Impact of lifestyle modification on left ventricular function and cardiopulmonary exercise capacity in patients with heart failure with normal ejection fraction and cardiometabolic syndrome: a prospective interventional study.

BACKGROUND: Heart failure with normal left ventricular ejection fraction (HFNEF) accounts for about one third of all heart failure patients with considerable mortality. The metabolic syndrome (MS) is a risk factor for diastolic dysfunction and HFNEF. We hypothesized that modifying metabolic burden by exercise training and weight loss might improve left ventricular diastolic function, heart failure symptoms and rehospitalization rate. METHODS AND RESULTS: Forty patients with HFNEF, MS and prediabetes were enrolled in this prospective study. Echocardiography and cardiopulmonary exercise testing (CPET) were done at baseline and after 3 months lifestyle modification (LSM). NT-pro BNP and adiponectin were determined at baseline as both peptidehormones play a crucial role in MS and heart failure. After discharge a 3-month LSM program with the aim of weight reduction by diet and exercise was started. After the intervention period a weight reduction of ≥ 2% was defined as successful LSM (group A = 23 patients), while a weight reduction < 2% was classified as unsuccessful LSM (group B = 17 patients). At baseline NT-pro BNP (424 ± 381 versus 121 ± 99 pg/ml, P < 0.01) and adiponectin (10.1 ± 6.2 versus 4.6-2.0 µg/ml, P < 0.01) were higher in group A than in group B. After 3 months of LSM, CPET showed a significant improve- ment of VO2 peak (P < 0.01), EqCO2 (P < 0.001), O2-pulse (P = 0.02) and VE / VCO2 slope (P = 0.01) in group A. After one year of follow-up a modest but significant reduction of left atrial size and mitral flow to mitral annulus velocity ratio E/E' was seen in group A. LSM resulted in significant improvement of NYHA status (P = 0.03) and higher freedom of rehospitalization (P = 0.04) in group A. CONCLUSION: Successful lifestyle modification in obese, prediabetic patients with HFNEF improves diastolic left ventricular function and cardiopulmonary exercise capacity. As these measures result in improved NYHA status and less hospitalization, LSM might be a promising approach to prevent chronic diastolic heart failure.

Reduction of QTD--A Novel Marker of Successful Reperfusion in NSTEMI. Pathophysiologic Insights by CMR.

BACKGROUND/OBJECTIVES: Non-ST segment elevation myocardial infarction (MI) poses similar detrimental long-term prognosis as ST-segment elevation MI. No marker on ECG is established to predict successful reperfusion in NSTEMI. QT dispersion is increased by myocardial ischemia and reduced by successful restoration of epicardial blood flow by PCI. Whether QT dispersion reduction translates to smaller infarcts and thus indicates successful reperfusion is unknown. We hypothesized that the relative reduction of QT dispersion (QTD-Rrel ) on a standard ECG in acutely reperfused NSTEMI is related to infarct size and infarct transmurality as assessed by delayed enhancement CMR (DE-CMR). METHODS AND RESULTS: 69 patients with a first acute NSTEMI were included. QTD-Rrel was stratified according to LV function and volumes, infarct transmurality and size as assessed by DE-CMR. Extensive myocardial infarction was defined as above median infarct size. LV function and end-systolic volume were only mildly related to QTD-Rrel . QTD-Rrel was inversely related to infarct size (r=-0.506,p=0.001) and infarct transmurality (r=-0.415, p=0.001). QTD-Rrel was associated with extensive myocardial infarction in univariate analysis (odds ratio (OR) 0.958, CI 0.935-0.982; p=0.001). Compared to clinical and angiographic data QTD-Rrel remained the only independent predictor of non-transmural infarcts (OR 1.110, CI 1.055-1.167; p=0.049). CONCLUSION: In patients with acute Non-ST-Segment Myocardial infarction QTd-Rrel calculated on a surface ECG prior and post PCI for restoration of epicardial blood flow detects small, non-transmural infarcts as assessed by delayed enhancement CMR. Thus, QTd-Rrel can indicate successful reperfusion therapy.

Predictors of 1-year mortality in patients with contemporary guideline-adherent therapy after acute myocardial infarction: results from the OMEGA study.

