Doppler echocardiographic myocardial stunning index predicts recovery of left ventricular systolic function after primary percutaneous coronary intervention.

BACKGROUND: Myocardial stunning is responsible for partially reversible left ventricular (LV) systolic dysfunction after successful primary percutaneous coronary intervention (PPCI) in patients with acute ST-elevation myocardial infarction (STEMI). AIM: To test the hypothesis that early coronary blood flow (CBF) to LV systolic function ratios, as an equivalent to LV stunning index (SI), predict recovery of LV systolic function after PPCI in patients with acute STEMI. METHODS: Twenty-four patients with acute anterior STEMI who had successful PPCI were evaluated and compared to 96 control subjects. Transthoracic echocardiography with measurement of LV ejection fraction (EF), LV, and left anterior descending (LAD) coronary artery area wall-motion score index (WMSI) as well as Doppler sampling of LAD blood velocities, early after PPCI and 5 days later, were performed. SI was evaluated as the early ratio of CBF parameters in the LAD to LV systolic function parameters. RESULTS: Early SI-LVEF well predicted late LVEF (r=.51, P<.01) and the change in LVEF (r=.48, P<.017). Early SI-LVMSI predicted well late LVEF (r=.56, P<.006) and the change in LVEF (r=.46, P<.028). Early SI-LADWMSI predicted late LVEF (r=.44, P<.028). Other SI indices measured as other LAD-CBF to LV systolic function parameters were not predictive of late LV systolic function. CONCLUSIONS: LV stunning indices measured as early LAD flow to LVEF, LVWMSI, and LADWMSI ratios well predicted late LVEF and the change in LVEF. Thus, greater early coronary artery flow to LV systolic function parameter ratios predict a better improvement in late LV systolic function after PPCI.

Bypassing the emergency room to reduce door-to-balloon time and improve outcomes of ST elevation myocardial infarction patients: analysis of data from 2004-2010 ACSIS registry.

OBJECTIVES: Our objective was to assess whether bypassing the emergency room (ER) is associated with meaningful reduction in Major Adverse Cardiac and Cerebrovascular Event (MACCE) or mortality in a large cohort of ST Elevation Myocardial Infarction (STEMI) patients. BACKGROUND: Prior studies suggest that bypassing the emergency room reduces door-to-balloon time (DBT). However, it is not clear whether this translates into reduced mortality. METHODS: We analyzed data of 1,552 consecutive patients with STEMI treated by primary percutaneous coronary intervention (PCI) and enrolled in the Acute Coronary Syndrome Israeli Survey (ACSIS) registry. Thirty percent of patients (n = 459) arrived directly to the Intensive Cardiac Care Unit or catheterization laboratory and 70% (n = 1093) were assessed first in the ER. Our primary end points were DBT, 30-day MACCE, and 30-day and 1-year mortality. Our secondary end points were pre-discharge ejection fraction less than 40%, in-hospital pulmonary edema, in-hospital cardiogenic shock, ST resolution, and duration of hospitalization. RESULTS: Bypassing the ER was associated with signficantly shorter DBT (59 vs. 97 minutes, P = 0.001). There was no difference in 30-day MACCE and 30-day or 1-year mortality between the 2 study groups. The findings were consistent in multiple subgroups, including women, anterior STEMI, off hours PCI, and patients with pain-to-door (PDT) time of less than 120 minutes. CONCLUSION: Bypassing the ER is associated with significant shortening of DBT. This reduction, however, is not associated with any change in 30-day MACCE and 30-day or 1-year mortality.

First experience in ambulatory ultrafiltration therapy for congested heart failure patients in Israel: a feasibility study.

BACKGROUND: The prevalence of heart failure (HF) is increasing rapidly with high readmission rates, mainly due to fluid retention. Ultrafiltration (UF) is a mechanical method for removing fluids. Since UF was introduced only recently in Israel, the skill and experience required for outpatient congested HF patients is scarce. OBJECTIVEs: To evaluate the feasibility and safety of UF therapy in congested HF patients in outpatient clinics under a strict protocol of monitoring and therapy that we developed. METHODS: Between April and September 2013 we applied UF in our outpatient clinic to seven chronically congested HF patients with NYHA III-IV who did not respond adequately to diuretics. We administered a total of 38 courses. RESULTS: On average, 1982 ml fluid per course was removed without significant adverse events and with patients' subjective feeling of improvement. Only two courses were interrupted prematurely due to mechanical problems but were completed without harm to the patients. CONCLUSIONS: Under appropriate professional medical supervision, UF therapy in an outpatient setting is a safe and effective procedure and serves as an additional tool for managing congested HF patients who do not respond adequately to diuretics.

