5-year Cumulative Rate Research Articles

CML-105: A Validation of Vascular Adverse Events Risk Assessment Method for Japanese CML Patients with Tyrosine Kinase Inhibitors

Background and Aim Tyrosine kinase inhibitors (TKIs) have substantially improved the prognosis of chronic myeloid leukemia (CML). However, TKIs can cause serious vascular adverse events (VAEs) such as ischemic heart disease (IHD), peripheral artery occlusive disease (PAOD), cerebral infarction (CI), and pulmonary embolism (PE). The Framingham general cardiovascular risk scores (FRS), Suita score (SS), and SCORE (Systematic Coronary Risk Evaluation) system are commonly used to predict the incidence of cardiovascular events, but their usefulness as evaluation methods for patients with CML is unknown. We aimed to determine the appropriateness of these evaluation methods for a Japanese CML cohort. Methods We retrospectively surveyed patients with CML who visited our institute between January 2003 and March 2020. All patients were evaluated using the three risk assessment tools (FRS, SS, low-risk SCORE chart). To predict the 5-year event-free survival, we determined the cut-off values of each scoring system from the receiver operating characteristic analysis (ROC) curve. Results Sixty-nine patients with CML (38 males) were registered. Their median age was 66 years (range, 25–91years), and the median follow-up time was 48 months. Eight patients (2 males) had VAEs (3 IHD, 2 PAOD, 1 CI, 1 PE, and 1 sudden death). Four patients were treated with nilotinib, 2 with imatinib,1 with dasatinib, and 1 with bosutinib. The cut-off values obtained from the ROC curve for the SS and SCORE chart were 45 and 2, respectively. The sensitivity, specificity, and area under the curve (AUC) were 0.574, 0.875, and 0.713 for the SS and 0.689, 0.750, and 0.755 for the SCORE chart, respectively. We were unable to calculate the FRS because of the small number of men with thrombosis. However, the cut-off value was 11 points when limited to the female patients. The 5-year cumulative incidence rates of VTEs were 14.9% and 0% in patients with SS of ≥45 and Conclusion For this Japanese CML cohort, we propose that the SS and SCORE chart are valid evaluation methods for VAE assessment.

Features of extrahepatic metastasis after radiofrequency ablation for hepatocellular carcinoma.

BACKGROUNDExtrahepatic metastasis (EHM) of hepatocellular carcinoma (HCC) is associated with poor outcomes. However, the clinical features and risk factors of EHM of HCC after radiofrequency ablation (RFA) remain unclear.AIMTo elucidate the characteristics and risk factors of EHM after RFA for HCC.METHODSFrom January 2008 to December 2017, we retrospectively enrolled 661 patients who underwent RFA as first-line treatment for HCC at 2 tertiary hospitals. The inclusion criteria were age ≥ 18 years, a diagnosis of HCC, and treatment-naivety. Abdominal computed tomography (CT) or magnetic resonance imaging (MRI) and alpha-fetoprotein measurements were routinely performed at 1 mo after RFA and followed-up at intervals of 3-6 mo. Univariate analyses were performed using the chi-squared test or Student’s t-test, and univariate and multivariate analyses were performed via logistic regression, as appropriate.RESULTSEHM was diagnosed in 44 patients (6.7%) during a median follow-up period of 1204 days. The 10-year cumulative rate of HCC recurrence and EHM was 92.7% and 33.7%, respectively. Initial recurrence was most often intrahepatic, and the rate of extrahepatic recurrence at initial recurrence was only 1.2%. The median time to the diagnosis of EHM was 2.68 years, and 68.2% of patients developed EHM within 2 years of the first recurrence, regardless of recurrence-free survival and 75.0% of patients developed EHM within 5 years after first recurrence. EHM was mostly diagnosed via abdominal CT/MRI in 33 (75.0%) and 38 of 44 patients (86.4%) with EHM had either positive abdominal CT scan results or serum AFP level elevation. In multivariate analysis, recurrence-free survival < 2 years, ablation zone/tumor size < 2, and alpha-fetoprotein level > 400 IU/mL were associated with a high EHM risk.CONCLUSIONEHM occurs following multiple intrahepatic recurrences after RFA and combined contrast-enhanced abdominal CT and serum AFP were useful for surveillance. Patients especially with high-risk factors require close follow-up for EHM.

Quantifying the Impact of Axillary Surgery and Nodal Irradiation on Breast Cancer-Related Lymphedema and Local Tumor Control: Long-Term Results From a Prospective Screening Trial.

