related fracture later in life. The accumulation of advanced glycation end products (AGEs) has been related to reduced bone density and osteoporotic fractures. Whether lens autofluorescence (LAF) based AGEs (LAF-AGEs) measurement could be used to assess the risk of osteopenia is aimed to investigate in this paper.</p><p><strong>Methods: </strong>Through routine health examination, 368 individuals under the age of 50 were enrolled. A dual-energy X-ray absorptiometry (DXA) device was used to measure bone mineral density (BMD) of the forearm and determine osteopenia. AGE levels were derived with LAF along with the other demographic and laboratory parameters. After deriving the age-adjusted AGE levels (AALs), a linear regression analysis and an ordered logistic regression analysis were applied to examine the associations between osteopenia and LAF-AGEs as well as AALs.</p><p><strong>Results: </strong>Negative correlations (Pearson r = -0.16, p < 0.001) were found between LAF-AGEs and T-scores. Higher AALs were significantly associated (p = 0.004) with escalated level of osteopenia in the ordered logistic analysis.</p><p><strong>Discussion: </strong>After reviewing the relevant studies, it is concluded that LAF-AGE is a more stable measure of long-term metabolic dysfunction than circulating AGE. LAF-AGEs are a valid, practical and non-invasive parameter for osteopenia risk evaluation. Further studies with longer follow-up will be helpful to clarify its effectiveness for osteoporosis risk assessment.</p>","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":" ","pages":"341-347"},"PeriodicalIF":1.3,"publicationDate":"2022-09-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/aa/e4/mder-15-341.PMC9467441.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"40359285","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Retrospective Comparison of Clinical and Economic Outcomes of Non-Donor Patients Undergoing Radical Nephrectomy Using One of Two Different Linear Stapler Technologies for Transection of the Renal Vessels: Fixed-Height Gripping Surface Reloads vs Variable-Height Reloads.","authors":"Stephen S Johnston,&nbsp;Barbara H Johnson,&nbsp;Divya Chakke,&nbsp;Sanjoy Roy,&nbsp;Philippe Grange,&nbsp;Esther Pollack","doi":"10.2147/MDER.S372629","DOIUrl":"https://doi.org/10.2147/MDER.S372629","url":null,"abstract":"<p><strong>Purpose: </strong>To compare outcomes of non-donor patients undergoing radical nephrectomy using fixed-height gripping surface (FHGS) vs variable-height Tri-Staple™ (VHTS) reloads for transection of the renal vessels.</p><p><strong>Patients and methods: </strong>Using the Premier Healthcare Database of US hospital discharge records, we selected non-donor patients undergoing inpatient radical nephrectomy with dates of admission between 1 October 2015, and 31 December 2020 (first=index admission). The primary outcome was in-hospital hemostasis-related complications (hemorrhage, acute posthemorrhagic anemia, and/or procedure to control bleeding) during the index admission. Secondary outcomes included index admission intraoperative injury, blood transfusion, conversion from minimally invasive to open surgery, total hospital costs, length of stay (LOS), discharge status, and mortality as well as 30-day all-cause inpatient readmission. We used stable balancing weights to balance the FHGS and VHTS groups on numerous patient, procedure, and hospital/provider characteristics, allowing a maximum post-weighting standardized mean difference ≤0.01 for all covariates; we also exactly matched the groups on laterality (right vs left kidney) and intended surgical approach (open, laparoscopic, robotic). We used bivariate multilevel mixed-effects generalized linear models accounting for hospital-level clustering to compare the study outcomes between the FHGS and VHTS groups.</p><p><strong>Results: </strong>After weighting, the FHGS and VHTS groups comprised 2952 and 795 patients, respectively. The observed incidence proportion of the primary outcome of hemostasis-related complications during the index admission was similar between the groups (8.6% for FHGS vs 9.0% for VHTS, difference 0.4% [95% CI -3.2% to 2.5%], <i>P</i>=0.808). Differences between the FHGS and VHTS groups were not statistically significant for any of the secondary outcomes.</p><p><strong>Conclusion: </strong>Endoscopic surgical staplers have become common for transection of the renal vessels during radical nephrectomy, with FHGS and VHTS being the predominant reload types. In this retrospective study of 3747 non-donor patients undergoing radical nephrectomy, use of FHGS vs VHTS reloads was associated with similar clinical and economic outcomes.</p>","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":" ","pages":"317-328"},"PeriodicalIF":1.3,"publicationDate":"2022-09-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/8b/a2/mder-15-317.PMC9450510.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"33461347","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Improving Performance and Access to Difficult-to-Reach Anatomy with a Powered Articulating Stapler.","authors":"Zhifan F Huang,&nbsp;James A Vandewalle,&nbsp;Jeffrey W Clymer,&nbsp;Crystal D Ricketts,&nbsp;William J Petraiuolo","doi":"10.2147/MDER.S379717","DOIUrl":"https://doi.org/10.2147/MDER.S379717","url":null,"abstract":"<p><strong>Background: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusion: </strong>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.</p>","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":" ","pages":"329-339"},"PeriodicalIF":1.3,"publicationDate":"2022-09-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/ee/c8/mder-15-329.PMC9447447.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"33455506","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}