Comparison between catheter ablation versus permanent pacemaker implantation as an initial treatment for tachycardia-bradycardia syndrome patients: a prospective, randomized trial.

BACKGROUND: Clinical outcomes after catheter ablation (CA) or pacemaker (PM) implantation for the tachycardia-bradycardia syndrome (TBS) has not been evaluated adequately. We tried to compare the efficacy and safety outcomes of CA and PM implantation as an initial treatment option for TBS in paroxysmal atrial fibrillation (AF) patients. METHODS: Sixty-eight patients with paroxysmal AF and TBS (mean 63.7 years, 63.2% male) were randomized, and received CA (n = 35) or PM (n = 33) as initial treatments. The primary outcomes were unexpected emergency room visits or hospitalizations attributed to cardiovascular causes. RESULTS: In the intention-to-treatment analysis, the rates of primary outcomes were not significantly different between the two groups at the 2-year follow-up (19.8% vs. 25.9%; hazard ratio (HR) 0.73, 95% confidence interval (CI) 0.25-2.20, P = 0.584), irrespective of whether the results were adjusted for age (HR 1.12, 95% CI 0.34-3.64, P = 0.852). The 2-year rate of recurrent AF was significantly lower in the CA group compared to the PM group (33.9% vs. 56.8%, P = 0.038). Four patients (11.4%) in the CA group finally received PMs after CA owing to recurrent syncope episodes. The rate of major or minor procedure related complications was not significantly different between the two groups. CONCLUSION: CA had a similar efficacy and safety profile with that of PM and a higher sinus rhythm maintenance rate. CA could be considered as a preferable initial treatment option over PM implantation in patients with paroxysmal AF and TBS. TRIAL REGISTRATION: KCT0000155.

The 5-factor modified frailty index (mFI-5) predicts adverse outcomes after elective anterior cervical discectomy and fusion (ACDF).

Background: Anterior cervical discectomy and fusion (ACDF) is a reliable procedure commonly performed in older patients with degenerative diseases of the cervical spine. Over 130,000 procedures are performed every year with an annual increase of 5%, and overall morbidity rates can reach as high as 19.3%, indicating a need for surgeons to gauge their patients' risk for adverse outcomes. Frailty is an age-associated decline in functioning of multiple organ systems and has been shown to predict adverse outcomes following various spine procedures. There have been several proposed frailty indices of various factors including the 11-factor modified frailty index (mFI-11), which has been shown to be an effective tool for predicting complications in patients undergoing ACDF. However, there is a paucity of literature assessing the utility of the 5-factor modified frailty index (mFI-5) as a risk stratification tool for patients undergoing ACDF. The purpose of this study was to analyze the predictive capability of the mFI-5 score for 30-day postoperative adverse events following elective ACDF. Methods: A retrospective review was performed using the National Surgical Quality Improvement Program (NSQIP) database from 2010 through 2019. Patients older than 50 years of age who underwent elective ACDF were identified using Current Procedural Terminology ([CPT] codes 22554, 22551, 22552, and 63075). Exclusion criteria removed patients under the age of 51, as well as those with fractures, sepsis, disseminated cancer, a prior operation in the last 30 days, ascites, wound infection, or an emergency surgery. Patients were grouped using mFI scores of 1, 2, and 3+. Univariate analysis, using chi-squared and one-way analysis of variance (ANOVA) tests, was conducted to compare demographics, comorbidities, and postoperative complications across the varying cohorts based on mFI-5 scores. Multivariate logistic regression, including patient demographics and preoperative comorbidities as covariates, was performed to evaluate if mFI-5 scores were independent predictors of 30-day postoperative adverse events. Covariates including race, BMI, sex, ASA, and comorbidities were included in regression models. Results: The 45,991 patients were identified and allocated in cohorts based on mFI-5 score. Rates for superficial surgical site infection (SSI), organ/deep space SSI, pneumonia, progressive renal insufficiency, acute renal failure (ARF), urinary tract infection (UTI), stroke/cardiovascular accident (CVA), cardiac arrest requiring cardiopulmonary resuscitation (CPR), myocardial infarction, bleeding requiring transfusions, deep vein thrombosis/thrombophlebitis, sepsis, septic shock, readmissions, reoperation, and mortality incrementally increased with mFI-5 scores from 0 to 3+. Multivariate regression analysis revealed that mFI-5 scores 1 to 3+ increased the odds, in a stepwise manner, of total complications, cardiac arrest requiring CPR, pneumonia and mortality. MFI-5 scores of 2 and 3+ were independent predictors of readmission (2: OR=1.5, p<.001; 3+: OR=2.0, p<.001) and myocardial infarction (2: OR=3.4, p=.001; 3+: OR=6.9, p<.001). A score of 3+ increased the odds of ARF (OR=9.7, p=.022), septic shock (OR=3.6, p=.036), UTI (OR=2.1, p=.007), bleeding requiring transfusions (OR=2.1, p=.016), and reoperations (OR=1.7, p=.004). Conclusion: mFI-5 score is a quick and viable option for surgeons to use as an assessment tool to stratify high risk patients undergoing elective ACDF, as increasing mFI-5 scores showed significantly higher rates of all adverse outcomes accounted for in this study, except for deep incisional SSI, wound disruption, and PE. Additionally, moderate to severe mFI-5 scores of 2 or 3+ were independent predictors for 30-day postoperative ARF, UTI, MI, bleeding requiring transfusions, septic shock, reoperation, and readmissions following elective ACDF surgery in adults over 50 years old.

