The association between proton-pump inhibitor use and recurrence of hepatocellular carcinoma after hepatectomy.

BACKGROUND AND AIM: The association between long-term proton-pump inhibitors (PPIs) use and malignancies had long been discussed, but it still lacks consensus. Our study investigated the association between PPI use and hepatocellular carcinoma (HCC) recurrence following curative surgery. METHODS: We retrospectively enrolled 6037 patients with HCC who underwent hepatectomy. Patients were divided into four groups according to their PPI usage. (non-users: < 28 cumulative defined daily dose [cDDD]; short-term users: 28-89 cDDD; mid-term users: 90-179 cDDD, and long-term users: ≥ 180 cDDD, respectively). Recurrence-free survival (RFS) and overall survival (OS) were analyzed using Kaplan-Meier method and Cox proportional hazard models. RESULTS: Among the 6037 HCC patients, 2043 (33.84%) were PPI users. PPI users demonstrated better median RFS (3.10 years, interquartile range [IQR] 1.49-5.01) compared with non-users (2.73 years, IQR 1.20-4.74; with an adjusted hazard ratio [aHR] of 0.57, 95% confidence interval [CI] 0.44-0.74, P < 0.001). When considering the cumulative dosage of PPI, only long-term PPI users had significant lower risk of HCC recurrence than non-PPI group (adj-HR: 0.50; 95% CI: 0.35-0.70; P < 0.001). Moreover, the impact of long-term PPIs use on improving RFS was significant in most of the subgroup analysis, except in patients with advanced tumor stages, with non-cirrhosis, or with a history of chronic kidney disease. However, there were no significant differences in median OS between PPI users and non-users (4.23 years, IQR 2.73-5.86 vs 4.04 years, IQR 2.51-5.82, P = 0.369). CONCLUSION: Long-term PPI use (≥ 180 cDDD) may be associated with a better RFS in HCC patients after hepatectomy.

Empagliflozin is associated with lower cardiovascular risk compared with dipeptidyl peptidase-4 inhibitors in adults with and without cardiovascular disease: EMPagliflozin compaRative effectIveness and SafEty (EMPRISE) study results from Europe and Asia.

BACKGROUND: Studies that have reported lower risk for cardiovascular outcomes in users of Sodium-Glucose Cotransporter-2 Inhibitors (SGLT-2i) are limited by residual cofounding and lack of information on prior cardiovascular disease (CVD). This study compared risk of cardiovascular events in patients within routine care settings in Europe and Asia with type 2 diabetes (T2D) initiating empagliflozin compared to dipeptidyl peptidase-4 inhibitors (DPP-4i) stratified by pre-existing CVD and history of heart failure (HF). METHODS AND RESULTS: Adults initiating empagliflozin and DPP-4i in 2014-2018/19 from 11 countries in Europe and Asia were compared using propensity score matching and Cox proportional hazards regression to assess differences in rates of primary outcomes: hospitalisation for heart failure (HHF), myocardial infarction (MI), stroke; and secondary outcomes: cardiovascular mortality (CVM), coronary revascularisation procedure, composite outcome including HHF or CVM, and 3-point major adverse cardiovascular events (MACE: MI, stroke and CVM). Country-specific results were meta-analysed and pooled hazard ratios (HR) with 95% confidence intervals (CI) from random-effects models are presented. In total, 85,244 empagliflozin/DPP4i PS-matched patient pairs were included with overall mean follow-up of 0.7 years. Among those with pre-existing CVD, lower risk was observed for HHF (HR 0.74; 95% CI 0.64-0.86), CVM (HR 0.55; 95% CI 0.38-0.80), HHF or CVM (HR 0.57; 95% CI 0.48-0.67) and stroke (HR 0.79; 95% CI 0.67-0.94) in patients initiating empagliflozin vs DPP-4i. Similar patterns were observed among patients without pre-existing CVD and those with and without pre-existing HF. CONCLUSION: These results from diverse patient populations in routine care settings across Europe and Asia demonstrate that initiation of empagliflozin compared to DPP-4i results in favourable cardioprotective effects regardless of pre-existing CVD or HF status.

Postoperative Sore Throat Helps Predict Swallowing Disturbance on Postoperative Day 30 of Anterior Cervical Spine Surgery: A Secondary Exploratory Analysis of a Randomized Clinical Trial of Tracheal Intubation Modes.

