Predictors of Optical Coherence Tomography-Defined Calcified Nodules in Patients With Acute Coronary Syndrome　- A Substudy From the TACTICS Registry.

BACKGROUND: Recent studies suggest that the presence of calcified nodules (CN) is associated with worse prognosis in patients with acute coronary syndrome (ACS). We investigated clinical predictors of optical coherence tomography (OCT)-defined CN in ACS patients in a prospective multicenter registry. METHODS AND RESULTS: We investigated 695 patients enrolled in the TACTICS registry who underwent OCT assessment of the culprit lesion during primary percutaneous coronary intervention. OCT-CN was defined as calcific nodules erupting into the lumen with disruption of the fibrous cap and an underlying calcified plate. Compared with patients without OCT-CN, patients with OCT-CN (n=28) were older (mean [±SD] age 75.0±11.3 vs. 65.7±12.7 years; P<0.001), had a higher prevalence of diabetes (50.0% vs. 29.4%; P=0.034), hemodialysis (21.4% vs. 1.6%; P<0.001), and Killip Class III/IV heart failure (21.4% vs. 5.7%; P=0.003), and a higher preprocedural SYNTAX score (median [interquartile range] score 15 [11-25] vs. 11 [7-19]; P=0.003). On multivariable analysis, age (odds ratio [OR] 1.072; P<0.001), hemodialysis (OR 16.571; P<0.001), and Killip Class III/IV (OR 4.466; P=0.004) were significantly associated with the presence of OCT-CN. In non-dialysis patients (n=678), age (OR 1.081; P<0.001), diabetes (OR 3.046; P=0.014), and Killip Class III/IV (OR 4.414; P=0.009) were significantly associated with the presence of OCT-CN. CONCLUSIONS: The TACTICS registry shows that OCT-CN is associated with lesion severity and poor clinical background, which may worsen prognosis.

Clinical Significance of Coronary Healed Plaques in Stable Angina Pectoris Patients Undergoing Percutaneous Coronary Intervention.

BACKGROUND: Coronary healed plaques (HPs) reportedly have high vulnerability or show advanced atherosclerosis and a risk of rapid plaque progression. However, the prognosis of stable angina pectoris (SAP) patients with HPs undergoing percutaneous coronary intervention (PCI) remains under-investigated.Methods and Results: We analyzed 417 consecutive lesions from SAP patients undergoing pre- and post-intervention optical coherence tomography (OCT) for which HPs were defined as having a layered appearance. We investigated the differences in clinical and lesion characteristics, and post-PCI outcomes between HPs and non-HPs. To account for differences in clinical characteristics, propensity score matching was performed between the groups. HPs were observed in 216 lesions (51.8%) in the total cohort. In the propensity-matched cohort (n=294), HPs had higher rates of angiographic-B2/C lesions (77.6% vs. 59.2%, P<0.001), OCT-lipid-rich plaques (40.8% vs. 25.9%, P=0.007), macrophages (78.2% vs. 44.2%, P<0.001), greater luminal area stenosis (73.5±11.0% vs. 71.5±10.3%, P=0.002), and a higher prevalence of post-stenting irregular tissue protrusion (45.1% vs. 14.7%, P<0.001) than non-HPs. In the total cohort, target lesion revascularization (TLR)-free survival was poorer for HPs (log-rank test 7.66; P=0.006), and Cox proportional hazards analysis showed HP as an independent predictor of TLR (hazard ratio, 5.98; 95% confidence interval, 1.72-20.82; P=0.005). CONCLUSIONS: In SAP patients, HPs had greater complexity of lesions and higher vulnerability, which may have contributed to the poorer post-PCI outcomes.

Left ventricular end-systolic contractile entropy can predict cardiac prognosis in patients with complete left bundle branch block.

