Surgical Management of Submucous Cleft Palate by Radical Muscle Dissection Veloplasty: Speech Outcomes in Patients with 22q11.2 Deletion Syndrome.

OBJECTIVE: To evaluate the benefit of anatomical muscle dissection repair for velopharyngeal insufficiency (VPI) in patients with submucous cleft palate (SMCP) with 22q11.2 deletion syndrome. DESIGN: Retrospective blinded randomised analysis of a surgeon's management over 10 years. SETTING: The study was performed at a specialised Paediatric hospital in the United Kingdom. PATIENTS: Children with SMCP and 22q11.2 deletion syndrome. INTERVENTIONS: All participants underwent radical muscle dissection veloplasty. OUTCOMES MEASURED: Pre- and post- operative measurements included severity of anatomical defect, speech samples and lateral images which were digitised, randomised then externally and blindly analysed using validated techniques. Stata software was used to perform statistical analysis. RESULTS: 57 children with 22q11.2 deletion syndrome were included in this analysis. Intra-operatively, the majority of cases were identified as SMCP Grade I anomalies. Post-operatively, a statistically significant improvement in hypernasality, resting palate length, palate length at maximum closure, palate excursion and gap size at maximum closure was observed. Secondary surgery was performed for 59% of patients by ten years. CONCLUSION: Muscle dissection repair improves hypernasality, palate closure function and the closure gap in patients with 22q11.2 deletion syndrome. Although over 50% of patients may require further surgery, muscle dissection repair should be a first step due to its utility at a younger age, when invasive investigations are impossible, its lower morbidity, speech and language benefits or altering the plans for less obstructive secondary surgery when it lead to reduced velo-pharyngeal gap and improved palate mobility even when adequate velo-pharyngeal closure was not achieved.

Plastic and Maxillofacial Training for War-Zones - A Systematic Review.

Study Design: Injuries sustained in war-zones are variable and constantly developing according to the nature of the ongoing conflict. Soft tissue involvement of the extremities, head and neck often necessitates reconstructive expertise. However, current training to manage injuries in such settings is heterogenous. This study involves a systematic review. Objective: To evaluate interventions in place to train Plastic and Maxillofacial surgeons for war-zone environments so that limitations to current training can be addressed. Methods: A literature search of Medline and EMBase was performed using terms relevant to Plastic and Maxillofacial surgery training and war-zone environments. Articles that met the inclusion criteria were scored then educational interventions described in included literature were categorised according to their length, delivery style and training environment. Between-group ANOVA was performed to compare training strategies. Results: 2055 citations were identified through this literature search. Thirty-three studies were included in this analysis. The highest scoring interventions were over an extended time-frame with an action-oriented training approach, using simulation or actual patients. Core competencies addressed by these strategies included technical and non-technical skills necessary when working in war-zone type settings. Conclusions: Surgical rotations in trauma centers and areas of civil strife, together with didactic courses are valuable strategies to train surgeons for war-zones. These opportunities must be readily available globally and be targeted to the surgical needs of the local population, anticipating the types of combat injuries that often occur in these environments.

Submucous Cleft Palate (SMCP): Indications and Outcomes of Radical Muscle Dissection Palatoplasty in Children Under 4 Years of Age.

To delineate the indications, referral sources and outcomes of radical muscle dissection palate repair in the first 4 years of life for patients with submucous cleft palate (SMCP).This study presents a retrospective analysis of a single surgeon's management.All children were treated at Great Ormond Street Hospital, United Kingdom.Twenty-three children with nonsyndromic SMCP were included in this study.All participants underwent radical muscle dissection repair before their fourth birthday.Parameters analyzed included: referral sources, indications for referral, extent of anatomical abnormality, and postoperative outcomes.Paediatricians provided the largest proportion of referrals to the cleft lip and palate clinic (39%) due to the presence of cleft lip/palate on prenatal scans or during neonatal examination. Over half (n = 12, 52%) of patients had severe anatomical anomalies being in grade IV (score 8-9), with the classical triad present to some extent in all but 2 of the patients. The main indication for surgery was nasal regurgitation of food and liquid (n = 9, 35%) followed by hypernasality (n = 6, 21%), difficulty feeding (n = 3, 8%), and severe anatomical defect (n = 2; 4%). Postoperatively, the presenting complaint improved in the majority of cases.Nonsyndromic SMCP is often missed, though may present with nasal regurgitation, feeding problems, and/or hypernasality, though may be missed in nonsyndromic children. Early radical muscle dissection repair in the first 4 years of life is safe and effective, facilitating normal speech development.