To independently evaluate the impact of axillary surgery type and regional lymph node radiation (RLNR) on breast cancer-related lymphedema (BCRL) rates in patients with breast cancer. From 2005 to 2018, 1,815 patients with invasive breast cancer were enrolled in a lymphedema screening trial. Patients were divided into the following 4 groups according to axillary surgery approach: sentinel lymph node biopsy (SLNB) alone, SLNB+RLNR, axillary lymph node dissection (ALND) alone, and ALND+RLNR. A perometer was used to objectively assess limb volume. All patients received baseline preoperative and follow-up measurements after treatment. Lymphedema was defined as a ≥ 10% relative increase in arm volume arising > 3 months postoperatively. The primary end point was the BCRL rate across the groups. Secondary end points were 5-year locoregional control and disease-free-survival. The cohort included 1,340 patients with SLNB alone, 121 with SLNB+RLNR, 91 with ALND alone, and 263 with ALND+RLNR. The overall median follow-up time after diagnosis was 52.7 months for the entire cohort. The 5-year cumulative incidence rates of BCRL were 30.1%, 24.9%, 10.7%, and 8.0% for ALND+RLNR, ALND alone, SLNB+RLNR, and SLNB alone, respectively. Multivariable Cox models adjusted for age, body mass index, surgery, and reconstruction type showed that the ALND-alone group had a significantly higher BCRL risk (hazard ratio [HR], 2.66; P = .02) compared with the SLNB+RLNR group. There was no significant difference in BCRL risk between the ALND+RLNR and ALND-alone groups (HR, 1.20; P = .49) and between the SLNB-alone and SLNB+RLNR groups (HR, 1.33; P = .44). The 5-year locoregional control rates were similar for the ALND+RLNR, ALND-alone, SLNB+RLNR, and SLNB-alone groups (2.8%, 3.8%, 0%, and 2.3%, respectively). Although RLNR adds to the risk of lymphedema, the main risk factor is the type of axillary surgery used.

Optimal breast reconstruction type for patients treated with neoadjuvant chemotherapy, mastectomy followed by radiation therapy.

To explore the optimal type of breast reconstruction and the time interval to postmastectomy radiotherapy (PMRT) associated with lower complications in breast cancer patients receiving neoadjuvant chemotherapy. We reviewed the medical records of 300 patients who received neoadjuvant chemotherapy, mastectomy with breast reconstruction and PMRT at our institution from 2000 to 2017. Reconstruction types included autologousflaps (AR), single-stage-direct-to-implant and two-stages expander/implant (TE/I). The primary endpoint was therate of reconstruction complications including infection, skin and fat necrosis. Subgroup analysis compared rates of capsular contracture, implant rupture, implant exposure and overall implant failure in single-stage-direct-to-implant to TE/I. The secondary endpoint was identifyingthe time interval between surgerywith immediate implant-based reconstruction and PMRT associated with lower probability of implant failure. Logistic regression models, Kaplan-Meier estimates and Polynomial regression were used to assess endpoints. The median follow-up was 43.5months. 29.3%, 28.3% and 42.4% of the cohort had AR, TE/I and single-stage-direct-to-implant D, respectively. The 5-year cumulative incidence rate of complications was 14.0%, 29.7% and 19.4% for AR, TE/I and single-stage-direct-to-implant, respectively (Log rank p = 0.02). Multivariate analysis showed significant association between TE/I and higher risk of infection (OR 8.1, p = 0.009) compared to AR, while single-stage-direct-to-implant and AR were comparable (OR 3.2, p = 0.2). On subgroup analysis, TE/I was significantly associated with higher rates of implant failure. The mean wait time to deliver PMRT after immediate reconstruction with no adjuvant chemotherapy was 8.4 and 10.7weeks in single-stage-direct-to-implant and TE/I, respectively (p < 0.005). Delivering PMRT after 8weeks of surgery yielded 10% probability of reconstruction failure in single-stage-direct-to-implant versus 40% in TE/I. In comparison to two stages reconstruction, single-stage-direct-to-implant following neoadjuvant chemotherapy has lower complications and offers timely delivery of PMRT.

Gamma Knife Radiosurgery for Trigeminal Neuralgia: Role of Trigeminal Length and Pontotrigeminal Angle on Target Definition and on Clinical Effects

Gamma Knife radiosurgery (GKRS) is a well-defined treatment for trigeminal neuralgia. The aim of this study was to determine how the GKRS planning might change on the basis of the patient's own anatomy and how to best choose the target location. Trigeminal cisternal length, pontotrigeminal angle, and distance between middle of the shot and emergence were evaluated in 112 consecutive GKRS plans for trigeminal neuralgia. Correlations with pain outcomes and facial hypoesthesia were analyzed. The mean angle was 29° ± 4.4° and 37° ± 0.9°, respectively, in patients developing and not developing severe hypoesthesia (P= 0.045), despite no significant difference on brainstem dose (11.9 ± 0.8 and 10.5 ± 0.3 Gy; P= 0.22). The length of the nerve was not relevant on clinical outcomes but the shot-emergence distance (mean 8.1 ± 0.2 mm) depended on both trigeminal length and angle (P= 0.01). At constant prescription dose, 6-month cumulative rates of pain relief and control without therapy were 52.9% when the shot-emergence distance was ≤8 mm, whereas 25% when this distance was >8 mm (P= 0.017). The maintenance of good pain control was more long lasting in the first group (49.5 ± 6.6 vs. 25.4 ± 5 months; P= 0.006) with a 5-year cumulative rate of 70% and 26%, respectively (P < 0.001). The pontotrigeminal angle and the shot-emergence distance should be considered during GKRS planning: the first as a potential risk factor for hypoesthesia, and the second should not exceed 8 mm.

