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Objectives: The aim of this report was to evaluate 12-month outcomes of facilitated percutaneous coronary intervention (PCI) in the FINESSE (Facilitated Intervention with Enhanced Reperfusion Speed to Stop Events) trial. Background: Treatment delays remain common for patients with primary PCI leading to studies evaluating possible benefit of “facilitated” PCI. In the FINESSE trial, no reduction in the 90-day primary ischemic end point and an increase in bleeding were observed with both facilitated approaches, although modest favorable trends were seen for some patient subgroups. Methods: A total of 2,452 patients with ST-segment elevation myocardial infarction (MI) and anticipated 1 to 4 h delay until catheterization were randomized to reduced-dose reteplase + abciximab, abciximab alone, or placebo, followed by expedited primary PCI. Placebo-treated patients received abciximab in the cath lab. One-year mortality was a pre-specified secondary end point. Results: One-year mortalities in the 3 groups noted in the preceding text were 6.3%, 7.4%, and 7.0%, respectively (p = NS), representing 1.1%, 1.9%, and 2.5% increments since the 90-day outcome (p = 0.053 for combination treatment vs. primary PCI). A favorable trend with combination treatment was seen for patients with anterior MI (p = 0.09), but no other specified groups benefited or tended to benefit. Independent baseline correlates of 1-year mortality were systolic blood pressure <100 mm Hg, prior MI, age, Killip class >1, anterior MI, body mass index ≤25 kg/m2, heart rate >100 beats/min, and no statin use. Conclusions: These results suggest that widespread utilization of the facilitated approaches tested cannot be justified, but that high-risk patient groups such as patients with anterior MI may deserve further study. (The FINESSE trial; NCT00046228) [Copyright &y& Elsevier]

Abstract: Cellular cardiomyoplasty is an investigational technique that may have the potential to reduce myocardial infarct size and improve cardiac function in patients with ischemic heart disease. However, experience with this approach is still limited to a few small trials, some of which were not blinded or had other design problems. The mechanism of benefit, long-term safety, and clinical efficacy of cellular cardiomyoplasty require further study. [Copyright &y& Elsevier]

Abstract: Aim: To examine the impact of primary stent implantation versus balloon angioplasty on long-term outcome (median 8 years) in 117 patients with ST-elevation myocardial infarction (STEMI) from randomized trials. Methods: Enrolled patients were those presenting with STEMI within 12 h of symptom onset. Patients were randomized to either Palmaz–Schatz stent implantation (N =25) or balloon angioplasty (N =23) between January and November 1996; or Palmaz–Schatz (N =26), or Cordis coil stent implantation (N =24) or balloon angioplasty (N =19) between February 1998 and March 1999. Results: Patients (67±11 years) arrived to the hospital within median 2.5 h of symptom onset with Killip 1/2/3/4 grade (72/19/7/2%, respectively). The culprit lesion was located in the left anterior descending (50%), right (39%), or left circumflex coronary artery (11%) with TIMI 0/1/2/3 flow (81/5/12/2%, respectively). Clinical/angiographic features were comparable between the 2 groups. During follow-up, there was a significant reduction in cardiac mortality in the stent group (5%) compared to the angioplasty group (17%, log-rank test p =0.04). In addition, the stent group had a lower target lesion revascularization rate (28% versus 52%, p =0.008), and a significantly lower major adverse cardiac event rate (37% versus 67%, p =0.005), than the angioplasty group. Conclusion: Compared to balloon angioplasty, primary stenting resulted in a sustained beneficial effect on cardiac mortality at 8 years. [Copyright &y& Elsevier]

