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Objective: The risk of procedure-related complications and rhythm outcomes differ between men and women after atrial fibrillation catheter ablation (AFCA). We evaluated whether consistent sex differences existed in mapping and rhythm outcomes in repeat ablation procedures.Methods: Among 3282 patients in the registry, we analysed 443 consecutive patients (24.6% female, 58.5±10.3 years old, 61.5% with paroxysmal atrial fibrillation) who underwent a second AFCA. We compared the clinical factors, mapping, left atrial (LA) pressure, complications and long-term clinical recurrences after propensity score matching.Results: LA volume index (43.1±18.6 vs 35.8±11.6 mL/m2, p<0.001) was higher, but LA dimension (40.0±6.8 vs 41.6±6.3 mm, p=0.018), LA voltage (0.94±0.55 vs 1.20±0.68 mV, p=0.002) and pericardial fat volume (89.5±43.1 vs 122.1±53.9 cm3, p<0.001) were lower in women with repeat ablation than in their male counterparts. Pulmonary vein (PV) reconnections were lower (58.7% vs 74.9%, p=0.001), but the proportion of extra-PV triggers (27.5% vs 17.0%, p=0.026) and elevated LA pulse pressures (79.7% vs 63.7%, p=0.019) was significantly higher in women than in men. There was no significant sex difference in the rate of procedure-related complications (4.6% vs 4.2%, p=0.791). During a 31-month (8-60) median follow-up, clinical recurrences were significantly higher in women after both the de novo procedure (log-rank p=0.039, antiarrhythmic drug (AAD)-free log-rank p<0.001) and the second procedure (log-rank p=0.006, AAD-free log-rank p=0.093). Female sex (HR 1.51, 95% CI 1.06 to 2.15, p=0.023), non-paroxysmal atrial fibrillation (HR 1.78, 95% CI 1.30 to 2.34, p<0.010) and extra-PV triggers (HR 1.88, 95% CI 1.28 to 2.75, p=0.001) were independently associated with clinical recurrences after repeat procedures.Conclusions: During repeat AFCA procedures, PV reconnections were lower in women than in men, and the existence of extra-PV triggers and an LA pressure elevation were more significant, which resulted in poor rhythm outcomes.Trial Registration Number: NCT02138695. [ABSTRACT FROM AUTHOR]

Background and Purpose: Charcot-Marie-Tooth (CMT) disease is the most common hereditary peripheral neuropathy. CMT type 1A (CMT1A) accounts for approximately 50% of CMT patients and is linked to PMP22 gene duplication. Histone deacetylase-6 (HDAC6) has pleiotropic effects, such as regulating lipid homeostasis and cellular stress. Although HDAC6 has been regarded as a promising drug target for neurodegenerative diseases, its inhibition has not yet been tested in CMT1A. Here we have tested the therapeutic potential of CKD-504, a clinical stage HDAC6 inhibitor, in a mouse model of CMT1A EXPERIMENTAL APPROACH: The potency and selectivity of CKD-504 was evaluated, using a HDAC enzyme panel assay and western blots. The therapeutic potential of CKD-504 was evaluated using behavioural testing and electrophysiological assessments in the C22 mouse model of CMT1A. PMP22 protein expression and aggregation were analysed in mesenchymal stem cell-derived Schwann cells from CMT1A patients and sciatic nerves from C22 mice.Key Results: The HDAC6 inhibitor, CKD-504, modulated molecular chaperon proteins such as HSP90 and HSP70, which are involved in the folding/refolding of proteins such as PMP22. CKD-504 treatment restored myelination in both mesenchymal stem cell-derived Schwann cells from CMT1A patients and sciatic nerves of C22 mice and improved the axonal integrity of the sciatic nerve, leading to behavioural, electrophysiological, and histological improvements in C22 mice.Conclusion and Implications: A novel HDAC6 inhibitor, CKD-504, has potent therapeutic efficacy for CMT1A. [ABSTRACT FROM AUTHOR]

Background: Suicide is a major cause of death in many countries, and previous suicidal attempt is known to be the predictor of future suicide. Korea is considered one of the countries with the highest suicide rate among the Organisation for Economic Co-operation and Development (OECD) members for over a decade. We aimed to investigate the epidemiologic characteristics of hospitalised patients after suicidal acts in Korea.Methods: Data from the Korean National Hospital Discharge In-depth Injury Survey were analysed, and patients older than 9 years admitted to nationwide hospitals after suicidal acts from 2005 to 2016 were included. Their epidemiologic characteristics were explored, and we divided them into groups according to suicidal means (injury vs. poisoning) and treatment outcome (good vs. poor). The association of each characteristic with injury as suicidal means and with poor treatment outcome were explored.Results: The sample included 7609 patients (corresponding to 227,571 in national population). More patients were female than male, and most were in their 40s in both sexes. Hospitalisation rate peaked in patients older than 80 years for both sexes. Male and young patients aged 10-19 years and capital residents showed relatively higher odds of choosing injury as suicidal means. Males and patients aged 40-64 and ≥65 years showed relatively higher odds of poor treatment outcome.Limitations: Some suicide attempters were excluded from the survey such as those who did not visit a hospital after the suicide attempt.Conclusions: This epidemiologic feature of suicide attempters might serve as baseline data for preventive policies regarding suicide. [ABSTRACT FROM AUTHOR]

