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Objectives A study was set up to validate the safety and feasibility of intravascular ultrasound-guided stenting without subsequent anticoagulation, and its impact on the 6 months restenosis rate.Methods The study was designed to be multicentred, prospective, and observational.Results One hundred and sixty-one patients with stable angina and a de novo coronary artery lesion were enrolled. In four patients, the implantation of a Palmaz–Schatz (with spiral bridge) stent had failed. One of these four patients died 3 days following bypass surgery. In two other patients, intravascular ultrasound assessment was not performed. One hundred and twenty-five of the remaining 155 patients (81%) were treated with aspirin (100mg.day−1), because all three criteria for optimized stent expansion were met. Twenty-two of the remaining 38 patients (25%), in whom at least one criterion was not met were treated with aspirin and acenocoumarol (3 months, INR 2·5–3·5), while 16 patients only received aspirin. Stent thrombosis was documented in two patients (1·3%) for which repeat angioplasty was performed. During the hospital stay, there were no deaths or Q-wave myocardial infarctions. Five patients (3·2%) sustained a non-Q-wave myocardial infarction. During the follow-up period (198±38 days, complete for all patients, except one), one patient (0·6%) sustained a Q-wave myocardial infarction, one (0·6%) underwent bypass surgery, and repeat angioplasty was performed in nine patients (5·7%). In two of the nine patients, repeat angioplasty involved another lesion. Therefore, the target lesion revascularization rate during follow-up was 4·5% (seven patients).At quantitative coronary angiography, the minimal lumen diameter (mean±SD) increased from 1·12± 0·34mm before to 2·89±0·35mm after stenting. Repeat angiography at 6 months was performed in 144 patients (92%). The minimal lumen diameter at follow-up was 2·12±0·67mm. Restenosis (diameter stenosis of 50% or more) was documented in 12 patients or 8·3%. When the two patients with documented stent thrombosis are included, the restenosis rate amounts to 9·7%.Conclusions These data confirm that, in selected patients, stents can safely be implanted without the use of systemic anticoagulation, provided optimal stent expansion is achieved. The exact role of intravascular ultrasound in the achievement of these results needs to be established by appropriately designed studies. In the meantime, intra-vascular ultrasound coupled with the Palmaz–Schatz stent incorporating a spiral bridge, may have contributed considerably to the immediate angiographic outcome, which in turn may explain the favourable clinical and angiographic outcome at 6 months. [ABSTRACT FROM PUBLISHER]

Introduction: 'Porcelain aorta' is listed in the second consensus document of the Valve Academic Research Consortium as a risk factor in aortic valve replacement. However, the extent of circumferential involvement is poorly defined with great variability in reported incidence. We present a simple, reproducible classification to describe the extent of aortic calcification and thus appropriately define 'porcelain aorta', aiding clinical decision-making and registry data collection., Methods: 175 consecutive CT aortograms were reviewed. The aorta was divided into three sections, and each section divided into quadrants. These were individually scored using a 5-point scale (0-no calcification, 5-complete contiguous calcification).Results for each quadrant were summated for each segment to provide an indication of the distribution of calcification., Results: Only one patient (0.6%) had a 'true' porcelain aorta, defined as contiguous calcification across all quadrants at any aortic level. Intraobserver and interobserver variation was excellent for the ascending aorta (K=0.85-0.88 and 0.81-0.96, respectively) while the interobserver variation in the transverse arch was good at 0.75., Conclusions: Our data suggest the incidence of 'true' porcelain aorta may be significantly lower than reported in the literature. The predominance of calcification within the anterior wall of the proximal ascending aorta and the superior wall of the transverse arch may be clinically important. Application of this quick, simple and reproducible grading system, with no requirement for advanced software, may provide a tool to support accurate assessment of focal aortic calcification and its relationship to subsequent procedural risk., Competing Interests: Competing interests: None declared.

