Effect of 15-mg Edoxaban on Clinical Outcomes in 3 Age Strata in Older Patients With Atrial Fibrillation: A Prespecified Subanalysis of the ELDERCARE-AF Randomized Clinical Trial.

Importance: Long-term use of oral anticoagulants (OACs) is necessary for stroke prevention in patients with atrial fibrillation (AF). The effectiveness and safety of OACs in extremely older patients (ie, aged 80 years or older) with AF and at high risk of bleeding needs to be elucidated. Objective: To examine the effects of very low-dose edoxaban (15 mg) vs placebo across 3 age strata (80-84 years, 85-89 years, and ≥90 years) among patients with AF who were a part of the Edoxaban Low-Dose for Elder Care Atrial Fibrillation Patients (ELDERCARE-AF) trial. Design, Setting, and Participants: This prespecified subanalysis of a phase 3, randomized, double-blind, placebo-controlled trial was conducted from August 5, 2016, to December 27, 2019. Patients with AF aged 80 years or older who were not considered candidates for standard-dose OACs were included in the study; reasons these patients could not take standard-dose OACs included low creatinine clearance (<30 mL per minute), low body weight (≤45 kg), history of bleeding from critical organs, continuous use of nonsteroidal anti-inflammatory drugs, or concomitant use of antiplatelet drugs. Eligible patients were recruited randomly from 164 hospitals in Japan and were randomly assigned 1:1 to edoxaban or placebo. Interventions: Edoxaban (15 mg once daily) or placebo. Main Outcomes and Measures: The primary efficacy end point was the composite of stroke or systemic embolism. The primary safety end point was International Society on Thrombosis and Hemostasis-defined major bleeding. Results: A total of 984 patients (mean [SD] age: age group 80-84 years, 82.2 [1.4] years; age group 85-89 years, 86.8 [1.4] years; age group ≥90 years, 92.3 [2.1] years; 565 women [57.4%]) were included in this study. In the placebo group, estimated (SE) event rates for stroke or systemic embolism increased with age and were 3.9% (1.2%) per patient-year in the group aged 80 to 84 years (n = 181), 7.3% (1.7%) per patient-year in the group aged 85 to 89 years (n = 184), and 10.1% (2.5%) per patient-year in the group aged 90 years or older (n = 127). A 15-mg dose of edoxaban consistently decreased the event rates for stroke or systemic embolism with no interaction with age (80-84 years, hazard ratio [HR], 0.41; 95% CI, 0.13-1.31; P = .13; 85-89 years, HR, 0.42; 95% CI, 0.17-0.99; P = .05; ≥90 years, HR, 0.23; 95% CI, 0.08-0.68; P = .008; interaction P = .65). Major bleeding and major or clinically relevant nonmajor bleeding events were numerically higher with edoxaban, but the differences did not reach statistical significance, and there was no interaction with age. There was no difference in the event rate for all-cause death between the edoxaban and placebo groups in all age strata. Conclusions and Relevance: Results of this subanalysis of the ELDERCARE-AF randomized clinical trial revealed that among Japanese patients aged 80 years or older with AF who were not considered candidates for standard OACs, a once-daily 15-mg dose of edoxaban was superior to placebo in preventing stroke or systemic embolism consistently across all 3 age strata, including those aged 90 years or older, albeit with a higher but nonstatistically significant incidence of bleeding. Trial Registration: ClinicalTrials.gov Identifier: NCT02801669.

Evaluation of the Effect of Topiroxostat on Renal Function in Patients with Hyperuricemia: STOP-C Study, a Retrospective Observational Cohort Study.

BACKGROUND: Serum uric acid-lowering therapy is associated with maintaining renal function. OBJECTIVE: We aimed to retrospectively evaluate renal function and serum uric acid in patients with hyperuricemia who received topiroxostat for over a year. METHODS: Medical records of patients from 1 January, 2015 to 31 October, 2019 in our hospital were used. From the medical records, data of 100 patients with hyperuricemia treated with topiroxostat were extracted (67:33 male:female). The primary endpoints were changes in serum creatinine level and estimated glomerular filtration rate at 12 months after topiroxostat administration. The secondary endpoints were changes in serum creatinine, serum uric acid, and estimated glomerular filtration rate before and after topiroxostat administration. RESULTS: The study mainly involved elderly individuals (77.2 ± 9.5 years). Forty-four patients administered uric acid-lowering drugs were switched to topiroxostat. After 12 months, the serum creatinine level and estimated glomerular filtration rate showed no significant changes from baseline; however, the serum uric acid level significantly decreased. The estimated glomerular filtration rate significantly decreased during the 6 months before topiroxostat administration (p < 0.001), but showed no significant change at 6 months after topiroxostat administration (p = 0.849). CONCLUSIONS: This study revealed that topiroxostat use not only reduced the serum uric acid level but also maintained renal function in elderly patients with hyperuricemia in daily clinical practice.

Cardiovascular Catheterization Using a New Antiseptic Agent Olanexidine Gluconate.