BACKGROUND: Predictors of long-term mortality after discharge after acute myocardial infarction (AMI) are well characterized. However, these established risk factors are based on data almost exclusively derived from older studies without consistent use of revascularization therapy and adjunctive therapy with statins, platelet inhibitors, beta-blockers and ACE inhibitors/ARBs. We therefore sought to investigate predictors of 1-year mortality in survivors of AMI treated with contemporary guideline-adherent therapy. METHODS AND RESULTS: We performed a retrospective analysis of 3,782 patients surviving acute ST-elevation and non ST-elevation myocardial infarction who were enrolled in the prospective, randomized, double-blind, controlled OMEGA trial with 104 German centers. The primary objective of the OMEGA study was to determine the effect of highly purified omega-3 fatty acid ethyl esters-90 on the rate of sudden cardiac death in patients surviving AMI and receiving current guideline-adherent treatment within the 1-year of follow-up. 80.8 % of the patients received early revascularization therapy. At discharge, 94.2 % of the patients received beta-blocker, 90.4 % ACE inhibitor/angiotensin receptor blocker, 94.3 % statin, 95.4 % aspirin and 88.4 % clopidogrel. During the 1-year follow-up 139 patients (3.7 %) died. Multivariate logistic regression analysis revealed the following independent predictors of 1-year mortality in decreasing order of importance: ejection fraction <45 % [odds ratio (OR) 2.28, 95 % confidence interval (CI) 1.53-3.41], age ≥70 years (OR 2.17, 95 % CI 1.42-3.32), no acute revascularization (OR 2.02, 95 % CI 1.33-3.08), prior stroke/transient ischemic attack (OR 1.90, 95 % CI 1.09-3.30), peripheral arterial disease (OR 1.86, 95 % CI 1.12-3.10), heart rate >85/min (OR 1.82, 95 % CI 1.23-2.71), chronic obstructive lung disease (OR 1.77, 95 % CI 1.01-3.10) and HDL cholesterol <40 mg/dl (OR 1.75, 95 % CI 1.15-2.67). CONCLUSIONS: In patients surviving AMI and treated with contemporary guideline-adherent therapy, 1-year mortality was low. Nevertheless, traditional risk factors such as ejection fraction <45 %, older age, no acute revascularization and comorbidities were the strongest predictors of long-term mortality supporting the findings from previous studies.

European Cardiovascular Magnetic Resonance (EuroCMR) registry--multi national results from 57 centers in 15 countries.

BACKGROUND: The EuroCMR registry sought to evaluate indications, image quality, safety and impact on patient management of clinical routine CMR in a multi-national European setting. Furthermore, interim analysis of the specific protocols should underscore the prognostic potential of CMR. METHODS: Multi-center registry with consecutive enrolment of patients in 57 centers in 15 countries. More than 27000 consecutive patients were enrolled. RESULTS: The most important indications were risk stratification in suspected CAD/Ischemia (34.2%), workup of myocarditis/cardiomyopathies (32.2%), as well as assessment of viability (14.6%). Image quality was diagnostic in more than 98% of cases. Severe complications occurred in 0.026%, always associated with stress testing. No patient died during or due to CMR. In 61.8% CMR findings impacted on patient management. Importantly, in nearly 8.7% the final diagnosis based on CMR was different to the diagnosis before CMR, leading to a complete change in management. Interim analysis of suspected CAD and risk stratification in HCM specific protocols revealed a low rate of adverse events for suspected CAD patients with normal stress CMR (1.0% per year), and for HCM patients without LGE (2.7% per year). CONCLUSION: The most important indications in Europe are risk stratification in suspected CAD/Ischemia, work-up of myocarditis and cardiomyopathies, as well as assessment of viability. CMR imaging is a safe procedure, has diagnostic image quality in more than 98% of cases, and its results have strong impact on patient management. Interim analyses of the specific protocols underscore the prognostic value of clinical routine CMR in CAD and HCM.

Usefulness of heart rate to predict one-year mortality in patients with atrial fibrillation and acute myocardial infarction (from the OMEGA trial).