BACKGROUND: Several patients with complete left bundle branch block (CLBBB) show left ventricular (LV) dyssynchrony and poor cardiac prognosis. However, the prognostic value of LV end-systolic contractile entropy which was measured by single-photon emission computer tomography (SPECT) has not been elucidated in patients with CLBBB. METHODS AND RESULTS: We recruited consecutive 115 sinus-rhythm patients with CLBBB who underwent ECG-gated 201TlCl-SPECT. After 30 days of observation, finally 102 patients (75.2 ± 9.5 years, 62 male) were enrolled and observed retrospectively for a median of 671 days. Twenty-five patients fell into major cardiac events. Multivariate Cox regression analysis showed estimated glomerular filtration rate (eGFR) ≤ 39.35 mL/min and entropy ≥ 79% were significant and independent predictors for major cardiac events (hazard ratio: 4.256 and 7.587, P value = 0.006 and < 0.001, respectively). Machine learning (Random Forest method) revealed eGFR and entropy had higher feature importance than other predictors (0.140 and 0.138, respectively). Kaplan-Meyer curve analysis demonstrated that the group with entropy ≥ 79% and eGFR ≤ 39.36 mL/min had the worst cardiac prognosis (Logrank: P = 0.002). CONCLUSIONS: Left ventricular end-systolic contractile entropy predicts poor cardiac prognosis in patients with CLBBB, which may be more valuable than the other parameters of SPECT.

Circadian variations in pathogenesis of ST-segment elevation myocardial infarction: an optical coherence tomography study.

Previous studies have reported a circadian variation in the onset of ST-segment elevation myocardial infarction (STEMI). However, underlying mechanisms for the circadian variation have not been fully elucidated. We investigated the relationship between onset of STEMI and the underlying pathology using optical coherence tomography (OCT). Patients with a diagnosis of STEMI were selected from a multicenter OCT registry. Patients were divided into 4 groups based on the estimated time of onset (00:00-05:59, 06:00-11:59, 12:00-17:59, or 18:00-23:59). Underlying pathologies of MI (plaque rupture, plaque erosion, and calcified plaque) were compared among the 4 groups. Among 648 patients, plaque rupture was diagnosed in 386 patients (59.6%), plaque erosion in 197 patients (30.4%), and calcified plaque in 65 patients (10.0%). A marked circadian variation was detected in the incidence of plaque rupture with a peak at 09:00, whereas it was not evident in plaque erosion or calcified plaque. The probability of plaque rupture significantly increased in the periods of 06:00-11:59 [odds ratio (OR) 2.13, 95% confidence interval (CI) 1.30-3.49, p = 0.002] and 12:00-17:59 (OR 2.10, 95% CI 1.23-3.58, p = 0.005), compared to the period of 00:00-05:59. This circadian pattern was observed only during weekdays (p = 0.010) and it was not evident during the weekend (p = 0.742). Plaque rupture occurred most frequently in the morning and this circadian variation was evident only during weekdays. Acute MI caused by plaque rupture may be related to catecholamine surge.

Clinical significance of the presence of puff-chandelier ruptures detected by nonobstructive aortic angioscopy.

OBJECTIVE: This study aimed to investigate the prevalence and prognostic significance of atherosclerotic aortic plaques (AAPs) or specific AAP types detected by nonobstructive angioscopy (NOA) in patients who underwent percutaneous coronary intervention (PCI). BACKGROUND: Although recent studies have reported the presence of various patterns of AAPs, identified by NOA, the clinical significance of the presence of AAPs remains elusive. METHODS: In this retrospective, multicenter cohort study, a total of 167 patients who underwent PCI and intra-aortic scans with NOA were studied. The association between AAPs and the incidence of major adverse cardiac events (MACEs), including cardiac death, myocardial infarction, stroke, and clinically driven unplanned revascularizations, was assessed. RESULTS: AAPs were detected in 126 patients (75%) who underwent NOA. MACEs occurred in 28 (17%) patients during the follow-up (median 2.9 years [range 2.1-3.8]). Among all types of AAPs, only puff-chandelier rupture (PCR) showed a significant difference in frequency between patients with and those without MACEs: 21 (75%) and 49 (35%), respectively (p < .001). Multivariable Cox proportional hazard analysis revealed that PCR (hazard ratio [HR] 3.73, 95% confidence interval [CI] 1.57-8.87, p = .004) and chronic kidney disease (HR 2.97, 95% CI 1.37-6.44, p = .010) were independent predictors of MACEs. Kaplan-Meier analysis revealed that PCR was significantly associated with more frequent MACEs. CONCLUSION: The detection of PCR in the aorta using NOA was significantly associated with an increased risk of subsequent adverse events after PCI.

