Results from a multicenter retrospective study of transradial iliac artery stenting in Japan.

Large-scale multicenter studies demonstrating the safety and effectiveness of transradial iliac artery stenting are lacking. We evaluated the data from a multicenter database in Japan. Transradial iliac artery stenting was performed on 115 lesions in 105 patients. The approach site was determined at the discretion of the operator. Patients with scheduled multiple sheath insertions for the bidirectional approach were excluded. Clinical data were retrospectively analyzed. The average age of this cohort was 71.1 ± 8.3 years. Eighty-six patients (81.9%) were male. Diabetes mellitus, hypertension, dyslipidemia, and smoking habit were present in 39 (37.1%), 84 (80.0%), 69 (65.7%), and 78 patients (74.3%), respectively. Rutherford classifications 1, 2, 3, 4, and 5 comprised 40 (34.8%), 42 (36.5%), 28 (24.3%), 3 (2.6%), and 2 (1.7%) lesions, respectively, while Trans-Atlantic Inter-Society Consensus II classifications A, B, C, and D comprised 74 (64.3%), 21 (18.3%), 15 (13.0%), and 5 (4.3%), respectively. Twenty-seven lesions (23.5%) had chronic total occlusion. All lesions were successfully treated with 141 stents. Four patients (3.8%) required additional puncture of the common femoral artery for successful stent implantation. The ankle-brachial index significantly improved from 0.65 ± 0.17 to 0.95 ± 0.15 (P < 0.0001). None of the patients experienced any procedural or access site-related complications. Asymptomatic radial artery occlusion was observed in three cases (2.9%) after the procedure. There were no target lesion revascularizations or complications at 1 month. Compared to the traditional transfemoral approach, transradial iliac artery stenting is safe and feasible without any specific complications in carefully selected patients.

Real-world outcomes of ponatinib treatment in 724 patients with CML and Ph+ ALL: a post-marketing surveillance study with a special interest in arterial occlusive events in Japan.

BACKGROUND: In September 2016, ponatinib was approved in Japan for the treatment of patients with chronic myeloid leukemia with resistance/intolerance to prior tyrosine kinase inhibitors and patients with relapsed or refractory Philadelphia chromosome-positive acute lymphoblastic leukemia. METHODS: We conducted a post-marketing all-case surveillance to study the safety and efficacy of ponatinib in clinical practice, focusing on arterial occlusive events. RESULTS: Data from 724 patients were collected for 2 years from the initiation of ponatinib. The arterial occlusive events were reported in 6.49% (47/724) with an exposure-adjusted incidence rate of 6.8/100 person-years. The risks associated with arterial occlusive events were age and comorbidities including hypertension and diabetes. At 104 weeks, the cumulative major molecular response rate in patients with chronic-phase chronic myeloid leukemia was 67.2% and the complete cytogenetic response in patients with Philadelphia chromosome-positive acute lymphoblastic leukemia was 80.0%. Furthermore, the estimated 1-year overall survival rate was 98.5% for chronic-phase chronic myeloid leukemia and 68.6% for Philadelphia chromosome-positive acute lymphoblastic leukemia. CONCLUSIONS: This surveillance demonstrated that ponatinib has a favorable safety and efficacy profile in Japanese patients and also showed the necessity of closely monitoring arterial occlusive events in older adults and patients with predisposing factors for atherosclerosis.

Clinical efficacy of tolvaptan in acute decompensated heart failure patients with severe aortic stenosis and atrial fibrillation: a sub-analysis from the LOHAS registry.

