Frail but Resilient: Frailty in Autologous Breast Reconstruction is Associated with Worse Surgical Outcomes but Equivalent Long-Term Patient-Reported Outcomes.

BACKGROUND: Frailty is associated with higher risk of complications following breast reconstruction, but its impact on long-term surgical and patient-reported outcomes has not been investigated. We examined the association of the five-item modified frailty index (MFI) score with long-term surgical and patient-reported outcomes in autologous breast reconstruction. PATIENTS AND METHODS: We conducted a retrospective cohort study of consecutive patients who underwent mastectomy and autologous breast reconstruction between January 2016 and April 2022. Primary outcome was any flap-related complication. Secondary outcomes were patient-reported outcomes and predictors of complications in the frail cohort. RESULTS: We identified 1640 reconstructions (mean follow-up 24.2 ± 19.2 months). In patients with MFI ≥ 2, the odds of surgical [odds ratio (OR) 2.13, p = 0.023] and medical (OR 17.02, p < 0.001) complications were higher than in nonfrail patients. We found no significant difference in satisfaction with the breast (p = 0.287), psychosocial well-being (p = 0.119), or sexual well-being (p = 0.314) according to MFI score. Chronic obstructive pulmonary disease was an independent predictor of infection (OR 3.70, p = 0.002). Tobacco use (OR 7.13, p = 0.002) and contralateral prophylactic mastectomy (OR 2.36, p = 0.014) were independent predictors of wound dehiscence. Dependent functional status (OR 2.36, p = 0.007) and immediate reconstruction (compared with delayed reconstruction; OR 3.16, p = 0.026) were independent predictors of skin flap necrosis. Dependent functional status was also independently associated with higher odds of reoperation (OR 2.64, p = 0.011). CONCLUSION: Frailty is associated with higher risk of complications in breast reconstruction, but there is no significant difference in long-term patient-reported outcomes. MFI should be considered in breast reconstruction to improve outcomes in high-risk frail patients.

Embracing Robotics in Microsurgery: Robotic-Assisted Deep Inferior Epigastric Perforator Flap Breast Reconstruction.

The integration of robotic-assisted surgery (RAS) has transformed various surgical disciplines, including more recently plastic surgery. While RAS has gained acceptance in multiple specialties, its integration in plastic surgery has been gradual, challenging traditional open methods. Robotic-assisted deep inferior epigastric perforator (DIEP) flap breast reconstruction is a technique aimed at overcoming drawbacks associated with the traditional open DIEP flap approach. These limitations include a relatively large fascial incision length, potentially increasing rates of postoperative pain, abdominal bulge, hernia rates, and core weakening. The robotic-assisted DIEP flap technique emerges as an innovative and advantageous approach in fascial-sparing abdominal autologous breast reconstruction. While acknowledging certain challenges such as increased operative time, ongoing refinements are expected to further improve the overall surgical experience, optimize results, and solidify the role of robotics in advancing reconstructive microsurgical procedures in plastic surgery. Herein, the authors provide an overview of robotic surgery in the context of plastic surgery and its role in the DIEP flap harvest for breast reconstruction.

Development and Assessment of Machine Learning Models for Individualized Risk Assessment of Mastectomy Skin Flap Necrosis.