Ex vivo and in vivo suppression of SARS-CoV-2 with combinatorial AAV/RNAi expression vectors.

Despite rapid development and deployment of vaccines against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), clinically relevant modalities to curb the pandemic by directly attacking the virus on a genetic level remain highly desirable and are urgently needed. Here we comprehensively illustrate the capacity of adeno-associated virus (AAV) vectors co-expressing a cocktail of three short hairpin RNAs (shRNAs; RNAi triggers) directed against the SARS-CoV-2 RdRp and N genes as versatile and effective antiviral agents. In cultured monkey cells and human gut organoids, our most potent vector, SAVIOR (SARS virus repressor), suppressed SARS-CoV-2 infection to background levels. Strikingly, in control experiments using single shRNAs, multiple SARS-CoV-2 escape mutants quickly emerged from infected cells within 24-48 h. Importantly, such adverse viral adaptation was fully prevented with the triple-shRNA AAV vector even during long-term cultivation. In addition, AAV-SAVIOR efficiently purged SARS-CoV-2 in a new model of chronically infected human intestinal cells. Finally, intranasal AAV-SAVIOR delivery using an AAV9 capsid moderately diminished viral loads and/or alleviated disease symptoms in hACE2-transgenic or wild-type mice infected with human or mouse SARS-CoV-2 strains, respectively. Our combinatorial and customizable AAV/RNAi vector complements ongoing global efforts to control the coronavirus disease 2019 (COVID-19) pandemic and holds great potential for clinical translation as an original and flexible preventive or therapeutic antiviral measure.

Cleft Lip and Palate Repair Training to Bridge the Gap in Low-Income Countries.

INTRODUCTION: There is a significant unmet need for cleft repair in low-income countries. The procedure is challenging due to limited access, small fragile flaps, and the depth at which sutures need to be placed. The aim of this analysis is to review available literature pertaining to cleft lip and palate repair training, with a focus on those applicable to low-income countries. METHODOLOGY: Literature searches of Medline and EMBase were performed to identify studies of cleft lip and/or palate training. Terms including "cleft," "lip," "palate," and "training" were searched. Literature published in English from inception to May 2021 in which the full text was available was considered for inclusion. Studies were included on the basis that they included interventions such as virtual/online training, simulation training, courses, fellowships, and/or hospital-based training. Studies that met this criterion were further assessed using a validated scoring tool then the applicability of each training strategy for low-income countries reviewed. RESULTS: Nineteen studies were included in this analysis. Of these 4 studies pertained to online training, 11 studies illustrated cleft models and simulation training, while 4 studies highlighted the role of charity led training achieved through direct hospital teaching and fellowship programs. The training strategies described have been summarised and presented herein in a narrative format. The simplicity, fidelity, and training benefit of palatoplasty models has also been described. CONCLUSIONS: Cleft lip and palate repair training should be accessible to surgeons in low-income countries. Direct practical experience has an important role in training to perform cleft procedures. Affordable, simple simulation models that resemble human tissue are essential so that surgeons can safely practice skills between initial training and operating on a living child.

Mastering microsurgery: A novel benchmarking tool for microsurgical training.

INTRODUCTION AND OBJECTIVE: The shift of surgical training from apprenticeship model towards competency-based training requires objective assessments of microsurgical skills to achieve mastery. Our objective was to create a novel platform to provide feedback to surgical trainees relative to competency expected at their level of exposure. METHODS: A 5-day simulated microsurgery course was run between 2013 and 2016 with 118 participants. Video recordings of end-to-end micro-anastomoses were collected on days 1, 3, and 5, along with analysis of hand motion . Videos were assessed to calculate the QMUL Global Rating Scale (QMUL GRS). Two charts were created to track the acquisition of microsurgical skills. One to plot the number of hand movements and the other for QMUL GRS, against the participants' cumulative number of micro-anastomoses performed. Participant data were used to calculate a skills acquisition line for each quartile, analogous to percentiles on a growth chart. RESULTS: For a cumulative number of 0 prior micro-anastomoses, the GRS score at the 25th, 50th, and 75th percentile was 45.5, 55, and 62, respectively. As the number of cumulative anastomoses increased, there was a distinct increase in the GRS score to 89.5, 93, and 92 for the group with 55-100 previous micro-anastomoses. This was in keeping with a decreased number of hand movements with increasing experience. CONCLUSION: In conclusion, our tool allows trainees to track where they lie in the skill spectrum relative to prior experience which permits the provision of focused training to trainees at lower percentiles, which has potential to translate to improved clinical outcomes.