Sequential evaluation of coronary flow patterns after primary angioplasty in acute anterior ST-elevation myocardial infarction predicts recovery of left ventricular systolic function.

BACKGROUND: Function of the microcirculation after primary percutaneous coronary intervention (PCI) is dynamic and contributes to unpredictability of recovery of left ventricular (LV) systolic function. AIM: This study was conducted to evaluate sequential Doppler velocity parameters of the left anterior descending coronary artery (LAD) in predicting recovery of global and regional LV systolic function. METHODS: Thirty-five consecutive patients, 24 males, age 59 ± 12 years, with acute anterior ST-elevation myocardial infarction (STEMI) who had primary PCI were studied. Thrombolysis in myocardial infarction (TIMI) and myocardial blush grades were evaluated. Transthoracic echocardiographic (TTE) studies, evaluation of left ventricular ejection fraction (LVEF), LAD territory wall-motion score index (WMSI), and sampling of LAD Doppler velocities up to 6 hours post-PCI, 48 hours postprocedure, and predischarge were performed. RESULTS: Thrombolysis in myocardial infarction grade before PCI averaged 0.86 ± 1.19 and post-PCI 2.89 ± 0.32, P < 0.05. Myocardial blush grade before PCI was 0.41 ± 0.98 and after PCI 2.22 ± 0.93, P < 0.05. Diastolic velocity deceleration time (DDT) in the LAD early after PCI was less than 600 ms in 16 subjects. Immediately after PCI, in subjects with DDT > 600 ms, LVEF was 38.5 ± 6% and predischarge 49.2 ± 8.7%, P = 9.77 × 10−5 and LAD-WMSI decreased from 2 ± 0.38 to 1.4 ± 0.48, P = 0.000163. In subjects with DDT < 600 ms LAD-WMSI did not change significantly. Early and minimal LAD-DDT correlated with improvement in LV systolic function, r = 0.6, whereas post-PCI blush grade had lower correlation with LVEF, r = 0.39. CONCLUSIONS: Global and regional LV systolic function after PCI in acute anterior MI can be predicted by LAD-DDT better than by post-PCI myocardial blush.

Targeted anti-inflammatory systemic therapy for restenosis: the Biorest Liposomal Alendronate with Stenting sTudy (BLAST)-a double blind, randomized clinical trial.

BACKGROUND: Activation of systemic innate immunity is critical in the chain of events leading to restenosis. LABR-312 is a novel compound that transiently modulates circulating monocytes, reducing accumulation of these cells at vascular injury sites and around stent struts. The purpose of the study was to examine the safety and efficacy of a single intravenous bolus of LABR-312 in reducing restenosis in patients treated for coronary narrowing. Patient response was examined in light of differential inflammatory states as evidenced by baseline circulating monocyte levels, diabetes mellitus, and acute coronary syndrome. METHODS: BLAST is a Phase II prospective, randomized, multicenter, double-blind, placebo-controlled trial that assessed the safety and efficacy of LABR-312. Patients were randomized to receive LABR-312 at 2 dose levels or placebo as an intravenous infusion during percutaneous coronary intervention and bare metal stent implantation. The primary end point was mean angiographic in-stent late loss at 6 months. RESULTS: Patients (N = 225) were enrolled at 12 centers. There were no safety concerns associated with the study drug. For the overall cohort, there were no differences between the groups in the primary efficacy end point (in-stent late loss of 0.86 ± 0.60 mm, 0.83 ± 0.57 mm, and 0.81 ± 0.68 mm for the placebo, low-dose, and high-dose group, respectively; P = not significant for all comparisons). In the prespecified subgroups of patients with a baseline proinflammatory state, patients with diabetes mellitus, and patients with high baseline monocyte count, there was a significant treatment effect. CONCLUSIONS: Intravenous administration of LABR-312 to patients undergoing percutaneous coronary intervention is safe and effectively modulates monocyte behavior. The average late loss did not differ between the treatment and placebo groups. However, in the inflammatory patient group with baseline monocyte count higher than the median value, there was a significant reduction in late loss with LABR-312.