OBJECTIVE: To develop, validate, and evaluate ML algorithms for predicting MSFN. BACKGROUND: MSFN is a devastating complication that causes significant distress to patients and physicians by prolonging recovery time, compromising surgical outcomes, and delaying adjuvant therapy. METHODS: We conducted comprehensive review of all consecutive patients who underwent mastectomy and immediate implant-based reconstruction from January 2018 to December 2019. Nine supervised ML algorithms were developed to predict MSFN. Patient data were partitioned into training (80%) and testing (20%) sets. RESULTS: We identified 694 mastectomies with immediate implant-based reconstruction in 481 patients. The patients had a mean age of 50 ± 11.5 years, years, a mean body mass index of 26.7 ± 4.8 kg/m 2 , and a median follow-up time of 16.1 (range, 11.9-23.2) months. MSFN developed in 6% (n = 40) of patients. The random forest model demonstrated the best discriminatory performance (area under curve, 0.70), achieved a mean accuracy of 89% (95% confidence interval, 83-94), and identified 10 predictors of MSFN. Decision curve analysis demonstrated that ML models have a superior net benefit regardless of the probability threshold. Higher body mass index, older age, hypertension, subpectoral device placement, nipple-sparing mastectomy, axillary nodal dissection, and no acellular dermal matrix use were all independently associated with a higher risk of MSFN. CONCLUSIONS: ML algorithms trained on readily available perioperative clinical data can accurately predict the occurrence of MSFN and aid in individualized patient counseling, preoperative optimization, and surgical planning to reduce the risk of this devastating complication.

Outcomes of Complex Abdominal Wall Reconstruction After Oncologic Resection: 14-Year Experience at an NCI-Designated Cancer Center.

BACKGROUND: Outcomes studies for abdominal wall reconstruction (AWR) in the setting of previous oncologic extirpation are lacking. We sought to evaluate long-term outcomes of AWR using acellular dermal matrix (ADM) after extirpative resection, compare them to primary herniorrhaphy, and report the rates and predictors of postoperative complications. METHODS: We conducted a retrospective cohort study of patients who underwent AWR after oncologic resection from March 2005 to June 2019 at a tertiary cancer center. The primary outcome was hernia recurrence (HR). Secondary outcomes included surgical site occurrences (SSOs), surgical site infection (SSIs), length of hospital stay (LOS), reoperation, and 30-day readmission. RESULTS: Of 720 consecutive patients who underwent AWR during the study period, 194 (26.9%) underwent AWR following resection of abdominal wall tumors. In adjusted analyses, patients who had AWR after extirpative resection were more likely to have longer LOS (ß, 2.57; 95%CI, 1.27 to 3.86, p < 0.001) than those with primary herniorrhaphy, but the risk of HR, SSO, SSI, 30-day readmission, and reoperation did not differ significantly. In the extirpative cohort, obesity (Hazard ratio, 6.48; p = 0.003), and bridged repair (Hazard ratio, 3.50; p = 0.004) were predictors of HR. Radiotherapy (OR, 2.23; p = 0.017) and diabetes mellites (OR, 3.70; p = 0.005) were predictors of SSOs. Defect width (OR, 2.30; p < 0.001) and mesh length (OR, 3.32; p = 0.046) were predictors of SSIs. Concomitant intra-abdominal surgery for active disease was not associated with worse outcomes. CONCLUSIONS: AWR with ADM following extirpative resection demonstrated outcomes comparable with primary herniorrhaphy. Preoperative risk assessment and optimization are imperative for improving outcomes.

Long-term Surgical and Patient-Reported Outcomes Comparing Skin-Preserving, Staged Versus Delayed Microvascular Breast Reconstruction.

BACKGROUND: Skin-preserving, staged, microvascular, breast reconstruction often is preferred in patients requiring postmastectomy radiotherapy (PMRT) but may lead to complications. We compared the long-term surgical and patient-reported outcomes between skin-preserving and delayed microvascular breast reconstruction with and without PMRT. METHODS: We conducted a retrospective, cohort study of consecutive patients who underwent mastectomy and microvascular breast reconstruction between January 2016 and April 2022. The primary outcome was any flap-related complication. The secondary outcomes were patient-reported outcomes and tissue-expander complications. RESULTS: We identified 1002 reconstructions (672 delayed; 330 skin-preserving) in 812 patients. Mean follow-up was 24.2 ± 19.3 months. PMRT was required in 564 reconstructions (56.3%). In the non-PMRT group, skin-preserving reconstruction was independently associated with shorter hospital stay (ß - 0.32, p = 0.045) and lower odds of 30-days readmission (odds ratio [OR] 0.44, p = 0.042), seroma (OR 0.42, p = 0.036), and hematoma (OR 0.24, p = 0.011) compared with delayed reconstruction. In the PMRT group, skin-preserving reconstruction was independently associated with shorter hospital stay (ß - 1.15, p < 0.001) and operative time (ß - 97.0, p < 0.001) and lower odds of 30-days readmission (OR 0.29, p = 0.005) and infection (OR 0.33, p = 0.023) compared with delayed reconstruction. Skin-preserving reconstruction had a 10.6% tissue expander loss rate and did not differ from delayed reconstruction in terms of patient-reported satisfaction with breast, psychosocial well-being, or sexual well-being. CONCLUSIONS: Skin-preserving, staged, microvascular, breast reconstruction is safe regardless of the need for PMRT, with an acceptable tissue expander loss rate, and is associated with improved flap outcomes and similar patient-reported quality of life to that of delayed reconstruction.

