Continuing Insurance Coverage for Flap-Based Breast Reconstruction: Is There a Reservation Cost Related to a Woman's Abdominal Flap Choice?

BACKGROUND: The recent proposed alterations to the Centers for Medicare and Medicaid Services regulations, although subsequently reversed on August 21, 2023, have engendered persistent concerns regarding the impact of insurance policies on breast reconstruction procedures coverage. This study aimed to identify factors that would influence women's preferences regarding autologous breast reconstruction to better understand the possible consequences of these coverage changes. METHODS: A survey of adult women in the United States was conducted via Amazon Mechanical Turk to assess patient preferences for breast reconstruction options, specifically deep inferior epigastric perforator (DIEP) and transverse rectus abdominis myocutaneous (TRAM) flap surgery. The Cochrane-Armitage test evaluated trends in flap preferences concerning incremental out-of-pocket payment increases. RESULTS: Of 500 total responses, 485 were completed and correctly answered a verification question to ensure adequate attention to the survey, with respondents having a median (interquartile range) age of 26 (25-39) years. When presented with the advantages and disadvantages of DIEP versus TRAM flaps, 78% of respondents preferred DIEP; however, as DIEP's out-of-pocket price incrementally rose, more respondents favored the cheaper TRAM option, with $3804 being the "indifference point" where preferences for both procedures converged (P < 0.001). Notably, respondents with a personal history of breast reconstruction showed a higher preference for DIEP, even at a $10,000 out-of-pocket cost (P = 0.04). CONCLUSIONS: Out-of-pocket cost can significantly influence women's choices for breast reconstruction. These findings encourage a reevaluation of emergent insurance practices that could potentially increase out-of-pocket costs associated with DIEP flaps, to prevent cost from decreasing equitable patient access to most current reconstructive options.

Purse-String DIEPplasty: A Technique to Improve Aesthetic Outcome of Autologous Breast Reconstruction.

The purse-string DIEPplasty technique is a method to improve aesthetic outcomes in breast reconstruction using deep inferior epigastric perforator (DIEP) free flaps. Traditionally, DIEP flaps, harvested from the lower abdomen, take on a triangular shape that can lead to sub-optimal aesthetic outcomes with occasionally poor breast projection, irregular contours, or minimal upper pole fullness. The purse-string DIEPplasty technique addresses these issues by using a 0 Polydioxanone continuous purse-string suture through the Scarpa's fascia to modify the harvested flap's shape before inset, giving it a more round base and a central dome-like projection similar to an implant. This method mimics the shape of a breast implant, enhancing the flap's projection, volumetric efficiency, and overall shape, leading to a reconstructed breast with improved aesthetic qualities. This technique represents a potential advancement in reconstructive breast surgery, aiming to reduce the extent of revision procedures and improve patient satisfaction. Further research, however, is needed to validate its effectiveness over time and assess potential complications.Level of Evidence IV This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

The Effects of Body Mass Index on Postoperative Complications in Patients Undergoing Autologous Free Flap Breast Reconstruction.

BACKGROUND: The prevalence of obesity in the United States exceeds 40%, yet perioperative effects of higher body mass index (BMI) in autologous breast reconstruction remain poorly studied. The purpose of this study was to investigate BMI's impact on postop complications in abdominal and gluteal-based autologous breast reconstruction. METHODS: We conducted a retrospective study using TriNetX, a health care database containing de-identified data from more than 250 million patients. Patients undergoing autologous breast reconstruction were identified by Current Procedural Terminology codes. Four cohorts were established by BMI class: <24.99, 25 to 29.99, 30 to 34.99, and 35 to 39.99 kg/m2. Outcomes of interest were defined by International Classification of Diseases, Tenth Revision (ICD-10) codes. A two-sample t-test was performed to compare incidence of postoperative complications between cohorts within 3 months of surgery. Patients with a BMI < 24.99 kg/m2 served as the control. Cohorts were balanced on age, race, and ethnicity. RESULTS: We identified 8,791 patients who underwent autologous breast reconstruction. Of those, 1,143 had a BMI < 24.99 kg/m2, 1,867 had a BMI of 25 to 29.99 kg/m2, 1,396 had a BMI of 30 to 34.99 kg/m2, and 559 had a BMI of 35 to 39.99 kg/m2. Patients with a BMI of 25 to 29.99 kg/m2 had a significantly increased risk of cellulitis. Patients with a BMI of 30 to 34.99 and 35 to 39.99 kg/m2 had a significantly increased risk of cellulitis, surgical site infection, need for debridement, wound dehiscence, and flap failure. CONCLUSION: Our study illustrates that there is an increased risk of postoperative complications associated with higher BMI classes. Understanding these data are imperative for providers to adequately stratify patients and guide the procedural decision-making.

