Histological Assessment of the Effectiveness of Microneedling Device-Assisted Filler Delivery.

BACKGROUND: Microneedling is used to enhance transcutaneous drug delivery. However, the extent to which microneedling devices impact filler delivery and whether this varies by filler type, microneedling device type, and treatment sequence is not known. OBJECTIVE: To histologically assess and quantify the delivery of commonly used fillers through microneedling, using both a microneedling pen and a microneedling roller. In addition, the authors investigated whether there is a variation in filler delivery based on the sequence of microneedling in relation to topical filler application. METHODS: Ex vivo human abdominal skin samples were subjected to microneedling pen or microneedling roller treatment. Black tissue marking ink, hyaluronic acid, poly-l-lactic acid, or undiluted calcium hydroxyapatite was topically applied before or immediately after microneedling treatment. RESULTS: Histological evaluation revealed a notable presence of black ink within channels formed by both microneedling treatments (15.5%-98.1%), whereas there was limited presence of the various filler types tested (0%-6.6%) in all settings. Topical application before microneedling treatment led to relatively higher filler/ink deposition within the channels formed by the microneedling treatments compared with topical application after microneedling. CONCLUSION: Transcutaneous delivery of fillers was not significantly helped by microneedling treatment, whereas the microneedling devices demonstrated effective delivery of an aqueous solution.

Women in Plastic Surgery Innovation: A 10-Year Review of Gender Representation in Mammary Device Patents.

BACKGROUND: This study aims to pioneer in evaluating women's representation in plastic surgery innovations, focusing on mammary prosthesis devices' inventorship. Despite growing gender parity in the field, women's involvement in innovation remains underexplored. This is especially crucial, as the predominant recipients of these innovative technologies are women, urging a necessity for broader female engagement in pioneering surgical advancements. METHOD: Patents under the "A61F2/12: Mammary prostheses and implants" classification between the dates January 1, 2011, to December 31, 2020, were identified using Google Patents Advanced. Inclusion criteria included patents (not designs) in English and applications (not grants), with no litigation limitations. Data collected included ID, title, assignee (categorized as industry, academic, private, individual), inventors, and dates (priority, filing, and publication). Sex of inventors was identified with the literature validated gender API, with manual resolution of unresolved genders or with ga_accuracy scores of less than 75%. Data were analyzed using 2-tailed Student t tests, χ2 analysis, and Pearson correlation coefficient (significance set at P ≤ 0.05). RESULTS: Of the more than 130,000 plastic surgery patents in English identified between the 10-year period, 1355 were classified as A61F2/12. A total of 374 unique patents were included for analysis (841 duplicates were removed, and 140 patents were excluded because of non-English character author names). There was a significant increase in patents over the decade (from 15 in 2011 to 88 in 2020, R2 = 0.74, P < 0.05), with a decrease in number of inventors per patent (R2 = 0.12, P < 0.05). Of the 1102 total inventors, 138 were female (11.2%), with a 4-fold increase in representation over the decade (R2 = 0.58, P < 0.05), including increase in patents filed with a woman first inventor (0%-14.8%). Women were equally likely to be first 3 inventors versus middle to last inventors (12.8% vs 11.1%, respectively). CONCLUSIONS: Over a decade, mammary device innovations rose significantly. Although women inventors' representation improved, it remains disproportionate compared with women in residency/practice. Hence, interventions should aim to align inventor representation with training ratios, through institutional optimization, reducing gender segmentation, and enhancing funding opportunities.

Vaso-Lock for sutureless anastomosis in a pig arteriovenous loop model.