Palpography detects mechanical dyssynchrony and worsens with right ventricular pacing and reduced left ventricular ejection fraction.

BACKGROUND: QRS width and echocardiography-derived indices are limited predictors of response to resynchronization therapy. We applied digital palpography, using vibration resonance imaging, to investigate the effects of right ventricular pacing and left ventricular ejection fraction (LVEF) on mechanical and electrical dyssynchrony. METHODS: Forty-nine subjects were examined: 24 normal controls, 18 subjects with right ventricular apical pacing (12 with reduced LVEF), and seven subjects with reduced LVEF and narrow QRS. Digital measurement of QRS width was performed. Electric dyssynchrony index (EDI) was measured as the time interval between peak R-waves of the same QRS complex of simultaneously recorded standard limb electrocardiograms, L1 and L2. A matrix of 6 × 6 vibration recording transducers was applied to chest. The interval between the onset of Q-wave and the peak of amplitude vibration for each transducer was measured, and a three-dimensional map for the whole matrix of transducers was generated. Median values (QE1) were measured. Mechanical vibration systolic dyssynchrony index (VSDI) for each subject was determined as the standard deviation of the difference between the median value and each transducer interval. RESULTS: EDI was larger in subjects with right ventricular pacing. Mechanical dyssynchrony indices were larger with pacing and reduced LVEF. EDI correlated with QRS width (r(2) = 0.7), with VSDI (r(2) = 0.42), and with QE1 (r(2) = 0.74). QRS width correlated with QE1 (r(2) = 0.75). CONCLUSIONS: Digital chest palpography can determine dyssynchrony indices that are larger in subjects with right ventricular pacing and reduced LVEF and correlate with parameters of electrical dyssynchrony.

Bypassing the emergency room to reduce door-to-balloon time and improve outcomes of patients with ST elevation myocardial infarction: the Acute Coronary Syndrome Israeli Survey experience.

BACKGROUND: Rapid reperfusion of an infarct-related artery is crucial for the successful treatment of ST elevation myocardial infarction. Every effort should be made to shorten door-to-balloon time. OBJECTIVES: To investigate whether bypassing the emergency room (ER) has a positive influence on door-to-balloon time in patients presenting with ST elevation myocardial infarction (STEMI) and whether the reduction in door-to-balloon time improves patients' clinical outcome. METHODS: We analyzed data of 776 patients with STEMI from the 2004 and the 2006 Acute Coronary Syndrome Israeli Survey (ACSIS) registry. The ACSIS is a biennial survey on acute myocardial infarction performed in all 25 intensive cardiac care units in Israel during a 2-month period. Twenty-five percent of patients (193 of 776) arrived directly to the intensive cardiac care unit (ICCU) and 75% (583 of 776) were assessed first in the ER. We compared door-to-balloon time, ejection fraction, 30 days MACE (major adverse cardiac and cerebrovascular events) and 30 days mortality in the two study groups. RESULTS: There was significantly shorter door-to-balloon time in the direct ICCU group as compared with the ER group (45 vs. 79 minutes, P< 0.002). Patients in the direct ICCU group were more likely to have door-to-balloon time of less than 90 minutes in accordance with ACC/AHA guidelines (88.7% vs. 59.2%, P < 0.0001). Moreover, patients in the direct ICCU group were less likely to have left ventricular ejection fraction < 30% (5.4% vs. 12.2%, P= 0.045) and less likely to have symptoms of overt congestive heart failure. Lastly, 30 days MACE was significantly lower in the direct ICCU group (22 vs. 30%, P< 0.004). CONCLUSIONS: There is significant reduction of the door-to-balloon time in the direct ICCU admission strategy. This reduction translates into improvement in clinical outcome of patients. It is reasonable to apply the direct ICCU strategy to patients with STEMI.

Screening, diagnosis, and treatment of renal artery stenosis by percutaneous transluminal renal angioplasty with stenting.