Development of a Porcine VCA Model Using an External Iliac Vessel-Based Vertical Rectus Abdominus Myocutaneous Flap.

BACKGROUND: Vascularized composite allotransplantation (VCA) involves transplanting a functional and anatomically complete tissue graft, such as a hand or face, from a deceased donor to a recipient. Although clinical VCA has resulted in successful outcomes, high rates of acute rejection and increased requirements for immunosuppression have led to significant long-term complications. Of note, immunosuppressed graft recipients are predisposed to infections, organ dysfunction, and malignancies. The long-term success of VCA grafts requires the discovery and implementation of unique approaches that avoid these complications altogether. Here, we describe our surgical technique and initial experience with a reproducible heterotopic porcine VCA model for the preclinical assessment of approaches to improve graft outcomes. METHODS: Six heterotopic porcine allogeneic vertical rectus abdominis myocutaneous flap transplants were performed using Sinclair donors and Yucatan recipients. Immunosuppressive therapy was not used. Each flap was based on the left external iliac vessel system. Animals were followed postoperatively for surgery-related complications. RESULTS: The six pigs underwent successful VCA and were euthanized at the end of the study. Each flap demonstrated complete survival following vessel anastomosis. For the allogeneic recipients, on average, minimal erythema and healthy flap color were observed from postoperative days 1 to 4. There were no surgery-related animal deaths or complications. CONCLUSION: We have developed a reproducible, technically feasible heterotopic porcine VCA model based on the left external iliac vessel system. Our results demonstrate this model's potential to improve VCA graft outcomes by exploring tolerance induction and rejection biomarker discovery in preclinical studies.

Trends in Gender-Affirming Surgeries in the United States from 2010 to 2021.

Introduction: In 2017, an estimated 1.6 million adults and 150,000 teenagers identified as transgender in the United States. With ever-changing legislative developments regarding health care benefits for this population and the increasing number of patients presenting for gender-affirming surgery (GAS), there is a scarcity of literature on the temporal trends within the past decade. The objective of this study was to examine the temporal trends of the utilization of GAS. Methods: We conducted a cross-sectional study using TriNetX, a federated research network containing deidentified aggregate patient data. Using International Code of Disease (ICD) and Current Procedural Terminology (CPT) codes, we identified patients with a diagnosis of gender dysphoria who underwent GAS from 2010 to 2021. Basic demographic information and complications were analyzed. Complications of interest included site failure, infection, and systemic complications. Results: We identified a total of 8,403 patients who underwent GAS between January 2010 and December 2021. The number of procedures per year increased nearly 500% between 2016 and 2021 from 421 procedures to 2,224 procedures. Our demographic results were consistent with previous survey-based studies. The average age of patients who underwent masculinizing surgeries was consistently younger than those who underwent feminizing surgeries. Most patients undergoing GAS were of white race. The overall complication rate was 4.7%. Conclusion: In conclusion, our study reveals a significant and rapid rise in the utilization of GAS in the United States, with a fivefold increase in procedures between 2016 and 2021. The demographic characteristics and low complication rates observed highlight the evolving landscape of health care for transgender individuals and the need for ongoing assessment and support in this field.

Macromastia and Reduction Mammaplasty: Analysis of Outpatient Cost of Care and Opioid Consumption at 5 Years Postoperatively.