Enhanced Recovery Pathways for Flap-Based Reconstruction: Systematic Review and Meta-Analysis.

BACKGROUND: Enhanced Recovery After Surgery (ERAS) pathways are known to improve patient outcomes after surgery. In recent years, there have been growing interest in ERAS for reconstructive surgery. OBJECTIVES: To systematically review and summarise literature on the key components and outcomes of ERAS pathways for autologous flap-based reconstruction. DATA SOURCES: Cochrane Central Register of Controlled Trials, MEDLINE, EMBASE, Current Controlled Trials, World Health Organization International Clinical Trials Registry Platform and reference lists of relevant studies. INCLUSION CRITERIA: All primary studies of ERAS pathways for free and pedicled flap-based reconstructions reported in the English language. OUTCOME MEASURES: The primary outcome measure was length of stay. Secondary outcomes were complication rates including total flap loss, partial flap loss, unplanned reoperation within 30 days, readmission to hospital within 30 days, surgical site infections and medical complications. RESULTS: Sixteen studies were included. Eleven studies describe ERAS pathways for autologous breast reconstructions and five for autologous head and neck reconstructions. Length of stay was lower in ERAS groups compared to control groups (mean reduction, 1.57 days; 95% CI, - 2.15 to - 0.99). Total flap loss, partial flap loss, unplanned reoperations, readmissions, surgical site infections and medical complication rates were similar between both groups. Compliance rates were poorly reported. CONCLUSION: ERAS pathways for flap-based reconstruction reduce length of stay without increasing complication rates. ERAS pathways should be adapted to each institution according to their needs, resources and caseload. There is potential for the development of ERAS pathways for chest wall, perineum and lower limb reconstruction. LEVEL OF EVIDENCE III: 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 .

Pharmacological activation of pyruvate kinase M2 reprograms glycolysis leading to TXNIP depletion and AMPK activation in breast cancer cells.

BACKGROUND: Aerobic glycolysis, discovered by Otto Warburg, is a hallmark of cancer metabolism even though not yet fully understood. The low activity of the cancerous pyruvate kinase isozyme (M2) is thought to play an important role by facilitating the conversion of glycolytic intermediates to other anabolic pathways to support tumors' high proliferation rate. METHODS: Five breast cancer cell lines representing different molecular subtypes were used in this study where real time measurements of cellular bioenergetics and immunoblotting analysis of energy- and nutrient-sensing pathways were employed to investigate the potential effects of PKM2 allosteric activator (DASA-58) in glucose rewiring. RESULTS: In this study, we show that DASA-58 can induce pyruvate kinase activity in breast cancer cells without affecting the overall cell survival. The drug is also able to reduce TXNIP levels (an intracellular glucose sensor) probably through depletion of upstream glycolytic metabolites and independent of AMPK and ER signaling. AMPK shows an induction in phosphorylation (T172) in response to treatment an effect that can be potentiated by combining DASA-58 with other metabolic inhibitors. CONCLUSIONS: Altogether, the multifaceted metabolic reprogramming induced by DASA-58 in breast cancer cells increases their susceptibility to other therapeutics suggesting the suitability of the intracellular glucose sensor TXNIP as a marker of PK activity.

Ascorbate kills breast cancer cells by rewiring metabolism via redox imbalance and energy crisis.

The idea to use megadoses of ascorbate (vitamin C) for cancer treatment has recently been revived. Despite clear efficacy in animal experimentation, our understanding of the cellular and molecular mechanisms of this treatment is still limited and suggests a combined oxidative and metabolic mechanism behind the selective cytotoxicity of ascorbate towards cancerous cells. To gain more insight into the cellular effects of high doses of ascorbate, we performed a detailed analysis of metabolic changes and cell survival of both luminal and basal-like breast cancer cells treated with ascorbate and revealed a distinctive metabolic shift virtually reversing the Warburg effect and triggering a severe disruption of redox homeostasis. High doses of ascorbate were cytotoxic against MCF7 and MDA-MB231 cells representing luminal and basal-like breast cancer phenotypes. Cell death was dependent on ascorbate-induced oxidative stress and accumulation of ROS, DNA damage, and depletion of essential intracellular co-factors including NAD+/NADH, associated with a multifaceted metabolic rewiring. This included a sharp disruption of glycolysis at the triose phosphate level, a rapid drop in ATP levels, and redirection of metabolites toward lipid droplet accumulation and increased metabolites and enzymatic activity in the pentose phosphate pathway (PPP). High doses of ascorbate also inhibited the TCA cycle and increased oxygen consumption. Together the severe disruptions of the intracellular metabolic homeostasis on multiple levels "redox crisis and energetic catastrophe" consequently trigger a rapid irreversible cell death.