BACKGROUND: Renal artery stenosis is one of the most frequent causes of secondary hypertension. Appropriate methods for screening, diagnosis and therapy are currently under debate. OBJECTIVES: To evaluate and recommend methods for screening and diagnosing renal artery stenosis, and to assess the clinical outcomes of renal artery stenting. METHODS: A total of 450 patients undergoing non-emergent coronary angiography fulfilled the selection criteria for selective renal arteriography; those with severe (luminal narrowing > or = 70%) renal artery stenosis underwent percutaneous transluminal renal angioplasty with renal artery stenting. RESULTS: Of 166 patients (36.9%) with renal artery stenosis, 41 (9.1%) had severe stenosis that required renal artery stenting, and 83% had ostial renal stenosis. The primary success rate was 100% and there were no complications. During the follow-up period, two patients required a second PTRA. After stent deployment, significant reductions were observed in systolic and diastolic pressures (P < 0.001 and P = 0.01, respectively) and in the number of antihypertensive drugs used by the patients (P < 0.001). These reductions were sustained during follow-up. Hypertension was cured (systolic blood pressure < 130 mmHg) in 9 patients (21.4%) and improved in 27 (64.3%). Plasma creatinine did not change significantly. CONCLUSIONS: Selective renal angiography is an effective diagnostic tool for identifying symptomatic cases of renal artery stenosis in patients undergoing coronary angiography. Our finding of a high success rate and low complication rate supports the use of primary renal artery stenting in symptomatic patients with renal artery stenosis.

A clinically meaningful metric of immune age derived from high-dimensional longitudinal monitoring.

Immune responses generally decline with age. However, the dynamics of this process at the individual level have not been characterized, hindering quantification of an individual's immune age. Here, we use multiple 'omics' technologies to capture population- and individual-level changes in the human immune system of 135 healthy adult individuals of different ages sampled longitudinally over a nine-year period. We observed high inter-individual variability in the rates of change of cellular frequencies that was dictated by their baseline values, allowing identification of steady-state levels toward which a cell subset converged and the ordered convergence of multiple cell subsets toward an older adult homeostasis. These data form a high-dimensional trajectory of immune aging (IMM-AGE) that describes a person's immune status better than chronological age. We show that the IMM-AGE score predicted all-cause mortality beyond well-established risk factors in the Framingham Heart Study, establishing its potential use in clinics for identification of patients at risk.

Coronary artery disease among asymptomatic diabetic and nondiabetic patients undergoing coronary computed tomography angiography.

OBJECTIVES: The aim of this study was to determine the prevalence and severity of coronary artery disease (CAD) and the plaque composition in asymptomatic diabetic and nondiabetic patients undergoing coronary computed tomography angiography (CCTA). BACKGROUND: CAD is the major cause of death among patients with diabetes. The true prevalence of CAD in asymptomatic diabetic patients, however, remains unknown. MATERIALS AND METHODS: A total of 328 consecutive patients (each with at least one risk factor or abnormal stress-test results) were referred for cardiac evaluation, 42 with diabetes and 286 without diabetes, all asymptomatic for cardiac-related symptoms. Groups were matched for age, sex, and CAD risk factors. CAD was defined as coronary atherosclerosis, with obstructive or nonobstructive lesions. CCTA was performed and findings compared between patients with diabetes and those without. RESULTS: CAD was present in 39 (93%) diabetic patients and in 211 (73%) nondiabetic patients (P=0.006). Obstructive CAD was more common in diabetic patients than in nondiabetic patients (29 vs. 6.6%, respectively; P<0.0001). In diabetic patients, more coronary segments with atherosclerosis per patient were detected (5.5 segments/patient vs. 2.8 segments/patient in nondiabetics; P<0.0001). The total Agatston score was significantly higher in diabetic patients vs. nondiabetic patients (370+/-96 and 79.9+/-16, respectively; P<0.0001). CONCLUSION: Our results indicate a high prevalence (93%) of CAD in asymptomatic diabetic patients with either nonobstructive or obstructive lesions. CCTA may be a useful imaging modality for selecting patients at high risk who would benefit most from further evaluation for subclinical ischemia.

Analysis of serial coronary artery flow patterns early after primary angioplasty: new insights into the dynamics of the microcirculation.

