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.
Drug-eluting stents have been effective in randomized controlled trials, but their safety and efficacy in patients with insulin-dependent diabetes has not been well studied. Baseline clinical and ...angiographic characteristics and in-hospital and follow-up events were recorded for enrolled patients. From October 2005 and October 2006, 581 patients with insulin-dependent diabetes and 1,078 with non-insulin-dependent diabetes treated with sirolimus- and paclitaxel-eluting stents were enrolled at 98 sites. The composite of death, myocardial infarction, and stroke, defined as major adverse cardiac and cerebrovascular events, as well as target vessel revascularization was used as the primary end point. Multiple logistic regression analysis was used to adjust for confounding parameters. Baseline clinical characteristics were more severe in patients with insulin-dependent diabetes, whereas descriptive characteristics were not unique. At 1-year follow-up, the comparison between the 2 groups revealed significantly higher rates of overall death (7.4% vs 4.6%, p <0.05), target vessel revascularization (15.1% vs 10.4%, p <0.05), and overall stent thrombosis (6.5% vs 4.1%, p <0.05) for insulin-dependent patients, while rates of major adverse cardiac and cerebrovascular events were not significantly different (12.8% vs 9.9%, p = 0.09). These results persisted even after risk adjustment for heterogenous baseline characteristics of the 2 groups. In conclusion, the data generated from the German Drug-Eluting Stent (DES.DE) registry revealed that even with drug-eluting stents, the annual risk for death, target vessel revascularization, and thrombotic events remains higher in patients with insulin-dependent diabetes compared to those with non-insulin-dependent diabetes.
Randomized clinical trials (RCTs) usually enroll selected patient populations that may not be representative for patients seen in everyday practice. Therefore, concerns have been raised regarding ...their external validity. For the present study we evaluated the MITRA Plus registry and included 20,175 patients with ST-elevation myocardial infarction. We defined RCT-ineligible patients as patients fulfilling ≥1 of the following criteria: age ≥75 years, prehospital delay >12 hours, prehospital cardiopulmonary resuscitation, cardiogenic shock, impaired renal function, and previous stroke. Those patients (n = 9,369, 46.4%) were compared to patients eligible for enrollment in RCTs (n = 11,806, 53.6%). Ineligible patients were older (p <0.0001), more often were women (p <0.0001), and more often had concomitant diseases (p <0.0001). Ineligible patients less often received early reperfusion therapy (p <0.0001), aspirin (p <0.0001), clopidogrel (p <0.0001), and statins (p <0.0001). Ineligible patients had a higher hospital mortality (20.1% vs 4.9%; p <0.0001) and a higher rate of nonfatal strokes (1.5% vs 0.4%, p <0.0001) compared to eligible patients. Early reperfusion therapy (thrombolysis and/or percutaneous coronary intervention PCI) in ineligible patients was associated with a significant decrease of hospital mortality (odds ratio 0.62, 95% confidence interval 0.49 to 0.79), with primary PCI being more effective than thrombolytic therapy (odds ratio 0.52, 95% confidence interval 0.41 to 0.65). In conclusion, about 50% of patients with ST-elevation myocardial infarction seen in clinical practice are usually excluded from RCTs. Hospital mortality in those patients is very high. Primary PCI improves the prognosis and is therefore the preferred reperfusion strategy in these patients.
