Customizable, biocompatible implants for dorsal nasal augmentation: An in vivo pilot study of eight polylactic acid scaffold designs.

Augmentation of the nasal dorsum often requires implantation of structural material. Existing methods include autologous, cadaveric or alloplastic materials and injectable hydrogels. Each of these options is associated with considerable limitations. There is an ongoing need for precise and versatile implants that produce long-lasting craniofacial augmentation. Four separate polylactic acid (PLA) dorsal nasal implant designs were 3D-printed. Two implants had internal PLA rebar of differing porosities and two were designed as "shells" of differing porosities. Shell designs were implanted without infill or with either minced or zested processed decellularized ovine cartilage infill to serve as a "biologic rebar", yielding eight total treatment groups. Scaffolds were implanted heterotopically on rat dorsa (N = 4 implants per rat) for explant after 3, 6, and 12 months followed by volumetric, histopathologic, and biomechanical analysis. Low porosity implants with either minced cartilage or PLA rebar infill had superior volume retention across all timepoints. Overall, histopathologic and immunohistochemical analysis showed a resolving inflammatory response with an M1/M2 ratio consistently favoring tissue regeneration over the study course. However, xenograft cartilage showed areas of degradation and pro-inflammatory infiltrate contributing to volume and contour loss over time. Biomechanical analysis revealed all constructs had equilibrium and instantaneous moduli higher than human septal cartilage controls. Biocompatible, degradable polymer implants can induce healthy neotissue ingrowth resulting in guided soft tissue augmentation and offer a simple, customizable and clinically-translatable alternative to existing craniofacial soft tissue augmentation materials. PLA-only implants may be superior to combination PLA and xenograft implants due to contour irregularities associated with cartilage degradation.

The financial toxicity of postbariatric body contouring surgery: a survey study of an urban tertiary care center's patients.

BACKGROUND: Patients with obesity who undergo bariatric surgery achieve sustained weight loss but are often left with excess skin folds that cause functional and psychological deficits. To remove excess skin, patients can undergo postbariatric BCS; however, cost and lack of insurance coverage present a significant barrier for many patients. OBJECTIVES: This study aimed to characterize the financial impact of treatment on all patients who received bariatric surgery and to compare between those receiving only bariatric surgery and those with postbariatric BCS. SETTING: Email-based survey study at an urban tertiary care center. METHODS: Surveys that included the COST-FACIT were sent to patients with a history of bariatric surgery and/or post-bariatric BCS. RESULTS: One hundred and five respondents completed the survey, of which 19 reported having postbariatric BCS. Patients with postbariatric BCS had slightly higher COST scores than those receiving bariatric surgery only, but this difference was not significant (15.6 versus 17.8, P = .23). Most patients (76%) did not have an awareness of BCS or BCS cost prior to bariatric surgery, and many (68%) had more loose skin than anticipated. CONCLUSIONS: Financial toxicity was similar across all postbariatric surgery patients surveyed regardless of history of BCS. However, survey respondents noted a gap between patient education and expectations around loose skin and body contouring that can be addressed through improved presurgical counseling.

Financial (dis)incentives to surgical management of head and neck cancer care.

BACKGROUND: Patients with head and neck cancer (HNC) often require complex surgical reconstruction. This retrospective, cross-sectional study compares financial factors influencing HNC and breast cancer (BC) care to examine care disparities. METHODS: Pricing data from 2012 to 2021 was abstracted from the CMS Physician Fee Schedule Look-Up Tool. Nonprofit and research support was quantified by searching the NIH, IRS, and GuideStar databases. New York State Department of Health data from 2015 to 2019 was analyzed to compare costs, charges, and payer mix. RESULTS: HNC reconstructive procedures reimburse lower than comparable breast procedures (p < 0.05). Nonprofit and research support for HNC is disproportionately low relative to disease burden. Patients hospitalized for HNC surgical procedures generated higher costs and lower charges than patients with BC (p < 0.05). CONCLUSION: Comparatively low procedure reimbursement, low nonprofit support, and high cost of care for patients with HNC relative to patients with BC may contribute to care disparities for patients with HNC.

Augmenting Breast Implant Research: Accessible Methods for Fabricating Miniature Smooth and Textured Breast Implants in a Laboratory Setting.

