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Neurointervention Jul 2024Hands-on training is a crucial part of education in neuroendovascular treatment to ensure safe and rapid acquisition of techniques. However, there is a significant gap...
Hands-on training is a crucial part of education in neuroendovascular treatment to ensure safe and rapid acquisition of techniques. However, there is a significant gap between training and actual clinical practice. This study will introduce innovations for more practical thrombus retrieval training that was developed in this process. A Smart Vascular Model 3 in 1 was used. A pink pseudothrombus was inserted into the M1 (horizontal segment of the middle cerebral artery) section of the model. Then, a "red underlay" purchased at a stationery store was placed to cover the proximal part of M1 and beyond so that the pseudothrombus was not visible. The thrombus was retrieved during training by looking for the location of the thrombus based on the behavior and resistance of the tip of the guidewire and deployment of the stent retriever. The participants were required to have detailed observation skills and precise manipulation skills using a red film to prevent the direct visualization of the pseudothrombus. The implementation of this innovation to the previous hands-on training made the training more practical and effective. If the exact thrombus location can be determined by the behavior of the wire tip, the device's capabilities can be maximized, and rapid retrieval can be expected. It could also reduce complications, as unnecessary peripheral guidance of the device could be avoided.
PubMed: 38939923
DOI: 10.5469/neuroint.2024.00094 -
JACC. Advances Jan 2024
PubMed: 38939821
DOI: 10.1016/j.jacadv.2023.100748 -
JACC. Advances Jan 2024A simple ambulatory measure of cardiac function could be helpful for monitoring heart failure patients.
BACKGROUND
A simple ambulatory measure of cardiac function could be helpful for monitoring heart failure patients.
OBJECTIVES
The purpose of this paper was to determine whether a novel pulse waveform analysis using data obtained by our developed multisensor-ambulatory blood pressure monitoring (ABPM) device, the 'Sf/Am' ratio, is associated with echocardiographic left ventricular ejection fraction (LVEF).
METHODS
Multisensor-ABPM was conducted twice at baseline in 20 heart failure (HF) patients with HF-reduced LVEF or HF-preserved LVEF (median age 66 years, male 65%) and over a 6- to 12-month follow-up after patient-tailored treatment. We assessed the changes in the pulse waveform index Sf/Am and LVEF that occurred between the baseline and follow-up. The Sf/Am consists of the area of the ejection part in the square forward wave (Sf) and the amplitude of the measured wave (Am). We divided the patients into the recovered (n = 11) and not-recovered (n = 9) groups defined by a ≥10% increase in LVEF.
RESULTS
Although the ambulatory BP levels and variabilities did not change in either group, the Sf/Am increased significantly in the recovered group (baseline 21.4 ± 4.5; follow-up, 25.6 ± 3.7, = 0.004). The not-recovered group showed no difference between the baseline and follow-up. The follow-up/baseline Sf/Am ratio was significantly associated with the LVEF ratio ( = 0.469, = 0.037). The Sf/Am was significantly correlated with the LVEF in overall measurements (n = 40, = 0.491, = 0.001).
CONCLUSIONS
These results demonstrated that a novel noninvasive pulse waveform index, the Sf/Am measured by multisensor-ABPM is associated with LVEF. The Sf/Am may be useful for estimating cardiac function.
PubMed: 38939805
DOI: 10.1016/j.jacadv.2023.100737 -
Journal of Arrhythmia Jun 2024Despite the positive impact of implantable cardioverter defibrillators (ICDs) and wearable cardioverter defibrillators (WCDs) on prognosis, their implantation is often...
Multicenter prospective observational study to clarify the current status and clinical outcome in Japanese patients who have an indication for implantable cardioverter defibrillator (ICD) or wearable cardioverter defibrillator (WCD) (TRANSITION JAPAN-ICD/WCD study): Rationale and design of a...
BACKGROUND
Despite the positive impact of implantable cardioverter defibrillators (ICDs) and wearable cardioverter defibrillators (WCDs) on prognosis, their implantation is often withheld especially in Japanese heart failure patients with reduced left ventricular ejection fraction (HFrEF) who have not experienced ventricular tachycardia (VT) or ventricular fibrillation (VF) for uncertain reasons. Recent advancements in heart failure (HF) medications have significantly improved the prognosis for HFrEF. Given this context, a critical reassessment of the treatment and prognosis of ICDs and WCDs is essential, as it has the potential to reshape awareness and treatment strategies for these patients.