Long-term outcome of endoscopic resection for intramucosal esophageal squamous cell cancer: a secondary analysis of the Japan Esophageal Cohort study.

Prospectively collected long-term data of patients undergoing endoscopic resection for superficial esophageal squamous cell carcinoma (ESCC) are limited. The aim of this study was to determine the prospectively collected long-term outcomes of endoscopic resection for ESCC as a secondary analysis of the Japan Esophageal Cohort (JEC) study. Patients who underwent endoscopic resection of intramucosal ESCC at 16 institutions between September 2005 and May 2010 were enrolled in the JEC study. All patients underwent endoscopic examination with iodine staining at 3 and 6 months after resection, and every 6 months thereafter. We investigated clinical courses after endoscopic resection, survival rates, and cumulative incidence of metachronous ESCC. 330 patients (mean age 67.0 years) with 396 lesions (mean size 20.4 mm) were included in the analysis. Lesions were diagnosed as high-grade intraepithelial neoplasia in 17.4 % and as squamous cell carcinoma in 82.6 % (limited to epithelium in 28.4 %, to lamina propria in 55.4 %, and to muscularis mucosa in 16.2 %). En bloc resection was achieved in 291 (73.5 %). The median follow-up period was 49.4 months. Local recurrences occurred in 13 patients (3.9 %) and were treated by endoscopic procedures. Lymph node metastasis occurred in two patients (0.6 %) after endoscopic resection. The 5-year overall, disease-specific, and metastasis-free survival rates were 95.1 %, 99.1 %, and 94.6 %, respectively. The 5-year cumulative incidence rate of metachronous ESCC was 25.7 %. Our study demonstrated that endoscopic resection is an effective treatment for intramucosal ESCC, with favorable long-term outcomes.

Postoperative Complications in Medicare Beneficiaries Following Endothelial Keratoplasty Surgery

To determine national-level incidence rates of major postoperative complications following endothelial keratoplasty (EK) procedures and to stratify these rates based on EK indications over an 8-year period using Medicare claims data. Retrospective, cohort study. Setting: population-based; study population: Medicare beneficiaries aged ≥65 years who underwent EK procedures; main outcome measurements: 1) occurrence of major postoperative complications (i.e., endophthalmitis, choroidal hemorrhage, infectious keratitis, cystoid macular edema [CME], retinal detachment [RD], or RD surgery) following EK surgery; 2) time-to-event analysis for glaucoma surgery; and 3) occurrence of graft complications. A total of 94,829 EK procedures (n= 71,040 unique patients) were included in the analysis. Of the total, 29% of patients had pre-existing glaucoma. The overall 90-day cumulative incidence of postoperative endophthalmitis and choroidal hemorrhage following EK was 0.03% and 0.05%, respectively. The overall 1-year cumulative rates of RD or RD surgery, infectious keratitis, and CME were 1.0%, 0.8%, and 4.1%, respectively. Approximately 7.6%, 12.2%, and 13.8% of all eyes in this study needed glaucoma surgery at 1-, 5-, and 8-years of follow-up, respectively. The probability of glaucoma surgery among patients with pre-existing glaucoma was 29% vs. 8% among those without pre-existing glaucoma at 8 years. The cumulative probabilities of developing any graft complications were 13%, 23.2%, and 27.1% at 1, 5, and 8 years, respectively, of follow-up. On average, patients undergoing EK procedures for a prior failed graft had the highest rate of complications, whereas those with Fuchs' corneal endothelial dystrophy had the lowest. The incidence of major postoperative complications including endophthalmitis, retinal detachment, and choroidal hemorrhage following EK procedures is low. A high proportion of eyes undergoing EK eventually require glaucoma surgery and experience graft-related complications. Postoperative outcomes are typically worse for patients undergoing EK for prior failed grafts than for those undergoing EK for Fuchs' corneal endothelial dystrophy.

