Clinical outcomes of spinal cord stimulation in patients with intractable leg pain in Japan.

BACKGROUND: Neuromodulation through spinal cord stimulation (SCS) is a therapeutic option for relieving leg pain and improving the chances of limb salvage in patients with intractable chronic limb-threatening ischemia (CLTI); however, there is no consensus on its indications. OBJECTIVE: The aim of this study was to assess the clinical outcomes of SCS in patients with intractable leg pain caused by various diseases treated in the department of cardiovascular medicine in Japan. METHODS: This was a retrospective study of patients who underwent SCS for pain management. Patients were considered eligible for the therapy if they met the following criteria: (1) intractable leg pain (numerical rating scale [NRS] score of 10), (2) no revascularization option, and (3) no septicemia. RESULTS: Twenty patients (mean age: 77 years; men/women: 11/9) were included in this study. The NRS score of the patients significantly reduced from 10 ± 0 before procedure to 4 ± 3 at discharge (p < 0.001). The clinical response rate of the entire cohort was 65% (13/20) at 17 ± 14 months after implantation; however, patients with intractable CLTI showed a low response rate (45%), whereas those with subacute limb ischemia showed a high response rate (100%). A multivariable regression analysis showed that hemoglobin level was significantly associated with treatment response, even after adjusting for age and sex (p = 0.026). The area under the receiver operating characteristic curve for the correlation between hemoglobin level (cutoff, 11.4 g/dL) and clinical response to SCS was 0.824 (0.619-1). CONCLUSIONS: SCS can reduce clinical symptoms in majority of patients with intractable leg pain. Although implantation of an SCS device has been shown to improve microvascular perfusion insufficiency, the correlation between hemoglobin level and the clinical effect of SCS indicates that a preserved microcirculatory vascular bed is essential for the therapy to be effective.

Assessment of the Initial Diagnostic Accuracy of a Fragility Fracture of the Sacrum: A Study of 56 Patients.

STUDY DESIGN: Retrospective study. PURPOSE: To investigate the clinical manifestations of a fragility fracture of the sacrum (FFS) and the factors that may contribute to a misdiagnosis. OVERVIEW OF LITERATURE: The number of patients diagnosed with FFS has increased because of extended life expectancy and osteoporosis. Patients with FFS may report nonspecific symptoms, such as back, buttock, groin, and/or leg pain, leading to a misdiagnosis and a delay in definitive diagnosis. METHODS: Fifty-six patients (13 males and 43 females) with an average age of 80.2±9.2 years admitted to the hospital for FFS between 2006 and 2021 were analyzed retrospectively. The following patient data were collected using medical records: pain regions, a history of trauma, initial diagnoses, and rates of fracture detection using radiography, computed tomography (CT), and magnetic resonance imaging (MRI). RESULTS: Forty-one patients presented with low back and/or buttock pain, nine presented with groin pain, and 17 presented with thigh or leg pain. There was no history of trauma in 18 patients (32%). At the initial visit, 27 patients (48%) were diagnosed with sacral or pelvic fragility fractures. In contrast, 29 patients (52%) were initially misdiagnosed with lumbar spine disease (23 patients), hip joint diseases (three patients), and buttock bruises (three patients). Fracture detection rates for FFS were 2% using radiography, 71% using CT, and 93% using MRI. FFS was diagnosed definitively using an MRI with a coronal short tau inversion recovery (STIR) sequence. CONCLUSIONS: Some patients with FFS have leg pain with no history of trauma and are initially misdiagnosed as having lumbar spine disease, hip joint disease, or simple bruises. When these clinical symptoms are reported, we recommend considering FFS as one of the differential diagnoses and performing lumbar or pelvic MRIs, particularly coronal STIR images, to rule out FFS.

Reactive hypoglycemia owing to an intrahepatic congenital portosystemic shunt in an older patient.