BACKGROUND: Because of the association of textured breast implants with breast implant-associated anaplastic large cell lymphoma, anatomically shaped breast implants, which rely on a textured surface to maintain rotational stability, have been recalled from the market. The dearth of anatomically shaped implants on the market reflects a need for novel breast implant technology, which has been traditionally developed by commercial breast implant manufacturers due to the complexities of implant manufacturing. To increase the accessibility of preclinical breast implant research, miniature breast implants made from polydimethylsiloxane were designed and fabricated for high throughput and low-cost prototyping and in vivo testing of both smooth and textured implants in a laboratory setting. METHODS: Two-piece negative molds measuring 2 × 1 cm were constructed in Fusion360 and 3D printed in Polysmooth filament. Textured molds were painted with a mixture of an epoxy and fine sugar or granular salt to create textured surfaces, while molds for smooth implants were smoothed using ethanol spray. Molds were injected with polydimethylsiloxane and cured for 12 hours at 37°C. The surface topography of laboratory-made implants and commercial textured and smooth implant shells was analyzed using scanning electron microscopy and implants were evaluated in vivo in an immunocompetent rodent model. RESULTS: Implants retained the original dome shape of the 3D-printed molds. Qualitative assessment of scanning electron microscopy images demonstrated similar surface topography between laboratory-made and commercial smooth and textured implants. There was no statistical difference in the diameter or density of the surface indentations of the Allergan's textured implant compared with laboratory-made textured implants ( P > 0.05). Finally, the surface topography and thickness of laboratory-made implant capsules were similar to previously published data using industry made miniature silicone devices implanted in rats. CONCLUSIONS: This study demonstrates a low-cost, highly customizable approach to fabricate miniature smooth and textured breast implant prototypes for in vivo studies. The accessibility of this implant fabrication strategy allows nonindustry investigators to develop novel implant designs more rapidly for preclinical investigation.

Online capacity building for the health workforce: the case of the Integrated Disease Surveillance and Response for the African region.

The World Health Organisation (WHO) Regional Office for Africa (AFRO) has developed a comprehensive capacity devel-opment programme to support the successful implementation of the Integrated Disease Surveillance and Response 3rd edition Technical Guidelines (IDSR). As part of the learning program, a series of asyn-chronous online courses are offered on OpenWHO in English, French and Portuguese. This paper describes the use of five IDSR online courses and reports on feedback received from learners on Course 1 in the English series. An online learner survey was developed, and a descriptive analysis was conducted. This paper also reports on use related empirical metadata from the OpenWHO platform. Overall, learners (97%-n/N) of Course 1 IDSR English series indicated a positive perception toward their online learning experience because of the quality of course content, its organization, ease of use and relevance to their workplace needs. In addition, 88% (n/N) of learners reported that they had used their acquired knowledge at least sometimes and 54.4% (n/N) had shared their learning with others. Lastly, the quiz analyses showed an average of right answers of 78.97% for quiz 1 and 69.94% for quiz 2. Online learning is an essential component of a blended capacity development programme and provides cost effective, equitable and impactful learning. Learners who have a learning goal and find their needs met in courses tend to show more satisfaction and motivation to share their learning.

Impact of UNOS allocation policy changes on utilization and outcomes of patients bridged to heart transplant with intra-aortic balloon pump.

OBJECTIVE: Intra-aortic balloon pump (IABP) support may improve the hemodynamic profiles of patients in cardiogenic shock and bridge patients to heart transplant. In 2018, the United Network for Organ Sharing (UNOS) introduced new heart allocation criteria that increased the waitlist status of patients with IABPs to Status 2. This study assesses the impact of this change on IABP use and outcomes of patients with IABPs. METHODS: We queried the UNOS database for first adult heart transplant candidates with IABPs listed or transplanted before and after the UNOS policy changes (October 18, 2016-October 17, 2018, or October 18, 2018-September 4, 2020). We compared post-transplant survival and waitlist outcomes using Kaplan-Meier and Fine-Gray analyses. RESULTS: Two thousand three hundred fifty-eight patients met inclusion criteria. Utilization of IABPs for hemodynamic support increased by 338% in the two years after the policy change. Patients with IABPs listed after the policy change were more likely to receive a transplant and were transplanted more quickly (p < .001). Posttransplant survival was comparable before and after the policy change (p = .056), but non-transplanted patients were more likely to be delisted post-policy change (p < .001). CONCLUSION: The UNOS allocation criteria have benefited patients bridged with an IABP, given the higher transplant rate and shorter time to transplant.