Olanexidine gluconate 1.5% (Olanedine®) is a colorless and transparent antiseptic agent introduced in 2015. In this study, we examined its usefulness and safety for cardiovascular catheterization and compared them to 10% povidone-iodine (PI). The study included 1,001 and 1,000 consecutively enrolled patients using Olanedine® and PI, respectively [649 (PI, 687) males; mean age: 72.1 ± 9.6 (70.9 ± 9.6) years] who underwent cardiovascular catheterization [diagnostic cardiac catheterization: 624 (509) cases, percutaneous coronary intervention: 288 (390) cases, and endovascular treatment: 89 (101) cases]. Clinically, there were no significant differences in the backgrounds between the two groups. The amount of Olanedine® used per case was approximately 20 mL. Blood tests were performed before and after catheterization. The presence or absence of discoloration on clothes containing cotton by Olanedine® was also examined. One mild rash that disappeared within one day occurred in each of the two groups. Some blood tests before and after cardiac catheterization indicated significant differences, but they did not seem to be clinically relevant. The use of Olanedine® in hemodialysis patients (117 cases) was uneventful. Its use in 37 patients with contraindications for ethanol disinfection was also uneventful. Although PI is extremely difficult to remove from white coats containing cotton, Olanedine® did not cause any discoloration on clothes. This is the first report of cardiovascular catheterization using Olanedine®. The efficacy and safety of Olanedine® and PI seem to be equivalent. Olanedine® could be a new useful option as a disinfectant of cardiovascular catheterization.

Supraventricular tachyarrhythmias that responded dramatically to bisoprolol transdermal patches in two patients undergoing hemodialysis.

We here report two patients with atrial flutter (AFL) and paroxysmal supraventricular tachycardia (PSVT) who were undergoing hemodialysis and returned quickly to normal sinus rhythm without hypotension when treated with bisoprolol transdermal patches (Bisono® Tape) (TOA EIYO, Tokyo, Japan). Spontaneous rhythm reversion had not occurred prior to these events in either patient. Our findings indicate that Bisono® Tape may be a new and more effective treatment for AFL and PSVT in patients undergoing hemodialysis.

Atrial Septal Defect of the Ostium Secundum Type in A 101-Year-Old Patient.

The patient was a 101-year-old woman whose chief complaints were difficulty of breathing and high fever. The history of the present illness included paroxysmal atrial flutter which was untreated, but she had not developed heart failure.At admission, auscultation of the chest revealed moist rales and systolic murmur but did not clearly show the presence of fixed splitting of S2. X-ray examination of the chest showed a cardiothoracic ratio of 61%, moderate bilateral pulmonary congestion, pleural fluid, and enlarged pulmonary arteries. Electrocardiogram showed atrial flutter with a heart rate of approximately 150 beats/minute. Echocardiographic examination revealed an atrial septal defect (ASD) of the ostium secundum type (left to right shunt) and right ventricular pressure 71 mmHg. The diameter of the ASD was approximately 10 mm.She began receiving an antibiotic and a diuretic immediately after admission, but died on the second day of hospitalization.This case could be the oldest individual with ASD among those reported to date.

Massive Pericardial Effusion in a Case of Acute Pericarditis with Slight ST-Segment Elevation of Short Duration.

We present the case of a 77-year-old woman who suffered from chest pain. Her white blood cell count was 10,200/µL and C-reactive protein level was 5.5 mg/dL. There was no electrocardiogram abnormality up to 5 hours after admission. At 15 hours, slight ST-segment elevation occurred, but this disappeared on day 4. Imaging revealed slight pericardial effusion. Nonsteroidal anti-inflammatory drugs and antibiotics were administered. However, the pericardial effusion, inflammatory response, and bilateral heart failure worsened. Pericardiotomy on day 6 released 350 mL of fluid, and symptoms improved. Viral pericarditis was assumed. Massive pericardial effusion is rare in cases of acute viral pericarditis, as is slight, short-duration ST-segment elevation.

Acute Myocardial Infarction with Severe ST Segment Elevation Treated with Percutaneous Coronary Intervention More than Two Days after Onset: A Case with Remarkable Recovery.

The patient was a 65-year-old man with marked ST-elevation myocardial infarction. Cardiac catheterization revealed an occluded middle portion of the left anterior descending artery and no collateral circulation. Percutaneous coronary intervention (PCI) was performed, and ST elevation improved 5 days after PCI. Almost all electrocardiogram (ECG) findings were normal 6 months later. Echocardiographic findings were also normal. This case was very successful and unusual in that no ventricular aneurysm formed despite ST elevation continuing for a few days and that ECG and left ventricular function were nearly normal after PCI performed days after the onset in a case without collateral circulation.

Angina pectoris with pharyngeal pain alone: a case report.

Patients with pharyngeal pain are frequently encountered in the department of otorhinolaryngology. The pharyngeal pain is usually caused by an inflammation or a malignant disease. In some cases, anginal pain radiates to the pharynx. However, patients with angina pectoris who suffer from pharyngeal pain without chest pain are believed to be very rare. The patient was a 70-year-old man whose chief complaint was only pharyngeal pain on exertion. The pharyngeal pain was similar to acute pharyngitis with burning pain. Upon cardiac catheterization, no abnormality was found in the right coronary artery or in the circumflex artery, but 99% stenosis was found in the middle portion of the left anterior descending artery. There was no collateral circulation to the left anterior descending artery. Thus, percutaneous coronary intervention was performed, and the pharyngeal pain vanished.