Background: To investigate the relationship between arterial access site choice (radial versus femoral) and clinical outcomes among STEMI patients undergoing routine PCI after fibrinolysis., Methods: Patient-level data from trials of STEMI patients evaluating routine PCI after fibrinolysis were included. The primary endpoint was 30-day major bleeding; secondary endpoints included 30-day death and re-infarction., Results: 1891 patients underwent PCI (trans-radial n=338, trans-femoral n=1553). Trans-radial PCI patients were less likely to be >75years (2% vs. 8%, p=0.0001), heavier (median weight 82 [72-90] vs. 80 [70-90] kg, p=0.0013) and more likely in Killip class I at presentation (87% vs. 82%, p=0.03). At 30days, trans-radial PCI was associated with a similar unadjusted risk for major bleeding (3.7% vs. 1.2%, Odds Ratio [OR] 0.43 [95% CI 0.13-1.48], p=0.18), mortality (3.4% vs. 1.2%, OR 0.34 [0.09-1.28], p=0.11) and re-infarction (3.9% vs. 4.7%, OR 1.25 [0.60-2.58], p=0.56). In multivariable analysis, radial access was associated with similar estimates for bleeding and death/reinfarction risk., Conclusions: In STEMI patients treated with fibrinolysis and undergoing an early routine invasive strategy, radial compared to femoral PCI is chosen in younger, less ill patients and is independently associated with similar risk of bleeding, re-infarction, and mortality., Summary: This study evaluated the relationship between arterial access choice (radial versus femoral) and in-hospital and 30-day outcomes in patients undergoing routine PCI after fibrinolysis for STEMI. We included patient-level data from trials evaluating a strategy of routine PCI after fibrinolysis for STEMI. Of 1891 patients undergoing PCI, trans-radial access (n=338) was chosen in younger, lower risk patients. At 30days, trans-radial access was associated with a similar unadjusted and adjusted risk of major bleeding, re-infarction and mortality., (Copyright © 2016 Elsevier Inc. All rights reserved.)

Background: The ZOMAXX I trial tested the noninferiority of a zotarolimus-eluting coronary stent (ZoMaxx(™) ) when compared with a paclitaxel-eluting coronary stent (Taxus(™) Express(2™) ) in a randomized trial of percutaneous intervention for de novo coronary artery stenosis. Angiographic analysis at the primary endpoint of 9 months has been reported previously. The purpose of this follow-on analysis was to describe the clinical results of the ZoMaxx and Taxus cohorts of the ZOMAXX I trial after 5 years., Methods and Results: In the ZOMAXX I trial, 199 patients received a ZoMaxx stent and 197 patients received a Taxus stent at 29 investigative sites in Europe, Australia, and New Zealand. The two groups were generally well matched with respect to both clinical and lesional characteristics, including the incidence of diabetes (ZoMaxx 22% vs. Taxus 26%; P = 0.29), reference vessel diameter (ZoMaxx 2.79 ± 0.43 mm vs. Taxus 2.81 ± 0.46 mm; P = 0.65), and lesion length (ZoMaxx 14.9 ± 5.7 mm vs. Taxus 14.6 ± 5.5; P = 0.61). Through 5 years of follow-up, a total of 21 patients had died, six patients had withdrawn, nine had been lost to follow-up, and 13 missed their 5-year visit, leaving a total of 347 patients for analysis (169 ZoMaxx and 178 Taxus). At the 5-year time point, there were no significant differences in any clinical metric including ischemia-driven target lesion revascularization (TLR; ZoMaxx 10.6% vs. Taxus 7.1%; P = 0.29), Q-wave myocardial infarction (ZoMaxx 1.5% vs. Taxus 1.0%; P = 0.99), definite/probable stent thrombosis (ZoMaxx 1.5% vs. Taxus 3.0%; P = 0.34), and cardiac death (ZoMaxx 3.0% vs. Taxus 1.0%; P = 0.28)., Conclusions: After 5 years, the differences in clinical outcome between patients treated with ZoMaxx vs. Taxus stents did not reach statistical significance. However, the nominally higher rate of ischemia-driven TLR (10.6 vs. 7.1%) and the previously reported higher rate of restenosis after 9 months suggest that the ZoMaxx stent afforded less neointimal inhibition when compared with Taxus. © 2013 Wiley Periodicals, Inc., (Copyright © 2013 Wiley Periodicals, Inc.)