A vascular anastomosis is a critical surgical skill that involves connecting blood vessels. Traditional handsewn techniques can be challenging and resource intensive. To address these issues, we have developed a unique sutureless anastomotic device called Vaso-Lock. This intraluminal device connects free vascular ends using anchors to maintain traction and enable a rapid anastomosis. We tested the anastomotic capability of Vaso-Locks in a pig common carotid-internal jugular arteriovenous model. The use of Vaso-Lock allowed us to accomplish this procedure in less than 10 min, in contrast to the approximately 40 min required for a handsewn anastomosis. The Vaso-Lock effectively maintained patency for at least 6 weeks without causing significant tissue damage. Histological analysis revealed that the device was successfully incorporated into the arterial wall, promoting a natural healing process. Additionally, organ evaluations indicated no adverse effects from using the Vaso-Lock. Our findings support the safety and effectiveness of the Vaso-Lock for arteriovenous anastomosis in pigs, with potential applicability for translation to humans. Our novel sutureless device has the potential to advance surgical practice and improve patient outcomes.

The impact of race and ethnicity in outpatient breast reconstruction decision-making and postoperative outcomes: A propensity score-matched NSQIP analysis.

BACKGROUND: Recent literature has established outpatient breast reconstruction (BR) to be a safe alternative to inpatient BR. However, the impact of race and ethnicity on BR patient decision-making and postsurgical outcomes remains unexplored. This study aims to assess the impact of race and ethnicity on outpatient BR timing and postoperative complication rates. METHODS: The 2013-2020 ACS-NSQIP database was utilized to identify women undergoing outpatient BR. Propensity score-matched analysis was conducted to generate balanced cohorts based on race and ethnicity. t-tests and Fisher's exact tests were used to assess group differences. Logistic regressions were modeled to evaluate differences in complications between groups. RESULTS: A total of 63,526 patients underwent outpatient BR. After propensity score matching, 7664 patients and 3948 patients were included in the race and ethnicity-based analysis, respectively. There were statistically significant differences in the timing of BR patients received across cohorts. NW patients had lower rates of immediate BR (IBR) compared with White patients (47% vs. 53%, p < 0.001), and this also was seen in Hispanic patients (97% vs. 3%, p = 0.018). Subsequently, there were higher rates of delayed BR (DBR) in the NW cohort (55% vs. 45%, p < 0.001) and in the Hispanic cohort (95% vs. 5%, p = 0.018). There were no significant differences in the rates of 30-day postoperative complications across cohorts. CONCLUSIONS: Ultimately, our findings suggest that minority patients are more likely to undergo DBR than nonminority patients. However, there were no differences in 30-day postoperative outcomes across race or ethnicity. Future studies to elucidate patients' decision-making process in choosing optimal BR types and timing are necessary to better understand the impact of the observed differences in patient care.

Diversity in online resources for breast reconstruction: What do patients see?

BACKGROUND: Online resources are commonly used by patients to obtain information on breast reconstruction. Despite the key role of these resources in patient decision-making, their visual content has not yet been evaluated. This study sought to 1) characterize the presence and content of visual aids in online patient education breast reconstruction resources and 2) determine if the women represented in these visual aids reflect the breast reconstruction patient population in the United States. METHODS: The top 10 Google websites and the first 400 Google Images containing photographs/graphics depicting human skin for the search phrase "breast reconstruction" were analyzed. Images were categorized by content as "Before/After," "Surgical/Anatomical," "Step-by-Step," or "Breast-Centric Stock Images." Image subjects were classified by skin tone into "White" or "Non-White" using the Fitzpatrick scale and by body type into "Lean" or "Full-Figured." RESULTS: In total, 471 images were analyzed. These were predominantly "Before/After" images (43.9%), followed by "Breast-Centric Stock Images" (27.4%), "Surgical/Anatomical" (24.2%), and "Step-by-Step" (4.5%). The majority of all images depicted "White" skin types (90.7%) and "Lean" body types (73.0%). "Before/After" images were more likely to show "Full-Figured" women than the other content categories (p < 0.0001) and had the highest percentage of "Non-White" skin types (35.3%). CONCLUSIONS: Our findings demonstrate that breast reconstruction online resources are not reflective of the patient population seeking reconstruction. Improving the diversity of online image resources can both better represent our diverse patient population as well as better align patient expectations with postoperative outcomes, likely improving patient satisfaction.