Relative risk of plaque erosion among different age and sex groups in patients with acute coronary syndrome.

Postmortem studies reported plaque erosion is frequent in young women. Recent in vivo studies failed to show age and sex differences in the plaque erosion prevalence. The aim of this study was to investigate the prevalence of plaque erosion by age and sex among acute coronary syndromes (ACS) patients. From 1699 ACS patients, 1083 with plaque erosion or rupture were analyzed. Patients were categorized as 5 age groups (≤ 50, 51-60, 61-70, 71-80, ≥ 81 years). Overall prevalence of plaque erosion was similar between males and females (p = 0.831). Males age ≤ 50 had higher (p = 0.018) and age 71-80 had lower (p = 0.006) prevalence of plaque erosion. Females age 61-70 had higher (p = 0.021) and age 71-80 had lower (p = 0.045) prevalence of plaque erosion. In advanced age groups (≥ 71 years), rupture was the dominant etiology in both sexes. In multivariate analysis of males, age ≤ 50 demonstrated a trend to increase (OR 1.418, 95% CI 0.961-2.093, p = 0.078) the erosion risk. Females age ≤ 70 independently increased (OR 2.138, 95% CI 1.249-3.661, p = 0.006) the risk for erosion. The prevalence of plaque erosion was similar between males and females. Plaque erosion risk was increased in the males age ≤ 50 and in the females age ≤ 70 among ACS patients.

Simple and novel technique to confirm complete mitral isthmus block.

BACKGROUND: Differential pacing technique to confirm mitral isthmus (MI) block is sometimes challenging due to destroyed tissues after extensive ablation. The purpose of this study is to set an endpoint of MI ablation using conduction time around the mitral annulus (MA). METHODS: Forty-five consecutive patients with persistent atrial fibrillation who received MI linear ablation were included. The geometry and activation times of the left atrium around the MA were collected using a multipolar catheter before ablation. During coronary sinus (CS) pacing, the time between the stimulus and the wave-front collision at the opposite side of the MA (defined as T/2) was calculated, and the doubled value was defined as the estimated perimitral conduction time (E-PMCT). The endpoint for complete MI block was when the stimulus (at distal CS) minus the maximal delayed potential (St-MDP) on the MI interval reached the E-PMCT. RESULTS: St-MDP reached E-PMCT during MI ablation in 44/45 patients. Among these 44 patients, differential pacing revealed bidirectional block in 39/44 (88.6%), whereas in 5/44 (11.4%), the differential pacing was not possible because of the loss of capture of local potentials due to extensive applications around the linear line. In one patient, the St-MDP did not reach E-PMCT (E-PMCT: 148 ms, St-MDP :130 ms) and differential pacing revealed no MI block. E-PMCT values (median 176 ms) correlated strongly with St-MDP (median 185 ms, P < 0.0001, R = 0.98). CONCLUSIONS: Although E-PMCT differs between individuals, the value is significantly correlated with the St-MDP. This technique may be useful in providing an individual endpoint of MI ablation as an alternative to differential pacing.

Intravascular Ultrasound and Angioscopy Assessment of Coronary Plaque Components in Chronic Totally Occluded Lesions.