BACKGROUND: Macromastia is associated with increased opioid consumption, which could potentially be the initial exposure for patients with an opioid use disorder amid an escalating opioid crisis in the United States. OBJECTIVES: The purpose of this study was to evaluate outpatient cost of care and opioid consumption in patients with macromastia and compare those who underwent reduction mammaplasty vs those who did not have surgery. METHODS: PearlDiver, a database encompassing a national cohort of private payers with 153 million unique patients, was queried. The study cohort included patients diagnosed with macromastia who did or did not undergo reduction mammaplasty utilizing both ICD-9 and ICD-10 and CPT codes. Outpatient cost of care and morphine milligram equivalents (MME) were calculated up to 5 years postoperatively for both cohorts. RESULTS: At 1 to 3 years postoperatively, there was no statistically significant difference in outpatient cost of care between cohorts. At every follow-up thereafter, outpatient cost of care was higher among macromastia patients who did not undergo reduction mammaplasty, with cohort differences of US$240.68 and US$349.90 at 4 years and 5 years, respectively (P < .05). MME consumption was greater in patients who underwent reduction mammaplasty up to 30 days postoperatively (P < .01). Beyond that, there was no significant difference in MME consumption between cohorts. However, patients who did not undergo surgery had opioid consumption levels above 50 MME/day until 3 years after diagnosis of macromastia. CONCLUSIONS: Patients with macromastia who undergo reduction mammaplasty have lower outpatient care costs than patients who do not undergo reduction mammaplasty, with safer long-term opioid consumption in alignment with current Centers for Disease Control and Prevention guidelines.

Analysis of Complications in Patients With a History of Cannabis Use and Tobacco Use Undergoing Implant-Based Breast Reconstruction.

BACKGROUND: There is limited information regarding the perioperative effects of marijuana in breast reconstructive surgeries. OBJECTIVES: The objective of this study was to explore the association between a history of cannabis use and postoperative complications in the setting of implant-based breast reconstruction. METHODS: Two databases, TriNetX and PearlDiver, were queried for patients undergoing implant-based breast reconstruction. Patients were divided into 4 groups based on active ICD-10 diagnostic codes: (1) cannabis use only, (2) tobacco use only, (3) cannabis and tobacco use, and (4) neither cannabis nor tobacco use. Associations with postoperative complications were analyzed with a logistic regression test. RESULTS: TriNetX search revealed that 327 patients had an active diagnosis of cannabis use only and 1118 had an active diagnosis of tobacco use only. Patients in the cannabis only cohort had a significantly increased risk of developing surgical site infection. Patients in the tobacco only cohort had significantly increased risk of developing wound dehiscence, need for debridement, and surgical site infection. The PearlDiver search included 472 patients who had an active diagnosis of both cannabis and tobacco use and 17,361 patients with a diagnosis of tobacco use only. Patients with a diagnosis of cannabis and tobacco use had a significantly increased risk of developing postoperative complications including surgical site infection, wound dehiscence, need for incision and drainage, and debridement. CONCLUSIONS: Patients undergoing implant-based breast reconstruction with an active diagnosis of cannabis with or without tobacco use were at increased risk of developing postoperative complications, and the risk was even higher in patients using both tobacco and cannabis.

Telehealth: Could It Be an Avenue to Microvascular Breast Reconstruction for Patients with Geographical Barriers?

BACKGROUND: All women undergoing a mastectomy have the right to reconstruction. However, many women do not receive reconstruction and many more are not aware of all the reconstructive options available to them. Travel distance to a center that provides reconstruction and subsequent follow-up may be a contributing factor to this disparity especially among those who seek microsurgical options. Telehealth, which provides patients with remote video consultations and decreases the travel burden, may be a solution to optimize the accessibility of breast reconstruction for these patients. The purpose of this study was to discuss the efficacy and reliability of telehealth to overcome geographic barriers. METHODS: Patients who received breast reconstruction and participated in video telehealth visits between February and May 2020 were included in this study. Patient demographics, comorbidities, and clinical outcomes were collected. Video telehealth encounters were reviewed to determine specific concerns and questions discussed during these encounters. RESULTS: A total of 235 breast reconstruction surgery patient encounters were recorded for 4 plastic surgeons who offer microsurgical breast reconstruction. Eighty-eight patients (37.4%) were seen as telehealth visits, 20 (22.7%) of which were new patient visits. Eight (9.09%) patients were microsurgical breast reconstruction candidates and 25 (28.4%) were following-up after microsurgical breast reconstruction. The majority of telehealth visits included normally healing wounds in the postoperative patient. CONCLUSION: Telehealth provides an avenue for premastectomy consultation, second opinion visits, and postoperative follow-up for patients who have geographical barriers precluding them from reaching plastic surgeons who perform all types of breast reconstruction.

