Influence of monitoring and atrial arrhythmia burden on quality of life and health care utilization in patients undergoing pulsed field ablation: A secondary analysis of the PULSED AF trial.

BACKGROUND: Freedom from atrial arrhythmia (AA) recurrence ≥30 seconds after pulsed field ablation (PFA) in patients with atrial fibrillation (AF) was reported in PULSED AF (Pulsed Field Ablation to Irreversibly Electroporate Tissue and Treat AF; ClinialTrials.gov Identifier: NCT04198701). AA burden may be a more clinically meaningful endpoint. OBJECTIVE: The purpose of this study was to determine the influence of monitoring strategies on AA detection and AA burden association with quality of life (QoL) and health care utilization (HCU) after PFA. METHODS: Patients underwent 24-hour Holter monitoring at 6 and 12 months and weekly, and symptomatic transtelephonic monitoring (TTM). AA burden post-blanking was calculated as the greater of (1) percentage of AA on total Holter time; or (2) percentage of weeks with ≥1 TTM with AA out of all weeks with ≥1 TTM. RESULTS: Freedom from all AAs varied by >20% when differing monitoring strategies were used. PFA resulted in zero burden in 69.4% of paroxysmal atrial fibrillation (PAF) and 62.2% of persistent atrial fibrillation (PsAF) patients. Median burden was low (<9%). Most PAF and PsAF patients had ≤1 week of AA detection on TTM (82.6% and 75.4%) and <30 minutes of AA per day of Holter monitoring (96.5% and 89.6%), respectively. Only PAF patients with <10% AA burden averaged a clinically meaningful (>19 point) QoL improvement. PsAF patients experienced clinically meaningful QoL improvements irrespective of burden. Repeat ablations and cardioversions significantly increased with higher AA burden (P <.01). CONCLUSION: The ≥30-second AA endpoint is dependent on the monitoring protocol used. PFA resulted in low AA burden for most patients, which was associated with clinically relevant improvement in QoL and reduced AA-related HCU.

Sequential organ failure assessment score on admission predicts long-term mortality in acute heart failure patients.

AIMS: The sequential organ failure assessment (SOFA) score has been a widely used predictor of outcomes in the intensive care unit, whereas short-term and long-term survivals of heart failure (HF) patients are predicted by the American Heart Association Get With the Guidelines-Heart Failure (GWTG-HF) risk score. The purpose of present study was to examine whether the SOFA score on admission is more useful for predicting long-term mortality in acute HF patients than the GWTG-HF risk score. METHODS AND RESULTS: A total of 269 patients (mean age, 78.5 ± 10.9 years; all-cause mortality, 53.9%) seen in a single facility from January 2007 to December 2016 were enrolled retrospectively. They were followed up for a mean of 32.1 ± 22.3 months. All-cause death was associated with higher SOFA and GWTG-HF risk scores. However, no significant difference was observed in the area under the curve value between the scores. Kaplan-Meier survival analysis indicated that higher SOFA scores (P < 0.001) and GWTG-HF risk scores (P < 0.001) were related to increased probabilities of all-cause death. On multivariate Cox proportional hazard model analysis, the SOFA score (P < 0.001) and GWTG-HF (P < 0.001) score were independent predictors of all-cause death. Incorporating the SOFA score into the GWTG-HF risk score yielded a significant net reclassification improvement and integrated discrimination improvement. On decision curve analysis, the net benefit of the SOFA score model when compared with the reference model was greater across the range of threshold probabilities. CONCLUSIONS: In acute HF patients, long-term all-cause mortality can be predicted by the SOFA score. Discriminative performance metrics, such as net reclassification improvement, integrated discrimination improvement, and decision curve analysis, for predicting mortality were improved when the SOFA score was incorporated.

Influence of secondary neutrons induced by proton radiotherapy for cancer patients with implantable cardioverter defibrillators.

BACKGROUND: Although proton radiotherapy is a promising new approach for cancer patients, functional interference is a concern for patients with implantable cardioverter defibrillators (ICDs). The purpose of this study was to clarify the influence of secondary neutrons induced by proton radiotherapy on ICDs. METHODS: The experimental set-up simulated proton radiotherapy for a patient with an ICD. Four new ICDs were placed 0.3 cm laterally and 3 cm distally outside the radiation field in order to evaluate the influence of secondary neutrons. The cumulative in-field radiation dose was 107 Gy over 10 sessions of irradiation with a dose rate of 2 Gy/min and a field size of 10 × 10 cm². After each radiation fraction, interference with the ICD by the therapy was analyzed by an ICD programmer. The dose distributions of secondary neutrons were estimated by Monte-Carlo simulation. RESULTS: The frequency of the power-on reset, the most serious soft error where the programmed pacing mode changes temporarily to a safety back-up mode, was 1 per approximately 50 Gy. The total number of soft errors logged in all devices was 29, which was a rate of 1 soft error per approximately 15 Gy. No permanent device malfunctions were detected. The calculated dose of secondary neutrons per 1 Gy proton dose in the phantom was approximately 1.3-8.9 mSv/Gy. CONCLUSIONS: With the present experimental settings, the probability was approximately 1 power-on reset per 50 Gy, which was below the dose level (60-80 Gy) generally used in proton radiotherapy. Further quantitative analysis in various settings is needed to establish guidelines regarding proton radiotherapy for cancer patients with ICDs.

Combined assessment of carotid vulnerable plaque, renal insufficiency, eosinophilia, and hs-CRP for predicting risky aortic plaque of cholesterol crystal embolism.

BACKGROUND: Cholesterol crystal embolism (CCE) is a serious complication of vascular procedures and based on the clinical features of patients with CCE, the aim of the present study was to establish screening criteria for aortic complex plaques (ACP) at high-risk of CCE. METHODS AND RESULTS: For the first study, 10 patients diagnosed as having CCE were recruited. They had prior multiple atherosclerotic disease and a high proportion of complex plaques of the carotid artery and aorta. Elevated levels of high-sensitivity C-reactive protein (hs-CRP), eosinophilia, and renal insufficiency were already recognized before CCE diagnosis. The second study prospectively enrolled 102 patients. ACP is related to CCE and predictive criteria of ACP were established. Among 19 patients with ACP, 2 presented with CCE. Multivariate analysis revealed carotid complex plaque, eosinophilia and multiple atherosclerotic risk factors as independent predictors of ACP. The criteria including these factors (multiple atherosclerotic risk factors, carotid complex plaque, hs-CRP > or =0.2 mg/dl, eGFR < or =60 ml . min(-1) . 1.73 m(-2), eosinophil count > or =400 /microl) could detect patients with ACP with 95% sensitivity, 94% specificity, and 79% positive predictive value. CONCLUSIONS: Multiple atherosclerotic risk factors, elevated hs-CRP, renal insufficiency, eosinophilia before CCE diagnosis and carotid complex plaques were features of patients with CCE. Diagnostic criteria including these characteristics effectively predict ACP patients at high-risk of CCE. (Circ J 2010; 74: 51 - 58).