Comparison of long-term oncologic outcomes of central lumpectomy and conventional breast-conserving surgery for invasive breast cancer: propensity score matching analysis.

PURPOSE: Central lumpectomy (CL) is a breast-conserving surgical (BCS) technique that involves excision of the nipple-areolar complex with breast tumor in centrally located breast cancers. We aimed to investigate the long-term clinical outcomes of CL in comparison with conventional BCS (cBCS). METHODS: Patient records who underwent BCS with clear resection margins for invasive breast cancer between 2004 and 2018 were retrospectively reviewed. Of the total 6,533 patients, 106 (1.6%) underwent CL. Median follow-up duration was 73.4 months. 1:3 propensity score matching (PSM) and inverse probability of treatment weighting (IPTW) were used to minimize selection bias. RESULTS: The CL group showed a significantly higher ipsilateral breast tumor recurrence (IBTR) rate than the cBCS group (10-year IBTR rate: 5.8% vs. 3.1%, p = 0.004), even after adjusting for other variables (hazard ratio (HR), 2.65; 95% confidence interval (CI), 1.07-6.60, p = 0.048). However, there were no significant differences observed in regional recurrence, distant metastasis, or overall survival rates between the two groups. Both PSM and IPTW analyses showed significantly higher IBTR in the CL group (PSM HR, 3.27; 95% CI, 0.94-11.36; p = 0.048 and IPTW HR, 4.66; 95%CI, 1.85-11.77; p < 0.001). Lastly, when analyzing 2,213 patients whose tumors were located within 3 cm of the nipple, the CL group showed a significantly higher IBTR than the cBCS group before and after PSM. CONCLUSION: CL was associated with a higher rate of IBTR compared to cBCS, while other survival outcomes were comparable. For centrally located tumors, CL may be considered for patients preferring breast preservation. However, higher risk for IBTR should be informed and careful surveillance may be necessary during the early post-operative follow-up periods.

The Impact of Patient Characteristics on Outcomes of Surgically Managed Vertebral Osteomyelitis in the United States: Insights from a National Database Study.

This study was conducted to assess the patient characteristics, types of treatment, and outcomes of patients who are surgically treated for vertebral osteomyelitis (VO) in the United States. VO can be treated with or without surgical intervention. Surgically treated cases of VO are associated with significant morbidity and mortality, and incur major healthcare costs. There are few studies assessing the characteristics and outcomes of patients with VO who are treated surgically, as well as the overall impact of surgically managed VO on the healthcare system of the United States. Utilizing the Nationwide Inpatient Sample (NIS) database, 44,401 patients were identified who underwent surgical treatment for VO over a fifteen year period. Severity of comorbidity burden was calculated using the Deyo Index (DI). Surgical approach and comorbidities were analyzed in regard to their impact on complications, mortality rate, LOS, and hospitalization charges. The incidence of surgical intervention for patients who had VO increased from 0.6 to 1.1 per U.S. persons over the study period. Surgically treated patients had a mean age of 56 years, were 75.8% white, were 54.5% male, 37.9% carried Medicare insurance, and they had a mean DI of 0.88. Anterior/posterior approach (OR: 3.53), thoracolumbar fusion (OR: 2.69), thoracolumbar fusion (OR: 19.94), and anterior/posterior approach (OR: 64.73) were the surgical factors that most significantly predicted any complication, mortality, increased LOS, and increased hospital charges, respectively (P < 0.001). The mean inflation-adjusted total hospital cost increased from $20,355 to $39,991 per patient over the study period. VO has been steadily increasing in the United States. Incidence and inflation-adjusted costs nearly doubled. Anterior/posterior approach and thoracolumbar fusion most significantly predicted negative outcomes. VO is associated with lengthy and expensive hospital stays resulting in a significant burden to patients and the healthcare system.

Are Patients With Segmental Cervical Kyphosis Appropriate Candidates for Cervical Disc Arthroplasty (CDA)? A Clinical and Radiographic Analysis Compared to Anterior Cervical Discectomy and Fusion (ACDF).

STUDY DESIGN: Retrospective cohort study. OBJECTIVES: To compare the clinical and radiographic outcomes of Anterior Cervical Discectomy and fusion (ACDF) and cervical disc arthroplasty (CDA) in patients with preoperative segmental kyphosis. METHODS: Patients with segmental cervical kyphosis at the operative levels undergoing 1- or 2-level ACDF or CDA from 2017 to 2020 with 2 years of follow were identified. Patient demographics, perioperative data, complication rates, radiographic findings and reported outcomes were analyzed. RESULTS: A total of 48 patients met inclusion criteria and were included in our study (ACDF: n = 24, CDA: n = 24). Patient demographic data between the 2 cohorts was similar expect for proportion of males (ACDF: 62.5% vs CDA: 33.3%, P = .043). There was no statistical significance in the change of segmental lordosis (ACDF: +8.09° vs CDA: +5.88°, P = .075) between the preoperative and final postoperative period. Additionally, the change in cervical lordosis was similar between groups (ACDF:+ 9.86° vs CDA: +7.60°, P = .226). VAS scores were similar between the 2 groups at every follow-up interval. NDI scores were significantly different at the 6-month, 12 month and the final follow-up. Mean improvements between preoperative and final postoperative periods were statistically superior in the CDA cohort compared to the ACDF cohort (ACDF: 22.8 vs CDA: 24.1, P = .0375). CONCLUSION: CDA was superior to ACDF in regards to NDI scores following index procedure in patients with preoperative segmental cervical kyphosis. Those in the CDA cohort had similar complication rates, revision rates and radiographic outcomes as those who underwent ACDF.