Background: We postulated that the use of robotics may improve outcomes in hiatal hernia repair.Methods: We performed a retrospective analysis of a prospectively collected Society of Thoracic Surgery database at a single institution of patients who underwent elective hiatal hernia repair from 2012 to 2017 using either laparoscopy or the da Vinci Xi robot. We compared patient characteristics and outcomes and then performed univariate and multivariate logistic regression modeling to determine the factors associated with postoperative morbidity.Results: There were 293 consecutive patients who underwent elective hiatal hernia repair using either a laparoscopic (n = 151) or a robotic (n = 142) technique. There were no significant differences in age, gender, BMI, smoking history, presence of comorbidity, or hiatal hernia type. Seventy percent of the cases were a repair of either type III or type IV hiatal hernia. There were significantly higher ASA III and IV (7.9% vs. 4.2%, P = 0.03), higher Toupet fundoplication (83.4% vs. 44.4%, P < 0.001), and lower redo-repair (7.3% vs. 20.4%, P = 0.001) in the laparoscopic group compared to the robotic group. The hospital length of stay was significantly shorter (1.3 ± 1.8 vs. 1.8 ± 1.5 days, P = 0.003) and there were significantly lower rates of complications (6.3 vs. 19.2%, P = 0.001) after robotic compared to laparoscopic hiatal hernia repair. There was no difference in readmission rate and mortality. Multiple logistic regression analysis showed that older age and laparoscopic technique were associated with higher complications after surgery.Conclusion: The use of the Da Vinci Xi robot in our institution was associated with improved outcomes compared to laparoscopic hiatal hernia repair despite a higher incidence of re-operative cases in the robotic group. Thus, short-term outcomes of Da Vinci Xi robot-assisted hiatal hernia repair are not inferior to laparoscopic hiatal hernia repair. Further studies are needed to determine if Da Vinci Xi robot provides superior short-term and long-term outcome in treatment of symptomatic hiatal hernia. [ABSTRACT FROM AUTHOR]

Background: Post-laparoscopic shoulder pain (PLSP) frequently follows a laparoscopic cholecystectomy. A proposed mechanism for PLSP is the irritation or injury of the phrenic nerve by the CO2 pneumoperitoneum during laparoscopic surgery. Here, we investigated whether a phrenic nerve block (PNB), performed under ultrasound guidance, could reduce the incidence and severity of PLSP after laparoscopic cholecystectomy.Method: Sixty patients were randomized into two groups, with one group receiving PNB with 4 ml (30 mg) of 0.75% ropivacaine (group P, n = 28) and a control group (group C, n = 32). The existence and severity of PLSP were assessed for 2 days postoperatively. A pulmonary function test (PFT) and diaphragmatic excursion test were performed pre- and postoperatively.Results: With ultrasound guidance, all PNBs were performed successfully in group P. In group P, the overall incidence and severity of PLSP decreased significantly. There were no significant differences in incisional pain, visceral pain, and analgesic requirements between the groups. Right-side diaphragmatic excursion decreased significantly in group P at 1 h postoperatively. The PFT results and respiratory discomfort assessed by a modified Borg's scale were not different significantly between the groups.Conclusion: Based on these findings, ultrasound-guided PNB can prevent or reduce the PLSP without clinically significant respiratory discomfort. [ABSTRACT FROM AUTHOR]

Background: Robotic modified radical neck dissection (MRND) using a gasless transaxillary approach has been reported to be a safe and meticulous technique in patients with papillary thyroid carcinoma (PTC) and lateral neck node metastasis (N1b). Few studies, however, have attempted to assess the long-term oncologic outcomes of robotic MRND in these patients. This study aimed to compare perioperative and 5-year oncologic outcomes of robotic MRND with conventional open procedures in patients with N1b PTC.Methods: Between September 2007 and February 2010, 193 patients with N1b PTC underwent total thyroidectomy and MRND by a single surgeon. Of these, 42 (21.8 %) underwent robotic procedures and 151 (78.2 %) underwent conventional open procedures. All patients received 3.7- to 5.5-GBq radioactive iodine (RAI) ablation, post-therapy whole-body scans (TxWBSs), and diagnostic WBS (DxWBSs) during follow-up. An exact 1:3 matching for age and stage was performed to minimize selection bias, and perioperative and 5-year oncologic outcomes were compared in the matched groups.Results: The mean follow-up period was 66.0 months (range 60-90 months). Number of retrieved cervical lymph nodes (LNs) (p = .102) and postoperative ablation success rates (p = .864) were similar between the two groups. TSH-suppressed serum Tg concentrations after 5 years (0.7 ± 1.5 vs. 2.4 ± 14.1 ng/ml; p = .471) and recurrence rates in the robotic and open groups (1/41 [2.4 %] vs. 3/102 [2.9 %]; p = .864) were similar for the 5-year follow-up period. Four patients experienced recurrence: Three exhibited regional lymph node metastasis, and one showed bilateral lung metastases.Conclusion: The perioperative and 5-year oncologic outcomes were similar after robotic and conventional open MRND. Large, prospective randomized controlled trials with long-term follow-up data are needed to validate these results. [ABSTRACT FROM AUTHOR]

