Prior Surgery Research Articles

Protection of entanglement in two independently decohering qubits via local prior and post parity-time symmetry operations

Protection of entanglement of two qubits undergoing two independent amplitude damping channels using a local parity-time ( PT ) symmetric operation is exactly studied. First, the explicit expressions of concurrence quantifying the entanglement of two qubits with both local PT symmetric operation and two amplitude damping channels are obtained. Then, we give two schemes, i.e. prior and post PT symmetric operations, to show the performance of PT symmetric operation on entanglement dynamics of two qubits. By investigation, we find that the effect of prior PT symmetric operation schemes on the protection of entanglement of two qubits in the double channel case is superior to that of the single channel case. Conversely, the effect of post PT symmetric operation scheme on the protection of entanglement of two qubits in the single channel case is better than that in the double channel case. In other words, the local PT symmetric operation approach may have potential applications in combating amplitude damping decoherence.

Sonographic Assessment of Asymptomatic Patellar and Achilles Tendons to Predict Future Pain: A Systematic Review and Meta-analysis.

Patients with clinical tendinopathy often demonstrate significant abnormalities with ultrasound (US) imaging. Tendon abnormalities likely precede pain in these patients. The purpose of this review was to systematically evaluate the available literature regarding the utility of US imaging as a method to predict Achilles and patellar tendon pain. Systematic review and meta-analysis. Inclusion criteria were as follows: prospective studies of Achilles and patellar tendon pain development with baseline US measurements, follow-up clinical measurements, and English-language studies published after 2000. Exclusion criteria were prior rupture or surgery and presence of rheumatologic disorder. N/A. Athletes without Achilles or patellar tendon pain at baseline. N/A. Risk ratios (RRs) were identified for the development of pain in those with Achilles or patellar tendon sonographic abnormalities. This review of 16 studies included 810 Achilles and 1156 patellar tendons from a variety of sports and demonstrated that the RR for pain development from abnormal Patellar and Achilles tendons was 6.07 [95% confidence interval (CI), 2.88-12.81; P < 0.001] and 3.96 [95% CI, 2.21-7.09; P < 0.001], respectively. The positive and negative predictive values of an abnormal US finding were 27.2% and 92.0% for the Achilles tendon and 27.2% and 93.5% for the patellar tendon, respectively. This systematic review and meta-analysis identified that the use of asymptomatic US scanning of the Achilles or patellar tendon has a low positive predictive value but a high negative predictive value for the future development of pain.

CLINICAL OUTCOMES OF AUTOLOGOUS OSTEOCHONDRAL TRANSPLANTATION FOR OSTEOCHONDRAL LESIONS OF THE TALUS: AN AGE-BASED MULTIVARIABLE ANALYSIS

IntroductionThe purpose of this study was to examine trends in patient characteristics and clinical outcomes that occur with age as a statistical variable when performing autologous osteochondral transplantation (AOT) for the treatment of osteochondral lesions of the talus (OLT).MethodsA retrospective cohort study for AOT procedures on 78 patients from 2006 to 2019. was conducted Clinical outcomes were evaluated via FAOS scores. A multivariable linear regression was used to assess the independent factors predictive of the first post-operative FAOS after AOT. The independent variables included pre-operative FAOS, age, defect size, shoulder lesion, cystic lesion, prior traumatic injury, and history of microfracture surgery. A p-value &lt;.05 was considered significant and 95% confidence limits (95% CL) for regression coefficient estimates (est.) were calculated.Results78 patients were included with a mean age of 35.5 ± 13.6years at a mean follow-up was 54.4 ± 18.9 months. The mean pre-operative FAOS was 54.3 ± 19.4 and the mean post-operative FAOS was 83.4 ± 13.6. The mean defect size was 109.3±62.4 mm2. The multivariable linear regression showed that the pre-operative FAOS was associated with a higher post-operative FAOS (est., 95% CL: 0.16, 0.012 – 0.307; p=0.034). Defect size (est., 95% CL: −0.05, −0.097 – −0.003; p=0.0358), having a shoulder lesion (est., 95% CL: −9.068, −15.448 – −2.688; p=0.006), or having a prior microfracture surgery (est., 95% CL: −7.07, −13.118 – −1.021; p=0.0226) were associated with a lower post-operative FAOS.ConclusionPatient age was not an independent risk factor for inferior clinical outcomes after AOT for OLT. Additionally, cystic lesions, or lesions with a traumatic aetiology were not significantly associated with post-operative FAOS. Having a shoulder lesion had the largest marginal effect on post-operative FAOS. These findings provide important information for providers when counseling and selecting patients for AOT procedure for treatment of OLT.

NRG-CC004 ancillary data study-exploring the effect of bupropion on sexual desire in female cancer survivors with and without vulvovaginal symptoms.