BACKGROUND: The in vivo lesion morphologies and plaque components of coronary chronic total occlusion (CTO) lesions remain unclear.Methods and Results:We investigated 57 consecutive CTO lesions in 57 patients with stable angina pectoris undergoing elective percutaneous coronary intervention with intravascular ultrasound (IVUS) and coronary angioscopy (CAS) examination. All CTO lesions were classified according to the proximal angiographic lumen pattern; tapered-type (T-CTO) and abrupt-type (A-CTO). The differences in the intracoronary images of these lesion types were evaluated according to the location within the CTO segment. A total of 35 lesions (61.4%) were T-CTO. T-CTO lesions had higher frequencies of red thrombi (proximal 71.4%; middle 74.3%; distal 31.4%; P<0.001) and bright-yellow plaques (yellow-grade 2-3) (48.6%; 74.3%; 2.9%; P<0.001) at the proximal or middle than at the distal subsegment; A-CTO lesions showed no significant differences among the 3 sub-segments. At the middle subsegment, T-CTO lesions showed higher frequencies of positive remodeling (51.4% vs. 18.2%, P=0.01) and bright-yellow plaques (74.3% vs. 13.6%, P<0.001) compared with A-CTO lesions. Multivariate analysis identified bright-yellow plaque as an independent predictor (odds ratio, 7.25; 95% confidence interval, 1.25-42.04; P=0.03) of the occurrence of periprocedural myocardial necrosis. CONCLUSIONS: The combination of IVUS and CAS analysis may be useful for identifying lesion morphology and plaque components, which may help clarify the pathogenetic mechanism of CTO lesions.

Observation of an Asymptomatic Dissecting Aortic Aneurysm Using Non-Obstructive Angioscopy.

Non-obstructive angioscopy has become a novel method of evaluating atheromatous plaques of the aortic intimal wall. A 77-year-old man with coronary artery disease underwent percutaneous coronary intervention in the left descending artery. We subsequently used non-obstructive angioscopy to identify aortic atheromatous plaques and incidentally diagnosed an aortic dissecting aneurysm. Non-obstructive angioscopy demonstrated a great fissure in severe atheromatous plaques at the entry site of the aortic dissection identified by enhanced computed tomography. This is the first report to describe the aortic intimal findings of an aortic dissecting aneurysm in vivo by using trans-catheter angioscopy.

Usefulness of Lipoprotein(a) for Predicting Clinical Outcomes After Endovascular Therapy for Aortoiliac Atherosclerotic Lesions.

PURPOSE: To evaluate the usefulness of serum lipoprotein(a) as a biomarker of clinical outcomes after endovascular therapy (EVT) for atherosclerotic aortoiliac lesions. METHODS: Serum lipoprotein(a) concentrations were measured at admission in 189 consecutive patients (median age 72 years; 160 men) with peripheral artery disease who underwent EVT for aortoiliac occlusive disease. The patients were dichotomized into 2 groups based on serum lipoprotein(a) levels ≤40 mg/dL (LOW; n=135) or >40 mg/dL (HIGH; n=54). After EVT, the incidences of major adverse limb events (MALE) were analyzed. Predictors of MALE were sought with a Cox proportional hazards analysis; results are presented as the hazard ratio (HR) and 95% confidence interval. RESULTS: At the median follow-up of 33 months (interquartile range 11, 54), MALE occurred in 44 (23.3%) patients. The MALE-free survival estimate was significantly lower in patients in the HIGH group (55.6% vs 85.2%, p<0.001). Independent predictors of MALE after EVT were hemodialysis (HR 2.23, 95% CI 1.04 to 4.78, p=0.039) and high lipoprotein(a) levels (HR 2.80, 95% CI 1.44 to 5.45, p=0.003). CONCLUSION: High lipoprotein(a) levels were associated with a higher incidence of MALE after EVT for patients with aortoiliac lesions.

Efficacy of Multidetector Computed Tomography to Predict Periprocedural Myocardial Injury After Percutaneous Coronary Intervention for Chronic Total Occlusion.

Specific signatures of culprit lesions detected on multidetector computed tomography (MDCT) were identified as predictors of periprocedural myocardial injury (PMI) after percutaneous coronary intervention (PCI) in patients with stable angina; PMI has been shown to be associated with a worse prognosis. We investigated the association between preprocedural culprit lesion characteristics, assessed by MDCT, and PMI after PCI for chronic total occlusion (CTO). From three medical centers, 81 patients who underwent pre-PCI MDCT and CTO PCI, and systematic cardiac troponin (cTn) sampling before and after PCI, were included. Patients were divided into two groups according to the presence or absence of post-PCI cTn elevation. Patient characteristics, MDCT findings, and procedural variables were compared between the two groups. Procedure success was observed in 65 patients (80.2%) and was not associated with PMI. The incidence of PMI was higher in patients treated with the retrograde versus the antegrade approach. On MDCT, lesion length and the presence of the napkin-ring sign were significantly associated with PMI. Multivariate analysis revealed that the lesion length (odds ratio [OR]: 1.04; 95% confidence interval [CI]: 1.01-1.08; P < 0.05), napkin-ring sign (OR: 5.41; 95% CI: 1.01-29.0; P < 0.05), and retrograde approach (OR: 4.78; 95% CI: 1.28-15.4; P < 0.05) were significant predictors of PMI. PMI is not uncommon in patients undergoing elective CTO PCI, regardless of procedure success or failure. Pre-PCI MDCT may help identify patients at high risk for PMI after CTO PCI.