BACKGROUND: Severe aortic valve stenosis (AS) and atrial fibrillation (AF) are risk factors of hemodynamic instability in heart failure (HF) management due to low cardiac output, respectively. Therefore, the treatment of HF due to severe AS complicated with AF is anticipated to be difficult. Tolvaptan, a vasopressin V2 receptor inhibitor, is effective in controlling acute decompensated heart failure (ADHF) with hemodynamic stability. However, its clinical efficacy against ADHF caused by AS with AF remains to be determined. METHODS: Clinical information (from September 2014 to December 2017) of 59 patients diagnosed with ADHF due to severe AS (20 patients with AF; 39 patients with sinus rhythm [SR]) was obtained from the LOHAS registry. The registry collected data from seven hospitals and assessed the short-term effects of tolvaptan in patients hospitalized for ADHF with severe AS. We attempted to identify clinical differences from baseline up to 4 days, comparing patients with AF (AF group) versus those with SR (SR group). RESULTS: There were no significant differences between the groups in age (83.7 ± 4.5 vs. 85.8 ± 6.9 years, respectively; p = 0.11) and aortic valve area (0.60 [0.46-0.73] vs. 0.56 [0.37-0.70] cm2, respectively; p = 0.50). However, left atrial volume was larger (104 [85-126] vs. 87 [64-103] mL, respectively; p < 0.01), whereas stroke volume was lower (51.6 ± 14.8 vs. 59.0 ± 18.7 mL, respectively; p = 0.08) in the AF group versus the SR group. Body weight decreased daily from baseline up to day 4 in both groups (from 55.4 to 53.2 kg [p < 0.01] and from 53.5 to 51.0 kg [p < 0.01], respectively) without change in heart rate. Notably, the systolic blood pressure decreased slightly in the AF group after 2 days of treatment with tolvaptan. CONCLUSIONS: Short-term treatment with tolvaptan improved HF in patients hospitalized for severe AS, regardless of the presence of AF or SR. After achieving sufficient diuresis, a slight decrease in blood pressure was observed in the AF group, suggesting an appropriate timeframe for safe and effective use of tolvaptan.

Volume-outcome relationship in balloon aortic valvuloplasty: results of a consecutive, patient-level data analysis from a Japanese nationwide multicentre registry (J-SHD).

OBJECTIVE: Transcatheter balloon aortic valvuloplasty (BAV) remains an important alternative treatment for severe, symptomatic aortic stenosis. With increasing numbers of BAVs being performed, the need for large-scale volume-outcome relationship assessments has become evident. Here, we aimed to explain such relationships by analysing consecutive, patient-level BAV data recorded in a prospective Japanese nationwide multicentre registry. DESIGN: Prospective study. SETTING: Data of 1920 BAVs performed in 200 Japanese hospitals from January 2015 to December 2019. PARTICIPANTS: The mean patient age was 85 years, and 36.9% of procedures involved male patients. METHODS: The efficacy of BAV was assessed by reducing the mean transaortic valve gradient after the procedure. We also assessed in-hospital complication rates, including in-hospital death, bleeding, urgent surgery, distal embolism, vessel rupture and contrast-induced nephropathy. Based on the distribution of case volume (median 20, IQR 10-46), we divided the patients into high-volume (≥20) and low-volume (<20) groups. In-hospital complication risk was assessed with adjustment by logistic regression modelling. RESULTS: Indications for BAV included palliative/destination (44.2%), bridge to transcatheter aortic valve replacement (34.5%), bridge to surgical aortic valve replacement (7.4%) and salvage (9.7%). Reduction of the mean transaortic valve gradient was similar between the high-volume and low-volume groups (20 mm Hg vs 20 mm Hg, p=0.12). The proportion of in-hospital complications during BAV was 4.2%, and the incidence of complications showed no difference between the high-volume and low-volume groups (4.2% vs 4.1%, p=1.00). Rather than hospital volume, salvage procedure was an independent predictor of in-hospital complications (OR, 4.04; 95% CI, 2.03 to 8.06; p<0.001). CONCLUSION: The current study demonstrated that procedural outcomes of BAV were largely independent of its institutional volume.

Incidence of Arterial Thrombotic and Bleeding Events in Patients Who Develop Cancer After ST-elevation Myocardial Infarction.

Objective Cancers increase the risk of both arterial thrombosis and bleeding. The present study investigated whether or not comorbid new-onset cancers increase arterial thrombosis and bleeding events in patients after ST-elevation myocardial infarction (STEMI). Methods Among 918 consecutive STEMI patients, excluding 300 who used mechanical hemodynamic supportive devices, the 67 with cancer and 851 without cancer were compared with respect to the frequency of thrombotic events, consisting of myocardial infarction (MI) and ischemic stroke, and bleeding events during the trackable observation period in this observational study. The predictive accuracy for bleeding events evaluated by the Academic Research Consortium (ARC) high bleeding risk (HBR) criteria and the patients receiving stent implantation and subsequent dual antiplatelet therapy (PRECISE-DAPT) score was assessed by C-statistics. Bleeding events were defined as type 3 or 5 according to the Bleeding Academic Research Consortium criteria. Results During the 1,233.3±1,284.4-day observation period, thrombotic events were observed in 13.4% of patients with cancer and 7.1% of patients without cancer (p=0.06; incidence rates, 2.4 vs. 2.4/100 person-years). MI and ischemic stroke were observed in 6.0% of patients with cancer and 3.5% of patients without cancer (p=0.23; incidence rates, 1.0 vs. 1.2/100 person-years) and 7.5% of patients with cancer and 3.6% of patients without cancer (p=0.18; incidence rates, 1.0 vs. 1.2/100 person-years), respectively. Bleeding events were observed in 26.9% of patients with cancer and 7.6% of patients without cancer (p<0.01; incidence rates, 4.4 vs. 2.4/100 person-years). The C-statistics for predicting bleeding events in patients with and without cancer were 0.65 vs. 0.71 using the ARC-HBR criteria and 0.67 vs. 0.71 using the PRECISE-DAPT scores, respectively. Conclusion Cancers increase unpredictable bleeding but not arterial thrombotic events in patients after STEMI.