Therapeutic Options for Migraines in the Microsurgical Patient: A Scoping Review.

BACKGROUND: There exists an increasing array of treatments proposed to prevent, alleviate, and abort symptoms of a migraine; however, for patients who undergo reconstructive microsurgery, caution must be taken to preserve vascular integrity. This study is the first-to-date scoping review of vascular and bleeding risk of current migraine therapies, with the purpose of identifying potential therapeutic agents for postoperative migraine management appropriate for microsurgical patients. METHODS: Currently available migraine therapeutics were compiled from UpToDate and the American Academy of Family Physicians. A PubMed literature review was performed for each therapeutic's effect on bleeding or vascular involvement. Data were compiled into tables of abortive, symptom-controlling and prophylactic, and non-pharmacologic treatments. Expert microsurgeons reviewed the data to provide recommendations for optimized patient care. RESULTS: Triptans and other ergot derivatives demonstrated strong evidence of vasoconstriction and were greatly advised against for immediate post-microsurgical use. Novel pharmaceutical therapies like Lasmiditan and CGRP antagonists have no literature indicating potential for vasoconstriction or hematoma and remain an investigational option for abortive medical treatment. For symptom control, acetaminophen appears the safest option, with clinical judgment and further research needed for use of NSAIDs. Alternative treatment techniques may include migraine prophylaxis with botulinum toxin injection or nutraceutical treatment via magnesium supplementation or Coenzyme Q10 administration, minimizing the need for additional medication in the postoperative setting. CONCLUSIONS: Patients undergoing reconstructive microsurgery have a unique medical profile limiting the therapeutic options available to treat migraines. This review provides preliminary evidence to be considered as a guide for prescribing therapeutics for migraine in the postoperative setting.

A Novel Sutureless Anastomotic Device in a Swine Model: A Proof of Concept Study.

INTRODUCTION: Vascular reconstruction requires technical expertise and is often time consuming. As a novel alternative to traditional hand-sewn vascular anastomoses, the VasoLock (VL), is a nonabsorbable, sutureless anastomosis device with traction anchors designed to hold free artery ends together. These anchors do not penetrate the vessel wall but adhere by leveraging the elasticity of the vessels to fasten blood vessels together. This pilot study assesses the performance and patency of this novel device in a porcine model of femoral artery injury. METHODS: Female swine (n = 7) underwent femoral artery exposure for a total of 10 VL implanted. Study animals underwent hemodilution to a target hematocrit of 15% and ROTEM was used to assess coagulopathy, followed by an arterial injury via transection. The VL was inserted without any sutures. Flow-probe monitors were positioned proximal and distal to the device and flow rates were measured continuously for a total of 90 min. Flow was analyzed and presented as a ratio of distal to proximal flow with the slope of this ratio across time subsequently determined. Angiographic assessment was completed to evaluate for patency and technical complications after 90 min of implant. RESULTS: The average animal weight was 44.1 ± 3.2 kg. The average mean arterial pressure at the time of implant was 51.2 ± 7.8 mmHg, median heart rate was 77.4 (IQR = 77.25-157.4) beats per minute, and average temperature was 36.1 ± 1.5°C. The baseline hematocrit was 13.5 ± 3.0%, average pH was 7.20 ± 0.1, average clotting time was 154.1 ± 58.7 s and average clot formation time was 103.4 ± 10.9 s all demonstrating the acidotic, hypothermic, and coagulopathic state of the swine at the time of insertion. During the 90-min observation period, the average flow gradient identified across the VL was 0.99 ± 0.24, indicating no significant change in flow across the VL. The average slope of the gradients was 0.0005 (P = 0.22), suggesting the ratio of proximal and distal flow did not change over the 90 min. Following 90 min of dwell time, all VL were patent without technical complication. Angiographic assessment at 90 min demonstrated no evidence of dissection, device migration, arterial extravasation, or thromboembolism with any of the 10 devices. CONCLUSIONS: This pilot study demonstrated technical feasibility of the novel VL device over a 90-min observation period. All VL were patent and no negative events or complications were identified. This technology demonstrated significant promise in a coagulopathic state: additional investigation, involving long-term survival, is warranted for further validation.

