Evaluation of thoracic impedance trends for implant-based remote monitoring in heart failure patients - Results from the (J-)HomeCARE-II Study.

AIMS: Remote monitoring by implantable devices substantially improves management of heart failure (HF) patients by providing diagnostic day-to-day data. The use of thoracic impedance (TI) as a surrogate measure of fluid accumulation is still strongly debated. The multicenter HomeCARE-II study evaluated clinically apparent HF events in the context of remote device diagnostics, focusing on the controversial role of TI. METHODS AND RESULTS: We followed 497 patients (66.6 ±â€¯10.1 years, 77% male, QRS 139.8 ±â€¯36.0 ms, ejection fraction 26.8 ±â€¯7.0%) implanted with a CRT-D (67%) or an ICD (33%) for 21.4 ±â€¯8.1 months. An independent event committee confirmed 171 HF events of which 82 were used to develop a TI-based algorithm for the prediction of imminent cardiac decompensation. Highly inter-individual variations in patterns of TI trends were observed. The algorithm resulted in a sensitivity of 41.5% (50.0%) with 0.95 (1.34) false alerts per patient year, and a positive predictive value of 7.9% overall and 27.9% in the HF event group of patients. Averaged ratio statistics showed a significant pre-hospital decrease and a highly significant in-hospital increase in TI after intensified diuresis. Recurrent decompensations turned out to be preceded by a significantly stronger decrease of TI compared to first events with a higher chance for detection (63.6% sensitivity, p < 0.05). CONCLUSIONS: Overall performance in predicting imminent decompensation by monitoring TI alone is limited due to its high inter-patient variability. TI stand-alone applications should be redirected towards a target population with more advanced symptoms where post-hospital observation aimed to maintain the patient's discharge status might be the most valuable approach. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov Identifier NCT00711360 (HomeCARE-II) and NCT01221649 (J-HomeCARE-II).

Sheathless guide catheter in transradial percutaneous coronary intervention for ST-segment elevation myocardial infarction.

OBJECTIVES: The aim of this study was to assess the safety and efficacy of sheathless guide catheters in transradial percutaneous coronary intervention (PCI) for ST-segment elevation myocardial infarction (STEMI). BACKGROUND: Transradial PCI for STEMI offers significant clinical benefits, including a reduced incidence of vascular complications. As the size of the radial artery is small, the radial artery is frequently damaged in this procedure using large-bore catheters. A sheathless guide catheter offers a solution to this problem as it does not require an introducer sheath. However, the efficacy and safety of sheathless guide catheters remain to be fully determined in emergent transradial PCI for STEMI. METHODS: Data on consecutive STEMI patients undergoing primary PCI at the Sendai Kousei Hospital between September 2010 and May 2013 were analyzed. The primary endpoint was the rate of acute procedural success without access site crossover. Secondary endpoints included door-to-balloon time, fluoroscopy time, volume of contrast, and radial artery stenosis or occlusion rate. RESULTS: We conducted transradial PCI for 478 patients with STEMI using a sheathless guide catheter. Acute procedural success was achieved in 466 patients (97.5%). The median door-to-balloon time was 45 min (range, 15-317 min). The median fluoroscopy time was 16.4 min (range, 10-90 min). The median volume of contrast was 134 mL (range, 31-431 mL). Radial stenosis or occlusion developed in 14 (3.8%) of the 370 evaluable patients. CONCLUSIONS: This study showed that use of a sheathless guide catheter taking a transradial approach was effective and safe in primary PCI for STEMI. © 2015 Wiley Periodicals, Inc.

Role of Coronary Calcium Scoring in the Assessment of Physiological Ischemia in Patients with Intermediate Stenosis.