Free-of-charge long-acting reversible contraception: two-year discontinuation, its risk factors, and reasons

Since 2013, the residents of the city of Vantaa, Finland, have been offered their first long-acting reversible contraceptive method (levonorgestrel-releasing intrauterine system, implant, and copper intrauterine device) free of charge. The primary aim of this study was to assess the 2-year cumulative discontinuation rates of long-acting reversible contraceptive methods when provided free of charge for first-time users in a real-world setting. Additional aims were to describe factors associated with discontinuation and to evaluate the reasons for discontinuation. This is a retrospective register-based cohort study of 2026 nonsterilized women aged 15 to 44 years, who initiated a free-of-charge long-acting contraceptive method in 2013-2014 in the city of Vantaa. Removals within 2 years after method initiation and reasons for discontinuation were obtained from electronic health records and from national registers. We calculated the 2-year cumulative incidence rates of discontinuation with 95% confidence intervals for each method. Furthermore, we assessed crude and adjusted incidence rate ratios of discontinuation with 95% confidence interval by Poisson regression models comparing implants and copper intrauterine device with levonorgestrel-releasing intrauterine systems. During the 2 -year follow-up, 514 women discontinued, yielding a cumulative discontinuation rate of 28.3 per 100 women-years (95% confidence interval, 26.2-30.4). Among the 1199 women who initiated the levonorgestrel-releasing intrauterine system, the cumulative discontinuation rate was 24.2 per 100 women-years (95% confidence interval, 21.7-26.9); among the 642 implant users, 33.3 per 100 women-years (95% confidence interval, 29.5-37.4); and among the 185 copper intrauterine device users, 37.8 per 100 women-years (95% confidence interval, 31.0-45.7). Compared with women aged 30 to 44 years, women aged 15 to 19 years (adjusted incidence rate ratio, 1.58; 95% confidence interval, 1.17-2.14) and 20 to 29 years (adjusted incidence rate ratio, 1.35; 95% confidence interval, 1.11-1.63) were more likely to discontinue. We observed a higher discontinuation rate in women who had given birth within the previous year (adjusted incidence rate ratio, 1.36; 95% confidence interval, 1.13-1.65), spoke a native language other than Finnish or Swedish (adjusted incidence rate ratio, 1.31; 95% confidence interval, 1.06-1.63), and had a history of a sexually transmitted infection (adjusted incidence rate ratio, 1.62; 95% confidence interval, 1.07-2.46). No association was found in marital status, overall parity, history of induced abortion, socioeconomic status, education level, or smoking status. The most common reason for discontinuation was bleeding disturbances, reported by 21% of women who discontinued the levonorgestrel-releasing intrauterine system, by 71% who discontinued the implant, and by 41% who discontinued the copper intrauterine device. One in 4 women who discontinued the copper intrauterine device reported heavy menstrual bleeding, whereas only 1% who discontinued the levonorgestrel-releasing intrauterine system and none who discontinued implants reported this reason. Abdominal pain was the reported reason for discontinuation in 20% of both intrauterine device users and in only 2% who discontinued implants. At 2 years, the use of implants and copper intrauterine devices was more likely to be discontinued than that of the levonorgestrel-releasing intrauterine system. Women younger than 30 years and those who gave birth in the preceding year, spoke a native language other than Finnish or Swedish, or had a history of sexually transmitted infections were more likely to discontinue. The levonorgestrel-releasing intrauterine system was least likely to be removed owing to bleeding disturbances.

INCIDENCE, PROGRESSION, AND RISK FACTORS OF EPIRETINAL MEMBRANES IN THE ELDERLY.

To determine the incidence, progression rate, and risk factors for epiretinal membranes (ERMs) in a population of French elderly subjects. Seven hundred and thirty-five eyes of 413 participants of the population-based ALIENOR study were included between 2009 and 2010. Participants were re-evaluated every 2 years between 2011 and 2017 (i.e., three follow-up visits). The mean duration of follow-up was 5.09 years (SD, 1.8; range, 0.99-7.85). Epiretinal membranes were graded from spectral-domain optical coherence tomography images according to a standardized classification. The incidence rate of ERMs was 9.42 per 100 eye-years (95% confidence interval, 7.36-12.05), corresponding to a 5-year cumulative incidence of 37.6%. In the final multivariable model, ERM incidence was significantly associated with vitreomacular or vitreopapillary adhesion at baseline (hazard ratio, 2.15; P = 0.02), choroidal thinning (hazard ratio, 1.04 per 10 μm decrease; P = 0.02), ERM in the contralateral eye (P = 0.02), and smoking after 85 years (hazard ratio, 6.01; P = 0.003). The 5-year cumulative progression rate was 6.9%. Incidence of ERMs was higher in our population than that previously reported, most probably because of the use of spectral-domain optical coherence tomography images. Incident ERMs were found to be associated with vitreous adhesion at baseline, choroidal thinning, ERM in the contralateral eye, and smoking after 85 years.

