Long-term outcomes of truncus arteriosus repair: A modulated renewal competing risks analysis.

OBJECTIVE: In this study, we sought to identify independent risk factors for mortality and reintervention after early surgical correction of truncus arteriosus using a novel statistical method. METHODS: Patients undergoing neonatal/infant truncus arteriosus repair between January 1984 and December 2018 were reviewed retrospectively. An innovative statistical strategy was applied integrating competing risks analysis with modulated renewal for time-to-event modeling. RESULTS: A total of 204 patients were included in the study. Mortality occurred in 32 patients (15%). Smaller right ventricle to pulmonary artery conduit size and truncal valve insufficiency at birth were significantly associated with overall mortality (right ventricle to pulmonary artery conduit size: hazard ratio, 1.34; 95% confidence interval, 1.08-1.66, P = .008; truncal valve insufficiency: hazard ratio, 2.5; 95% confidence interval, 1.13-5.53, P = .024). truncal valve insufficiency at birth, truncal valve intervention at index repair, and number of cusps (4 vs 3) were associated with truncal valve reoperations (truncal valve insufficiency: hazard ratio, 2.38; 95%, confidence interval, 1.13-5.01, P = .02; cusp number: hazard ratio, 6.62; 95% confidence interval, 2.54-17.3, P < .001). Right ventricle to pulmonary artery conduit size 11 mm or less was associated with a higher risk of early catheter-based reintervention (hazard ratio, 1.54; 95% confidence interval, 1.04-2.28, P = .03) and reoperation (hazard ratio, 1.96; 95% confidence interval, 1.33-2.89, P = .001) on the right ventricle to pulmonary artery conduit. CONCLUSIONS: Smaller right ventricle to pulmonary artery conduit size and truncal valve insufficiency at birth were associated with overall mortality after truncus arteriosus repair. Quadricuspid truncal valve, the presence of truncal valve insufficiency at the time of diagnosis, and truncal valve intervention at index repair were associated with an increased risk of reoperation. The size of the right ventricle to pulmonary artery conduit at index surgery is the single most important factor for early reoperation and catheter-based reintervention on the conduit.

Factors Associated with Re-Resection in T1 Bladder Cancer: Identifying Patients Who Do Not Receive Guideline-Concordant Care at the Population Level.

PURPOSE: Prior research has shown that concordance with the guideline-endorsed recommendation to re-resect patients diagnosed with primary T1 bladder cancer (BC) is suboptimal. Therefore, the aim of this population-based study was to identify factors associated with re-resection in T1 BC. MATERIALS AND METHODS: We linked province-wide BC pathology reports (January 2001 to December 2015) with health administrative data sources to derive an incident cohort of patients diagnosed with T1 BC in the province of Ontario, Canada. Re-resection was ascertained by a billing claim for transurethral resection within 2 to 8 weeks after the initial resection, accounting for system-related wait times. Multivariable logistic regression analysis accounting for the clustered nature of the data was used to identify various patient-level and surgeon-level factors associated with re-resection. P values <0.05 were considered statistically significant (2-sided). RESULTS: We identified 7,373 patients who fulfilled the inclusion criteria. Overall, 1,678 patients (23%) underwent re-resection. Patients with a more aggressive tumor profile and individuals without sufficiently sampled muscularis propria as well as younger, healthier and socioeconomically advantaged patients were more likely to receive re-resection (all p <0.05). In addition, more senior, lower volume and male surgeons were less likely to perform re-resection for their patients (all p <0.05). CONCLUSIONS: Only a minority of all patients received re-resection within 2 to 8 weeks after initial resection. To improve the access to care for potentially underserved patients, we suggest specific knowledge translation/exchange interventions that also include equity aspects besides further promotion of evidence-based instead of eminence-based medicine.

Reoperaciones no programadas en un servicio de cirugía adultos: análisis del protocolo MINSAL / Unscheduled reoperations in adult surgery: analysis of the MINSAL protocol

Resumen Introducción: El análisis de reoperaciones no programadas (RONP) es un indicador de calidad solicitado por el Ministerio de Salud de Chile (MINSAL) desde julio de 2010 como una forma de retroalimentar a los equipos quirúrgicos sobre las causas de reintervenciones en cirugía electiva, promoviendo la discusión técnica en una reunión clínica de pares. Objetivo: Evaluar los resultados de un protocolo de RONP en un hospital público docente de alta complejidad. Materiales y Método: Estudio descriptivo que analiza la base de datos prospectiva iniciada en nuestro centro en julio de 2010 incluyendo todos los pacientes reoperados antes de 30 días desde la intervención inicial electiva. El indicador se consideró cumplido si hubo un análisis crítico del caso antes de 15 días desde la fecha de la reintervención y si hay un documento que lo respalda. Resultados: En el periodo de 9,5 años se efectuaron 18.536 intervenciones electivas con una tasa global de RONP de 2,5%. El protocolo se cumplió en el 97% de los casos. Las RONP representan el 45,5% de la mortalidad global de los equipos estudiados en el periodo. Conclusión: El indicador de las RONP nos parece una práctica relevante en el contexto acotado de un servicio y su evolución en el tiempo. No es útil como indicador global de una institución que involucra servicios de adultos y niños con múltiples especialidades no comparables. Para cumplir con el objetivo debe medirse en forma prospectiva, completa, no discriminatoria y sin carácter punitivo. Teóricamente podría retroalimentar la estrategia quirúrgica de los equipos.