Poor Below Knee Runoff Impacts Femoropopliteal Stent Failure and Fluoropolymer Antithrombotic Effect in Healthy Swine Model.

OBJECTIVE: Poor below knee (BTK) runoff is a predictor of stent failure after endovascular femoropopliteal artery treatment; however, lack of pathological evaluation has prevented characterisation of stent failure. The study aimed to investigate the impact of poor BTK runoff and the antithrombotic effect of the polymer of fluoropolymer coated paclitaxel eluting stents (FP-PESs) in a healthy swine femoropopliteal artery model. METHODS: FP-PESs and bare metal stents (BMSs) and FP-PES and polymer free paclitaxel coated stents (PF-PCSs) were implanted in the bilateral femoral arteries of healthy swine (n = 6, respectively) following coil embolisation in both tibial arteries to induce poor BTK runoff. Histological assessment and intravascular imaging device evaluation were performed at one month. The Japanese Association for Laboratory Animal Science approved the study protocol (reference number: IVT22-90). RESULTS: Optical coherence tomography showed significantly lower percent area stenosis in FP-PES compared with BMS (37.3%, [interquartile range (IQR), 25.6 - 54.3] % vs. 92.5% [IQR, 75.5 - 96.1] %, respectively, p = .031), and PF-PCS (8.3% [IQR, 4.5 - 27.0] % vs. 31.2% [IQR, 23.3 - 52.2] %, respectively, p = .031). Histopathological evaluation demonstrated that thin fibrin attachment without re-stenosis was the most dominant neointimal tissue characteristic in FP-PES. On the other hand, neointimal tissue characteristics with significant restenosis of BMS and PF-PCS were mainly organising or organised thrombus. CONCLUSION: Organising and or organised thrombus attachment due to poor BTK runoff was the main cause of in stent restenosis of the swine femoral artery. FP-PES demonstrated the least percent area stenosis, suggesting the importance of the antithrombotic effect of polymer.

Echocardiographic score for the screening of cardiac amyloidosis with positive 99m technetium pyrophosphate scintigraphy result.

INTRODUCTION: Speckle-tracking-derived strains in cardiac chambers may provide better solutions for transthyretin amyloid cardiomyopathy (ATTR-CM) screening. This study aimed to evaluate the efficacy of biventricular strain measurements using speckle tracking for screening 99m Tc-pyrophosphate (99m Tc-PYP) scintigraphy-positive cardiomyopathy, which is nearly equivalent to ATTR-CM. METHODS: We performed a retrospective analysis of transthoracic echocardiographic studies using vendor-independent speckle tracking analysis in older patients (≥65 years) who underwent 99m Tc-PYP scintigraphy to evaluate the etiology of suspected ATTR-CM in our institute between January 2019 and December 2022. RESULTS: The entire cohort (n = 89) was divided into two subgroups positive 99m Tc-PYP scan results (n = 34) and negative 99m Tc-PYP scan results (n = 55). In the multivariate analysis, posterior wall thickness (p = .003, odds ratio [OR]:1.48, 95% confidence interval [CI]:1.14 -1.92), left ventricular longitudinal strain apical/basal ratio (LVLSapi/bas) (p = .015, OR: 2.78, 95% CI: 1.23-6.32, and right ventricular longitudinal strain (RVLS) (p = .003, OR: 1.15, 95% CI: 1.05 -1.26) were selected to be the most representative echocardiographic findings in 99m Tc-PYP positive cardiomyopathy. The receiver operating characteristic analysis indicated that posterior wall thickness (p < .0001, area under the curve [AUC]: .821, cut-off value: 14.0 mm), LVLSapi/bas (p < .001, AUC: .802, cut-off value: 2,16), and RVLS (p < .001, AUC: .791, cut-off value: -18.7%) could significantly detect 99m Tc-PYP positive results with an excellent credibility. Echocardiographic score points calculated using the summary of these three parameters in each patient revealed that a 2-point score had a fair sensitivity (85%) and an excellent specificity (93%), while a 1-point score had an excellent sensitivity (91%) and a modest specificity (53%). CONCLUSION: Our proposed echocardiographic screening tool for 99m Tc-PYP scintigraphy-positive cardiomyopathy may help clinicians manage patients with suspected ATTR-CM.