Although coronary artery calcium (CAC) is an established marker of coronary atherosclerosis, whether it also reflects the physiological significance is unknown. This study aims to evaluate if CAC could indicate physiological ischemia in intermediate stenosis defined by an invasive fractional flow reserve (FFR). CAC score (CACS) derived from either whole coronary arteries or individual arteries was measured by computed tomography among patients with intermediate de novo lesions (percent diameter stenosis from 30% to less than 70%). All stenoses were evaluated by invasive FFR; lesions with an FFR ≤ 0.80 were considered significant. We enrolled 119 patients with 143 lesions. Of these, 42 lesions (29.4%) demonstrated significant ischemia by FFR measurement. FFR values had modest but significant correlations with CACS in individual arteries with intermediate stenosis (r = - 0.290; p < 0.001). A receiver operating characteristic curve analysis showed that CACS of individual arteries with intermediate stenosis had 71.4% sensitivity and 67.3% specificity as a predictor of significant ischemia at a cut off value of 145.9. Multivariable analysis showed that percent diameter stenosis and CACS in individual arteries with intermediate stenosis were independent predictors for significant ischemia. By net reclassification improvement analysis, CACS in individual arteries with intermediate stenosis provided incremental prediction for significant ischemia over minimum lumen diameter, percent diameter stenosis, and lesion length. CACS measured in each artery, but not the total CACS, provides additional information as to whether an angiographically intermediate stenosis within the artery is significant enough to cause myocardial ischemia.

Transradial Approach of Alcohol Septal Ablation Using a Sheathless Guiding Catheter: A Feasibility Study.

OBJECTIVES: We aimed to investigate the feasibility and safety of alcohol septal ablation (ASA) via transradial approach using a sheathless guiding catheter. BACKGROUND: Although ASA is conventionally performed via the femoral artery, there is a potential risk of bleeding and other vascular complications. The transradial approach may be associated with a lower rate of such complications. A sheathless guiding catheter, with an advanced hydrophilic coating along its full length, could reduce radial artery occlusion and spasm. METHODS: We enrolled 14 consecutive patients with hypertrophic obstructive cardiomyopathy treated with ASA via the radial access at Sendai Kousei Hospital from December 2012 to May 2014. Left radial access was used for the sheathless guiding catheter, while right radial access was used for monitoring left ventricular pressure with a 4 Fr diagnostic catheter. A temporary pacemaker was inserted via the right jugular vein. RESULTS: Procedural success rate was 93% (13/14 patients). The left ventricular outflow tract pressure gradient at rest was reduced from a median of 128 mm Hg (interquartile range, 49-147 mm Hg) at baseline to a median of 16 mm Hg (interquartile range, 13-26 mm Hg) at 30-day follow-up (P=.01). The New York Heart Association functional class improved from a median of II (II-III) at baseline to a median of I (I-I) at 30-day follow-up (P=.01). There were no cases of access-site complication, including radial artery occlusion and spasm. CONCLUSIONS: The transradial approach using a sheathless guiding catheter was feasible and safe for ASA.

Early Phase Arterial Reaction Following Drug-Eluting and Bare-Metal Stent Implantation in Patients With ST-Segment Elevation Myocardial Infarction.

The early phase arterial reaction after implantation of second-generation drug-eluting stents (2nd DES) and baremetal stents (BMS) in patients with ST-segment elevation myocardial infarction (STEMI) remains unclear.The MECHANISM pilot study is a multi-center prospective registry that enrolled 24 STEMI patients (from 11 centers) who had undergone implantation of everolimus-eluting (n = 6), biolimus A9-eluting (n = 6) or zotarolimus-eluting stents (n = 6), or BMS (n = 6). Scheduled optical coherence tomography (OCT) was performed 2 weeks after implantation, and images were independently analyzed at a core laboratory in a blinded fashion. Intra-stent thrombus was quantitatively analyzed in terms of the maximal area and the percentage of cross-sections with thrombus (the numbers of cross-section with thrombus × 100 divided by total number of cross-sections within the stented segment). More than 90% of struts were already covered 2 weeks after the index procedure, regardless of the stent type. There were no differences in stent diameter, minimal lumen diameter, minimal lumen area, neointimal thickness, or the frequencies of malapposed and uncovered struts among the 4 groups. The quantity of intra-stent thrombus also did not differ among the 4 groups.The results of this pilot study suggest that the 2-week vascular responses seem to be similar among 2nd DES and BMS in STEMI patients. Considering the possible advantage of 2nd DES in the prevention of restenosis, 2nd DES are a feasible option for the treatment of patients with STEMI.

Sheathless guide catheter coronary intervention via radial artery: single-center experience with 9658 procedures.

