Angioscopic Evaluation of Atrial Septal Defect Closure Device Neo-Endothelialization.

Background Current guidelines recommend at least 6 months of antithrombotic therapy and antibiotic prophylaxis after septal-occluding device deployment in transcatheter closure of atrial septal defect. It has been estimated that it takes ≈6 months for complete neo-endothelialization; however, neo-endothelialization has not previously been assessed in vivo in humans. Methods and Results The neointimal coverage of septal occluder devices was evaluated 6 months after implantation in 15 patients by angioscopy from the right atrium. Each occluder surface was divided into 9 areas; the levels of endothelialization in each area were semiquantitatively assessed by 4-point grades. Device neo-endothelialization was sufficient in two thirds of patients, but insufficient in one third. In the comparison between patients with sufficiently endothelialized devices of average grade score ≥2 (good endothelialization group, n=10) and those with poorly endothelialized devices of average grade score <2 (poor endothelialization group, n=5), those in the poor endothelialization group had larger devices deployed (27.0 mm [25.0-31.5 mm] versus 17.0 mm [15.6-22.5 mm], respectively) and progressive right heart dilatation. The endothelialization was poorer around the central areas. Moreover, the prevalence of thrombus formation on the devices was higher in the poorly endothelialized areas than in the sufficiently endothelialized areas (Grade 0, 94.1%; Grade 1, 63.2%; Grade 2, 0%; Grade 3, 1.6%). Conclusions Neo-endothelialization on the closure devices varied 6 months after implantation. Notably, poor endothelialization and thrombus attachment were observed around the central areas and on the larger devices.

Influence of coronary artery disease and percutaneous coronary intervention on mid-term outcomes in patients with aortic valve stenosis treated with transcatheter aortic valve implantation.

BACKGROUND: A high frequency of coronary artery disease (CAD) is reported in patients with severe aortic valve stenosis (AS) who undergo transcatheter aortic valve implantation (TAVI). However, the optimal management of CAD in these patients remains unknown. HYPOTHESIS: We hypothesis that AS patients with TAVI complicated by CAD have poor prognosis. His study evaluates the prognoses of patients with CAD and severe AS after TAVI. METHODS: We divided 186 patients with severe AS undergoing TAVI into three groups: those with CAD involving the left main coronary (LM) or proximal left anterior descending artery (LAD) lesion (the CAD[LADp] group), those with CAD not involving the LM or a LAD proximal lesion (the CAD[non-LADp] group), and those without CAD (Non-CAD group). Clinical outcomes were compared among the three groups. RESULTS: The CAD[LADp] group showed a higher incidence of major adverse cardiovascular and cerebrovascular events (MACCEs) and all-cause mortality than the other two groups (log-rank p = .001 and p = .008, respectively). Even after adjustment for STS score and percutaneous coronary intervention (PCI) before TAVI, CAD[LADp] remained associated with MACCE and all-cause mortality. However, PCI for an LM or LAD proximal lesion pre-TAVI did not reduce the risk of these outcomes. CONCLUSIONS: CAD with an LM or LAD proximal lesion is a strong independent predictor of mid-term MACCEs and all-cause mortality in patients with severe AS treated with TAVI. PCI before TAVI did not influence the outcomes.

A novel risk stratification system "Angiographic GRACE Score" for predicting in-hospital mortality of patients with acute myocardial infarction: Data from the K-ACTIVE Registry.