Safety and Efficacy of Outpatient Anterior Cervical Disk Replacement (ACDR) in an Ambulatory Surgery Center Versus Hospital Setting: A 2-year Retrospective Analysis.

STUDY DESIGN: Retrospective cohort analysis. OBJECTIVE: To compare clinical outcomes of outpatient anterior cervical disk replacements (ACDR) performed in free-standing private ambulatory surgery centers versus tertiary hospital centers. SUMMARY OF BACKGROUND DATA: ACDR is an increasingly popular technique for treating various degenerative pathologies of the cervical spine. There has been an increase in the utilization of ambulatory surgery centers (ASCs) for outpatient cervical procedures due to economic and convenience benefits; however, a paucity of literature exists in evaluating long-term safety and efficacy of ACDRs performed in ASCs versus outpatient hospital centers. METHODS: A retrospective cohort review of all patients undergoing 1- or 2-level ACDRs at 2 outpatient ASCs and 4 tertiary care medical centers from 2012 to 2020, with a minimum follow-up of 24 months, was performed. Approval by each patient's insurance and patient preference determined distribution into an ASC or non-ASC. Demographics, perioperative data, length of follow-up, complications, and revision rates were analyzed. Functional outcomes were assessed using VAS and NDI at follow-up visits. RESULTS: One hundred seventeen patients were included (65 non-ASC and 52 ASC). There were no significant differences in demographics or length of follow-up between the cohorts. ASC patients had significantly lower operative times (ASC: 89.5 minutes vs. non-ASC: 110.5 minutes, P<0.001) and mean blood loss (ASC: 17.5 mL vs. non-ASC: 25.3 mL, P<0.001). No significant differences were observed in rates of dysphagia (ASC: 21.2% vs. non-ASC: 15.6%, P<0.001), infection (ASC: 0.0% vs. non-ASC: 1.6%, P=0.202), ASD (ASC: 1.9% vs. non-ASC: 1.6%, P=0.202), or revision (ASC: 1.9% vs. non-ASC: 0.0%, P=0.262). Both groups demonstrated significant improvements in VAS and NDI scores (P<0.001), but no significant differences in the degree of improvement were observed. CONCLUSIONS: Our 2-year results demonstrate that ACDRs performed in ASCs may offer the advantages of reduced operative time and blood loss without an increased risk of postoperative complications.

Comparing outcomes between anterior cervical disc replacement (ACDR) and minimally invasive posterior cervical foraminotomy (MI-PCF) in the treatment of cervical radiculopathy.

BACKGROUND CONTEXT: Anterior cervical disc replacement (ACDR) and minimally invasive posterior cervical foraminotomy (MI-PCF) have emerged as two increasingly popular alternatives to anterior cervical discectomy and fusion (ACDF) for the management of cervical radiculopathy. Both techniques provide advantages of segmental motion preservation and lower rates of adjacent segment degeneration (ASD) compared to ACDF. PURPOSE: The purpose of this study was to analyze the clinical and functional outcomes of patients undergoing ACDR or MI-PCF for the treatment of unilateral cervical radiculopathy. STUDY DESIGN/SETTING: Retrospective Cohort Review. PATIENT SAMPLE: A total of 152 patients were included (86 ACDR and 66 MI-PCF). OUTCOME MEASURES: (1) Patient demographics; (2) perioperative data; (3) rates of complications and revisions; (5) visual analogue scale (VAS) and Neck Disability Index (NDI) scores. METHODS: A retrospective cohort review was performed to identify all patients at a single institution between 2012-2020 who underwent 1- or 2- level ACDR or MI-PCF from C3-C7 with a minimum follow-up of 24 months. Patient demographics, perioperative data, postoperative complications, and revisions were analyzed. Patient reported outcome measures including VAS and NDI scores were compared. RESULTS: The ACDR group had a significantly greater mean operative time (99.8 minutes vs 79.2 minutes, p<.001), but comparable estimated blood loss and length of stay following surgical intervention (p=.899). The overall complication rate was significantly greater in the ACDR group than the MI-PCF group (24.4% vs 6.2%; p=.003) but was largely driven by approach-related dysphagia in 20.9% of ACDR patients. The MI-PCF group had significantly greater revision rates (13.6% vs 1.2%; p=.002) with an average time to revision of 20.7 months in the MI-PCF group compared to 40.3 months in the ACDR group. The ACDR cohort had significantly greater improvements in NDI scores at the final follow-up (25.0 vs 21.3, p<.001). CONCLUSION: Our results suggest that ACDR offer clinically relevant advantages over MI-PCF in terms of long-term revision rates despite an increased approach-related risk of transient postoperative dysphagia. Additionally, patients in the ACDR cohort achieved greater mean improvements in NDI scores but these results may have limited clinical significance due to inability to reach minimally clinically important difference (MCID) thresholds.

Should patient eligibility criteria for cervical disc arthroplasty (CDA) be expanded? A retrospective cohort analysis of relatively contraindicated patients undergoing CDA.