A 10-Year Analysis of Representation of Women in Patent Applications and NIH Funding in Vascular Surgery.

BACKGROUND: There has been an increasing focus on gender disparities in the medical field and in the field of vascular surgery specifically. We aimed to characterize gender representation in vascular surgery innovation over the past 10 years, using metrics of patents and National Institutes of Health (NIH) support. METHODS: We performed a retrospective review of all vascular-related patent filings (Google Scholar) and NIH-funded grants (NIH RePORTER) over a 10-year period (January 1st, 2012, to December 31st, 2021). Gender-API (Application Programming Interface) was used to identify the gender of the inventors, with manual confirmation of a 10% random sample. Gender representation for patent inventors and grant principal investigators (PIs) were compared using Chi-squared and Student's t-tests as appropriate. Yearly temporal changes in representation were analyzed using Wilcoxon signed-rank tests and linear regression analyses. RESULTS: We identified 2,992 unique vascular device patents with 6,093 associated inventors over 10 years. Women were underrepresented in patent authorship overall (11.5%), and were least likely to be listed as first inventor (8.9%) and most commonly fourth and fifth inventors (15.5% and 14.1%, respectively) compared to men. There was no significant change in representation of women inventors over time (-0.2% females per year, 95% confidence interval (CI) -0.54 to 0.10). We identified 1736 total unique NIH grants, with 23.8% of funded projects having women PIs. There was an increase in the proportion of women PIs over time (+1.31% per year, 95% CI 0.784 to 1.855; P < 0.001). Projects with women PIs received mean total awards that were significantly lower than projects with men PIs ($350,485 ± $220,072 vs. $451,493 ± $411,040; P < 0.001), but the overall ratio of funding:women investigators improved over time (+$11,531 per year, 95% CI $6,167 to $16,895; P = 0.0011). CONCLUSIONS: While we have made strides in increasing the number of women in the surgical research space, there is still room for improvement in funding parity. In addition, we found substantial and persistent room for improvement in representation of women in surgical innovation. As we enter a new frontier of surgery hallmarked by equalizing gender representation, these data should serve as a call-to-action for initiative aimed at rebuilding the foundation of surgical innovations upon equal gender representation.

Comparative Benefits of Open versus Closed Reduction of Condylar Fractures: A Systematic Review and Meta-Analysis.

BACKGROUND: Many fractures of the mandibular condylar neck are amenable to both open reduction and internal fixation (ORIF) and closed treatment. Clinical outcomes following these two modalities remains a topic of debate. This systematic review critically appraises the literature to compare them following these treatment options. METHODS: A systematic review and meta-analysis was performed to test the null hypothesis of no difference in clinical outcomes in ORIF versus closed treatment of mandibular condyle fractures. The PubMed, Embase, Cochrane Library, Elsevier text mining tool database, and clinicaltrials.gov trial registries were queried from 1946 to 2020. The quality of evidence was determined using Grading of Recommendations Assessment, Development, and Evaluation methodology. RESULTS: Of 1507 screened articles, 14 met inclusion criteria. ORIF was favored significantly when evaluating temporomandibular joint pain [relative risk (RR), 0.3; 95% CI, 0.1 to 0.7] (number needed to treat to prevent an outcome in one patient, 3; 95% CI, 2 to 6), laterotrusive movements of the mandible (mean difference, 2.3; 95% CI, 1.7 to 3.0) (standardized mean difference, 0.9; 95% CI, 0.4 to 1.3), and malocclusion (RR, 0.5; 95% CI, 0.4 to 0.7) (number needed to treat to prevent an outcome in one patient, 19; 95% CI, 10 to 200). However, ORIF yielded a higher incidence of postoperative infection (RR, 3.6; 95% CI, 0.9 to 13.8) and must be weighed against the understood risk of facial nerve injury. CONCLUSIONS: Meta-analysis of high-level evidence in randomized controlled trial suggests that ORIF significantly improves functional outcomes, decreases pain, and restores occlusion and jaw symmetry. These long-term benefits must be weighed against the increased risk of postoperative infection and exposure of the facial nerve to potential injury.