Female cancer survivors often experience estrogen-deprivation symptoms, which may lead to decreases in sexual desire, vulvovaginal health (lubrication, dryness, discomfort), and sexual satisfaction. Interventions are needed to address these concerns. The objective of this secondary analysis was to determine if women with higher (better) scores on the Female Sexual Function Index (FSFI) lubrication and pain subscales reported higher desire scores based on treatment with bupropion vs placebo. Participants were part of NRG Oncology's NRG-CC004 (NCT03180294), a randomized placebo-controlled clinical trial evaluating bupropion (150 vs 300mg) to improve sexual desire in survivors of breast or gynecologic cancer. All participants with baseline data from the FSFI lubrication, pain, and desire subscales with 5- and/or 9-week data were analyzed. The FSFI subscale scores were correlated using Spearman correlation coefficients. Logistic regression was used to determine associations between FSFI desire and other FSFI subscales while accounting for treatment arm and other covariates. The primary outcome of NRG Oncology's NRG-CC004 (NCT03180294) randomized phase II dose-finding trial was change from baseline to 9weeks on the FSFI desire subscale score. Similar to the parent study, the primary outcome for this ancillary data study was the FSFI desire subscale score at 5 and 9weeks. Overall, 230 participants completed the FSFI at baseline and 189 at 9weeks. The strongest correlations were between lubrication and pain at baseline (all participants, rho= 0.77; bupropion arms, rho = 0.82), week 5 (all participants, rho = 0.71; bupropion arms, rho = 0.68), and week 9 (all participants, rho = 0.75; bupropion arms, rho = 0.78), and the weakest correlations were between desire and pain. In patients in the treatment arms there were no interactions between lubrication or pain.The impact of various covariates on the FSFI score for desire at 9weeks demonstrated that participants of non-White race (odds ratio [OR],0.42; 95% CI, 0.21-0.81; P= .010), with a high lubrication score (OR,0.36; 95% CI, 0.21-0.61; P= .0002), with a high pain score (less pain) (OR,0.50; 95% CI, 0.29-0.87; P= .014), or with prior pelvic surgery (OR,0.38; 95% CI, 0.23-0.63; P= .0002) had lower odds of having low desire. Acute estrogen-deprivation symptoms should be addressed prior to sexual desire intervention. This secondary analysis was not powered to examine all variables. Lubrication and pain were predictors of low desire. Therefore, vulvovaginal atrophy and associated genitourinary symptoms of menopause such as vaginal dryness and dyspareunia should be addressed prior to or in parallel with interventions for sexual desire.

Microvascular reconstruction of midface osteoradionecrosis.

Head and neck osteoradionecrosis (ORN) of the midface requiring free flap (FF) reconstruction is uncommon. This multi-institutional study was designed to review outcomes for this rare patient population. Retrospective multi-institutional review of FF reconstruction for midface ORN (2005-2022; n = 54). The FF survival rate was 87% (n = 54). Patients were less likely to be tolerating a regular diet at 3 months postoperative if they had a preoperative history of prior head and surgery (80% vs. 95%; p = 0.02), a pathologic fracture (50% vs. 90%; p = 0.04), exposed bone intraorally (43% vs. 94%; p = 0.002), or a fistula (67% vs. 96%; p = 0.03). Mean albumin was higher in patients whose FF survived (3.6 ± 0.5 vs. 2.7 ± 1.4; p = 0.03). Patients with low prealbumin were more likely to undergo a hematoma evacuation (27% vs. 0%; p = 0.02). In this series of midface ORN requiring FF reconstruction preoperative nutritional status impacted postoperative complications. Preoperative occurrence of a fistula, pathologic fracture, and intraoral bone exposure correlated with decreased tolerance of a regular diet following reconstruction.

Rectal Injury During Penile Inversion Vaginoplasty

ObjectiveTo evaluate the incidence, management and outcomes of rectal injury (RI) and subsequent rectovaginal fistula (RVF) during gender-affirming vaginoplasty (GAV) at a high-volume transgender surgery center. MethodsWe performed a retrospective review of pre-operative, intra-operative and post-operative findings of all patients with RI during GAV from January 2016-September 2022. Descriptive statistics were calculated using Microsoft Excel. ResultsRI occurred in nine of 1011 primary GAV and colorectal surgery (CRS) consulted in five cases, which included sigmoidoscopy with an air leak test in four and with temporary bowel diversion in two. Of the nine, six proceeded with full depth GAV, and three were converted to minimal depth vaginoplasty. Two had bulbospongiosus muscle interposition and none had a concomitant urethral injury. 1/9 with RI developed a RVF which occurred in a patient with prior perineal surgery and no intraoperative sigmoidoscopy. Three (50%) with full depth GAV developed vaginal stenosis postoperatively. ConclusionsRI during primary GAS in experienced hands is uncommon with an incidence of 0.89% in our series of 1011. Unusual tissue dissection planes were a risk factor. If injuries were identified intraoperatively, repaired with multilayer closure and evaluated by CRS, patients did well without the development of RVF despite completion of full depth GAV. It is reasonable to complete the full depth vagina, but patients should be advised of a significant risk of post-operative vaginal stenosis.