Outcomes of Complex Abdominal Wall Reconstruction with Biologic Mesh in Patients with 8 Years of Follow-Up.

BACKGROUND: While many studies evaluated outcomes of abdominal wall reconstruction with biologic mesh, long-term data is lacking. In this study, we sought to analyze the outcomes of complex AWR with biologic mesh in a robust cohort of patients with a mean follow up of 8 years. METHODS: We conducted a longitudinal study of AWR patients from 2005 to 2019. Hernia recurrence was the primary outcome, and surgical site occurrence was the secondary outcome. Predictive/protective factors were identified using a Cox proportional hazards regression models. RESULTS: We identified 109 consecutive patients who met the inclusion criteria. Patient's mean (± SD) age was 57.5 ± 11.8 years, mean body mass index was 30.7 ± 7.2 kg/m2, and mean follow-up time was 96.2 ± 15.9 months. Fifty-six percent had clean defects, 34% had clean-contaminated defects, and 10% had contaminated/infected defects. Patients had a mean defect size of 261 ± 199.6 cm2 and mean mesh size of 391.3 ± 160.2 cm2. Nineteen patients (17.4%) developed HR at the final follow-up date. Obesity was independently associated with a four-fold higher risk of HR (hazard ratio, 3.98; 95%CI, 1.34 to 14.60, p = 0.02). SSOs were identified in 24.8% of patients. A prior hernia repair was associated with a three-fold higher risk of SSOs (Odds ratio, 3.13; 95%CI, 1.10 to 8.94, p = 0.03). No patient developed mesh infection. CONCLUSION: These longitudinal data demonstrate that complex AWR with biologic mesh provides long-term durable outcomes with acceptable HR and SSO rates despite high contamination levels, patients complexity, and large defect size.

Outcomes of Autologous Free Flap Reconstruction Following Infected Device Explantation.

BACKGROUND: Following implant-based breast reconstruction (IBR) infection and explantation, autologous reconstruction is a common option for patients who desire further reconstruction. However, few data exist about the outcomes of secondary autologous reconstruction (i.e., free flap breast reconstruction) in this population. We hypothesized that autologous reconstruction following infected device explantation is safe and has comparable surgical outcomes to delayed-immediate reconstruction. METHODS: We conducted a retrospective analysis of patients who underwent IBR explantation due to infection from 2006 through 2019, followed by secondary autologous reconstruction. The control cohort comprised patients who underwent planned primary delayed-immediate reconstruction (tissue expander followed by autologous flap) in 2018. RESULTS: We identified 38 secondary autologous reconstructions after failed primary IBR and 52 primary delayed-immediate reconstructions. Between secondary autologous and delayed-immediate reconstructions, there were no significant differences in overall complications (29 and 37%, respectively, p = 0.45), any breast-related complications (18 and 21%, respectively, p = 0.75), or any major breast-related complications (13 and10%, respectively, p = 0.74). Two flap losses were identified in the secondary autologous reconstruction group while no flap losses were reported in the delayed-immediate reconstruction group (p = 0.18). CONCLUSION: Autologous reconstruction is a reasonable and safe option for patients who require explantation of an infected prosthetic device. Failure of primary IBR did not confer significantly higher risk of complications after secondary autologous flap reconstruction compared with primary delayed-immediate reconstruction. This information can help plastic surgeons with shared decision-making and counseling for patients who desire reconstruction after infected device removal.