Evaluation of Health Literacy in Plastic Surgery Using a Crowdsourced Patient Survey.

Little is known about the levels of health literacy (HL) among plastic and reconstructive surgery (PRS) patients compared with the general population. This study aimed to characterize HL levels in patients interested in plastic surgery and identify potential risk factors associated with inadequate levels of HL among this population. Methods: Amazon's Mechanical Turk was used to distribute a survey. The Chew's Brief Health Literacy Screener was used to evaluate the level of HL. The cohort was divided into two groups: non-PRS and PRS groups. Four subgroups were created: cosmetic, noncosmetic, reconstructive, and nonreconstructive groups. A multivariable logistic regression model was constructed to assess associations between levels of HL and sociodemographic characteristics. Results: A total of 510 responses were analyzed in this study. Of those, 34% of participants belong to the PRS group and 66% to the non-PRS group. Inadequate levels of HL were evidenced in 52% and 50% of the participants in the non-PRS and PRS groups, respectively (P = 0.780). No difference in HL levels was found in the noncosmetic versus cosmetic groups (P = 0.783). A statistically significant difference in HL levels was evidenced between nonreconstructive versus reconstructive groups after holding other sociodemographic factors constant (0.29, OR; 95% CI, 0.15-0.58; P < 0.001). Conclusions: Inadequate levels of HL were present in almost half of the cohort, which highlights the importance of adequately assessing HL levels in all patients. It is of utmost importance to evaluate HL in clinical practice using evidence-based criteria to better inform and educate patients interested in plastic surgery.

Underreporting of Traumatic Brain Injuries in Pediatric Craniomaxillofacial Trauma: A 20-Year Retrospective Cohort Study.

BACKGROUND: Despite clinical concerns associated with pediatric traumatic brain injuries (TBIs), they remain grossly underreported. This is the first retrospective study to characterize concomitant pediatric TBIs and craniomaxillofacial (CMF) trauma patients, including frequency, presentation, documentation, and outcomes. METHODS: An institutional review board-approved retrospective cohort study was performed to identify all pediatric patients presenting with CMF fractures at a high-volume, tertiary trauma center between the years 1990 and 2010. Patient charts were reviewed for demographic information, presentation, operative management, length of stay, mortality at 2 years, dentition, CMF fracture patterns, and concomitant TBIs. Data were analyzed using two-tailed t tests and chi-square analysis. A value of P≤ 0.05 was considered statistically significant. RESULTS: Of the 2966 pediatric CMF trauma patients identified and included for analysis [mean age, 7 ± 4.7 years; predominantly White (59.8%), and predominantly male (64.0%)], 809 had concomitant TBI (frequency, 27.3%). Only 1.6% of the TBI cases were documented in charts. Mortality at 2 years, length of stay in the hospital, and time to follow-up increased significantly from mild to severe TBIs. Concomitant TBIs were more common with skull and upper third fractures than CMF trauma without TBIs (81.8% versus 61.1%; P < 0.05). CONCLUSIONS: Concomitant TBIs were present in a significant number of pediatric CMF trauma cases but were not documented for most cases. CMF surgeons should survey all pediatric CMF trauma patients for TBI and manage with neurology and/or neurosurgery teams. Future prospective studies are necessary to characterize and generate practice-guiding recommendations. CLINICAL QUESTION/LEVEL OF EVIDENCE: Risk, II.