An 85-year-old woman was admitted to our hospital because of hypoglycemia and impairment of consciousness several hours after breakfast. Because the hypoglycemia predominantly occurred 2-4 h after meals, we diagnosed reactive hypoglycemia. An oral glucose tolerance test showed prolonged hyperinsulinemia following the postprandial hyperglycemia, with a subsequent rapid decrease in blood glucose concentration. The post-stimulus plasma C-peptide concentration was relatively low compared to the plasma insulin concentration. Abdominal computed tomography revealed an intrahepatic congenital portosystemic shunt (CPSS). On the basis of these findings, we concluded that the reactive hypoglycemia was induced by the CPSS, via a reduction in hepatic insulin extraction. Treatment with an alpha-glucosidase inhibitor resolved the reactive hypoglycemia. CPSS comprises anomalous vascular connections between the portal vein and the systemic venous circulation, and reactive hypoglycemia is a rare complication of this malformation, which has most frequently been reported in children, with only a few cases reported in adults. However, this case indicates that even in adult patients, imaging studies should be conducted to rule out CPSS as the cause of the reactive hyperglycemia.

Medical Accidents Related to Ferromagnetic Objects Brought into the MRI Room: Analysis of the National Multicenter Database by Orthopedic Surgeons.

Introduction: Magnetic resonance imaging (MRI) is widely used in orthopedics, but orthopedic surgeons, including spine surgeons, do not have detailed knowledge of MRI-related accidents. We, as orthopedic surgeons, investigated the details of medical accidents related to ferromagnetic objects brought into the MRI room using a national multicenter database. Methods: We conducted an exploratory analysis of accidents involving MRI ferromagnets based on the Japanese database of adverse medical occurrences. From a total of 104,659 accident reports over nine years, 172 involving the presence of ferromagnetic objects in the MRI room were extracted and analyzed. Results: The accident reports frequently involved children and the elderly. Nurses filed the highest number of reports (44.8%) by occupation, which was more than twice as many as physicians (19.8%). The most common ferromagnetic devices brought into the MRI rooms were pacemakers (n = 22). There were also large magnetic objects such as oxygen cylinders (n = 12) and IV stands (n = 7). In the field of orthopedics, ankle weights (n = 4), pedometers (n = 3), and artificial limbs (n = 2) were brought in. "Failure to check" was the most common cause of accidents (69%). Actual harm to patients occurred in 9% of cases, with no fatalities. Conclusions: Manuals and checklists should be developed and continuous education provided to prevent accidents involving magnetic objects brought into the MR scanner room. As orthopedic surgeons, including spine surgeons, we should be cautious with emergency, geriatric, and pediatric patients because their information and medical history may not be accurate. We should not overlook equipment commonly found in orthopedic practice such as ankle weights and pedometers.

Up-Titration of Sacubitril/Valsartan Among Patients With Heart Failure and Preserved Ejection Fraction.

AIMS: In recent large trials, sacubitril/valsartan demonstrated favorable effects in patients with HF. However, many patients do not achieve the target dose of treatment. This study investigated the factors linked to up-titration of sacubitril/valsartan in patients with heart failure and preserved ejection fraction (HFpEF). METHODS: Using a multicenter retrospective database, 204 consecutive patients with HFpEF (left ventricular ejection fraction ≥ 40%) who were treated with sacubitril/valsartan between October 2020 and March 2022 were analyzed. Up-titration was defined as an increase in dosage above 24/26 mg BID beyond 12 weeks after the initiation of sacubitril/valsartan. RESULTS: Among the patients, 55% underwent up-titration, and 8% discontinued the drug. The baseline systolic blood pressure (SBP) was higher in patients with up-titration than in those with no up-titration; SBP values similar to that at baseline were observed between the 2 groups at 2 to 4 weeks and at 12 weeks after the commencement of sacubitril/valsartan treatment. The majority of those who discontinued sacubitril/valsartan did so because of hypotension. The multivariable logistic regression model showed that a history of hypertension, history of atrial fibrillation, baseline SBP, and baseline estimated glomerular filtration rate <60 mL/min/1.73 m2 were associated with sacubitril/valsartan up-titration. CONCLUSION: Approximately half of all patients did not undergo up-titration, and 8% of those with HFpEF discontinued the sacubitril/valsartan therapy. For aggressive up-titration and continuation of sacubitril/valsartan, patients with lower baseline SBP, renal dysfunction, absence of a history of hypertension, and presence of atrial fibrillation may require more careful monitoring.

