Background and Objectives: Evidence regarding the efficacy and safety of intracardiac echocardiography (ICE) for guidance during transcatheter aortic valve replacement (TAVR) is limited. This study aimed to compare the clinical efficacy and safety of ICE versus transesophageal echocardiography (TEE) for guiding TAVR. Methods: This prospective cohort study included patients who underwent TAVR from August 18, 2015, to June 31, 2021. Eligible patients were stratified by echocardiographic modality (ICE or TEE) and anesthesia mode (monitored anesthesia care [MAC] or general anesthesia [GA]). Primary outcome was the 1-year composite of all-cause mortality, rehospitalization for cardiovascular cause, or stroke, according to the Valve Academic Research Consortium-3 (VARC-3) definition. Propensity score matching was performed, and study outcomes were analyzed for the matched cohorts. Results: Of the 359 eligible patients, 120 patients were matched for the ICE-MAC and TEEGA groups, respectively. The incidence of primary outcome was similar between matched groups (18.3% vs. 20.0%; adjusted hazard ratio, 0.94; 95% confidence interval [CI], 0.53– 1.68; p=0.843). ICE-MAC and TEE-GA also had similar incidences of moderate-to-severe paravalvular regurgitation (PVR) (4.2% vs. 5.0%; adjusted odds ratio, 0.83; 95% CI, 0.23– 2.82; p=0.758), new permanent pacemaker implantation, and VARC-3 types 2–4 bleeding. Conclusions ICE was comparable to TEE for guidance during TAVR for the composite clinical efficacy outcome, with similar incidences of moderate-to-severe PVR, new permanent pacemaker implantation, and major bleeding. These results suggest that ICE could be a safe and effective alternative echocardiographic modality to TEE for guiding TAVR.

BACKGROUND: A prolonged-release formulation of oxycodone/naloxone has been shown to be effective in European populations for the management of chronic moderate to severe pain. However, no clinical data exist for its use in Korean patients. The objective of this study was to assess efficacy and safety of prolonged-release oxycodone/naloxone in Korean patients for management of chronic moderate-to-severe pain. METHODS: In this multicenter, single-arm, open-label, phase IV study, Korean adults with moderate-to-severe spinal disorder-related pain that was not satisfactorily controlled with weak opioids and nonsteroidal anti-inflammatory drugs received prolonged-release oral oxycodone/naloxone at a starting dose of 10/5 mg/day (maximum 80/40 mg/day) for 8 weeks. Changes in pain intensity and quality of life (QoL) were measured using a numeric rating scale (NRS, 0–10) and the Korean-language EuroQol-five dimensions questionnaire, respectively. RESULTS: Among 209 patients assessed for efficacy, the mean NRS pain score was reduced by 25.9% between baseline and week 8 of treatment (p < 0.0001). There was also a significant improvement in QoL from baseline to week 8 (p < 0.0001). The incidence of adverse drug reactions was 27.7%, the most common being nausea, constipation, and dizziness; 77.9% of these adverse drug reactions had resolved or were resolving at the end of the study. CONCLUSIONS: Prolonged-release oxycodone/naloxone provided significant and clinically relevant reductions in pain intensity and improved QoL in Korean patients with chronic spinal disorders. (ClinicalTrials.gov identifier: NCT01811238)
Adult ; Analgesia ; Analgesics, Opioid ; Chronic Pain* ; Constipation ; Dizziness ; Drug-Related Side Effects and Adverse Reactions ; Humans ; Incidence ; Nausea ; Quality of Life ; Spine