Misconceptions, Myths, and Mystery: A Cross-sectional Survey Study on Public Knowledge and Values of Microsurgery.

BACKGROUND: Microsurgery is a foundational plastic surgery principle. However, public unawareness of microsurgery and its associated rigorous training in the United States may contribute to current misconceptions and undervaluing of plastic and reconstructive surgeons. This study aims to characterize public knowledge of microsurgery. METHODS: A cross-sectional survey was conducted from August to September 2021 using Amazon Mechanical Turk to assess baseline public knowledge of microsurgery. A multivariable logistic regression model was constructed to evaluate the association between baseline knowledge and demographic characteristics. Significance was set to a p < 0.05. RESULTS: A total of 516 responses were analyzed. The mean age was 36.7 years (standard deviation, 16.04 years; white, 84%; non-Hispanic, 70%). Of those surveyed, 52% agreed that general surgeons perform microsurgery, while only 28% agreed that plastic and reconstructive surgeons perform microsurgery. When asked if head and neck reconstruction, breast reconstruction, and finger replantation required microsurgery, only 28, 41, and 41% of respondents agreed, respectively. When controlled for sociodemographic factors, Hispanics had significantly more odds to mistake that head and neck reconstruction did not require microsurgery (odds ratio [OR] 95% CI 0.49; 0.30-0.80; p = 0.004) and less odds to consider plastic and reconstructive surgeons for reconstruction (OR 0.51; 95% CI 0.32-0.84; p = 0.008). Females had 1.63 more odds of considering plastic and reconstructive surgeons for reconstruction (95% CI 1.09-2.43; p = 0.017). Low-educated participants had significantly more odds to consider general surgeons as those who performed reconstructive microsurgery (OR 8.70; 95% CI 1.09-69.40; p = 0.041). CONCLUSION: Misconceptions of microsurgery as a foundational principle of plastic surgery persist and correlate with undervaluing the specialty. Knowledge differs by ethnicity, level of education, and gender. Therefore, patient counseling should use culturally appropriate elements to demystify microsurgery, build value, and better inform risks and benefits.

Predictors and Consequences of Intraoperative Anastomotic Failure in DIEP Flaps.

BACKGROUND: Successful intraoperative microvascular anastomoses are essential for deep inferior epigastric perforator (DIEP) flap survival. This study identifies factors associated with anastomotic failure during DIEP flap reconstruction and analyzes the impact of these anastomotic failures on postoperative patient outcomes and surgical costs. METHODS: A retrospective cohort study was conducted of patients undergoing DIEP flap reconstruction at two high-volume tertiary care centers from January 2017 to December 2020. Patient demographics, intraoperative management, anastomotic technique, and postoperative outcomes were collected. Data were analyzed using Student's t-tests, Chi-square analysis, and multivariate logistic regression. RESULTS: Of the 270 patients included in our study (mean age 52, majority Caucasian [74.5%]), intraoperative anastomotic failure occurred in 26 (9.6%) patients. Increased number of circulating nurses increased risk of anastomotic failure (odds ratio [OR] 1.02, 95% confidence Interval [CI] 1.00-1.03, p <0.05). Presence of a junior resident also increased risk of anastomotic failure (OR 2.42, 95% CI 1.01-6.34, p <0.05). Increased surgeon years in practice was associated with decreased failures (OR 0.12, CI 0.02-0.60, p <0.05). Intraoperative anastomotic failure increased the odds of postoperative hematoma (OR 8.85, CI 1.35-59.1, p <0.05) and was associated with longer operating room times (bilateral DIEP: 2.25 hours longer, p <0.05), longer hospital stays (2.2 days longer, p <0.05), and higher total operating room cost ($28,529.50 vs. $37,272.80, p <0.05). CONCLUSION: Intraoperative anastomotic failures during DIEP flap reconstruction are associated with longer, more expensive cases and increased rates of postoperative complications. Presence of increased numbers of circulators and junior residents was associated with increased risk of anastomotic failure. Future research is necessary to develop practice guidelines for optimizing patient and surgical factors for intraoperative anastomotic success.