Risk factors for celiac artery and superior mesenteric artery stenosis in preoperative lumbar and thoracolumbar spinal surgery patients.

BACKGROUND: Ischemic necrosis of the abdominal organs caused by compression of the celiac artery (CA) and superior mesenteric artery (SMA) by the median arcuate ligament (MAL) after correction surgery has been recognized as acute celiac artery compression syndrome (ACACS). Here, using contrast-enhanced computed tomographic (CT) images, we sought to determine the prevalence and degree of CA and SMA stenosis in spinal patients preoperatively, and the risk factors associated with the stenosis. METHODS: We retrospectively examined contrast-enhanced abdominal CT of 90 patients with preoperative lumbar degenerative disease, lumbar burst fracture, or adult spinal deformity. The trunks of the CA and SMA were detected using three-dimensional reconstructed CT. To investigate their degree of stenosis, we determined the ratio of the narrowest diameter of the stenotic segment to the distal normal lumen's diameter. Patients with a degree of stenosis ≥35% were defined as being in the group with stenosis and the remainder as in the group without. To determine the risk factors for stenosis of these arteries, the relationship between the stenosis and CA and SMA calcification or the median arcuate ligament (MAL) crossing the proximal portion of the celiac axis (MAL overlap) was also investigated. RESULTS: The average degree of stenosis of the CA trunk was 12.1% ± 13.9% and that for the SMA trunk was 8.5% ± 8.8%. There were 8 patients (8.9%) in the group with CA stenosis and 2 patients (2.2%) in the group with SMA stenosis. The number of patients in the group with CA stenosis was significantly greater than the number with MAL overlap or CA calcification (P < 0.05). DISCUSSION: The prevalence of CA or SMA stenosis was 11.2% of preoperative patients due to undergo thoracolumbar fusion surgery. Calcifications of the CA trunk and MAL overlap are risk factors for CA stenosis.

Impact of Sex in Left Atrial Indices for Prognosis of Heart Failure with Preserved Ejection Fraction.

OBJECTIVE: We aim to clarify the differences in the association between re-admission for heart failure (HF) and left atrial (LA) overload indices by sex in heart failure and a preserved ejection fraction (HFpEF). METHODS: We analyzed 898 HFpEF patients hospitalized for acute decompensated HF. Blood tests and transthoracic echocardiography were performed before discharge. The primary endpoint was re-admission for HF during the first year. RESULTS: The ratio of diastolic elastance to arterial elastance (p = 0.014), a relative index of LA pressure overload, in men and LA volume index (LAVI, p = 0.020) in women were significant for re-admission for HF during the first year in the multivariable Fine-Gray analysis. Stroke volume (SV)/LA volume (LAV), another index for LAV overload, was not a significant prognostic factor of re-admission for HF during this time. CONCLUSION: LA overload was an important prognostic factor for HF re-readmission during the first year after enrolment in patients with HFpEF, but the indices relating to LA overload differed by sex.

Efficacy of lateral lumbar interbody fusion combined with posterior spinal fusion compared with three-column osteotomy for adult spinal deformity with severe lumbar sagittal deformity.