Ischemic and Bleeding Outcomes in Patients Who Underwent Percutaneous Coronary Intervention With Chronic Kidney Disease or Dialysis (from a Japanese Nationwide Registry).

The relation between chronic kidney disease (CKD) and outcomes in patients receiving percutaneous coronary intervention (PCI) is thought to be bidirectional; these patients are at a higher risk of ischemic and bleeding events. From a Japanese nationwide PCI registry, ischemic (cardiovascular death, nonfatal myocardial infarction, or nonfatal ischemic stroke) and bleeding events (fatal or nonfatal major bleeding) 1 year after discharge among patients who had second- or newer-generation drug-eluting stent implantation were analyzed. Patients on oral anticoagulants were excluded. Patients were stratified according to their preprocedural renal function: CKD stages 1 to 2 (estimated glomerular filtration rate [eGFR] ≥60 ml/min/1.73 m2), 3 (eGFR 30 to 59), or 4 to 5 (eGFR <30), or those receiving dialysis. Overall, 23,349 patients, including 2,798 patients with CKD 3 to 5 (12.0%) and 1,464 patients on dialysis (6.3%), were investigated. One-year ischemic events were observed in 1.5%, 5.2%, 9.7%, and 5.3% in the CKD stages 1-to-2, 3, 4-to-5, and dialysis groups, respectively; patients with CKD stages 3 or 4 to 5 and those receiving dialysis were associated with higher risks of ischemic events after adjustment of covariates than were patients without CKD. Compared with ischemic events, 1-year bleeding events were low, with incidence rates of 1.5%, 2.0%, 3.4%, and 2.3%, respectively. Furthermore, the presence of CKD or dialysis was not associated with a higher risk of bleeding events after adjustment of covariates. In conclusion, in the contemporary nationwide PCI registry, the presence of CKD and dialysis was independently associated with a higher risk of ischemic events but not with bleeding events, and this suggests a need to alter the models of care delivery in these patients.

Interim Report of a Japanese Phase II Trial for Cardiac Stereotactic Body Radiotherapy in Refractory Ventricular Tachycardia　- Focus on Target Determination.

Background: Cardiac radiotherapy using stereotactic body radiation therapy (SBRT) has attracted attention as a minimally invasive treatment for refractory ventricular tachycardia. However, a standardized protocol and software program for determining the irradiation target have not been established. Here, we report the first preclinical stereotactic radioregulation antiarrhythmic therapy trial in Japan, focused on the target-setting process. Methods and Results: From 2019 onwards, 3 patients (age range 60-91 years) presenting with ischemic or non-ischemic cardiomyopathy were enrolled. Two patients were extremely serious and urgent, and were followed up for 6 and 30 months. To determine the irradiation targets, we aggregated electrophysiological, structural, and functional data and reflected them in an American Heart Association 17-segment model, as per the current recommendations. However, in all 3 patients, invasive electrophysiological study, phase-contrast computed tomography, and magnetic resonance imaging could not be performed; therefore, electrophysiological and structural information was limited. As alternatives, high-resolution ambulatory electrocardiography and nuclear medicine studies were useful in assessing arrhythmic substrates; however, concerns regarding test weighting and multiple scoring remain. Risks to surrounding organs were fully taken into account. Conclusions: In patients requiring cardiac SBRT, the information needed for target planning is sometimes limited to minimally invasive tests. Although there are issues to be resolved, this is a promising option for the life-saving treatment of patients in critical situations.

Clinical expert consensus document on drug-coated balloon for coronary artery disease from the Japanese Association of Cardiovascular Intervention and Therapeutics.

