High-risk Percutaneous Intervention Research Articles

The Impella Device

The Impella small catheter like 6 inch long device which works on principle of submersible water pump. It is inserted in to heart without any surgical procedure it provides 2.5- 5.5 litters/min blood flow. Impella device is available in various types according to their location, size and flow rate. There are some indications of Impella device implantation cardiac failure, high risk percutaneous intervention, risk of bleeding, left ventricular failure ect. This device is contraindicated in some disease conditions like Left Ventricular Thrombus, Ventricular Septal Defect, Severe Peripheral Arterial Disease, Aortic Stenosis and Regurgitation, Mechanical Haemolysis, Peripheral Vascular Ischemia. In this article we provide information about Impella device. There are total 57 cases has done till 2019 were Impella 5.0 inserted in 14 cases via axillaries access. In 36 cases Impella CP inserted via percutaneous Trans femoral approach, but one, in a young patient, who due to the small calibre of his femoral artery required inter positioning of a 6 mm Dacron graft on his common femoral artery. In 07 cases Impella RP were implanted percutaneously through the femoral accesses.

The Use of Mechanical Circulatory Assist Devices for ACS Patients with Cardiogenic Shock and High-Risk PCI.

There has been a significant expansion of the use of mechanical circulatory support (MCS) devices for patient with acute coronary syndromes (ACS) with cardiogenic shock (CS) and in patients undergoing high-risk percutaneous interventions (PCI). The purpose of this review is to provide an overview of the indications and outcomes of these devices in high-risk cardiac patients. Early revascularization of the culprit-lesion is the immediate goal in ACS patients with CS and the use of pulmonary artery catheters has been associated with improved outcomes in patients with cardiogenic shock. The MCS devices that are used for myocardial support include the intra-aortic balloon pump (IABP), the left ventricle (LV) to aorta pumps, left atrium (LA) to arterial pumps, and right atrial (RA) to arterial pumps. This review provides an overview on the use of these devices in patients with ACS and CS and those undergoing high-risk PCI. Attention is focused on the IABP, the Impella (LV-aorta pump), the TandemHeart (LA-arterial pump), and veno-arterial extracorporeal membrane oxygenation (RA-arterial pump). The indications, evidence, and complications of each device are reviewed. Each device varies in its physiological effect on native heart function, complexity in insertion, and complications. The use of MCS devices for high-risk PCI and CS has increased in recent years and have demonstrated efficacy in supporting a vulnerable myocardium. Although recommendations can be made for use of each device in certain clinical scenarios, further evidence through registries and clinical trials is necessary to guide appropriate device utilization.

Percutaneous Mechanical Circulatory Support Devices Use in Cardiogenic Shock and High-Risk Percutaneous Intervention.

Statistical data has shown that patients now treated in cardiac catheterization laboratories are older with several comorbidities, including renal failure, diabetes, and heart failure [1]. In past patients who were not suitable candidates for percutaneous coronary intervention due to their numerous comorbidities now seems to be a suitable candidate due to tremendous advancements in the field of interventional cardiology like new stent design and availability of advance mechanical circulatory support devices, i.e., Impella performing PCI on these high-risk patients become a viable option. There are two areas of cardiology in which mechanical circulatory support devices keep evolving: one is high-risk (percutaneous coronary intervention) PCI, and the other is a cardiogenic shock that is refractory to initial pressor support. 
 In this article, we review evidence base data regarding the use of mechanical circulatory support devices in high-risk percutaneous intervention and cardiogenic shock.

The Endoscopic Trans-Sinusoidal Trans-Pterygopalatine Route to the Foramen Rotundum Approach in Trigeminal Neuralgia Treatment.

To describe a new, minimally invasive, and safe access to foramen rotundum via the endoscopic endonasal trans-sinusoidal route for trigeminal nerve blockage. We studied 5 fresh cadavers bilaterally, and 10 pterygopalatine fossae and maxillary nerves using the endoscopic endonasal trans-sinusoidal trans-pterygopalatine approach. The proposed approach enabled the maxillary nerve to be visualized after revealing the foramen rotundum with the help of some craniometric measurements. Distance between sphenoid sinus lateral wall and maxillary sinus posterior wall was measured. This measurement was found to be an important triangulation point to determine the location of the entrance to the pterygopalatine fossa. The distance between the foramen rotundum and the sphenopalatine artery was found to be significant. The foramen rotundum diameter was calculated, and the maxillary nerve was found to be situated inferolateral to the foramen rotundum. Therefore, the safe entry zone was determined superomedially. No significant difference was found between male and female and the right and left nostrils. Various surgical procedures have been applied to treat drug-resistant trigeminal neuralgia. Nevertheless, their cure rates remain less than anticipated. Recurrences up to 30% have been reported in the literature. In this study, the endoscopic endonasal transmaxillary trans-pterygopalatine route offers a new perspective on the foramen rotundum approach and provides a panoramic and safe view in previously high-risk percutaneous interventions.