OBJECTIVES: To evaluate the efficacy and safety of transradial coronary intervention (TRI) using a sheathless guide catheter (sheathless TRI) in a large, retrospective, single-center study. BACKGROUND: The sheathless guide catheter was designed to be inserted without an introducer sheath to decrease stress to the radial artery. Although the sheathless guide catheter has some potential limitations, such as its procedural complexity or the risk of coronary ostial dissection, no large studies have been reported. METHODS: We retrospectively investigated all TRIs performed at Sendai Kousei Hospital from January 2004 to December 2013. RESULTS: Out of a total of 12,617 percutaneous coronary interventions (PCIs), sheathless TRIs were performed in 9658 cases (76.5%) and TRIs using a conventional sheath (sheath TRI) were performed in 1070 cases (8.5%). Procedural success was achieved in 98.81% of sheathless TRIs and 96.82% of sheath TRIs (P<.001); after propensity matching, the success rate was 98.9% in sheathless TRIs and 97.6% in sheath TRIs (P=.01). The conversion of the guide catheter system occurred in 0.40% of sheathless TRIs and 0.28% in sheath TRIs (P=.54). Coronary ostial dissection occurred in 0.26% of sheathless TRIs and 0.47% in sheath TRIs (P=.22). CONCLUSION: Sheathless TRI was utilized in the majority of cases, and the propensity-matched procedural success was similar but statistically higher as compared with sheath TRI. Complications were rare and equivalent to sheath TRI. Sheathless TRI is effective and safe as an initial PCI technique after the consideration of its benefits and limitations.

Successful penetration and bougie dilatation with Brockenbrough needle for severely calcified occlusion in superficial femoral artery.

A 75-year-old hemodialysis patient with right critical limb ischemia received endovascular therapy for a chronic total occlusion (CTO) in a diffusely calcified superficial femoral artery (SFA). During a retrograde approach, a Brockenbrough needle (BN) was able to penetrate the calcified hard plaque formed in the middle segment of the CTO. Moreover, bougie dilatation with the BN allowed balloon crossing and stent deployment, even after failure to pass a 2.0-mm monorail balloon across the plaque. These results suggest that the BN offers a new therapeutic option in the penetration and modification of severely calcified CTO in SFA.

Percutaneous closure of post-infarction ventricular septal defect using an Amplatzer septal occluder.

A 77-year-old woman underwent percutaneous closure of post-infarction ventricular septal defect. The defect was successfully closed with a 20-mm Amplatzer septal occluder with a small residual shunt and Qp/Qs improved from 3.38 to 1.48. She was discharged 30 days after procedure. To our knowledge, this is the first case reported in Japan.

Interatrial mechanical dyssynchrony shown by tissue doppler imaging during atrial flutter.

Although regular supraventricular tachycardia is traditionally classified on the basis of P-wave morphology, diagnostic accuracy is limited to information obtained from surface electrocardiography. Intracardiac electrophysiology is a conclusive although invasive diagnostic method. We report a case of regular supraventricular tachycardia with a heart rate of 162 bpm. M-mode echocardiography of the interatrial septum clarified both the atrial rate and the ventricular response ratio. Tissue Doppler M-mode imaging demonstrated the delay between the posterior wall motion of the left and right atrium. Although it deserves further study, transthoracic echocardiography may provide useful information in addition to electrocardiography.

[Role of bare metal stent in drug eluting stent era].

Although drug eluting stent (DES) reduced the target vessel revascularization, there are still some unsolved concerns such as late stent thrombosis, late catch up, adequate duration of dual antiplatelet agents and surgical complication after DES implantation. Individually bare metal stent should be used considering several factors such as patient characteristic, lesion characteristic, the tolerance of dual antiplatelet therapy for long-term, informed consent and also surgery after PCI.

Three-dimensional relationship between the conus branch and the precordial leads confirmed by 64-multidetector-row computed tomography.