Drug-coated balloon (DCB) technology was developed to deliver the antiproliferative drugs to the vessel wall without leaving any permanent prosthesis or durable polymers. The absence of foreign material can reduce the risk of very late stent failure, improve the ability to perform bypass-graft surgery, and reduce the need for long-term dual antiplatelet therapy, potentially reducing associated bleeding complications. The DCB technology, like the bioresorbable scaffolds, is expected to be a therapeutic approach that facilitates the "leave nothing behind" strategy. Although newer generation drug-eluting stents are the most common therapeutic strategy in modern percutaneous coronary interventions, the use of DCB is steadily increasing in Japan. Currently, the DCB is only indicated for treatment of in-stent restenosis or small vessel lesions (< 3.0 mm), but potential expansion for larger vessels (≥ 3.0 mm) may hasten its use in a wider range of lesions or patients with obstructive coronary artery disease. The task force of the Japanese Association of Cardiovascular Intervention and Therapeutics (CVIT) was convened to describe the expert consensus on DCBs. This document aims to summarize its concept, current clinical evidence, possible indications, technical considerations, and future perspectives.

Estimation of adverse events associated with P2Y12 receptor inhibitors stratified by academic research consortium for high bleeding risk criteria in acute coronary syndrome.

BACKGROUND: The usefulness of the Academic Research Consortium for High Bleeding Risk (ARC-HBR) criteria in the selection of P2Y12 receptor inhibitors for acute coronary syndrome is unknown. This study investigated whether the selection of antiplatelet agents according to the ARC-HBR criteria could improve clinical outcomes. METHODS: This multicenter retrospective study included 1261 patients with acute coronary syndrome who received dual antiplatelet therapy, namely clopidogrel (75 mg, n = 529) or prasugrel (3.75 mg, n = 732) in addition to aspirin. The primary endpoint was net adverse clinical events (NACE) after hospital admission, including ischemic (death, myocardial infarction, ischemic stroke) and bleeding events (Bleeding Academic Research Consortium 3 or 5). Secondary outcomes were ischemic and bleeding events. For each patient, the observation period was defined as the duration of dual antiplatelet therapy after admission. RESULTS: During the observation period (average: 313 days), the rate of NACE was lower in the prasugrel group than the clopidogrel group (20.6% vs. 12.6%, respectively, P < 0.01). In patients who satisfied or did not satisfy the ARC-HBR criteria, prasugrel was associated with a 3.7% and 2.1% lower incidence of NACE, respectively, versus clopidogrel. Ischemic and bleeding events were less frequent in the prasugrel group than the clopidogrel group (11.5% vs. 7.9%, respectively, P = 0.03; 10.6% vs. 5.2%, respectively, P < 0.01). The estimated incidence models for NACE suggested that the difference between clopidogrel and prasugrel was greater in patients who satisfied the ARC-HBR criteria than in those who did not. CONCLUSIONS: Prasugrel is preferable to clopidogrel regardless of the ARC-HBR.

Heavy Ion Irradiation Reduces Vulnerability to Atrial Tachyarrhythmias　- Gap Junction and Sympathetic Neural Remodeling.

BACKGROUND: Low-invasive stereotactic body radiation therapy is a novel anti-arrhythmic strategy. The mechanisms underlying its effects against ventricular tachycardia/fibrillation (VT/VF) are gradually becoming clear, whereas those underlying atrial tachycardia/fibrillation (AT/AF) remain unknown. This study investigated the effects of carbon ion beam on gap junction expression and sympathetic innervation.Methods and Results: Atrial and ventricular tachyarrhythmia models was established in 26 hypercholesterolemic (HC) 3-year-old New Zealand white rabbits; 12 rabbits were irradiated with a single 15-Gy carbon ion beam (targeted heavy ion irradiation [THIR]) and 14 were not (HC group). Eight 3-month-old rabbits (Young) were used as a reference group. In vivo induction frequencies in the Young, HC, and HC+THIR groups were 0%, 9.9%, and 1.2%, respectively, for AT/AF and 0%, 7.8%, and 1.2%, respectively, for VT/VF (P<0.01). The conduction velocity of the atria and ventricles on optical mapping was significantly reduced in the HC group; this was reversed in the HC+THIR group. Connexin-40 immunolabelling in the atria was 66.1-78.7% lower in the HC than Young group; this downregulation was less pronounced in the HC+THIR group (by 23.1-44.4%; P<0.01). Similar results were obtained for ventricular connexin-43. Sympathetic nerve densities in the atria and ventricles increased by 41.9-65.3% in the HC vs. Young group; this increase was reversed in the HC+THIR group. CONCLUSIONS: Heavy ion radiation reduced vulnerability to AT/AF and VT/VF in HC elderly rabbits and improved cardiac conductivity. The results suggest involvement of connexin-40/43 upregulation and suppression of sympathetic nerve sprouting.

