Arrhythmia monitoring and outcome after myocardial infarction (BIO|GUARD-MI): a randomized trial.

Objectives: Cardiac arrhythmias predict poor outcome after myocardial infarction (MI). We studied if arrhythmia monitoring with an insertable cardiac monitor (ICM) can improve treatment and outcome. Design: BIO|GUARD-MI was a randomized, international open-label study with blinded outcome assessment. Setting: Tertiary care facilities monitored the arrhythmias, while the follow-up remained with primary care physicians. Participants: Patients after ST-elevation (STEMI) or non-ST-elevation MI with an ejection fraction >35% and a CHA2DS2-VASc score ≥4 (men) or ≥5 (women). Interventions: Patients were randomly assigned to receive or not receive an ICM in addition to standard post-MI treatment. Device-detected arrhythmias triggered immediate guideline recommended therapy changes via remote monitoring. Main outcome measures: MACE, defined as a composite of cardiovascular death or acute unscheduled hospitalization for cardiovascular causes. Results: 790 patients (mean age 71 years, 72% male, 51% non-STEMI) of planned 1,400 pts were enrolled and followed for a median of 31.6 months. At 2 years, 39.4% of the device group and 6.7% of the control group had their therapy adapted for an arrhythmia [hazard ratio (HR) = 5.9, P < 0.0001]. Most frequent arrhythmias were atrial fibrillation, pauses and bradycardia. The use of an ICM did not improve outcome in the entire cohort (HR = 0.84, 95%-CI: 0.65-1.10; P = 0.21). In secondary analysis, a statistically significant interaction of the type of infarction suggests a benefit in the pre-specified non-STEMI subgroup. Risk factor analysis indicates that this may be connected to the higher incidence of MACE in patients with non-STEMI. Conclusions: The burden of asymptomatic but actionable arrhythmias is large in post-infarction patients. However, arrhythmia monitoring with an ICM did not improve outcome in the entire cohort. Post-hoc analysis suggests that it may be beneficial in non-STEMI patients or other high-risk subgroups. Clinical Trial Registration: [https://www.clinicaltrials.gov/ct2/show/NCT02341534], NCT02341534.

Outcomes After Left Main Percutaneous Coronary Intervention in Patients With Acute Myocardial Infarction Complicated by Cardiogenic Shock (from the German ALKK PCI Registry).

Early revascularization therapy with percutaneous coronary intervention (PCI) has been shown to improve outcomes in patients with acute myocardial infarction (AMI) complicated by cardiogenic shock (CS). Data from consecutive patients with AMI and CS treated with PCI enrolled into the prospective Arbeitsgemeinschaft Leitende Kardiologische Krankenhausärzte-PCI registry were centrally collected and analyzed. Patients were divided into 4 groups with PCI for left main (LM), 1-vessel, 2-vessel, and 3-vessel diseases. Patients' characteristics, procedural features, antithrombotic therapies, and in-hospital complications were compared between the 4 groups. Between 2010 and 2015 a total of 2,348 consecutive patients with AMI and CS were treated by PCI in 51 hospitals, 295 for LM (15 for protected, 280 for unprotected) and single-vessel (n = 491), 2-vessel (n = 524), and 3-vessel disease (n = 1,038). Thrombolysis in myocardial infarction 3 patency of the culprit lesion after PCI was 84.3%, 84.0%, 80.8%, and 84.6% in single-vessel, 2-vessel, 3-vessel disease, and LM PCI, respectively, whereas in-hospital mortality was 27.9%, 33.9%, 46.5%, and 55.9%. Bleeding rates were low (2.0%-2.3 %) and not different between groups. In a multivariate analysis a higher age, thrombolysis in myocardial infarction flow <3 after PCI, 3-vessel disease, and LM PCI were independent predictors of mortality. In conclusion, PCI of the LM is performed in about 12.5% of patients with AMI and CS and was associated with a high procedural success rate, whereas mortality is increased with LM PCI.

Detection of Viral Infection and Bacterial Coinfection and Superinfection in Coronavirus Disease 2019 Patients Presenting to the Emergency Department Using the 29-mRNA Host Response Classifier IMX-BVN-3: A Multicenter Study.

Background: Identification of bacterial coinfection in patients with coronavirus disease 2019 (COVID-19) facilitates appropriate initiation or withholding of antibiotics. The Inflammatix Bacterial Viral Noninfected (IMX-BVN) classifier determines the likelihood of bacterial and viral infections. In a multicenter study, we investigated whether IMX-BVN version 3 (IMX-BVN-3) identifies patients with COVID-19 and bacterial coinfections or superinfections. Methods: Patients with polymerase chain reaction-confirmed COVID-19 were enrolled in Berlin, Germany; Basel, Switzerland; and Cleveland, Ohio upon emergency department or hospital admission. PAXgene Blood RNA was extracted and 29 host mRNAs were quantified. IMX-BVN-3 categorized patients into very unlikely, unlikely, possible, and very likely bacterial and viral interpretation bands. IMX-BVN-3 results were compared with clinically adjudicated infection status. Results: IMX-BVN-3 categorized 102 of 111 (91.9%) COVID-19 patients into very likely or possible, 7 (6.3%) into unlikely, and 2 (1.8%) into very unlikely viral bands. Approximately 94% of patients had IMX-BVN-3 unlikely or very unlikely bacterial results. Among 7 (6.3%) patients with possible (n = 4) or very likely (n = 3) bacterial results, 6 (85.7%) had clinically adjudicated bacterial coinfection or superinfection. Overall, 19 of 111 subjects for whom adjudication was performed had a bacterial infection; 7 of these showed a very likely or likely bacterial result in IMX-BVN-3. Conclusions: IMX-BVN-3 identified COVID-19 patients as virally infected and identified bacterial coinfections and superinfections. Future studies will determine whether a point-of-care version of the classifier may improve the management of COVID-19 patients, including appropriate antibiotic use.