Patient Safety in Microvascular Plastic Surgery.

Patient safety is defined as freedom from accidental or preventable harm produced by medical care. The identification of patient- and procedure-related risk factors enables the surgical team to carry out prophylactic measures to reduce the rate of complications and adverse events.The purpose of this review is to identify the characteristics of patients, practitioners, and microvascular surgical procedures that place patients at risk for preventable harm, and to discuss evidence-based prevention practices that can potentially help to generate a culture of patient safety.

Comparison of Synthetic and Biologic Mesh in Ventral Hernia Repair Using Components Separation Technique.

Ventral hernia repair (VHR) for large abdominal wall defects is challenging. Prior research established that the use of mesh is superior to suture closure alone and that component separation is an effective technique to combat loss of abdominal domain. Studies comparing component separation technique (CST) outcomes utilizing synthetic versus biologic mesh are limited. A retrospective review was conducted of 72 consecutive patients who underwent VHR with CST between 2006 and 2010 at our institution. Surgeon preference and the presence of contamination guided whether synthetic mesh (27 patients) or biologic mesh (45 patients) was used. Mean follow-up interval for all comers was 13.9 months and similar in both groups (P > 0.05). Degree of contamination and severity of premorbid medical conditions were significantly higher in the biologic mesh group, as reflected in the higher Ventral Hernia Working Group (VHWG) score (2.04 versus 2.86). Clinical outcomes, as measured by both minor and major complication rates and recurrence rates, were not significantly different. Minor complication rates were 26% in the synthetic group and 37% in the biologic group and major complication rates 15% in the synthetic group and 22% in the biologic group. There was 1 recurrence (4%) in the synthetic mesh group versus 5 (11%) in the biologic mesh group. Multivariable analysis for major complications revealed no significant difference for either synthetic or biologic mesh while controlling for other variables. Subset analysis of uncontaminated cases revealed recurrence rates of 4% in the synthetic mesh group and 6% in the biologic mesh group. VHR using CST and either synthetic mesh or biologic mesh resulted in low recurrence rates with similar overall complication profiles, despite the higher average VHWG grading score in the biologic mesh group. Our results support the VHWG recommendation for biologic mesh utilization in higher VHWG grade patients. In VHWG grade 2 patients, our clinical outcomes were similar, supporting the use of either type of mesh.

Stable mixed hematopoietic chimerism permits tolerance of vascularized composite allografts across a full major histocompatibility mismatch in swine.

This study tested the hypothesis that vascularized composite allografts (VCA) could be accepted in a robust model of hematopoietic chimerism by injecting allogeneic bone marrow cells (BMC) into swine fetuses. Outbred Yorkshire sows and boars were screened to ensure the absence of the major histocompatibility (MHC) allele SLA(cc) of inbred MGH miniature swine and then mated. Bone marrow harvested from an SLA(cc) swine donor was T-cell depleted and injected intravenously into the fetuses between days 50-55 of gestation. After birth, the piglets were studied with flow cytometry to detect donor cells and mixed lymphocyte reactions (MLR) and cell-mediated lympholysis (CML) assays to assess their response to donor. Donor-matched VCAs from SLA(cc) donors were performed on four chimeric and two nonchimeric swine. The results showed donor cell engraftment and multilineage macrochimerism after the in utero transplantation of adult BMC, and chimeric animals were unresponsive to donor antigens in vitro. Both control VCAs were rejected by 21 days and were alloreactive. Chimeric animals accepted the VCAs and never developed antidonor antibodies or alloreactivity to donor. These results confirm that the intravascular, in utero transplantation of adult BMC leads to donor cell chimerism and donor-specific tolerance of VCAs across a full MHC barrier in this animal model.

Comparison of outcomes using AlloDerm versus FlexHD for implant-based breast reconstruction.