BACKGROUND: The Global Registry of Acute Coronary Events (GRACE) score is the most accurate risk assessment system for acute myocardial infarction (AMI), which was proposed in Western countries. However, it is unclear whether GRACE score is applicable to the present Japanese patients with a high prevalence of emergent percutaneous coronary intervention (PCI) and vasospasm. This study aimed to clarify the usefulness of GRACE risk score for risk stratification of Japanese AMI patients treated with early PCI and to evaluate a novel risk stratification system, "angiographic GRACE score," which is the GRACE risk score adjusted by the information of the culprit coronary artery and its flow at pre- and post-PCI, to improve its predicting availability. METHODS: The subjects were 1817 AMI patients who underwent PCI within 24 h of onset between October 2015 and August 2017 and were registered in Kanagawa Acute Cardiovascular (K-ACTIVE) Registry via survey form. The association between the clinical parameters and in-hospital mortality was investigated. RESULTS: A total of 79 (4.3%) in-hospital deaths were identified. The C-statistics for the in-hospital mortality of the GRACE score was 0.86, which was higher than that of the other conventional risk factors, including age (0.65), systolic blood pressure (0.70), heart rate (0.62), Killip classification (0.77), and serum levels of creatinine (0.68) and peak creatine kinase (0.74). The angiographic GRACE score improved the C-statistics from 0.86 of the original GRACE score to 0.89 (p < 0.05). In the setting of the cut-off value at 200, in-hospital mortality in the patients with the angiographic GRACE score <200 was 0.6%, which was relatively lower than those with ≥200, 9.4%. CONCLUSIONS: The GRACE score is a useful predictor of in-hospital mortality among Japanese AMI patients in the PCI era. Moreover, the angiographic GRACE score could improve the predicting availability.

Clinical and procedure characteristics in patients treated with polytetrafluoroethylene-covered stents after coronary perforation: a CIRC-8U multicenter registry and literature review.

This study aimed at identifying the clinical characteristics and in-hospital outcomes of patients treated with polytetrafluorethylene (PTFE)-covered stents after coronary interventions in a multicenter registry. Subjects with coronary artery perforation were selected from 31,262 consecutive patients who underwent coronary interventions in the hospital registries. Subjects were divided into two groups: those with a PTFE-covered stent implantation and those without a PTFE-covered stent implantation. Clinical characteristics and in-hospital outcomes were compared between the two groups. Data for 82 consecutive coronary perforations (15 PTFE-covered stents and 67 non-PTFE-covered stents) were extracted from each hospital registry. The PTFE-covered stent group had a higher prevalence of perforations due to pre-dilatation before stenting or post-dilatation after stenting (80% vs. 10.4%; p < 0.001), more Ellis classification III perforations (66.6% vs. 28.4%; p = 0.019), longer perforation to hemostasis time (74 min vs. 10 min; p < 0.001), lower hemostatic success rates (73.3% vs. 94.0%; p = 0.015), and higher in-hospital mortality (26.7% vs. 6.0%; p = 0.015) than the non-PTFE-covered stent group. Although the prevalence of intravascular ultrasound (IVUS) usage was high during coronary interventions (86.7%), IVUS was performed in less than half the cases just before coronary perforations (47%) in the PTFE-covered stent group. Patients requiring PTFE-covered stents are more likely to be observed after balloon dilatation before or after stenting and have a poor prognosis. Careful coronary intervention is needed when IVUS image acquisition is not achieved in addition to proper evaluation of IVUS. Furthermore, if coronary artery perforation occurs, it is important to determine the need for a prompt PTFE-covered stent.

Endothelialization of a Venous Stent at 1 Month Post Implantation: First-in-Human Angioscopic Assessment.

This is the first report to evaluate endothelialization in vivo; the evidence of endothelialization on the venous stent in the early phase suggests that antithrombotic therapy could be stopped in some patients with high risk of bleeding in the chronic phase.

A multicenter study on the clinical characteristics and risk factors of in-hospital mortality in patients with mechanical complications following acute myocardial infarction.

Mechanical complications (MCs) following acute myocardial infarction (AMI), such as ventricular septal rupture (VSR), free-wall rupture (FWR), and papillary muscle rupture (PMR), are fatal. However, the risk factors of in-hospital mortality among patients with MCs have not been previously reported in Japan. The purpose of this study was to evaluate the prognostic factors of in-hospital mortality in these patients. The study cohort consisted of 233 consecutive patients with MCs from the registry of 10 facilities in the Cardiovascular Research Consortium-8 Universities (CIRC-8U) in East Japan between 1997 and 2014 (2.3% of 10,278 AMI patients). The authors conducted a retrospective observational study to analyse the correlation between the subtypes of MCs with in-hospital mortality, clinical data, and medical treatment. We observed a decreasing incidence of MC (1997-2004: 3.7%, 2005-2010: 2.1%, 2011-2014: 1.9%, p < 0.001). In-hospital mortality among patients with MCs was 46%. Thirty-three percent of patients with MCs were not able to undergo surgical repair due to advanced age or severe cardiogenic shock. In-hospital mortality among patients who had undergone surgical repair was 29% (VSR: 21%, FWR: 33%, PMR: 60%). In patients with MCs, hazard ratio for in-hospital mortality according to multivariate analysis of without surgical repair was 5.63 (95% CI 3.54-8.95). In patients with surgical repair, the hazard ratios of blow-out-type FWR (5.53, 95% confidence interval (CI) 2.22-13.76), those with renal dysfunction (3.11, 95% CI 1.37-7.05), and those receiving venoarterial extracorporeal membrane oxygenation (VA-ECMO) (3.79, 95% CI 1.81-7.96) were significantly high. Although primary percutaneous coronary intervention (PCI) is associated with decreased incidence of MCs, high in-hospital mortality persisted in patients with MCs that also presented with renal dysfunction and in those requiring VA-ECMO. Early detection and surgical repair of MCs are essential.