AN IMPELLA’S JOURNEY THROUGH AORTOILIAC DISEASE WITH BALLOON TRACKING

There is increasing use of Impella for high risk percutaneous interventions with or without left ventricular dysfunction. Patients with complex coronary anatomy often have aortoiliac disease. Inability to place Impella device through difficult aortoiliac anatomy may preclude the high risk procedure

Trends, etiologies, and predictors of 90-day readmission after percutaneous ventricular assist device implantation: A national population-based cohort study.

Percutaneous ventricular assist devices (pVADs) are indicated to provide hemodynamic support in high-risk percutaneous interventions and cardiogenic shock. However, there is a paucity of published data regarding the etiologies and predictors of 90-day readmissions following pVAD use. We studied the data from the US Nationwide Readmissions Database (NRD) for the years 2013 and 2014. Patients with a primary discharge diagnosis of pVAD use were collected by searching the database for International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) procedural code 37.68 (Impella and TandemHeart devices). Amongst this group, we examined 90-day readmission rates. Comorbidities as identified by "CM_" variables provided by the NRD were also extracted. The Charlson Comorbidity Index was calculated using appropriate ICD-9-CM codes, as a secondary diagnosis. A 2-level hierarchical logistic regression model was then used to identify predictors of 90-day readmission following pVAD use. Records from 7074 patients requiring pVAD support during hospitalization showed that 1562 (22%) patients were readmitted within 90 days. Acute decompensated heart failure (22.6%) and acute coronary syndromes (11.2%) were the most common etiologies and heart failure (odds ratio [OR]: 1.39, 95% confidence interval [CI]: 1.17-1.67), chronic obstructive pulmonary disease (OR: 1.26, 95% CI: 1.07-1.49), peripheral vascular disease (OR: 1.305, 95% CI: 1.09-1.56), and discharge into short- or long-term facility (OR: 1.28, 95% CI: 1.08-1.51) were independently associated with an increased risk of 90-day readmission following pVAD use. This study identifies important etiologies and predictors of short-term readmission in this high-risk patient group that can be used for risk stratification, optimizing discharge, and healthcare transition decisions.

IN-HOSPITAL AND LONG TERM RESULTS OF PERCUTANEOUS CORONARY INTERVENTION WITH BIVENTRICULAR SUPPORT AND EXTRACORPOREAL MEMBRANE OXYGENATION

Patients, due to various reasons not indicated for coronary bypass (CABG), usually have extremely high risk of complications in percutaneous intervention (PCI) as well. Recently it was shown that extracorporeal membrane oxygenation (ECMO) might provide a necessary support in the case of high risk PCI. ECMO can be effective in PCI in patients with refractory cardiogenic shock too, however evidence base for the technological approach in high risk PCI remains underdeveloped. Aim. To evaluate in-hospital and long-term results of high risk PCI with biventricular bypass and ECMO in patients not fitted for CABG. Material and methods. We conducted a retrospective analysis of the treatment of 12 patients having extremely high risk of complications in CABG. In all cases PCI was done in conditions of biventricular bypass and ECMO. Stable angina and non-STelevation acute coronary syndrome occurred in 42 and 58% cases, respectively. Clinical picture of cardiogenic shock was the criteria of exclusion. All patients had severe comorbidity with high score by “EuroScore” — 6,3±4,9%. In all cases there was multivessel disease with high level of coronary lesion involvement by “Syntax Score” (30,1±10,1). Mean level of left ventricle ejection fraction was satisfactory — 51±12,6%. Ten patients (83%) had significant (≥50 %) lesion of unprotected stem of the left coronary artery (SLCA). Results. All procedures were successful. As a success of PCI we meant the opened artery with the flow rate not worse than TIMI 3 and absent of significant cardiovascular complications. Mean quantity of the implanted drug-eluting stents was 2,4±1. Full revascularization was reached in 42% cases. Residual value of “Syntax Score” was at the level about 6,33±6,88. Significant adverse cardiovascular complications (death, myocardial infarction, repeated non-planned revascularization) during inhospital phase were not registered. In one case there was an iliac artery dissection, that did not lead to necessity of surgery. Hemorrhagic complications were found just in one patients (8%, 2nd type by “BARC”). All patients were discharged. There were no any fatal cases or myocardial infarction (MI) in 6 months after observation. Two patients required another revascularization (17%). In long-term period there were no and signs of “definite” or “probable” stent thrombosis. Conclusion. PCI in the conditions of biventricular bypass and ECMO might be effective alternative strategy of revascularization in a cohort of patients not indicated for CABG due to high complications risk.