The proportion of asymptomatic recurrence after catheter ablation of atrial fibrillation in patients with a pacemaker for sick sinus syndrome.

BACKGROUND: Catheter ablation (CA) of paroxysmal atrial fibrillation (PAF) is an effective treatment. However, the frequency of asymptomatic AF recurrence after CA in patients with PAF and sick sinus syndrome (SSS) is not clear. The aim of this study was to elucidate the real AF recurrence after CA in patients with PAF and a pacemaker for SSS. METHODS AND RESULTS: Fifty-one consecutive patients (mean age 66.6 ± 7.0 years, male 34) with PAF and SSS and pacemakers underwent CA. All patients were followed at 1, 3, 6, 9, and 12 months after the CA using a 12-lead ECG, Holter-ECG, and 1-month event recorder as a conventional follow-up. In addition, the pacemakers were interrogated every 12 months. During a 5-year follow-up after the final CA procedure, AF recurrences were observed in 7 patients (13.7%) with a conventional follow-up, including 1 (2.0%) asymptomatic patient. Pacemaker-interrogation revealed another 10 patients (19.6%) with asymptomatic AF recurrences. Ultimately, the conventional follow-up plus pacemaker-interrogation provided a higher incidence of AF recurrences (P = 0.009). Multiple CA procedures contributed to a significant increase in the AF-free survival rate at 5 years: 58.6% after a single CA and 86.0% after multiple CA procedures with a conventional follow-up, but which decreased to 40.6% and 60.9% with a conventional follow-up plus a pacemaker interrogation, respectively. CONCLUSIONS: One-third of PAF patients with SSS and pacemakers recurred after multiple CA sessions. However, 65% of them were asymptomatic and difficult to be identified with conventional follow-up. Pacemaker interrogation significantly increased the detection rate of AF-recurrence.

Impact of Non-Pulmonary Vein Foci on the Outcome of the Second Session of Catheter Ablation for Paroxysmal Atrial Fibrillation.

BACKGROUND: Paroxysmal atrial fibrillation (AF) is primarily triggered by pulmonary veins (PVs). However, non-PV AF foci may also trigger AF. METHODS: We examined 207 patients (mean age, 62 ± 11 years; 166 men) who underwent a second catheter ablation (CA) and evaluated the clinical significance of non-PV AF foci on the outcomes. RESULTS: Electrical reconnections between the PVs and left atrium (LA) were observed in 162 patients (78.3%). Non-PV AF foci were identified in 95 patients (45.9%, 60 patients with successfully ablated non-PV AF foci and 35 with unmappable non-PV AF foci). During a median follow-up period of 22.7 months, 61 patients (29.5%; 18/112 [16.1%] without non-PV AF foci vs. 20/60 [33.3%] with successfully ablated non-PV AF foci vs. 23/35 [65.7%] with unmappable non-PV AF foci, P < 0.0001) developed AF recurrence; 52 (85.2%) developed recurrence within 1 year. The presence of non-PV AF foci was a significant clinical predictor of AF recurrence after the second CA; successfully ablated non-PV AF foci increased the AF recurrence risk by 2.24 times (95% confidence interval [CI], 1.12-4.54; P = 0.02), and unmappable AF foci increased this risk by 5.58 times (95% CI, 2.73-11.63; P < 0.0001). CONCLUSION: Nearly half of the patients had non-PV AF foci at the second CA session. AF recurred after the second CA session in approximately 30%, with most recurrences happening within 1 year. The presence of non-PV AF foci significantly increased the AF recurrence risk after a second CA. When non-PV AF foci were unmappable, the AF recurrence rate was extremely high.