Background: Unplanned reoperations (UPRO) after elective surgery was proposed by Ministry of Health (MINSAL) as a quality indicator since 2010. The goal was to promote the discussion between pairs as an effective feedback for the surgical team. Aim: The purpose of this study is to analyze the results of a protocol of UPRO in a high complexity public institution. Materials and Method: The 9.5 years data base starting in July 2010 was analyzed. All reoperations within 30 days of the initial surgery were included. The UPRO indicator was considered fulfilled if the critical discussion of the case occurred in the clinical meeting within 15 days of the reoperation and if there is a document to support it. Results: in the indicated period the rate of UPRO was 2.5% (455 of 18,536 patients) and the protocol was accomplished in 97% of the cases. The stay in hospital and mortality rate in re-operated patients were high, with great differences between the surgical teams. Conclusions: The UPRO indicator is useful as a detailed analysis of postoperative morbidity of specific surgical teams and the changes along the years. Considering the great differences between the procedures in adults and children and the huge variation and complexity of the operations of multiple surgical specialties, it seems not relevant as a global indicator of a General Hospital. The UPRO must be prospective, complete, non-discriminatory and non-punitive. Theoretically UPRO could be useful as a feedback of surgical teams.

The Association of "U.S. News & World Report" Hospital Rankings and Outcomes Following Anterior Cervical Fusions: Do Rankings Even Matter?

STUDY DESIGN: Retrospective observational study. OBJECTIVE: The aim of this study was to evaluate whether there are any differences in outcomes and costs for elective one- to three-level anterior cervical fusions (ACFs) performed at US News and World Report (USNWR) ranked and unranked hospitals. SUMMARY OF BACKGROUND DATA: Although the USNWR rankings are advertised by media and are routinely used by patients as a guide in seeking care, evidence regarding whether these rankings are reflective of actual clinical outcome remains limited. METHODS: The 2010-2014 USNWR hospital rankings were used to identify ranked hospitals in "Neurosurgery" and "Orthopedics." The 2010-2014 100% Medicare Standard Analytical Files (SAF100) were used to identify patients undergoing elective ACFs at ranked and unranked hospitals. Multivariable logistic regression and generalized linear regression analyses were used to assess for differences in 90-day outcomes and costs between ranked and unranked hospitals. RESULTS: A total of 110,520 patients undergoing elective one- to three-level ACFs were included in the study, of which 10,289 (9.3%) underwent surgery in one of the 100 ranked hospitals. Following multivariate analysis, there were no significant differences between ranked versus unranked hospitals with regards to wound complications (1.2% vs. 1.1%; P = 0.907), cardiac complications (12.9% vs. 11.9%; P = 0.055), pulmonary complications (3.7% vs. 6.7%; P = 0.654), urinary tract infections (7.3% vs. 5.8%; P = 0.120), sepsis (9.3% vs. 7.9%; P = 0.847), deep venous thrombosis (1.9% vs. 1.3%; P = 0.077), revision surgery (0.3% vs. 0.3%; P = 0.617), and all-cause readmissions (4.7% vs. 4.4%; P = 0.266). Ranked hospitals, as compared to unranked hospitals, had a slightly lower odds of experiencing renal complications (7.0% vs. 4.9%; P = 0.047), but had significantly higher risk-adjusted 90-day charges (+$17,053; P < 0.001) and costs (+ $1695; P < 0.001). CONCLUSION: Despite the higher charges and costs of care at ranked hospitals, these facilities appear to have similar outcomes as compared to unranked hospitals following elective ACFs.Level of Evidence: 3.

Association of Neurosurgical Work Relative Value Units with Objective Markers of Operative Complexity.

