A meta-analysis of randomized controlled clinical trials implications of acute treatment effects on glomerular filtration rate for long-term kidney protection.

Pharmacologic interventions to slow chronic kidney disease progression, such as ACE-inhibitors, angiotensin receptor blockers, or sodium glucose co-transporter 2 inhibitors, often produce acute treatment effects on glomerular filtration rate (GFR) that differ from their long-term chronic treatment effects. Observational studies assessing the implications of acute effects cannot distinguish acute effects from GFR changes unrelated to the treatment. Here, we performed meta-regression analysis of multiple trials to isolate acute effects to determine their long-term implications. In 64 randomized controlled trials (RCTs), enrolling 154,045 participants, we estimated acute effects as the mean between-group difference in GFR slope from baseline to three months, effects on chronic GFR slope (starting at three months after randomization), and effects on three composite kidney endpoints defined by kidney failure (GFR 15 ml/min/1.73m2 or less, chronic dialysis, or kidney transplantation) or sustained GFR declines of 30%, 40% or 57% decline, respectively. We used Bayesian meta-regression to relate acute effects with treatment effects on chronic slope and the composite kidney endpoints. Overall, acute effects were not associated with treatment effects on chronic slope. Acute effects were associated with the treatment effects on composite kidney outcomes such that larger negative acute effects were associated with lesser beneficial effects on the composite kidney endpoints. Associations were stronger when the kidney composite endpoints were defined by smaller thresholds of GFR decline (30% or 40%). Results were similar in a subgroup of interventions with supposedly hemodynamic effects that acutely reduce GFR. For studies with GFR 60 mL/min/1.73m2 or under, negative acute effects were associated with larger beneficial effects on chronic GFR slope. Thus, our data from a large and diverse set of RCTs suggests that acute effects of interventions may influence the treatment effect on clinical kidney outcomes.

Outpatient Prescription Opioid Use following Discharge after Deep Inferior Epigastric Perforator Breast Reconstruction with and without an Educational Intervention.

BACKGROUND: There is limited evidence for appropriate postoperative opioid prescribing in autologous breast reconstruction. We sought to describe postoperative outpatient prescription opioid use following discharge after deep inferior epigastric perforator (DIEP) breast reconstruction with and without an educational video. METHODS: Patients undergoing DIEP reconstruction were given a 28-day postoperative pain and medication logbook from August 2022 to June 2023. Our practice implemented an educational video upon discharge on proper opioid consumption. Descriptive statistics on patient characteristics, intraoperative and postoperative opioid consumption, and outpatient prescription opioid use after discharge were compared between the two cohorts. RESULTS: A total of 53 logbooks were completed with 20 patients in the no video cohort and 33 in the video cohort. On average, the days to cessation of opiates was longer in the no video cohort (8.2 vs. 5.1 days, p = 0.003). The average number of oxycodone 5 mg equivalents consumed following discharge was 13.8 in the no video cohort and 7.8 in the video cohort, which was statistically significant (p = 0.01). Overall, the percentage of opioids prescribed that were consumed in the video cohort was 28.3% versus 67.1% in the no video cohort. CONCLUSION: For patients discharging home after DIEP reconstruction, we recommend a prescription for 12 oxycodone 5 mg tablets. With the use of an educational video regarding proper opioid consumption, we were able to reduce the total outpatient opioid use to 5 oxycodone 5 mg tablets following hospital discharge.

The Effect of Body Mass Index on Free Flap Breast Reconstruction.

BACKGROUND: Literature addressing the risks associated with increasing body mass index (BMI) for patients undergoing free flap breast reconstruction is limited. Often, an arbitrary BMI cutoff (i.e., BMI of 30 kg/m2) is used to determine candidacy for a free flap without substantial backing evidence. This study utilized a national multi-institutional database to analyze outcomes of free flap breast reconstruction and stratified complications by BMI class. METHODS: Using the 2010 to 2020 National Surgical Quality Improvement Program database, patients who underwent free flap breast reconstruction were identified. Patients were divided into six cohorts based on the World Health Organization BMI classes. Cohorts were compared by basic demographics and complications. A multivariate regression model was created to control for age, diabetes, bilateral reconstruction, American Society of Anesthesiologists class, and operative time. RESULTS: Surgical complications increased with each BMI class, with the highest rates occurring in class I, II, and III obesity, respectively. In a multivariable regression model, the risk for any complication was significant for class II and III obesity (odds ratio [OR]: 1.23, p < 0.004; OR: 1.45, p < 0.001, respectively). Diabetes, bilateral reconstruction, and operative time were independently associated with an increased risk of any complication (OR: 1.44, 1.14, 1.14, respectively, p < 0.001). CONCLUSION: This study suggests that the risks of postoperative complications following free flap breast reconstruction are highest for patients with a BMI greater than or equal to 35 kg/m2, having nearly 1.5 times higher likelihood of postoperative complications. Stratifying these risks by weight class can help guide preoperative counseling with patients and help physicians determine candidacy for free flap breast reconstruction.