A Multicenter, International Collaborative Study for American Joint Committee on Cancer Staging of Retinoblastoma: Part II: Treatment Success and Globe Salvage

To evaluate the ability of the American Joint Committee on Cancer (AJCC) 8th edition to predict local tumor control and globe salvage for children with retinoblastoma (RB). International, multicenter, registry-based retrospective case series. A total of 2854 eyes of 2097 patients from 18 ophthalmic oncology centers from 13 countries over 6 continents. International, multicenter, registry-based data were pooled from patients enrolled between January 2001 and December 2013. All RB eyes with adequate records to allow tumor staging by the AJCC 8th edition criteria and follow-up to ascertain treatment outcomes were included. Globe-salvage rates were estimated by AJCC clinical (cTNMH) categories and tumor laterality. Local treatment failure was defined as use of enucleation or external beam radiation therapy (EBRT), with or without plaque brachytherapy or intra-arterial chemotherapy (IAC). Unilateral RB occurred in 1340 eyes (47%). Among the 2854 eyes, tumor categories were cT1 to cT4 in 696 eyes (24%), 1334 eyes (47%), 802 eyes (28%), and 22 eyes (1%), respectively. Of these, 1275 eyes (45%) were salvaged, and 1179 eyes (41%) and 400 eyes (14%) underwent primary and secondary enucleation, respectively. The 2- and 5-year Kaplan-Meier cumulative globe-salvage rates without the use of EBRT by cTNMH categories were 97% and 96% for category cT1a tumors, 94% and 88% for cT1b tumors, 68% and 60% for cT2a tumors, 66% and 57% for cT2b tumors, and 32% and 25% for cT3 tumors, respectively. Risk of local treatment failure increased with increasing cT category (P < 0.001). Cox proportional hazards regression analysis confirmed a higher risk of local treatment failure in categories cT1b (hazard ratio [HR], 3.5; P= 0.004), cT2a (HR, 15.1; P < 0.001), cT2b (HR, 16.4; P < 0.001), and cT3 (HR, 45.0; P < 0.001) compared with category cT1a. Use of plaque brachytherapy and IAC improved local tumor control in categories cT1a (P= 0.031) and cT1b (P < 0.001). Multicenter, international, internet-based data sharing validated the 8th edition AJCC RB staging to predict globe-salvage in a large, heterogeneous, real-world patient population with RB.

Incidence of rhegmatogenous retinal detachment after bag-in-the-lens IOL implantation: extended follow-up in a larger cohort of patients.

To report the incidence of rhegmatogenous retinal detachment (RRD) and associated risk factors after cataract surgery using the bag-in-the-lens (BIL) intraocular lens (IOL) implantation technique. Department of Ophthalmology, Antwerp University Hospital, Belgium. Prospective cohort study. All consecutive BIL IOL surgeries performed between January 2001 and December 2010 were included, with the exclusion of combined procedures and IOL exchanges. The incidence of RRD was reported first in the total cohort, then in a subgroup of patients with 1 year to 5 years of follow-up, and finally in the group remaining after exclusion of all risk factors, except gender. Risk factors associated with RRD were examined using multiple Cox regression analysis with a random intercept. Rhegmatogenous RD was diagnosed in 36 eyes (1.06%) of 3385 BIL cases, with a mean follow-up of 48.28 ± 40.05 months (range 0 to 195 months). The 2-year cumulative RRD incidence rate was 0.66% (17 cases in 1024 eyes; 0.00% in patients without risk factors). The 5-year cumulative RRD incidence rate was 1.17% (26 cases in 931 eyes; 0.15% without risk factors). Five risk factors were confirmed: male sex, age less than 60 years at the time of surgery, axial length 25.0 mm or greater, a history of contralateral RD, and intraoperative surgical complications. The incidence of RRD after BIL IOL implantation is comparable with that of lens-in-the-bag (LIB) implantation. This larger study provided a longer follow-up and suggested that RRD incidence is even lower than that previously reported. This study also confirmed intraoperative surgical complications as an additional risk factor for RRD development, as already described with LIB implantation.

Efficacy and Safety of Glandular Flap Techniques in Surgical Treatment of Large Ductal Carcinoma in situ

Background: It is well known that full segmentary resection can be performed using oncoplastic surgery (OPS) techniques, and the anatomic resection of the ductal system is possible. Therefore, the efficacy and safety of OPS should be investigated in the treatment of ductal carcinoma in situ (DCIS). Patients and Methods: Patients who were diagnosed as pure DCIS and underwent surgical treatment and follow-up were retrospectively evaluated. Patients who underwent OPS and conventional breast-conserving surgery (BCS) were included in the study. The number of patients who required an intervention after the surgery and had a relapse during the follow-up period was determined in both groups. Results: There were 45 patients in the OPS group and 138 patients in the BCS group. The mean tumor size was larger in patients in the OPS group (36 ± 12 mm vs. 24 ± 8 mm, p = 0.02). Six (12.7%) patients were reoperated in the OPS group. Of these, 4 were re-excisions and 2 were mastectomies. In this group, breast conservation was possible in 45 (95.7%) patients. Thirty-nine (27%) patients were reoperated in the BCS group. Of these, 23 were re-excisions, and 16 were mastectomies. In this group, breast conservation was possible in 126 (88.7%) patients (p = 0.02). There was no significant difference between the groups in terms of 5-year cumulative local recurrence rates. While the 5-year local recurrence-free survival rate was 93.3% in the OPS group, it was 90.8% in the BCS group. Conclusion: This study provided evidence that OPS can be used safely in the surgical treatment of DCIS by reducing re-excision and completion mastectomy rates compared to BCS.