Impact of a 6–12-h delay between ileocolic intussusception diagnostic US and fluoroscopic reduction on patients’ outcomes

BackgroundImage-guided reduction of intussusception is considered a radiologic urgency requiring 24-h radiologist and technologist availability.ObjectiveTo assess whether a delay of 6–12 h between US diagnosis and fluoroscopic reduction of ileocolic intussusception affects the success frequency of fluoroscopic reduction.Materials and methodsRetrospective review of 0–5-year-olds undergoing fluoroscopic reduction for ileocolic intussusception from 2013 to 2023. Exclusions were small bowel intussusception, self-reduced intussusception, first fluoroscopic reduction attempt>12 h after US, prior bowel surgery, inpatient status, and patient transferred for recurrent intussusception. Data collected included demographics, symptoms, air/contrast enema selection, radiation dose, reduction failure, 48-h recurrence, surgery, length of stay, and complications. Comparisons between<6-h and 6–12-h delays after ultrasound diagnosis were made using chi-square, Fisher’s exact test, and Mann–Whitney U tests (P< 0.05 considered significant).ResultsOf 438 included patients, 387 (88.4%) were reduced in <6 h (median age 1.4 years) and 51 (11.7%) were reduced between 6 and 12 h (median age 2.05 years), with median reduction times of 1:42 and 7:07 h, respectively. There were no significant differences between the groups for reduction success (<6 h 87.3% vs. 6–12 h 94.1%; P-value = 0.16), need for surgery (<6 h 11.1% vs. 6–12 h 3.9%; P-value=0.112), recurrence of intussusception within 48 h after reduction (<6 h 9.3% vs. 6–12 h 15.7%; P-value=0.154), or length of hospitalization (<6 h 21:07 h vs. 6–12 h 20:03 h; P-value=0.662).ConclusionA delay of 6–12 h between diagnosis and fluoroscopic reduction of ileocolic intussusception is not associated with reduced fluoroscopic reduction success, need for surgical intervention after attempted reduction, recurrence of intussusception following successful reduction, or hospitalization duration after reduction.Graphical

Comparison of the efficacy of fat, cartilage, and bone grafts in traumatic and asymmetric noses

BackgroundCorrection of asymmetry and irregularity deformities with autologous grafts, without osteotomies, offers advantages to both plastic surgeons and patients with severe deviation. Various autologous tissues such as fat, bone, and cartilage grafts are viable options for this purpose. ObjectivesThis study aims to compare the efficacy of three autologous filling materials in patients with bone asymmetry. MethodsA retrospective evaluation was conducted on 297 patients seeking aesthetic nose surgery between 2015 and 2022. Only primary patients without prior surgery, those with bone asymmetry from trauma, dorsum protrusion less than 3 mm, and no osteotomy were included. Patients were divided into fat, cartilage, and bone groups. Grafts were applied to the concave side during closed rhinoplasty, and evaluations were done at 12 months post-surgery by blinded plastic surgeons and patients using established assessment tools. ResultsFat, cartilage, and bone grafts were utilized in 74, 127, and 96 patients respectively, with mean follow-up of 19 months. Mean graft volumes were 1.0 cc (bone), 1.3 cc (cartilage), and 1.6 cc (fat). Patient self-assessment scores were 75%, 84.9%, and 86.6% respectively. Asher-McDade averages were 77.2%, 86.7%, and 88.4%. Cartilage and bone graft results were statistically similar in patient self-evaluation, both significantly higher than fat grafts. Blinded assessments showed no significant difference between cartilage and bone groups. ConclusionPlacing autologous grafts on the concave side for patients with minimal nasal bone protrusion (<3 mm) yields successful results. Cartilage grafts offer advantages in volume, result estimation, and preparation time, suitable for larger patient cohorts.

Long-Term Outcomes of Enucleation and Secondary Orbital Implantation Surgeries Using Polyester Mesh-Wrapped Acrylic Orbital Implants.

To reveal the long-term outcomes of enucleation and secondary orbital implantation surgeries employing nonabsorbable surgical mesh-wrapped acrylic orbital implants for various reasons. A retrospective interventional study of 48 eyes that underwent primary or late primary enucleation and secondary orbital implantation using polyester mesh-wrapped acrylic orbital implants, between 2012 and 2021. Patient demographics, diagnosis, prior ophthalmic surgery, implant size, follow-up periods, and implant-associated complications were evaluated. The records of 36 patients who underwent primary or late primary enucleation and 12 who underwent secondary orbital implantation due to sphere extrusion were evaluated. Patients' mean age was 38.7 (range: 2-75) and the mean follow-up period was 48.3 months (range: 24-72mo). Major causes for surgeries were trauma and malignancies (54.1% and 33.3%, respectively). No complications, such as conjunctival dehiscence, implant exposure or extrusion, contracted socket, or fornix insufficiency were observed in any patient during the long-term follow-up period postsurgeries. Using polyester mesh-wrapped acrylic orbital implants in enucleation and secondary orbital implantation surgeries proves to be a successful, safe, and cost-effective option.