In the setting of acute myocardial infarction and sinus rhythm, the heart rate (HR) has been demonstrated to correlate closely with mortality. In patients presenting with acute myocardial infarction and atrial fibrillation (AF) on admission, however, the prognostic relevance of the HR has not yet been systematically addressed. A post hoc subgroup analysis of the data from the OMEGA trial was conducted to analyze whether the admission HR determines the 1-year mortality in patients presenting with AF in the setting of acute myocardial infarction. Of 3,851 patients enrolled in the OMEGA study, 211 (6%) presented with AF on admission. This subgroup was dichotomized according to the admission HR (cutoff 95 beats/min). Multiple regression analysis revealed that an admission HR of ≥95 beats/min independently determined the 1-year mortality in patients with AF (odds ratio 4.69, 95% confidence interval 1.47 to 15.01; p = 0.01). In conclusion, this is the first study demonstrating that a high HR (≥95 beats/min) on admission in patients with AF and acute myocardial infarction is associated with an almost fivefold mortality risk.

Long-term follow-up after coronary stenting with the sirolimus-eluting stent in clinical practice: results from the prospective multi-center German Cypher Stent Registry.

AIMS: To obtain long-term follow-up data of the sirolimus-eluting coronary stent (SES) and to determine factors associated with clinical events and target vessel revascularization (TVR). METHODS AND RESULTS: Between 2002 and 2005, 5,946 patients were treated with at least one SES. A follow-up after a median of 4.1 years was obtained in 5,247 patients (88.2 %). During the follow-up, death occurred in 9.2 % of patients, nonfatal myocardial infarction in 5.9 %, nonfatal stroke in 2.2 % and MACCE (death/myocardial infarction/stroke) in 16.3 %. Any TVR was performed in 20.3 %. Independent predictors of MACCE were: older age (p < 0.0001), renal insufficiency (p < 0.0001), prior myocardial infarction (p < 0.0001), diabetes mellitus (p < 0.0001), cardiogenic shock (p = 0.0002), three-vessel disease (p = 0.0012), reduced left ventricular function (p = 0.0048), target vessel = bypass graft (p = 0.0122), indication for treatment = ACS (p = 0.0181) and PCI before implantation (p = 0.0308). Independent predictors of TVR were target vessel = coronary bypass (<0.0001), two- or three-vessel disease (p < 0.0001), ostial lesions (p < 0.0001), total length of SES implanted (p = 0.0012) and older age being a protective factor (p = 0.0187). CONCLUSIONS: Long-term follow-up of the SES in clinical practice showed clinical event rates that were comparable to randomized trials with a MACCE rate of 16.3 % and TVR rate of 20.3 %.

Treatment of coronary bifurcation lesions with drug-eluting stents: insights from the first phase of the prospective multicenter german drug-eluting stent registry.

BACKGROUND: Controversy exists about the impact of treating bifurcations on overall outcome of coronary interventions using drug-eluting stents (DES). We sought to investigate 1-year outcome of the treatment of bifurcation lesions using DES in a large "real-world" cohort. METHODS AND RESULTS: Among 5,126 patients enrolled in phase I of the multicenter German Drug-Eluting Stent Registry, 814 (16%) were treated for a bifurcation lesion. Patients with bifurcations were compared to those without bifurcations in terms of baseline characteristics, major adverse cardiac and cerebrovascular events (MACCE) and target vessel revascularization (TVR) at 1 year. Usage of sirolimus-eluting stents (SES) versus paclitaxel-eluting stents (PES) was also evaluated. In total, 1,021 and 5,189 stents were implanted in the bifurcation (1.25 stents/patient) and nonbifurcation (1.2 stents/patient) group, respectively, but 64.5% of bifurcation lesions were treated with a single stent. More complex lesion and procedural characteristics were observed in the bifurcation group. However, there was no difference in 1-year MACCE rates (a composite of death, myocardial infarction, and stroke) between the bifurcation group and nonbifurcation group (8.1% vs. 8.3%, P = 0.85). Rates of TVR (11.2% vs. 10.8%, P = 0.75) and Academic Research Consoritum-defined definite stent thrombosis (0.9% vs. 0.8%, P = 0.67) were also comparable. MACCE and TVR rates remained similar after adjustment for differences in baseline characteristics. MACCE and TVR in SES patients were 7.2% and 12.6% versus 8.7% and 10.2% in PES patients (P = 0.46 and P = 0.30, respectively). CONCLUSION: In this large multicenter registry, treatment of bifurcation lesions with DES appears effective and safe. The presence of bifurcations did not affect 1-year outcomes after DES implantation. The outcomes for SES and PES were similar.