Calcified Nodule Protruding Into the Lumen Through Stent Struts: An In Vivo OCT Analysis.

We observed a calcified nodule (CN) protruding into the coronary lumen through the stent struts of an in-stent restenosis (ISR) lesion in detail using optical coherent tomography (OCT). The patient was a 56-year-old Japanese male on regular hemodialysis for his end-stage renal disease who had multiple coronary risk factors. He previously underwent percutaneous coronary intervention (PCI) for the middle left anterior descending artery and a drug-eluting stent was implanted. OCT showed a CN in the culprit lesion. He underwent coronary angiography 9 months later, and an ISR lesion was observed. Re-PCI was done, and a drug-coated balloon was used. OCT showed a CN protruding into the coronary lumen through the stent struts in the ISR lesion. Although this phenomenon was previously reported in a pathological study, the observation of a CN protruding through stent struts by in vivo OCT has been rarely demonstrated previously. The present study provides support for the previous pathological report, and demonstrates a useful application of OCT imaging that can help in the treatment of ISR lesions.

First Case Report of Successful PCI with Thrombocytopenia Treated with Partial Splenic Artery Embolization.

Percutaneous coronary intervention (PCI) for patients with thrombocytopenia presents a difficult problem in that dual antiplatelet therapy (DAPT) after drug-eluting stent (DES) implantation is not suitable. This first case report describes our patient with angina pectoris and thrombocytopenia who we successfully treated with PCI after partial splenic artery embolization (PSE). A 70-year-old Japanese male was transferred to our hospital because of acute decompensated heart failure (ADHF). After medical treatment was administered, a coronary angiography (CAG) revealed three-vessel disease. He had severe thrombocytopenia (nadir of 27,000/µL) due to liver fibrosis. Coronary artery bypass grafting (CABG) and PCI were not feasible. PSE was performed, and splenic volume reduction was confirmed by computed tomography. As a result, the platelet count increased after PSE and we completed the PCI with a DES. Major bleeding complications and cardiac events did not occur under the DAPT. To the best of our knowledge, performing PSE before PCI for increasing a patient's platelet count for thrombocytopenia has never been reported. This method may be considered as one of the treatment strategies for angina patients with thrombocytopenia.

Novel Use of GuideLiner with a Low-Profile Balloon for the Retrieval of Disrupted Balloon Catheter.

We report a case of successful percutaneous retrieval of an unexpectedly disrupted balloon catheter using GuideLiner and a low-profile balloon. The procedure and the mechanism of this novel technique were described in detail with ex-vivo testing. This case demonstrated the utility of the combination of GuideLiner and low-profile balloon as a bail-out for intravascular foreign body.

Minimally invasive percutaneous transluminal renal artery stenting.