BACKGROUND: Prosthetic reconstruction using human acellular dermis (ADM) is a common practice in breast reconstruction. AlloDerm and FlexHD are two different forms of ADM, each with unique characteristics. No studies have directly compared the postoperative complications of these 2 products. METHODS: The outcomes of 547 consecutive implant-based breast reconstructions were reviewed. RESULTS: Reconstruction was performed in 382 consecutive women (547 total breasts), employing mostly immediate reconstruction (81%). Mean follow-up was 6.4 months. Among immediate reconstructions, 165 used AlloDerm and 97 used FlexHD. Complications were similar by univariate analysis. In multivariate analysis, smoking and higher initial implant fill were risk factors for delayed healing. The use of FlexHD, single-stage reconstruction, and smoking were independent risk factors for implant loss. CONCLUSIONS: There is no significant difference in the complication rates between AlloDerm and FlexHD in immediate breast reconstruction. Multivariate analysis suggests that FlexHD may be a risk factor for implant loss.

Patient Satisfaction Using BREAST-Q and Breast Implant Illness after Breast Reconstruction in Transwomen.

Background: Gender-affirming breast augmentation comprises an increasing portion of breast augmentations performed by plastic surgeons. Satisfaction and breast implant illness (BII) symptoms in this population have not been well studied. This study aimed to evaluate satisfaction and BII symptoms in transwomen who received nontextured implants as part of their breast reconstruction. Methods: We conducted a retrospective review of transwomen who underwent breast augmentation for gender-affirming surgery. We performed telephone survey evaluation using the BREAST-Q questionnaire preoperatively, 6 months and 1 year after breast implant placement. Survey evaluation asking about BII symptoms was also administered at the same time points. Results: Twenty-six patients completed the BREAST-Q survey, which demonstrated significantly improved satisfaction postoperatively at 6 and 12 months when compared with median preoperative scores for psychosocial (P < 0.001; P < 0.001), sexual (P < 0.001; P < 0.001), and overall satisfaction with breasts (P < 0.001; P < 0.001). Physical well-being of the chest decreased at 6 months (P < 0.001) but improved in comparison with 12 months (P < 0.001). Thirty-four patients completed the BII survey, with 18% reporting symptoms at 3 months and 29% at 1 year. Zero patients requested explantation. Conclusions: Transwomen exhibit a significant increase in breast, psychosocial, and sexual well-being after breast augmentation. However, patients experienced a decreased physical well-being, and many report symptoms associated with BII. These results can be used to better counsel these individuals preoperatively and set reasonable postoperative expectations. Further studies investigating long-term satisfaction in larger cohorts are needed.

The use of flaps for management of deep sternal wound complications: A systematic review and meta-analysis.

BACKGROUND: Many options are available for reconstruction after deep sternal wound infections. However, these options have not been critically appraised. The aim of this systematic review and meta-analysis was to assess the existing evidence on sternal rewiring versus flap reconstruction and pectoralis major muscle flaps (PMFs) versus greater omental flaps (GOFs). METHODS: A systematic review and meta-analysis was performed. CENTRAL, MEDLINE and EMBASE were searched. Outcomes of interest included mortality, treatment failure and length of hospital stay (LOS). RESULTS: Fourteen studies were included. Nine studies compared flaps to rewiring, reporting on 618 patients. Patients treated with flaps had significantly lower mortality compared with patient treated with rewiring (Risk ratio [RR] 0.42, 95% confidence interval [CI]: 0.23-0.77, P < 0.01). Flap patients had significantly lower treatment failure compared with those who were treated with rewiring (RR 0.22, 95% CI: 0.14-0.37, P < 0.01). No statistically significant differences were observed in LOS between patients treated with flaps compared those treated with rewiring (standard mean difference -0.84, 95% CI: -1.91 to 0.24, P = 0.13). Five studies compared PMF with GOF, reporting on 599 patients. No statistically significant differences were found in mortality (RR 0.63, 95% CI: 0.24-1.68, P = 0.36), LOS (standard mean difference -14.52, 95% CI: -42.00 to 12.96, P = 0.30) or treatment failure (RR 1.37, 95% CI: 0.31-6.07, P = 0.68) in patients treated with PMF compared with patients treated with GOF. CONCLUSIONS: Flap-based reconstruction demonstrated improved mortality and treatment outcomes compared to sternal rewiring. However, no significant differences were observed in outcomes between the PMF- and GOF-based reconstructions.

Capsular contracture in breast reconstruction: A systematic review and meta-analysis.