Objective: To assess the efficacy of butterfly inlay cartilage tympanoplasty and compare it with conventional underlay cartilage tympanoplasty in terms of success rate and hearing outcomes.Materials and Methods: The study included 35 patients (36 ears) who underwent butterfly inlay cartilage tympanoplasty (inlay group, 23 ears of 22 patients) or conventional underlay cartilage tympanoplasty (underlay group, 13 ears). The anatomical success rate and hearing outcomes were analysed.Results: Re-perforation occurred in 2 cases (8.7%) in the inlay group and 3 (23.1%) in the underlay group. One patient in the inlay group developed a serious infection, and one in the underlay group developed massive granulation of the tympanic membrane. In the inlay group, the air-bone gap (ABG) decreased from 19.9 (±12.6) dB HL preoperatively to 13.8 (±11.3) dB HL postoperatively (p=0.047), in the underlay group, it decreased from 23.5 (±15.8) dB HL to 18.3 (±20.6) dB HL. Regarding improvement in ABG, the difference between the group was not statistically significant (p=0.968).Conclusion: Butterfly inlay cartilage tympanoplasty is comparable with conventional underlay cartilage tympanoplasty in both anatomic and audiological success rates. Owing to its simplicity, shorter operation time, and rapid patient recovery, butterfly inlay cartilage tympanoplasty could be considered a favourable surgical option. [ABSTRACT FROM AUTHOR]

Background: Three-dimensional (3D) imaging for laparoscopy was introduced to overcome the limitations of conventional two-dimensional (2D) imaging that lacked depth perception and spatial orientation. This study aimed to evaluate the effect of 3D imaging in laparoscopic colectomy with D3 lymphadenectomy for colon cancer.Methods: From February 2014 to October 2016, the prospective database of 278 consecutive patients with colon cancer was analyzed retrospectively; these patients underwent laparoscopic surgery with 2D (n = 111) and 3D (n = 167) imaging, with curative intent.Results: No difference was found in sex, body mass index, history of abdominal surgery, and American Society of Anesthesiologists grade between the 3D and 2D groups. The estimated blood loss was less in the 3D group than in the 2D group (50 mL [30-100 mL] versus 100 mL [50-100 mL], P < .001). The number of resected lymph nodes was higher in the 3D group (n = 47 [37.5-60] versus 41 [32-51.5], P = .001). However, a difference in operative time was not observed in both groups (150 minutes [125-175 minutes] versus 155 minutes [135-177.5 minutes], P = .186). Postoperative morbidity was similar in both groups (7.8% versus 8.1%, P = 1.000). Time to pass first flatus (3 days [2-4 days] versus 3 days [3-4 days], P = .746) and postoperative hospital stay (6 days [6-8 days] versus 6 days [6-7 days], P = .087) were also similar.Conclusions: This study shows that laparoscopic colectomy with D3 lymphadenectomy for colon cancer using 3D laparoscopic systems appears to be beneficial, with less blood loss, which should be addressed in prospective studies. [ABSTRACT FROM AUTHOR]

Background: Many studies advocate hormonal treatments including high-dose oral prednisolone as an effective treatment for epileptic spasms. However, little is known about the effects of intravenous methylprednisolone pulse therapy on infantile spasms. We investigated the short-term response to intravenous methylprednisolone pulse therapy for the treatment of infantile spasms.Methods: Patients with newly diagnosed infantile spasms and hypsarrhythmia on electroencephalography (EEG) at two tertiary centers in Korea were included. Patients received intravenous infusions of 30 mg/kg/day methylprednisolone for three days with tapering doses of oral prednisolone for two to four weeks for the treatment of infantile spasms. Response to methylprednisolone pulse therapy was evaluated by seizure frequency and follow-up EEG within three weeks.Results: Fourteen patients were sudied. The mean age at the onset of spasms was 7.0 months (range, 2.0 to 11.0 months). Etiological factors included structural abnormalities (N = 11), chromosomal anomaly (N = 1), and unknown (N = 2). Nine of 14 participants (64.3%) demonstrated complete freedom from spasm and resolution of hypsarrhythmia on EEG within 3 weeks; however, only five of nine responders (55.5%) remained free of spasms after the discontinuation of oral steroids. Adverse effects, including irritability or infection, were observed in four patients but were tolerable in all.Conclusions: Short-term methylprednisolone pulse therapy for the treatment of infantile spasms or hypsarrhythmia demonstrated rapid improvement in EEG and cessation of spasms without serious adverse effects. Further studies are needed to determine the long-term effects of spasm control. [ABSTRACT FROM AUTHOR]