The occurrence of angina necessitated investigation of a patient seven years after an operation to protect his dilated Marfan aorta. The customized support, manufactured by a process of computer-aided design, had been fitted in May 2004 when the aortic root measured 49 mm. The magnetic resonance imaging appearances of the aorta remained unchanged over a postoperative period of 7 years and he remained completely well until he began to experience exercise-related angina in 2011. Coronary angiography showed the cause of angina to be an atherosclerotic left anterior descending coronary artery stenosis which was successfully stented. Aortography and coronary angiography performed at that time showed widely patent coronary orifices with no sign of impingement of the external support on the smooth lumen of his coronary arteries. The soft pliant nature of the textile from which the support was made, its intimate fit to the aorta and porous nature allowing incorporation into the aortic adventitia were deliberately built into the design. Nevertheless it was affirming to see these features realized on imaging seven years later. The patient is again completely well and angina free. He is one of a consecutive series of 30 patients who have had this device. There have been no device-related events in over 100 patient/years of follow-up, and all the patients remain alive and well.

Objectives: This study assessed the ability of the SYNTAX score (SXscore) to stratify risk in patients treated with percutaneous coronary intervention (PCI) using zotarolimus-eluting or everolimus-eluting stents., Background: The SXscore can identify patients treated with PCI who are at highest risk of adverse events., Methods: The SXscore was calculated prospectively in 2,033 of the 2,292 patients enrolled in the RESOLUTE All Comers study (RESOLUTE III All Comers Trial: A Randomized Comparison of a Zotarolimus-Eluting Stent With an Everolimus-Eluting Stent for Percutaneous Coronary Intervention). Clinical outcomes in terms of a patient-oriented composite endpoint (POCE) of all-cause death, myocardial infarction (MI), and repeat revascularization; the individual components of POCE; target lesion failure (TLF) (a composite of cardiac death, target-vessel MI, and clinically driven target lesion revascularization); and stent thrombosis were subsequently stratified according to SXscore tertiles: SXscore(LOW) ≤ 9 (n = 698), 9 17 (n = 659)., Results: At 12-month follow-up, rates of POCE, MI, repeat revascularization, TLF, and the composite of death/MI were all significantly higher in patients in the highest SXscore tercile. Rates of stent thrombosis were all highest in the SXscore(HIGH) tertile (p > 0.05). After multivariate adjustment, the SXscore was identified as an independent predictor of POCE, MI, repeat revascularization, and TLF (p < 0.05 for all). At 12-month follow-up, the SXscore, ACEF score, and Clinical SXscore had C-statistics of 0.57, 0.78, and 0.67, respectively, for mortality and of 0.62, 0.56, 0.63, respectively, for POCE. No significant between-stent differences were observed for TLF or POCE in any of the SXscore tertiles., Conclusions: The SYNTAX score is able to stratify risk amongst an all-comers population treated with PCI with second-generation drug-eluting stents (DES); however, improvements can be made with the inclusion of clinical variables. (RESOLUTE III All Comers Trial: A Randomized Comparison of a Zotarolimus-Eluting Stent With an Everolimus-Eluting Stent for Percutaneous Coronary Intervention; NCT00617084)., (Copyright © 2011 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: New-generation coronary stents that release zotarolimus or everolimus have been shown to reduce the risk of restenosis. However, it is unclear whether there are differences in efficacy and safety between the two types of stents on the basis of prospectively adjudicated end points endorsed by the Food and Drug Administration., Methods: In this multicenter, noninferiority trial with minimal exclusion criteria, we randomly assigned 2292 patients to undergo treatment with coronary stents releasing either zotarolimus or everolimus. Twenty percent of patients were randomly selected for repeat angiography at 13 months. The primary end point was target-lesion failure, defined as a composite of death from cardiac causes, any myocardial infarction (not clearly attributable to a nontarget vessel), or clinically indicated target-lesion revascularization within 12 months. The secondary angiographic end point was the extent of in-stent stenosis at 13 months., Results: At least one off-label criterion for stent placement was present in 66% of patients. The zotarolimus-eluting stent was noninferior to the everolimus-eluting stent with respect to the primary end point, which occurred in 8.2% and 8.3% of patients, respectively (P<0.001 for noninferiority). There were no significant between-group differences in the rate of death from cardiac causes, any myocardial infarction, or revascularization. The rate of stent thrombosis was 2.3% in the zotarolimus-stent group and 1.5% in the everolimus-stent group (P=0.17). The zotarolimus-eluting stent was also noninferior regarding the degree (+/-SD) of in-stent stenosis (21.65+/-14.42% for zotarolimus vs. 19.76+/-14.64% for everolimus, P=0.04 for noninferiority). In-stent late lumen loss was 0.27+/-0.43 mm in the zotarolimus-stent group versus 0.19+/-0.40 mm in the everolimus-stent group (P=0.08). There were no significant between-group differences in the rate of adverse events., Conclusions: At 13 months, the new-generation zotarolimus-eluting stent was found to be noninferior to the everolimus-eluting stent in a population of patients who had minimal exclusion criteria. (ClinicalTrials.gov number, NCT00617084.), (2010 Massachusetts Medical Society)