A 65-year-old man with effort angina pectoris underwent percutaneous coronary intervention of the proximal right coronary artery. The lesion was dilated with a bare-metal stent under wire protection of the conus branch (CB). However, the jailed CB was occluded. Electrocardiogram with conventional precordial leads (V(1) through V(6)) accompanied with the supplementary leads (V(1) through V(6)) positioned 1 intercostal space higher showed marked ST elevation in V(1) through V(3) that was more prominent in V(1) through V(3). The 64-multidetector-row computed tomographic coronary angiography showed recanalization of the CB located just in the center of the V(1), V(2), V(1), and V(2) electrodes.

Outcome of percutaneous intrapericardial fibrin-glue injection therapy for left ventricular free wall rupture secondary to acute myocardial infarction.

Left ventricular free wall rupture (LVFWR) is a fetal complication of acute myocardial infarction. This study was conducted to test the feasibility of percutaneous intrapericardial fibrin-glue injection therapy (PIFIT) for LVFWR after acute myocardial infarction and to assess its clinical outcome. From January 2000 to December 2004, LVFWR was confirmed by echocardiography in 22 patients. Thirteen patients showing abrupt hemodynamic collapse failed to recover from resuscitation maneuvers and died <2 hours after LVFWR. The remaining 9 patients (5 women, mean age 73 +/- 10 years) underwent PIFIT. Pericardiocentesis was performed from the subxiphoid process, and a 6Fr pigtail catheter was introduced into the pericardial space. After bloody fluid was drained from the catheter, the fibrin glue was injected into the pericardial space. There were no complications relating to pericardiocentesis and PIFIT. One patient underwent surgical repair on the day of PIFIT because of uncontrollable bleeding from pericardial drainage. In-hospital death as a result of rerupture occurred in 2 patients on days 4 and 7 after PIFIT. Echocardiography during follow-up revealed no evidence of pseudoaneurysm or left ventricular restriction. On follow-up at a median of 4.0 years (interquartile range 3.1 to 4.8), 1 noncardiac death occurred at 3.3 months. The other 5 patients were free of cardiovascular events and in New York Heart Association functional class I. In conclusion, PIFIT is a simple, effective, and less invasive technique for the management of LVFWR and thus can be an alternative to surgical repair for LVFWR after acute myocardial infarction.

Responsiveness to dobutamine stimulation in patients with left ventricular apical ballooning syndrome.

To investigate the underlying mechanisms of the left ventricular (LV) apical ballooning syndrome, we evaluated the functional responsiveness to dobutamine stimulation in patients with the syndrome. Over a 22-month period, 11 consecutive patients with the apical ballooning syndrome were referred to our institution. All 11 patients were women and 57 to 85 years of age (mean 73 +/- 10). Among them, 10 patients underwent low-dose dobutamine echocardiography within 24 hours after admission (17 +/- 8 hours). Echocardiography was repeated in the convalescent phase (48 +/- 33 days) to assess functional outcome. In the resting state, all patients showed akinetic wall motion in the midportion of the left ventricle and apical left ventricle. After low-dose dobutamine infusion, akinetic wall motion detected at rest did not show any improvement despite the hypercontractile basal LV wall. In the convalescent phase, LV dysfunction was not observed on echocardiography in all 11 patients. The LV apical ballooning syndrome has a unique feature that reversible dysfunction lacks functional amelioration during dobutamine administration. In conclusion, this finding suggests that the pathophysiologic mechanisms of the syndrome appear to be distinct from those of myocardial stunning after transient ischemia, and catecholamine-mediated cardiac toxicity may play a role in the development of the syndrome.

Intramyocardial injection of allogenic bone marrow-derived mesenchymal stem cells without immunosuppression preserves cardiac function in a porcine model of myocardial infarction.