Implant-Positioning and Patient Factors Associated with Acromial and Scapular Spine Fractures After Reverse Shoulder Arthroplasty

Background: This study aimed to identify implant positioning parameters and patient factors contributing to acromial stress fractures (ASFs) and scapular spine stress fractures (SSFs) following reverse shoulder arthroplasty (RSA). Methods: In a multicenter retrospective study, the cases of patients who underwent RSA from June 2013 to May 2019 and had a minimum 3-month follow-up were reviewed. The study involved 24 surgeons, from 15 U.S. institutions, who were members of the American Shoulder and Elbow Surgeons (ASES). Study parameters were defined through the Delphi method, requiring 75% agreement among surgeons for consensus. Multivariable logistic regression identified factors linked to ASFs and SSFs. Radiographic data, including the lateralization shoulder angle (LSA), distalization shoulder angle (DSA), and lateral humeral offset (LHO), were collected in a 2:1 control-to-fracture ratio and analyzed to evaluate their association with ASFs/SSFs. Results: Among 6,320 patients, the overall stress fracture rate was 3.8% (180 ASFs [2.8%] and 59 SSFs [0.9%]). ASF risk factors included inflammatory arthritis (odds ratio [OR] = 2.29, p &lt; 0.001), a massive rotator cuff tear (OR = 2.05, p = 0.010), osteoporosis (OR = 2.00, p &lt; 0.001), prior shoulder surgery (OR = 1.82, p &lt; 0.001), cuff tear arthropathy (OR = 1.76, p = 0.002), female sex (OR = 1.74, p = 0.003), older age (OR = 1.02, p = 0.018), and greater total glenoid lateral offset (OR = 1.06, p = 0.025). Revision surgery (versus primary surgery) was associated with a reduced ASF risk (OR = 0.38, p = 0.019). SSF risk factors included female sex (OR = 2.45, p = 0.009), rotator cuff disease (OR = 2.36, p = 0.003), osteoporosis (OR = 2.18, p = 0.009), and inflammatory arthritis (OR = 2.04, p = 0.024). Radiographic analysis of propensity score-matched patients showed that a greater increase in the LSA (ΔLSA) from preoperatively to postoperatively (OR = 1.42, p = 0.005) and a greater postoperative LSA (OR = 1.76, p = 0.009) increased stress fracture risk, while increased LHO (OR = 0.74, p = 0.031) reduced it. Distalization (ΔDSA and postoperative DSA) showed no significant association with stress fracture prevalence. Conclusions: Patient factors associated with poor bone density and rotator cuff deficiency appear to be the strongest predictors of ASFs and SSFs after RSA. Final implant positioning, to a lesser degree, may also affect ASF and SSF prevalence in at-risk patients, as increased humeral lateralization was found to be associated with lower fracture rates whereas excessive glenoid-sided and global lateralization were associated with higher fracture rates. Level of Evidence: Prognostic Level III. See Instructions for Authors for a complete description of levels of evidence.

Management of spontaneous pyogenic spondylodiscitis: a descriptive cohort study

BackgroundSpontaneous spondylodiscitis (SD) is an inflammation of the vertebral endplate and the intervertebral disc with no prior surgery or intervention. The treatment of spontaneous pyogenic SD mainly consists of systemic antibiotics and rest. Some cases require surgery due to failure of medical treatment or due to neurological compromise. Due to the disease heterogeneity, there are no standardized, widely adopted treatment protocols. We conducted this study to assess the clinical outcome of the different treatment modalities.ResultsThis is a retrospective analysis of prospectively collected data of patients with spontaneous non-tuberculous spondylodiscitis. Thirty-eight patients were identified, including 14 males and 24 females. The mean age was 49 years. Twenty-three patients underwent surgery from the start while 15 patients received conservative medical treatment. Among the latter, 8 patients showed disease progression and required surgical intervention. The ODI/NDI at 1 year (mean = 8) was significantly better than before treatment (mean = 18). Among 11 patients with motor deficit at presentation, 8 improved and 3 remained stable. There were 14 complications, including 11 minor and 3 major, requiring one revision surgery.ConclusionsSurgical decompression and debridement with or without instrumented fusion for complicated SD cases is a safe and effective treatment modality. Close follow-up is needed in case of conservative treatment for early detection of treatment failure and disease progression. Baseline characteristic variabilities in patients with spontaneous pyogenic SD could predict conservative treatment failure, but this needs to be validated in larger series.

Management of Petrous Bone Cholesteatoma: The Gruppo Otologico Experience.