PCV9 A 5-YEAR REAL WORLD PATIENT LEVEL ANALYSIS OF LOW-DOSE ASPIRIN PRIMARY PREVENTION BENEFIT AND RISK ANALYSIS BASED ON A MULTI-HOSPITAL EMR DATABASE

Recently, there are conflicting publications on the primary prevention benefits and risks of low dose aspirin therapy. The objective of this study was to evaluate the benefits and risks of low-dose aspirin (75-100mg/d) therapy in high-risk population based on a real world Electronic Medical Record (EMR) database. A retrospective database study research was conducted including individuals age ≥50 years-old and with the history of hypertension, and diabetes between 2000.01.01 to 2018.08.10 in Suvalue EMR Database. Study population was divided into two groups taking aspirin vs. not taking aspirin. And patients with prior cardiovascular and bleeding events were excluded. Our main outcomes were the occurrence of first serious vascular events (i.e., myocardial infarction, stroke or transient ischemic attack) and the first major bleeding events (i.e., intracranial haemorrhage or gastrointestinal bleeding) in 5-year follow-up period. To minimize confounding, aspirin group were matched based on nearest neighbour propensity score in a 1:1 ratio to non-aspirin group. A total of 2592 matched pair individuals were included in the study. The patient’s characteristics were well comparable between two study groups. We observed that the 5-year cumulative rate of serious vascular events was significantly lower in the aspirin group than in the non-aspirin group (3.8% vs. 9.7%; hazard ratio:0.34; P<0.001). Stroke occurred in 44 (3.4%) patients in the aspirin group versus 110 (8.5%) in the non-aspirin group (P<0·05). No statistically significant difference was found in the incidence of myocardial infarction and transient ischemic attack. On the risk side, no statistically significant difference was found in the incidence of major bleeding events between two groups (1.0% vs.1.0%; P=0.700). As primary prophylaxis, aspirin low dose therapy reduced the risks of incidence of serious vascular events and did not result in additional major bleeding events in individuals age ≥50 with the comorbidity of hypertension, diabetes.

Prototype single-balloon enteroscopy with passive bending and high force transmission improves depth of insertion in the small intestine.

Background/AimsWe retrospectively analyzed Crohn’s disease (CD) patients with small intestinal strictures who underwent single-balloon enteroscopy (SBE) to ascertain whether prototype SBEs with a passive bending mechanism and high force transmission insertion tube had better insertability in the small intestine than a conventional SBE.MethodsAmong 253 CD patients who underwent SBE, we identified 94 CD patients who had undergone attempted endoscopic balloon dilatation (EBD) for small intestinal stenosis for inclusion in this study. We analyzed whether the type of scope used for their initial procedure affected the cumulative surgery-free rate. For the insertability analysis, patients who underwent SBE at least twice were divided into 3 groups according to the type of scope used: conventional SBE only, prototype SBE only, and both conventional and prototype SBEs. For each group, depth of insertion, procedure time, and number of EBDs were compared in the same patient at different time points.ResultsThe success rate of EBD was 88.3%. The 5- and 10-year cumulative surgery-free rate was 75.7% and 72.8%, respectively. Cox regression analysis indicated that the factors contributing to surgery were long stricture (≥2 cm), EBD failure, and elevated Crohn’s Disease Activity Index, but not the type of scope used for EBD. The prototype SBEs significantly improved the depth of insertion (P=0.03, Wilcoxon’s signed-rank test).ConclusionsIn CD patients with small intestinal stenosis, the prototype SBEs with a passive bending mechanism and high force transmission insertion tube did not improve long-term EBD outcome but did improve deep insertability. (Clinical Trial Registration No. UMIN000037102)

Dasatinib vs. imatinib in patients with chronic myeloid leukemia in chronic phase (CML-CP) who have not achieved an optimal response to 3 months of imatinib therapy: the DASCERN randomized study

Early molecular response is associated with improved probability of deep molecular response and superior survival in patients with CML-CP. However, ~1 in 3 patients on first-line imatinib do not achieve this threshold. The phase 2b DASCERN trial (NCT01593254) assessed the outcome of early switch to dasatinib in patients with suboptimal response to first-line imatinib. Adult patients with CML-CP were randomized (2:1) to receive 100 mg dasatinib (n = 174) or continue imatinib at ≥400 mg (n = 86). The primary endpoint was the rate of major molecular response (MMR) at 12 months, which was 29% (dasatinib) and 13% (imatinib; P = 0.005). After ≥2 years of follow-up, 45 patients (52%) randomized to continue imatinib had crossed over to dasatinib. Considering treatment crossover, the 2-year cumulative MMR rate was 64% with dasatinib and 41% with imatinib (66% and 67%, respectively by intent-to-treat). Adverse events were consistent with the established safety profiles of both drugs. The results of this first prospective study support early monitoring of patients treated with first-line imatinib, and suggest that switching to dasatinib in cases of suboptimal response may offer clinical benefit. Further follow-up is needed to assess the long-term clinical benefit of early switching.