Additional effect of hemodialysis on mortality estimated from renal function in ischemic heart disease.

Aim: The present study examined whether hemodialysis in patients with ischemic heart disease increases mortality more than the estimated mortality from renal function. Patients & methods: A total of 1621 patients with angina pectoris (n = 815), ST-elevation myocardial infarction (n = 421) or non-ST-elevation acute coronary syndrome (n = 385) were examined. An estimated mortality curve according to the estimated glomerular filtration rate was drawn using the marginal effect from the logit model. The probability of mortality in patients with hemodialysis was plotted on these curves. Results: The probability of mortality in patients undergoing hemodialysis crossed the estimated mortality curves at the estimated glomerular filtration rate of 5.7 ml/min/1.73 m2 in angina pectoris, 31.3 ml/min/1.73 m2 in STEMI and 45.9 ml/min/1.73 m2 in non-ST-elevation acute coronary syndrome. Conclusion: Hemodialysis does not have an additional adverse impact on the estimated mortality.

The present study examined whether maintenance hemodialysis in patients with ischemic heart disease has an additional adverse impact on the estimated mortality calculated using a parameter of renal function. The results showed that hemodialysis in patients who undergo optimal medical treatment does not have an additional adverse impact on the estimated mortality.

Clinical Characteristics and Outcomes of Patients Presenting With Acute Myocardial Infarction Without Cardiogenic Shock.

BACKGROUND: Most patients with acute myocardial infarction (AMI) present in the emergency department in a hemodynamically stable condition (i.e., non-cardiogenic shock) (AMI-NCS). However, few studies specifically focused on the clinical characteristics and outcomes of AMI-NCS patients. Temporal trends in clinical characteristics, in-hospital occurrence of in-hospital adverse outcomes, and the effect of primary percutaneous coronary intervention (PPCI) were examined.Methods and Results: Between April 2012 and March 2018, 176,275 AMI-NCS patients (67.7% of the total AMI population; 25.4% female; mean age 68.6±13.1 years) were identified in a nationwide Japanese administrative database. During the 6-year study period, AMI-NCS patients have been getting older and had an increasing burden of comorbidities. The rates of 30-day all-cause mortality and in-hospital complications were 2.6% and 30.5%, respectively. Thirty-day all-cause mortality did not change significantly over time, whereas in-hospital complications, especially major non-cardiac events, increased progressively. On multivariable analyses, higher age, higher Killip class, atrial fibrillation, chronic renal failure, and malignancy were independently associated with both increased 30-day mortality and in-hospital complications. PPCI was independently associated with lower mortality and in-hospital complications. CONCLUSIONS: The clinical background of AMI-NCS patients has been becoming more complex with increasing age and the burden of comorbidities, with increased in-hospital complications. More active and appropriate application of PPCI may further decrease adverse events and improve survival of AMI-NCS patients.

Gender Differences in Takotsubo Syndrome.

Most patients with Takotsubo Syndrome (TTS) are postmenopausal females. TTS in males is rare and gender differences have not been sufficiently investigated. Therefore, we investigated gender differences in TTS. TTS in males and females is often triggered by physical and emotional stress, respectively. Heart failure, a severe in-hospital complication, requires greater mechanical respiratory support in males. Fatal arrhythmias such as ventricular tachycardia and ventricular fibrillation and in-hospital mortality rates are higher in males. The white blood cell (WBC) count has been shown to be higher in males than in females with cardiovascular death compared with non-cardiovascular death. Therefore, the WBC count, a simple marker, may reflect severe TTS. Decreased estrogen levels, common in postmenopausal females, are a pathogenic mechanism of TTS. Females have a more significant increase in the extracellular matrix-receptor interaction than males. Moreover, the pathological findings after hematoxylin-eosin staining were different in males and females. Males had more severe complications than females in the acute phase of TTS; thus, more careful observations and interventions are likely required. From these results, it can be considered that the mechanism of the onset of TTS may be different between males and females. Therefore, it is necessary to fully understand the gender differences in order to more effectively manage TTS.