BACKGROUND: Capsular contracture after implant-based breast reconstruction is not an uncommon problem and affects reconstruction outcomes. It can be influenced by various factors, such as the plane of implant placement, implant surface and implant type. This systematic review and meta-analysis aimed to evaluate how the abovementioned risk factors can affect capsular contracture rates. METHODS: A systematic review and meta-analysis was performed. PubMed MEDLINE, EMBASE (OvidSP) and Cochrane Library were searched. Comparison groups included subpectoral versus prepectoral implant placement, smooth versus textured implants and saline versus silicone implants. Odds ratios (ORs) were calculated for capsular contracture for each group. The level of evidence was evaluated using the Oxford Centre for Evidence-Based Medicine. RESULTS: Twenty-three studies met the inclusion criteria. Sixteen studies compared subpectoral versus prepectoral implant placement, with no statistically significant differences in capsular contracture rates [OR, 1.21; 95% confidence interval (95% CI), 0.75-1.95; P = 0.44]. Five studies compared smooth versus textured implants, with no statistically significant differences in capsular contracture rates (OR, 0.99; 95% CI, 0.50-1.93; P = 0.97). Two studies compared saline versus silicone implants for capsular contracture. Patients receiving saline implants had significantly lower capsular contracture rates than silicone implants (OR, 0.19; 95% CI, 0.08-0.43; P < 0.0001). CONCLUSIONS: Implant-based breast reconstruction using saline implants demonstrated reduced capsular contracture rates compared to silicone implants. However, no significant differences were observed in capsular contracture rates between subpectoral versus prepectoral implant placement and smooth versus textured implants.

Successful Extension of Vascularized Composite Allograft Perfusion Cold Storage to 24 h in a Rat Hindlimb Transplant Model.

Background: Vascularized composite allograft transplantation is a treatment option for complex tissue injuries; however, ischemia reperfusion injury and high acute rejection rates remain a challenge. Hypothermic machine perfusion using acellular storage perfusate is a potential solution. This study evaluated the University of Wisconsin Kidney Preservation Solution-1 (KPS-1) compared with normal saline (NS) for preservation of donor rat hindlimbs subjected to 24 h of ex vivo perfusion cold storage. Methods: Hindlimbs were subjected to 24-h perfusion cold storage with heparinized KPS-1 (n = 6) or heparinized NS (n = 6). Flow, resistance, and pH were measured continuously. At the end of the 24-h period, tissue was collected for histological analysis of edema and apoptosis. Results: KPS-1 perfused limbs showed significantly less edema than the NS group, as evidenced by lower limb weight gain (P < 0.001) and less interfascicular space (P < 0.001). KPS-perfused muscle had significantly less cell death than NS-perfused muscle based on terminal deoxynucleotidyl transferase dUTP nick-end labeling (P < 0.001) and cleaved caspase-3 staining (P = 0.045). During hypothermic machine perfusion, a significant decrease in pH over time was detected in both groups, with a significantly greater decline in pH in the KPS-1 group than in the NS group. There were no significant differences overall and over time in flow rate or vascular resistance between the KPS and NS groups. Conclusions: Perfusion with KPS-1 can successfully extend vascularized composite allograft perfusion cold storage for 24 h in a rat hindlimb model without significant edema or cell death.

Toxicology, pharmacokinetics, and immunogenicity studies of CCR4-IL2 bispecific immunotoxin in rats and minipigs.