BACKGROUND: The temporal behavior of the coronary microcirculation in acute myocardial infarction may affect outcome. Diastolic deceleration time and early systolic flow reversal derived from coronary artery blood flow velocity patterns reflect microcirculatory function. OBJECTIVES: To assess left anterior descending coronary artery flow velocity patterns using Doppler transthoracic echocardiography after primary percutaneous coronary intervention, in patients with anterior AMI. METHODS: Patterns of flow velocity patterns of the LAD were obtained using transthoracic echocardiography-Doppler in 31 consecutive patients who presented with anterior AMI. Measurements were done at 6 hours, 36-48 hours, and 5 days after successful PPCI. Measurements of DDT and pressure half times (Pt%), as well as observation for ESFR were performed. RESULTS: In the first 2 days following PPCI, the average DDT (600 +/- 340 msec) was shorter than on day 5 (807 +/- 332 msec) (P < 0.012), FVP in the first 2 days were dynamic and bidirectional: from short DDT (< 600 msec) to long DDT (> 600 msec) and vice versa. On day 5 most DDTs became longer. Pt1/2 at 6 hours was not different than at day 2 (174 +/- 96 vs. 193 +/- 99 msec, P = NS) and became longer on day 5 (235 +/- 98 msec, P = 0.012). Bidirectional patterns were also observed in the ESFR in 6 patients (19%) at baseline, in 4 (13%) at 36 hours, and in 2 (6.5%) on day 5 after PPCI. CONCLUSIONS: Flow velocity patterns of the LAD after PPCI in AMI are dynamic and reflect unpredictable changes in microcirculation.

WIRION Embolic Protection System in Lower Extremity Arterial Interventions: Results of the Pivotal WISE LE Trial.

OBJECTIVES: The WISE LE (WIRION™ EPS in Lower Extremities Arteries) study was designed to assess the clinical performance of the WIRION Embolic Protection System (EPS) in subjects undergoing lower extremity atherectomy for the treatment of peripheral artery disease. BACKGROUND: Embolization is ubiquitous during endovascular procedures for lower extremity peripheral artery disease. METHODS: The WISE LE was a multicenter study, performed in the United States and Germany. The primary endpoint was freedom from major adverse events (MAEs) occurring within 30 days post-procedure and was compared with an objective performance goal derived from historical atherectomy trials. MAE was defined as a serious adverse event that resulted in death, acute myocardial infarction, thrombosis, pseudoaneurysm, dissection (grade C or greater), or clinical perforation at the filter location, clinically relevant distal embolism, unplanned amputation, or clinically driven target vessel revascularization. The study also included a histopathological analysis of debris captured by the filter during the procedures. RESULTS: The study protocol specified enrollment of 153 patients with the primary endpoint successfully met if 18 (12.0%) or fewer MAEs occurred. A pre-specified interim analysis performed after 103 patients revealed only 2 MAEs, and the study was stopped because it had met its pre-determined metric for success. Lesion deemed not accessible by the WIRION EPS occurred in 7 patients. Debris of <1-mm, 1- to 2-mm, and >2-mm diameter were found in 98%, 22%, and 9% of patients, respectively. CONCLUSIONS: The WIRION EPS is safe and noninferior to the pre-specified performance goal in capturing debris in the vast majority of patients and with the use of a broad range of atherectomy systems.

Myocardial bridge: evaluation on MDCT.

OBJECTIVE: The correlation between myocardial bridge and atherosclerotic changes has been controversial. The aim of this study was to evaluate the relation between myocardial bridge and atheromatous coronary artery disease (CAD). MATERIALS AND METHODS: Three hundred consecutive subjects who underwent coronary CT angiography (CTA) were included in this study. The prevalence, length, depth, precise location, and concomitant atheromatous changes were evaluated. The group of subjects with myocardial bridge was compared with another subgroup, the control group, which included subjects without myocardial bridge. RESULTS: From a total of 300 subjects, 78 subjects (26%) were found to have one myocardial bridge each. The mid left anterior descending artery (LAD) was the most common coronary artery involved (48/78). A significant difference was found between the LAD myocardial bridge group and the control group regarding presence of atheromatous changes in a similar LAD segment proximal to the myocardial bridge (p < 0.0001) and in the severity of atheromatous changes in these segments (mild, p < 0.0001; moderate, p < 0.02; and severe, p < 0.0001). The presence of stenosis in the LAD proximal to the myocardial bridge correlated with the thickness and length of the bridge. CONCLUSION: Myocardial bridge predisposes to the development of atherosclerosis in the coronary artery segment proximal to the bridge. This may indicate that myocardial bridge should be considered an anatomic risk factor in the evaluation of CAD.

Dimensions and anatomic variations of left main coronary artery in normal population: multidetector computed tomography assessment.