PURPOSE: The clinical and radiological results of adult spinal deformity (ASD) patients with a severe lumbar sagittal deformity undergoing multilevel lateral lumbar interbody fusion (LLIF) + posterior spinal fusion (PSF) were compared to patients undergoing three-column osteotomy (3CO). METHODS: We defined severe lumbar sagittal deformity as fulcrum backward bending (FBB) pelvic incidence minus lumbar lordosis (PI-LL) ≧ 20 degrees. A total of twenty-five patients with an ASD were enrolled between 2013 and 2018. Fifteen patients were in the LLIF + PSF group, and ten patients were in the 3CO group. We evaluated patient demographics, clinical outcomes, and radiographic parameters such as the Cobb angle and spinopelvic parameters from standing X-ray films in each group. RESULTS: The LLIF + PSF group had a significantly shorter follow-up time than the 3CO group. Postoperatively, the LLIF + PSF group had significantly lower PI-LL and a shorter sagittal vertical axis than the 3CO group. Postoperative PI-LL changes in the LLIF + PSF group were significantly smaller than those in the 3CO group. There were no differences in other patient demographics, radiographic parameters, or clinical outcomes between the groups. CONCLUSION: Multilevel LLIF + PSF improved the PI-LL and SVA more than did 3CO for ASD patients with severe lumbar sagittal deformity. This indicated that the multilevel LLIF with open PSF can provide good clinical outcomes even in cases with severe lumbar sagittal deformity such as large FBB PI-LL in which 3CO techniques usually are needed.

Difference in left atrial D-dimer level in patients with atrial fibrillation treated with direct oral anticoagulant.

BACKGROUND: Atrial fibrillation (AF) may cause cerebral and systemic embolism. An increased D-dimer level indicates hyperactivation of secondary fibrinolysis, resulting in predilection for thrombosis. To clarify the differential effects of anticoagulation therapy, we compared the D-dimer levels in peripheral and left atrial (LA) blood of atrial fibrillation patients scheduled for ablation. METHODS: We analyzed 141 patients with non-valvular AF (dabigatran, n = 30; apixaban, n = 47; edoxaban, n = 64; mean age: 68 years, male: 60%). Peripheral venous blood and LA blood was collected before pulmonary vein isolation. We examined the laboratory and echocardiographic parameters. RESULTS: After adjusting for baseline characteristics, D-dimer level in the LA was significantly higher in patients treated with edoxaban than that in those on apixaban (0.77 ± 0.05 vs. 0.60 ± 0.05 µg/mL, P = 0.047), although there were no significant differences in peripheral D-dimer levels. We classified the D-dimer value of the LA into a normal group (< 0.9) and a high value group (≥ 1.0); the peripheral prothrombin fragment F1 + 2 level (odds ratio [OR] 1.012; 95% confidence interval [CI]: 1.003-1.022; P = 0.008) and left ventricular ejection fraction (LVEF) (OR, 0.947; 95% CI, 0.910-0.986; P = 0.008) were potential predictors of high LA D-dimer levels. CONCLUSIONS: In apixaban-treated patients, the D-dimer level in the left atrium was lower than in edoxaban-treated patients on the day of ablation, suggesting that the anticoagulant effect of apixaban on the left atrium is better than that of edoxaban in patients with AF.

Incidence, Risk Factors, and Prevention Strategy for Proximal Junctional Kyphosis in Adult Spinal Deformity Surgery.

INTRODUCTION: Proximal junctional kyphosis (PJK) is an acute complication of adult spinal deformity (ASD) surgery and may require re-operation because of proximal junctional failure (PJF). PJK causes and prevention strategies remain unknown. This study aimed to investigate the differences in the backgrounds of patients with PJK, compared to those without PJK, in ASD surgery. METHODS: We included data from 86 patients who underwent ASD surgery between 2012 and 2018. There were 40 patients (46.5%) with PJK; 46 patients did not have PJK until the last follow-up. We evaluated patient demographics, clinical outcomes, and radiographic parameters, such as Cobb angle and spinopelvic parameters on standing X-ray films, in each group. RESULTS: There was no significant difference in patient demographics, clinical outcomes, or preoperative radiographic parameters. Postoperative pelvic incidence minus lumbar lordosis (PI-LL) and pelvic tilt (PT) were significantly lower in the PJK group, and thoracic kyphosis (TK) was higher. The cutoff values were 34.5° for TK, 0.5° for PI-LL, and 15.5° for PT. Other radiographic parameters were not significantly different. PJF developed in seven patients (17.5%) in the PJK group. PJF patients had significantly older age, higher postoperative TK, higher postoperative proximal junctional Cobb angle (PJA), more changes between pre- and postoperative PJA, and lower satisfaction scores on the Scoliosis Research Society Outcomes Questionnaire (SRS-22 satisfaction) than non-PJF patients in the PJK group. CONCLUSIONS: One risk factor for PJK was lower postoperative PI-LL that was 0° or less. In ASD surgery, the most critical factor in a PJK prevention strategy is to obtain a postoperative LL adjusted by PI, which is >0°.