Impact of Obesity on Outcomes of Prepectoral vs Subpectoral Implant-Based Breast Reconstruction.

BACKGROUND: The impact of obesity on outcomes of prepectoral vs subpectoral implant-based reconstruction (IBR) is not well-established. OBJECTIVES: The goal of this study was to assess the surgical and patient-reported outcomes of prepectoral vs subpectoral IBR. The authors hypothesized that obese patients would have similar outcomes regardless of device plane. METHODS: We conducted a retrospective review of obese patients who underwent 2-stage IBR from January 2017 to December 2019. The primary endpoint was the occurrence of any breast-related complication; the secondary endpoint was device explantation. RESULTS: The authors identified a total of 284 reconstructions (184 prepectoral, 100 subpectoral) in 209 patients. Subpectoral reconstruction demonstrated higher rates of overall complications (50% vs 37%, P = .047) and device explantation (25% vs 12.5%, P = .008) than prepectoral reconstruction. In multivariable regression, subpectoral reconstruction was associated with higher risk of infection (hazard ratio [HR], 1.65; P = .022) and device explantation (HR, 1.97; P = .034). Subgroup analyses demonstrated significantly higher rates of complications and explantation in the subpectoral group in those with a body mass index (BMI) ≥ 35 and BMI ≥40. The authors found no significant differences in mean scores for satisfaction with the breast (41.57 ± 13.19 vs 45.50 ± 11.91, P = .469), psychosocial well-being (39.43 ± 11.23 vs 39.30 ± 12.49, P = .915), and sexual well-being (17.17 ± 7.83 vs 17.0 ± 9.03, P = .931) between subpectoral and prepectoral reconstruction. CONCLUSIONS: Prepectoral reconstruction was associated with significantly decreased overall complications, infections, and device explantation in obese patients compared with subpectoral reconstruction. Prepectoral reconstruction provides superior outcomes to subpectoral reconstruction with comparable patient-reported outcomes.

The Skin Necrosis Conundrum: Examining Long-term Outcomes and Risk Factors in Implant-Based Breast Reconstruction.

BACKGROUND: Mastectomy skin flap necrosis (MSFN) is a common complication following mastectomy that causes significant distress to patients and physicians and also compromises oncologic, surgical, and quality-of-life outcomes. OBJECTIVES: We sought to investigate the long-term outcomes of MSFN following implant-based reconstruction (IBR) and determine the rates and predictors of post-MSFN complications. METHODS: This was a 20-year analysis of consecutive adult (>18 years) patients who developed MSFN following mastectomy and IBR from January 2001 to January 2021. Multivariable analyses were performed to identify factors associated with post-MSFN complications. RESULTS: We identified 148 reconstructions, with a mean follow-up time of 86.6 ± 52.9 months. The mean time from reconstruction to MSFN was 13.3 ± 10.4 days, and most cases (n = 84, 56.8%) were full-thickness injuries. Most cases (63.5%) were severe, 14.9% were moderate, and 21.6% were mild. Forty-six percent (n = 68) developed a breast-related complication, with infection being the most common (24%). An independent predictor of overall complications was longer time from reconstruction to MSFN (odds ratio [OR], 1.66; P = .040). Aging was an independent predictor of overall complications (OR, 1.86; P = .038); infection (OR, 1.72; P = .005); and dehiscence (OR, 6.18; P = .037). Independent predictors of dehiscence were longer interval from reconstruction to MSFN (OR, 3.23; P = .018) and larger expander/implant size (OR, 1.49; P = .024). Independent predictors of explantation were larger expander/implant size (OR, 1.20; P = .006) and nipple-sparing mastectomy (OR, 5.61; P = .005). CONCLUSIONS: MSFN is associated with high risk of complications following IBR. Awareness of the timing and severity of MSFN and the predictors of post-MSFN complications is crucial for guiding evidence-based decision-making and improving outcomes.