Nasotracheal intubation benefits dysphonia recovery after anterior cervical spine surgery (ACSS). The aim of the present study was to investigate the effect of tracheal intubation modes on post-ACSS swallowing function and identify factors associated with deglutition on postoperative day 30 (POD 30). Adult patients were randomized to receive either nasotracheal or orotracheal intubation during surgery. A numerical rating scale (NRS) was used to assess postoperative sore throat, and the Bazaz grading system was used to assess the severity of swallowing disturbance. The primary endpoints were the effect of tracheal intubation modes on postoperative sore throat and deglutition. Thereafter, we further elucidated the predictors of swallowing disturbance on POD 30. Postoperative sore throat and swallowing disturbance did not differ between the nasotracheal and orotracheal intubation groups. A secondary dataset analysis revealed that among 108 patients with complete follow-up until POD 30, 71 (65.7%) presented complete recovery without swallowing disturbance, whereas 37 (34.3%) presented varying degrees of swallowing disturbance. Receiver operating characteristic curve analysis indicated that the NRS score for sore throat predicted a swallowing disturbance-free status on POD 30. The optimal cutoff values were ≤ 4 and ≤ 2 on PODs 1 and 2, respectively. The adjusted odds ratio (OR) for independent predictors was a sore throat NRS score of ≤ 4 on POD 1 (OR 3.2; 95% CI 1.29-7.89; P = 0.012) and score of ≤ 2 on POD 2 (OR 6.67; 95% CI 2.41-18.47; P < 0.001). Therefore, tracheal intubation mode did not affect the incidence of post-ACSS swallowing disturbance, and the severity of sore throat on PODs 1 and 2 could predict a swallowing disturbance-free status on POD 30.The trial was registered at clinicaltrials.gov (Trial No. NCT03240042, date of registration 10/17/2017).

Practice and outcomes of airway management in patients with cervical orthoses.

BACKGROUND/PURPOSE: Increasing evidence indicates an association of video laryngoscopy with the success rate of airway management in patients with neck immobilization. Nevertheless, clinical practice protocols for tracheal intubation in patients immobilized using various types of cervical orthoses and the outcomes remain unclear. METHODS: We retrospectively assessed the tracheal intubation techniques selected for patients immobilized using cervical orthoses from 2015 to 2018. The endpoints were the intubation outcomes of the different techniques and the factors associated with the selection of the technique. RESULTS: We included 218 patients, 118 of whom wore halo vest braces (halo vest group) and 100 wore cervical collars (collar group). GlideScope video laryngoscopy (GVL) and fiberoptic bronchoscopy (FOB) were the initial intubation methods in 98 and 120 patients, respectively. GVL had a higher first-attempt success rate than did FOB in the collar group (p = 0.002) but not in the halo vest group (p = 0.522). GVL was associated with a lower risk of episodes of SaO2< 90% (adjusted relative risk [aRR], 0.11; 95% CI, 0.02-0.67; p = 0.016) and shorter intubation time (aRR, -3.52; 95% CI, -4.79∼-2.25; p < 0.001) in the collar group. However, in the halo vest group, more frequent requirement of a rescue technique (p = 0.002) and necessity of patient awakening (p = 0.001) was noted when GVL was used. Use of the halo vest brace and noting of severe cord compression were independent predictors of the initial selection of FOB. CONCLUSION: Caution should be exercised when using GVL for tracheal intubation in patients immobilized using halo vest braces.

Second victim: Malpractice disputes and quality of life among primary care physicians.

PURPOSE: The health of physicians can have a strong impact on the quality and safety of the health care they provide. Studies have shown a link between work stress, burnout, and depression. The aim of this study was to examine the association between malpractice dispute experiences and the well-being of physicians. METHODS: We conducted a cross-sectional survey to collect information about the malpractice experiences of primary care physicians in 2004. Data on sociodemographic and clinical characteristics and SF-36 measures were also collected. We used propensity score matching to estimate the association of medical malpractice experience with the general health, mental health, and vitality of physicians. RESULTS: Among the 1206 primary care physicians who completed the survey (response rate of 13.4%), 25.2% reported having ever experienced a malpractice dispute. After adjustment for baseline variables, physicians who had experienced a malpractice dispute had significantly worse health-related quality of life with regard to general health [-4.85; 95% confidence interval (CI), -7.61 to -1.80; P = 0.0016], mental health (-2.68; 95% CI, -5.03 to -0.34; P = 0.0252), and vitality (-3.28; 95% CI, -6.10 to -0.47; P = 0.0224). The effects were particularly strong among physicians specializing in surgery or obstetrics and gynecology. CONCLUSION: The results reveal that a malpractice dispute can have a long-term negative effect on the health of physicians. Harm reduction programs for physicians involved in malpractice disputes should be implemented.

Real-world cost-effectiveness of laparoscopy versus open colectomy for colon cancer: a nationwide population-based study.

