Three-dimensional medical printing and associated legal issues in plastic surgery: a scoping review

Three-dimensional printing (3DP) represents an emerging field of surgery. 3DP can facilitate the plastic surgeon’s workflow, including preoperative planning, intraoperative assistance, and postoperative follow-up. The broad clinical application spectrum stands in contrast to the paucity of research on the legal framework of 3DP. This imbalance poses a potential risk for medical malpractice lawsuits. To address this knowledge gap, we aimed to summarize the current body of legal literature on medical 3DP in the US legal system. By combining the promising clinical use of 3DP with its current legal regulations, plastic surgeons can enhance patient safety and outcomes

Three-dimensional Medical Printing and Associated Legal Issues in Plastic Surgery: A Scoping Review

Three-dimensional printing (3DP) represents an emerging field of surgery. 3DP can facilitate the plastic surgeon’s workflow, including preoperative planning, intraoperative assistance, and postoperative follow-up. The broad clinical application spectrum stands in contrast to the paucity of research on the legal framework of 3DP. This imbalance poses a potential risk for medical malpractice lawsuits. To address this knowledge gap, we aimed to summarize the current body of legal literature on medical 3DP in the US legal system. By combining the promising clinical use of 3DP with its current legal regulations, plastic surgeons can enhance patient safety and outcomes

Racial Disparities in Surgical Outcomes after Mastectomy in 223,000 Female Breast Cancer Patients - A Retrospective Cohort Study

BACKGROUND: Breast cancer mortality and treatment differ across racial groups. It remains unclear whether such disparities are also reflected in perioperative outcomes of breast cancer patients undergoing mastectomy. STUDY DESIGN: We reviewed the American College of Surgeons National Surgical Quality Improvement Program (ACS-NSQIP) database (2008-2021) to identify female patients who underwent mastectomy for oncological purposes. The outcomes were stratified by five racial groups (white, Black/African American, Asian, American Indian/Alaska Native, and Native Hawaiian/Pacific Islander) and included 30-day mortality, reoperation, readmission, surgical and medical complications, and non-home discharge. RESULTS: The study population included 222,947 patients, 68% (n=151,522) of whom were white, 11% (n=23,987) Black/African American, 5% (n=11,217) Asian, 0.5% (n=1,198) American Indian/Alaska Native, and 0.5% (n=1,018) Native Hawaiian/Pacific Islander. While 136,690 (61%) patients underwent partial mastectomy, 54,490 (24%) and 31,767 (14%) women received simple and radical mastectomy, respectively. Overall, adverse events occurred in 17, 222 (7.7%) patients, the largest portion of which were surgical complications (n=7,246; 3.3%). Multivariable analysis revealed that being of Asian race was protective against perioperative complications (OR=0.71; P<0.001), whereas American Indian/Alaska Native women were most vulnerable to the complication occurrence (OR=1.41; P<0.001). Black/African American patients had a significantly lower risk of medical (OR=0.59; P<0.001) and surgical complications (OR=0.60; P<0.001) after partial and radical mastectomy, respectively, their likelihood of readmission (OR=1.14; P=0.045) following partial mastectomy was significantly increased. CONCLUSION: We identified American Indian/Alaska Native women as particularly vulnerable to complications following mastectomy. Asian patients experienced the lowest rate of complications in the perioperative period. Our analyses revealed comparable confounder-adjusted outcomes following partial and complete mastectomy between Black and white races. Our findings call for care equalization in the field of breast cancer surgery

A Ready-to-Use Grading Tool for Facial Palsy Examiners—Automated Grading System in Facial Palsy Patients Made Easy

Background: The grading process in facial palsy (FP) patients is crucial for time- and cost-effective therapy decision-making. The House-Brackmann scale (HBS) represents the most commonly used classification system in FP diagnostics. This study investigated the benefits of linking machine learning (ML) techniques with the HBS. Methods: Image datasets of 51 patients seen at the Department of Plastic, Hand, and Reconstructive Surgery at the University Hospital Regensburg, Germany, between June 2020 and May 2021, were used to build the neural network. A total of nine facial poses per patient were used to automatically determine the HBS. Results: The algorithm had an accuracy of 98%. The algorithm processed the real patient image series (i.e., nine images per patient) in 112 ms. For optimized accuracy, we found 30 training runs to be the most effective training length. Conclusion: We have developed an easy-to-use, time- and cost-efficient algorithm that provides highly accurate automated grading of FP patient images. In combination with our application, the algorithm may facilitate the FP surgeon’s clinical workflow

Fibroblasts – the cellular choreographers of wound healing

Injuries to our skin trigger a cascade of spatially- and temporally-synchronized healing processes. During such endogenous wound repair, the role of fibroblasts is multifaceted, ranging from the activation and recruitment of innate immune cells through the synthesis and deposition of scar tissue to the conveyor belt-like transport of fascial connective tissue into wounds. A comprehensive understanding of fibroblast diversity and versatility in the healing machinery may help to decipher wound pathologies whilst laying the foundation for novel treatment modalities. In this review, we portray the diversity of fibroblasts and delineate their unique wound healing functions. In addition, we discuss future directions through a clinical-translational lens