BACKGROUND: We investigated the efficacy of directly injected allogenic bone marrow-derived mesenchymal stem cells in improving left ventricular function in a porcine model of myocardial infarction. METHODS: Left ventricular infarction was created in 16 adult Yorkshire pigs by coil embolization and thrombotic occlusion distal to the second diagonal artery. One month after myocardial infarction was induced, the animals were randomized to either direct injection of allogenic mesenchymal stem cells or sham treatment (culture medium). Allogenic bromodeoxyuridine-labeled mesenchymal stem cells (2 +/- 0.1 x 10(8)) were directly injected into the infarct and peri-infarct areas during an open chest procedure. No immunosuppressive therapy was used. The left ventricular function was measured using serial biplane left ventricular angiography at baseline, 30, 60, and 90 days before sacrifice. Mesenchymal stem cells were localized using bromodeoxyuridine, and differentiation of mesenchymal stem cells was assessed by confocal microscopic colocalization of bromodeoxyuridine with immunofluorescent antibodies specific for cardiomyocytes (troponin I and MF-20) and endothelial cells (von Willebrand factor). RESULTS: Mesenchymal stem cells labeled with bromodeoxyuridine engrafted the peri-infarct zone and colocalized with both cardiomyocyte-specific and endothelial cell-specific immunofluorescence. No intramyocardial bromodeoxyuridine was observed in sham-treated animals. At the time of the mesenchymal stem cell injection 30 days after myocardial infarction, the left ventricular ejection fraction (LVEF) was 58% +/- 3% in mesenchymal stem cell-treated pigs and 56% +/- 2% in sham-treated pigs (P = NS). LVEF deteriorated progressively thereafter in untreated pigs (8.5% and 10.5% decline at 60 days and 90 days after myocardial infarction, respectively), but was preserved in mesenchymal stem cell-treated pigs (2.1% increase and -2.0% decline at 60 and 90 days post-MI respectively) (P < .05). CONCLUSIONS: Direct intramyocardial injection of mesenchymal stem cells results in successful intramyocardial engraftment and differentiation into cardiomyocytes and endothelial cells and preserves left ventricular function after myocardial infarction in pigs.

Use of everolimus-eluting stent with a bioresorbable polymer coating for treatment of recurrent in-stent restenosis.

Recently, an everolimus-eluting stent utilizing a bioresorbabale PLA polymer coating to release the agent everolimus has proven safe and effective in preventing restenosis for up to six months in de novo coronary arteries. But the use of a bioresorbable polymer-coated everolimus-eluting stent for in-stent restenosis lesions has not been previously investigated. This is a case report of one-year angiographic follow-up results after the implantation of a bioresorbable PLA polymer-coated everolimus-eluting stent for the treatment of recurrent in-stent restenosis. The case involved a 63-year-old female who had repeatedly presented with recurrent in-stent restenosis in the LCX. We successfully treated this recurrent ISR lesion by using a bioresorbable PLA polymer-coated everolimus-eluting stent; the one-year follow-up angiography revealed prevention of ISR after the implantation of this device.

Intracoronary beta-irradiation enhances balloon-injury-induced tissue factor expression in the porcine injury model.

Intracoronary brachytherapy (ICBT) effectively reduces restenosis but is associated with late thrombosis. Since tissue factor (TF) is an important mediator of arterial thrombosis, we tested the hypothesis that ICBT results in persistently augmented TF expression. Coronary arteries from 12 pigs were randomized to: control (C; no injury), oversized balloon injury (BI), or BI followed by ICBT. Animals were sacrificed at 1, 7, 14, or 60 days postprocedure, and coronary arteries collected for expression analyses and immunostaining. ICBT-treated arteries had higher TF antigen and activity at all time-points compared to BI arteries (Western blot: 16 571 +/- 2090 vs 10 135 +/- 2939 densitometric units, p = 0.001; ELISA: 0.42 +/- 0.13 nM vs 0.25 +/- 0.14 nM, p = 0.001; TF activity assay: 0.303 +/- 0.11 nM vs 0.18 +/- 0.07 nM, p = 0.01; immunohistochemical staining: 30.6 +/- 6.6% vs 11.5% +/- 3.2%, p = 0.01). TF expression increased following BI, increased further following ICBT, and persisted for the duration of the study. We conclude that TF expression increases after BI, but is further increased and persists for a longer duration following ICBT, suggesting that a TF-mediated mechanism may play a role in late thrombosis following ICBT.

Effectiveness of right or left radial approach for coronary angiography.