Background A significant proportion of patients undergoing transcatheter aortic valve implantation (TAVI) have concomitant peripheral arterial disease (PAD), which plays a crucial role in the ...preinterventional selection process of determining an optimal vascular access site. The aim of our study was to determine the impact of PAD on clinical outcome after TAVI in a real-world setting. Methods A total of 1,315 patients (mean logistic European System for Cardiac Operative Risk Evaluation 20.6% ± 13.7%) underwent TAVI in 27 centers and were included in the prospective German TAVI Registry. Results Of the 1,315 patients with TAVI, 330 (25.1%) had PAD. These patients had a higher logistic European System for Cardiac Operative Risk Evaluation score (27.7% ± 16.0% vs 18.3% ± 12.0%, P < .0001), mainly attributed to more frequent and severe comorbidities. Compared with patients without PAD, patients with PAD had a higher rate of vascular complications (28.5% vs 20.7%, P < .01), dialysis-dependent renal failure (11.2% vs 5.4%, P < .001), myocardial infarction (1.2% vs 0.3%, P < .05), and, subsequently, 30-day mortality (12.7% vs 6.9%, P < .001). Choosing a surgical approach, for example, transapical access, did not reduce the periprocedural risk associated with PAD; in-hospital mortality was 15.7% for surgical and 10.5% for percutaneous patients with TAVI having PAD ( P < .001). In a multivariate regression analysis, PAD was an independent predictor of 30-day mortality (hazard ratio 1.8, 95% CI 1.2-2.7, P = .004) after TAVI. Conclusions In this real-world TAVI Registry, PAD was an independent predictor of mortality in patients with percutaneous and surgical TAVI, including vascular complications. Assessment of PAD should play a crucial role in the preinterventional selection process, regardless of the access strategy.
Abstract Aims This investigation addresses procedural characteristics of catheter ablation in patients with atrial fibrillation (AF) and sinus bradycardia. Methods From the prospective, multi-center ...German Ablation Registry 1073 patients with sinus rhythm at the time of AF ablation were divided into two groups according to heart rate at start of procedure (A, < 60 beats per minute (bpm), n = 197; B, 60–99 bpm, n = 876). Results Acute procedural success was high (≥ 98%) and similar between groups. Procedure duration and energy application time were increased in group A (180 min vs. 155 min and 2561 s vs. 1879 s, respectively). Major complications were more frequent in group A (2.2% vs. 0.5%), and a greater proportion of these patients was discharged under antiarrhythmic medication (64% vs. 52%). Conclusion Catheter ablation of AF with concomitant sinus bradycardia is associated with high procedural efficacy, longer procedure- and energy application durations, and a slightly elevated complication rate.
High blood glucose in patients with acute coronary syndromes have been associated with adverse short-term outcomes in patients without diabetes. However, the relation of admission glucose to ...long-term outcomes in these patients was less well established. Accordingly, consecutive patients with ST-elevation myocardial infarction (STEMI) without diabetes enrolled at 155 sites from July 2000 to November 2002 in the ACOS Registry were evaluated. Patients were categorized into tertiles based on admission blood glucose. Clinical end points of interest were 1-year mortality and composite of death, reinfarction, stroke, or rehospitalization (major adverse cardiac clinical events MACCEs) in the hospital and after discharge. Of 5,866 patients with STEMI, 36.9% had blood glucose <120 mg/dl; 33.1%, 120 to 150 mg/dl; and 30.0%, >150 mg/dl. Admission blood glucose was significantly related to increased risk of not only in-hospital events (death, glucose >150 vs <120 mg/dl, adjusted odds ratio OR 2.86, 95% confidence interval CI 2.13 to 3.82, p <0.0001; and MACCE, >150 vs <120 mg/dl, adjusted OR 1.88, 95% CI 1.52 to 2.33; p <0.0001), but this increased risk persisted beyond the acute phase during 1-year follow-up of a mean 380 days (median 387; death, glucose >150 vs <120 mg/dl, adjusted OR 1.46, 95% CI 1.04 to 2.03, p <0.0001; and MACCE, >150 vs <120 mg/dl, adjusted OR 1.31, 95% CI 1.00 to 1.71, p <0.0001). In conclusion, high blood glucose at admission to the hospital independently correlated with short- and midterm mortality in patients with STEMI.