Objectives: The purpose of this research was to compare the Thrombolysis In Myocardial Infarction (TIMI) frame count (CTFC) with coronary flow velocity reserve (CFVR) in patients undergoing percutaneous coronary intervention (PCI)., Background: The relationship between CTFC and CFVR has not been adequately assessed in patients with coronary artery disease., Methods: We studied 62 patients who underwent successful non-emergent PCI. All patients had Doppler evaluation of CFVR, CTFC, and quantitative coronary angiography. In an additional 17 patients, a frame count reserve was calculated as baseline CTFC/CTFC at peak hyperemia, induced by intracoronary adenosine after PCI., Results: The CTFC decreased from 27 +/- 13 to 18 +/- 8, and CFVR increased from 1.5 +/- 0.4 to 2.6 +/- 0.7 (both p < 0.0001). The pre-PCI CTFC and the CFVR were closely related to minimal lumen diameter (p < 0.0001). After PCI, there was no correlation between CFVR and CTFC. In addition, no relationship was observed between CFVR and the frame count reserve., Conclusions: There was no significant correlation between CFVR and CTFC in patients undergoing coronary intervention. The relative utility of these measures in predicting outcomes in this setting requires further evaluation, but CTFC (or frame count reserve) does not appear to be an adequate surrogate measure of Doppler-derived CFVR.

We report 2 cases of directional coronary atherectomy performed by using the Percu-Surge System to prevent distal embolization. A discrete amount of material was aspirated after the procedure. No clinical sequelae occurred in the immediate follow-up. These cases underline the problem of distal embolization during directional atherectomy, and the possibility to prevent it by using protection devices.

Background: Thromboembolism due to atrial fibrillation (AF) is a frequent cause of stroke. More than 90% of thrombi in AF form in the left atrial appendage (LAA). Obliteration of the appendage may prevent embolic complications., Methods and Results: We evaluated the feasibility and safety of implanting a novel device for percutaneous left atrial appendage transcatheter occlusion (PLAATO). LAA occlusion using the PLAATO system was attempted in 15 patients with chronic AF at high risk for stroke, who are poor candidates for long-term warfarin therapy. The implant consists of a self-expanding nitinol cage covered with a polymeric membrane (ePTFE). The LAA was successfully occluded in 15/15 patients (100%). Angiography and transesophageal echocardiography (TEE) during the procedure showed that the device was well-seated in all patients and that there was no evidence of perforation, device embolization, or interference with surrounding structures. In 1 patient, the first procedure was complicated by a hemopericardium, which occurred during LAA access. A second attempt 30 days later was successful with no untoward sequela. No other complications occurred. At 1-month follow-up, chest fluoroscopy and TEE revealed continued stable implant position with smooth atrial-facing surface and no evidence of thrombus., Conclusions: Thus, transcatheter closure of the LAA is feasible in humans. This novel implant technology may be appropriate for patients with AF who are not suitable candidates for anticoagulation therapy. Further trials are needed to show the long-term safety and its efficacy in reducing stroke.