The Mechanical Strength of Side-to-Side Tendon Repair Using a Modified Krackow Technique.

Background: The purpose of the present study was to assess the biomechanical strength and properties of a modified Krackow technique for side-to-side tendon repair with a short overlap length. Methods: The flexor digitorum superficialis, flexor digitorum profundus, and flexor pollicis longus muscles were harvested from 10 fresh frozen cadavers. Overall, 60 tendon repairs were divided into four groups based on the suture technique: modified Krackow technique repair (KT); weave suture repair (WS); mattress suture repair (MS); and composite technique repair (CT), a combination of the modified Krackow and weave suture techniques. Single loading mechanical tests were performed, and the results for each suture technique were compared. Results: Ultimate loads for KT, WS, MS, and CT were 155 ± 45 N, 122 ± 18 N, 92 ± 31 N, and 163 ± 22 N, respectively. KT and CT had significantly higher ultimate loads than the other groups. However, the difference between the KT and CT groups in terms of ultimate load was not significant. Conclusions: Based on the results from the single loading tests, the use of the modified Krackow and composite techniques appeared to provide stronger fixation than that with the use of the weave and mattress sutures with a short overlap length.

Electrophilic Substitution of Asymmetrically Distorted Benzenes within Triptycene Derivatives.

Herein, we disclose a unique directing effect of 9-substituted triptycenes in electrophilic substitution to achieve the regioselective functionalization of the triptycene core. The Hirshfeld population analysis was adopted to predict the selectivity in electrophilic substitution. TMS and t-Bu groups were found to considerably accelerate the reaction at C2 positions to produce C3-symmetric isomers. Correlation between distortion and charge distribution within benzene rings was systematically examined.

Protracted impairment of left atrial compliance after cryoballoon ablation in recurrence-free patients with paroxysmal atrial fibrillation.

The relationship between alterations in left ventricular (LV) diastolic function and the incidence of recurrence, as well as the associated factors after cryoballoon (CB) and radiofrequency (RF) catheter ablation in patients with paroxysmal atrial fibrillation (Paf), require clarification. We enrolled 138 patients with Paf (RF/CB 69/69) who underwent the first catheter ablation and follow-up for 12 months. Transthoracic echocardiography was performed before and after ablation. An afterload-integrated index of LV diastolic function was calculated as diastolic elastance (Ed)/arterial elastance (Ea), Ed/Ea. No significant increases were observed in Ed/Ea 3 days after RF ablation in patients with (n=12) and without (n=57) recurrence. However, a significant increase was observed in recurrence-free patients with CB ablation (n=59; P<0.05), although this level was restored after 6 months. Ed/Ea 3 days after CB ablation was correlated with left atrial pressure immediately after (r=0.630, P<0.001), but not before (r=0.290, P=0.159), ablation. The increment of creatine kinase- myocardial band release was positively associated with that of Ed/Ea (r=0.388, P<0.05) after CB ablation. Thus, the transient manifestation of LV diastolic dysfunction after CB ablation, evaluated by a new echocardiographic index, was observed only in recurrence-free patients with Paf. Protracted impairment of left atrial compliance due to ablation-induced myocardial injury may be related to the lack of recurrence in patients after CB ablation.