OBJECTIVE: Relative value units (RVUs) form the backbone of health care service reimbursement calculation in the United States. However, it remains unclear how well RVUs align with objective measures of procedural complexity within neurosurgery. METHODS: The 2018 American College of Surgeons National Surgical Quality Improvement Program database was queried for neurosurgical procedures with >50 patients, using Current Procedural Terminology (CPT) codes. Length of stay (LOS), operative time, mortality, and readmission and reoperation rates were collected for each code and a univariate correlation analysis was performed, with significant predictors entered into a multivariate logistic regression model, which generated predicted work RVUs, which were compared with actual RVUs to identify undervalued and overvalued procedures. RESULTS: Among 64 CPT codes, LOS, operative time, mortality, readmission, and reoperation were significant independent predictors of work RVUs and together explained 76% of RVU variance in a multivariate model (R2 = 0.76). Using a difference of >1.5 standard deviations from the mean, procedures associated with greater than predicted RVU included surgery for intracranial carotid circulation aneurysms (CPTs 61697 and 61700; residual RVU = 12.94 and 15.07, respectively), and infratemporal preauricular approaches to middle cranial fossa (CPT 61590; residual RVU = 15.39). Conversely, laminectomy/foraminotomy for decompression of additional spinal cord, cauda equina, and/or nerve root segments (CPT 63048; residual RVU = -21.30), transtemporal craniotomy for cerebellopontine angle tumor resection (CPT 61526; residual RVU = -9.95), and brachial plexus neuroplasty (CPT 64713; residual RVU = -11.29) were associated with lower than predicted RVU. CONCLUSIONS: Work RVUs for neurosurgical procedures are largely predictive of objective measures of surgical complexity, with few notable exceptions.

Transcatheter Mitral Valve Replacement After Surgical Repair or Replacement: Comprehensive Midterm Evaluation of Valve-in-Valve and Valve-in-Ring Implantation From the VIVID Registry.

BACKGROUND: Mitral valve-in-valve (ViV) and valve-in-ring (ViR) are alternatives to surgical reoperation in patients with recurrent mitral valve failure after previous surgical valve repair or replacement. Our aim was to perform a large-scale analysis examining midterm outcomes after mitral ViV and ViR. METHODS: Patients undergoing mitral ViV and ViR were enrolled in the Valve-in-Valve International Data Registry. Cases were performed between March 2006 and March 2020. Clinical endpoints are reported according to the Mitral Valve Academic Research Consortium (MVARC) definitions. Significant residual mitral stenosis (MS) was defined as mean gradient ≥10 mm Hg and significant residual mitral regurgitation (MR) as ≥ moderate. RESULTS: A total of 1079 patients (857 ViV, 222 ViR; mean age 73.5±12.5 years; 40.8% male) from 90 centers were included. Median STS-PROM score 8.6%; median clinical follow-up 492 days (interquartile range, 76-996); median echocardiographic follow-up for patients that survived 1 year was 772.5 days (interquartile range, 510-1211.75). Four-year Kaplan-Meier survival rate was 62.5% in ViV versus 49.5% for ViR (P<0.001). Mean gradient across the mitral valve postprocedure was 5.7±2.8 mm Hg (≥5 mm Hg; 61.4% of patients). Significant residual MS occurred in 8.2% of the ViV and 12.0% of the ViR patients (P=0.09). Significant residual MR was more common in ViR patients (16.6% versus 3.1%; P<0.001) and was associated with lower survival at 4 years (35.1% versus 61.6%; P=0.02). The rates of Mitral Valve Academic Research Consortium-defined device success were low for both procedures (39.4% total; 32.0% ViR versus 41.3% ViV; P=0.01), mostly related to having postprocedural mean gradient ≥5 mm Hg. Correlates for residual MS were smaller true internal diameter, younger age, and larger body mass index. The only correlate for residual MR was ViR. Significant residual MS (subhazard ratio, 4.67; 95% CI, 1.74-12.56; P=0.002) and significant residual MR (subhazard ratio, 7.88; 95% CI, 2.88-21.53; P<0.001) were both independently associated with repeat mitral valve replacement. CONCLUSIONS: Significant residual MS and/or MR were not infrequent after mitral ViV and ViR procedures and were both associated with a need for repeat valve replacement. Strategies to improve postprocedural hemodynamics in mitral ViV and ViR should be further explored.

Benchmarking Outcomes: Reoperation for Aortic Valve Patient-Prosthesis Mismatch.

BACKGROUND: Surgical reoperations for symptomatic aortic valve patient-prosthesis mismatch (PPM) are complex. The purpose of this research was to investigate the clinical and echocardiographic outcomes of patients who underwent reoperation for correction of symptomatic PPM after prior aortic valve replacement. METHODS: An institutional review identified 60 patients from 2004 to 2018 who underwent reoperative aortic valve replacement for PPM without structural valve degeneration. Univariate analyses were conducted to evaluate risk factors for perioperative mortality. RESULTS: Median patient age was 62.8 (interquartile range, 48.3-68.7) years, and mean body mass index was 29.2 ± 6.6 kg/m2. Thirty-nine (66%) patients underwent a first-time reoperation, and 18 (30.5%) underwent a second-time reoperation. The median interval between initial operation to reoperation for the treatment of PPM was 89 months. Thirty-four (56.7%) patients underwent aortic root replacement, while the remainder (43.3%) underwent aortic valve replacement. Additional procedures included replacement of the ascending aorta with or without aortic arch in 26 (43.3%) patients and coronary artery bypass grafting in 7 (12%) patients. Operative mortality and the rates of stroke and renal failure were 5.0%, 3.3%, and 5.0%, respectively. Echocardiographic follow-up was available in 64.9% of patients at a mean follow-up of 36.5 months. Preoperative mean pressure gradients were 32.1 ± 16.0 mm Hg and mean aortic valve area was 0.8 ± 0.3 cm2, and both improved to 6.6 ± 4.2 mm Hg and 2.3 ± 0.7 cm2 (P < .001). CONCLUSIONS: Reoperative surgery for PPM is complex but may be performed with good outcomes and low mortality in experienced centers. These data provide excellent clinical and hemodynamic benchmarks for the treatment of PPM in the current era of valve-in-valve transcatheter aortic valve replacement.