Percutaneous distal limb perfusion via portable, miniaturized, extracorporeal membrane oxygenation resuscitation

As extracorporeal membrane oxygenation systems become miniaturized, their role for rapid implementation, as an adjunct to resuscitation and high-risk percutaneous interventions, grows. We describe a percutaneous approach to short term mechanical circulatory support, in the setting of cardiogenic shock, which employs a percutaneous, self-contained, distal limb perfusion system. We feel that this technique is highly important for both interventional cardiologists and cardiothoracic surgeons as well.

Overview of the 2012 Food and Drug Administration circulatory system devices panel meeting on the reclassification of external counterpulsation, intra-aortic balloon pump, and non–roller-type cardiopulmonary bypass blood pump devices

The Food and Drug Administration held a Circulatory System Devices Advisory Panel meeting, December 5 and 6, 2012, to review the classification or potential reclassification of the following device types: external counterpulsation, intra-aortic balloon pump (IABP), and non-roller-type cardiopulmonary bypass blood pumps. These 3 devices are preamendment (Medical Device Amendments of 1976) class III devices. The advisory panel discussed the data and provided recommendations for reclassification of these devices. The panel recommended reclassification of ECP to class II for stable angina pectoris and to retain a class III for all other indications. For IABP, the recommendation was to reclassify IABP to class II for several indications (acute coronary syndrome, cardiac and noncardiac surgery, and heart failure complications) and remain class III for all other indications. As for non-roller type, the panel recommended that for cardiopulmonary bypass and temporary circulatory bypass, these devices should be reclassified to class II while retaining a class III device status for all other indications, including ventricular support both for hemodynamically unstable patients and for prophylactic support in high-risk percutaneous interventions.

Evolution of Critical Care Cardiology: Transformation of the Cardiovascular Intensive Care Unit and the Emerging Need for New Medical Staffing and Training Models

Critical care, defined as the diagnosis and management of life-threatening conditions that require close or constant attention by a group of specially trained health professionals, is inherent to the practice of cardiovascular medicine. The demand for cardiovascular critical care is increasing with the aging of the population and is reflected by trends in the use of critical care in general.1 Between 2000 and 2005, although the total number of hospital beds in the United States declined by 4.2%, the number of critical care beds increased by 6.5% and the annual costs attributed to critical care increased by 44%, representing 13.4% of hospital costs.2 Projections for the next 15 years suggest that the need for critical care will increase markedly in the United States and globally.1,3–5 For example, in Canada, a 57% increase in the need for critical care beds is anticipated during that period.5 Concurrent with increases in demand, the medical demographics of general and cardiac critical care have evolved toward a patient population with an increasing number of comorbid medical conditions who require more prolonged and more technologically sophisticated invasive support. As a result, the delivery of critical care is advancing substantially in its complexity. Moreover, accumulating evidence has indicated that outcomes are better when critical care is provided by specially trained providers in a dedicated intensive care unit (ICU).6–9 In the context of this evolution, provision of optimal care in the contemporary cardiac ICU (CICU) presents a different set of challenges and requires an expanded set of skills compared with 10 years ago. Cardiovascular medicine has lagged behind other medical disciplines that have met the “critical care crisis”4 with ICU-focused innovations in organization, training, and quality improvement. Therefore, the American Heart Association Council on Cardiopulmonary, Critical …

Treating Refractory Cardiogenic Shock With the TandemHeart and Impella Devices: A Single Center Experience