Ablation index-guided cavotricuspid isthmus ablation with contiguous lesions using fluoroscopy integrated 3D mapping in atrial flutter.

PURPOSE: The feasibility and safety of cavotricuspid isthmus (CTI) ablation with contiguous lesions using ablation index (AI) under the guidance of fluoroscopy integrated 3D mapping (CARTO UNIVU/CU) in typical atrial flutter (AFL) remains uncertain. This study aimed to determine the efficacy of AI-guided CTI ablation with contiguous lesions in patients with AFL. METHODS: In this single-center, prospective, non-randomized, single-arm, observational study, procedural outcomes were determined in 151 patients undergoing AI-guided CTI ablation (AI group) with a target AI value of 450 and an interlesion distance of ≤ 4 mm under CU guidance. These outcomes were compared with those of 30 patients undergoing non-AI-guided ablation (non-AI group). RESULTS: Among 151 patients, first-pass conduction block was achieved in 120 (80%) patients in the AI group (67% in the non-AI group, P = 0.152) with a shorter fluoroscopy time of 0.2 ± 0.4 min (1.7 ± 2.0 min in the non-AI group, P < 0.001). Conduction gaps were located at the atrial aspects near the inferior vena cava in 24 of 31 (78%) patients without first-pass conduction block. The AI group received 11 ± 5 (12 ± 4 in the non-AI group, P = 0.098) radiofrequency (RF) applications, and the RF time was 4.2 ± 2.4 (5.1 ± 2.5 min in the non-AI group, P = 0.011). Despite the occurrence of steam pop in 3 (2%) patients, none of them developed cardiac tamponade. No patients had recurrence within 6 months of follow-up. CONCLUSIONS: AI-guided CTI ablation in combination with CU was feasible and effective in reducing radiation exposure in patients with AFL.

Impact of atrial fibrillation and the clinical outcomes in patients with acute myocardial infarction from the K-ACTIVE registry.

BACKGROUND: The clinical incidence and impact of atrial fibrillation (AF) in Japanese acute myocardial infarction (AMI) patients is not fully understood. METHODS: To elucidate the clinical incidence and impact of AF on in-hospital mortality in AMI patients, we analyzed a Japanese observational prospective multicenter registry of acute myocardial infarction (K-ACTIVE: Kanagawa ACuTe cardIoVascular rEgistry), which spans 2015 to 2019. A major adverse cardiac event (MACE) was defined as cardiovascular death, non-fatal myocardial infarction (MI), and non-fatal stroke. For assessing bleeding events, Bleeding Academic Research Consortium (BARC) type 3 or 5 was used. MACE plus BARC type 3 or 5 bleeding were considered as composite events. The clinical outcomes were followed for 1 year. RESULTS: The total of 5059 patients included 531 patients with AF (10.5%) and 4528 patients with sinus rhythm (SR; 89.5%). AF patients were significantly older and tended to have more comorbidities than SR patients. Oral anticoagulation therapy (OAC) was used in 44% of AF patients while single antiplatelet therapy was selected for 52% of patients with OAC. Crude in-hospital mortality was significantly greater in AF patients than in SR patients (10.4%, 5.0%, respectively, p < 0.01). The multivariate analysis was adjusted for age, sex, diabetes, hypertension, hemodialysis, smoking, previous MI, body mass index, Killip classification, out of hospital cardiac arrest, and OAC. In-hospital mortality was still significantly greater in AF patients than in SR patients in the logistic regression analysis [adjusted odds ratio 2.02 (1.31-3.14)]. AF was an independent risk factor for MACE and composite events in the Cox proportional hazards model [adjusted risk ratio (ARR) 1.91 (1.36-2.69), p < 0.01; ARR 1.72 (1.25-2.36), p < 0.01]. In contrast, AF was not an independent risk factor for bleeding [ARR 1.71 (0.79-3.71), p = 0.18]. CONCLUSION: In Japanese AMI patients, AF was often observed and was associated with worse MACE but not worse bleeding.

Distal radial artery approach for endovascular therapy.