BACKGROUND: Laparoscopic colectomy is increasingly being adopted for the treatment of colon cancer; however, the long-term effectiveness of this approach in a real-world clinical setting has yet to be verified. This study aims to compare the effectiveness and costs associated with laparoscopic and open colectomy from the perspective of the National Health Insurance (NHI) system in Taiwan. METHODS: A nationwide population-based colon cancer cohort was observed by linking the Taiwan Cancer Registry, claims data from NHI system, and the National Death Registry. Adult patients with Stage I to Stage III colon cancer who underwent primary cancer resection using either laparoscopy or open colectomy between 2009 and 2011 were included. A propensity score-matched cohort (1745 pairs) was applied to examine three clinical endpoints: overall survival, recurrence-free survival, and disease-free survival within 2 years after the operation. To comply with the perspective as well as the analytic horizon of the study, we limited the research to NHI claims from the study population for the corresponding time period. The health outcomes and net monetary benefits were verified by multivariate mixed-effect models. RESULTS: This analysis revealed that laparoscopy resulted in longer overall survival (adjusted difference 16.8 days, 95 % CI 7.3-26.2), recurrence-free survival (16.8 days, 5.0-28.6) and disease-free survival (26.4 days, 7.4-45.4), compared to open colectomy at 2 years post-op. Laparoscopy also led to a significantly shorter length of stay (3.2 days, 2.4-3.9) and lower index hospitalization costs (US$ 455, 181-729) than open colectomy; however, no differences in costs were observed over the long term. Overall, laparoscopy was more cost-effective than open colectomy under various willingness-to-pay thresholds in the setting of the Taiwan NHI. CONCLUSIONS: The continued adoption of laparoscopy in primary curable colon cancer resection is expected to reduce health care costs over the short term while providing considerable health benefits over the long term.

Comparing the effectiveness of capecitabine versus 5-fluorouracil/leucovorin therapy for elderly Taiwanese stage III colorectal cancer patients based on quality-of-life measures (QLQ-C30 and QLQ-CR38) and a new cost assessment tool.

BACKGROUND: Colorectal cancer (CRC) is a leading cause of cancer-related deaths in developed countries and its incidence increases with age. Intravenous administration of bolus 5-fluorouracil (5-FU) and leucovorin (LV) has been a standard treatment regime for stage III CRC. However, patients generally prefer oral therapy such as Capecitabine. Studies showed that combination of oxaliplatin and capecitabine demonstrated efficacy and safety on par with treatment involving various 5-FU/LV-based regimens in elderly patients as they are in younger ones. However, little is known regarding the cost of adjuvant therapy or the effect of therapy on HRQoL. Thus the aims of this study were to evaluate the influence of different adjuvant care for stage III CRC on the HRQoL of elderly patients and to compare the economic costs associated with capecitabine-based and 5-FU/LV-based adjuvant treatments from a societal perspective in Taiwan. METHODS: A prospective, open-label, observational, multicenter study involving 123 patients aged 70 and over from 11 different centers was conducted between July 2008 and July 2011 in Taiwan. The adjusted monthly costs per patient and HRQoL were evaluated from individual-level data. The HRQoL of patients was assessed before and after adjuvant treatment. Direct and indirect costs of adjuvant treatment were estimated from a number of sources, and QoL scores were compared between groups. RESULTS: After correcting for baseline characteristics of patients, no significant differences were observed in the global HRQoL scores between treatment groups during the study period. According to QLQ-CR38 results, capecitabine-based therapy appeared to alleviate problems related to defecation (4.54 vs. 8.5; P = 0.011); however, micturition problems increased (9.27 vs. 7.51; P = 0.04), compared with 5-FU/LV-based treatment. The adjusted monthly treatment cost per patient was NT$27,300 for capecitabine-based treatment and NT$53,671 for 5-FU/LV-based treatment. The total cost of 5-FU/LV-based treatment was 59 % greater than that of capecitabine-based treatment. CONCLUSIONS: Analyzing from the societal perspective in Taiwan, capecitabine-based therapy incurred lower treatment costs than 5-FU/LV-based therapy and did not jeopardize HRQoL. Therefore, capecitabine, with or without oxaliplatin, could be considered as an alternative treatment option for elderly patients with stage III CRC.

Health-related quality of life and cost comparison of adjuvant capecitabine versus 5-fluorouracil/leucovorin in stage III colorectal cancer patients.

PURPOSE: The purpose of this study was to compare health-related quality of life (HRQoL) and costs associated with 2 adjuvant chemotherapy regimens [capecitabine-based therapy versus 5-fluorouracil/leucovorin (5-FU/LV)-based therapy] in stage III colorectal cancer patients. METHODS: We conducted a prospective, open-label, observational, multicenter study from July 2008 to July 2011. The European Organization for Research and Treatment of Cancer QLQ-C30 and QLQ-CR38 questionnaires was used to assess HRQoL before, during, and after treatment. The direct and indirect costs of adjuvant treatment were estimated from a specially prepared questionnaire, the National Health Insurance Research Database, and other published sources. We used propensity scoring to match samples between groups and performed multivariate analyses to adjust for differences in patient demographics and clinical characteristics. RESULTS: A total of 497 patients were enrolled, and 356 completed the surveys. Following propensity score matching, 239 patients were included in the analysis (122 in the capecitabine-based group, 117 in the 5-FU/LV-based group). Global HRQoL scores did not differ significantly between the two groups. However, compared to patients in the 5-FU/LV-based group, patients in the capecitabine-based group had less nausea and vomiting (mid-term, P = 0.024; final, P = 0.013), appetite loss (mid-term, P < 0.0001; final, P = 0.001), and fewer side effects from chemotherapy (mid-term, P = 0.017). In addition, the monthly cost of capecitabine-based therapy was lower than those of 5-FU/LV-based therapy [NT$31,895.46 (US$1063.18) vs. NT$79,159.24 (US$2638.64) per patient]. CONCLUSIONS: Capecitabine is a reasonable alternative and cost-effective treatment option under current conditions for patients with stage III colorectal cancer.