BackgroundPatients with cardiogenic shock (CS) are routinely treated with intra-aortic balloon pumps (IABPs). The utility of 2 new percutaneous left ventricular assist devices (PLVADs), the Impella and TandemHeart, is unknown. The objective of this study was to describe the use of PLVADs for patients with CS at our institution.MethodsAll cases involving PLVADs in patients with CS between between January 1, 2008 and June 30, 2010 at a private, tertiary referral hospital were reviewed retrospectively.ResultsAll 76 cases were identified (50 IABP only, 7 Impella, 19 TandemHeart). Most Impella (5/7) and TandemHeart (10/19) patients were initially treated with an IABP before "upgrading" for increased hemodynamic support. All 76 devices (100%) were initiated successfully. Percutaneous revascularization was attempted in 63 patients with angiographic success in 57 (90%). The incidences of major complications were similar between groups, except bleeding occurred less frequently with the IABP. Mean ejection fraction on presentation was 30.4±16.5% and increased by a mean of 6.6±11.4% (P < 0.001). With the institutional approach of treating patients with CS initially with vasopressors and IABPs, then upgrading to an Impella or TandemHeart device for patients refractory to IABP therapy, the overall mortality rate was 40%.ConclusionThe Impella and TandemHeart devices can be initiated successfully in patients with CS, are associated with high rates of angiographic success during high risk percutaneous interventions and may benefit the myocardium during myocardial infarction. Randomized trials are warranted investigating use of the Impella and TandemHeart devices in patients with CS and in patients refractory to conventional IABP therapy.

Abstract 50: Use of Impella Ventricular Assist Device in Patients with Severe Coronary Artery Disease Presenting with Cardiac Arrest

Background: Impella is a percutaneously inserted ventricular assist device (VAD). It has been increasingly used in patients with severe heart failure, cardiogenic shock and high risk percutaneous intervention (PCI). However, the use and efficacy of Impella in patients with severe coronary artery disease (CAD) presenting with cardiac arrest has rarely been reported. Objective: To report our center experience in using Impella VAD in CAD patients presenting with cardiac arrest. Case Reports: From December 2010 to March 2011, three patients with severe CAD presented to our center with cardiac arrest underwent PCI with Impella support (Table 1). Summary: We reported 3 cases of severe CAD presenting with cardiac arrest successfully treated with PCI and Impella support. Our experience demonstrated that Impella VAD may play an adjunctive role in obtaining hemodynamic stability in these high risk patients undergoing PCI. One of the patients was supported to LVAD implantation and the other two had excellent neurological and functional recovery. Our reports suggest an important role of Impella in cardiac arrest population. Earlier Impella implantation after cardiac arrest might provide cardiac support and tissue perfusion until recovery or high risk PCI.

Letter regarding the article “Transradial access compared with femoral puncture closure devices in percutaneous coronary procedures”: An underestimated revolution

We comment on the results of a recently published study that shows how the transradial approach for coronary procedures is safer and is preferred by patients. We comment on the possibility of using a stronger antithrombotic treatment in case of high risk percutaneous interventions. Is scientific evidence regarding the transradial approach enough to warrant its widespread use?

Preoxygenated hemoglobin-based oxygen carrier HBOC-201 annihilates myocardial ischemia during brief coronary artery occlusion in pigs