Simultaneous isolation of superior and inferior pulmonary veins on both the left and right sides could yield better outcomes in patients with paroxysmal atrial fibrillation.

AIMS: This study investigated whether disappearance patterns of pulmonary vein (PV) potentials (PVPs) during PV isolation (PVI) affect the outcome of catheter ablation (CA) in patients with paroxysmal atrial fibrillation (PAF). METHODS AND RESULTS: Extensive PVI was performed in 1149 PAF patients (age, 61 ± 10 years). Clinical and demographic characteristics, ablation data, and follow-up outcomes were prospectively collected. During an initial CA, simultaneous disappearance of superior and inferior PVPs in both right and left PVs was observed in 464 (40.4%) patients (Group S). Atrial fibrillation-recurrence free rates at 1, 3, and 5 years after the initial CA in Group S were 78.9, 71.9, and 68.1%, respectively, which were higher than those in Group Non-S (P = 0.004). However, those were similar after the final CA between both groups. The incidence of PV-left atrium (LA) electrical reconnection was significantly lower in Group S than in Group Non-S in the second (Group S, 65.6% vs. Group Non-S, 82.1%; P = 0.004) and third (Group S, 8.3% vs. Group Non-S, 47.6%; P = 0.03) CAs. Furthermore, the reconnections more frequently occurred on the side of PVs where simultaneous PVP elimination had not been achieved at the initial CA. Simultaneous disappearance of superior and inferior PVPs in both right and left PVs independently reduced the risk of AF recurrence after the initial CA by 26%. CONCLUSIONS: The simultaneous disappearance of superior and inferior PVPs in both right and left PVs is associated with less frequent PV-left atrium reconnection and may yield a better clinical outcome after the initial CA.

Association of Intravascular Ultrasound- and Optical Coherence Tomography-Assessed Coronary Plaque Morphology With Periprocedural Myocardial Injury in Patients With Stable Angina Pectoris.

BACKGROUND: Periprocedural myocardial injury (PMI) is not an uncommon complication and is related to adverse cardiac events after percutaneous coronary intervention (PCI). We investigated the predictors of PMI in patients with stable angina pectoris (SAP) on intravascular imaging. METHODS AND RESULTS: We enrolled 193 SAP patients who underwent pre-PCI intravascular ultrasound (IVUS) and optical coherence tomography (OCT). Clinical characteristics, lesion morphology, and long-term follow-up data were compared between patients with and without PMI, defined as post-PCI elevation of high-sensitivity cardiac troponin-T. PMI were observed in 79 patients (40.9%). Estimated glomerular filtration rate (odds ratio [OR], 0.973; 95% confidence interval [CI]: 0.950-0.996; P=0.020), ≥2 stents (OR, 3.100; 95% CI: 1.334-7.205; P=0.009), final myocardial blush grade 0-2 (OR, 4.077; 95% CI: 1.295-12.839; P=0.016), and IVUS-identified echo-attenuated plaque (EA; OR, 3.623; 95% CI: 1.700-7.721; P<0.001) and OCT-derived thin-cap fibroatheroma (OCT-TCFA; OR, 3.406; 95% CI: 1.307-8.872; P=0.012) were independent predictors of PMI on multivariate logistic regression analysis. A combination of EA and OCT-TCFA had an 82.4% positive predictive value for PMI. On Cox proportional hazards analysis, PMI was an independent predictor of adverse cardiac events during 1-year follow-up (hazard ratio, 2.984; 95% CI: 1.209-7.361; P=0.018). CONCLUSIONS: Plaque morphology assessment using pre-PCI IVUS and OCT may be useful for predicting PMI in SAP patients.

Latex-enhanced turbidimetric immunoassay for everolimus in whole blood using the Nanopia TDM everolimus assay with the JCA-BM6010 automatic analyzer.