Identifying Public Perceptions, Attitudes, and Concerns about Breast Implants and Their Complications: A National Survey.

BACKGROUND: Aesthetic and reconstructive implant-based breast operations are among the most common plastic surgery procedures. This study assessed the baseline knowledge of common breast implant-associated complications, and their influence on consideration of breast implants among adult laywomen within the United States. METHODS: Five hundred women were recruited through Amazon's Mechanical Turk. Respondents self-reported demographics and experience with breast implants. Questions were asked addressing respondents' understanding of complications and concerns regarding breast implants. RESULTS: Of the authors' cohort (average age, 37.8 ± 11.7 years), 12.0% had received breast implants, 72.8% knew someone with implants, and nearly 50% would consider receiving implants in the future. As many as 82.2% reported at least one concern influencing their consideration of implants: safety (75.2%), cost (70.0%), unnatural shape (43.3%), and feel (45.2%). Respondents not considering implants were significantly concerned by foreign body implantation ( P < 0.001). Almost 75% believed that implants last longer than 10 years. Following education about risks of capsular contracture and implant rupture, one-third of respondents considering implants and half of those unsure were "less likely" to receive implants. The majority were unchanged in their likelihood after learning about infection (74.4%) and implant migration (69.2%). Respondents with a history of implants were significantly less likely to believe there is strong evidence supporting the aforementioned complications ( P < 0.001). CONCLUSIONS: The rising awareness surrounding breast implant safety has the potential to significantly impact perceptions and receptivity. This study identifies public perceptions of common breast implant-associated complications and primary long-term concerns, highlighting the importance of education on postoperative complications in informed consent and surgical decision-making.

Policies and Price Tags: The Public's Perception of Face Transplantation and Its Funding.

Study Design: Survey study. Objective: Facial vascularized composite allotransplantation (FVCA) can cost over 1 million dollars per procedure and is usually not covered by insurance, yet this financial burden and public opinion surrounding this procedure are not well understood. This study is the first to evaluate the layperson's opinions on the allocation of financial responsibility for FVCA and its inclusion in organ donation registries. Methods: Eight hundred and fifteen laypersons were surveyed through MTurk to assess their agreement with 11 statements about FVCA perceptions, funding, and inclusion on organ donation registries. Responses were analyzed with the Wilcoxon Signed-Rank test, the Kruskal-Wallis test, and the Dunn's test. Results: The majority of respondents were supportive of FVCA in 10 out of 11 statements (P < 0.0001). They would be willing to undergo FVCA if they suffered from facial disfigurement; believe FVCA is as important as other organ transplants; believe faces should be included on the organ donation registry; support insurance companies providing coverage for FVCA regardless of trauma etiology; support tax dollars funding the procedure; and believe FVCA improves physical appearance and quality of life. Although respondents generally supported their tax dollars funding the procedure, fewer supported this for self-inflicted trauma (P > 0.01). Conclusions: This study highlights a disconnect between public preference for insurance coverage of FVCA and current lack of coverage in practice. Respondents' acceptance of including faces in organ donation registries may help alleviate the issue of locating a donor, and increasing financial coverage may broaden this procedure's accessibility to a wider range of individuals.

Translational design for limited resource settings as demonstrated by Vent-Lock, a 3D-printed ventilator multiplexer.

