Background: Patients with appropriately selected low-risk pulmonary embolism (PE) can be treated at home, although it has been controversial whether applies to patients with cancer, who are considered not to be at low risk. Methods and Results: The current predetermined companion report from the ONCO PE trial evaluated the 3-month clinical outcomes of patients with home treatment and those with in-hospital treatment. The ONCO PE trial was a multicenter, randomized clinical trial among 32 institutions in Japan investigating the optimal duration of rivaroxaban treatment in cancer-associated PE patients with a score of 1 using the simplified version of the Pulmonary Embolism Severity Index (sPESI). Among 178 study patients, there were 66 (37%) in the home treatment group and 112 (63%) in the in-hospital treatment group. The primary endpoint of a composite of PE-related death, recurrent venous thromboembolism (VTE) and major bleeding occurred in 3 patients (4.6% [0.0-9.6%]) in the home treatment group and in 2 patients (1.8% [0.0-4.3%]) in the in-hospital treatment group. In the home treatment group, there were no cases of PE-related death or recurrent VTE, but major bleeding occurred in 3 patients (4.6% [0.0-9.6%]), and 2 patients (3.0% [0.0-7.2%]) required hospitalization due to bleeding events. Conclusions: Active cancer patients with PE of sPESI score=1 could be potential candidates for home treatment.
Primary aldosteronism (PA) causes biochemical abnormalities such as hypokalemia and metabolic alkalosis. This study aimed to compare the effects of aldosterone on serum potassium and corrected bicarbonate (cHCO(3)(-), defined as Na - Cl - 12) between PA and non-PA and between unilateral and bilateral PA (uPA and bPA, respectively). A total of 463 patients from the Japan Primary Aldosteronism Study II, who had been enrolled as of January 2024, were analyzed. Correlations between plasma aldosterone concentration (PAC) and serum potassium, as well as cHCO(3)(-), were evaluated in PA vs. non-PA and in uPA vs. bPA. In the PA group, PAC was significantly correlated with both serum potassium (r = -0.449, P < 0.05) and cHCO(3)(-) (r = 0.439, P < 0.05), whereas no significant correlations were observed in the non-PA group. Among PA subtypes, uPA showed significant correlations between PAC and serum potassium (r = -0.299, P < 0.05) and cHCO(3)(-) (r = 0.420, P < 0.05). Conversely, in bPA, PAC showed a weaker correlation with serum potassium (r = -0.178, P < 0.05) and no significant correlation with cHCO(3)(-). Even in the analysis with matched PAC between uPA and bPA, a significant correlation between PAC and cHCO(3)(-) was observed only in uPA (r = 0.415, P < 0.05), whereas no such correlation was found in bPA, with a significant difference between the two groups (P < 0.05). uPA was observed in 96.7% of patients with PA who had PAC >= 150 pg/mL and cHCO(3)(-) >= 28 mmol/L. In conclusion, PAC is significantly correlated with cHCO(3)(-) in uPA, but not in non-PA or bPA. cHCO(3)(-) is potentially useful for evaluating disease activity in uPA and detecting uPA.
Background: Previous randomized clinical trials did not support a benefit of screening for occult cancer after diagnosis of venous thromboembolism (VTE), although screening may be of potential benefit for selected high-risk patients. Methods and Results: The COMMAND VTE Registry-2 enrolled consecutive patients with acute symptomatic VTE between 2015 and 2020 from 31 centers across Japan. The 3,706 patients in the registry without known active cancer at the time of VTE diagnosis were divided into 2 groups: those with (n=250) and without (n=3,456) newly diagnosed cancer during the follow-up period. The cumulative incidence of newly diagnosed cancer was 1.5% at 30 days, 3.7% at 1 year, and 7.0% at 3 years. The multivariable Cox proportional hazard model demonstrated that older age (hazard ratio [HR] 1.02 per 1 year increase; 95% confidence interval [CI] 1.01-1.03; P<0.001), a history of cancer (HR 3.57; 95% CI 2.73-4.64; P<0.001), autoimmune disorders (HR 1.48; 95% CI 1.06-2.02; P=0.02), a history of major bleeding (HR 1.64; 95% CI 1.04-2.48; P=0.04), and the absence of transient provoking risk factors for VTE (HR 1.44; 95% CI 1.08-1.92; P=0.01) were independently associated with newly diagnosed cancer. Conclusions: The incidence of newly diagnosed cancer after VTE diagnosis was 3.7% at 1 year, and several independent risk factors for newly diagnosed cancer after VTE diagnosis were identified.
Very high acute pacing thresholds (VHPT) during AVEIR-AR atrial leadless pacemaker (ALP) implantation often prompt device repositioning, although excessive manipulation may increase procedural risk. To evaluate the safety and early electrical performance of ALP release despite VHPT using a current-of-injury (COI)-guided strategy. We retrospectively analyzed 28 consecutive patients who underwent AVEIR-AR ALP implantation at two centers in Japan and compared procedural safety and short-term electrical performance between patients with normal PTs (NPT <5.5 V at 0.4 ms) and those with VHPT (≥5.5 V at 0.4 ms). In the VHPT group, ALP device release was permitted when pre-screw COI was adequate (≥1 mV). The mean age was 85±6 years, body weight was 54±8 kg, and 11 patients were female. Single-site pre-mapping successful implantation was achieved in 36
OBJECTIVES:This study aimed to establish a risk prediction model for the relapse of anti-synthetase syndrome-associated interstitial lung disease (ASyS-ILD). METHODS:Patients diagnosed with ASyS-ILD and treated with prednisolone and calcineurin inhibitors as remission induction therapy were enrolled in the Japanese multicentre MYKO cohort. We followed up on patients who experienced relapse of ASyS-ILD after remission induction therapy, and examined the risk factors for predicting relapse by comparing initial clinical and laboratory findings. RESULTS:Of 487 patients diagnosed with idiopathic inflammatory myopathies between 1991 and 2024, 101 patients with ASyS-ILD were included. Tacrolimus was used by 81.2% of patients and 18.8% used ciclosporin as calcineurin inhibitors for a remission induction therapy. Thirty-nine patients (38.6%) relapsed ASyS-ILD during a median follow-up of 4.3 years, and 5-year relapse rate was 45.1%. Multivariate Cox regression analyzes showed that the presence of acute/subacute ILD and a lower % forced vital capacity (FVC) on admission were independently identified as risk factors for relapse in patients with ASyS-ILD. Using the receiver operating curve analysis, %FVC ≤77% was determined as the cut-off levels for indicating a poor prognosis. The 5-year relapse rate was significantly higher in patients with acute/subacute ILD, %FVC ≤77% than in those without these parameters. A risk prediction model based on these parameters can stratify patients into low-, moderate- and high-risk ILD relapse groups. CONCLUSION:Our multicentre cohort study showed that the RPM model using the presence of acute/subacute ILD and %FVC values was a useful tool for stratifying risk of ASyS-ILD relapse.