Acute adverse reactions to gadolinium-based contrast agents in CMR: multicenter experience with 17,767 patients from the EuroCMR Registry.

OBJECTIVES: The purpose of this study was to assess the frequency, manifestation, and severity of acute adverse reactions associated with administration of several gadolinium-based contrast agents to patients who underwent cardiac magnetic resonance (CMR) imaging in the EuroCMR (European Cardiovascular Magnetic Resonance) Registry multinational and multicenter setting. BACKGROUND: The frequency, manifestations, and severity of acute adverse reactions associated with gadolinium-based contrast agents in the specific setting of cardiovascular magnetic resonance have not been systematically evaluated yet. METHODS: This is a multicenter and multinational registry with consecutive enrollment of patients in 45 European centers. During the current observation, 17,767 doses of gadolinium-based contrast agent were administered to 17,767 patients. The mean dose was 25.6 ml (range 5 to 80 ml), which is equivalent to 0.128 mmol/kg (range 0.012 to 0.3 mmol/kg). RESULTS: Thirty acute adverse reactions due to contrast administration occurred (0.17%). All reactions were classified as mild according to the American College of Radiology definition. The most frequent complaints following contrast administration were rashes and hives (9 of 30), followed by nausea (7 of 30), and anxiety (6 of 30). The event rate ranged from 0.06% (linear nonionic agent gadodiamide) to 0.47% (linear ionic agent gadobenate dimeglumine). Interestingly, we also found different event rates between the three main indications for CMR imaging, ranging from 0.1% (risk stratification in suspected coronary artery disease) to 0.42% (viability in known coronary artery disease). CONCLUSIONS: The incidence of acute adverse reactions after administration of gadolinium-based contrast in the "off-label" setting of CMR in our population was not different from the incidence in the U.S. Food and Drug Administration-approved general radiology setting. Thus, the off-label use of gadolinium-based contrast in CMR should be regarded as safe concerning the frequency, manifestation, and severity of acute events.

Accuracy and variability of right ventricular volumes and mass assessed by dual-source computed tomography: influence of slice orientation in comparison to magnetic resonance imaging.

OBJECTIVE: To evaluate the accuracy and variability of right ventricular (RV) volumes and mass using dual-source computed tomography (DSCT) and the influence of slice orientation in comparison to cardiac magnetic resonance imaging (CMR). METHODS: In 33 patients undergoing cardiac DSCT and CMR, RV parameters were calculated using the short-axis (DSCT, CMR) and axial orientation (DSCT). Intra- and interobserver variability were assessed by Bland-Altman analysis. RESULTS: Short-axis orientation: RV parameters of the two techniques were not statistically different. Axial orientation: RV volumes and mass were significantly overestimated compared with short-axis parameters whereas EF was similar. The short-axis approach resulted in low variability, although the axial orientation had the least amount of intra- and interobserver variability. CONCLUSION: RV parameters can be more accurately assessed by DSCT compared with CMR using short-axis slice orientation. RV volumes and mass are significantly higher using axial compared with short-axis slices, whereas EF is unaffected. RV parameters derived from both approaches yield high reproducibility.

Clinical outcome of percutaneous treatment of in-stent restenosis with drug-eluting stents: results from the first phase of the prospective multicentre German DES.DE registry.