Because of their ability to perfuse remote regions and deliver oxygen, hemoglobin-based oxygen carriers (HBOCs) may be considered in the treatment of several ischemic conditions such as acute coronary syndromes or high-risk percutaneous intervention. Here we studied the effects of intracoronary infusion of ex vivo preoxygenated HBOC-201 during brief total coronary artery occlusion (CAOs) on myocardial oxygenation and left ventricular (LV) function in a large animal model and investigated the influence of HBOC-201 temperature and infusion rate on these effects. Thirteen open-chest anesthetized swine were instrumented for measurement of global and regional LV function and metabolism. CAOs were induced by inflating an intracoronary balloon catheter; preoxygenated HBOC-201 (12 g/dL) was infused distally through the central lumen of the balloon catheter. Animals underwent consecutive 3-min CAOs interspersed by 30 min of reperfusion, accompanied by different HBOC-201 infusion rates (0, 15, 23, 30, 40, and 50 ml/min) and/or two infusion temperatures (18 degrees C or 37 degrees C) in random order. CAO elicited immediate loss of systolic shortening (SS) in the ischemic region (19 +/- 1% at baseline vs. -3 +/- 2% at end of CAO), resulting in decreases in maximum rate of rise in LV pressure (15 +/- 5%) and stroke volume (12 +/- 4%; all P < 0.05). Balloon deflation resulted in marked coronary reactive hyperemia (to 472 +/- 74% of baseline), increases in coronary venous concentrations of adenosine + inosine (to 218 +/- 26% of baseline; both P < 0.05) and rapid restoration of SS toward baseline. HBOC-201 ameliorated the CAO-induced changes in SS, stroke volume, reactive hyperemia, and coronary venous adenosine + inosine. The effects were temperature and flow dependent with full preservation of SS at 50 ml/min HBOC-201 of 37 degrees C. In conclusion, intracoronary preoxygenated HBOC-201 preserved myocardial oxygenation and LV function in swine during CAO in a dose- and temperature-dependent manner. In our study setting, preoxygenated HBOC-201 can match the oxygen delivery role of endogenous blood in the heart on an almost equivalent-volume basis.

High-dose tirofiban with enoxaparin and inflammatory markers in high-risk percutaneous intervention

The study assessed the benefit of high bolus dose tirofiban (HD-tirofiban) with enoxaparin compared with HD-tirofiban with unfractionated heparin (UFH). The study examined markers of platelet activation, thrombin generation and inflammation. The study is a prospective single centre open-label trial of patients with high-risk acute coronary syndrome treated with percutaneous intervention (PCI) who were randomized to anticoagulation with UFH or enoxaparin with HD-tirofiban (25 microg kg(-1) bolus). This study measured a panel of platelet activation markers, inflammatory biomarkers and thrombus generation between the two groups. Sixty patients undergoing high-risk PCI were enroled in the study. Platelet inhibition as assessed by whole blood aggregometry following HD-tirofiban infusion was similar in both the UFH and enoxaparin groups. CD40 ligand expression on platelets was significantly reduced following PCI with HD-tirofiban and either UFH or enoxaparin. Following PCI, there were significant reductions measured in other markers of platelet activation including PAC-1, P selectin, factor V/Va, platelet-monocyte aggregates and monocyte expression of Mac-1 as determined by analysis of venous blood samples using flow cytometry. Prothrombin fragment 1+2, D-dimer, von Willebrand factor and high sensitive C-reactive protein levels were significantly less post PCI in the enoxaparin group compared with those patients receiving UFH. The combination of HD tirofiban with enoxaparin resulted in an attenuated inflammatory response when compared with that of the combination of HD tirofiban with UFH.

Effect of intra-aortic balloon pump support on microcirculation during high-risk percutaneous intervention

Intra-aortic balloon counter-pulsation (IABP) is recommended for hemodynamic support in cardiogenic shock. In addition, it can be applied during high-risk percutaneous interventions (PCI). While IABP support improves microflow in cardiogenic shock, its effect in hemodynamically stable patients is still unclear. We, therefore, sought to evaluate the effect of IABP treatment on microflow in hemodynamically stable patients undergoing elective high-risk PCI. In six patients with >50% left main stenosis, microflow was evaluated according to current guidelines, using side-stream dark-field microscopy, visualizing microcirculatory vessels without using fluorescent dyes. Microflow was analyzed separately for each vessel category (diameter: 10-25microm and 26-50microm), using a semiquantitative system (0= no flow; 1= intermittent flow; 2= sluggish flow; 3= continuous flow) by a trained investigator. Steady state recordings and additional recordings twenty seconds after discontinuation of the electively implanted IABP were acquired. Microflow in vessel categories 10-25microm and 26-50microm increased in this group of hemodynamically stable patients on use of IABP. Microflow decreased from 2.73 + or - 0.39 (p=0.052; 26-50microm: 2.88 + or - 0.20, p=0.008) to 2.22 + or - 0.23 (2.18 + or - 0.45) after stopping the IABP and increased to 2.90 + or - 0.14 (p=0.009; 2.85 + or - 0.28, p=0.009) after restart of the IABP. Circulatory support with IABP increases microcirculatory flow in the smallest vessels of the sublingual mucosa. Our data support the hypothesis that intra-aortic balloon counter-pulsation increases coronary and microvascular perfusion, thus, improving microcirculation even in hemodynamically stable patients. The use of IABP may increase safety of complex PCI and decrease the risk of deleterious complications.