Purpose: To explore the long-term functional outcomes of stroke patients with very mild severity at 6 months after stroke. Methods: This study presents the interim results of the Korean Stroke Cohort for Functioning and Rehabilitation. On day 7, stroke evaluation was performed using the functional assessment battery including the National Institute of Health Stroke Scale (NIHSS). At 6 months after stroke, functional outcomes using the face-to-face functional assessment battery including Functional Independence Measure (FIM) were analyzed in the patients who had a score of 0 on the NIHSS at 7 days after stroke onset. Results: In the very mild stroke group, 455 patients were followed up at 6 months. Out of these patients, 11.0% had impairments in cognitive function, 14.1% had motor impairment, and 2.1% had impairments in their mobility measured by the functional assessment battery. At 6 months after onset, 3.3% of stroke survivors without recurrence showed dependency according to the FIM. Conclusions: Many acute stroke patients with mild stroke severity as assessed by the NIHSS had impairments in various functional domains, and could have been easily overlooked for intensive rehabilitation therapy. Candidates for comprehensive rehabilitation therapy might be better identified by the functional assessment battery. Many acute stroke patients with mild stroke severity assessed by NIHSS could be easily overlooked for intensive rehabilitation therapy. Candidates for comprehensive rehabilitation therapy should be evaluated using a functional assessment battery rather than the NIHSS. [ABSTRACT FROM AUTHOR]

Background: This study aimed to evaluate the efficacy of a high dose of oral tegafur-uracil (400 mg/m2) plus leucovorin with preoperative chemoradiation of locally advanced rectal cancer and to explore the impact of polymorphisms of cytochrome P 2A6 (CYP2A6), uridine monophosphate synthetase (UMPS), and ATP-binding cassette B1 (ABCB1) on clinical outcome.Methods: Patients with cT3 or cT4 rectal cancer were enrolled and were given tegafur-uracil 400 mg/m2/day and leucovorin 90 mg/m2/day for 7 days a week during preoperative chemoradiation (50.4 Gy/28 fractions) in this phase II trial. Primary endpoint was pathologic complete response rate, and the secondary endpoint was to explore the association between clinical outcomes and genetic polymorphisms CYP2A6 (*4, *7, *9 and *10), UMPS G638C, and three ABCB1 genotypes (C1236T, C3435T, and G2677T).Results: Ninety-one patients were given study treatment, and 90 underwent surgery. Pathologic complete response was noted in 10 patients (11.1%). There was no grade 4 or 5 toxicity; 20 (22.0%) experienced grade 3 toxicities, including diarrhea (10, 11.0%), abdominal pain (2, 2.2%), and anemia (2, 2.2%). Relapse-free survival and overall survival at 5 years were 88.6% and 94.2%, respectively. Patients with the UMPS 638 CC genotype experienced significantly more frequent grade 2 or 3 diarrhea (p for trend = 0.018).Conclusions: Preoperative chemoradiation with tegafur-uracil 400 mg/m2/day with leucovorin was feasible, but did not meet the expected pathologic complete response rate. The UMPS 638 CC genotype might be a candidate biomarker predicting toxicity in patients receiving tegafur-uracil/leucovorin-based preoperative chemoradiation for locally advanced rectal cancer.Trial Registration: ISRCTN11812525 , registered on 25 July 2016. Retrospectively registered. [ABSTRACT FROM AUTHOR]

Identification of early clinical markers that predict later treatment outcomes in first-episode psychosis is highly valuable. The present study was conducted to determine the best time at which to predict the late treatment response in first-episode psychosis patients treated with paliperidone extended release (ER), the factors predicting early treatment responses (at Week 2 and Week 3) and the relationships between the paliperidone ER plasma concentrations at Week 2 and Week 3, and the treatment responses at Week 2, Week 3 and Week 8. Various criteria for assessing treatment response were employed. We determined the plasma paliperidone concentrations at Week 2 and Week 3, using validated high-performance liquid chromatography/tandem mass spectrometry (HPLC-MS/MS). The treatment response at Week 3 optimally predicted the later (Week 8) response, in terms of negative predictive value (NPV). Independent predictors for good treatment responses at Week 2 and Week 3 were: Female gender, a higher educational level, a higher Positive and Negative Syndrome Scale (PANSS) excited score, and/or a shorter duration of untreated psychosis (DUP). The plasma paliperidone concentration at Week 3, but not Week 2, was a significant predictor of the late treatment response at Week 8. These results may help appropriate clinical decision-making for early non-responders after having their first episode of psychosis. [ABSTRACT FROM AUTHOR]