BACKGROUND: Everolimus is a novel proliferation signal inhibitor used in immunosuppressive therapies for the prevention of acute and chronic rejection. It is an immunosuppressant requiring routine monitoring in whole blood. We evaluated analytical performance of the Nanopia TDM Everolimus assay kit for the measurement of everolimus in whole blood. METHODS: Whole blood samples from patients receiving immunosuppressive therapy with everolimus after heart transplantation were used, and everolimus concentrations were measured by liquid chromatography combined with mass spectrometric detection and fluorescence polarization immunoassay and Nanopia TDM Everolimus assay. RESULTS: The within-assay coefficient of variation was 4.0%-6.8% (n = 20) at everolimus concentrations of 4.4-15.7 ng/mL, whereas the day-to-day coefficient of variation ranged from 3.6% to 5.4% at everolimus concentrations of 4.8-15.9 ng/mL. The limit of quantitation was 1.5 ng/mL. Calibration curves were stable for at least 14 days. The presence of conjugated bilirubin, unconjugated bilirubin, lipemic material, rheumatoid factor, and variation of the hematocrit did not affect this assay system. There was a strong positive correlation between values obtained with the Nanopia TDM Everolimus assay kit and the results of liquid chromatography combined with mass spectrometric detection (y = 0.960x + 0.312 ng/mL; r = 0.946; n = 91), as well as with data from the fluorescence polarization immunoassay (y = 0.966x - 0.440 ng/mL; r = 0.942; n = 91). CONCLUSIONS: The Nanopia TDM Everolimus assay showed good analytical performance. These results indicate that the Nanopia TDM Everolimus assay may be suitable for routine clinical use.

The impact of haemodialysis on the outcomes of catheter ablation in patients with paroxysmal atrial fibrillation.

AIMS: The outcomes of catheter ablation (CA) in patients with paroxysmal atrial fibrillation (PAF) who are undergoing haemodialysis (HD) have not been fully elucidated. This study aimed to determine the impact of HD on CA outcome in these patients. METHODS AND RESULTS: We examined 1364 consecutive PAF patients (mean age, 61 ± 10 years) who underwent CA, including 32 (2.3%) patients undergoing HD. The patients undergoing HD had a significantly lower body mass index (P < 0.0001), higher CHADS2 score (P = 0.006), and higher prevalence of structural heart disease (P < 0.0001), hypertension (P = 0.002), and congestive heart failure (P = 0.02). Echocardiography indicated a larger left atrial diameter (P < 0.0001) and left ventricular diameter (P = 0.0002) in the HD patients. Haemodialysis was a significant predictor of AF recurrence (hazard ratio 2.56; 95% confidence interval 1.56-4.03; P = 0.0004) in the overall population. Sinus rhythm maintenance rates in the HD patients at 1, 3, and 5 years were 42.3, 37.6, and 19.7%, respectively, after the first procedure, and 64.7, 54.9, and 47.1%, respectively, after the final procedure (median, 2; range, 1-2 procedures); these rates were significantly lower than those in the non-HD patients (P < 0.0001). The 5-year survival rate was 78.1% in the HD patients. CONCLUSION: Haemodialysis was significantly associated with AF recurrence after CA for PAF. However, an ∼50% success rate for sinus rhythm maintenance without antiarrhythmic drug therapy in HD patients suggested that CA could be an option for the treatment of AF.

Relationships of elevated systemic pentraxin-3 levels with high-risk coronary plaque components and impaired myocardial perfusion after percutaneous coronary intervention in patients with ST-elevation acute myocardial infarction.