Re-operative parathyroidectomy: How many positive localization studies are required?

BACKGROUND: Re-operative parathyroidectomy in patients with recurrent or persistent hyperparathyroidism can be challenging. We review our experience to determine the optimal number of localization studies prior to re-operation. METHODS: From 2001 to 2019, 251 patients underwent re-operative parathyroidectomy. Parathyroidectomies were stratified to 4 groups based upon the number of positive localization studies obtained: A) ZERO, B) 1-positive, C) 2-positive, D) 3-positive. RESULTS: The overall cure rate was 97%, where 201 single gland resections, 23 two-gland resections, 22 subtotal/total, and 5 forearm autograft resections were performed. Thirty-two patients had no positive studies (A), 172 patients had 1-positive (B), 42 patients had 2-positive (C), and 5 patients had 3-positive studies (D). There was no difference in surgical cure rates between groups (p = 0.71). The majority of patients had one or no positive imaging studies yet almost all still achieved cure. CONCLUSION: Successful re-operative parathyroidectomy can be performed with minimal pre-operative scans in certain clinical contexts.

Patient-Reported Outcome Measures (Pain, Function, and Quality of Life) After Aseptic Revision Total Knee Arthroplasty.

BACKGROUND: Despite the growing frequency of revision total knee arthroplasty (rTKA), there is limited information regarding patient-reported outcome measures (PROMs) after that procedure. Therefore, the purpose of this study was to determine (1) PROM improvements in pain, function, quality of life (QOL), and global health and (2) predictors of PROMs for patients undergoing aseptic rTKA as determined using a multilevel model with patients nested within surgeons. METHODS: A prospective cohort of 246 patients who underwent aseptic rTKA from January 2016 to December 2017 and had baseline and 1-year postoperative PROMs were analyzed. The most common surgical indications were aseptic loosening (n = 109), instability (n = 73), and implant failure (n = 64). The PROMs included in this study were the Knee injury and Osteoarthritis Outcome Score (KOOS)-Pain, -Physical Function Short Form (PS), and -Quality of Life (QOL) as well as the Veterans Rand-12 (VR-12) Physical Component Summary (PCS) and Mental Component Summary (MCS). Multivariable linear regression models with patients nested within surgeons were constructed for predicting change in PROMs from baseline to 1 year. RESULTS: The mean 1-year postoperative improvements in the KOOS-Pain and PS PROMs were 30.3 and 19.15 points, respectively, for the overall rTKA series. Improvement in the KOOS-Pain was associated with older age, baseline arthrofibrosis, lower baseline pain, and non-Medicare/Medicaid insurance and worsening of the scores was associated with multiple prior surgical procedures and instability. Improvement in the KOOS-PS was associated with baseline arthrofibrosis and female sex and worsening was associated with limited baseline function, an instability diagnosis, multiple prior surgical procedures, and increased hospital length of stay (LOS). Overall, the mean KOOS-QOL improved by 29.7 points. Although the mean VR-12 PCS improved, 54.9% of the patients saw no clinical improvement. Additionally, only 31.3% of the patients reported improvements in the VR-12 MCS. A multilevel mixed-effects model with patients/operations nested within surgeons demonstrated that the differences in the surgeons' results were minimal and explained only ∼1.86%, ∼1.12%, and ∼1.65% of the KOOS-Pain, KOOS-PS, and KOOS-QOL variance that was not explained by other predictors, respectively. CONCLUSIONS: Overall, patients undergoing aseptic rTKA had improvements in pain, function, and QOL PROMs at 1 year. Although overall QOL improved, other global-health PROMs remained unchanged. The associations highlighted in this study can help guide the preoperative clinical decision-making process by setting expectations before aseptic rTKA. LEVEL OF EVIDENCE: Therapeutic Level IV. See Instructions for Authors for a complete description of levels of evidence.

Evaluating the optimum number of biopsies to assess histological inflammation in ulcerative colitis: a retrospective cohort study.