A Comparison of Postoperative Outcomes between Unilateral and Bilateral Palatoplasty: Analysis of 2015-2020 Pediatric NSQIP Data.

OBJECTIVE: We sought to identify differences in 30-day medical and surgical complications in unilateral versus bilateral palatoplasty. DESIGN: The NSQIP-P 2015-2020 database was queried to identify cleft palate repairs using CPT codes. Cases were stratified as unilateral (Veau III) and bilateral (Veau IV) using ICD-9 and -10 codes. SETTING: A nationally representative random sample. PATIENTS/PARTICIPANTS: A total of 3791 cases were identified with 2608 undergoing unilateral repair and 1183 undergoing bilateral repair. MAIN OUTCOMES/MEASURES: The postoperative outcomes of interest included surgical complications (surgical site infections, wound dehiscence), medical complications (pneumonia, urinary tract infection, seizure, cardiac arrest, bleeding/transfusions, systemic sepsis, unplanned intubation), readmission, and reoperation. RESULTS: The bilateral cohort was older (696 days versus 619 days, P < .001) and had longer operative times (157.3 min versus 144.5 min, P < .001). The unilateral cohort had more comorbidities including developmental delay, structural CNS abnormalities, need for nutritional support, and bleeding disorders. The bilateral cohort had statistically significant higher occurrences of wound dehiscence (2.1% versus. 1.2%, P = .03) and readmission (3.2% versus 1.7%, P = .01). On multivariate analysis, bilateral cleft repair (OR: 1.83, CI: 1.176-2.840, P = .007) and ASA class 4 (OR: 13.1, CI 2.288- 62.586, P = .002) were associated with greater odds of readmission. CONCLUSION: Patients who underwent bilateral cleft repair had a higher proportion of 30-day postoperative complications and a two-fold increased odds of readmission. While palatoplasty is generally regarded as a safe procedure in the pediatric population, identifying factors related to an increased risk of early postoperative complications can help surgical teams better manage high-risk individuals.

Analysis of Readmissions and Reoperations in Pediatric Microvascular Reconstruction.

BACKGROUND: Free tissue transfer is utilized as a reconstructive option for various anatomic defects. While it has long been performed in adults, reconstructive surgeons have used free tissue transfer to a lesser degree in children. As such, there are few analyses of factors associated with complications in free tissue transfer within this population. The aim of this study is to assess factors associated with readmission and reoperation in pediatric free flap patients utilizing the pediatric National Surgical Quality Improvement Program database. METHODS: Pediatric patients who underwent microvascular reconstruction between 2015 and 2020 were included. Patients were identified by five microvascular reconstruction Current Procedural Terminology codes and were then stratified by flap site (head and neck, extremities, trunk) and defect etiology (congenital, trauma, infection, neoplasm). Multivariate logistic regression was performed to identify factors associated with readmissions and reoperations. RESULTS: The study cohort consisted of 258 patients. The average age was 10.0 ± 4.7 years and the majority of patients were male (n = 149, 57.8%), were of white race (n = 164, 63.6%), and had a normal body mass index. Twenty-two patients (8.5%) experienced an unplanned readmission within 30 days of the initial operation, most commonly for wound disruption (31.8% of readmissions). The overall rate of unplanned reoperation within 30 days was 11.6% (n = 30) for all patients, with an average of 8.9 ± 7.5 days to reoperation. On multivariate regression analysis, each hour increase in operative time was associated with an increased odds of reoperation (odds ratio [OR]: 1.27; 95% confidence interval [CI]: 1.12, 1.45) and readmission (OR: 1.16; 95% CI: 1.02, 1.34). CONCLUSION: In pediatric patients undergoing free tissue transfer, higher readmission and reoperation risk was associated with longer operative duration. Overall, free tissue transfer is safe in the pediatric population with relatively low rates of readmission and reoperation.