The Use of the Bipedicled Deep Inferior Epigastric Perforator Flap for Unilateral Breast Reconstruction: A Systematic Review and Meta-analysis.

INTRODUCTION: The use of abdominal flaps is recognized as a very advantageous approach for breast reconstruction with gradual refinements leading from the pedicled transverse rectus abdominis musculocutaneous flap to the criterion standard deep inferior epigastric perforator (DIEP) flap and its several variations. A systematic review with meta-analysis attempts to investigate the safety of the bipedicled DIEP flap for unilateral breast reconstruction. METHODS: The literature search used "PubMed" database, and a relevant study conducted at the Queen Victoria Hospital was also included. The extraction of data included study type, follow-up, patients' age, body mass index, preexisting abdominal scars, timing of reconstruction, operating time, flap inset, pedicles' configuration, flap failure, revision, and complication rates. Proportions were pooled with Freeman-Tukey arcsine transformation, and meta-regression was performed to evaluate whether complication rates were modified by different variables. RESULTS: Fourteen eligible articles provided an overall sample of 486 flaps, with a median follow-up of 18.5 months. In most cases, immediate reconstruction with undivided flap was performed, with equal use of extraflap and intraflap pedicles' configuration. Only 4 cases of flap failure (0.82%) were documented, with 18% overall complications and 3% fat necrosis rate. The forest plot showed significant between-study heterogeneity, and meta-regression revealed marginal positive association between older patient and complication rate. CONCLUSIONS: Bipedicled DIEP flap for unilateral breast reconstruction is a technique that maintains the complications rate relatively low in challenging postmastectomy cases. Further comparative studies are needed to substantiate the findings of this study.

Injectable platelet-rich fibrin for facial rejuvenation: A prospective, single-center study.

BACKGROUND: Autologous platelet-derived preparations have been used in many surgical fields to improve healing outcomes, with benefits reported in several aesthetic indications. AIMS: This single-center, prospective, uncontrolled study evaluated the efficacy of injectable platelet-rich fibrin (i-PRF) for facial skin rejuvenation using an objective skin analysis system and validated patient-reported outcome measures. PATIENTS/METHODS: PRF® PROCESS system technology was used to prepare i-PRP. Eleven healthy female individuals were included in the study and over 3-months received monthly intradermal injections of i-PRF in 3 facial regions: malar areas (1 mL each side), nasolabial fold (0.5 mL each side), and upper lip skin above the vermilion border (1 mL). The efficacy of the procedures was assessed by objective skin analysis (VISIA® ) and a subjective patient-reported outcome (FACE-Q) assessment at baseline and after 3 months. RESULTS: A significant improvement in skin surface spots (P = .01) and pores (P = .03) was seen at 3-months follow-up. Other variables, such as skin texture, wrinkles, ultraviolet spots, and porphyrins, showed a numerical improvement. FACE-Q scales that measure satisfaction with appearance all showed a significant improvement from baseline, including satisfaction with skin (P = .002), satisfaction with facial appearance (P = .025), satisfaction with cheeks (P = .001), satisfaction with lower face and jawline (P = .002), and satisfaction with lips (P = .04). No major adverse effects were reported. CONCLUSIONS: A series of three i-PRF injections resulted in significant rejuvenation of the face skin at 3-month follow-up, as shown by improved skin analysis parameters and patient self-assessment scores.

The end game - A quantitative assessment tool for anastomosis in simulated microsurgery.

With the move towards simulation based microsurgical training and emphasis on the declining usage of animal models, there is a need for an objective method to evaluate microvascular anastomosis in a non-living, simulated microsurgical training environment. Our aim was to create a validated assessment tool to evaluate the intimal surface of the end product to measure skills acquisition. The intimal surface of 200 anastomoses from 23 candidates and 2 experts were assessed using ImageJ to measure 4 parameters: 1) distance between the distal insertion points, 2) distance between the proximal insertion points, 3) length of sutures placed, 4) number of axes. Using these parameters, a 9-component scoring system was produced based on the hypothesis of the ideal anastomosis having equidistance between the above parameters. The scoring system was devised based on population performance to give a maximum score of 100. The EPIA tool demonstrated its ability to differentiate between seniority from undergraduate to expert. Furthermore, predictive validity was shown by demonstrating skill acquisition between day 3 and 5 of the microsurgery course. The EPIA tool is a valid and feasible method to assess and provide feedback regarding the end product as an adjunct to current scoring systems in simulated microsurgery.