BACKGROUND CONTEXT: Cervical disc arthroplasty (CDA) is a safe and effective alternative to anterior cervical discectomy and fusion (ACDF) in the treatment of various degenerative pathologies with advantages of motion preservation and lower rates of adjacent segment degeneration (ASD). Absolute contraindications for CDA have been well outlined in order to prevent adverse outcomes in patients. However, in cases of patients with relative contraindications (kyphotic deformity, prior cervical surgery, etc.), there remains controversy. There is minimal literature evaluating long-term outcomes in this patient population. PURPOSE: To compare long-term clinical and functional outcomes of CDA in typical patients versus those with relative contraindications. DESIGN: Retrospective cohort review. PATIENT SAMPLE: Eighty-nine patients were included in the study: 55 (no contraindications) in Group 1 and 34 (relatively contraindicated) in Group 2 and 26 (preoperative segmental kyphosis) in Group 3. OUTCOME MEASURES: (1) Patient demographics; (2) perioperative data; (3) rates of complications and revisions; (5) visual analogue scale (VAS), and neck disability index (NDI) scores. METHODS: Patients were placed in the relatively contraindicated cohort if they possessed at least one of the following: (1) segmental kyphosis of 5° to 10°, (2) significant loss of disc height (between 50% and 75% of initial measurements or 1.5-3mm), (3) bridging osteophytes, and (4) prior cervical spine surgery based on preoperative cervical radiographs. The other cohort included patients without any relative contraindication who underwent CDA over the same time frame. Additionally, a subgroup analysis was used to compare those without any contraindications to those with only preoperative segmental kyphosis. Patients were included in this study if they met the following criteria: over 18 years of age, minimum follow-up of 24 months, and availability of complete medical records. Patient demographics, levels operated on, and perioperative outcomes were assessed between the two groups. Revision and complication rates were recorded. Functional outcomes scores were compared using VAS and NDI scores at 6-months, 12-months and final follow-up. RESULTS: Mean follow-up was 40.8 months in Group 1 and 38.3 months in Group 2 (p=.569). Complication rates were 21.8% in Group 1 and 26.4% in Group 2 (p=.615). Complication rates in a comparison between Groups 1 and 3 were statistically insignificant (p=.383). The most common complication was transient approach-related postoperative dysphagia (Group 1: 20% vs Group 2: 23.5%, p=.693). No significant differences were observed in the rates of transient dysphonia (Group 1: 0.0% vs Group 2: 2.9%, p=.201), adjacent segment degeneration (ASD) (Group 1: 1.8% vs Group 2: 0.0%, p=.429), infection (Group 1: 1.8% vs Group 2: 2.9%, p=.712), heterotopic ossification (Group 1: 49.1% vs Group 2: 50.0%, p=.934) or spontaneous fusion (Group 1: 1.8% vs Group 2: 2.9%, p=.728). No revision surgeries were observed in either cohort. All three groups demonstrated significant improvements in their VAS and NDI scores compared with preoperative measurements (p<.001), but no significant differences were found in the degree of improvement between groups at any point in time. CONCLUSIONS: Our study found no significant differences in clinical and functional outcomes between patients undergoing 1- and 2-level CDA with relative contraindications versus typical patients. These findings suggest that patient eligibility criteria for CDA may warrant expansion. However, future prospective studies over a longer period of follow-up are necessary to corroborate our results.

Enhanced Osteocyte Differentiation: Cathepsin D and L Secretion by Human Adipose-Derived Mesenchymal Stem Cells.

Adipose-derived mesenchymal stem cells (ASCs) have the potential to differentiate into bone, cartilage, fat, and neural cells and promote tissue regeneration and healing. It is known that they can have variable responses to hypoxic conditions. In the present study, we aimed to explore diverse changes in the cells and secretome of ASCs under a hypoxic environment over time and to present the possibility of ASCs as therapeutic agents from a different perspective. The expression differences of proteins between normoxic and hypoxic conditions (6, 12, or 24 h) were specifically investigated in human ASCs using 2-DE combined with MALDI-TOF MS analysis, and secreted proteins in ASC-derived conditioned media (ASC-derived CM) were examined by an adipokine array. In addition, genetic and/or proteomic interactions were assessed using a DAVID and miRNet functional annotation bioinformatics analysis. We found that 64 and 5 proteins were differentially expressed in hypoxic ASCs and in hypoxic ASC-derived CM, respectively. Moreover, 7 proteins among the 64 markedly changed spots in hypoxic ASCs were associated with bone-related diseases. We found that two proteins, cathepsin D (CTSD) and cathepsin L (CTSL), identified through an adipokine array independently exhibited significant efficacy in promoting osteocyte differentiation in bone-marrow-derived mesenchymal stem cells (BM-MSCs). This finding introduces a promising avenue for utilizing hypoxia-preconditioned ASC-derived CM as a potential therapeutic approach for bone-related diseases.

Survival Outcomes in Premenopausal Patients With Invasive Lobular Carcinoma.