METHODS
We are initiating a prospective multicenter observational study for HFrEF patients eligible for ICD in primary and secondary prevention, and WCD, regardless of device use, including all consenting patients. Study subjects are to be enrolled from 31 participant hospitals located throughout Japan from April 1, 2023, to December 31, 2024, and each will be followed up for 1 year or more. The planned sample size is 651 cases. The primary endpoint is the rate of cardiac implantable electronic device implementation. Other endpoints include the incidence of VT/VF and sudden death, all-cause mortality, and HF hospitalization, other events. We will collect clinical background information plus each patient's symptoms, Clinical Frailty Scale score, laboratory test results, echocardiographic and electrocardiographic parameters, and serial changes will also be secondary endpoints.
RESULTS
Not applicable.
CONCLUSION
This study offers invaluable insights into understanding the role of ICD/WCD in Japanese HF patients in the new era of HF medication.
PubMed: 38939793
DOI: 10.1002/joa3.13028 -
Journal of Arrhythmia Jun 2024A 26-year-old man with long QT syndrome (LQTS) underwent subcutaneous implantable cardioverter-defibrillator (S-ICD) implantation. The patient exhibited sinus...
A 26-year-old man with long QT syndrome (LQTS) underwent subcutaneous implantable cardioverter-defibrillator (S-ICD) implantation. The patient exhibited sinus bradycardia relative to his age. The heart rate decreased, and the QT interval became longer with the administration of β-blockers, the first-line therapy for LQTS. The patient experienced frequent S-ICD discharges. Subsequently, a single-chamber pacemaker was implanted, and the 12-lead electrocardiogram showed atrial pacing and ventricular sensing at 60 beats per minute with a shorter QTc interval. After converting to "double-device therapy," the patient did not experience any ventricular arrhythmia events.
PubMed: 38939789
DOI: 10.1002/joa3.13027 -
JACC. Advances Apr 2024Managing patients with atrial fibrillation (AF) and worsening renal function (WRF) remains a clinical challenge due to the need of dose adjustment of non-vitamin K...
BACKGROUND
Managing patients with atrial fibrillation (AF) and worsening renal function (WRF) remains a clinical challenge due to the need of dose adjustment of non-vitamin K antagonist oral anticoagulants.
OBJECTIVES
To determine the incidence of WRF in patients with AF treated with edoxaban, the association of WRF with clinical outcomes, and predictors of WRF and clinical outcomes in these patients.
METHODS
This is a subanalysis of the Edoxaban Treatment in routiNe clinical prActice for patients with non-valvular Atrial Fibrillation in Europe study (NCT02944019), an observational study of edoxaban-treated patients with AF. WRF was defined as a ≥25% reduction in creatinine clearance between baseline and 2 years.
RESULTS
Of the 9,054 patients included (69% of the total 13,133 enrolled), most did not experience WRF (90.3%) during the first 2 years of follow-up. WRF occurred in 9.7% of patients. Patients with WRF had significantly higher rates of all-cause death (3.88%/y vs 1.88%/y; < 0.0001), cardiovascular death (2.09%/y vs 0.92%/y; < 0.0001), and major bleeding (1.51%/y vs 0.98%/y; = 0.0463) compared with those without WRF. Rates of intracranial hemorrhage (0.18%/y vs 0.18%/y) and of any stroke/systemic embolic events were low (0.90%/y vs 0.69%/y; = 0.3161) in both subgroups. The strongest predictors of WRF were a high CHADS-VASc score, high baseline creatinine clearance, low body weight, and older age. Most predictors of WRF were also predictors of clinical outcomes.
CONCLUSIONS
WRF occurred in approximately 10% of edoxaban-treated AF patients. Rates of death and major bleeding were significantly higher in patients with WRF than without. Stroke events were low in both subgroups.
PubMed: 38939675
DOI: 10.1016/j.jacadv.2024.100880 -
JACC. Advances Apr 2024Major adverse cardiovascular events (MACE) are a leading cause of morbidity and mortality among adults with type 2 diabetes. Currently, available MACE prediction models...
BACKGROUND
Major adverse cardiovascular events (MACE) are a leading cause of morbidity and mortality among adults with type 2 diabetes. Currently, available MACE prediction models have important limitations, including reliance on data that may not be routinely available, narrow focus on primary prevention, limited patient populations, and longtime horizons for risk prediction.
OBJECTIVES
The purpose of this study was to derive and internally validate a claims-based prediction model for 1-year risk of MACE in type 2 diabetes.
METHODS
Using medical and pharmacy claims for adults with type 2 diabetes enrolled in commercial, Medicare Advantage, and Medicare fee-for-service plans between 2014 and 2021, we derived and internally validated the annualized claims-based MACE estimator (ACME) model to predict the risk of MACE (nonfatal acute myocardial infarction, nonfatal stroke, and all-cause mortality). The Cox proportional hazards model was composed of 30 covariates, including patient age, sex, comorbidities, and medications.