Role of left atrial appendage occlusion in patients with HeartMate 3.

OBJECTIVES: Left atrial appendage occlusion (LAAO) at the time of implantation may reduce thromboembolic events (TEs) during continuous-flow left ventricular assist device support. The HeartMate 3 (HM3) reduces TEs overall, but the efficacy of LAAO in HM3 is unknown. METHODS: Adults receiving first HM3 implantation from November 2014 through December 2019 at a single, large medical centre were retrospectively reviewed. TEs included device thrombosis and ischaemic stroke. Patients were classified by whether they received LAAO or not. Incidence of TEs was compared between groups using cumulative incidence curves with competing risks (death and heart transplant) and risk factors for TEs were assessed with Fine and Gray competing risk regression. RESULTS: A total of 182 patients received HM3, of whom 99 (54%) received LAAO versus 83 (46%) who did not. There were 14 TEs, including 13 strokes (7%) and 1 pump thrombosis (0.5%). No significant difference in the incidence of TEs in each group was found (Gray's test: P = 0.35). LAAO was not associated with TEs in multivariable Fine-Gray analysis (P = 0.10) and no significant risk factors for TEs were found. There were zero disabling strokes in those who received LAAO compared to 6 (7%) in those who did not receive LAAO (P = 0.008). CONCLUSIONS: A low number of TEs was observed in HM3 recipients. LAAO did not further reduce the overall rate of TEs in this patient population, though its use may be beneficial in preventing disabling ischaemic strokes after HM3 implantation.

One Year of Pandemic Learning Response: Benefits of Massive Online Delivery of the World Health Organization's Technical Guidance.

The World Health Organization (WHO) launched the first web-based learning course on COVID-19 on January 26, 2020, four days before the director general of the WHO declared a public health emergency of international concern. The WHO is expanding access to web-based learning for COVID-19 through its open-learning platform for health emergencies, OpenWHO. Throughout the pandemic, OpenWHO has continued to publish learning offerings based on the WHO's emerging evidence-based knowledge for managing the COVID-19 pandemic. This study presents the various findings derived from the analysis of the performance of the OpenWHO platform during the pandemic, along with the core benefits of massive web-based learning formats.

Evaluating the Impact of Oncology Care Model Reporting Requirements on Biomarker Testing and Treatment.

PURPOSE: The Oncology Care Model (OCM) is Medicare's first alternative payment model program for patients with cancer. As of October 2017, participating practices were required to report biomarker testing of patients with advanced non-small-cell lung cancer (aNSCLC). Our objective was to evaluate the effect of this OCM reporting requirement on quality of care. METHODS: We selected patients with aNSCLC receiving care in practices in a nationwide de-identified electronic health record-derived database. We used an adjusted difference-in-differences (DID) logistic regression model to compare changes in biomarker testing rates (EGFR, ROS1, and ALK) and receipt of biomarker-guided therapy between patients in OCM versus non-OCM practices, before and after OCM implementation. RESULTS: The analysis included 14,048 patients from 45 OCM practices (n = 8,151) and 105 non-OCM practices (n = 5,897). The overall unadjusted rates for biomarker testing and receipt of biomarker-guided therapy increased over the study period (2011-2018) in both OCM (55.5% v 71.6%; 89.8% v 94.6%, respectively) and non-OCM (55.2% v 69.7%; 90.1% v 95.2%, respectively) practices. In the adjusted DID model, the rates of biomarker testing (odds ratio [OR], 1.09 [95% CI, 0.88 to 1.34]; P = .45) and receipt of biomarker-guided therapy (OR, 0.87 [95% CI, 0.52 to 1.45]; P = .58) were similar between OCM and non-OCM practices. CONCLUSION: OCM biomarker documentation and reporting requirements did not appear to increase the proportions of patients with aNSCLC who underwent testing or who received biomarker-guided therapy in OCM versus non-OCM practices.