Abstract: Background: Acute anterior myocardial infarction (MI) caused by proximal occlusion of the left anterior descending coronary artery (LAD), is associated with unfavourable outcome and should be recognized by simple noninvasive methods like the 12-lead electrocardiogram (ECG). Methods: In a prospective post-hoc DANAMI-2 substudy we compared two pre-specified ECG patterns to determine the level of LAD occlusion. The ECG findings were correlated to coronary angiography from the acute phase. The impact on clinical outcome of ECG and angiographic signs of proximal versus distal LAD occlusion was studied. Results: In 146 patients without confounding factors on the ECG, either ST-elevation ≥0.5 mm in lead aVL or any ST-elevation in lead aVR in association with precordial ST-segment elevation in at least two contiguous leads (including V2, V3 or V4) had a sensitivity of 94%, specificity of 49%, positive predictive value of 85% and negative predictive value of 71% to predict a proximal LAD lesion. Surprisingly, ECG or angiographic signs of lesion proximality were not associated with worse outcome at 30 day or 2.7 year follow-up. Conclusions: The site of occlusion in the LAD could be reliably predicted by 12-lead ECG in patients with acute anterior MI. The prognostic significance of the level of occlusion in the LAD in the modern era of acute ST-elevation MI treatment should be reassessed. [Copyright &y& Elsevier]

We evaluated the use and outcomes of drug-eluting stents (DESs) and bare metal stents (BMSs) in a large primary percutaneous coronary intervention (PCI) acute ST-elevation myocardial infarction (MI) trial. Recently concerns have been raised with “off-label” use of DESs for short- and long-term clinical outcomes. Limited randomized data exist evaluating DESs versus BMSs in ST-elevation MI. Patients (n = 5,745) in the Assessment of Pexelizumab in Acute Myocardial Infarction (APEX-AMI) trial were categorized by stent type used. Baseline variables and clinical outcomes were collected at 90 days and 6 months. Outcomes by stent type were adjusted for using conventional multivariable predictors of 90-day mortality (age, anterior location, total ST-segment deviation, and Killip class), time to PCI, and Thrombolysis In Myocardial Infarction grade flow. Stents were deployed (at the investigator''s discretion) in 5,124 patients (89.2%) with acute MI, with DES use in 2,221 (43.3%) and BMS use in 2,903 (56.7%). Patients receiving DESs were younger (median 59 vs 63 years of age, p <0.001), had left anterior descending coronary artery PCI (57.9% vs 48.1%, p <0.001), and often were treated in the United States (58.2%). DES-treated patients had a lower adjusted mortality at 90 days (hazard ratio 0.73, 95% confidence interval [CI] 0.54 to 0.99, p = 0.046) and trended toward lower mortality (hazard ratio 0.77, 95% CI 0.58 to 1.03, p = 0.084) and recurrent MI (hazard ratio 0.81, 95% CI 0.59 to 1.11, p = 0.186) at 6 months compared with BMSs. In conclusion, in this observational analysis of stent use from a large primary percutaneous intervention for acute MI trial, DESs appear as safe as BMSs with similar 6-month clinical outcomes with regard to death and recurrent MI. [Copyright &y& Elsevier]

Summary: Aims: The Hypothermia after Cardiac Arrest (HACA) trial assessed whether mild therapeutic hypothermia improved the rate of good neurological recovery in patients after ventricular fibrillation cardiac arrest of presumed cardiac origin. We evaluated the impact of hypothermia on myocardial injury. Methods: Re-analysis of a HACA trial subset for our department (cooling, n =55; controls, n =56). Plasma levels of CK, CKMB and ST-scores were used as a measure of infarct size. Results: Area under the curve (AUC) for CK was 28,786U/l×24h (IQR 5646–44,998) in the cooling group and 20,373U/l×24h (IQR 8211–30,801) for controls (p =0.40), for CKMB AUC was 1691U/l×24h (IQR 724–3330) and 1187U/l×24h (IQR 490–2469), respectively (p =0.18). The ST score was −40% (IQR [−55]−[+16]) in the cooling group (n =23) and −22% (IQR [−84]−[+33]) for controls (n =24) (p =0.76). When the cooling group was stratified into early (≤8h) and longer (>8h) time to target temperature, the early group displayed a significantly lower CK 7340U/l×24h (IQR 3921–33,753) vs. 38,986U/l×24h (IQR 23,945–57,514, p =0.007) and a lower CKMB. Conclusion: Cooling after successful resuscitation for ventricular fibrillation cardiac arrest did not influence infarct size. Cautious interpretation of the subgroup analysis may indicate a favourable trend for early cooling. [Copyright &y& Elsevier]