The lateral intercostal artery perforator as an alternative donor vessel for free vascularized lymph node transplantation

Chronic lymphedema is caused by an impairment of the lymphatic system due to primary or secondary causes. Vascularized lymph node transplantation (VLNT) is currently the most promising and frequently used technique besides lymphaticovenous anastomosis. However, the vessel anatomy in the lateral thoracic region is sometimes quite variable. Based on our experiences with vascular anatomical inconstancy in the lateral thoracic region, we planned a lateral intercostal artery perforator flap for VLNT in a female patient with chronic stage II lymphedema of both legs after cervical cancer treatment. After surgery, the patient reported significant improvement in limb volume and the accompanying symptoms. The limb circumference was reduced by an average of 19.2% at 6 months postoperatively. Despite having a short pedicle and small vessel caliber, the lateral intercostal artery perforator flap can safely be used for VLNT in lymphedema patients with anatomical variants

Angiogenic Potential of Co-Cultured Human Umbilical Vein Endothelial Cells and Adipose Stromal Cells in Customizable 3D Engineered Collagen Sheets

The wound healing process is much more complex than just the four phases of hemostasis, inflammation, proliferation, and maturation. Three-dimensional (3D) scaffolds made of biopolymers or ECM molecules using bioprinting can be used to promote the wound healing process, especially for complex 3D tissue lesions like chronic wounds. Here, a 3D-printed mold has been designed to produce customizable collagen type-I sheets containing human umbilical vein endothelial cells (HUVECs) and adipose stromal cells (ASCs) for the first time. In these 3D collagen sheets, the cellular activity leads to a restructuring of the collagen matrix. The upregulation of the growth factors Serpin E1 and TIMP-1 could be demonstrated in the 3D scaffolds with ACSs and HUVECs in co-culture. Both growth factors play a key role in the wound healing process. The capillary-like tube formation of HUVECs treated with supernatant from the collagen sheets revealed the secretion of angiogenic growth factors. Altogether, this demonstrates that collagen type I combined with the co-cultivation of HUVECs and ACSs has the potential to accelerate the process of angiogenesis and, thereby, might promote wound healing

Fibrin Glue Enhances Adipose-Derived Stromal Cell Cytokine Secretion and Survival Conferring Accelerated Diabetic Wound Healing

Introduction. Although chronic wounds are a major personal and economic burden, treatment options are still limited. Among those options, adipose-derived stromal cell- (ASC-) based therapies rank as a promising approach but are restricted by the harsh wound environment. Here we use a commercially available fibrin glue to provide a deliverable niche for ASCs in chronic wounds. Material and Methods. To investigate the in vitro effect of fibrin glue, cultivation experiments were performed and key cytokines for regeneration were quantified. By using an established murine chronic diabetic wound-healing model, we evaluated the influence of fibrin glue spray seeding on cell survival (In Vivo Imaging System, IVIS), wound healing (wound closure kinetics), and neovascularization of healed wounds (CD31 immunohistochemistry). Results. Fibrin glue seeding leads to a significantly enhanced secretion of key cytokines (SDF-1, bFGF, and MMP-2) of human ASCs in vitro. IVIS imaging showed a significantly prolonged murine ASC survival in diabetic wounds and significantly accelerated complete wound closure in the fibrin glue seeded group. CD31 immunohistochemistry revealed significantly more neovascularization in healed wounds treated with ASCs spray seeded in fibrin glue vs. ASC injected into the wound bed. Conclusion. Although several vehicles have shown to successfully act as cell carrier systems in preclinical trials, regulatory issues have prohibited clinical usage for chronic wounds. By demonstrating the ability of fibrin glue to act as a carrier vehicle for ASCs, while simultaneously enhancing cellular regenerative function and viability, this study is a proponent of clinical translation for ASC-based therapies

Use of human mesenchymal cells to improve vascularization in a mouse model for scaffold-based dermal regeneration

All engineered bioartificial structures developed for tissue regeneration require oxygen and nutrients to establish proper physiological functions. Aiming to improve vascularization during dermal regeneration, we combined the use of a bioartificial collagen scaffold and a defined human mesenchymal cell (MC) line. This cell line, termed V54/2, exhibits typical morphologic and immunohistochemical characteristics of MC. V54/2 cells seeded in the scaffold were able to survive, proliferate, and secrete significant amounts of vascular endothelial growth factor (VEGF) and basic fibroblast growth factor (bFGF) during 2 weeks in vitro. To induce dermal regeneration, scaffolds with or without cells were transplanted in a nude mice full skin defect model. After 2 weeks of transplantation, scaffolds seeded with V54/2 cells showed more vascularization during the dermal regeneration process than controls, and the presence of human cells in the regenerating tissue was detected by immunohistochemistry. To confirm if local presence of angiogenic growth factors is sufficient to induce neovascularization, scaffolds were loaded with VEGF and bFGF and used to induce dermal regeneration in vivo. Results showed that scaffolds supplemented with growth factors were significantly more vascularized than control scaffolds (scaffolds without growth factors). The present work suggests that combined use of MC and bioartificial scaffolds induces therapeutic angiogenesis during the scaffold-based dermal regeneration process