Short-duration, submaximal intensity exercise stress combined with adenosine triphosphate decreases artifacts in myocardial perfusion single-photon emission computed tomography.

BACKGROUND: Myocardial perfusion single-photon emission computed tomography (SPECT) imaging with stress is a useful examination for detecting coronary artery disease. Since the presence of artifacts is remaining challenges, we aimed to define the minimum intensity of low-grade exercise stress levels combined with drug stress to reduce undesired artifacts and their related factors. METHODS: We divided patients with suspicious coronary artery disease into 4 groups as follows: group A, adenosine triphosphate (ATP) for 6 min; group A + 25 W, ATP + 25 W exercise for 6 min; group A + 35 W, ATP + 35 W exercise for 6 min; group A + 45 W, ATP + 45 W exercise for 6 min) and enrolled only those whose summed stress scores were < 3. Undesired artifacts were evaluated on the basis of heart-to-liver activity (H/L) ratio and heart-to-10 pixels below the heart (H/below the H) ratio. RESULTS: The logarithmic values of H/L and H/below the H ratios were significantly higher in groups A + 35 W and A + 45 W than in group A (p < 0.05, each). In all the patients, the logarithmic values of H/L and H/below the H ratios positively correlated with the increment of rate pressure product (RPP, p = 0.002 and p = 0.005, respectively) after stress in the univariate analysis. The left ventricular end-diastolic volume (LVEDV) after stress (p = 0.002) negatively correlated with the logarithmic value of H/below the H ratio, but not H/L ratio. Although the increment of RPP was independently associated with the logarithmic values of both H/L (p = 0.001) and H/below the H ratios (p = 0.005), LVEDV was also independently associated with the logarithmic value of H/below the H ratio (p < 0.001) in multivariate regression analysis under adjusting with age and sex. CONCLUSION: ATP plus ≥35 W exercise stress for 6 min was useful for reducing undesired artifacts after stress in myocardial perfusion SPECT. LVEDV after stress in addition to the increment of RPP was independently associated with the H/below the H ratio, but not the H/L ratio.

Tolvaptan-induced hypernatremia related to low serum potassium level accompanying high blood pressure in patients with acute decompensated heart failure.

BACKGROUNDS: Tolvaptan significantly increases urine volume in acute decompensated heart failure (ADHF); serum sodium level increases due to aquaresis in almost all cases. We aimed to elucidate clinical factors associated with hypernatremia in ADHF patients treated with tolvaptan. METHODS: We enrolled 117 ADHF patients treated with tolvaptan in addition to standard therapy. We examined differences in clinical factors at baseline between patients with and without hypernatremia in the initial three days of hospitalization. RESULTS: Systolic (p = 0.045) and diastolic (p = 0.004) blood pressure, serum sodium level (p = 0.002), and negative water balance (p = 0.036) were significantly higher and serum potassium level (p = 0.026) was significantly lower on admission day in patients with hypernatremia (n = 22). In multivariate regression analysis, hypernatremia was associated with low serum potassium level (p = 0.034). Among patients with serum potassium level ≤ 3.8 mEq/L, the cutoff value obtained using receiver operating characteristic curve analysis, those with hypernatremia related to tolvaptan treatment showed significantly higher diastolic blood pressure on admission day (p = 0.004). CONCLUSION: In tolvaptan treatment combined with standard therapy in ADHF patients, serum potassium level ≤ 3.8 mEq/L may be a determinant factor for hypernatremia development. Among hypokalemic patients, those with higher diastolic blood pressure on admission may be carefully managed to prevent hypernatremia.

Maturity-Onset diabetes of the young type 5 treated with the glucagon-like peptide-1 receptor agonist: A case report.