Background: Antiplatelet therapy with clopidogrel and acetylsalicylic acid (ASA) reduces major cardiovascular events in patients with ST and non-ST-segment-elevation acute coronary syndromes (ACS). Recent mechanistic and clinical data suggest that higher loading and maintenance doses of clopidogrel may achieve a more rapid and greater degree of platelet inhibition that translates into improved clinical outcomes, but this is yet to be formally evaluated in an adequately powered randomized trial. Objectives: To evaluate the efficacy and safety of (1) a higher loading and initial maintenance dose of clopidogrel compared with the standard-dose regimen and (2) high-dose ASA compared with low-dose ASA in patients with ST or non-ST-segment-elevation ACS managed with an early invasive strategy. Design: Multicenter, international, randomized, 2 x 2 factorial design trial evaluating a clopidogrel high-dose regimen (600 mg loading dose on day 1 followed by 150 mg once daily on days 2 to 7, followed by 75 mg once daily on days 8-30) compared with the standard-dose regimen (300 mg loading dose on day 1, followed by 75 mg once daily on days 2-30) and high-dose ASA (300-325 mg daily) versus low-dose ASA (75-100 mg daily) in patients with ST or non-ST-segment-elevation ACS managed with an early invasive strategy. The clopidogrel dose comparison is double-blind and the ASA dose comparison is open-label. The primary outcome is the composite of death from cardiovascular causes, myocardial (re)infarction or stroke up to day 30. The primary safety outcome is major bleeding. The sample size is 18,000 to 20,000 patients. Conclusions: The CURRENT-OASIS 7 trial will help to define optimal dosing regimens for clopidogrel and ASA in patients with ST and non-ST-segment-elevation ACS treated with an early invasive strategy. [ABSTRACT FROM AUTHOR]

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Abstract: Objectives: Estimation of long-term outcome for patients suffering from acute myocardial infarction treated with primary angioplasty in an alsatian public center. Patients and methods: Two-hundred and ninety-eight patients who underwent an urgent coronarography in a non-university center, with a view to immediate angioplasty, between January 1999 and December 2001. Results: Two-hundred and sixty-four patients (88.6%) were actually treated with urgent angioplasty, which has been successful in 87.1% of cases. Hospital mortality was of 7.7%. The population was composed of 16.4% patients older than 75 and of 11.7% patients with Killip 3 or 4 at admission. Mean follow-up was 34 months, lost to follow-up rate was of 4.7%. The global survival rate was of 78.9% and eventless survival rate of 41.9%. Conclusion: Our results confirm the efficiency of angioplasty in real-life conditions as well at short-term as at long-term. [Copyright &y& Elsevier]