OBJECTIVES: The aim of our study was to determine the dimensions, morphology and anatomic variations of the left main coronary artery (LMCA) in normal participants, on multidetector computed tomography. BACKGROUND: Accurate imaging of LMCA dimensions and configuration is crucial to avoid misdiagnosis of LMCA disease. MATERIALS AND METHODS: Seventy morphologically normal LMCAs of 70 participants were carefully selected from among 600 consecutive coronary computed tomography angiography studies performed in our institute. LMCA cross-sectional diameters and areas were obtained at three points of each vessel: ostium, midvessel and distal. The length, cross-sectional shape, three-dimensional (3D) morphology and position of origin were studied. Influences of age, body weight, height and body surface area (BSA) on LMCA dimensions were evaluated. RESULTS: Different dimensions in each measured point of the LMCA were detected. Cross-sectional elliptic shape at ostium, mid-LMCA and distal LMCA was found in 66/70 (94%), 51/70 (73%) and 54/70 (77%) of the participants, respectively. On the basis of the 3D presentation, four types of LMCA were identified: biconcave-shape appearance (type 1), tapering morphology (type 2), combined morphology (type 3) and funnel-shape appearance (type 4). Fifty-two of the 70 participants had an LMCA orifice originating in the middle third of the aortic sinus, 15/70 in the posterior third and 3/70 in the anterior third. In men, significant correlation was found between LMCA cross-sectional area and body weight, height and BSA. In women, no correlation was found regarding body weight, height and BSA. CONCLUSION: LMCA is not a simple straight tube but usually has various anatomical configurations, variable dimensions and cross-sectional shapes. Ostial angulation is a normal variant usually associated with the posterior position of the LMCA orifice of origin in the aortic sinus.

Noninvasive assessment of coronary artery ectasia using multidetector computed tomography.

OBJECTIVES: The aim of this study is to determine the prevalence of coronary artery ectasia and its relationship to atheromatous changes in participants undergoing coronary computed tomography angiography. BACKGROUND: Coronary artery ectasia occasionally encountered on conventional coronary angiography is considered a manifestation of atherosclerosis. METHODS: Four hundred consecutive participants, 300 men (mean age 56 years) who underwent coronary computed tomography angiography were evaluated. Coronary artery ectasia was defined as an arterial segment with a diameter of at least 1.5 times the diameter of the adjacent normal coronary artery. The prevalence and location of coronary artery ectasia as well as concomitant atherosclerotic changes were evaluated. The association of coronary artery ectasia with coronary risk factors was also studied. RESULTS: Coronary artery ectasia was encountered in 31 participants (8%), 29 men. The right coronary artery was most commonly affected with ectasia (50%) and most participants had single-vessel involvement (74%). Twenty-six of 31 participants (84%) had coexisting atheromatous wall changes or insignificant coronary artery disease; four participants out of 31 (13%) had significant coronary artery disease. Coronary artery ectasia thrombosis was found only in one patient (3%). No apparent correlation was present between coronary artery ectasia and diabetes mellitus, hypertension, hyperlipidemia, smoking and family history of coronary artery disease. CONCLUSION: The prevalence of coronary artery ectasia in consecutive participants who underwent coronary computed tomography angiography is 8%. The right coronary artery was most commonly affected and most participants had single-vessel involvement. Coronary artery ectasia usually is associated with atheromatous changes, but not with significant coronary artery disease. Coronary artery ectasia thrombosis was a rare complication. No specific predisposing factors have been identified.

Platelet counts on admission affect coronary flow, myocardial perfusion and left ventricular systolic function after primary percutaneous coronary intervention.

BACKGROUND: Patients with acute ST-elevation myocardial infarction (STEMI) and increased platelet count treated by fibrinolysis have worse outcomes. AIM: The aim of this study was to test the hypothesis that platelet blood count at admission in patients with acute STEMI treated by primary percutaneous coronary intervention affects coronary flow, myocardial perfusion and recovery of left ventricular systolic function. METHODS: A total of 174 patients presenting with acute anterior STEMI and treated with primary percutaneous coronary intervention were included and divided into subgroups of admission platelet blood count of <200 K, 200-300 K, 300-400 K and >400 K. Evaluation of coronary artery flow and myocardial blush grade was performed according to the TIMI criteria. Electrocardiographic ST elevation resolution post-primary percutaneous coronary intervention was evaluated. Doppler echocardiographic evaluation of left anterior descending coronary artery velocities early and late after primary percutaneous coronary intervention and assessment of left ventricular ejection fraction and wall motion score index (WMSI) of left ventricular and left anterior descending coronary artery territory were performed. RESULTS: Post-primary percutaneous coronary intervention TIMI, myocardial blush grade and ST elevation resolution were similar in all groups. Patients with platelet counts <200 K had higher peak diastolic left anterior descending coronary artery velocity both early and late after primary percutaneous coronary intervention, and higher prevalence of left anterior descending coronary artery velocity deceleration time exceeding 600 ms, (45.5% vs. 40%, P<0.05). Patients with platelet counts >400 K presented with worse left ventricular ejection fraction, left ventricular WMSI and left anterior descending coronary artery WMSI, and before discharge this subgroup had worse left ventricular WMSI and left anterior descending coronary artery WMSI, P<0.01. CONCLUSIONS: Patients with anterior STEMI treated by primary percutaneous coronary intervention with lower admission platelet count had higher left anterior descending coronary artery diastolic velocities, better myocardial perfusion with more patients having left anterior descending coronary artery-descending coronary artery velocity deceleration time >600 ms. Patients with higher platelet counts had lower left ventricular systolic function both at admission and before discharge.