AIMS: Treatment of in-stent restenosis (ISR) was historically considered the Achilles heel of percutaneous coronary intervention (PCI) and has been associated with worse clinical outcome than PCI of de novo lesions. However, comparative data on ISR and de novo lesions using drug-eluting stents (DES) are scarce. Therefore, we aimed to assess the impact of ISR on procedural and long-term outcome in patients treated with DES. METHODS AND RESULTS: We analysed data from 5,144 patients enrolled in the prospective multicentre German Drug-Eluting Stent Registry (DES.DE). The registry included 872 patients (17%) treated for ISR with follow-up data (median 12.4 months) available for 817 patients (94%). Of the ISR patients, 37.1% (n=323) presented with acute coronary syndromes. In total, 1,027 DES were used (528 sirolimus-eluting stents and 499 paclitaxel-eluting stents), with successful implantation in 97.7% of patients. In the ISR cohort, myocardial infarction (MI) during hospitalisation was observed in 1.6% of patients (n=14) and in-hospital mortality was only 0.3% (n=3). Major adverse cardiac and cerebrovascular events (MACCE) rate at follow-up (defined as a composite of death, MI and stroke) was 8.7% (n=71) versus 8.2% (n=325) in patients treated for de novo lesions (p=0.63). Target vessel revascularisation (TVR) rate was 12.7% (n=100), numerically higher than in patients with de novo lesions (10.5%, p=0.07). Ten patients (1.3%) suffered from ARC definite stent thrombosis versus 0.7% observed in patients with de novo lesions (p=0.13). After adjustment for differences in baseline characteristics, TVR rates were statistically higher in the ISR cohort (OR 1.27, 95%CI 1.01-1.61, p=0.04), while MACCE rates remained comparable (OR 1.10, 95%CI 0.83-1.44, p=0.51). The type of stent used (sirolimus vs. paclitaxel-eluting stent) did not impact the rate of MACCE, TVR or definite stent thrombosis at one year. CONCLUSIONS: Results from this large prospective multicentre registry confirm that treatment of ISR with DES is effective and safe, with similar procedural outcome but slightly higher revascularisation rates at one year compared to patients treated for de novo lesions, with no differences in outcome between sirolimus- and paclitaxel-eluting stents.

Gender-related differences in patients with ST-elevation myocardial infarction: results from the registry study of the ST elevation myocardial infarction network Essen.

BACKGROUND: The Myocardial Infarction Network Essen was initiated in order to establish a standardized procedure with immediate reopening of the infarcted vessel for patients with ST-elevation myocardial infarction (STEMI) in the city of Essen, Germany. The present study aims to evaluate gender-related differences in presentation of disease and clinical outcome. HYPOTHESIS: Gender is associated with differences in presentation and outcome of STEMI. METHODS: All patients with STEMI were included without exception. Parameters such as risk profile, mortality, and relevant time intervals were documented. The follow-up period was 1 year. RESULTS: For this study, 1365 patients (72.1% male) were recruited. Women were significantly older, with higher prevalence of diabetes (28.1% vs 20.3%, P = 0.004) and hypertension (76.5% vs 64.8%, P<0.0005). Analysis of time intervals between symptoms to actions showed no significant differences. However, women tended to wait longer before calling for medical assistance (358 vs 331 min, P = 0.091). In-hospital mortality was comparable with respect to gender, whereas women had higher 1-year mortality (18.6% vs 13.2%). Age and diabetes were associated with a higher mortality. Adjusted for age, gender is no longer an independent risk factor. In the follow-up period, significantly more women were readmitted to the hospital without a difference in the frequency of reangiography, surgery, or target-vessel revascularization. CONCLUSIONS: The present data display a successful implementation of a standardized procedure in patients with STEMI. Although differences between genders are not as obvious as expected, efforts should be taken to perform a gender-specific risk analysis as well as to promote education about proper behavior in case of new onset of angina.

Comparison between on-label versus off-label use of drug-eluting coronary stents in clinical practice: results from the German DES.DE-Registry.

BACKGROUND: Observational studies from the USA have demonstrated that off-label use of drug-eluting stents (DES) is common. Data on off-label use in Western Europe are limited. METHODS: We analyzed the data of consecutive patients receiving DES prospectively enrolled in the multicenter German DES.DE registry (Deutsches Drug-Eluting Stent Register) between October 2005 and October 2006. Off-label use was defined in the presence of one of the following criteria: ST-elevation myocardial infarction, in-stent stenosis, chronic total occlusion, lesions in a bypass graft, in bifurcation or left main stem, stent length per lesion ≥32 mm, and vessel diameter <2.5 or >3.5 mm. RESULTS: Overall, 4,295 patients were included in this analysis and divided into two groups: 2,366 (55.1%) received DES for off-label and 1,929 (44.9%) for on-label indications. There were substantial differences in the rates of off-label use at the participating hospitals. Patients with off-label DES more often presented with high-risk features such as acute coronary syndrome, cardiogenic shock, congestive heart failure, and more complex coronary anatomy. Among hospital survivors, the incidence of the composite endpoint of death, myocardial infarction and stroke (MACCE) (9.2 vs. 7.4%, p < 0.05), and target vessel revascularization (TVR) (11.3 vs. 9.1%, p < 0.05) was increased in the off-label group at the 1-year follow-up. However, in the multivariate analysis off-label use was not linked with an elevated risk for MACCE (hazard ratio 0.86, 95% confidence interval 0.62-1.18) and TVR (hazard ratio 1.05, 95% confidence interval 0.78-1.42). CONCLUSIONS: In clinical practice, DES was very frequently used off-label. After adjustment for confounding variables, off-label use was not associated with an increase of adverse events.