Exploring provider- and practice-level drivers of cost-consciousness in breast cancer reconstruction-secondary analysis of a survey of the American Society of Plastic Surgeons.

BACKGROUND: The role of physicians in dampening health care costs is a renewed focus of policy-makers. We examined provider- and practice-level factors affecting four domains of cost-consciousness among plastic surgeons performing breast reconstruction. METHODS: Secondary analysis was performed on the survey responses of 329 surgeons who routinely performed breast reconstruction. Using a 5-point Likert scale, we queried four domains of cost-consciousness: out-of-pocket cost awareness, cost discussions, cognizance of patients' financial burden, and attitudes regarding cost discussions. Multivariable linear regression was performed to identify provider- and practice-level factors affecting these domains according to composite scores. RESULTS: Overall cost-consciousness scores (CS) were moderate and ranged from 2.14 to 4.30. There were no significant differences across practice settings. Male gender (p = 0.048), Hispanic ethnicity (p = 0.021), and increasing clinical experience (p = 0.015) were associated with higher out-of-pocket cost awareness. Increasing surgeon experience was also associated with having cost discussions (p = 0.039). No provider- or practice-level factors were associated with cognizance of patients' financial burden. Salaried physicians displayed a more positive attitude toward out-of-pocket cost discussions (p = 0.049). On pairwise testing, the out-of-pocket cost awareness was significantly different between Hispanic surgeons and white surgeons (4.30 vs. 3.55), and between surgeons with more than 20 years' experience and with less than 5 years' experience (3.87 vs. 3.37). CONCLUSIONS: Surgeon gender, ethnicity, and experience and practice compensation type inform various domains of cost-consciousness in breast reconstruction. Structural and behavioral interventions could possibly increase physicians' cost-consciousness.

Allograft vs Xenograft Bioprosthetic Mesh in Tissue Expander Breast Reconstruction: A Blinded Prospective Randomized Controlled Trial.

BACKGROUND: With the increased use of acellular dermal matrix (ADM) in breast reconstruction, the number of available materials has increased. There is a relative paucity of high-quality outcomes data for use of different ADMs. OBJECTIVES: The goal of this study was to compare the outcomes between a human (HADM) and a bovine ADM (BADM) in implant-based breast reconstruction. METHODS: A prospective, single-blinded, randomized controlled trial was conducted to evaluate differences in outcomes between HADM and BADM for patients undergoing immediate tissue expander breast reconstruction. Patients with prior radiation to the index breast were excluded. Patient and surgical characteristics were collected and analyzed. RESULTS: From April 2011 to June 2016, a total of 90 patients were randomized to a mesh group, with 68 patients (HADM, 36 patients/55 breasts; BADM, 32 patients/48 breasts) included in the final analysis. Baseline characteristics were similar between the 2 groups. No significant differences in overall complication rates were identified between HADM (n = 14, 25%) and BADM (n = 13, 27%) (P = 0.85). Similar trends were identified for major complications and complications requiring reoperation. Tissue expander loss was identified in 7% of HADM patients (n = 4) and 17% of BADM patients (n = 8) (P = 0.14). CONCLUSIONS: Similar complication and implant loss rates were found among patients undergoing immediate tissue expander breast reconstruction with HADM or BADM. Regardless of what material is used, careful patient selection and counseling, and cost consideration, help to improve outcomes and sustainability in immediate breast reconstruction.

Consensus Statement on Robotic Mastectomy-Expert Panel From International Endoscopic and Robotic Breast Surgery Symposium (IERBS) 2019.