Clinical Efficacy of Mixing Natural Teeth and Implant Supported Denture Sleeve

Objective: To analyze the clinical efficacy of Mixing natural teeth and implant supported denture sleeve, and provide reference for clinical treatment. Methods: 46 patients with Molarless in hospital from December 2010 - December 2014 were selected, patients were randomly divided into observer group and control group, two groups of patients were designed and planted natural teeth fixed bridge and natural teeth and implants mixed support sleeve denture, regular follow patients and the surrounding alveolar bone height changes, 5-year cumulative retention rate, clinical efficiency and other indicators. Results: During clinical observation, patients with no obvious symptoms, the use of feel good, no loose superstructure situation. Two groups of patients were 2 cases of patients with implant loosening occurs, the amount of bone resorption annual observation group (0.22 ± 0.10) mm less than the control group (0.24 ± 0.08) mm, but no significant difference (P&gt; 0.05), clinical observation group efficiency (100%) was significantly higher (72.3%) (P &lt;0.05), the observation group study implants 5-year cumulative retention rate was 94.4%. Conclusion: Mixing natural teeth and implant - supported telescopic denture success rate of 100% was observed during the clinical results were satisfactory, with use value.

Predictive value of phase analysis of gated myocardial perfusion imaging for major adverse cardiac events in patients with coronary artery disease

Objective To evaluate the value of phase analysis of gated myocardial perfusion imaging (GMPI) in predicting major adverse cardiac events (MACE) in patients with coronary atherosclerotic heart disease. Methods Patients who underwent two-day rest-stress GMPI in the Department of Nuclear Medicine of Beijing Hospital from September 2012 to January 2014 were selected as observed subjects and analyzed retrospectively. The general clinical information, GMPI images and related parameters including phase standard deviation (PSD), phase histogram bandwidth (PBW), entropy, left ventricular ejection fraction (LVEF), summed stress score (SSS), peak ejection rate (PER), peak filling rate (PFR) were noted. Patients were followed up until the onset of MACE (cardiac death, nonfatal myocardial infarction, and late revascularization within 60 d after GMPI). χ2 test, independent-sample t test or Wilcoxon rank sum test were used to compare data between different groups. The independent risk factors of MACE were obtained by Cox proportional risk regression model. Kaplan-Meier survival curve analysis was used to analyze the cumulative survival rate without MACE. Results A total of 505 patients (235 males, 270 females, median age: 73 years) were followed up successfully, with a median follow-up period of 55.6(52.0, 60.5) months. There were 54 cases (10.7%) with MACE: 6 patients with cardiac death, 27 patients with non-fatal myocardial infarction, and 21 patients with late revascularization. The incidence of hypertension and hyperlipidemia in patients with MACE was significantly higher than that in patients without MACE (χ2 values: 4.126, 6.021, both P 80°), abnormal entropy(>58 J·mol-1·K-1) and SSS≥12 were independent risk factors for MACE (odds ratio(OR) values: 2.795(95% CI: 1.259-6.201), 3.213(95% CI: 1.468-7.029), 3.640 (95% CI: 1.999-6.628), all P 26.7°), abnormal PBW group and abnormal entropy group were 51.2%, 63.2% and 46.7%, which were significantly lower than those of normal PSD group (92.3%; χ2=77.768, P<0.05), normal PBW group (94.2%; χ2=77.741, P<0.05) and normal entropy group (92.8%; χ2=117.437, P<0.05). The 5-year cumulative MACE-free survival rate (31.7%) of patients with abnormal PBW and SSS≥12 was significantly lower than that of patients with normal PBW or patients with abnormal PBW and SSS<12 (80.1%-94.4%; χ2=185.4, P<0.01). The combination analysis of entropy and SSS showed similar results. Conclusions PBW and entropy obtained by GMPI phase analysis are independent risk factors for predicting MACE in coronary artery disease. GMPI phase analysis is useful for coronary artery disease risk stratification. Key words: Coronary artery disease; Prognosis; Myocardial perfusion imaging; Tomography, emission-computed, single-photon; Tomography, X-ray computed; Technetium Tc 99m sestamibi

Oncologic Outcomes of Nipple-sparing Mastectomy and Immediate Reconstruction After Neoadjuvant Chemotherapy for Breast Cancer.