Impact of hyperglycemia at admission in patients with acute ST-segment elevation myocardial infarction as assessed by contrast-enhanced MRI.

BACKGROUND: Blood glucose level at admission in ST-segment elevation myocardial infarction (STEMI) is a predictor of heart failure and mortality. This study was performed to investigate the impact of hyperglycemia at admission in non-diabetic patients on infarct size, microvascular obstruction, and long-term outcome using contrast-enhanced magnetic resonance imaging (CMR) in patients with acute STEMI. METHODS: One hundred and seven consecutive patients (84 males; mean age 59.4 years ± 11.3 years) with a first acute STEMI successfully treated by primary PCI were included. Admission hyperglycemia was defined as blood glucose above 7.8 mmol/l. CMR was performed 3.6 days ± 1.9 days after admission on a 1.5-tesla MR system. The imaging protocol included single-shot steady-state free precession (SSFP) cine sequences for assessing segmental and global left ventricular (LV) function and microvascular obstruction (MVO)/late gadolinium enhancement (LGE) imaging immediately and 10 min after the administration of 0.2 mmol gadodiamide/kg of body weight using an inversion-recovery SSFP (IR-SSFP) sequence. A receiver operating characteristics analysis was used to detect the best cut-off point of microvascular obstruction that predicted myocardial infarction and death during follow-up. RESULTS: Of 107 patients, 37 (35%) had hyperglycemia on admission. Compared to normoglycemic patients, patients with admission hyperglycemia had a lower LV ejection fraction (38.6 ± 13.7% vs. 47.5 ± 12.2%, p < 0.001), greater ESV (88.8 ± 41.8 ml vs. 72.3 ml ± 35.1 ml, p = 0.01), greater infarct size (LGE% 21.1 ± 14.9% vs. 9.8 ± 8.7%, p < 0.001), and greater MVO (MVO% 9.6 ± 9.9% vs. 2.5 ± 4.3%, p < 0.001). Admission hyperglycemia was an independent predictor of the presence and extent of microvascular obstruction. Microvascular obstruction as a percentage of left ventricular mass was the only variable independently related to clinical outcome in a Cox proportional hazard model (Wald 18.78, HR 1.155, p < 0.001). CONCLUSION: Hyperglycemia at admission in STEMI patients who are successfully treated by PCI is independently associated with the presence and extent of microvascular obstruction on contrast-enhanced CMR. Thus, microvascular obstruction as assessed by CMR may be a mechanism that relates admission hyperglycemia in acute STEMI to worse outcome.

OMEGA, a randomized, placebo-controlled trial to test the effect of highly purified omega-3 fatty acids on top of modern guideline-adjusted therapy after myocardial infarction.

BACKGROUND: There is no randomized, double-blind trial testing the prognostic effect of highly purified omega-3 fatty acids in addition to current guideline-adjusted treatment of acute myocardial infarction. METHODS AND RESULTS: OMEGA is a randomized, placebo-controlled, double-blind, multicenter trial testing the effects of omega-3-acid ethyl esters-90 (1 g/d for 1 year) on the rate of sudden cardiac death in survivors of acute myocardial infarction, if given in addition to current guideline-adjusted treatment. Secondary end points were total mortality and nonfatal clinical events. Patients (n=3851; female, 25.6%; mean age, 64.0 years) were randomized in 104 German centers 3 to 14 days after acute myocardial infarction from October 2003 until June 2007. Acute coronary angiography was performed in 93.8% and acute percutaneous coronary intervention in 77.8% of all patients. During a follow-up of 365 days, the event rates were (omega and control groups) as follows: sudden cardiac death, 1.5% and 1.5% (P=0.84); total mortality, 4.6% and 3.7% (P=0.18); major adverse cerebrovascular and cardiovascular events, 10.4% and 8.8% (P=0.1); and revascularization in survivors, 27.6% and 29.1% (P=0.34). CONCLUSIONS: Guideline-adjusted treatment of acute myocardial infarction results in a low rate of sudden cardiac death and other clinical events within 1 year of follow-up, which could not be shown to be further reduced by the application of omega-3 fatty acids. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00251134.