It has been reported that the distal transradial approach (dTRA) is safe and useful for percutaneous coronary intervention (PCI). In this study we evaluated the safety and efficacy of the dTRA for endovascular therapy (EVT). The dTRA for EVT was performed in 43 lesions from 35 patients. Approach site was determined at the discretion of the operator. Clinical data were analyzed retrospectively. Average patient age was 74.0 ± 6.5 years; 30 (86%) were male; average height was 161.1 ± 8.4 cm. Diabetes mellitus, hypertension, dyslipidemia, and smoking habit were present in 19 (54.3%), 31 (88.6%), 29 (82.9%), and 29 (82.9%) patients, respectively. Target lesions were iliac artery in 38 (88.4%) patients, superficial femoral artery in 4 (9.3%) and renal artery in the remaining patient (2.3%). Eight lesions (18.6%) were chronic total occlusions. Thirteen (30.2%), 2 (4.7%), and 28 (65.1%) lesions were treated using 4.5, 6, and 7 French long guiding systems, respectively. All lesions were successfully treated without any procedural or access site-related complications. No additional puncture sites were required. Ankle brachial index significantly improved from 0.62 ± 0.20 to 0.92 ± 0.17 (p < 0.0001) post-treatment for the lower limbs. There were no radial artery occlusions, target lesion revascularization, or complications 1 month later. Similar to PCI, the dTRA for EVT is safe and feasible without any specific complications in carefully selected patients.

Effect of Cardiac Rehabilitation on Glomerular Filtration Rate Using Serum Cystatin C Concentration in Patients With Cardiovascular Disease and Renal Dysfunction.

PURPOSE: Among patients with chronic kidney disease (CKD), little is known about whether the effect of cardiac rehabilitation (CR) on renal function differs across baseline estimated glomerular filtration rate using the serum concentration of cystatin C (eGFRcys). The aim of this study was to evaluate the effect of CR on renal function in patients with CKD. METHODS: We performed a retrospective cohort study of patients with CKD (15 ≤ eGFRcys < 60 mL/min/1.73 m2) who participated in our CR program for cardiovascular disease. First, the patients were divided into three groups according to the baseline severity of the eGFRcys: G3a, G3b, and G4 groups. We compared the eGFRcys before and after the CR in each group. Second, to determine the association of baseline eGFRcys with the effect of CR, we fitted a linear regression model using the percent change in the eGFRcys (%ΔeGFRcys) as an outcome. RESULTS: Of the 203 patients, 122 were in G3a, 60 were in G3b, and 21 were in G4 groups. The mean improvement of eGFRcys in each group was 1.3, 3.1, and 4.8 mL/min/1.73 m2, respectively. The %ΔeGFRcys was larger among patients with lower baseline eGFRcys (0.47% greater improvement of %ΔeGFRcys/one lower baseline eGFRcys; 95% CI, 0.23-0.72%). This association remained significant after adjustment for potential confounders (0.63% greater improvement of %ΔeGFRcys/one lower baseline eGFRcys; 95% CI, 0.35-0.91%). CONCLUSIONS: The effect of CR on renal function was greater in patients with worse renal dysfunction measured by eGFRcys. A CR program could be useful for patients with severe renal dysfunction and it might have a beneficial effect on their renal function.

Impact of exercise capacity on the long-term incidence of atrial arrhythmias in heart failure.

We sought to demonstrate the impact of improved peak exercise oxygen consumption (V̇O2) during maximal exercise testing after cardiac rehabilitation (CR) on the incidence of arrhythmias in patients with heart failure (HF). The present study comprised of 220 patients with HF, and peak V̇O2 was examined at 2 and 5 months after CR. Of the 220 patients, 110 (50%) had a low peak V̇O2 of < 14 mL/min/kg at 2 months. The peak V̇O2 improved in 86 of these 110 (78%) patients at 5 months after CR. During a median follow-up of 6 years, the patients with improvement in peak V̇O2, compared to those without peak V̇O2 improvement, had a lower rate of mortality (4% vs. 29%, log-rank, P < 0.001) and HF hospitalization (6 vs. 17%, log-rank, P = 0.044) and a lower incidence of new-onset atrial arrhythmias (9 vs. 27%, log-rank, P = 0.013), with no difference in the incidence of ventricular arrhythmias between groups (1 vs. 4%, log-rank, P = 0.309). The majority of deaths in the patients without an improved peak V̇O2 were because of cardiovascular events (73%), particularly progressive HF (55%). Early detection and management of atrial arrhythmias may improve outcomes in patients without peak V̇O2 improvement after CR.