Objectives: To compare outcomes and rates of optimal stent placement between optical coherence tomography (OCT) and intravascular ultrasound (IVUS) guided percutaneous coronary intervention (PCI).Background: Unlike IVUS-guided PCI, rates of clinical outcomes and optimal stent placement have not been well characterized for OCT-guided PCI.Methods: The study enrolled 290 patients who underwent implantation of a second generation drug eluting stent under OCT (122 patients) or IVUS (168 patients) guidance. The two groups were compared after adjusting for baseline differences using 1:1 propensity score matching (PSM) (114 patients in each group). Optimal stent placement was defined as achieving an adequate lumen (optimal minimum stent area [MSA > 4.85 mm(2) for OCT, >5 mm(2) for IVUS] or a final MSA ≥ 90% of the distal reference lumen area, without edge dissection, incomplete stent apposition, or tissue prolapse), or otherwise performing additional interventions to address suboptimal post-stenting OCT or IVUS findings. The primary endpoint was one-year cumulative incidence of major adverse cardiac events (MACE; cardiac death, myocardial infarction and target lesion revascularization). Definite or probable stent thrombosis (ST) rates were evaluated.Results: In adjusted comparisons between OCT and IVUS groups, there was no significant difference in rates of MACE (3.5% vs. 3.5%, P = 1.000) and ST (0% vs. 0.9%, P = 1.000) at 1 year, optimal stent placement (89.5% vs. 92.1%, P = 0.492), and further intervention (7.9% vs.13.2%, P = 0.234), despite OCT significantly more frequently detecting tissue prolapse (97.4% vs. 47.4%, P < 0.001), and numerically more edge dissection (10.5% vs. 4.4%, P = 0.078) or incomplete stent apposition (48.2% vs. 36.8%, P = 0.082).Conclusions: OCT guidance showed comparable results to IVUS in mid-term clinical outcomes, suggesting that OCT can be an alternative tool for stent placement optimization. [ABSTRACT FROM AUTHOR]

Background: Published studies on laparoscopic surgery for transverse colon cancer are scarce. More studies are necessary to evaluate the feasibility, safety, and long-term oncologic outcomes of laparoscopic surgery for transverse colon cancer.Subjects and Methods: From April 1996 to December 2010, 102 consecutive patients with stage II or III disease who had undergone curative resection for transverse colon cancer were enrolled. Seventy-nine patients underwent laparoscopy-assisted colectomy (LAC), whereas 23 patients underwent conventional open colectomy (OC). Short- and long-term outcomes of the two groups were compared.Results: The OC group had a larger tumor size (7.6 ± 3.4 cm versus 5.2 ± 2.3 cm, P = .004) and more retrieved lymph nodes (26.4 ± 11.6 versus 17.5 ± 9.4, P = .002), without differences in resection margins. In the LAC group, return to diet was faster (4.5 ± 1.2 days versus 5.4 ± 1.8 days, P = .013), and postoperative hospital stay was shorter (12.1 ± 4.2 days versus 15.9 ± 4.8 days, P = .000). There were no differences in occurrence of intra- or postoperative complications. There were no statistically significant differences in overall survival rate (OS) or disease-free survival rate (DFS) between the two groups (5-year OS, 90.4% versus 90.5%, P = .670; 5-year DFS, 84.2% versus 90.7%, P = .463).Conclusions: Laparoscopic surgery for transverse colon cancer has better short-term outcomes compared with open surgery, with acceptable long-term outcomes. As in colorectal cancer of other sites, laparoscopic surgery can be a feasible alternative to conventional surgery for transverse colon cancer. [ABSTRACT FROM AUTHOR]

Background: It is unclear whether the benefits of post-resuscitative percutaneous coronary intervention (PCI) are equally observed across out-of-hospital cardiac arrests (OHCAs) with different clinical presentations. The purpose of this study was to assess the effect of PCI in outcomes of OHCA and to compare patient prognosis by history of heart disease (HD) and presentations of nonshockable vs. shockable arrest rhythm by electrocardiogram (ECG).Methods: A population-based observational study was conducted on OHCAs of cardiac etiology in Korea who survived to admission between 2009 and 2013. Multivariable logistic regression analyses were conducted to assess the associations between PCI and outcomes (favorable neurological outcome and survival-to-discharge) and to test the interaction effects of PCI with history of HD and with presence of shockable rhythm.Results: A total of 9762 OHCAs were analyzed. PCI was done in 1140 (11.7%), and neurological recovery were observed in 45.7% of the PCI group and 13.3% of the untreated group. Effects of PCI on neurological recovery were observed similarly in patients with and without history of HD (OR=2.33 (1.62-3.35) and OR=2.37 (1.95-2.89), respectively). PCI was associated with survival-to-discharge only in patients without history of HD (OR=1.80 (1.51-2.15)). PCI was associated with neurological recovery and survival-to-discharge in both shockable and nonshockable rhythms, although the estimates were relatively higher in those with nonshockable rhythms (OR for neurological recovery=2.60 (2.04-3.32); and OR for survival=1.78 (1.46-2.17)).Conclusions: This study corroborates that PCI is an advantageous treatment option for all patients with OHCA regardless of established diagnosis with HD and presentations of shockable rhythm. [ABSTRACT FROM AUTHOR]