RESULTS
The study cohort comprised 6,623,526 adults with type 2 diabetes, mean age 68.1 ± 10.6 years, 49.8% women, and 73.0% Non-Hispanic White. ACME had a concordance index of 0.74 (validation index range: 0.739-0.741). The predicted 1-year risk of the study cohort ranged from 0.4% to 99.9%, with a median risk of 3.4% (IQR: 2.3%-6.5%).
CONCLUSIONS
ACME was derived in a large usual care population, relies on routinely available data, and estimates short-term MACE risk. It can support population risk stratification at the health system and payer levels, participant identification for decentralized clinical trials of cardiovascular disease, and risk-stratified observational studies using real-world data.
PubMed: 38939660
DOI: 10.1016/j.jacadv.2024.100852 -
JACC. Advances Sep 2023Accurate intravascular ultrasound (IVUS) measurements are important in IVUS-guided percutaneous coronary intervention optimization by choosing the appropriate device...
BACKGROUND
Accurate intravascular ultrasound (IVUS) measurements are important in IVUS-guided percutaneous coronary intervention optimization by choosing the appropriate device size and confirming stent expansion.
OBJECTIVES
The purpose of this study was to assess the accuracy of machine learning (ML) automatic segmentation of coronary artery vessel and lumen dimensions and balloon sizing.
METHODS
Using expert analysis as the gold standard, ML segmentation of 60 MHz IVUS images was developed using 8,076 IVUS cross-sectional images from 234 patients, which were randomly split into training (83%) and validation (17%) data sets. The performance of ML segmentation was then evaluated using an independent test data set (437 images from 92 patients). The endpoints were the agreement rate between ML vs experts' measurements for appropriate balloon size selection, and lumen and acute stent areas. Appropriate balloon size was determined by rounding down from the mean vessel diameter or rounding up from the mean lumen diameter to the next balloon size. The difference of lumen area ≥0.5 mm was considered as clinically significant.
RESULTS
ML model segmentation correlated well with experts' segmentation for training data set with a correlation coefficient of 0.992 and 0.993 for lumen and vessel areas, respectively. The agreement rate in lumen and acute stent areas was 85.5% and 97.0%, respectively. The agreement rate for appropriate balloon size selection was 70.6% by vessel diameter only and 92.4% by adding lumen diameter.
CONCLUSIONS
ML model IVUS segmentation measurements were well-correlated with those of experts and selected an appropriate balloon size in more than 90% of images.
PubMed: 38939499
DOI: 10.1016/j.jacadv.2023.100564 -
JACC. Advances Aug 2023Early coronary occlusion detection by portable personal device with limited number of electrocardiographic (ECG) leads might shorten symptom-to-balloon time in acute...
BACKGROUND
Early coronary occlusion detection by portable personal device with limited number of electrocardiographic (ECG) leads might shorten symptom-to-balloon time in acute coronary syndromes.
OBJECTIVES
The purpose of this study was to compare the accuracy of coronary occlusion detection using vectorcardgiographic analysis of a near-orthogonal 3-lead ECG configuration suitable for credit card-size personal device integration with automated and human 12 lead ECG interpretation.
METHODS
The 12-lead ECGs with 3 additional leads ("abc") using 2 arm and 2 left parasternal electrodes were recorded in 66 patients undergoing percutaneous coronary intervention prior to ("baseline", n = 66), immediately before ("preinflation", n = 66), and after 90-second balloon coronary occlusion ("inflation", n = 120). Performance of computer-measured ST-segment shift on vectorcardgiographic loops constructed from "abc" and 12 leads, standard 12-lead ECG, and consensus human interpretation in coronary occlusion detection were compared in "comparative" and "spot" modes (with/without reference to "baseline") using areas under ROC curves (AUC), reliability, and sensitivity/specificity analysis.
RESULTS
Comparative "abc"-derived ST-segment shift was similar to two 12-lead methods (vector/traditional) in detecting balloon coronary occlusion (AUC = 0.95, 0.96, and 0.97, respectively, = NS). Spot "abc" and 12-lead measurements (AUC = 0.72, 0.77, 0.68, respectively, = NS) demonstrated poorer performance ( < 0.01 vs comparative measurements). Reliability analysis demonstrated comparative automated measurements in "good" agreement with reference (preinflation/inflation), while comparative human interpretation was in "moderate" range. Spot automated and human reading showed "poor" agreement.
CONCLUSIONS
Vectorcardiographic ST-segment analysis using baseline comparison of 3-lead ECG system suitable for credit card-size personal device integration is similar to established 12-lead ECG methods in detecting balloon coronary occlusion.
PubMed: 38939446
DOI: 10.1016/j.jacadv.2023.100454 -
JACC. Advances Feb 2024
PubMed: 38939370
DOI: 10.1016/j.jacadv.2023.100770