Is a diabetes pay-for-performance program cost-effective under the National Health Insurance in Taiwan?

PURPOSE: In October 2001, a pay-for-performance (P4P) program for diabetes was implemented by the National Health Insurance (NHI), a single-payer program, in Taiwan. However, only limited information is available regarding the influence of this program on the patient's health-related quality of life. The aim of this study was to estimate the costs and consequences of enrolling patients in the P4P program from a single-payer perspective. METHODS: A retrospective observational study of 529 diabetic patients was conducted between 2004 and 2005. The data used in the study were obtained from the National Health Interview Survey (NHIS) in Taiwan. Direct cost data were obtained from NHI claims data, which were linked to respondents in the NHIS using scrambled individual identification. The generic SF36 health instrument was employed to measure the quality-of-life-related health status and transformed into a utility index. Patients enrolled in the P4P program for at least 3 months were categorized as the P4P group. Following propensity score matching, 260 patients were included in the study. Outcomes included life-years, quality-adjusted life-years (QALYs), diabetes-related medical costs, overall medical costs, and incremental cost-effectiveness ratios (ICERs). A single-payer perspective was assumed, and costs were expressed in US dollars. Nonparametric bootstrapping was conducted to estimate confidence intervals for cost-effectiveness ratios. RESULTS: Following matching, no significant difference was noted between two groups with regard to the patients' age, gender, education, family income, smoking status, BMI, or whether insulin was used. The P4P group had an increase of 0.08 (95 % CI 0.077-0.080) in QALYs, and the additional diabetes-related medical cost was US$422.74 (95 % CI US$413.58-US$435.05), yielding an ICER of US$5413.93 (95 % CI US$5226.83-US$5562.97) per QALY gained. CONCLUSIONS: Our results provides decision makers with valuable information regarding the impact of the P4P program of diabetes care through a direct comparison of equivalent groups of patients receiving regular care. Under the single-payer NHI system, the use of financial incentives under the DM-P4P program may be an effective means to ensure the quality of follow-up treatment.

Discrepancies Among Hospitals and Regions in the Provision of Low-Value Care.

BACKGROUND: Low-value care is a critical issue in terms of patient safety and fiscal policy; however, little has been known in Asia. For the purpose of better understanding the extent of low-value care on a national level, the utilization, costs and associated characteristics of selected international recommendations were assessed in this study. METHODS: This retrospective cohort study used the National Health Insurance claims data during 2013-2017 to evaluate the low-value care utilization. Adult beneficiaries who enrolled in the National Health Insurance program and received at least one of the low-value services in hospitals were included. We measured seven procedures derived from the international recommendations at the hospital level, and a composite measure was created by summing the total utilization of selected services to determine the overall prevalence and corresponding cost. The generalized estimating equation model was adopted to estimate the association. RESULTS: A total of 1,970,496 episodes of low-value care was identified among 1,218,146 beneficiary-year observations and 2,054 hospital-year observations. Overall, the utilization rate of the composite measure increased from 150.70 to 186.23 episodes per 10,000 beneficiaries with the growth in cost from US$5.40 to US$6.90 million. Low-value care utilization was proportional to the volume of outpatient visits and length of stay. Also, hospitals with a large volume of outpatient visits (aOR [95% CI], 2.10 [1.26 to 3.49] for Q2- Q3, 2.88 [1.45 to 5.75] for ≥Q3) and a higher proportion of older patients (aOR [95% CI], 1.06 [1.02 to 1.11]) were more likely to have high costs. CONCLUSION: The utilization and corresponding cost of low-value care appeared to increase annually despite the relatively lower prevalence compared to other countries. Multicomponent interventions such as recommendations, de-implementation policies and payment reforms are considered effective ways to reduce low-value care. Repeated measurements would be needed to evaluate the effectiveness of interventions.

Conventional and machine-learning based risk score for patients with early-stage hepatocellular carcinoma.