Background: This study evaluated the efficacy and safety of S-1 combined with docetaxel (SD) following doxorubicin plus cyclophosphamide (AC) as neoadjuvant therapy in patients with HER2-negative, stage II-III breast cancer.Methods: Patients received AC every 3 weeks for four cycles followed by S-1 (30 mg/m2 orally b.i.d. on days 1-14) and docetaxel (75 mg/m2 i.v. on day 1) every 3 weeks for four cycles. The primary endpoint was the pathological complete response (pCR) rate in breast and axillary lymph nodes.Results: The study included 49 patients with a median age of 43 years. The median breast tumor size was 4.0 cm by palpation. All patients were positive for involvement of axillary lymph node and five patients also had supraclavicular lymph node metastasis, which was confirmed by histological examination. In total, 85.4% of patients (41/49) completed eight cycles of therapy and 95.9% of patients (47/49) received curative surgery. The pCR rate was 22.5% (n = 11). The clinical response rate was 67.4%. During SD chemotherapy, the most frequent grade 3-4 toxicity was neutropenia (8.5% by cycle). There was a single treatment-related mortality from severe neutropenia. Grade 3 S-1 specific toxicities such as epigastric pain (12.2% by person), stomatitis (4.1% by person), and diarrhea (2.0% by person) were also observed. In particular, gastrointestinal discomfort led to dose reduction of S-1 in 45.8% of patients.Conclusions: Given all axillary lymph node positive diseases, neoadjuvant S-1 combined with docetaxel following AC showed a favorable anti-tumor activity but gastrointestinal discomfort should be carefully considered for future studies.Trial Registration: NCT00994968. [ABSTRACT FROM AUTHOR]

Abstract: Background: Nicotinic acid is an effective treatment for dyslipidemia. Patients are more tolerant of the extended-release form of nicotinic acid because it has a lower incidence of side effects, such as facial flushing, than the immediate-release formulation. Objective: This study was designed to evaluate the efficacy and tolerability of an experimental extended-release formulation of nicotinic acid in Korean adults with mixed dyslipidemia as a regulatory requirement to allow marketing of this product in Korea. Methods: This study was a multicenter, prospective, randomized, double-blind, and placebo-controlled trial. Patients with low high-density lipoprotein cholesterol (HDL-C) levels, high low-density lipoprotein cholesterol (LDL-C) levels, or high triglyceride levels were enrolled. Patients in the treatment group received 500 mg of extended-release niacin for 4 weeks and 1000 mg of extended-release niacin for the next 4 weeks. Results: Twenty-five patients (24% males; mean [SD] age, 57.4 [6.9] years) comprised the treatment group, and 22 patients (5% males; mean [SD] age 61.8 [8.3] years) comprised the placebo group. After 8 weeks of treatment, HDL-C levels were increased significantly in the treatment group (17.6% vs –1.7%, respectively, from 35 [7] mg/dL to 42 [11] mg/dL in the treatment group and from 38 [6] mg/dL to 36 [7] mg/dL in the placebo group; P < 0.001). LDL-C levels were decreased significantly in the treatment group (–11.4% vs 3.6%, respectively, from 147 [33] mg/dL to 126 [22] mg/dL in the treatment group and from 146 [31] mg/dL to 148 [26] mg/dL in the placebo group; P = 0.003). The incidence of drug-related adverse events, including facial flushing in the treatment group, was not significantly different from that in the placebo group. Conclusions: The tested extended-release formulation of nicotinic acid increased HDL-C levels significantly but decreased LDL-C levels with a low incidence of facial flushing in this small, select group of Korean adults with mixed dyslipidemia. [Copyright &y& Elsevier]

Gastric adenocarcinoma is the second leading cause of cancer death worldwide. In Western series, survival rates vary widely and are generally lower than those reported from Eastern series. We performed a retrospective analysis of cases operated on at the Johns Hopkins Hospital over the past 18 years and collected data on demographics, tumor characteristics, pathologic stage, treatment methods, complications, survival time, and other relevant factors. Survival according to stage of disease, Lauren tumor type, tumor location, time period, and administration of adjuvant therapy was analyzed, and results were compared with those of other Western series. During this period, 436 patients with gastric adenocarcinoma underwent resection. We have shown a statistically significant association between survival and margin status, stage of disease, and Lauren tumor type. Overall 5-year survival was 26%, and 5-year survival after R0 resection was 33%. No significant difference was detected between survival and tumor location, time period of treatment, or administration of adjuvant therapy. Analysis of various Western series reveals major differences between the cohorts under study, such as stage of disease, extent of resection, tumor type, and tumor location. Many of the reported differences among Western series may be due to cohort differences, such as stage of disease, extent of resection, tumor type, and tumor location. [Copyright &y& Elsevier]