Importance: The disparate prognostic implications between invasive ductal carcinoma (IDC) and invasive lobular carcinoma (ILC) have been demonstrated. However, information on premenopausal patients remains insufficient. Objective: To examine long-term survival outcomes of ILC and IDC in premenopausal patients using national databases. Design, Setting, and Participants: This cohort study used the Surveillance, Epidemiology, and End Results (SEER), Korean Breast Cancer Registry (KBCR), and Asan Medical Center Research (AMCR) databases to identify premenopausal patients with stage I to III ILC or IDC between January 1, 1990, and December 31, 2015. The median follow-up time was 90 (IQR, 40-151) months in the SEER database, 94 (IQR, 65-131) months in the KBCR database, and 120 (IQR, 86-164) months in the AMCR database. Data were analyzed from January 1 to May 31, 2023. Main Outcomes and Measures: The primary outcome was breast cancer-specific survival (BCSS), which was analyzed according to histological type, and the annual hazard rate was evaluated. Survival rates were analyzed using a log-rank test and a Cox proportional hazards regression model with time-varying coefficients. Multivariable analysis was performed by adjusting for tumor characteristics and treatment factors. Results: A total of 225 938 women diagnosed with IDC or ILC and younger than 50 years were identified. Mean (SD) age at diagnosis was 42.7 (5.3) years in the SEER database, 41.8 (5.5) years in the KBCR database, and 41.8 (5.5) years in the AMCR database. In terms of race (available for the SEER database only), 12.4% of patients were Black, 76.1% were White, 11.0% were of other race (including American Indian or Alaska Native, Asian, and Native Hawaiian or Other Pacific Islander), and 0.5% were of unknown race). Patients with ILC had better BCSS in the first 10 years after diagnosis than those with IDC (hazard ratios [HRs], 0.73 [95% CI, 0.68-0.78] in the SEER database, 1.20 [95% CI, 0.91-1.58] in the KBCR database, and 0.50 [95% CI, 0.29-0.86] in the AMCR database), although BCSS was worse after year 10 (HRs, 1.80 [95% CI, 1.59-2.02] in the SEER database, 2.79 [95% CI, 1.32-5.88] in the KBCR database, and 2.23 [95% CI, 1.04-4.79] in the AMCR database). Similar trends were observed for hormone receptor-positive tumors (HRs, 1.55 [95% CI, 1.37-1.75] in the SEER database, 2.27 [95% CI, 1.01-5.10] in the KBCR database, and 2.12 [95% CI, 0.98-4.60] in the AMCR database). Considering the annual hazard model of BCSS, IDC events tended to decline steadily after peaking 5 years before diagnosis. However, the annual peak event of BCSS was observed 5 years after diagnosis for ILC, which subsequently remained constant. Conclusions and Relevance: These findings suggest that premenopausal women with ILC have worse BCSS estimates than those with IDC, which can be attributed to a higher late recurrence rate of ILC than that of IDC. Histological subtypes should be considered when determining the type and duration of endocrine therapy in premenopausal women.

Prognostic Implication of Focal Breast Edema on Preoperative Breast Magnetic Resonance Imaging in Breast Cancer Patients.

PURPOSE: In this study, we investigated the prognostic implications of focal breast edema on preoperative breast magnetic resonance imaging (MRI) in patients with breast cancer. METHODS: Data of 899 patients with breast cancer at a single institution were retrospectively analyzed. The patients were divided into an edema-positive group (EPG) and an edema-negative group (ENG) based on the presence of peritumoral, prepectoral, or subcutaneous edema. Two radiologists evaluated the presence or absence of focal edema and its subtypes on preoperative breast MRI. Clinicopathologic characteristics and survival outcomes were compared between the two groups and among the three subtypes using Pearson's χ² test, Kaplan-Meier estimator, and Cox proportional hazards model. RESULTS: There were 399 (44.4%) and 500 (55.6%) patients in the EPG and ENG, respectively. The EPG showed significantly higher rates of axillary lymph node metastasis (55.6% vs. 19.2%, p < 0.001) and lymphovascular invasion (LVI) (57.9% vs. 12.6%, p < 0.001) than the ENG. Patients in the EPG showed significantly worse overall survival (OS) rate (log-rank p < 0.001; hazard ratio [HR], 4.83; 95% confidence interval [CI], 2.56-9.11) and recurrence-free survival rate (log-rank p < 0.001; HR, 3.00; 95% CI, 1.94-4.63) than those in the ENG. After adjusting for other variables, focal breast edema remained a significant factor affecting the OS rate, regardless of the edema type. Specifically, the presence of subcutaneous edema emerged as the strongest predictor for OS with the highest HR (p < 0.001; HR, 9.10; 95% CI, 3.05-27.15). CONCLUSION: Focal breast edema on preoperative breast MRI implies a higher possibility of LVI and axillary lymph node metastasis, which can lead to a poor prognosis. A detailed description of focal breast edema, especially subcutaneous edema, on preoperative breast MRI may provide prognostic predictions. More intensive surveillance is required for patients with breast cancer and focal preoperative breast edema.

Real-World Safety and Effectiveness of Fluticasone Furoate/Vilanterol in Patients with Asthma and/or Chronic Obstructive Pulmonary Disease: A Post-Marketing Study in Korea.