BACKGROUND: Minimally invasive percutaneous transluminal renal artery stenting (MIPTRS) is a method that prevents complications to the greatest extent possible. The present study aimed to investigate the safety and efficacy of MIPTRS performed in cases of renal artery stenosis with an estimated glomerular filtration rate (eGFR)≤45mL/min. METHODS: Cases of patients who underwent MIPTRS at our hospital between December 2010 and June 2015 in whom eGFR was ≤45mL/min were retrospectively analysed. MIPTRS was performed as follows: 1) using a 4Fr sheathless guiding catheter in a trans-radial approach and 2) using a guiding catheter non-touch technique. The amount of contrast agent used was maintained at ≤10mL with 3) carbon dioxide enhancement and 4) intravascular ultrasound guide stenting, and 5) a distal protection device was used. RESULTS: MIPTRS was performed in 22 patients (32 lesions). The pre-MIPTRS creatinine level and eGFR were 2.01±0.88mg/dL and 29.2±9.0mL/min/1.73m2, respectively. On postoperative day 2, they were 1.78±0.73mg/dL and 35.1±12.3mL/min/1.73m2; at 1month after the procedure, they were 1.80±0.74mg/dL and 33.3±12.3mL/min/1.73m2. Creatinine level did not change significantly, but eGFR was significantly elevated after versus before the procedure, both 2days later (p<0.01) and 1month later (p<0.05). CONCLUSION: The results of this study demonstrated the usefulness of MIPTRS for protecting renal function. This method can be safely used in patients with decreased renal function.

Angioscopic and optical coherence tomographic evaluation of neointimal coverage: 9 months after expandable polyterafluoroethylene covered stent implantation.

An expandable polytetrafluoroethylene (ePTFE) covered stent is generally employed to seal coronary artery perforation. The frequency of ePTFE covered stent use is relatively low; thus, only a handful of studies have reported neointimal coverage and endothelialization inside the deployed ePTFE and clinical time course after ePTFE implantation. This case report presents a 78-year-old man treated with an ePTFE covered stent when he suffered from coronary artery perforation after the implantation of two everolimus eluting stents in the left anterior descending artery. Follow-up coronary angiography 9 months after ePTFE covered stent implantation depicted favorable stent patency. Optical coherence tomography showed thin and uneven stent strut coverage at the culprit. Angioscopy also depicted partial white-coated coverage and stent strut exposure. The outcome of this case suggested that long-term dual antiplatelet therapy should be prescribed for preventing thrombosis after ePTFE covered stent implantation.

Aortic annulus displacement assessed by contrast left ventriculography during invasive coronary angiography as a predictor of adverse events.

BACKGROUND: We propose the use of aortic annulus displacement (AAD) detected on contrast left ventriculography (LVG) during invasive coronary angiography as a marker of left ventricular (LV) long-axis shortening. In the present study, we aimed to investigate whether AAD is associated with adverse events in patients who underwent coronary angiography because of suspected coronary artery disease. METHODS: In this retrospective study, we evaluated the medical records of 998 consecutive patients who underwent invasive coronary angiography and LVG. LV lengths were measured from the apex to the aortic valve insertion by using LVG images. AAD (%) was calculated as [(LV end-diastolic length-LV end-systolic length)/LV end-diastolic length]×100. RESULTS: The participants' median age was 67 years. Ninety-six adverse events (composite events; all-cause death, 39; congestive heart failure, 21; late revascularization, 34; and myocardial infarction, 2) were observed during a median follow-up period of 3.1 years. In multivariate Cox regression analysis, adverse events were associated with lower AAD (hazard ratio, 0.703; p=0.002), after adjusting for traditional risk factors and coronary artery stenosis. The area under the curve of AAD for predicting adverse events was greater than that of LV ejection fraction (0.656 vs. 0.541, p<0.05). CONCLUSIONS: AAD was superior to LV ejection fraction as a predictor of adverse events in patients with and without coronary arterial stenosis. AAD may be the optimal method for assessing longitudinal LV systolic function in the catheter laboratory.

Prevalence of electrocardiographic abnormalities in young, elite Japanese athletes.

BACKGROUND: The question as to whether or not electrocardiogram (ECG) evaluations should be performed in all athletes is still controversial. So, in this study, the prevalence of electrocardiographic abnormalities was evaluated in young, elite Japanese athletes. METHODS: Subjects included 174 male and 101 female Japanese athletes (mean age, 21.5 years). Sports activities included baseball, basketball, diving, fencing, gymnastics, judo, rhythmic gymnastics, soccer, swimming, tennis, track and field, volleyball, and water polo. A 12-lead resting ECG was recorded and evaluated. We used the criteria for distinctly abnormal ECG patterns as defined by Pelliccia et al. Subjects were divided into 2 groups on the basis of their exercise training type: an endurance training group and a static training group. RESULTS: Twenty six of 174 male subjects (14.9%) and 11 of 101 (10.9%) female subjects presented with abnormal ECG results. ECG abnormalities were observed much more frequently in track athletes compared to athletes of other sporting events. Field players did not present with any ECG abnormalities. Overall, the incidences of ECG abnormalities were statistically lower in the static exercise training group than in the endurance training group both in male and female. High voltage of left ventricle was observed in 114 of 175 male subjects (65.1%), and 27 of 101 female subjects (26.7%). CONCLUSIONS: The prevalence of ECG abnormalities in young, elite, Japanese athletes was comparable to that previously reported by both Western and Asian investigators.