Background/Aims: The performance of machine-learning (ML) in predicting the outcomes of patients with hepatocellular carcinoma (HCC) remains uncertain. We aimed to develop risk scores using conventional methods and ML to categorize early-stage HCC patients into distinct prognostic groups. Methods: The study retrospectively enrolled 1411 consecutive treatment-naïve patients with the Barcelona Clinic Liver Cancer (BCLC) stage 0 to A HCC from 2012 to 2021. The patients were randomly divided into a training cohort (n=988) and validation cohort (n=423). Two risk scores (CATS-IF and CATS-INF) were developed to predict overall survival (OS) in the training cohort using the conventional methods (Cox proportional hazards model) and ML-based methods (LASSO Cox regression), respectively. They were then validated and compared in the validation cohort. Results: In the training cohort, factors for the CATS-IF score were selected by the conventional method, including age, curative treatment, single large HCC, serum creatinine and alpha-fetoprotein levels, fibrosis-4 score, lymphocyte-to-monocyte ratio, and albumin bilirubin grade. The CATS-INF score, determined by ML-based methods, included the above factors and two additional ones (aspartate aminotransferase and prognostic nutritional index). In the validation cohort, both CATS-IF score and CATS-INF score outperformed other modern prognostic scores in predicting OS, with the CATS-INF score having the lowest Akaike information criterion value. A calibration plot exhibited good correlation between predicted and observed outcomes for both scores. Conclusions: Both the conventional Cox-based CATS-IF score and ML-based CATS-INF score effectively stratified patients with early-stage HCC into distinct prognostic groups, with the CATS-INF score showing slightly superior performance.

Entecavir versus tenofovir on prognosis of hepatitis B virus-related hepatocellular carcinoma after curative hepatectomy.

BACKGROUND: There is still controversy about whether tenofovir disoproxil fumarate (TDF) and entecavir (ETV) have different effects on the outcomes of patients with hepatitis B virus (HBV)-related hepatocellular carcinoma (HCC). AIMS: The aim of this study was to compare the prognoses between ETV and TDF treatment among patients with HBV-related HCC after hepatectomy. METHODS: An analysis was done on data from the Taiwan Cancer Registry, which was linked to Taiwan National Health Insurance Research Database, for the years 2011-2016. We identified 7107 patients with HBV-related HCC after curative hepatectomy, and 25.3% of them used ETV or TDF after surgery. After propensity score overlap weighting, 1797 patients treated with ETV (n = 1365) or TDF (n = 432) were included for analyses. Cox proportional hazards models were used to compare the efficacy of ETV and TDF for recurrence and overall survival (OS). RESULTS: After hepatectomy, the recurrence rate per 100 person-years was 14.87 for the ETV group and 9.25 for the TDF group. The risk of recurrence was similar in the TDF group and the ETV group (HR [95% CI]: 0.91 [0.69-1.19; p = 0.479]), as was the risk of all-cause mortality (HR [95% CI]: 0.67 [0.42-1.07]; p = 0.091). When considering early recurrence (<2 years) and late recurrence (≧2 years), the TDF and ETV groups showed no significant differences. Subgroup analyses and sensitivity analyses demonstrated consistent results. CONCLUSION: Both TDF and ETV showed similar health benefits in terms of recurrence and OS in patients with HBV-related HCC patients after hepatectomy.

Empagliflozin is associated with lower risk of cardiovascular events and all-cause mortality in routine care in East Asia: Results from the EMPRISE study.

AIMS/INTRODUCTION: The EMPA-REG OUTCOME® trial demonstrated benefits of empagliflozin, a sodium-glucose cotransporter-2 inhibitor (SGLT2i), on cardiovascular, renal outcomes and all-cause mortality in patients with type 2 diabetes and established cardiovascular disease. The EMPRISE study program evaluates how these effects translate in a broad population of patients with type 2 diabetes in routine clinical care across countries. MATERIALS AND METHODS: The study included patients ≥18 years with type 2 diabetes initiating empagliflozin or any dipeptidyl peptidase-4 inhibitors (DPP-4i) from large administrative databases in Japan, South Korea, and Taiwan. Propensity score-matched (1:1) 'as-treated' analyses comparing the risk of cardiovascular outcomes and all-cause mortality between empagliflozin and DPP-4i use were performed in each country. Pooled hazard ratios (pHR) with 95% confidence intervals (CI) were computed using random effects meta-analysis models comparing both empagliflozin and SGLT2i with DPP-4i use, respectively. Intention-to-treat and subgroup analyses in patients with/without cardiovascular disease and in patients receiving 10 mg empagliflozin were performed. RESULTS: The study included 28,712 and 70,233 matched patient pairs for empagliflozin/DPP-4i and SGLT2i/DPP-4i analyses, respectively. The risk of composite outcomes including (i) hospitalization for heart failure (HHF) and all-cause mortality was lower with empagliflozin (pHR 0.76, 95% CI 0.67-0.86) and SGLT2i (0.71, 0.65-0.77); (ii) combined myocardial infarction, stroke, and all-cause mortality was also lower with empagliflozin (0.74, 0.61-0.88) and SGLT2i (0.69, 0.60-0.78) compared to DPP-4i. The intention-to-treat and three subgroup analyses were consistent with results of the main analyses. CONCLUSIONS: The results suggest that both empagliflozin and SGLT2i compared with DPP-4i are associated with a lower risk of cardiovascular events and all-cause mortality in routine clinical care in East Asia.