A Comparison of Postoperative Outcomes Between Immediate, Delayed Immediate, and Delayed Autologous Free Flap Breast Reconstruction: Analysis of 2010-2020 NSQIP Data.

BACKGROUND: While many factors influence decisions related to the timing between mastectomy and flap-based breast reconstruction, there is limited literature comparing postoperative complications between immediate (IBR), delayed immediate (DIBR), and delayed (DBR) reconstruction modalities. Using the National Surgical Quality Improvement Program (NSQIP), we sought to compare postoperative complication rates of each timing modality. METHODS: The NSQIP 2010-2020 database was queried for patients who underwent free flap breast reconstruction. Cases were categorized to include mastectomy performed concurrently with a free flap reconstruction, removal of a tissue expander with free flap reconstruction, and free flap reconstruction alone which are defined as IBR, DIBR, and DBR, respectively. The frequency of postoperative outcomes including surgical site infection (SSI), wound dehiscence, intraoperative transfusion, deep venous thrombosis (DVT), and return to operating room (OR) was assessed. Overall complication rates, hospital length of stay (LOS), and operative time were analyzed. Multivariable regression analysis controlling for age, race, BMI, diabetes, hypertension, ASA class, and laterality was performed. RESULTS: A total of 7,907 cases that underwent IBR, DIBR (n = 976), and DBR reconstruction (n = 6,713) were identified. No statistical difference in occurrence of SSIs, wound dehiscence, or DVT was identified. DIBR (9%) and DBR (11.9%) were associated with less occurrences of reoperation than IBR (13.2%, p < 0.001). Univariate and multivariate regression analysis demonstrated that DIBR and DBR were associated with a lower odds of complications and shorter operation time versus IBR. No statistically significant differences between DIBR and DBR in surgical complications, LOS, and operative time were identified. CONCLUSION: Awareness of overall complication rates associated with each reconstructive timing modality can be used to help guide physicians when discussing reconstructive options. Our data suggests that DIBR and DBR are associated with less overall complications than IBR. Physicians should continue to consider patients' unique circumstances when deciding upon which timing modality is appropriate.

Scheduled Postoperative Ketorolac Does Not Decrease Opiate Use following Free Flap Breast Reconstruction.

BACKGROUND: In the setting of the opioid crisis, managing postoperative pain without the exclusive use of opiates has become a topic of interest. Many hospitals have begun implementing enhanced recovery after surgery protocols to decrease postoperative complications, hospital costs, and opiate utilization. Ketorolac has been added to many of these protocols, but few studies have examined its effects independently. METHODS: A retrospective chart review was performed on all patients that received autologous breast reconstruction from October 2020 to June 2022 at an academic institution. We identified patients who did and did not receive postoperative ketorolac. Use of ketorolac was based upon surgeon preference. The two groups were compared in basic demographics, reconstruction characteristics, length of stay, complications, reoperations, and morphine milligram equivalents (MMEs). RESULTS: One-hundred ten patients were included for the analysis, with 55 receiving scheduled postoperative ketorolac and 55 who did not receive ketorolac. There were seven incidences of postoperative complications in each group (12.7%, p = 1.00). The total mean postoperative MMEs were 344.7 for the nonketorolac group and 336.5 for the ketorolac group (p = 0.81). No variable was found to be independently associated with postoperative opiate use. Ketorolac was not found to contribute significantly to any postoperative complication. CONCLUSION: In this study, the use of ketorolac did not significantly reduce opiate use in a cohort of 110 patients. Surgeons should consider whether the use of ketorolac alone is the best option to reduce postoperative opiate use following free flap breast reconstruction.

Characterizing the volume of surgery and post-operative complications during the COVID-19 pandemic.