BACKGROUND: Mechanical ventilators are essential to patients who become critically ill with acute respiratory distress syndrome (ARDS), and shortages have been reported due to the novel severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). METHODS: We utilized 3D printing (3DP) technology to rapidly prototype and test critical components for a novel ventilator multiplexer system, Vent-Lock, to split one ventilator or anesthesia gas machine between two patients. FloRest, a novel 3DP flow restrictor, provides clinicians control of tidal volumes and positive end expiratory pressure (PEEP), using the 3DP manometer adaptor to monitor pressures. We tested the ventilator splitter circuit in simulation centers between artificial lungs and used an anesthesia gas machine to successfully ventilate two swine. RESULTS: As one of the first studies to demonstrate splitting one anesthesia gas machine between two swine, we present proof-of-concept of a de novo, closed, multiplexing system, with flow restriction for potential individualized patient therapy. CONCLUSIONS: While possible, due to the complexity, need for experienced operators, and associated risks, ventilator multiplexing should only be reserved for urgent situations with no other alternatives. Our report underscores the initial design and engineering considerations required for rapid medical device prototyping via 3D printing in limited resource environments, including considerations for design, material selection, production, and distribution. We note that optimization of engineering may minimize 3D printing production risks but may not address the inherent risks of the device or change its indications. Thus, our case report provides insights to inform future rapid prototyping of medical devices.

A national analysis of outpatient mastectomy and breast reconstruction trends from 2013 through 2019.

BACKGROUND: Traditionally, patients with breast reconstruction (BR) were hospitalized at least one day postoperatively. However, new trends suggest that outpatient surgery is a viable and safe alternative. This study aims to assess trends among patients with breast cancer who underwent outpatient mastectomy alone, with immediate BR (IBR) or delayed BR (DBR). METHODS: A retrospective analysis of the 2013-2019 ACS NSQIP® database was conducted. All women who underwent outpatient mastectomy were included in this study. The cohort was divided as follows: (1) mastectomy without BR, (2) IBR, and (3) DBR. A Cochran-Armitage test and adjusted multivariable logistic regression models were performed to evaluate linear trends over time within groups, and overall and pairwise comparisons between groups across the years, respectively. RESULTS: A total of 84,954 women were included in this study. Overall, 54.9%, 16.2%, and 28.9% underwent mastectomy without BR, IBR, and DBR, respectively. From the BR groups, the majority had implant placement. A significant difference in incidence trends between the three groups was evidenced over time (p<0.001). The greatest increase was evidenced in the IBR group and the lowest in the mastectomy without BR group. CONCLUSION: In this cohort of patients, a significant difference in linear trends was evidenced over time within and between the three groups. Our results suggest that outpatient IBR procedures are increasing in a greater proportion compared to other surgical approaches. Further studies are required to better characterize this population and comprehend the decision-making process toward a surgical procedure within each of the three groups.

Face Off: 3D-Printed Masks as a Cost-Effective and Reusable Alternative to N95 Respirators: A Feasibility Study.

BACKGROUND: One of the best methods for protection against respiratory diseases is the use of an N95 mask. Supply shortages have demonstrated a significant need for effective alternatives to N95 masks. Benefits of 3D-printed respirators over N95s include reduced cost and ease of production, widespread availability, reusability/sterilizability, and customizability. 3D-printed mask designs have been downloaded thousands of times; however, there is little to no data on the efficacy of these potential alternatives. METHODS: Three of the most popular 3D-printed respirator designs were modified to allow for the Occupational Safety and Health Administration (OSHA) quantitative fit testing that disperses saline into the ambient air and determines concentrations within the mask during multiple trials. Five volunteers conducted standardized fit tests of these masks, as well as an N95 and a KN95, and the results were compared. RESULTS: One of the 3D-printed respirators, low poly COVID-19 face mask respirator (mask 2), achieved a fit factor greater than 100 in every trial, representing sufficient fit according to OSHA protocols. The N95 mask achieved a sufficient fit in 60% of the trials, and none of the remaining masks provided a suitable fit factor reliably according to the OSHA fit test. Further trials showed no change in fit factor when different 3D-printable plastics are used or when a widely available high efficiency particulate air (HEPA) filter was used. CONCLUSION: 3D-printed respirators provide a possible alternative to N95 masks to protect against respiratory pathogens such as severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Fit testing results demonstrate that certain 3D-printed mask designs may exceed the fit of N95 masks.