BACKGROUND: The optimal ulcerative colitis biopsy protocol is unclear. AIM: To evaluate the number of biopsies required to accurately assess microscopic disease activity in ulcerative colitis METHODS: Biopsies from patients with ≥4 rectosigmoid samples, and clinical and endoscopic data, were retrospectively obtained from a prospective biobank. Histology and endoscopic videos were read blindly. A 4-biopsy Robarts Histopathology Index (RHI) reference score, consisting of the worst item-level ratings from four biopsies, was compared to 1-, 2- and 3-biopsy estimates. Agreement was determined using bivariate errors-in-variable regression analysis (acceptance interval: ±8.25). Endoscopic activity and disease location subgroup analyses were also performed. RESULTS: Forty-six patients had ≥4 rectosigmoid biopsies available (N = 287). The 2-biopsy (tolerance interval: -7.66, 4.79) and 3-biopsy (tolerance interval: -4.86, 3.46) RHI scores demonstrated acceptable agreement with 4-biopsy scores. One-biopsy scores demonstrated unacceptable agreement (tolerance interval: -13.99, 7.78). Mean RHI scores using the 2-, 3- and 4-biopsy approaches were similar (6.1 ± 9.6 P = 0.36; 6.8 ± 10.5, P = 0.7; 7.5 ± 11.2), whereas the 1-biopsy estimate was lower (4.4 ± 8.1, P = 0.06). Histological remission rates were identical for the 2-, 3- and 4-biopsy methods (65.2%, P = 1.0). Subgroup analysis demonstrated that three biopsies were required in patients with endoscopically active disease. Sampling additional colonic locations yielded lower histological remission rates compared to rectosigmoid sampling alone (33.3% vs 61.9%, P = 0.1). CONCLUSIONS: A minimum of two - conservatively, three - biopsies are required to reliably assess disease activity in a single colonic segment using the RHI. Further studies are needed of endoscopically active patients and sampling locations. These results have implications for biopsy strategies in clinical trials and practice.

Reoperation rate after breast conserving surgery as quality indicator in breast cancer treatment: A reappraisal.

AIM: To analyse the role of repeated breast surgery (RBS) after breast conserving surgery (BCS) as a quality indicator in a consecutive series of breast cancer patients. METHODS: Data from 1233 breast cancer patients submitted to BCS from 2015 to 2019 were reviewed. The influence of several variables on RBS rate (182/1232; 14.8%) was examined. Univariate and multivariate analyses were conducted to look for significant associations with the risk of RBS. RESULTS: Surgical workload, BCS rate and clinicopathological variables were consistent over the study period, while RBS rate decreased after the introduction of shaving of cavity margins (from 17.9% to 9.5%). Tumor persistence at RBS was higher for mastectomy vs. re-excision (87.3% vs. 37.8%; p = 0.05), inconclusive vs. positive diagnostic biopsy (48.2% vs. 69.4%; p = 0.003), ductal carcinoma in situ vs. invasive carcinoma (69.0% vs. 51.3%; p = 0.046) and lower after neoadjuvant therapy (14.3% vs. 57.8%; p = 0.044). Several clinicopathological variables were associated with the risk of RBS, but only multifocality [Odds Ratio (OR): 1.8; p = 0.009], microcalcifications (OR: 2.0, p = 0.000), neoadjuvant therapy (OR: 0.4; p = 0.014), pathological intraoperative assessment (OR: 0.6; p = 0.010) and shaving of cavity margins (OR: 0.3; p = 0.000) retained independent value at multivariate analysis. CONCLUSIONS: RBS rate can be reduced by shaving of cavity margins. Current standards for RBS should not be made more stringent due to the existence of non-actionable risk factors. The value of RBS as a quality indicator should be scrutinzed.

How the elderly fare after brain tumor surgery compared to younger patients within a 30-day follow-up: A National surgical Quality Improvement Program analysis of 30,183 cases.

The growing elderly population in Western societies has led to an increasing number of primary brain tumors occurring in patients beyond the age of 65. The purpose of this study was to assess and compare the safety, efficacy, and outcomes of oncological craniotomy procedures between patients above and below 65 years. We performed a retrospective analysis of the ACS-NSQIP database to identify patients undergoing supratentorial and infratentorial tumor excisions by neurosurgeons between 2008 and 2016. We stratified them based on a cutoff age of 65 years and analyzed for minor and major complications, reoperation, the total length of hospital stay, and mortality within a standardized 30-day follow-up. Among the 30,183 analyzed patients, 9,652 (32%) were elderly (age ≥ 65). The bivariate analysis demonstrated significantly increased risk of complications, including major and minor complications and mortality in patients with metabolic syndrome, preoperative steroid use, and ASA classification ≥3. (p-value ≤ 0.001***). After controlling for confounding variables in our logistic regression models, older age, metabolic syndrome, extended operative time beyond 5 h, dependent functional health status, ASA class ≥3, steroid use pre-operatively, and black/African American race were found to be significant predictors of major and minor complication. Our study provides a comprehensive analysis of perioperative risk factors and predictors of adverse outcomes following craniotomy for supratentorial and infratentorial tumors in elderly patients. We identified increased age as an independent risk factor for minor and major adverse events as well as extended hospitalization.