Partial Removal of the Submaxillary Gland for Aesthetic Indications: A Systematic Review and Critical Analysis of the Evidence.

BACKGROUND: Neck aesthetics is an essential feature for a youthful attractive appearance. Deep neck surgery involving partial resection of the submandibular gland (SMG) has been a controversial issue in aesthetic surgery given its challenging technique and potential risks. The aim of this review is to evaluate the safety and efficacy of partial SMG resection in patients undergoing aesthetic neck surgery. METHODS: We undertook a systematic review of the literature and analysis of studies reporting surgical outcomes and complications of partial SMG resection from Medline, Cochrane and Google Scholar databases from 1950 to March 30, 2019. Two independent reviewers conducted titles and abstracts screening and data extraction. Data were analyzed using mixed methods appraisal tool and a clinical impact score. RESULTS: Six studies including 602 patients who underwent 1200 partial SMG resections were included. All studies reported aesthetic improvement according to Ellenbogen aesthetic neck ideals. Hematoma related to partial SMG resection was encountered in one case (0.08%), hematoma related to cervicofacial skin flap was encountered in 26 cases (1.4%), sialoceles happened in 16 cases (1.3%), transient marginal mandibular nerve weakness occurred in 86 cases (4.7%). No mortalities, permanent motor nerve damage or dry mouth were reported. The clinical impact score was positive for five out of the six reports. CONCLUSION: Partial SMG resection in patients undergoing aesthetic neck surgery may represent an effective procedure to enhance neck aesthetics and is associated with minor, self-limiting complications. Future controlled studies with prospective evaluation of aesthetic outcome and patient-reported outcome measures are needed. LEVEL OF EVIDENCE III: 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.

Fractional radiofrequency in the treatment of skin aging: an evidence-based treatment protocol.

Fractional radiofrequency (FRF) has recently emerged for the treatment of scars, cellulite and skin rejuvenation. The aim of this paper was to investigate the evidence behind its use in skin aging and evaluate efficacy, safety, and standardization of protocols. The literature was systematically searched and finally 25 full-text articles were included. Two were randomized controlled trials, 3 were comparative studies, and 20 were case series. Most studies were underpowered with low methodological quality. The participants had skin phototype I-VI with variable baseline severity of signs. Fractional radiofrequency using microneedles or electrode pins was performed on the face, neck, and décolletage. There was heterogeneity in outcomes measurement, but the efficacy of FRF was confirmed in all relevant studies. Mainly, the improvement of rhytides and skin tightening were reported. Mild to moderate pain, transient erythema and edema were the commonest adverse events. Hyperpigmentation was also noted in some cases. There was no consistency in the protocols used and in the description of procedures. A clinical impact score was created to assess the studies and to aid the generation of an evidence-based protocol for minimally invasive radiofrequency procedures. However, there is a need for large scale, well-designed trials to better investigate the efficacy and safety of FRF and to produce clear guidelines.

Use of Augmented Reality in Reconstructive Microsurgery: A Systematic Review and Development of the Augmented Reality Microsurgery Score.

BACKGROUND: Augmented reality (AR) uses a set of technologies that overlays digital information into the real world, giving the user access to both digital and real-world environments in congruity. AR may be specifically fruitful in reconstructive microsurgery due to the dynamic nature of surgeries performed and the small structures encountered in these operations. The aim of this study was to conduct a high-quality preferred reporting items for systematic reviews and meta-analyses (PRISMA) and assessment of multiple systematic reviews 2 (AMSTAR 2) compliant systematic review evaluating the use of AR in reconstructive microsurgery. METHODS: A systematic literature search of Medline, EMBASE, and Web of Science databases was performed using appropriate search terms to identify all applications of AR in reconstructive microsurgery from inception to December 2018. Articles that did not meet the objectives of the study were excluded. A qualitative synthesis was performed of those articles that met the inclusion criteria. RESULTS: A total of 686 articles were identified from title and abstract review. Five studies met the inclusion criteria. Three of the studies used head-mounted displays, one study used a display monitor, and one study demonstrated AR using spatial navigation technology. The augmented reality microsurgery score was developed and applied to each of the AR technologies and scores ranged from 8 to 12. CONCLUSION: Although higher quality studies reviewing the use of AR in reconstructive microsurgery is needed, the feasibility of AR in reconstructive microsurgery has been demonstrated across different subspecialties of plastic surgery. AR applications, that are reproducible, user-friendly, and have clear benefit to the surgeon and patient, have the greatest potential utility. Further research is required to validate its use and overcome the barriers to its implementation.