Association between inflammatory biomarkers and thin-cap fibroatheroma detected by optical coherence tomography in patients with coronary heart disease.

INTRODUCTION: The relationship between plaque morphology detected by optical coherence tomography (OCT) and inflammatory biomarkers is not well known. MATERIAL AND METHODS: This study included 47 patients with ischemic heart disease (22 patients with acute coronary syndrome and 25 patients with effort angina pectoris) who underwent percutaneous coronary intervention (PCI). Before PCI, peripheral blood levels of the inflammatory biomarkers high-sensitivity C-reactive protein (hs-CRP) and interleukin-6 (IL-6) were measured. The OCT can detect thin-cap fibroatheroma (TCFA), a lesion with high potential for adverse cardiac events. We investigated the relationships between TCFAs in culprit lesions detected by OCT and the peripheral blood levels of these biomarkers. RESULTS: We observed 12 lesions detected as TCFAs. The natural logs of hs-CRP and IL-6 levels in the TCFA group were higher than those in the non-TCFA group (hs-CRP 0.87 (-0.96 to 0.87) vs. -0.47 (-0.92 to 0.30) mg/l, p = 0.027; and IL-6 1.63 (0.63-3.23) vs. 0.53 (-0.21 to 1.05) pg/dl, p = 0.005, respectively). In multivariate logistic regression analysis, log IL-6 was an independent predictor for TCFA detected by OCT (log IL-6, 0.970 pg/dl, p = 0.023). Receiver operating characteristic curve analysis confirmed that IL-6, compared to hs-CRP, has a higher area under the curve for predicting TCFA (0.783 vs. 0.715, respectively). CONCLUSIONS: Peripheral blood levels of both hs-CRP and IL-6 were associated with TCFAs, as detected by OCT. Moreover, IL-6 has a higher potential than hs-CRP for predicting TCFA.

Evaluation of the influence of cardiac motion on the accuracy and reproducibility of longitudinal measurements and the corresponding image quality in optical frequency domain imaging: an ex vivo investigation of the optimal pullback speed.

Longitudinal measurement using intravascular ultrasound is limited because the motorized pullback device assumes no cardiac motion. A newly developed intracoronary imaging modality, optical frequency domain imaging (OFDI), has higher resolution and an increased auto-pullback speed with presumably lesser susceptibility to cardiac motion artifacts during pullback for longitudinal measurement; however, it has not been fully investigated. We aimed to clarify the influence of cardiac motion on the accuracy and reproducibility of longitudinal measurements obtained using OFDI and to determine the optimal pullback speed. This ex vivo study included 31 stents deployed in the mid left anterior descending artery under phantom heartbeat and coronary flow simulation. Longitudinal stent lengths were measured twice using OFDI at three pullback speeds. Differences in stent lengths between OFDI and microscopy and between two repetitive pullbacks were assessed to determine accuracy and reproducibility. Furthermore, three-dimensional (3D) reconstruction was used for evaluating image quality. With regard to differences in stent length between OFDI and microscopy, the intraclass correlation coefficient values were 0.985, 0.994, and 0.995 at 10, 20, and 40 mm/s, respectively. With regard to reproducibility, the values were 0.995, 0.996, and 0.996 at 10, 20, and 40 mm/s, respectively. 3D reconstruction showed a superior image quality at 10 and 20 mm/s compared with that at 40 mm/s. OFDI demonstrated high accuracy and reproducibility for longitudinal stent measurements. Moreover, its accuracy and reproducibility were remarkable at a higher pullback speed. A 20-mm/s pullback speed may be optimal for clinical and research purposes.