Cervical spine immobilization does not interfere with nasotracheal intubation performed using GlideScope videolaryngoscopy: a randomized equivalence trial.

GlideScope-assisted nasotracheal intubation (NTI) has been proposed as an alternative to difficult orotracheal intubation for critical patients or those under cervical immobilization. We evaluated the difficulty of performing NTI using GlideScope under cervical orthosis. A total of 170 patients scheduled for elective cervical spinal surgery that required NTI were randomized to receive cervical immobilization using a cervical collar (collar group) or no cervical immobilization at all (control group) before anesthetic induction (group assignment at 1:1 ratio). All NTI during anesthetic induction were performed using the GlideScope. The primary outcome was time to intubation. The secondary outcomes were ease of intubation, including the necessity of auxiliary manipulations to assist intubation, and the nasotracheal intubation difficulty scale (nasoIDS). An exploratory analysis identified morphometric parameters as predictors of time to intubation, the necessity of auxiliary manipulations, and a nasoIDS score ≥ 4. For time to intubation, the mean difference (collar group-control) was - 4.19 s, with a 95% confidence interval (CI) of - 13.9 to 5.52 that lay within our defined equivalence margin of 16 s. Multivariate regressions precluded the association of cervical immobilization with a necessity for auxiliary manipulations (adjusted odds ratio [aOR] 0.53, 95% CI [0.26-1.09], P = 0.083) and a nasoIDS ≥ 4 (aOR 0.94 [0.84-1.05], P = 0.280). Among all morphometric parameters, the upper lip bite test class was predictive of a longer time to intubation (all analyses relative to class 1, 14 s longer for class 2, P = 0.032; 24 s longer for class 3, P = 0.070), increased necessity for auxiliary manipulation (aOR 2.29 [1.06-4.94], P = 0.036 for class 2; aOR 6.12 [1.04-39.94], P = 0.045 for class 3), and nasoIDS ≥ 4 (aOR 1.46 [1.14-1.89], P = 0.003 for class 3).The present study demonstrated that GlideScope achieved NTI in patients with or without cervical immobilization equivalently with respect to intubation time and ease.

A Tapered Cuff Tracheal Tube Decreases the Need for Cuff Pressure Adjustment After Surgical Retraction During Anterior Cervical Spine Surgery: A Randomized Controlled, Double-Blind Trial.

Background: Surgical retraction to expose the vertebrae during anterior cervical spine surgery increases tracheal tube cuff pressure and may worsen postoperative sore throat and dysphonia. This randomized double-blind study investigated the effect of cuff shape on intraoperative cuff pressure and postoperative sore throat and dysphonia. Methods: Eighty patients were randomized to tracheal intubation with a tapered cuff or a conventional cylindrical high-volume low-pressure cuff (control) during anesthesia. Intraoperative cuff pressures were compared. The primary outcome was the incidence of pressure adjustment needed when the cuff pressure increased to > 25 mm Hg after surgical retraction. The secondary outcome was the incidence of postoperative sore throat and dysphonia. Results: The incidence of pressure adjustment after surgical retraction was significantly lower in the tapered group than in the control group (13% vs. 48%; P = 0.001; relative risk reduction, 74%). The median [interquartile range (IQR)] cuff pressure (mm Hg) was significantly lower for the tapered cuff than for the control cuff before surgical retraction [9 (7-12) vs. 12 (10-15); P < 0.001] and after retraction [18 (15-23) vs. 25 (18-31); P = 0.007]. The median (IQR) postoperative dysphonia score assessed by a single speech-language pathologist was lower in the tapered group than in the control group [4 (3-6) vs. 5.5 (5-7); P = 0.008]. Conclusion: A tapered cuff tracheal tube decreased the need for the adjustment of cuff pressure after surgical retraction during anterior cervical spine surgery, thereby avoiding intraoperative pressure increase. It also has a better outcome in terms of dysphonia. Clinical Trial Registration: [www.clinicaltrials.gov], identifier [NCT04591769].

Clinical outcomes and cumulative healthcare costs of TAVR vs. SAVR in Asia.