OBJECTIVES: To achieve a consensus statement on robotic mastectomy. BACKGROUND: Robotic-assisted surgery has gained much attention especially the results of few case series reporting on the technical feasibility, safety and early oncologic outcomes of robotic-assisted mastectomy in a few centers worldwide. The aim of this consensus statement was to develop and provide standardized guidelines on robotic mastectomy based on consensus statement by a panel of experts from indications to outcome measures and indicators, thereby providing a valuable guide for breast surgeons worldwide. METHODOLOGY: An internationally representative expert panel of 10 surgeons was invited to participate in the generation of a consensus statement. 52 statements were created in 6 domains: indications, contraindications, technical considerations, patient counseling, outcome measures and indicators, training and learning curve assessment. Experts were asked to vote if they agree, disagree or of the opinion that the statement should be rephrased. Two electronic rounds via online survey of iterative rating and feedback were anonymously completed, followed by a final round of in-person meeting during the inaugural International Endoscopic and Robotic Breast Surgery Symposium 2019 from May 24 to 25, 2019. Consensus was reached when there was at least 80% agreement on each statement. RESULTS: A total of 53 statements with at least 80% agreement were generated after 3 rounds of voting; 21 statements from first round of voting, 20 statements from second round of voting and 12 statements from the final round of in-person meeting. All experts agreed that the consensus statement served as expert recommendations but not mandatory for a successful and safe practice of robotic mastectomy. CONCLUSION: Robotic mastectomy is a promising technique and could well be the future of minimally invasive breast surgery whereas proving to be safe and feasible. The first consensus statement on robotic mastectomy from an international panel of experts serves as an extremely important milestone and provides recommendations for breast surgeons keen to embark on this technique.

Synthetic Mesh Versus Acellular Dermal Matrix for Oncologic Chest Wall Reconstruction: A Comparative Analysis.

BACKGROUND: Management of chest wall defects after oncologic resection is challenging due to multifactorial etiologies. Traditionally, skeletal stabilization in chest wall reconstruction (CWR) was performed with synthetic prosthetic mesh. The authors hypothesized that CWR for oncologic resection defects with acellular dermal matrix (ADM) is associated with a lower incidence of complications than synthetic mesh. METHODS: Consecutive patients who underwent CWR using synthetic mesh (SM) or ADM at a single center were reviewed. Only oncologic defects involving resection of at least one rib and reconstruction with both mesh and overlying soft tissue flaps were included in this study. Patients' demographics, treatment factors, and outcomes were prospectively documented. The primary outcome measure was surgical-site complications (SSCs). The secondary outcomes were specific wound-healing events, cardiopulmonary complications, reoperation, and mortality. RESULTS: This study investigated 146 patients [95 (65.1%) with SM; 51 (34.9%) with ADM] who underwent resection and CWR of oncologic defects. The mean follow-up period was 29.3 months (range 6-109 months). The mean age was 51.5 years, and the mean size of the defect area was 173.8 cm2. The SM-CWR patients had a greater number of ribs resected (2.7 vs. 2.0 ribs; p = 0.006) but a similar incidence of sternal resections (29.5% vs. 23.5%; p = 0.591) compared with the ADM-CWR patients. The SM-CWR patients experienced significantly more SSCs (32.6% vs. 15.7%; p = 0.027) than the ADM-CWR patients. The two groups had similar rates of specific wound-healing complications. No differences in mortality or reoperations were observed. CONCLUSIONS: The ADM-CWR patients experienced fewer SSCs than the SM-CWR patients. Surgeons should consider selectively using ADM for CWR, particularly in patients at higher risk for SSCs.

The effect of sarcopenia on perioperative complications in abdominally based free-flap breast reconstruction.