The term petrous bone cholesteatoma (PBC) refers to lesions extending deep to the bony labyrinth via superior, inferior, and posterior cell tracts. PBC is a rare incidence accounting for only 4-9% of petrous bone lesions. Lesions of petrous bone represent a real surgical challenge due to its complex relationship with critical neurovascular structures. To demonstrate our 40-plus years' experience in the management of PBC, depict the clinical features of PBC according to Sanna's Classification, evaluate the postoperative follow-up of surgically treated PBC patients, and determine the recurrence rate. Retrospective medical record review. Medical records of 298 PBC cases operated from the year 1983 to 2024 were thoroughly evaluated. A total of 298 PBC cases were surgically treated at our center. The average age at presentation in this series was 47 years. Males are more affected than females with a male-to-female ratio of 2.2:1. The most common presenting symptoms were hearing loss (84%), tinnitus (48%), and facial nerve paralysis (45%). Mixed hearing loss (41%) was the commonest audiometric pattern of hearing loss followed by conductive hearing loss (26%) and profound sensorineural hearing loss (4%) and a total of 86 (29%) had anacusis at presentation. On preoperative facial nerve function examination, 133(45%) of patients had various degrees of paresis and complete paralysis whereas 55% had normal HB-I function. The commonest degree of paresis noted was HB-III (18%) followed by HB-VI (5%). A total of 150 (50%) patients had previous otologic surgery and two-thirds of these cases had two or more prior otologic surgeries. According to Sanna's PBC Classification system, we identified that the supralabyrinthine class (44%) is the commonest of all classes followed by massive (33%), infralabyrinthine-apical (9%), infralabyrinthine(8%), and apical (5%) classes in that order. However, only ten patients had congenital type of PBC. Extension to clivus, sphenoid, nasopharynx, intradural space, and occipital condyle was found in 8, 2, 1, and 2 cases respectively. The most commonly used surgical approaches at our center were TO, MTCA with rerouting of the facial nerve, and TLAB with external auditory canal (EAC) closure. Postoperative complications were minimal and the duration of follow-up ranged from one to 458 months with a mean duration of 65 months. Residual lesions were evident in 11 cases (3.7%), with the surgical cavity, middle and posterior fossa dura, and jugular bulb being the commonest sites. Petrous bone cholesteatoma represents diagnostically and surgically challenging lesions of temporal bone which are usually frustrating to the treating surgeon. A high index of clinical suspicion, thorough clinical evaluation examination, and preoperative radiologic evaluation make the diagnosis easier. Preoperative anatomic classification of the lesion enables the physician to choose the appropriate surgical approach. Sanna's classification is widely used to classify PBC in relation to the labyrinthine block. Radical disease removal should always come before hearing preservation. Cavity obliteration is the solution to the problems related to a large cavity. Finally, advancements in lateral skull base approaches create adequate surgical access for the complete removal of the lesion with excellent control of critical neurovascular structures.

Does prior rotator cuff surgery influence the outcomes and complications after reverse total shoulder arthroplasty in patients with cuff tear arthropathy or massive rotator cuff tear? A propensity score-matched study

BackgroundThe aim of this study was to compare outcomes and complications in patients with and without a history of prior rotator cuff surgery who underwent reverse total shoulder arthroplasty (RTSA). MethodsTwo-hundred and nine consecutive patients who had undergone RTSA for rotator cuff insufficiency with a minimum 12-months follow-up period were reviewed. A total of 35 patients with a history of prior rotator cuff surgery were made the study group (PS group). Using propensity score matching for age and sex, these patients were matched 1:3 with a control group of 105 patients with no history of prior surgery (NPS group). The mean follow-up period was 41.4 months. ResultsBoth groups showed a significant improvement of clinical scores and range of motion after RTSA. The PS group showed a significantly higher final visual analog scale (VAS) pain score compared with the NPS group (P = 0.020). The PS group showed a significantly higher incidence of acromial stress fracture compared with the NPS group (17.1% vs 4.8%, P = 0.018), but no significant difference in the overall complication rate was observed (25.7% vs 13.3%, P > 0.05). The PS group showed a significantly higher reoperation rate compared with the NPS group (14.3% vs 1.9%, P = 0.004). ConclusionsOur study demonstrated that a history of prior rotator cuff surgery was associated with a high incidence of acromial stress fracture and reoperation after RTSA as well as a high final VAS pain score, although satisfactory clinical outcomes after RTSA were achieved in both groups.