Background: In patients with acute myocardial infarction receiving potent antiplatelet therapy, the bleeding risk remains high during the maintenance phase. We sought data on a uniform unguided de-escalation strategy of dual antiplatelet therapy (DAPT) from ticagrelor to clopidogrel after acute myocardial infarction.Methods: In this open-label, assessor-masked, multicentre, non-inferiority, randomised trial (TALOS-AMI), patients at 32 institutes in South Korea with acute myocardial infarction receiving aspirin and ticagrelor without major ischaemic or bleeding events during the first month after index percutaneous coronary intervention (PCI) were randomly assigned in a 1:1 ratio to a de-escalation (clopidogrel plus aspirin) or active control (ticagrelor plus aspirin) group. Unguided de-escalation without a loading dose of clopidogrel was adopted when switching from ticagrelor to clopidogrel. The primary endpoint was a composite of cardiovascular death, myocardial infarction, stroke, or bleeding type 2, 3, or 5 according to Bleeding Academic Research Consortium (BARC) criteria from 1 to 12 months. A non-inferiority test was done to assess the safety and efficacy of de-escalation DAPT compared with standard treatment. The hazard ratio (HR) for de-escalation versus active control group in a stratified Cox proportional hazards model was assessed for non-inferiority by means of an HR margin of 1·34, which equates to an absolute difference of 3·0% in the intention-to-treat population and, if significant, a superiority test was done subsequently. To ensure statistical robustness, additional analyses were also done in the per-protocol population. This trial is registered at ClinicalTrials.gov, NCT02018055.Findings: From Feb 26, 2014, to Dec 31, 2018, from 2901 patients screened, 2697 patients were randomly assigned: 1349 patients to de-escalation and 1348 to active control groups. At 12 months, the primary endpoints occurred in 59 (4·6%) in the de-escalation group and 104 (8·2%) patients in the active control group (pnon-inferiority<0·001; HR 0·55 [95% CI 0·40-0·76], psuperiority=0·0001). There was no significant difference in composite of cardiovascular death, myocardial infarction, or stroke between de-escalation (2·1%) and the active control group (3·1%; HR 0·69; 95% CI 0·42-1·14, p=0·15). Composite of BARC 2, 3, or 5 bleeding occurred less frequently in the de-escalation group (3·0% vs 5·6%, HR 0·52; 95% CI 0·35-0·77, p=0·0012).Interpretation: In stabilised patients with acute myocardial infarction after index PCI, a uniform unguided de-escalation strategy significantly reduced the risk of net clinical events up to 12 months, mainly by reducing the bleeding events.Funding: ChongKunDang Pharm, Medtronic, Abbott, and Boston Scientific. [ABSTRACT FROM AUTHOR]

Background: In cases of difficult bile duct cannulation, the use of wire-guided cannulation over a pancreatic stent (WGC-PS) or the double guidewire technique (DGT) may facilitate biliary cannulation. The aim of this study was to compare the outcomes of WGC-PS and DGT in patients with difficult biliary cannulation.Methods: We conducted a retrospective cohort study of all endoscopic retrograde cholangiopancreatographies (ERCPs) performed between July 2009 and November 2014 at a single tertiary referral center. WGC-PS or DGT was performed in patients for whom biliary cannulation was difficult and guidewire insertion into the pancreatic duct (PD) was inadvertently achieved while attempting the standard WGC technique. In those cases, we used the WGC-PS technique from July 2009 to January 2012 (WGC-PS group), and the DGT technique from February 2012 to November 2014 (DGT group). In the DGT group, WGC-PS was sequentially performed if successful biliary cannulation was not achieved during the DGT attempt. Consecutive patients who underwent DGT and/or WGC-PS with the aim of selective biliary cannulation were enrolled. The primary outcome parameter was the rate of initial successful biliary cannulation.Results: During the study period 3270 ERCPs were performed and a total of 177 patients were enrolled. The rate of initial successful cannulation was 66.7 % (60/90) in the WGC-PS group and 70.1 % (61/87) in the DGT group (P = 0.632). In 26 cases of failed DGT, WGC-PS was sequentially performed in the DGT group, and cannulation was successful in 14 of these patients. The rate of successful cannulation without the needle-knife precut technique was significantly higher in the DGT group compared with the WGC-PS group (75/87, 86.2 % vs. 60/90, 66.7 %, P = 0.003). The incidence of post-ERCP pancreatitis was 3.3 % (3/90) in the WGC-PS group and 10.3 % (9/87) in the DGT group (P = 0.077).Conclusions: In patients for whom biliary cannulation was difficult and PD access was inadvertently achieved while attempting the standard WGC technique, both WGC-PS and DGT were equally effective. Furthermore, the stepwise approach using DGT followed by WGC-PS as needed facilitated successful biliary cannulation and reduced the need for the needle-knife precut technique. [ABSTRACT FROM AUTHOR]