RATIONALE: Maturity-onset diabetes of the young type 5 (MODY 5) is a form of monogenic diabetes that is often accompanied by pancreatic dysfunction. To date, no cases of MODY 5 treated with glucagon-like peptide-1 receptor agonist (GLP-1RA) have been reported. We present the first case of MODY 5 treated with GLP-1RA. PATIENT CONCERNS: A 17-year-old woman, with a history of being operated for congenital ileal atresia at birth, was admitted to our hospital due to hyperglycemia. She had been clinically diagnosed with type 1 diabetes 1 month prior, and administered 14 units of insulin glargine 300 U/mL per day. DIAGNOSIS: She had hypopotassemia, hypomagnesaemia, pancreatic body, and tail defects, multiple renal cysts, and a family history of diabetes, and urogenital anomaly. Genetic testing revealed heterozygous deletion of hepatocyte nuclear transcription factor-1 beta, leading to the diagnosis of MODY 5. INTERVENTIONS: The patient was treated with multiple daily insulin injections for 9 days (22 units/d) before administration of GLP-1RA, and then liraglutide was initiated. OUTCOMES: Liraglutide treatment (0.6 mg/d) alone maintained the patient's glycated hemoglobin level below 7.0% for at least 12 months after discharge. A higher dose, 0.9 mg/d, of liraglutide was not tolerated by the patient due to nausea. Serum levels of C-peptide immunoreactivity were 1.15 ng/mL and 1.91 ng/mL, respectively, after 6 and 12 months of liraglutide therapy. LESSONS: GLP-1RA might be effective at regulating glucose metabolism by utilizing residual pancreatic endocrine function in patients with MODY 5. Imaging and genetic screening were helpful in the diagnosis of MODY 5.

Risk Factors for Loosening of S2 Alar Iliac Screw: Surgical Outcomes of Adult Spinal Deformity.

STUDY DESIGN: Retrospective study. PURPOSE: To determine the risk factors for S2 alar iliac (S2AI) screw loosening and its association with lumbosacral fusion in patients with adult spinal deformity (ASD). OVERVIEW OF LITERATURE: S2AI screws have been widely used for ASD surgery in recent years. However, no studies have analyzed the risk factors for loosening of S2AI screws and its association with lumbosacral fusion. METHODS: Cases of 50 patients with ASD who underwent long spinal fusion (>9 levels) with S2AI screws were retrospectively reviewed. Loosening of S2AI screws and S1 pedicle screws and bone fusion at the level of L5-S1 at 2 years after surgery were investigated using computed tomography. In addition, risk factors for loosening of S2AI screws were determined in patients with ASD. RESULTS: At 2 years after surgery, 33 cases (66%) of S2AI screw loosening and six cases (12%) of S1 pedicle screw loosening were observed. In 40 of 47 cases (85%), bone fusion at L5-S1 was found. Pseudarthrosis at L5-S1 was not significantly associated with S2AI screw loosening (19.3% vs. 6.3%, p=0.23), but significantly higher in patients with S1 screw loosening (83.3% vs. 4.9%, p<0.001). On multivariate logistic regression analyses, high upper instrumented vertebra (UIV) level (T5 or above) (odds ratio [OR], 4.4; 95% confidence interval [CI], 1.0-18.6; p=0.045) and obesity (OR, 11.4; 95% CI, 1.2-107.2; p=0.033) were independent risk factors for S2AI screw loosening. CONCLUSIONS: High UIV level (T5 or above) and obesity were independent risk factors for S2AI screw loosening in patients with lumbosacral fixation in surgery for ASD. The incidence of lumbosacral fusion is associated with S1 screw loosening, but not S2AI screw loosening.

Patient Satisfaction and Clinical Efficacy of Flash Glucose Monitoring in Patients with Type 1 Diabetes: A Prospective, Single-Center, Single-Arm Study.