PURPOSE: The COVID-19 pandemic led to unprecedented changes in volume and quality of surgery. Utilizing the American College of Surgeons National Surgical Quality Improvement Program (NSQIP) database, the current study assesses the impact of COVID-19 on surgical volume during each quarter of 2020 in comparison to 2019. Quality of surgical care during 2020 was also investigated by assessing postoperative complications, readmissions, and reoperations during 2020 in comparison to the previous 5 years. MATERIALS AND METHODS: The NSQIP database was queried from 2015 to 2020. Descriptive statistics and a chi-squared test were utilized to compare demographic variables. A seasonal autoregressive integrated moving average time-series model was fit to assess the trend and seasonality of complications from 2015 to 2019 and was used to forecast the proportion of complications in the year 2020 and compared the forecast with the actual proportions graphically. RESULTS: There were fewer patients operated on in 2020 compared to 2019, with the most dramatic drop in Q2 with a nearly 27% decrease. Patients with ASA class 3 or greater were operated on at a greater proportion in every quarter of 2020. Q2 of 2020 represented the highest proportion of any operative complications since 2015 at ~13%. Q4 of 2020 demonstrated a return to 2020 Q1 complication proportions. CONCLUSION: Surgical volume was heavily affected in 2020, particularly in Q2. Patients during Q2 of 2020 were generally of a higher ASA class and had increased operative complications. Operative volume and overall surgical complication rate normalized over the next two quarters.

Outcomes after tissue expander exchange to implant in two-stage prepectoral breast reconstruction with and without acellular dermal matrix: A retrospective cohort study.

As prepectoral implant placement becomes widely adopted, recent studies investigating the use of acellular dermal matrix (ADM) during tissue expander placement have demonstrated no major benefit with regard to postoperative outcomes. We sought to evaluate second-stage outcomes 1 year after tissue expander exchange to implant with and without ADM. Consecutive patients who underwent prepectoral tissue expander-based breast reconstruction with and without ADM were identified. Patients were followed up for 1 year after tissue expander exchange to implant. Second-stage outcomes of interest including implant rippling, capsular contracture, implant explantation, additional revision surgeries, and patient-reported outcomes were collected and compared. Sixty-eight breasts in the ADM cohort and sixty-one breasts in the no ADM cohort underwent tissue expander exchange to implant. Second-stage outcomes of interest were similar between the ADM and no ADM cohorts with no statistically significant differences identified regarding incidences of implant rippling (24.6% vs. 12.1%, p = 0.08), capsular contracture (4.5% vs. 3.3%, p = 1.00), and explantation (6.6% vs. 1.7%, p = 0.67) between the two cohorts. BREAST-Q scores were similar between the two cohorts with the exception of physical wellbeing and satisfaction in terms of implant rippling, as can be seen, which improved in the no ADM cohort (p = 0.04). Our study reports no major benefit for the inclusion of ADM with respect to implant rippling, capsular contracture, explantation, need for additional revision surgeries, and patient-reported satisfaction in prepectoral second-stage implant-based breast reconstruction.

An Evaluation of Early Complications after Prepectoral Tissue Expander Placement in First-Stage Breast Reconstruction with and without Acellular Dermal Matrix.

PURPOSE: Prepectoral breast reconstruction has become popularized with the concurrent use of acellular dermal matrix (ADM). We sought to compare three-month postoperative complication rates and explantation rates for first stage, tissue expander based prepectoral breast reconstruction with and without the use of ADM. METHODS: A single institution retrospective chart review was performed to identify consecutive patients undergoing prepectoral tissue-expander based breast reconstruction from August 2020 to January 2022. Chi-squared tests were used to compare demographic categorical variables and multiple variable regression models were used to identify variables associated with three-month postoperative outcomes. RESULTS: We enrolled 124 consecutive patients. Fifty-five patients (98 breasts) were included in the no-ADM cohort and 69 patients (98 breasts) were included in the ADM cohort. There were no statistically significant differences between ADM and no-ADM cohort in regard to 90-day postoperative outcomes. On multivariable analysis, there were no independent associations between seroma, hematoma, wound dehiscence, mastectomy skin flap necrosis, infection, unplanned return to the OR, or explanation in the ADM or no ADM groups after controlling for age, BMI, history of diabetes, tobacco use, neoadjuvant chemotherapy, and postoperative radiotherapy. CONCLUSION: Our results reveal no significant differences in odds of postoperative complications, unplanned return to the OR, or explantation between ADM and no-ADM cohorts. More studies are needed to evaluate the safety of prepectoral, tissue expander placement without ADM.