BACKGROUND AND OBJECTIVE: Fluticasone furoate/vilanterol (FF/VI; RELVAR ELLIPTA) is approved in Korea for patients with asthma or chronic obstructive pulmonary disease (COPD). This study evaluated the effectiveness and safety of FF/VI in Korean patients with asthma and/or COPD over a 6-year period. METHODS: This was an open-label, multicentre, observational, post-marketing surveillance study in patients newly treated with FF/VI (100 or 200 µg/25 µg once daily). Safety endpoints were the incidence of adverse events (AEs), including unexpected AEs/adverse drug reactions (ADRs) and serious AEs/ADRs. Effectiveness was assessed after 24 weeks by Global Physician Assessment (logistic regression) and forced expiratory volume in 1 s (FEV1; paired t-tests). RESULTS: Of the 3426 patients enrolled across 45 hospitals between July 2014 and June 2020, 3216 were included in the safety analysis (50.5% female; mean age ± standard deviation [SD]: 58.6 ± 16.3 years). Overall incidence of AEs was 30.9% (n = 992); 4.1% (n = 132) were ADRs. Serious AEs were reported in 4.1% (n = 132) of patients; 0.1% (n = 4) were ADRs. Of 1543 patients analysed for symptomatic improvement, 89.2% (n = 1377) improved, 9.4% (n = 145) were unchanged, and 1.4% (n = 21) worsened. Mean FEV1 (difference ± SD) increased significantly in patients with asthma (0.09 ± 0.29 L; p < 0.0001), COPD (0.11 ± 0.24 L; p = 0.0011), or both (0.05 ± 0.18 L; p = 0.0399), indicating improved lung function. CONCLUSION: In this real-world study, FF/VI administered to Korean patients was well tolerated and effective for the treatment of asthma and COPD. These results were consistent with other studies in Asian and global populations.

The 5-Factor Modified Frailty Index is Associated With Increased Risk of Reoperations and Adjacent Level Disease Following Single-Level Transforaminal Lumbar Interbody Fusion.

STUDY DESIGN: Retrospective Cohort Study. OBJECTIVES: To determine the predictive capability between the 5-factor modified frailty index (mFI-5) scores and adverse clinical and radiographic outcomes following single-level transforaminal lumbar interbody fusion (TLIF). METHODS: All patients over the age of 50 undergoing single-level open or minimally invasive TLIF from 2012 to 2021 with a minimum follow-up of 1 year were identified. Deformity, trauma, emergency, and tumor cases were excluded as were patients undergoing revision surgeries. An mFI-5 score was computed for each patient using a set of five factors which included hypertension requiring medication, chronic obstructive pulmonary disease, diabetes mellitus, congestive heart failure, and partially or fully dependent functional status. Univariate and multivariate logistic regression analysis were performed to evaluate the impact of mFI-5 scores on readmissions, reoperations, and postoperative complications. RESULTS: 156 patients were included and grouped according to their level of frailty: no-frailty (mFI = 0, n = 67), mild frailty (mFI = 1, n = 59), and severe frailty (mFI = 2+, n = 30). Multivariate analysis found high levels of frailty (mFI = 2+) to be independent predictors of reoperation (OR: 16.9, CI: 2.7 - 106.9, P = .003) and related readmissions (OR = 16.5, CI: 2.6 - 102.7, P = .003) as compared to the no-frailty group. An mFI-5 score of 2+ was also predictive of any complication (OR = 4.5, CI: 1.4 - 14.3, P = .01) and adjacent segment disease (ASD) (OR = 12.5, CI: 1.2 - 134.0, P = .037). CONCLUSION: High levels of frailty were predictive of related readmissions, reoperations, any complications, and ASD in older adult patients undergoing single-level TLIF.

Comparing clinical and radiological outcomes between single-level OLIF and XLIF: A systematic review and meta-analysis.

Background Context: Oblique lumbar interbody fusion (OLIF) and extreme lateral interbody fusion (XLIF) are 2 popular minimally invasive spinal fusion techniques with unique approach-related complication profiles. Accordingly, patient-specific anatomical factors, such as vascular anatomy or iliac crest height, greatly influence which technique to use. Previous studies comparing these approaches do not account for the inability of XLIF to access the L5-S1 disc space and therefore do not exclude this level in their analysis. The purpose of this study was to compare radiological and clinical outcomes of these techniques in the L1-L5 region. Methods: A query of 3 electronic databases (PubMed, CINAHL plus, and SCOPUS) was performed, without time restriction, to identify studies that evaluated outcomes of single-level OLIF and/or XLIF between L1 and L5. Based on heterogeneity, a random effects meta-analysis was performed to evaluate the pooled estimation of each variable between the groups. An overlap of 95% confidence intervals suggests no statistically significant difference at the p<.05 level. Results: A total of 1,010 patients (408 OLIF, 602 XLIF) were included from 24 published studies. Improvements in disc height (OLIF: 4.2 mm; XLIF: 5.3 mm), lumbar segmental (OLIF: 2.3°; XLIF: 3.1°), and lumbar lordotic angles (OLIF: 5.3°; XLIF: 3.3°) showed no significant difference. The rate of neuropraxia was significantly greater in the XLIF group at 21.2% versus 10.9% in the OLIF group (p<.05). However, the rate of vascular injury was higher in the OLIF cohort at 3.2% (95% CI:1.7-6.0) as compared to 0.0 (95% CI: 0.0-1.4) in the XLIF cohort. Improvements in VAS-b (OLIF: 5.6; XLIF: 4.5) and ODI (OLIF: 37.9; XLIF: 25.6) scores were not significantly different between the 2 groups. Conclusions: This meta-analysis demonstrates similar clinical and radiological outcomes between single-level OLIF and XLIF from L1 to L5. XLIF had significantly higher rates of neuropraxia, whereas OLIF had greater rates of vascular injury.

Direct Extracorporeal Membrane Oxygenation Bridged Heart Transplantation: The Importance of Multi-Organ Failure.