We have developed a diphtheria toxin-based recombinant human CCR4-IL2 bispecific immunotoxin (CCR4-IL2-IT) for targeted therapy of cutaneous T-cell lymphoma (CTCL). CCR4-IL2-IT demonstrated superior efficacy in an immunodeficient mouse CTCL model. Recently, we have compared the in vivo efficacy of CCR4-IL2-IT versus Brentuximab (FDA approved leading drug in CTCL market) in the same immunodeficient mouse CTCL model. The comparison demonstrated that CCR4-IL2-IT was significantly more effective than Brentuximab. In this study, we have performed non-GLP (Good Laboratory Practice) toxicology, pharmacokinetics, immunogenicity studies of CCR4-IL2-IT in both rats and minipigs. CCR4-IL2-IT demonstrated excellent safety profiles in both rats and minipigs. The maximum tolerated dose of CCR4-IL2-IT was determined as 0.4 mg/kg in both rats and minipigs. Complete blood count and chemistry analysis did not show significant difference for all measured parameters between the blood samples of pre-injection versus post-injection from the five-day toxicology studies of CCT4-IL2-IT in both rats and minipigs. Histology analysis did not show difference between the PBS treatment group versus CCR4-IL2-IT treatment group at 50 µg/kg in both rats and minipigs. The half-life of CCR4-IL2-IT was determined as about 45 min in rats and 30 min in minipigs. The antibodies against CCR4-IL2-IT were detected in about two weeks after CCR4-IL2-IT treatment. CCR4-IL2-IT did not induce cytokine release syndrome in a peripheral blood mononuclear cell derived humanized mouse model. The depletion of CCR4+ cell and CD25+ cell (two target cell populations of CCR4-IL2-IT) was observed in minipigs. The excellent safety profile promoted us to further develop CCR4-IL2-IT towards clinical trials.

Abdominal donor-site complications following autologous breast reconstruction: A multi-institutional multisurgeon study.

BACKGROUND: The deep inferior epigastric perforator (DIEP) free flap is the gold standard procedure for autologous breast reconstruction. Although breast-related complications have been well described, donor-site complications and contributing patient risk factors are poorly understood. METHODS: We examined a multi-institutional, prospectively maintained database of patients undergoing DIEP free flap breast reconstruction between 2015 and 2020. We evaluated patient demographics, operative details, and abdominal donor-site complications. Logistic regression modeling was used to predict donor-site outcomes based on patient characteristics. RESULTS: A total of 661 patients were identified who underwent DIEP free flap breast reconstruction across multiple institutions. Using logistic regression modeling, we found that body mass index (BMI) was an independent risk factor for umbilical complications (odds ratio [OR] 1.11, confidence interval [CI] 1.04-1.18, p = 0.001), seroma (OR 1.07, CI 1.01-1.13, p = 0.003), wound dehiscence (OR 1.10, CI 1.06-1.15, p = 0.001), and surgical site infection (OR 1.10, CI 1.05-1.15, p = 0.001) following DIEP free flap breast reconstruction. Further, immediate reconstruction decreases the risk of abdominal bulge formation (OR 0.22, CI 0.108-0.429, p = 0.001). Perforator selection was not associated with abdominal morbidity in our study population. CONCLUSIONS: Higher BMI is associated with increased abdominal donor-site complications following DIEP free flap breast reconstruction. Efforts to lower preoperative BMI may help decrease donor-site complications.

Vacuum-assisted closure therapy for the management of deep sternal wound complications: A systematic review and meta-analysis.

BACKGROUND: Vacuum-assisted closure (VAC) therapy has become a popular treatment option for wound healing. The aim of this meta-analysis was to assess the use of VAC therapy as a bridge before the definitive treatment for the management of deep sternal wound complications. METHODS: A systematic literature review and meta-analysis were performed in PubMed and Embase. Outcomes of interest included mortality, treatment failure, length of hospital stay (LOS), length of intensive care unit (ICU) stay and cost of treatment. RESULTS: Twenty-two studies involving 1980 patients were included in the quantitative synthesis of this meta-analysis. Patients treated with VAC had significantly lower overall mortality [1738 patients; Risk ratio [RR] = 0.36 (95% confidence interval [CI]: 0.25, 0.51)], treatment failure [1210 patients; RR = 0.26 (95% CI: 0.19, 0.37)], LOS [498 patients; (standard mean difference = -0.44 (95% CI: -0.81, -0.07)] and ICU stay [309 patients; (standard mean difference = -0.34 (95% CI: -0.67, -0.01)] compared to that of non-VAC patients. VAC therapy was associated with reduced cost of treatment per patient compared with that of non-VAC therapies (reductions of 3600 USD, 6000 USD and 8983 USD in the reported studies). CONCLUSIONS: VAC therapy as an adjunct in the definitive treatment of patients with deep sternal wound complications was associated with lower mortality, treatment failure, LOS, ICU stay and cost of treatment when compared with a non-VAC approach. Randomised controlled trials would be essential to confirm these findings.