Thrombotic and hemorrhagic complications of COVID-19 in adults hospitalized in high-income countries compared with those in adults hospitalized in low- and middle-income countries in an international registry.

Background: COVID-19 has been associated with a broad range of thromboembolic, ischemic, and hemorrhagic complications (coagulopathy complications). Most studies have focused on patients with severe disease from high-income countries (HICs). Objectives: The main aims were to compare the frequency of coagulopathy complications in developing countries (low- and middle-income countries [LMICs]) with those in HICs, delineate the frequency across a range of treatment levels, and determine associations with in-hospital mortality. Methods: Adult patients enrolled in an observational, multinational registry, the International Severe Acute Respiratory and Emerging Infections COVID-19 study, between January 1, 2020, and September 15, 2021, met inclusion criteria, including admission to a hospital for laboratory-confirmed, acute COVID-19 and data on complications and survival. The advanced-treatment cohort received care, such as admission to the intensive care unit, mechanical ventilation, or inotropes or vasopressors; the basic-treatment cohort did not receive any of these interventions. Results: The study population included 495,682 patients from 52 countries, with 63% from LMICs and 85% in the basic treatment cohort. The frequency of coagulopathy complications was higher in HICs (0.76%-3.4%) than in LMICs (0.09%-1.22%). Complications were more frequent in the advanced-treatment cohort than in the basic-treatment cohort. Coagulopathy complications were associated with increased in-hospital mortality (odds ratio, 1.58; 95% CI, 1.52-1.64). The increased mortality associated with these complications was higher in LMICs (58.5%) than in HICs (35.4%). After controlling for coagulopathy complications, treatment intensity, and multiple other factors, the mortality was higher among patients in LMICs than among patients in HICs (odds ratio, 1.45; 95% CI, 1.39-1.51). Conclusion: In a large, international registry of patients hospitalized for COVID-19, coagulopathy complications were more frequent in HICs than in LMICs (developing countries). Increased mortality associated with coagulopathy complications was of a greater magnitude among patients in LMICs. Additional research is needed regarding timely diagnosis of and intervention for coagulation derangements associated with COVID-19, particularly for limited-resource settings.

Gender Representation Among Presenters in Ophthalmology Subspecialties in 2019: A Retrospective Review.

PURPOSE: To describe gender representation at 8 national ophthalmology conferences, stratified by role, session category, and subspecialty. DESIGN: Retrospective cross-sectional study. METHODS: Data were examined on 3817 presenters at the 2019 American Academy of Ophthalmology subspecialty days, American Society of Cataract and Refractive Surgery, American Glaucoma Society, American Society of Retina Specialists, American Society of Ophthalmic Plastic and Reconstructive Surgery, American Association for Pediatric Ophthalmology and Strabismus, North American Neuro-Ophthalmology Society, and American Uveitis Society meetings. The main outcome measure was the gender of presenters in 7 subspecialties, stratified by category and role. RESULTS: The proportion of female presenters was less than the American Board of Ophthalmology (ABO)-estimated proportion of women in their respective fields in glaucoma (28.0% vs 39.8%), neuro-ophthalmology (35.3% vs 45.3%), and pediatrics (42.1% vs 53.3%) and greater than expected in retina (24.6% vs 19.8%). Overall, the proportion of female presenters exceeded the ABO-estimated proportion of women in ophthalmology (24.5%) for clinical (mean = 38.5%, 95% CI [35.8%, 41.4%]) and scientific (39.4% [30.3%, 49.2%]) sessions. For clinical subspecialty sessions, the proportion of female leaders exceeded the overall proportion of female leaders in the respective subspecialty in cornea (35.1% [30.4%, 40.1%] vs 24.6% all sessions). Females represented fewer than the expected number of surgical session leaders in cornea (22.0% [19.9%, 24.3%]), glaucoma (18.0% [13.2%, 24.1%]), pediatrics (22.0% [14.4%, 32.1%]), and retina (18.6% [14.2%, 24.1%]). CONCLUSIONS: Gender representation varied, with fewer than expected female presenters in glaucoma, neuro-ophthalmology, and pediatrics. Women led relatively more clinical sessions but were underrepresented in surgical sessions in most subspecialties.