Objective: Although hemostatic gelatin sponge is a gelatin-based packing material with a powerful hemostatic effect, there were no studies in regard to its efficacy for packing material after septoplasty. The purpose of this study was to investigate the efficacy of hemostatic gelatin sponge nasal packing on patient's subjective symptoms, hemostasis, and wound healing following septoplasty.Subjects and Methods: Seventy six adult patients with nasal septum deviation requiring septoplasty were included. Following surgery, one nasal cavity was packed with hemostatic gelatin sponge and the other one with polyvinyl acetate. Patients' subjective symptoms while the packing was in situ, hemostatic properties, patients' pain on removal, degree of bleeding on removal of the packing, time for hemostasis after removal, postoperative wound healing, and the cost of the pack were evaluated.Results: Both packs were equally effective in the control of postoperative bleeding following septoplasty. However, hemostatic gelatin sponge packing was significantly more comfortable while in situ and less painful on removal of the pack. The polyvinyl acetate packing was associated with significantly more bleeding on removal, therefore much time was needed to control hemorrhage. There was no significant difference in the cost of the pack used and outcome of wound healing.Conclusion: The use of hemostatic gelatin sponge after septoplasty results in significantly less discomfort and greater patient satisfaction with no adverse reactions when compared with polyvinyl acetate packing. Therefore, hemostatic gelatin sponge may be a useful packing material after septoplasty. [ABSTRACT FROM AUTHOR]

Background: Real-world data on baseline characteristics, clinical practice, and outcomes of late presentation (12 to 48 h of symptom onset) in patients with ST-segment elevation myocardial infarction (STEMI) are limited.Objectives: This study aimed to investigate real-world features of STEMI late presenters in the contemporary percutaneous coronary intervention (PCI) era.Methods: Of 13,707 patients from the Korea Acute Myocardial Infarction Registry-National Institutes of Health database, 5,826 consecutive patients diagnosed with STEMI within 48 h of symptom onset during 2011 to 2015 were categorized as late (12 to 48 h; n = 624) or early (<12 h; n = 5,202) presenters. Coprimary outcomes were 180-day and 3-year all-cause mortality.Results: Late presenters had remarkably worse clinical outcomes than early presenters (180-day mortality: 10.7% vs. 6.8%; 3-year mortality: 16.2% vs. 10.6%; both log-rank p < 0.001), whereas presentation at ≥12 h of symptom onset was not independently associated with increased mortality after STEMI. The use of invasive interventional procedures abruptly decreased from the first (<12 h) to the second (12 to 24 h) 12-h interval of symptom-to-door time ("no primary PCI strategy" increased from 4.9% to 12.4%, and "no PCI" from 2.3% to 6.6%; both p < 0.001). Mortality rates abruptly increased from the first to the second 12-h interval of symptom-to-door time (from 6.8% to 11.2% for 180-day mortality; from 10.6% to 17.3% for 3-year mortality; all p < 0.05).Conclusions: Data from a nationwide prospective Korean registry reveal that inverse steep differences in the use of invasive interventional procedures and mortality rates were found between early and late presenters after STEMI. A multidisciplinary approach is required in identifying late presenters of STEMI who can benefit from invasive interventional procedures until further studied. [ABSTRACT FROM AUTHOR]

Background: The extent of coronary disease affects clinical outcomes and may predict the effectiveness of coronary revascularization with either coronary artery bypass graft (CABG) surgery or percutaneous coronary intervention (PCI). The SYNTAX (Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery) score quantifies the extent of coronary disease.Objectives: This study sought to determine whether SYNTAX scores predicted outcomes and the effectiveness of coronary revascularization compared with medical therapy in the BARI-2D (Bypass Angioplasty Revascularization Investigation 2 Diabetes) trial.Methods: Baseline SYNTAX scores were retrospectively calculated for BARI-2D patients without prior revascularization (N = 1,550) by angiographic laboratory investigators masked to patient characteristics and outcomes. The primary outcome was major cardiovascular events (a composite of death, myocardial infarction, and stroke) over 5 years.Results: A mid/high SYNTAX score (≥23) was associated with a higher risk of major cardiovascular events (hazard ratio: 1.36, confidence interval: 1.07 to 1.75, p = 0.01). Patients in the CABG stratum had significantly higher SYNTAX scores: 36% had mid/high SYNTAX scores compared with 13% in the PCI stratum (p < 0.001). Among patients with low SYNTAX scores (≤22), major cardiovascular events did not differ significantly between revascularization and medical therapy, either in the CABG stratum (26.1% vs. 29.9%, p = 0.41) or in the PCI stratum (17.8% vs. 19.2%, p = 0.84). Among patients with mid/high SYNTAX scores, however, major cardiovascular events were lower after revascularization than with medical therapy in the CABG stratum (15.3% vs. 30.3%, p = 0.02), but not in the PCI stratum (35.6% vs. 26.5%, p = 0.12).Conclusions: Among patients with diabetes and stable ischemic heart disease, higher SYNTAX scores predict higher rates of major cardiovascular events and were associated with more favorable outcomes of revascularization compared with medical therapy among patients suitable for CABG. (Bypass Angioplasty Revascularization Investigation in Type 2 Diabetes; NCT00006305). [ABSTRACT FROM AUTHOR]