BACKGROUND: We aimed to assess the relationships of pentraxin-3 (PTX3) with coronary plaque components and myocardial perfusion after percutaneous coronary intervention (PCI) in order to clarify the mechanisms underlying the prognostic function of PTX3 in ST-elevation acute myocardial infarction (STEMI) patients. METHODS AND RESULTS: We enrolled 75 STEMI patients who underwent pre-PCI virtual histology (VH)-intravascular ultrasound. Relationships of the systemic pre-PCI PTX3 level with coronary plaque components and post-PCI myocardial blush grade (MBG) were evaluated. Lesions with elevated pre-PCI PTX3 (median ≥3.79ng/ml) had higher frequencies of VH-derived thin-cap fibroatheroma (65.8% vs. 24.3%, P<0.0001), plaque rupture (63.2% vs. 24.3%, P=0.001), and post-PCI MBG (0-1) (65.8% vs. 40.5%, P=0.03) than those with PTX3 <3.79ng/ml. In multivariate analysis, pre-PCI PTX3 level was independently related to post-PCI MBG (0-1) (odds ratio, 11.385; 95% confidence interval (CI), 1.346-96.289; P=0.026). At 9-month follow-up, cardiac event-free survival was poorer for patients with post-PCI MBG (0-1) (log-rank test χ(2)=8.6; P=0.003). Cox proportional-hazards analysis showed post-PCI MBG (0-1) (hazard ratio, 4.109; 95% CI, 1.372-12.309; P=0.012) and Killip class >2 on admission (hazard ratio, 5.356; 95% CI, 1.409-20.359; P=0.014) as independent predictors of adverse cardiac events during follow-up. CONCLUSIONS: Systemic pre-PCI PTX3 was associated with high-risk plaque components and impaired post-PCI myocardial perfusion. Thus, PTX3 may be a reliable predictor of outcome in STEMI patients.

Late-phase thromboembolism after catheter ablation for paroxysmal atrial fibrillation.

BACKGROUND: The aim of this study was to investigate the incidence and predictors (which have not previously been fully elucidated) of late-phase thromboembolism (TE) after catheter ablation (CA) for paroxysmal atrial fibrillation (AF). METHODS AND RESULTS: We studied 1,156 consecutive patients (61±10 years; 891 men; CHADS2score, 0.8±1.0) after CA for symptomatic paroxysmal AF and examined the details of late-phase TE. During a follow-up of 49.5±21.9 months (median, 47 months; range, 6-113 months) after CA, 9 patients (0.78%) developed late-phase TE, all of which were ischemic stroke. Of these, 5 patients with AF recurrence experienced cardioembolism; the AF was asymptomatic at recurrence. The remaining 4 without AF recurrence experienced cardioembolism (n=1), small-vessel occlusion (n=1), large-artery atherosclerosis (n=1), and stroke of other determined etiology (n=1). On Kaplan-Meier analysis patients with structural heart disease (P=0.003), AF recurrence after the final CA (P=0.01), prior stroke (P=0.002), CHADS2score ≥2 (P=0.0002), left ventricular ejection fraction <50% (P<0.0001), and spontaneous echo contrast on transesophageal echocardiogram (P=0.0004) had a significantly higher risk of late-phase TE. Multivariate analysis indicated that CHADS2score ≥2 (HR, 4.49; 95% CI: 1.08-22.56; P=0.04) independently predicted late-phase TE. CONCLUSIONS: The incidence of TE was low after CA for paroxysmal AF, but CHADS2score ≥2 independently increased the risk of late-phase TE.

[Evaluation of the Creatine Kinase MB Activity Assay Kit].

CK-MB activity, which is measured by the immunoinhibition method, is an important marker for use in the diagnosis of acute coronary syndromes. In the present study, we evaluated the basal performance of a recently improved CK-MB activity kit, "L-system CK-MB," in which the activity of mitochondrial CK subunits is inhibited. Within-run and between-day precision were in the range of 1.9-2.3% and 3.2-6.0%, respectively. Diluted linearity and limit of detection were determined to be 600 U/L and 0.8 U/L, respectively. The use of L-system CK-MB allowed the inhibition of the activity of 98.1% of sarcomeric mitochondrial CK, 97.7% of ubiquitous mitochondrial CK, and 99.9% of CK-MM. The correlation coefficient (r) between CK-MB activity and CK-MB protein was 0.968. However, we found 4 cases showing CK-MB activity significantly higher than the protein concentration. Increased CK-BB activity was detected by electrophoresis in these cases. In some patients with malignant tumors, the presence of CK-immunoglobulin complex also lead to elevated CK-MB concentrations. Thus, the discrepancy in the CK-MB activity and the protein concentration may be caused by the presence of CK-BB and/or CK-immunoglobulin complex. More attention needs to be focused on samples with high CK-MB protein concentrations, especially when the CK-MB/CK ratio is high.