Novel Risk Calculator for Suboccipital Decompression for Adult Chiari Malformation.

BACKGROUND: Patient counseling and selection for surgical therapy in adult Chiari malformation type I (CM-1) remain debatable. We aimed to develop a clinical calculator predicting the risk of nonhome discharge and reoperation using the American College of Surgeons-National Surgical Quality Improvement Program database. METHODS: The database from years 2011 through 2017 was queried to identify the subset of CM-1 patients undergoing suboccipital decompression. Univariable analysis was conducted to identify baseline factors associated with nonhome discharge and 30-day reoperation following the initial decompression procedure. Logistic regression and the Akaike Information Criterion were used to identify the optimal models predictive of both outcomes. Performance was assessed using receiver operating curves and validated with bootstrapping. RESULTS: In 706 CM-1 patients, the rate of nonhome discharge was 5.2% and the reoperation rate was 6.6% with most reoperations consisting of cerebrospinal fluid flow diversion and cerebrospinal fluid leak repair. The optimal model predictive of nonhome discharge consisted of age (odds ratio [OR] = 1.05, P = 0.001), diabetes (OR = 2.44, P = 0.080), and American Society of Anesthesiologists class (OR = 1.94, P = 0.082) with an area under the curve of 0.720. The optimal model predictive of reoperation consisted of female sex (OR = 0.48, P = 0.031), body mass index (OR = 1.05, P = 0.002), and ASA class (OR = 3.44, P = 0.001) with an area under the curve of 0.726. A calculator for both outcomes was deployed under the following URL: https://jhuspine3.shinyapps.io/Discharge_Reop_Calculator/. CONCLUSIONS: We have used a large international database to develop a simple risk calculator based on readily available preoperative variables. Following subsequent validation, this tool can help optimize patient counseling and decision making in adult CM-1.

Does Augmented Reality Navigation Increase Pedicle Screw Density Compared to Free-Hand Technique in Deformity Surgery? Single Surgeon Case Series of 44 Patients.

STUDY DESIGN: Retrospective comparison between an interventional and a control cohort. OBJECTIVE: The aim of this study was to investigate whether the use of an augmented reality surgical navigation (ARSN) system for pedicle screw (PS) placement in deformity cases could alter the total implant density and PS to hook ratio compared to free-hand (FH) technique. SUMMARY OF BACKGROUND DATA: Surgical navigation in deformity surgery provides the possibility to place PS in small and deformed pedicles were hooks would otherwise have been placed, and thereby achieve a higher screw density in the constructs that may result in better long-term patient outcomes. METHODS: Fifteen deformity cases treated with ARSN were compared to 29 cases treated by FH. All surgeries were performed by the same orthopedic spine surgeon. PS, hook, and combined implant density were primary outcomes. Procedure time, deformity correction, length of hospital stay, and blood loss were secondary outcomes. The surgeries in the ARSN group were performed in a hybrid operating room (OR) with a ceiling-mounted robotic C-arm with integrated video cameras for AR navigation. The FH group was operated with or without fluoroscopy as deemed necessary by the surgeon. RESULTS: Both groups had an overall high-density construct (>80% total implant density). The ARSN group, had a significantly higher PS density, 86.3% ±â€Š14.6% versus 74.7% ±â€Š13.9% in the FH group (P < 0.05), whereas the hook density was 2.2% ±â€Š3.0% versus 9.7% ±â€Š9.6% (P < 0.001). Neither the total procedure time (min) 431 ±â€Š98 versus 417 ±â€Š145 nor the deformity correction 59.3% ±â€Š16.6% versus 60.1% ±â€Š17.8% between the groups were significantly affected. CONCLUSION: This study indicates that ARSN enables the surgeon to increase the PS density and thereby minimize the use of hooks in deformity surgery without prolonging the OR time. This may result in better constructs with possible long-term advantage and less need for revision surgery. LEVEL OF EVIDENCE: 3.

Volume Standards for Open Abdominal Aortic Aneurysm Repair Are Not Associated With Improved Clinical Outcomes.