Independent Modular Filter for Embolic Protection in Carotid Stenting.

BACKGROUND: Embolic protection during carotid artery stenting reduces the rate of thromboembolic events. The Wirion Embolic Protection System is used to deploy an independent distal filter using any 0.014″ guidewire. WISE study (Wirion Study Europe) evaluated the safety and performance of Wirion Embolic Protection System in patients undergoing carotid artery stenting. METHODS AND RESULTS: A prospective, multicenter, nonrandomized, open-label, single-arm study of carotid artery stenting in high surgical risk patients was performed. The primary end point, a composite of death, stroke, and myocardial infarction at 30 days, was compared with performance goal derived from historical controls. Secondary end points were components of the primary end point and the device, angiographic, procedural, and clinical success rates. Preplanned interim analysis was performed on the first 120 patients. At interim analysis, the primary end point was significantly lower for the Wirion Embolic Protection System group, compared with historical data (3.3% versus 6.3%, respectively; P value =0.0008). Analysis of primary end point components in the WISE group, compared with the historical control group, shows numerically lower mortality (0% versus 1.7%, respectively; P=0.21), stroke (2.5% versus 4.6%, respectively; P=0.18), and myocardial infarction (0.8% versus 1.5%, respectively; P=0.50). Device, angiographic, procedural, and clinical success was achieved in 99.2%, 99.1%, 98.3%, and 96.6% of cases, respectively. CONCLUSIONS: The data suggest that independent modular filter use in carotid artery stenting in high surgical risk patients is safe and effective. The outcomes suggest that use of an independent modular filter may be associated with a lower rate of embolic complications associated with carotid stent placement. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01783639.

Treatment of saphenous vein bypass grafts with ultrasound thrombolysis: a randomized study (ATLAS).

BACKGROUND: Percutaneous coronary interventions (PCIs) in saphenous vein grafts (SVGs) with thrombus have a high frequency of distal embolization. Acolysis (therapeutic ultrasound) can break up thrombus in vitro in animal models and humans. Whether this is beneficial during percutaneous SVG interventions is unknown. METHODS AND RESULTS: We performed a trial of coronary ultrasound thrombolysis in which patients with an acute coronary syndrome undergoing PCI in SVGs were randomly assigned to receive acolysis or abciximab. The primary end point was a successful procedure, defined as final luminal diameter stenosis 30% or less with Thrombolysis In Myocardial Infarction grade 3 flow and freedom from major adverse cardiac events (composite of death, Q-wave, and non-Q-wave myocardial infarction [MI], emergency bypass procedure, disabling stroke, and target lesion revascularization). Of 181 enrolled, 92 received acolysis and 89 abciximab. Angiographic procedural success was achieved in 63% of acolysis patients and 82% of abciximab patients (P=0.008). Incidence of major adverse cardiac events at 30 days was 25% with acolysis and 12% with abciximab (P=0.036), attributable mainly to a greater frequency of non-Q-wave MI with acolysis (19.6% versus 7.9%, P=0.03). The incidence of Q-wave MI was also higher with acolysis (5.4% versus 2.2%, P=nonsignificant). The primary end point was achieved in 53.8% of acolysis patients and 73.1% of abciximab patients (P=0.014). CONCLUSIONS: Use of therapeutic ultrasound in vein graft lesions in patients with acute coronary syndrome had poor angiographic outcome and increased the incidence of acute ischemic complications.