PURPOSE: The identification of patient-specific risk factors, which predict morbidity following abdominally based microvascular breast reconstruction is difficult. Sarcopenia is a proxy for patient frailty and is an independent predictor of complications in a myriad of surgical disciplines. We predict that sarcopenic patients will be at higher risk for surgical complications following abdominally based microvascular breast reconstruction. METHODS: A retrospective study of all patients who underwent delayed abdominally based autologous breast reconstruction following postmastectomy radiation therapy from 2007 to 2013 at a single institution was conducted. Univariate and multiple logistic regression models were used to assess the effect of sarcopenia on postoperative outcomes. RESULTS: Two hundred and eight patients met the inclusion criteria, of which 30 met criteria for sarcopenia (14.1%). There were no significant differences in demographics between groups. There were no significant differences in minor (36.7% vs 44.4%; P = .43) or major (16.7% vs 25.3%; P = .36) complications between groups as well as hospital length of stay. Multivariable logistic regression demonstrated that a staged reconstruction with the use of a tissue expander was the only consistent variable, which predicted major complications (OR, 2.24; 95% CI, 1.18-4.64; P = .015). CONCLUSIONS: Sarcopenia does not predispose to minor or major surgical complications in patients who undergo abdominally based microsurgical breast reconstruction.

Application of the ORBEYE three-dimensional exoscope for microsurgical procedures.

BACKGROUND: Advances in digital imaging, screen technology, and optics have led to the development of extracorporeal telescopes, also known as exoscopes, as alternatives to surgical loupes (SLs) and traditional operating microscopes (OMs) for surgical magnification. Theoretical advantages of the exoscope over conventional devices include improved surgeon ergonomics; superior three-dimensional, high-definition optics; and greater ease-of-use. The ORBEYE exoscope, in particular, has demonstrated early efficacy in the surgical arena. The purpose of this study was to compare the ORBEYE with conventional microscopy. METHODS: In this case-control pilot study, we compared the ORBEYE (n = 22) with conventional microscopy (n = 27) across 49 consecutive microsurgical cases during a 6-week period. Both visualization methods consisted of breast, and head and neck cases, while the ORBEYE was also used for extremity and lymphedema microsurgical cases. The ORBEYE was utilized during flap dissection and microvascular anastomosis. Baseline demographics, operative time, ischemia time, and intra- and postoperative microvascular complications were examined and compared. Attending surgeons completed an ergonomics and performance survey postoperatively comparing the ORBEYE with their previous use of SL/OM using a 5-point Likert scale. RESULTS: There was no difference in operative time (507 ± 132 min vs. 522 ± 139, p = .714), ischemia time (77.9 ± 31.4 min vs. 77.5 ± 36.0, p = .972), or microsurgical complications (0% vs. 4%, p = 1) between the ORBEYE and conventional microscopy groups. In a survey administered immediately postoperatively, surgeons reported favorable ergonomics, excellent image quality, and ease of equipment manipulation using the exoscope. CONCLUSIONS: The ORBEYE is an effective microsurgical tool and may be considered as an alternative to conventional optical magnification technology.

Safety and Efficacy of Smooth Surface Tissue Expander Breast Reconstruction.

BACKGROUND: Traditional 2-stage breast reconstruction involves placement of a textured-surface tissue expander (TTE). Recent studies have demonstrated textured surface devices have higher propensity for bacterial contamination and biofilm formation. OBJECTIVES: The purpose of this study was to evaluate the safety and efficacy of smooth surface tissue expanders (STE) in immediate breast reconstruction. METHODS: The authors retrospectively reviewed consecutive women who underwent STE breast reconstruction from 2016 to 2017 at 3 institutions. Indications and outcomes were evaluated. RESULTS: A total 112 patients underwent STE reconstruction (75 subpectoral, 37 prepectoral placement), receiving 173 devices and monitored for a mean follow-up of 14.1 months. Demographics of patients included average age of 53 years and average BMI of 27.2 kg/m2, and 18.6% received postmastectomy radiation therapy. Overall complication rates were 15.6% and included mastectomy skin flap necrosis (10.4%), seroma (5.2%), expander malposition (2.9%), and infection requiring intravenous antibiotic therapy (3.5%). Six (3.5%) unplanned reoperations with explantation were reported for 3 infections and 3 patients requesting change of plan with no reconstruction. CONCLUSIONS: STEs represent a safe and efficacious alternative to TTE breast reconstruction with at least equitable outcomes. Technique modification including tab fixation, strict pocket control, postoperative bra support, and suture choice may contribute to observed favorable outcomes and are reviewed. Early results for infection control and explantation rate are encouraging and warrant comparative evaluation for potential superiority over TTEs in a prospective randomized trial.