BACKGROUND: Volume-outcome relationships exist for many complex surgical procedures, prompting institutions to adopt surgical volume standards for credentialing. The current Leapfrog Group Hospital volume standard for open abdominal aortic aneurysm repair (OAR) is 15 per year. However, this is primarily based on data from the 1990s and may not be appropriate given the dramatic decline in OAR. We sought to quantify the proportion of hospitals meeting volume standards, the difference in perioperative outcomes between low-volume and high-volume hospitals, and the potential travel burden of volume credentialing on patients. METHODS: We identified Medicare beneficiaries for individuals aged ≥65 years undergoing OAR in 2013-2014. Hospital "all-payer" annual volume was estimated based on the national proportion of patients undergoing OAR covered by Medicare in the Vascular Quality Initiative. Hospital annual OAR volume was characterized as <5/year, 5-9/year, 10-14/year, and ≥15/year (high volume). Adjusted rates of postoperative morbidity, reoperation, failure to rescue, and mortality in 2014 were compared across volume cohorts. Distance between patients' home zip code and high-volume hospitals was calculated. RESULTS: A total of 21,191 OARs were performed at 1,445 hospitals between 2013 and 2014. The average hospital OAR annual volume was 7.8 (standard deviation [SD] ± 9.3) with a median of 4.5. Among the 1,445 hospitals, only 190 (13.1%) performed ≥15 OARs per year whereas 756 hospitals (53.3%) performed <5 per year. Among patients who underwent OAR in 2014, 5,395 (53.3%) received care at a hospital that performed <15 per year. There was no difference in complication, reoperation, or failure to rescue rates between high-volume and low-volume hospitals. Mortality did not significantly differ among OAR volume cohorts. Hospitals performing <5 OARs per year had a mortality rate of 5.7% compared with 5.6% at high-volume hospitals (P = 0.817). One-quarter of patients who received care at a low-volume hospital would have had to travel more than 60 miles to reach a high-volume hospital. CONCLUSIONS: By conservative estimates, only 13% of hospitals performing OAR meet current volume standards. Triaging all patients to high-volume hospitals would require shifting over 5,000 patients annually with no associated improvement in perioperative outcomes. Implementation of the current OAR hospital volume standard may significantly burden patients and hospitals without improving surgical outcomes.

Treatment of failed aortic bioprostheses: An evaluation of conventional redo surgery and transfemoral transcatheter aortic valve-in-valve implantation.

BACKGROUND: The use of bioprostheses for surgical aortic valve replacement increased substantially within the last years. In case of prosthesis failure, re-SAVR is standard of care, whereas valve-in-valve deployment of a transfemoral transcatheter aortic valve prosthesis (VinV-TFAVI) has recently emerged as an alternative. We sought to evaluate early safety, clinical efficacy, and all-cause 1-year-mortality of VinV-TFAVI and redo surgery for failing aortic bioprostheses (re-SAVR). METHODS AND RESULTS: Patients receiving either VinV-TFAVI (n = 147) or re-SAVR (n = 111) for a degenerated aortic bioprosthesis between 01/2006 and 05/2017 were included in this analysis. All-cause 1-year mortality was the primary outcome measure. Early safety and clinical efficacy according to VARC-2 endpoint definitions were evaluated at 30 days. Baseline characteristics differed significantly between both groups including age, STS-PROM, and incidence of relevant comorbidities. Re-stenosis was the predominant mode of failure in 45.9% of re-SAVR and 63.1% of VinV-TFAVI patients. The rate of "early safety" endpoints was lower with VinV-TFAVI (17.7% vs. 64.9%, p < 0.01), the rate of "clinical efficacy" endpoints was lower, e.g. better with re-SAVR (53.1% vs. 32.4%, p < 0.01). All-cause 1-year-mortality (VinV-TFAVI 8.8% vs re-SAVR 9.9%, p = 0.84) was not different. Treatment strategy was not associated with 1-year-mortality in a Cox regression analysis. The incidence of prosthesis-patient-mismatch was higher in VinV-TFAVI compared to re-SAVR. CONCLUSION: VinV-TFAVI represents a viable alternative for treatment of degenerated aortic bioprostheses in patients at increased surgical risk. However, in patients at low risk for reoperation, a better clinical efficacy and acceptable safety may favour re-SAVR.

Exploring the views of female genital mutilation survivors, their male partners and healthcare professionals on the timing of deinfibulation surgery and NHS FGM care provision (the FGM Sister Study): protocol for a qualitative study.

INTRODUCTION: Female genital mutilation (FGM) is a significant global health concern and is likely to become an increasingly important healthcare challenge in destination countries such as the UK owing to rising levels of migration from FGM-affected countries. Currently, there is no consensus on the optimal timing of deinfibulation (opening) surgery for women who have experienced type 3 FGM and care provision remains suboptimal in the UK. This qualitative study aims to explore the views of survivors, male partners and healthcare professionals (HCPs) on the timing of deinfibulation and delivery of NHS FGM services. METHODS AND ANALYSIS: A qualitative study, informed by the Sound of Silence conceptual framework, will be undertaken via two work packages (WPs). WP1 will explore views on timing preferences for deinfibulation and NHS FGM services through interviews and discussion groups with FGM survivors (n~50), male partners (n~10) and HCPs (n~50). WP2 will use established techniques via two workshops (community (n~20-25 participants) and national stakeholder (n~30-35 participants)) to synthesise qualitative research findings and inform best practice and policy recommendations around the timing of deinfibulation and NHS FGM care provision. Supported by trained interpreters, data collection will be audio recorded and transcribed. Data will be analysed using the framework method to facilitate a systematic mapping and exploration of qualitative data from multiple sources. ETHICS AND DISSEMINATION: The study has received ethical approval from the North West Greater Manchester East Research Ethics Committee (18/NW/0498). The outputs for this study will be recommendations for best practice and policy around FGM care provision that reflects the views and preferences of key stakeholders. The findings will be disseminated via conference presentations, peer-reviewed publications, patient groups, third sector organisations and social media. TRIAL REGISTRATION NUMBER: ISRCTN 14710507.