Background and Objectives: Recently, approximately 40% of all heart transplantation (HTx) in South Korea are performed using the direct extracorporeal membrane oxygenation (ECMO) bridging method. We conducted a study to examine the clinical outcome of direct ECMO-bridged HTx and to investigate the impact of multi-organ failure (MOF). Methods: From June 2014 to September 2022, a total of 96 adult patients who underwent isolated HTx at a single tertiary hospital were included in the study. The patients were sub-grouped into ECMO (n=48) and non-ECMO group (n=48), and the ECMO group was subdivided into awake (n=22) and non-awake (n=26) groups based on mechanical ventilator (MV) dependency. Baseline characteristics, 30-day, and 1-year mortality were analyzed retrospectively. Results: The 1-year survival rate was significantly lower in the ECMO group (72.9% vs. 95.8%, p=0.002). There was a significant difference in the 30-day survival rate between the awake and non-awake ECMO groups (81.8% vs. 65.4%, p=0.032). In the univariate analysis of logistic regression for 1-year mortality, the odds ratio was 8.5 for ECMO bridged HTx compared to the non-ECMO group, 12.3 in patients who required MV (p=0.003), and 23 with additional hemodialysis (p<0.001). Conclusions: Patients who required MV in ECMO bridged HTx showed higher preoperative MOF rates and early mortality than those extubated. When considering ECMO bridged HTx, the severity of MOF should be thoroughly investigated, and careful patient selection is necessary.

The Clinical Outcomes of Marginal Donor Hearts: A Single Center Experience.

BACKGROUND AND OBJECTIVES: Although the shortage of donor is a common problem worldwide, a significant portion of unutilized hearts are classified as marginal donor (MD) hearts. However, research on the correlation between the MD and the prognosis of heart transplantation (HTx) is lacking. This study was conducted to investigate the clinical impact of MD in HTx. METHODS: Consecutive 73 HTxs during 2014 and 2021 in a tertiary hospital were analyzed. MD was defined as follows; a donor age >55 years, left ventricular ejection fraction <50%, cold ischemic time >240 minutes, or significant cardiac structural problems. Preoperative characteristics and postoperative hemodynamic data, primary graft dysfunction (PGD), and the survival rate were analyzed. Risk stratification by Index for Mortality Prediction after Cardiac Transplantation (IMPACT) score was performed to examine the outcomes according to the recipient state. Each group was sub-divided into 2 risk groups according to the IMPACT score (low <10 vs. high ≥10). RESULTS: A total of 32 (43.8%) patients received an organ from MDs. Extracorporeal membrane oxygenation was more frequent in the non-MD group (34.4% vs. 70.7, p=0.007) There was no significant difference in PGD, 30-day mortality and long-term survival between groups. In the subgroup analysis, early outcomes did not differ between low- and high-risk groups. However, the long-term survival was better in the low-risk group (p=0.01). CONCLUSIONS: The outcomes of MD group were not significantly different from non-MD group. Particularly, in low-risk recipient, the MD group showed excellent early and long-term outcomes. These results suggest the usability of selected MD hearts without increasing adverse events.

Oral anticoagulants and concurrent rifampin administration in tuberculosis patients with non-valvular atrial fibrillation.

BACKGROUND: Evidence and guidelines for Non-vitamin K antagonist oral anticoagulants (NOACs) use when prescribing concurrent rifampin for tuberculosis treatment in patients with non-valvular atrial fibrillation (NVAF) are limited. METHODS: Using the Korean National Health Insurance Service database from January 2009 to December 2018, we performed a population-based retrospective cohort study to assess the net adverse clinical events (NACE), a composite of ischemic stroke or systemic embolism and major bleeding, of NOACs compared with warfarin among NVAF patients taking concurrent rifampin administration for tuberculosis treatment. After a propensity matching score (PSM) analysis, Cox proportional hazards regression was performed in matched cohorts to investigate the clinical outcomes. RESULTS: Of the 735 consecutive patients selected, 465 (63.3%) received warfarin and 270 (36.7%) received NOACs. Among 254 pairs of patients after PSM, the crude incidence rate of NACE was 25.6 in NOAC group and 32.8 per 100 person-years in warfarin group. There was no significant difference between NOAC and warfarin use in NACE (hazard ratio [HR], 0.74; 95% confidence interval [CI], 0.48-1.14; P = 0.172). Major bleeding was the main driver of NACE, and NOAC use was associated with a statistically significantly lower risk of major bleeding than that with warfarin use (HR, 0.63; 95% CI, 0.40-1.00; P = 0.0499). CONCLUSIONS: In our population-based study, there was no statically significant difference in the occurrence of NACE between NOAC and warfarin use. NOAC use may be associated with a lower risk of major bleeding than that with warfarin use.

Clinical benefits and risks of anticoagulation therapy according to the degree of chronic kidney disease in patients with atrial fibrillation.