STUDY DESIGN: Retrospective patient data collection and investigator survey. PURPOSE: To investigate patterns of opioid treatment for pain caused by spinal disorders in Korea. OVERVIEW OF LITERATURE: Opioid analgesic prescription and adequacy of consumption measures in Korea have markedly increased in the past decade, suggesting changing patterns in pain management practice; however, there is lack of integrated data specific to Korean population. METHODS: Patient data were collected from medical records at 34 university hospitals in Korea. Outpatients receiving opioids for pain caused by spinal disorders were included in the study. Treatment patterns, including opioid types, doses, treatment duration, outcomes, and adverse drug reactions (ADRs), were evaluated. Investigators were interviewed on their perceptions of opioid use for spinal disorders. RESULTS: Among 2,468 analyzed cases, spinal stenosis (42.8%) was the most common presentation, followed by disc herniation (24.2%) and vertebral fracture (17.5%). In addition, a greater proportion of patients experienced severe pain (73.9%) rather than moderate (19.9%) or mild (0.7%) pain. Oxycodone (51.9%) and fentanyl (50.8%) were the most frequently prescribed opioids; most patients were prescribed relatively low doses. The median duration of opioid treatment was 84 days. Pain relief was superior in patients with longer treatment duration (≥2 months) or with nociceptive pain than in those with shorter treatment duration or with neuropathic or mixed-type pain. ADRs were observed in 8.6% of cases. According to the investigators' survey, "excellent analgesic effect" was a perceived advantage of opioids, while safety concerns were a disadvantage. CONCLUSIONS: Opioid usage patterns in patients with spinal disorders are in alignment with international guidelines for spinal pain management. Future prospective studies may address the suitability of opioids for spinal pain treatment by using appropriate objective measurement tools.
Analgesics, Opioid ; Chronic Pain ; Data Collection ; Drug-Related Side Effects and Adverse Reactions ; Fentanyl ; Hospitals, University ; Humans ; Korea* ; Medical Records ; Nociceptive Pain ; Outpatients ; Oxycodone ; Pain Management ; Prescriptions ; Prospective Studies ; Research Personnel ; Retrospective Studies* ; Spinal Diseases ; Spinal Stenosis ; Spine

OBJECTIVE: To evaluate the prevalence of known risk factors for contrast-induced nephropathy (CIN) and their association with the actual occurrence of CIN in patients undergoing intravenous contrast-enhanced computed tomography (CECT) in Korea. MATERIALS AND METHODS: Patients who underwent CECT in 2008 were identified in the electronic medical records of 16 tertiary hospitals of Korea. Data on demographics, comorbidities, prescriptions and laboratory test results of patients were collected following a standard data extraction protocol. The baseline renal function was assessed using the estimated glomerular filtration rate (eGFR). We identified the prevalence of risk factors along the eGFR strata and evaluated their influence on the incidence of CIN, defined as a 0.5 mg/dL or 25% increase in serum creatinine after CECT. RESULTS: Of 432425 CECT examinations in 272136 patients, 140838 examinations in 101487 patients met the eligibility criteria for analysis. The mean age of the participants was 57.9 +/- 15.5 years; 25.1% of the patients were older than 70 years. The prevalence of diabetes mellitus was 11.9%, of hypertension 13.7%, of gout 0.55% and of heart failure was 1.7%. Preventive measures were used in 40238 CECT examinations (28.6%). The prevalence of risk factors and use of preventive measures increased as the renal function became worse. A CIN was occurred after 3103 (2.2%) CECT examinations, revealing a significant association with decreased eGFR, diabetes mellitus, and congestive heart failure after adjustment. CONCLUSION: Risk factors for CIN are prevalent among the patients undergoing CECT. Preventive measures were seemingly underutilized and a system is needed to improve preventive care.
Adult ; Aged ; Aged, 80 and over ; Comorbidity ; Contrast Media/*adverse effects ; Female ; Glomerular Filtration Rate ; Humans ; Incidence ; Kidney Diseases/*chemically induced/epidemiology/*radiography ; Male ; Middle Aged ; Prevalence ; Republic of Korea/epidemiology ; Risk Factors ; Tomography, X-Ray Computed/*methods