Lay People Esthetic Evaluation of Primary Surgical Repair on Three-Dimensional Images of Cleft Lip and Palate Patients.

Background and Objectives: Previous literature has disclosed that facial attractiveness affects the esthetic evaluation of nose and lip deformity on frontal and lateral photographs. However, it has never been debated if the removal of the external facial features on three-dimensional (3D) models ("cropped assessment bias") could provide a considerable usefulness in the interpretation and comparison of the results. Additionally, it has been assumed on two-dimensional (2D) studies that esthetic assessment biases with respect to observer gender, and it is not acknowledged if and to the extent that "gender assessment bias" may be influenced by a three-dimensional layout. The aim of this study is to investigate if facial traits and observers' gender may affect the esthetic ratings of unilateral cleft lip and palate (UCLP) patients after soft tissue reconstruction. Materials and Methods: Three-dimensional images of ten UCLP patients' images were acquired before the intervention (T0), one-month (T1) and six-months (T2) postoperative. Geomagic® software (version 2014; 3D Systems, Rock Hill, SC, USA) was used to remove the external facial features of 3D surface models. Five-point scale developed by Asher-McDade et al. was used to rate both nasolabial attractiveness and impairment for full-face (FF) and cropped-face (CF) 3D images. Forty-three judges (21 males, 22 females) were enrolled for the esthetic evaluation. Intraclass correlation coefficient (ICC) was used to test intra- and inter-examiner reliability; a value of 0.7 was set as the minimum acceptable level of reliability. Results: When comparing the 2 sets of observations (FF and CF), the ICC ranged from 0.654 to 0.823. Concerning gender assessment bias, the ICC ranged from 0.438 to 0.686 and from 0.722 to 0.788 for males and females, respectively. Concerning inter-examiner reliability, ICC for questions 2-7 ranged from 0.448 to 0.644 and from 0.659 to 0.817 at T0 and T2, respectively. Conclusions: The removal of external facial features provides subtle differences on the esthetic assessment of UCLP patients. Moreover, based on our data, examiners' gender differences may affect esthetic assessment of UCLP patients. Despite the subjectivity of esthetic judgments, a reliable, validated and reproducible scoring protocol should consider the influence of gender differences on 3D esthetic assessment of UCLP patients.

Revision total knee arthroplasty (TKA): mid-term outcomes and bone loss/quality evaluation and treatment.

BACKGROUND: Revision total knee arthroplasty (rTKA) is a demanding procedure, with a high complication and failure rate and a high rate of bone losses and poor bone quality. Different classifications for bone losses have been proposed, but they do not consider bone quality, which may affect implant fixation. The aim of this study is to describe the outcomes of a consecutive series of rTKA. Furthermore, a modified bone loss classification will be proposed based also on bone quality. Finally, the association between radiolucent line (RLL) development and different risk factors will be evaluated. METHODS: All the patients who underwent rTKA between 2008 and 2016 in the same institution were included. rTKAs were performed by the same surgeon according to the three-step technique. Bone losses were classified according to the proposed classification, including bone quality evaluation. The Knee Scoring System (KSS), the Hospital for Special Surgery Knee Score (HSS), and the SF-12 were used for the clinical evaluation. Radiological evaluation was performed according to the Knee Society Roentgenographic Evaluation System. Different possible risk factors (i.e., gender, age, amount of bone losses) associated to RLL development were identified, and this association was evaluated using logistic regression. RESULTS: Fifty-one patients (53 knees) were included (60.8% female, average age 71.5 years). The average follow-up was 56.6 months (range 24-182). The most frequent cause of failure was aseptic loosening (41.5%). 18.9% of the cases demonstrated poor bone quality. Bone losses were treated according to the proposed algorithm. In all the cases, there was a significant improvement in all the scores (P < 0.05). The average post-operative range of motion was 110.5° (SD 10.7). At the radiological evaluation, all the implants resulted well aligned, with 15.1% of non-progressive RLL. There were 2 failures, with a cumulative survivorship of 92.1% at the last follow-up (SD 5.3%). At the logistic regression, none of the evaluated variables resulted associated to RLL development. CONCLUSION: rTKA is a demanding procedure, and adequate treatment of bone losses is mandatory to achieve good results. However, also bone quality should be taken into consideration when approaching bone losses, and the proposed classification may need surgeons after an adequate validation. LEVEL OF EVIDENCE: Level IV.