To evaluate the oncologic outcomes and risk factors for locoregional recurrence (LRR) and nipple-areola complex recurrence (NR) in a large series of breast cancer patients who underwent nipple-sparing mastectomy (NSM) and immediate reconstruction after neoadjuvant chemotherapy (NACT). The use of NSM and immediate reconstruction in breast cancer patients receiving NACT is increasing. However, the oncologic safety of this approach is unclear. A total of 310 breast cancer patients (319 breasts) who underwent NACT and NSM between February 2010 and November 2016 were retrospectively analyzed. Clinical and pathologic factors associated with increased risks of LRR and NR were analyzed using univariate (Chi-square or Fisher exact test) and multivariate (Cox proportional hazard regression model) analyses. During a mean follow-up of 63 ± 22 months, 38 cases had LRR as the first event, including 6 cases of NR as the first event. The 5-year cumulative LRR and NR rates were 11.0% and 1.9%, respectively. In univariate analysis, clinical T stage, pathologic nodal status, histologic grade, lymphovascular invasion, and post-NACT Ki67 status were associated with increased LRR risk, and post-NACT Ki67 status was the only significant risk factor for NR. In multivariate analysis, post-NACT Ki67 ≥10% (hazard ratio, 4.245; 95% confidence interval, 1.865-9.663; P = 0.001) was an independent risk factor for LRR. NSM and immediate reconstruction seem to be oncologically safe with acceptable LRR and NR rates for appropriately selected breast cancer patients treated with NACT. Post-NACT Ki67 ≥10% was associated with increased risk of LRR or NR, and therefore, necessitates cautious follow-up.

Fate of contralateral asymptomatic bullae in patients with primary spontaneous pneumothorax.

This retrospective cohort study aimed to analyse the impact of asymptomatic blebs/bullae on the occurrence of primary spontaneous pneumothorax (PSP) by monitoring the natural course of contralateral blebs/bullae in patients with ipsilateral pneumothorax. From January 2003 to December 2017, 1055 patients [age 19.6 ± 3.98 years (mean ± standard deviation), 953 men] experiencing the first episode of unilateral PSP were enrolled in this study, excluding patients aged 30 years or more. The presence, number and maximal size of the blebs/bullae were investigated in contralateral asymptomatic lungs based on high-resolution computed tomography. Multiple and single blebs/bullae were noted in contralateral lungs in 425 (40.3%) and 88 (8.3%) patients, respectively. The median follow-up period was 44.0 (interquartile range 71.5) months. The 1-, 3- and 5-year cumulative occurrence rates of PSP in contralateral lungs were 7.9%, 13.7% and 16.7%, respectively. On multivariable analysis, younger age [hazard ratio (HR) 1.19, 95% confidence interval (CI) 1.12-1.27; P < 0.001) and multiple bullae (HR 4.42, 95% CI 3.06-6.38; P < 0.001) were independent risk factors for spontaneous pneumothorax in the contralateral lung. The 5-year cumulative occurrence rates of PSP were significantly higher in patients with multiple blebs/bullae than in those with no or a single bleb/bulla (28.2% vs 8.5%, respectively; P < 0.001). Asymptomatic blebs/bullae often lead to PSP. If the patient is eligible for surgery for pneumothorax, preemptive surgery for contralateral bullae could be considered, especially in patients with multiple blebs/bullae.

Long-Term Observation of Post Copings Retaining Overdenture Prostheses.

To investigate the long-term (up to 20 years) outcomes of customized post copings (PC) and to evaluate potential factors influencing the risk for complications. Patients treated with PC-retained overdenture prostheses (OD) in a university setting were selected. Data collected included dental and periodontal parameters, periapical radiographs, and assessment of the OD design. Patient-reported satisfaction levels were evaluated using visual analog scales (VAS), and 20-year cumulative survival and success rates were calculated. A total of 73 patients with 81 ODs and 152 PCs were included. PC survival rate was 80.9%, and the success rate amounted to 64.5% after a mean observation period of 105.4 (± 67.9; range: 6 to 240) months. The 5-year cumulative PC rates were 91.5% for survival and 79.3% for success. Activation of matrices was more frequent with ball attachments than with cylindrical retention (odds ratio [OR] 0.43; 95% confidence interval [CI] 0.2 to 0.94; P = .034). Cylindrical retention was rated significantly better at 96% (interquartile range [IQR] 89.5% to 100%) compared to ball attachment at 88% (IQR 79% to 98.2%; P = .012). The risk for PC complications was higher for OD designs with coverage of the periodontal tissues compared to open designs (OR 0.34; 95% CI 0.15 to 0.78; P = .010). Customized PCs on natural abutment teeth for the retention of ODs are a valid treatment in partially dentate patients. Correct prosthesis design and integration into a regular dental hygiene program are mandatory factors for long-term success.