STUDY DESIGN: A cross-sectional study. PURPOSE: To explore the impact of chronic low back pain (CLBP) on individuals' quality of life; to understand current treatment practices and level of satisfaction with treatment in patients with CLBP. OVERVIEW OF LITERATURE: Assessing subjective, patient-reported outcomes such as quality of life is essential to health care research. METHODS: Influences of the CLBP were analyzed via a questionnaire, which contained the character of CLBP, effect of pain management, Korean version Oswestry Disability Index (K-ODI) and Korean version of 12-item Short Form Health Survey (SF-12v2). RESULTS: Of 3,121 subjects who responded, 67.3% had moderate to severe pain; 43.5% presented prolonged CLBP of more than two years; and 32.4% had suffered from sleep disturbance due to pain. 22.8% of the patients were not satisfied with current pain management. The mean K-ODI score was 37.63; and it was positively correlated with the mean pain intensity (r=0.6, p<0.001). The SF-12v2 result was negatively correlated with mean pain intensity (PCS: r=-0.5, p<0.001; MCS: r=-0.4, p<0.001) and also negatively correlated with the K-ODI score (PCS: r=-0.75, p<0.001; MCS: r=-0.5, p<0.001). The conformity between patients and doctors in pain assessment was fair (kappa=0.2463). CONCLUSIONS: CLBP negatively affects quality of life. Of total 22.8% of the patients were not satisfied with current pain management. Such needs to be taken more seriously by doctors for improvement of satisfaction and quality of life in patients with CLBP.
Back Pain* ; Cross-Sectional Studies* ; Health Services Research ; Health Surveys ; Humans ; Low Back Pain ; Pain Management ; Pain Measurement ; Quality of Life* ; Surveys and Questionnaires

PURPOSE: The aim of this study was to explore the usefulness of the resistive index (RI) on spectral Doppler ultrasonography (US) in the detection of renal cell carcinoma (RCC) in patients with end-stage renal disease (ESRD). METHODS: Seventeen ESRD patients with kidneys in which renal masses were suspected in routine US were subjected. They underwent computed tomography scans and additional Doppler US for the characterization of the detected lesions. All underwent radical nephrectomy with the suspicion of RCC. Fourteen patients finally were included. RI measurements were conducted in the region of the suspected renal mass and the background renal parenchyma. The intraclass correlation coefficient was used to assess the reproducibility of the RI measurement. A paired t-test was used to compare the RI values between the renal mass and the background renal parenchyma (P<0.05). RESULTS: The RI values measured at the RCCs were significantly lower than those measured at the background renal parenchyma (0.41-0.65 vs. 0.75-0.89; P<0.001). The intrareader reproducibility proved to be excellent and good for the renal masses and the parenchyma, respectively (P<0.001). CONCLUSION: RI on spectral Doppler US is useful in detecting RCC in patients with ESRD. The RI values measured at the RCCs were significantly lower than those measured at the background renal parenchyma.
Carcinoma, Renal Cell* ; Humans ; Kidney ; Kidney Failure, Chronic* ; Nephrectomy ; Ultrasonography, Doppler* ; Ultrasonography, Doppler, Color ; Ultrasonography, Doppler, Pulsed

PURPOSE: The purpose of our study was to assess the usefulness of ultrasounddetermined testicular volume in the evaluation of the infertile men with azoospermia. MATERIALS AND METHODS: A computerized search from October 2005 to June 2010 generated a list of 45 infertile men with azoospermia (mean age, 34 years; age range, 26-44 years) who underwent both scrotal ultrasound and testis biopsy. Ultrasounddetermined testicular volumes were compared between infertile men with obstructive azoospermia and those with non-obstructive azoospermia. RESULTS: Testicular volume for obstructive azoospermia ranged from 6.4 ml to 26.9 ml, with a median volume of 14.0 ml. This volume was significantly larger than that of those with non-obstructive azoospermia, which ranged from 1.0 ml to 12.8 ml, with a median volume of 6.1 ml (p < 0.001). The area under the ROC curve for distinguishing non-obstructive azoospermia from obstructive azoospermia using testicular volume was 0.91. A cutoff value of less than or equal to 11.4 ml could distinguish non-obstructive azoospermia from obstructive azoospermia, with a sensitivity of 94.1% (95% CI; 71.3-99.9%) and a specificity of 73.3% (95% CI; 54.1-87.7%). CONCLUSION: Ultrasound-determined testicular volume can be helpful in the differentiation of obstructive azoospermia from non-obstructive azoospermia.
Azoospermia ; Biopsy ; Humans ; Male ; ROC Curve ; Sensitivity and Specificity ; Testis