Data on the safety of carotid artery stenting (CAS) in a large number of unselected patients with contralateral occlusion and significant ipsilateral stenosis are less known. Accordingly, we ...evaluated 3,137 patients undergoing CAS who were enrolled in a German Registry from 2000 to 2008 and compared the clinical features and in-hospital outcomes of those with and without contralateral carotid occlusion. Contralateral carotid occlusion was present in 191 patients (6.1%) undergoing CAS. Despite the similar age of the patients with and without contralateral carotid occlusion, those with contralateral occlusion had a greater prevalence of co-morbidities, complex carotid stenosis, and greater number of focal neurologic lesions on the contralateral side. The incidence of in-hospital events, including death (1.0% vs 0.5%), ipsilateral major stroke (1.1% vs 1.1%), death or major ipsilateral stroke (1.6% vs 1.4%), ipsilateral transient ischemic attack (2.7% vs 2.5%), myocardial infarction (0.0% vs 0.1%), and reintervention (0.5% vs 1.1%), was low and was not significantly different between those with and without contralateral occlusion (p >0.05 for all comparisons). Among patients with carotid occlusion, major ipsilateral stroke (2.2%), death (2.2%), and a combination of these 2 events (3.3%) were observed exclusively in symptomatic patients with no event in asymptomatic patients. In conclusion, our data from a large number of patients undergoing CAS in a recent contemporary community-based practice attests to the low risk of periprocedural events among patients with contralateral carotid occlusion supporting CAS as an attractive option for the treatment of these patients.
Background Both left bundle branch block and right bundle branch block (RBBB) have been associated with increased inhospital and long-term mortality in patients with acute ST elevation myocardial ...infarction (STEMI). However, the prognostic role of RBBB in acute non-ST elevation myocardial infarction (NSTEMI) is not well known. Therefore, the aim of the study was to evaluate the incidence and clinical impact of RBBB in patients with NSTEMI compared to patients with STEMI. Methods From the German prospective multicenter registry “Maximal Individual Therapy of Acute Myocardial Infarction” (MITRA PLUS), 6,403 consecutive patients with NSTEMI and 20,233 patients with STEMI were analyzed. Patients with left bundle branch block were excluded. The median follow-up time for NSTEMI was 378 days and for STEMI 479 days. Results A total of 455 (7.1%) patients with NSTEMI and 894 (4.4%) patients with STEMI presented with RBBB on admission. In general, RBBB patients were older, more often had comorbidities, and less often received short-term inhospital treatment according to guidelines. In STEMI, RBBB patients had higher peak enzyme levels and lower left ventricular ejection fraction (LV-EF) than patients without BBB. Right bundle branch block in STEMI was associated with an increased inhospital and long-term mortality. In NSTEMI, however, peak enzyme levels and LV-EF were similar in both groups with and without RBBB. Right bundle branch block in NSTEMI was not independently associated with a worse outcome. Conclusions Unlike RBBB in STEMI, RBBB in NSTEMI is not an independent predictor of inhospital and long-term mortality.
The modified American College of Cardiology/American Heart Association (ACC/AHA) lesion morphology classification scheme has prognostic impact for early and late outcomes when bare-metal stents are ...used. Its value after drug-eluting stent placement is unknown. The predictive value of this lesion morphology classification system in patients treated using sirolimus-eluting stents included in the German Cypher Registry was prospectively examined. The study population included 6,755 patients treated for 7,960 lesions using sirolimus-eluting stents. Lesions were classified as type A, B1, B2, or C. Lesion type A or B1 was considered simple (35.1%), and type B2 or C, complex (64.9%). The combined end point of all deaths, myocardial infarction, or target vessel revascularization was seen in 2.6% versus 2.4% in the complex and simple groups, respectively (p = 0.62) at initial hospital discharge, with a trend for higher rates of myocardial infarction in the complex group. At the 6-month clinical follow-up and after adjusting for other independent factors, the composite of cumulative death, myocardial infarction, and target vessel revascularization was nonsignificantly different between groups (11.4% vs 11.2% in the complex and simple groups, respectively; odds ratio 1.08, 95% confidence interval 0.8 to 1.46). This was also true for target vessel revascularization alone (8.3% of the complex group, 9.0% of the simple group; odds ratio 0.87, 95% confidence interval 0.72 to 1.05). In conclusion, the modified ACC/AHA lesion morphology classification system has some value in determining early complications after sirolimus-eluting stent implantation. Clinical follow-up results at 6 months were generally favorable and cannot be adequately differentiated on the basis of this lesion morphology classification scheme.
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.
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