A Systematic Review of the Literature of Delayed Inflammatory Reactions After Hyaluronic Acid Filler Injection to Estimate the Incidence of Delayed Type Hypersensitivity Reaction.

BACKGROUND: Hyaluronic acid (HA) dermal filler injection is believed to be a safe procedure. However, with the increase in the number of performed procedures and indications, the number of product-related complications, especially delayed inflammatory reactions, has also increased. Delayed-type hypersensitivity (DTH) reaction is one of these delayed inflammatory reactions, which is preventable by performing a pretreatment skin test. OBJECTIVES: The authors sought to find the incidence of delayed inflammatory reactions and DTH reaction after HA injection and to determine whether a pretreatment skin test is worthwhile to be performed. METHODS: The authors conducted a systematic literature review of all the relevant prospective studies, retrospective studies, and case reports on delayed inflammatory reactions and DTH reaction after HA filler injection. RESULTS: The incidence of delayed inflammatory reactions calculated from the prospective studies was 1.1% per year, and that of possible DTH reaction was 0.06% per year. Most retrospective studies estimated a percentage of delayed inflammatory reactions of less than 1% in 1 to 5.5 years. The incidence of DTH reaction would be lower than that. Among all the DTH cases reported, only about 5% of them were proven to be genuine DTH reactions. CONCLUSIONS: The incidence of both delayed inflammatory reactions and DTH reaction is low. There is evidence that genuine DTH reactions caused by HA fillers approved by the Food and Drug Administration do exist. This adverse event can be prevented by performing a pretreatment skin test. However, the incidence of DTH reaction is so low that the pretreatment skin test is not mandatory if Food and Drug Administration-approved HA fillers are used.

Fat Grafting for Facial Rejuvenation through Injectable Tissue Replacement and Regeneration: A Differential, Standardized, Anatomic Approach.

Injectable tissue replacement and regeneration (ITR2) is a standardized fat grafting technique, which anatomically addresses losses of facial volume, laxity, and sun damage of the skin resulting from the natural processes of aging. Based on the structural differences of fat existing in the deeper versus the superficial fat compartments of the face, while accounting for skeletal losses and skin aging, ITR2 utilizes 3 sizes of fat grafts-millifat (parcel size 2.0-2.5 mm), microfat (1.0 mm), and nanofat (<500 µm)-to replicate characteristics of fat cells lost with facial decay and provide increased blood supply and improvements in aging skin.

Standardized Practice Reduces Complications in Breast Augmentation: Results with the First 290 Consecutive Cases Versus Non-standardized Comparators.

BACKGROUND: Several systematic methods for breast augmentation have been published, providing key principles and technical steps for minimizing complications and optimizing patient satisfaction. The aim of this study was to compare complication rates in patients receiving a breast augmentation performed using a structured, standardized approach versus comparator patients operated on without a standardized approach. METHODS: This was a single-center, retrospective review of 290 consecutive breast augmentations performed between October 2016 and September 2017 based on a standardized technique (Randquist's "five P's" combined with Adams' 14-point plan), and 235 comparators who underwent breast augmentations prior to standardization between April 2014 and September 2016. All study subjects were females aged ≥ 18 years, undergoing bilateral breast augmentation, either alone or in the context of augmentation mastopexy or implant replacement. Various implant ranges were used before standardization; most (94.8%) of the standardized procedures used Natrelle® devices. Follow-up lasted for ≥ 12 months. RESULTS: Significantly fewer patients in the standardized surgery group experienced complications (14.5%, n = 42) compared with the non-standardized group [29.4%, n = 69; Chi square = 6.57; degrees of freedom (df) = 1; p = 0.01041]. Complication rates were also significantly lower in the standardized surgery group for each of the three types of breast augmentation surgery assessed separately. Reoperation rates with standardized and non-standardized surgery were 4.1% (n = 12) and 11.9% (n = 28), respectively (Chi square = 6.4; df = 1; p = 0.01145). Patient satisfaction was increased post-surgery in both groups. CONCLUSIONS: The use of a structured, standardized approach to breast augmentation reduced the risk of postoperative 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 .