Myocardial scar visualized by cardiovascular magnetic resonance imaging predicts major adverse events in patients with hypertrophic cardiomyopathy.

OBJECTIVES: We sought to establish the prognostic value of a comprehensive cardiovascular magnetic resonance (CMR) examination in risk stratification of hypertrophic cardiomyopathy (HCM) patients. BACKGROUND: With annual mortality rates ranging between 1% and 5%, depending on patient selection, a small but significant number of HCM patients are at risk for an adverse event. Therefore, the identification of and prophylactic therapy (i.e., defibrillator placement) in patients with HCM who are at risk of dying are imperative. METHODS: Two-hundred forty-three consecutive patients with HCM were prospectively enrolled. All patients underwent initial CMR, and 220 were available for clinical follow-up. The mean follow-up time was 1,090 days after CMR. End points were all-cause and cardiac mortality. RESULTS: During follow-up 20 of the 220 patients died, and 2 patients survived sudden cardiac death due to adequate implantable cardioverter-defibrillator discharge. Most events (n = 16) occurred for cardiac reasons; the remaining 6 events were related to cancer and accidents. Our data indicate that the presence of scar visualized by CMR yields an odds ratio of 5.47 for all-cause mortality and of 8.01 for cardiac mortality. This might be superior to classic clinical risk factors, because in our dataset the presence of 2 risk factors yields an odds ratio of 3.86 for all-cause and of 2.20 for cardiac mortality, respectively. Multivariable analysis also revealed the presence of late gadolinium enhancement as a good independent predictor of death in HCM patients. CONCLUSIONS: Among our population of largely low or asymptomatic HCM patients, the presence of scar indicated by CMR is a good independent predictor of all-cause and cardiac mortality.

Right ventricular involvement in acute left ventricular myocardial infarction: prognostic implications of MRI findings.

OBJECTIVE: The purpose of this study was to investigate the prevalence and prognostic importance of the cardiac MRI finding of right ventricular involvement in patients with acute ST-segment elevation myocardial infarction (MI). SUBJECTS AND METHODS: Fifty patients (41 men, nine women; mean age, 58 +/- 11 years) with first-ST-segment elevation MI underwent 1.5-T cardiac MRI immediately after successful percutaneous coronary intervention. The cardiac MRI protocol included steady-state free precession cine sequences for functional assessment of the left, right, and both ventricles and inversion recovery FLASH delayed enhancement sequences after contrast administration for the quantification of myocardial damage. The prevalence of right ventricular involvement detected with ECG and echocardiography was compared with the prevalence detected with cardiac MRI, which was the reference standard. Patients underwent follow-up for 32 +/- 8 months. RESULTS: Right ventricular involvement was diagnosed with cardiac MRI in 27 patients (54%): 14 of 30 patients (47%) with inferior ST-segment elevation MI and 13 of 20 patients (65%) with anterior ST-segment elevation MI. ECG and echocardiographic findings showed only moderate agreement with cardiac MRI findings in the detection of right ventricular involvement in inferior acute MI (kappa = 0.38). Patients with right ventricular involvement in anterior ST-segment elevation MI had larger infarcts (delayed enhancement, 25.9% +/- 14.5% vs 11.4% +/- 10.1%; p = 0.030), lower left ventricular ejection fraction (34.3% +/- 8.2% vs 45.2% +/- 9.5%; p < 0.015), and lower right ventricular ejection fraction (39.8% +/- 6.6% vs 54.9% +/- 8.8%; p < 0.001) than those without right ventricular involvement. In a multivariate logistic regression model, right ventricular involvement was a strong independent predictor (odds ratio, 15.8; 95% CI, 4-63%) of major cardiac adverse events. CONCLUSION: Right ventricular involvement in ST-segment elevation MI is detected more frequently with cardiac MRI than with ECG and echocardiography and is an independent prognostic indicator.