Although pharmacologic therapy has made impressive advances in the past decade and is the mainstay of therapy for heart failure (HF), there is still a large unmet need, because morbidity and mortality remain unacceptably high. Implanted medical devices are gaining increasing utility in this group of patients and have the potential to revolutionize the treatment of HF. The majority of devices in clinical use or under active investigation in HF can be grouped into 1 of 4 categories: devices to monitor the HF condition, devices to treat rhythm disturbances, devices to improve the mechanical efficiency of the heart, and devices to replace part or all of the heart’s function. There are several devices either approved or under development to monitor the HF condition, ranging from interactive weight scales to implantable continuous pressure monitors. The challenge is to demonstrate that this technology can improve patient outcomes. Pacemakers and implantable cardioverter defibrillators (ICDs) are used to treat heart rhythms in a broad range of patients with heart disease, but they now have a special place in HF management with the prophylactic use of ICDs in patients who have advanced systolic dysfunction. The Multicenter Automatic Defibrillator Implantation Trial (MADIT) II study demonstrated a 29% reduction in all-cause mortality with ICDs in patients with a history of a myocardial infarction and a left ventricular (LV) ejection fraction <0.30. LV and multisite pacing are means of improving the mechanical efficiency of the heart. The concept is to create a more coordinated contraction of the ventricles to overcome the inefficiency associated with conduction system delays, which are common in HF. The acute hemodynamic effect can be impressive and is immediate. Several studies of intermediate duration (3 to 6 months) have consistently demonstrated that biventricular pacing improves symptoms and exercise capacity. Mechanical methods of remodeling the heart into a more efficient shape have been under scrutiny for several years. New methods of restraining the heart with prosthetic material are under investigation in humans, with encouraging pilot results. Heart replacement has been evaluated clinically with LV assist devices for several decades. The Randomized Evaluation of Mechanical Assistance Therapy as an Alternative in Congestive Heart Failure (REMATCH) study has demonstrated a proof of concept for the use of mechanical blood pumps to improve survival, functional capacity, and symptoms. Several assist devices with such features as total implantability, improved durability, and smaller size are now under study; these may further improve the outcomes of patients. One year ago, the world witnessed the first clinical use of a totally implantable total artificial heart. Although the long-term outcomes were limited, the device demonstrated an impressive ability to improve organ function and extend survival in the population facing imminent death. Further development in this field is expected. The use of devices in HF now has a strong foothold, and the potential exists for substantially greater use of a broad range of devices in the near future. [Copyright &y& Elsevier]

Abstract: Background: Bifurcation lesions at the time of emergent PCI for STEMI are relatively common. However, there are little data regarding their significance. The objective of this study is to evaluate the impact of bifurcation lesions in the setting of emergent percutaneous coronary intervention (PCI) for ST-segment elevation myocardial infarction (STEMI). Methods: In 391 patients who underwent primary and rescue PCI, the clinical characteristics, procedural success, and in-hospital cardiac events were compared retrospectively between the patients with and without bifurcation lesions. The PCI strategy was at the discretion of the operator. Results: The culprit artery involved a bifurcation lesion in 54/391 (14%) patients. The baseline clinical characteristics between the groups with and without bifurcation lesions were similar. The majority of bifurcation lesions (81%) were seen in the left anterior ascending (LAD) artery. All lesions were treated with the provisional stenting approach, and only 2 (3%) patients required 2 stents. There were no difference in the procedural success and the final TIMI-3 flow, but PCI of bifurcation lesion required higher amount of contrast use. There was no in-hospital MACE in the bifurcation group. The peak cardiac enzyme, left ventricular function, and length of stay were similar in these 2 groups. Conclusions: Bifurcation lesions are relatively common in emergent PCI for STEMI involving the LAD. It can be safely treated with a provisional stenting approach, and the immediate outcome is similar to non-bifurcation lesions. [Copyright &y& Elsevier]

Abstract: Despite important progress in cardiology, acute myocardial infarction (AMI) is the major cause of congestive heart failure and subsequent mortality. The rationale for cell therapy to be administered after AMI is derived from the assumption that given the insufficient regeneration in the injured heart tissue, stem cells from the bone marrow may be able to replace or repair damaged vascular and cardiac tissue. Results of the first phase I clinical trials using bone marrow stem/progenitor cell therapy for AMI were published in 2002 to 2004. Although not designed to test the efficacy of the intervention, the initial trials indicated a promising improvement in a number of clinical outcomes and cardiac function and suggested the intervention was safe. Recently, randomized controlled trials of cardiac cell therapy for AMI were published, with mixed results. A meta-analysis including 13 trials with a total of 811 participants showed an improved left ventricular ejection fraction by 2.99%. A large multicentre international trial is warranted to further document the efficacy of cardiac cell therapy on clinical outcomes. [Copyright &y& Elsevier]