Intravascular ultrasound assessment of atherosclerotic plaque in the aorta.

BACKGROUND: Intravascular ultrasound (IVUS) has been used for assessment of the coronary arteries. However, few IVUS studies have been reported on the aorta. MATERIALS AND METHODS: To assess the presence of atherosclerotic disease in the aorta by the use of IVUS, 29 patients with heart disease (24 men and 5 women; mean age, 61+/-11 years) including ischemic heart disease (n=21) and valvular disease or dilated cardiomyopathy (n=8) were enrolled in the study. An IVUS catheter was inserted through the femoral artery, and IVUS images were obtained in the descending aorta (DA) at the level of the pulmonary artery bifurcation, and in the proximal and distal regions of the abdominal aorta (AA) at the level of the renal artery bifurcation. Percent plaque area (%PA) was calculated as vessel cross-sectional area surrounded by media minus lumen cross-sectional area divided by vessel cross-sectional area. RESULTS: %PAs differed significantly between the three aortic levels: DA, 14.9+/-5.5%; proximal AA, 19.0+/-6.9%; and distal AA, 28.3+/-9.7% (p<0.05). However, PA did not differ significantly between the three levels (DA, 94.7+/-38.0 mm2; proximal AA, 90.9+/-35.0 mm2; distal AA, 79.7+/-32.3 mm2). %PA and PA in the DA and proximal AA correlated with age (r=0.39-0.46, p<0.05), but not with coronary angiography findings or multiple risk factors. CONCLUSIONS: The aortic plaque is clearly observed by IVUS. The plaque is diffuse at the 3 levels, had little relationship with risk factor of arteriosclerosis or coronary artery disease, and aging affected the increase of plaque.

Evaluation of the heart and great vessel calcification by conventional computed tomography in hemodialysis patients.

Heart diseases are responsible for death in hemodialysis patients. The aim of this study was to determine whether we can assess the degree of calcification of the heart and great vessels in hemodialysis patients by non-gated conventional computed tomography (CT) without contrast media. Thirty patients were included in the present study. The hemodialysis group comprised 15 patients and the age-matched control group comprised 15 patients without hemodialysis or cardiac diseases who underwent CT scanning. Axial cross-sectional images were taken from the aortic arch to the diaphragm to detect calcification of the aorta and coronary arteries. Eleven patients in the hemodialysis group showed calcification in 1.9 +/- 1.4 coronary vessels, a frequency significantly greater than that of the 0.3 +/- 0.2 coronary vessels in the control group (p < 0.01). Fourteen patients in the hemodialysis group showed calcification of the aorta with a mean score 9.7 +/- 7.2, significantly greater than mean score in the control group (3.5 +/- 2.2; p < 0.01). These results suggest that we can assess an increase in the incidence of calcification of the coronary arteries and the aorta by conventional CT scanning without contrast media in patients undergoing hemodialysis.

Pulmonary Artery Calcification in Contact with a Left Coronary Artery Bypass Graft: An X-ray Computed Tomographic Study.

Calcification in the pulmonary artery (PA) occurs in rare cases. There have been no studies of calcification in the PA at the site of its contact with a left coronary artery bypass graft (CABG). In the present study, X-ray computed tomography (CT) was employed for examination of such calcification. The subjects were 53 patients (49 male and 4 female, mean age of 56.7 years) who underwent 74 left CABGs (69 saphenous veins and five internal thoracic arteries). Following surgery, non-contrasted CT was performed from the lower level of the aortic arch to the lower boundary of the left ventricle at 5-mm horizontal intervals, and contrasted CT was performed at the level of the PA; this procedure was repeated at approximately six-month intervals after the operation. In addition, aortography and selective graft angiography were carried out at 7.6 months postoperatively. The inner diameter of the grafts and the levels of serum cholesterol were also examined. Calcification in the PA was detected in 24 cases (all of them saphenous vein grafts), but graft angiography found no stenosis in those sites. Calcification size varied from 1 mm to 14 mm, with 10 of the cases at or exceeding 10 mm and showing high density. Only three of the cases enlarged with time. Calcification appeared at 2.9 to 54.3 months postoperatively and the mean time of onset was 10.0 +/- 15.7 months. The mean age of the patients with PA calcification was 58.7 +/- 5.9 years while that of the patients without calcification was 57.3 +/- 10.0 years. Graft diameter was 5.9 +/- 1.9 mm in the former group and 5.6 +/- 1.7 mm in the latter. Serum cholesterol level was 235 +/- 32 mg/dl in the former group and 243 +/- 42 mg/dl in the latter. There were three cases of occlusion in the calcification group, and four in the other. There were no significant intergroup differences in these four parameters. The incidence of CT-detected calcification in the PA was found to be high at its point of contact with saphenous vein grafts.