INTRODUCTION: Frequent self-monitoring of blood glucose (SMBG) is usually required in patients with type 1 diabetes (T1D). However, the fear of self-testing, hygiene, and social obstacles may deter some patients from SMBG. Flash glucose monitoring (FGM), a less-invasive glucose monitoring method, was launched in Japan in September 2017. The aim of this study was to evaluate patient satisfaction and the clinical efficacy of FGM in Japanese patients with T1D. METHODS: Patient satisfaction with FGM was assessed using the Diabetes Treatment Satisfaction Questionnaire (DTSQ) and Diabetes Therapy-Related Quality of Life (DTR-QOL) questionnaire before (baseline) and 4 and 12 weeks after initiating FGM use in 20 Japanese patients with T1D. Clinical parameters related to glucose metabolism, such as glycated hemoglobin (HbA1c) levels, were assessed, and glucose fluctuations were evaluated using the FGM data. Values at 4 and 12 weeks after initiating FGM were compared with baseline data using the Wilcoxon signed-rank test. The mean absolute relative difference (MARD) between glucose values detected using the FGM device and by SMBG was also calculated. RESULTS: The DTSQ scores significantly improved 12 weeks after initiating FGM (P < 0.001). The DTR-QOL scores related to "burden in social activities" and "treatment satisfaction" also significantly improved 12 weeks after initiating FGM (P = 0.024 and 0.007, respectively). The HbA1c values and the percentage of time within the target glucose range (3.9-7.8 mmol/L) at the 12-week time point also improved, from 58 ± 5 (baseline) to 54 ± 4 mmol/mol (P = 0.002) and from 36% (interquartile range [IQR] 25-44.5%) (baseline) to 43% (IQR 39-50%) (P = 0.016), respectively. The MARD between glucose values detected using FGM and those detected using SMBG was 12.2% throughout the study period. CONCLUSIONS: Flash glucose monitoring contributed to improved patient satisfaction and the adjustment of blood glucose levels in patients with T1D. TRIAL REGISTRATION: University Hospital Medical Information Network Clinical Trials Registry (UMIN-CTR): UMIN000029673.

Below-the-Ankle Arrival Time as a Novel Limb Tissue Perfusion Index: Two-dimensional Perfusion Angiography Evaluation.

Purpose: To identify lower limb 2-dimensional (2D) perfusion angiographic parameters that are related to skin perfusion pressure (SPP), a predictor of wound healing in patients with chronic limb-threatening ischemia (CLTI) undergoing below-the-knee (BTK) endovascular treatment (EVT). Materials and Methods: Thirty-three consecutive patients (mean age 74.5 years; 18 men) with 47 isolated BTK lesions in 33 limbs (Rutherford category 3-5) underwent EVT. Dorsal and plantar SPPs were measured before EVT and the day after. The indexed blood flow below the ankle was measured using 2D perfusion angiography before and after EVT to determine changes in perfusion parameters [arrival time (AT), time to peak, wash-in rate, mean transit time, and width and area under the time-density curve] at rest vs during hyperemia induced with a 20-mg intra-arterial papaverine infusion. Correlations between the 2D perfusion parameters and SPPs were assessed using the Pearson coefficient. The cutoff points to predict mean SPPs >40 mm Hg were analyzed using a receiver operating characteristic curve; outcomes are reported as the area under the curve (AUC) with 95% confidence interval (CI). Results: After EVT at rest and during hyperemia, only AT was significantly changed, although hyperemia produced significant changes in all the pre-/post-EVT 2D perfusion parameters except the wash-in rate. Dorsal and plantar SPPs after EVT were significantly increased and correlated with hyperemic AT and the AT ratio (hyperemia/at rest values) below the ankle. Hyperemic ATs <6.3 seconds and AT ratios <0.78 were predictive factors for a mean SPP >40 mm Hg, with AUCs of 0.83 (95% CI 0.67 to 0.99) and 0.78 (95% CI 0.61 to 0.95), respectively. Conclusion: Hyperemic ATs <6.3 seconds or AT ratios <0.78 below the ankle may be essential to obtain sufficient SPPs for limb salvage in BTK lesions. Thus, the use of 2D perfusion angiography enabled the monitoring of lower limb tissue perfusion throughout EVT and may thereby optimize treatment of CLTI.