US FDA Breast Implant Postapproval Studies: Long-term Outcomes in 99,993 Patients.

OBJECTIVE: To analyze the long-term safety and efficacy outcomes of patients with breast implants. SUMMARY BACKGROUND DATA: Research is ongoing regarding the safety of silicone breast implants. Despite the number of patients with breast implants followed by United States Food and Drug Administration large postapproval studies (LPAS), this database has not been thoroughly analyzed or reported. METHODS: This is a multicentered, cohort study. LPAS prospectively monitor long-term implant-related outcomes and systemic harms for silicone/saline implants from 2 manufacturers (Allergan and Mentor) placed for primary/revision augmentation/reconstruction. Systemic harms, self-harm, and reproductive outcomes are compared with normative data. Implant-related complications are analyzed by implant composition and operative indication in the short and long terms. RESULTS: LPAS data includes 99,993 patients, 56% of implants were silicone for primary augmentation. Long-term magnetic resonance imaging surveillance is under 5%. Compared with normative data, silicone implants are associated with higher rates of Sjogren syndrome (Standardized incidence ratio [SIR]8.14), scleroderma (SIR 7.00), rheumatoid arthritis (SIR5.96), stillbirth (SIR4.50), and melanoma (SIR3.71). One case of BI-ALCL is reported. There is no association with suicide. In the short term, rupture is higher for saline (2.5% vs. 0.5%, P < 0.001), and capsular contracture higher for silicone (5.0% vs. 2.8%, P < 0.001). At 7 years, reoperation rate is 11.7% for primary augmentation, and 25% for primary/revision reconstruction. Capsular contracture (III/IV) occurs in 7.2% of primary augmentations, 12.7% primary reconstructions, and is the most common reason for reoperation among augmentations. CONCLUSIONS: This is the largest study of breast implant outcomes. Silicone implants are associated with an increased risk of certain rare harms; associations need to be further analyzed with patient-level data to provide conclusive evidence. Long-term safety and implant-related outcomes should inform patient and surgeon decision-making when selecting implants.

Applying a value-based care framework to post-mastectomy reconstruction.

PURPOSE: Reconstructive breast surgeons, like all procedural care providers, face a transition from volume reimbursement (i.e., per unit of service) to value-based care. Value can be defined as the relationship between outcomes and costs, or more specifically healthcare outcomes per unit cost. Although the definition of a meaningful outcome for a particular treatment can vary, some weighted average of survival, function, complications, process measures, and patient-reported outcomes (PROs) comprise the numerator, while the total cost of a complete care cycle is the denominator. We aim to construct a value-based care framework for reconstructive surgery using post-mastectomy reconstruction as an organizing element. METHODS: A preexisting value framework was applied to breast reconstruction using expert opinion and literature review. Domains and associated realization strategies were constructed based on established health economic principles. RESULTS: Seven domains were identified including: implementing an inclusive and transparent process for stakeholder engagement, practicing clear and explicit treatment goals, anchoring care delivery to the patient perspective, maximizing value across the entire continuum of care, optimizing operation efficiency, and scaling best practices with implementation science. CONCLUSIONS: In the near future, reconstructive plastic surgeons may be asked to solve clinical problems for fixed reimbursement (i.e. bundled payments). Considering breast reconstruction through a value lens provides surgeons with an opportunity to adapt and thrive in an evolving healthcare landscape. Lastly, we hope this document helps promote value assessment within the specialty.