Risk of Cardiac Reoperation: An Analysis of The Society of Thoracic Surgeons Congenital Heart Surgery Database

BackgroundThe increasing number of congenital heart disease patients undergoing reoperative cardiac surgery presents critical and growing challenges. Our objective was to evaluate the association between the number of prior cardiopulmonary bypass operations and operative mortality and morbidity in a national cohort. MethodsThe Society of Thoracic Surgeons Congenital Heart Surgery Database (STS-CHSD) was reviewed for index cardiac operations on cardiopulmonary bypass during 2016 to 2021. Infants and patients with functionally univentricular physiology were excluded. Multivariable logistic regression adjusted for covariates in the STS-CHSD Mortality Risk Model, the STS-European Association for Cardio-Thoracic Surgery (STAT) Mortality Category, and institutional volume. ResultsOf 50,625 eligible operations, 22,100 (44%) were performed on patients with ≥1 prior cardiopulmonary bypass operations. Most common diagnoses were tetralogy of Fallot (4340 of 22,100 [19.6%]), pulmonary atresia/ventricular septal defect (1334 of 22,100 [6.0%]), and aortic stenosis (966 of 22,100 [4.4%]). Operative mortality correlated with number of prior cardiopulmonary bypass operations: 157 of 28,525 (0.6%) for 0, 127 of 13,488 (0.9%) for 1, 81 of 5,664 (1.4%) for 2, 61 of 2039 (3.0%) for 3, 35 of 623 (5.6%) for 4, 10 of 207 (4.8%) for 5, and 5 of 79 (6.3%) for ≥6 operations (P < .001). On multivariable analysis, patients with ≥3 prior cardiopulmonary bypass operations had higher risk of operative mortality (odds ratio, 2.31; P < .001) and major morbidity (odds ratio, 1.60; P < .001). Annual institutional volume and age were not associated with either outcome. ConclusionsThree or more prior cardiopulmonary bypass operations was an independent risk factor for operative mortality/morbidity, even after controlling for risk factors and institutional volume. Future research is needed to identify modifiable factors to optimize outcomes, particularly for those with ≥3 prior cardiopulmonary bypass operations.

CNS efficacy of trastuzumab deruxtecan in metastatic breast cancer: A single-institution, real-world analysis.

e13117 Background: Trastuzumab deruxtecan (T-DXd) is an antibody-drug conjugate that revolutionized the management of patients with HER2+ (HER2 FISH+, IHC 3+) and HER2low (HER2 FISH-, IHC 1+/2+) metastatic breast cancer (MBC). Studies have shown that T-DXd may induce antitumor activity in HER2+ MBC with brain metastases (BM). However, data is limited on the central nervous system (CNS) efficacy of T-DXd in HER2low disease. The only report thus far is from the HER2low cohorts in the DEBBRAH study with 12 patients showing an intracranial overall response rate (ORR-IC) of 50% and progression free survival (PFS) of 5.7 months. Here, we provide a real-world, retrospective analysis of the CNS efficacy of T-DXd in HER2+, HER2low, and HER2null MBC with BM. Methods: This is a single institution, retrospective analysis of patients with MBC with BM who received T-DXd between January 2020 and November 2023. Patients with HER2+, HER2low, or HER2null MBC and BM, treated or untreated at the time of T-DXd initiation, were included. All patients had baseline brain magnetic resonance imaging before T-DXd initiation. Efficacy analyses were performed using the RECIST 1.1 criteria to CNS target lesions by investigator assessment. ORR-IC and intracranial clinical benefit rate (CBR-IC) were reported. CNS PFS, defined as time until CNS progression or death of any cause, and overall survival (OS) were also evaluated. Results: 29 patients were included in the study: 10 (35%) had HER2+, 16 (55%) had HER2low, and 3 (10%) had HER2null disease. The patients had ECOG performance status ranging from 0 to 3, and received a median of 3 prior lines of therapy (range 1-8). At baseline, 3 patients (10%) had untreated BM, 6 (21%) had prior surgery, and 23 (79%) had prior radiation. 28 (97%) had concurrent extra-cranial metastases. Best CNS response and duration of response are listed in the table below. ORR-IC was 10% overall and 6% in HER2low group. CBR-IC was 58% overall and 50% in HER2low group. Median OS in all patients was 65 weeks. Median CNS PFS was not statistically different in the overall group (24 weeks) compared to the HER2low group (21 weeks) with p=0.4661 via log rank test. Conclusions: This is the first real-world study reporting the CNS efficacy of T-DXd in patients with MBC across HER2 expression levels. The CNS efficacy of T-DXd in our institutional experience was similar in HER2+ and HER2low MBC, and was much lower than previously reported in prospective clinical trials. Performance status, extent of prior treatment, and systemic disease burden likely contributed to this difference. Larger cohort and prospective studies on patients with HER2low MBC with BM are warranted. [Table: see text]

A randomized, double-blind, placebo-controlled phase II study of adjuvant pembrolizumab versus placebo in patients with head and neck squamous cell cancers at high risk for recurrence: The PATHWay study.