The transradial approach for catheterization is becoming increasingly more popular. At present, the choice of the right or left radial artery depends on the operator's preference. We examined how the laterality influenced the effectiveness of the approach. Employing Judkins-type catheters, we performed coronary angiography in 232 patients with the left approach and in 205 patients with the right approach. Although access time did not differ between the two groups of patients, the duration of catheter manipulation was shorter in the left- than in the right-approach group (11.7 +/- 5.9 vs. 9.8 +/- 4.4 min; P < 0.001). Because of the shorter duration of catheter manipulation, the total procedural duration was shorter in the left-approach group (13.7 +/- 6.4 vs. 11.4 +/- 4.8 min; P < 0.001). The fluoroscopy time was shorter in the left- than in the right-approach group (3.7 +/- 2.5 vs. 5.0 +/- 3.3 min; P < 0.001). The amount of contrast material did not differ between the groups (79 +/- 27 vs. 83 +/- 25 ml). The rate of guidewire usage to engage the coronary ostium was higher in the right- than in the left-approach group because of the severe tortuosity of the right subclavian artery (20/205 vs. 0/232; P < 0.001). Thus, for operators with significant experience, the left radial approach may provide increased procedural efficacy for coronary angiography compared to the right radial approach.

Mesenchymal stem cell injection induces cardiac nerve sprouting and increased tenascin expression in a Swine model of myocardial infarction.

UNLABELLED: Stem Cell Induces Cardiac Nerve Sprouting. INTRODUCTION: Mesenchymal stem cell (MSC) transplantation is a promising technique to improve cardiac function. Whether MSC can increase cardiac nerve density and contribute to the improved cardiac function is unclear. METHODS AND RESULTS: Anterior wall myocardial infarction was created in 16 swine. One month later, 6 swine were given MSC and fresh bone marrow (BM) into infarcted myocardium (MSC group). Four swine were given fresh BM only (BM group), and 6 swine were given culture media (MI-only group). The swine were sacrificed 95.8 +/- 3.5 days after MI. Six normal swine were used as control. Immunocytochemical staining was performed using antibodies against growth-associated protein 43 (GAP43), tyrosine hydroxylase (TH), and three subtypes of tenascin (R, C, and X). Five fields per slide were counted for nerve density. The results show the following. (1). There were more GAP43-positive nerves in the MSC group than in the BM, MI-only, or Control group (P < 0.0001). TH staining showed higher nerve densities in the MSC group than in the MI-only (P < 0.01) or Control group (P < 0.0001) in the atria. (2). There were more sympathetic (TH-positive) nerves in myocardium distant from infarct than in the peri-infarct area (P < 0.05). (3). Optical intensity and color analyses showed significantly higher tenascin R and tenascin C expression in the MSC and BM groups than in the MI-only or Control group (P < 0.01). CONCLUSION: MSC injected with BM into swine infarct results in overexpression of cardiac tenascin, increased the magnitude of cardiac nerve sprouting in both atria and ventricles, and increased the magnitude of atrial sympathetic hyperinnervation 2 months after injection.

Local drug delivery via a coronary stent with programmable release pharmacokinetics.

BACKGROUND: Fixed drug release kinetics and vessel wall partitioning may limit the effectiveness of drug-eluting stents. We report preliminary experience using a new coronary stent with programmable pharmacokinetics. METHODS AND RESULTS: A newly designed metallic stent contains honeycombed strut elements with inlaid stacked layers of drug and polymer. In vitro studies evaluated recipes for loading paclitaxel to establish the parameters for controlling drug release. Manipulation of the layers of biodegradable polymer and drug allowed varying of the initial 24-hour burst release of paclitaxel from 69% to 8.6% (P<0.0001). Late release of drug could be adjusted dependently or independently of early burst release. A biphasic release profile was created by the addition of blank layers of polymer within the stack. In the 30-day porcine coronary model (n=17 pigs), there was a 70% reduction in late loss (0.3+/-0.5 versus 1.0+/-0.5 mm, P=0.04), a 28% increase in luminal volume (132+/-12 versus 103+/-21 mm(3), P=0.02), and a 50% decrease in histological neointimal area (2.0+/-0.5 versus 4.0+/-1.6 mm(2); P<0.001) compared with bare metal controls. Temporal and regional variations in vascular healing were seen histologically. CONCLUSIONS: Layered polymer/drug inlay stent technology permits flexible and controllable pharmacokinetic profiles. Programmable, complex chemotherapy using this approach may be feasible for the treatment of cardiovascular disease.