Objectives: This study compared transcatheter aortic valve replacement (TAVR) and surgical aortic valve replacement (SAVR) in terms of short- and long-term effectiveness. Methods: This retrospective cohort study based on nationwide National Health Insurance claims data and Cause of Death data focused on adult patients (n = 3,643) who received SAVR (79%) or TAVR (21%) between 2015 and 2019. Propensity score overlap weighting was applied to account for selection bias. Primary outcomes included all-cause mortality (ACM), hospitalization for heart failure, and a composite endpoint of major adverse cardiac events (MACE). Secondary outcomes included medical utilization, hospital stay, and total medical costs at index admission for the procedure and in various post-procedure periods. The Cox proportional-hazard model with competing risk was used to investigate survival and incidental health outcomes. Generalized estimation equation (GEE) models were used to estimate differences in the utilization of medical resources and overall costs. Results: After weighting, the mean age of the patients was 77.98 ± 5.86 years in the TAVR group and 77.98 ± 2.55 years in the SAVR group. More than half of the patients were female (53.94%). The incidence of negative outcomes was lower in the TAVR group than in the SAVR group, including 1-year ACM (11.39 vs. 17.98%) and 3-year ACM (15.77 vs. 23.85%). The risk of ACM was lower in the TAVR group (HR [95% CI]: 0.61 [0.44-0.84]; P = 0.002) as was the risk of CV death (HR [95% CI]: 0.47 [0.30-0.74]; P = 0.001) or MACE (HR [95% CI]: 0.66 [0.46-0.96]; P = 0.0274). Total medical costs were significantly higher in the TAVR group than in the SAVR in the first year after the procedure ($1,271.89 ± 4,048.36 vs. $887.20 ± 978.51; P = 0.0266); however, costs were similar in the second and third years after the procedure. The cumulative total medical costs after the procedure were significantly higher in the TAVR group than in the SAVR group (adjusted difference: $420.49 ± 176.48; P = 0.0172). Conclusion: In this real-world cohort of patients with aortic stenosis, TAVR proved superior to SAVR in terms of clinical outcomes and survival with comparable medical utilization after the procedure.

Healthcare resource utilization in patients treated with empagliflozin in East Asia.

AIMS/INTRODUCTION: We investigated the utilization of healthcare resources in patients with type 2 diabetes treated with empagliflozin, a sodium-glucose co-transporter-2 (SGLT2) inhibitor, versus dipeptidyl peptidase-4 (DPP-4) inhibitors in clinical practice in Japan, South Korea, and Taiwan. MATERIALS AND METHODS: We analyzed the Japanese Medical Data Vision database (December 2014-April 2018), the South Korean National Health Information Database, and the Taiwanese National Health Insurance claims database (both May 2016-December 2017). Patients with type 2 diabetes starting empagliflozin, 10 or 25 mg, or a DPP-4 inhibitor were matched 1:1 via propensity scores (PS). We compared inpatient care needs, emergency room (ER) visits, and outpatient visits between the treatment groups using Poisson regression and Cox proportional hazards models, pooled across countries by random-effects meta-analysis. RESULTS: We identified 28,712 pairs of PS-matched patients; the mean follow-up was 5.7-6.8 months. Empagliflozin-treated patients had a 27% lower risk of all-cause hospitalization compared with DPP-4 inhibitor-treated patients (rate ratio [RR] 0.73, 95% CI 0.67-0.79), and 23% reduced risk for first hospitalization (hazard ratio 0.77, 95% CI 0.73-0.81). The risk for an ER visit was 12% lower with empagliflozin than with DPP-4 inhibitors (RR 0.88, 95% CI 0.83-0.94) while the risk for outpatient visit was 4% lower (RR 0.96, 95% CI 0.96-0.97). These findings were generally consistent across countries, regardless of baseline cardiovascular disease, and in the subgroup starting empagliflozin with the 10 mg dose. CONCLUSIONS: Empagliflozin treatment was associated with lower inpatient care needs and other healthcare resource utilization than DPP-4 inhibitors in routine clinical practice in East Asia in this study.

Cardiovascular and renal effectiveness of empagliflozin in routine care in East Asia: Results from the EMPRISE East Asia study.

Aim: To evaluate the effectiveness of empagliflozin in clinical practice in East Asia in the Empagliflozin Comparative Effectiveness and Safety (EMPRISE) East Asia study. Materials and methods: Data were obtained from the Medical Data Vision database (Japan), National Health Insurance Service database (South Korea) and National Health Insurance database (Taiwan). Patients aged ≥ 18 years with type 2 diabetes initiating empagliflozin or a dipeptidyl peptidase-4 (DPP-4) inhibitor were 1:1 propensity score (PS) matched into sequentially built cohorts of new users naïve to both drug classes. This design reduces confounding due to switching treatments, time lag and immortal time biases. Outcomes included hospitalization for heart failure (HHF), end-stage renal disease (ESRD) and all-cause mortality. Hazard ratios (HRs) and 95% CIs were estimated using Cox proportional models, controlling for > 130 baseline characteristics in each data source and pooled by random-effects meta-analysis. Results: Overall, 28 712 pairs of PS-matched patients were identified with mean follow-up of 5.7-6.8 months. Compared with DPP-4 inhibitors, the risk of HHF was reduced by 18% and all-cause mortality was reduced by 36% with empagliflozin (HR 0.82; 95% CI 0.71-0.94, and HR 0.64; 95% CI 0.50-0.81, respectively). Reductions were consistent across countries, and in patients with and without baseline cardiovascular disease. ESRD was also significantly reduced with empagliflozin versus DPP-4 inhibitors (HR 0.37; 95% CI 0.24-0.58). Conclusions: Empagliflozin treatment was associated with reduced risk for HHF, all-cause mortality and ESRD compared with DPP-4 inhibitors in routine clinical practice in Japan, South Korea and Taiwan.