6008 Background: Anti-PD1 therapy has become an essential treatment in recurrent and metastatic head/neck squamous cell carcinoma (HNSCC). The optimal use of anti-PD1 therapy in the curative setting is not established. Understanding the benefits of adjuvant anti-PD1 treatment in high risk HNSCC patients treated with curative intent is necessary. Methods: The PATHWay trial (NCT02841748) is a multi-site, randomized, placebo (PL) controlled trial of pembrolizumab (IO) in patients following curative treatment of high recurrence risk HNSCC. Patients with AJCC 7th edition stage IVa, IVb, and select III HNSCC or multiple primaries were eligible if their cancers had an estimated &gt; 40% chance of recurrence and were not eligible for additional therapy. Patients enrolled into six group criteria: A) high risk nodal disease or interrupted radiation treatment; B) salvage surgery including positive margin; C) Indeterminate distant lesions concerning for metastasis; D) Oligometastatic disease treated definitively; E) Microscopic residual disease after surgery; or F) Multiple prior recurrences or multiple treated primaries who have undergone surgery ≥ 2 times. Patients were randomized with stratification for HPV and EBV status, and received pembrolizumab 200mg IV or placebo for up to 18 cycles. The primary study endpoint was progression-free survival (PFS). The targeted sample size was N=100 patients (50 per arm), which provided &gt;90% power to detect a hazard ratio (HR) of 0.45, based on a stratified logrank test at a one-sided alpha level of 0.10. Results: A total of n=49 IO and n=51 PL patients were enrolled between 2016 and 2023 across 10 US sites. Mean age was 62; 33% female; 45% nonsmoker; 20% HPV+, 2% EBV+. Cancers were stage III (24%), IVa (39%), IVb (8%), with prior surgery in 95% and prior RT in 78%. Median follow-up was 33 months. Compared to PL, IO treated patients had superior PFS with HR 0.61 (80% CI: 0.43-0.86, one-sided p=0.021). PFS rates for IO were 65% and 54% at 1 and 2 years, respectively compared to 48% and 33%, respectively for PL. Overall survival (OS) was not significantly different in IO vs. PL treatment (HR = 1.00, 80% CI: 0.6-1.68, p=0.45). IO improved PFS in 2 sub-groups: In post-salvage surgery patients (group B, n=37), IO had superior PFS vs. PL (HR 0.34, 80% CI: 0.18-0.67, p=0.016); In patients with multiple recurrences/primaries (group F, n=37) IO had superior PFS vs. PL (HR 0.48, 80% CI: 0.27-0.88, p=0.057). Adverse events between treatments were comparable, with 3 (6%) grade 4 adverse events in PL and 1 (2%) grade 5 (2%, unrelated) and 1 grade 4 (2%) in IO. Conclusions: Pembrolizumab treatment for 1 year in patients with high risk of recurrent HNSCC following curative therapy resulted in a statistically significant improvement in PFS compared to placebo, and the benefit was maintained in key subgroups. Clinical trial information: NCT02841748 .

Supracondylar ostectomy and shortening (S.O.S.) for distal humerus nonunions

Many distal humerus nonunions are associated with bone loss, and rigid internal fixation is difficult to obtain, especially for low transcondylar nonunions and those with severe intra-articular comminution. The purpose of this study was to analyze the results of a strategy to address this challenge utilizing internal fixation using the Supracondylar Ostectomy+Shortening (S.O.S.) procedure for distal humerus nonunions. The goals of this procedure are to (1) optimize bony contact and compression through re-shaping the nonunited fragments at the supracondylar level with selective humeral metaphyseal shortening, (2) maximize fixation using parallel-plating, and (3) provide biologic and structural augmentation with bone graft. Between 1995 and 2019, 28 distal humerus nonunions underwent internal fixation using the S.O.S. procedure at a single Institution. There were 14 males and 14 females with mean age of 47 (range 14-78) years at the time of the S.O.S procedure and an average of 1.7 prior surgeries. Medical records and radiographs were reviewed to determine rates of union, reoperations, complications, and Mayo Elbow Performance Scores (MEPS). Patients were also prospectively contacted to update their MEPS and gather additional information on complications and reoperations. Mean clinical exam follow-up was 17months, mean clinical contact follow-up was 19months, and mean radiographic follow-up was 32months. Four patients did not have adequate follow-up to determine union. Of the remaining 24 elbows, 22 achieved union. Two elbows developed collapse of the articular surface and were converted to a total elbow arthroplasty. There were complications in 10 elbows: contracture (5), superficial infection (2), ulnar neuropathy (1), deep infection (1), and hematoma (1). Twelve elbows underwent reoperation: 4 for contracture release, 3 for hardware removal, 2 for total elbow arthroplasty, 1 for bone grafting, 1 for hematoma evacuation, and 1 for ulnar nerve neurolysis. Compared to preoperative data, there was a significant improvement in postoperative flexion, extension and pronation (P<.01). The mean range of motion was 21° of extension, 119° of flexion, 79° of pronation, and 77° of supination. The mean MEPS was 80 points (range, 25-100 points) and 19 elbows (76%) rated as excellent or good. Stable fixation and high union rates are possible in distal humerus nonunions with bone loss using a technique that combines supracondylar humeral shortening, parallel plating, and bone grafting. Secondary procedures are commonly needed to restore function in this challenging patient population.

Incidence and Risk Factors for Stroke After Combined Heart-Kidney and Heart-Liver Transplantation.