Coronary stenting with the sirolimus-eluting stent in patients with restenosis after intracoronary brachytherapy: results from the prospective multicentre German Cypher Stent Registry.

BACKGROUND: Treatment of restenosis following intracoronary brachytherapy (ICB) is still a challenging problem. Implantation of sirolimus-eluting stents (SES) in this setting may be an option to be evaluated. METHODS AND RESULTS: We analysed the prospective multicentre SES registry, the German Cypher Stent Registry. 7,445 patients treated with an SES during percutaneous coronary intervention (PCI) were registered. Out of these patients, 61 (0.8%) were treated for restenosis after ICB: 56 patients with completed follow-up could be evaluated. Median age was 65 years, with 80% male patients. 48% of patients had a prior myocardial infarction and 25% had already coronary bypass surgery (CABG). Type B2 lesion was present in 40% and type C lesion in 22.4%. Event rates from SES implantation until 6.6 months follow-up were death 0%, myocardial infarction 3.6%, stroke 2.1%. Target vessel revascularization rate (TVR) was 16.4%, and major adverse cardiovascular or cerebral events (MACCE) or TVR occurred in 17.9% of patients. This TVR rate was higher compared with that of other patients treated with an SES: 8.4% (P = 0.04). During 65 months follow-up MACCE or TVR occurred in 44.6% of patients. CONCLUSIONS: The treatment of lesions after ICB occurred in 0.8% out of all patients treated with an SES. Clinical event rates during early follow-up were low. However, the TVR rate was 16.4%, which was significantly higher when compared with other SES-treated patients (8.4%, P = 0.04). The treatment of restenosis after ICB with SES seems to be safe and reasonably effective; however, there might be a late catch-up phenomenon.

Rapid MR assessment of left ventricular systolic function after acute myocardial infarction using single breath-hold cine imaging with the temporal parallel acquisition technique (TPAT) and 4D guide-point modelling analysis of left ventricular function.

We compared four-dimensional guide-point modelling left ventricular function analysis (4DVF) results of cine images in four short-axis and two long-axis slices acquired in a single breath-hold, obtained with the temporal parallel acquisition technique (TPAT), with standard left ventricular function (LVF) analysis results determined by the summation of discs method, in patients who had recently suffered myocardial infarction. Despite wall motion abnormalities, 4DVF yields results for left ventricular ejection fractions and end-diastolic and end-systolic volumes that are in excellent agreement with standard LVF analysis results in these patients. A shortened cardiac magnetic resonance (CMR) protocol using single breath-hold cine image acquisition could facilitate the assessment of left ventricular function soon after myocardial infarction in critically ill patients who are unable to comply with the multiple breath-holds required for standard LVF analysis.

Coronary stenting with the sirolimus-eluting stent in clinical practice: final results from the prospective multicenter German Cypher Stent Registry.

AIMS: Drug-eluting coronary stents (DES) have gained widespread use for the treatment of coronary artery disease. However, because of safety concerns and frequent "off-label" use data from "real life," registries are necessary to monitor indications and outcome of DES in daily clinical practice. METHODS AND RESULTS: We evaluated data from the German Cypher Stent Registry. A total of 10,894 patients treated with at least one sirolimus-eluting stent (SES) at 152 hospitals were included. Follow-up at a median of 6.4 months was available in 10,006 patients (92%). Median age was 64.8 years and 75.5% were male. Per lesion a mean of 1.09 +/- 0.41 SES were implanted with a mean length of 21.1 +/- 11.5mm. During follow-up, death rate was 1.8% and the rates of myocardial infarction or stroke were 2.1% and 0.5%. Any target vessel revascularization (TVR) was performed in 8.0% of patients. Independent predictors for death, myocardial infarction, or stroke were: cardiogenic shock, acute coronary syndromes, reduced left ventricular function, renal insufficiency, diabetes mellitus, advanced age, three-vessel disease, degree of stenosis, and prior myocardial infarction. Predictors for a TVR were: two- or three-vessel disease, target vessel = coronary bypass, advanced age, stent diameter, ostial lesions, indication in-stent restenosis, renal failure, and target vessel = left anterior descended artery. CONCLUSIONS: These results demonstrate that SES use in clinical practice is safe and effective. The main predictors of clinical events during follow-up are clinical parameters whereas as predictors of TVR mainly are angiographic parameters.