On‐site immediate removal of intraortic ballon pump after high‐risk percutaneous intervention with a 6 F closure suture device with the “preclosure” technique

Intraaortic balloon counterpulsation (IABP) may be necessary during percutaneous intervention (PCI) and sometimes it would be useful to withdraw it at the end of procedure. We describe the utility of a closure suture device to retrieve the IABP in the cardiac catheterization laboratory immediately after the intervention. Observational study of nine consecutive high-risk PCI where an 8.5 F IABP had been retrieved at the end of the procedure with a 6 F Perclose with the "preclosure" technique. The baseline clinical characteristics as well as the in-hospital and 90-days follow-up are described. The patients age was 67.4 +/- 14.9 years (mean 45-85; three patients were >80; 3 females (33.3%). Left main coronary artery was the target lesion in 8 (88.8%) and 4 (44.4%) patients, performed by radial access. Abciximab was used in 7 patients (77.7%). Successful hemostasis was achieved in all the cases without manual or mechanical compression. Only one patient was transferred to the Coronary Care Unit due to advanced age, left main coronary artery stenting, and severe ventricular dysfunction. Five patients (55.5%) were discharged 24 h after the PCI, three (33.3%) 48 h, and only one remained 72 h after the procedure. There were no events in the 90-days follow-up. The "preclosure" technique with the 6 F Perclose is an ingenious approach to achieve successful hemostasis after IABP removal. It may permit to transfer the patients to units without critical care facilities, shorten the admission and reduce vascular complications in patients with peripheral vascular disease who may need the counterpulsation only during the percutaneous intervention.

Cardiology Grand Rounds from The University of Texas Medical Branch

GP IIb/IIIa inhibitors are one of the most exciting pharmacological advances in the treatment of coronary artery disease to be developed this decade. They have proven benefit in the treatment of patients undergoing high-risk percutaneous interventions and in patients with unstable angina or non-Q-wave myocardial infarction. In all of these patients, they should be used in conjunction with aspirin and heparin. Although bleeding complications are high in initial studies, they are much less common with increased clinical experience and careful attention to heparin dosing. Important questions that will be answered in the next several years include whether there are significant differences between the available agents and whether oral formulations will be safe and effective.

Use of Glycoprotein Ilb/llla Inhibitors in Patients with Coronary Artery Disease

GP IIb/IIIa inhibitors are one of the most exciting pharmacological advances in the treatment of coronary artery disease to be developed this decade. They have proven benefit in the treatment of patients undergoing high-risk percutaneous interventions and in patients with unstable angina or non-Q-wave myocardial infarction. In all of these patients, they should be used in conjunction with aspirin and heparin. Although bleeding complications are high in initial studies, they are much less common with increased clinical experience and careful attention to heparin dosing. Important questions that will be answered in the next several years include whether there are significant differences between the available agents and whether oral formulations will be safe and effective.

GUARD during ischemia against necrosis (GUARDIAN) trial in acute coronary syndromes

The plasma membrane sodium–hydrogen exchange system plays a major role in the pathophysiology of myocardial ischemia and reperfusion injury. The GUARD During Ischemia Against Necrosis (GUARDIAN) trial was undertaken to assess the potential clinical benefits of cariporide, a novel inhibitor of the sodium–hydrogen exchanger, in patients with acute coronary syndromes at risk of myocardial necrosis. This prospective, double-blind, randomized, multicenter trial enrolled 11,733 patients who had unstable angina/non–Q-wave myocardial infarction (MI), or who required high-risk percutaneous interventions or coronary bypass surgery. Strict entry criteria were applied to ensure the enrollment of a population at high risk of developing complications. The patients were randomized to receive intravenous cariporide 20, 80, or 120 mg every 8 hours or placebo every 8 hours. Treatment was applied for the period of risk between 48 hours and 7 days. The primary efficacy endpoint was a composite of all-cause mortality and MI at 36 days. Secondary endpoints included the occurrence of the composite endpoint at day 10, events related to left ventricular dysfunction at day 36 and 6 months, extent of infarction, and refractory ischemia at day 36. Enrollment was completed in August 1998, and the results were presented at the American College of Cardiology meeting in New Orleans, Louisiana, USA, in March 1999.