Background: Intracoronary ultrasound (ICUS) is increasingly used in clinical practice to study the natural history of coronary artery disease and to assess the effects of intracoronary, catheter-based interventions. However, the risk associated with the procedure is not well documented., Methods and Results: ICUS studies performed in 28 centers were retrospectively included; these centers agreed to contribute to the study among a total of 60 centers initially invited. Among the 2207 ICUS studies, 505 (23%) were performed in heart transplant recipients and 1702 (77%) in nontransplant patients. Indication for ICUS was diagnostic imaging in 915 (41%), drug testing in 244 (11%), and guidance for intracoronary interventions in 1048 patients (47%). There were no complications in 2034 patients (92.2%). In 87 patients (3.9%), complications occurred but were judged to be "not related" to ICUS by the operator. In 63 patients (2.9%), spasm occurred during ICUS imaging. In 9 patients (0.4%), complications other than spasm were judged to have a "certain relation" to ICUS, including acute procedural events in 6 (3 acute occlusion, 1 embolism, 1 dissection, and 1 thrombus) and major events in 3 patients (2 occlusion and 1 dissection; all resulting in myocardial infarction). In 14 patients (0.6%), complications with "uncertain relation" to ICUS were recorded, including acute procedural events in 9 (5 acute occlusion, 3 dissection, and 1 arrhythmia) and major events in 5 patients (2 myocardial infarction and 3 emergency coronary artery bypass surgery). The incidence of acute procedural or major complications judged to be associated with ICUS (uncertain relation or certain relation to ICUS) was compared in different patient groups. The complication rate was higher in patients with unstable angina or acute myocardial infarction (2.1% events) as compared with patients with stable angina pectoris and asymptomatic patients (0.8% and 0.4%, respectively; chi 2 = 10.9, P < .01). These complications were also more frequent in patients undergoing interventions (1.9%) as compared with transplant and nontransplant patients undergoing diagnostic ICUS imaging (0% and 0.6%, respectively; chi 2 = 13.5, P < .001). Adverse events were few, and no association was detected between these events and the size or type of ICUS catheter used., Conclusions: ICUS is associated with (but not necessarily the direct cause of) a minor acute clinical risk. Vessel spasm is the most frequent event occurring during ICUS. Other complications predominantly occur in patients with acute coronary syndromes and during guidance for intervention.

A survey to assess the perceived prevalence of aluminum-related disease was conducted by the Medical Review Board of the End-Stage Renal Disease Network 28 from 1986 to 1987. Responses were obtained for 855 of 3000 patients on dialysis representing 17 of 39 participating dialysis units within the network. Almost 40% of the patients surveyed had been receiving dialysis therapy for over 3 years. Patients on hemodialysis (83% of the study group) had the water used to prepare the dialysate pretreated. Serum aluminum determinations were obtained in 240 (28%) of the 855 patients; other methods of assessing body aluminum burden were performed in less than 10% of the survey population. When obtained, elevated serum aluminum measurements were more likely to be found with each year patients were given dialysis and with each year patients were treated with oral aluminum gels. With the exception of patients with bone pain, clinical signs and symptoms did not correlate with elevated serum aluminum. However, the prevalence of muscle weakness, bone pain, fractures, and dementia in the survey group did correlate with years on dialysis and/or years receiving oral aluminum gels. Data gathered from this survey are consistent with the view that signs and symptoms suggestive of an increased body aluminum burden occur in the minority of patients on dialysis. Nevertheless, patients at risk for aluminum intoxication (years on dialysis, years receiving gels, patients with clinical signs) may not be adequately identified.