BACKGROUND: The clinical benefits and risks of anticoagulation therapy in patients with chronic kidney disease (CKD) are still inconclusive. We describe the outcomes of patients with atrial fibrillation (AF) after anticoagulation therapy according to differences in creatinine clearance (CrCl). We also aimed to determine the patients who could benefit from anticoagulation therapy. METHODS: This is a retrospective observational review of patients with AF who were managed at Asan Medical Center (Seoul, Korea) between January 1, 2006, and December 31, 2018. Patients were categorized into groups according to their baseline CrCl by Cockcroft-Gault equation and their outcomes were evaluated (CKD 1, ≥ 90 mL/min; CKD2, 60-89 mL/min; CKD3, 30-59 mL/min; CKD4, 15-29 mL/min; CKD 5, < 15 mL/min). The primary outcome was NACE (net adverse clinical events), defined as a composite of all-cause mortality, thromboembolic events, and major bleeding. RESULTS: We identified 12,714 consecutive patients with AF (mean 64.6 ± 11.9 years, 65.3% male, mean CHA2DS2-VASc score 2.4 ± 1.6 points) between 2006 and 2017. In patients receiving anticoagulation therapy (n = 4447, 35.0%), warfarin (N = 3768, 84.7%) was used more frequently than NOACs (N = 673, 15.3%). There was a higher 3-year rate of NACE with renal function deterioration (14.8%, 18.6%, 30.3%, 44.0%, and 48.8% for CKD stages 1-5, respectively).The clinical benefit of anticoagulation therapy was most prominent in patients with CKD 1 (hazard ratio [HR] 0.49, 95% confidence interval [CI] 0.37-0.67), 2 (HR 0.64 CI 0.54-0.76), and 3 (HR 0.64 CI 0.54-0.76), but not in CKD 4 (HR 0.86, CI 0.57-1.28) and 5 (HR 0.81, CI 0.47-1.40). Among patients with CKD, the benefit of anticoagulation therapy was only evident in those with a high risk of embolism (CHA2DS2-VASc score ≥ 4, HR 0.25, CI 0.08-0.80). CONCLUSION: Advanced CKD is associated with a higher risk of NACE. The clinical benefit of anticoagulation therapy was reduced with the increasing CKD stage.

Differences in clinical significance of bronchodilator responses measured by forced expiratory volume in 1 second and forced vital capacity.

BACKGROUND: The clinical implication of bronchodilator response (BDR) is not fully understood. However, BDR is frequently present in patients with chronic obstructive pulmonary disease (COPD). We identified the differences in clinical features regarding BDR. In addition, we divided BDR into BDR for forced expiratory volume in 1 s (FEV1) and BDR for forced vital capacity (FVC; i.e., BDR-FEV1 and BDR-FVC, respectively) and analyzed clinical significance. METHODS: We used data from the Korea COPD Subgroup Study, a multicenter cohort study of COPD patients recruited from 54 centers in South Korea since April 2012. We analyzed differences in baseline characteristics, 1-year exacerbation rate, and 3-year FEV1 decline between BDR negative and positive patients. Moreover, we analyzed the differences in clinical features between BDR-FEV1 positive and negative patients and between BDR-FVC positive and negative patients. RESULTS: Of the 2,181 patients enrolled in this study, 366 (16.8%) were BDR positive. BDR positive patients were more likely to be ever-smokers and to have a lower body mass index and higher symptom scores compared to BDR negative patients. Baseline FEV1 and FEV1/FVC were lower in the BDR positive compared to the BDR negative group (1.7 ± 0.6 and 1.6 ± 0.5, respectively, p < 0.01; 50.9 ± 12.1 and 46.5 ± 14.8, respectively, p < 0.01). BDR positive patients were more likely to have been diagnosed with asthma-COPD overlap and to receive inhaled corticosteroids (ICS) than BDR negative patients. BDR-FVC patients were more likely to be smokers, suffer from worse symptoms and have lower lung function than those with no BDR-FVC. BDR had no significant effect on 1-year moderate to severe or severe exacerbation rates or 3-year annual FEV1 decline. Interactive effects of ICS and BDR on the exacerbation rate were not significant in any group. CONCLUSIONS: In this study, BDR positive patients were more likely to be ever-smokers and to have worse symptoms and lung function than BDR negative patients. BDR-FVC was associated with worse symptom control and lung function compared to BDR-FEV1. However, there were no significant differences in exacerbation rate or decline in lung function in any BDR group. In addition, the effects of ICS on exacerbations were not significant in any group.

Diagnostic accuracy of a three-protein signature in women with suspicious breast lesions: a multicenter prospective trial.

BACKGROUND: Mammography screening has been proven to detect breast cancer at an early stage and reduce mortality; however, it has low accuracy in young women or women with dense breasts. Blood-based diagnostic tools may overcome the limitations of mammography. This study assessed the diagnostic performance of a three-protein signature in patients with suspicious breast lesions. FINDINGS: This trial (MAST; KCT0004847) was a prospective multicenter observational trial. Three-protein signature values were obtained using serum and plasma from women with suspicious lesions for breast malignancy before tumor biopsy. Additionally, blood samples from women who underwent clear or benign mammography were collected for the assays. Among 642 participants, the sensitivity, specificity, and overall accuracy values of the three-protein signature were 74.4%, 66.9%, and 70.6%, respectively, and the concordance index was 0.698 (95% CI 0.656, 0.739). The diagnostic performance was not affected by the demographic features, clinicopathologic characteristics, and co-morbidities of the participants. CONCLUSIONS: The present trial showed an accuracy of 70.6% for the three-protein signature. Considering the value of blood-based biomarkers for the early detection of breast malignancies, further evaluation of this proteomic assay is warranted in larger, population-level trials. This Multi-protein Assessment using Serum to deTermine breast lesion malignancy (MAST) was registered at the Clinical Research Information Service of Korea with the identification number of KCT0004847 ( https://cris.nih.go.kr ).