OBJECTIVE: The purpose of the current study was to develop support vector machine (SVM) and artificial neural network (ANN) models for the pre-operative prediction of advanced prostate cancer by using the parameters acquired from transrectal ultrasound (TRUS)-guided prostate biopsies, and to compare the accuracies between the two models. MATERIALS AND METHODS: Five hundred thirty-two consecutive patients who underwent prostate biopsies and prostatectomies for prostate cancer were divided into the training and test groups (n = 300 versus n = 232). From the data in the training group, two clinical decision support systems (CDSSs-[SVM and ANN]) were constructed with input (age, prostate specific antigen level, digital rectal examination, and five biopsy parameters) and output data (the probability for advanced prostate cancer [> pT3a]). From the data of the test group, the accuracy of output data was evaluated. The areas under the receiver operating characteristic (ROC) curve (AUC) were calculated to summarize the overall performances, and a comparison of the ROC curves was performed (p < 0.05). RESULTS: The AUC of SVM and ANN is 0.805 and 0.719, respectively (p = 0.020), in the pre-operative prediction of advanced prostate cancer. CONCLUSION: The performance of SVM is superior to ANN in the pre-operative prediction of advanced prostate cancer.
Adult ; Aged ; Aged, 80 and over ; Area Under Curve ; Biopsy, Needle ; *Decision Support Systems, Clinical ; Humans ; Male ; Middle Aged ; *Neural Networks (Computer) ; Prostate-Specific Antigen/blood ; Prostatectomy ; Prostatic Neoplasms/*diagnosis/pathology/surgery ; ROC Curve ; Sensitivity and Specificity ; *Support Vector Machines

PURPOSE: To evaluate the performance of a newly-designed ultrasound (US)-guided puncture device. MATERIALS AND METHODS: A newly-designed US-guided puncture device was composed of a guide segment and an attachable segment. The guide segment allowed the needle to be placed in the plane of US view with a maximal degree of freedom, and the attachable segment was designed to attach to most convex US probes. Six operators punctured 144 targets in phantoms using either the new device (n = 72) or free-hand technique (n = 72). The number of required needle passages and the necessary procedure times were compared between the two groups. RESULTS: The number of required needle passages and the necessary procedure time were significantly reduced in five operators when the newly-designed US-guided puncture device was used (p < 0.05). CONCLUSION: A newly-designed US-guided puncture device, which allows for a maximal degree of freedom in needle placement and can attach to most convex US probes, showed good performance in our study.
Freedom ; Needles ; Punctures

OBJECTIVE: We wanted to assess the relationship between pain and the prostate volume during transrectal ultrasound (TRUS) guided biopsy. MATERIALS AND METHODS: Between July and September 2006, 71 patients scheduled for TRUS biopsy of the prostate were considered for inclusion to this study. These patients underwent periprostatic neurovascular bundle block with lidocaine prior to biopsy. Pain was assessed using a Visual Analogue Scale (VAS) during periprostatic neurovascular bundle block (VAS 1), during biopsy (VAS 2), and 20 minutes after biopsy (VAS 3). The mean pain scores were analyzed in the large prostate group (prostate volume > 40 cc) and the small prostate group (prostate volume < or = 40 cc). P values < 0.05 were considered significant. RESULTS: The mean prostate volume was 42.2 cc (standard deviation: 8.6). The mean pain scores of VAS 1, 2 and 3 were 4.70 +/- 1.61, 3.15 +/- 2.44 and 1.05 +/- 1.51, respectively. In the large prostate group, the mean pains scores of VAS 1, 2 and 3 were 4.75 +/- 1.76, 3.51 +/- 2.76 and 1.29 +/- 1.70, respectively, whereas in the small prostate group, the means pain scores were 4.66 +/- 1.46, 2.77 +/- 2.0, and 0.80 +/- 1.26, respectively. Although there were no statistical differences of VAS 1, the larger prostate group revealed higher pain scores of VAS 2 and 3 compared with the small prostate group (p < 0.05). CONCLUSION: Patients with larger prostate volumes tend to feel more pain during and after TRUS guided prostate biopsy. Our findings suggest that additional analgesic strategies may be necessary when the patients with larger prostate undergo TRUS guided prostate biopsy.
Aged ; Anesthetics, Local/therapeutic use ; *Biopsy, Fine-Needle ; Humans ; Lidocaine/therapeutic use ; Male ; Middle Aged ; Nerve Block ; *Pain Measurement ; Prospective Studies ; Prostate/*pathology ; Ultrasonography, Interventional