While stroke is a well-recognized complication of isolated heart transplantation, stroke in patients undergoing simultaneous heart-liver (HLT) and heart-kidney transplantation (HKT) has not been explored. This study assessed postoperative stroke incidence, risk factors, and outcomes in HLT and HKT compared with isolated heart transplant. The United Network for Organ Sharing database was queried for adult patients undergoing HLT, HKT, and isolated heart transplants between 1994 and 2022. Patients were stratified by presence of in-hospital stroke after transplant. Post-transplant survival at 1-year was assessed using Kaplan-Meier analysis and log-rank tests. Separate multivariable logistic regression models were constructed to identify risk factors for stroke after HKT and HLT. Of 2326 HKT recipients, 85 experienced stroke, and of 442 HLT recipients, 19 experienced stroke. Stroke was more common after HKT and HLT than after an isolated heart transplant (3.7% vs. 4.3% vs. 2.9%, p=0.01). One-year post-transplant survival was lower in those with stroke among both HKT recipients (64.5% vs. 88.7%, p(log-rank)<0.001) and HLT recipients (43.8% vs. 87.4%, p(log-rank)<0.001. Pre-transplant pVAD, prior stroke, postoperative dialysis, diabetes, prior cardiac surgery, and heart cold ischemic time were independent risk factors for stroke after HKT, after adjusting for age, sex, and need for blood transfusion on the waitlist. For HLT, postoperative dialysis was a significant risk factor. Stroke is more common after HKT and HLT than after isolated heart transplant, and results in poor survival. Independent risk factors for stroke include pre-transplant percutaneous VAD (HKT) and postoperative dialysis (HKT and HLT).

SOGUG-NEOWIN: A phase 2, open-label, multi-centre, multi-national interventional trial evaluating the efficacy and safety of erdafitinib (ERDA) monotherapy and ERDA and cetrelimab (CET) as neoadjuvant treatment in patients with cisplatin-ineligible muscle-invasive bladder cancer (MIBC) whose tumours express FGFR gene alterations.

TPS4623 Background: The standard treatment for nonmetastatic MIBC is neoadjuvant cisplatin-based therapy followed by radical cystectomy (RC). However, many patients are ineligible for cisplatin. Immune checkpoint inhibitors (ICIs) have changed the treatment landscape for metastatic urothelial cancer (mUC), including for cisplatin-ineligible patients. Based on these results, ICIs are being explored as neoadjuvant treatment in resectable UC with preliminary data suggesting antitumour activity. ERDA is a Fibroblast Growth Factor Receptor (FGFR) inhibitor, which has shown efficacy in advanced UC with select FGFR2/3 mutations/fusions. ERDA plus cetrelimab demonstrated clinically meaningful activity in patients with newly diagnosed FGFR-altered mUC in the phase 2 NORSE trial. We hypothesize that ERDA plus cetrelimab will improve the pathological complete response (pCR) rate in patients with FGFR+ MIBC who are candidates for RC and are ineligible for or refuse neoadjuvant cisplatin-based therapy. Methods: SOGUG-NEOWIN is a prospective, non-comparative, open label, multicentre, international trial to assess the efficacy of 9 or 12 weeks of neoadjuvant ERDA (cohort 1) or the combination of cetrelimab and ERDA (cohort 2) in patients with MIBC (cT2-Ta N0/1 M0) and FGFR alterations. Key eligibility criteria include ECOG PS 0-1; pure or predominant UC histology; decline or ineligible for cisplatin-based chemotherapy as defined by one of the following criteria: impaired renal function (GFR &lt; 60 mL/min), ≥ grade 2 hearing loss, or ≥ grade 2 peripheral neuropathy; patients are considered fit for cystectomy; no prior FGFR-targeted or anti-PD-(L)1 therapy; no prior systemic therapy, radiation or surgery (except TURBT or biopsies) for bladder cancer; prior BCG was allowed if completed ≥ 6 weeks before initiation of study treatment; no current retinopathy. A total of 45 patients will be allocated to each cohort by a centralized system. Co-primary endpoints are pCR rate and percentage of pathological downstaging response (&lt;ypT2). Secondary endpoints include event-free survival, overall survival, overall response rate, safety, tolerability, and delay to surgery. Biomarkers of response and resistance will be assessed using baseline archival tissues, blood and urine. Quality of life (QoL) will be assessed using FACT-Bl and EQ-5D-5L. Tumour response assessment via PET-MRI will be performed in a subset of patients. The trial is approved in 4 countries. The first patient was included on 31-Jan-2024. This trial would be the first to systematically address whether ERDA ± cetrelimab improves pCR in patients with FGFR-positive MIBC. (EudraCT 2022-002586-15). Clinical trial information: 2022-002586-15.

SAT-051 The clinical relevance of prior bariatric surgery in alcohol-related liver disease in a nationwide belgian liver transplant population

SAT-051 The clinical relevance of prior bariatric surgery in alcohol-related liver disease in a nationwide belgian liver transplant population