Effect of Tracheal Intubation Mode on Cuff Pressure During Retractor Splay and Dysphonia Recovery After Anterior Cervical Spine Surgery: A Randomized Clinical Trial.

MINI: This randomized clinical trial showed different intubation mode in anesthesia did not affect the increase of endotracheal cuff pressure caused by the retractor splay in anterior cervical spine surgery. However, nasotracheal intubation improved postoperative dysphonia recovery after anterior cervical spine surgery. STUDY DESIGN: Prospective, randomized, double-blinded trial. OBJECTIVE: The aim of this study was to investigate whether the mode of tracheal intubation affects intraoperative endotracheal tube cuff pressure on retractor splay and post-anterior cervical spine surgery (ACSS) voice outcome. SUMMARY OF BACKGROUND DATA: The combination of endotracheal tube (ETT) and cervical retractors has been implicated in recurrent laryngeal nerve compression and neuropraxia after ACSS. The asymmetric position of the oroETT within the larynx, as being fixed distally by the cuff and proximally by taping on one side of the mouth, may contribute to unilateral vocal palsy. METHODS: Adult patients undergoing ACSS were randomized to receive either nasotracheal or orotracheal intubation under anesthesia. The primary endpoint was the maximal endotracheal tube cuff pressure (ETCP) when the retractors were set up. After the maximal ETCPs were recorded, then ETCPs were controlled to less than 25 mmHg. Secondary endpoints were self-assessed hoarseness, pitch, and loudness of voice on postoperative days (PODs) 1, 2, 7, and 30. RESULTS: We equally allocated 110 patients to nasotracheal and orotracheal intubation. The maximal ETCP during retractor splay did not differ for both the means and distributions of pressure range. After the surgery, more patients in the nasotracheal intubation group reported none or mild change of voice than did the orotracheal intubation group on PODs 1 and 2, in terms of hoarseness, pitch, and loudness (P = 0.001, 0.001, and 0.005, respectively, on POD 1; P = 0.002, 0.003, and 0.011, respectively, on POD 2). Mixed model analysis demonstrated that patients with nasotracheal intubation had significantly lower dysphonia scores after surgery (estimate treatment effect: -1.62, P < 0.0001). Statistics was adjusted to exclude interaction with ETT sizes. CONCLUSION: The tracheal intubation modes did not affect ETCP during retractor splay. However, nasotracheal intubation had a beneficial effect on dysphonia recovery after ACSS. LEVEL OF EVIDENCE: 2.

Prospective, randomized, double-blinded trial. The aim of this study was to investigate whether the mode of tracheal intubation affects intraoperative endotracheal tube cuff pressure on retractor splay and post-anterior cervical spine surgery (ACSS) voice outcome. The combination of endotracheal tube (ETT) and cervical retractors has been implicated in recurrent laryngeal nerve compression and neuropraxia after ACSS. The asymmetric position of the oroETT within the larynx, as being fixed distally by the cuff and proximally by taping on one side of the mouth, may contribute to unilateral vocal palsy. Adult patients undergoing ACSS were randomized to receive either nasotracheal or orotracheal intubation under anesthesia. The primary endpoint was the maximal endotracheal tube cuff pressure (ETCP) when the retractors were set up. After the maximal ETCPs were recorded, then ETCPs were controlled to less than 25 mmHg. Secondary endpoints were self-assessed hoarseness, pitch, and loudness of voice on postoperative days (PODs) 1, 2, 7, and 30. We equally allocated 110 patients to nasotracheal and orotracheal intubation. The maximal ETCP during retractor splay did not differ for both the means and distributions of pressure range. After the surgery, more patients in the nasotracheal intubation group reported none or mild change of voice than did the orotracheal intubation group on PODs 1 and 2, in terms of hoarseness, pitch, and loudness (P = 0.001, 0.001, and 0.005, respectively, on POD 1; P = 0.002, 0.003, and 0.011, respectively, on POD 2). Mixed model analysis demonstrated that patients with nasotracheal intubation had significantly lower dysphonia scores after surgery (estimate treatment effect: −1.62, P < 0.0001). Statistics was adjusted to exclude interaction with ETT sizes. The tracheal intubation modes did not affect ETCP during retractor splay. However, nasotracheal intubation had a beneficial effect on dysphonia recovery after ACSS. Level of Evidence: 2.