Left atrial appendage closure with the watchman device reduces atrial fibrillation management costs.

AIMS: To report hospitalization costs of patients with non-valvular atrial fibrillation (AF) submitted to percutaneous left atrial appendage closure (LAAC) with the Watchman device. METHODS: Pre- and post-procedural hospitalization AF-related costs were calculated using the DRG system (diagnosis-related groups) and compared. RESULTS: Between 2012 and 2016, 677 non-valvular AF patients underwent LAAC. Median time from first cardiac hospitalization to LAAC was 5.9 years (IQR 1.6-9.1) and median follow-up after LAAC was 4.8 years (IQR 3.6-5.6). LAAC mortality was 1.3% and follow-up mortality 16.9%. Median pre-LAAC hospitalization cost was € 17,867 (IQR € 7512-35,08) and post-LAAC € 8772 (IQR € 1183-25,159) (p < 0.0001). Annualized cost pre-LAAC was 3773 € (IQR € 1644-8,493) and post-LAAC 2,001 € (IQR € 260-6913) (p < 0.0001). Follow-up survivors had significantly lower post-LAAC costs (p < 0.0001) and after a survival cut-off time of 4.6 years LAAC procedural and post-procedural hospitalization costs achieved parity with pre-LACC costs (AUC 0.64; p = 0.02). CHA2DS2-VASc score (B = 0.04; p = 0.02; 95% CI 0.006-0.08), and HAS-BLED score (B = 0.08; p = 0.004; 95% CI 0.02-0.14) were independent determinants for annualized hospitalization costs post-LAAC. At Cox-regression analysis the DRG mean clinical complexity level (CCL) was the only independent determinant for follow-up mortality (OR = 2.2; p < 0.0001; 95% CI 1.6-2.8) with a cut-off value of 2.25 to predict follow-up mortality (AUC 0.72; p < 0.0001; Spec. 70%; Sens. 70%). CONCLUSION: Hospitalization costs pre-LAAC are consistent, and after LAAC, they are significantly reduced. Costs seem related to the patient's risk profile at the time of the procedure. With the increase in post-LAAC survival time, the procedure becomes economically more profitable.

Source attribution of community-acquired cases of Legionnaires' disease-results from the German LeTriWa study; Berlin, 2016-2019.

INTRODUCTION: Sources of infection of most cases of community-acquired Legionnaires' disease (CALD) are unknown. OBJECTIVE: Identification of sources of infection of CALD. SETTING: Berlin; December 2016-May 2019. PARTICIPANTS: Adult cases of CALD reported to district health authorities and consenting to the study; age and hospital matched controls. MAIN OUTCOME MEASURE: Percentage of cases of CALD with attributed source of infection. METHODS: Analysis of secondary patient samples for monoclonal antibody (MAb) type (and sequence type); questionnaire-based interviews, analysis of standard household water samples for Legionella concentration followed by MAb (and sequence) typing of Legionella pneumophila serogroup 1 (Lp1) isolates; among cases taking of additional water samples to identify the infectious source as appropriate; recruitment of control persons for comparison of exposure history and Legionella in standard household water samples. For each case an appraisal matrix was filled in to attribute any of three source types (external (non-residence) source, residential non-drinking water (RnDW) source (not directly from drinking water outlet), residential drinking water (RDW) as source) using three evidence types (microbiological results, cluster evidence, analytical-comparative evidence (using added information from controls)). RESULTS: Inclusion of 111 study cases and 202 controls. Median age of cases was 67 years (range 25-93 years), 74 (67%) were male. Among 65 patients with urine typable for MAb type we found a MAb 3/1-positive strain in all of them. Compared to controls being a case was not associated with a higher Legionella concentration in standard household water samples, however, the presence of a MAb 3/1-positive strain was significantly associated (odds ratio (OR) = 4.9, 95% confidence interval (CI) 1.7 to 11). Thus, a source was attributed by microbiological evidence if it contained a MAb 3/1-positive strain. A source was attributed by cluster evidence if at least two cases were exposed to the same source. Statistically significant general source types were attributed by calculating the population attributable risk (analytical-comparative evidence). We identified an external source in 16 (14%) cases, and RDW as source in 28 (25%). Wearing inadequately disinfected dentures was the only RnDW source significantly associated with cases (OR = 3.2, 95% CI 1.3 to 7.8) and led to an additional 8% of cases with source attribution, for a total of 48% of cases attributed. CONCLUSION: Using the appraisal matrix we attributed almost half of all cases of CALD to an infectious source, predominantly RDW. Risk for LD seems to be conferred primarily by the type of Legionella rather than the amount. Dentures as a new infectious source needs further, in particular, integrated microbiological, molecular and epidemiological confirmation.

Changes in treatment for NSTEMI in women and the elderly over the past 16 years in a large real-world population.

AIMS: This study investigates the changes in therapy for Non-ST-Elevation Myocardial Infarction (NSTEMI) over the past 16 years in a large German registry. In particular, the high-risk population of female and elderly patients was analyzed. METHODS: In total, 19.383 patients presenting with NSTEMI were included in this study. Patients were stratified by age groups <75 years and ≥75 years and by sex. Four different time periods from 2000-2004, 2005-2008, 2009-2012 and 2013-2016 were compared. Influence on hospital mortality as the primary outcome measure was assessed by logistic regression analysis. Secondary outcome measures included percutaneous coronary intervention (PCI), the use of drug eluting stents (DES), radial access route and major adverse cardiovascular events (MACE), defined as all-cause mortality, stroke, re-infarction, percutaneous re-intervention, intervention-related bleeding, cardiopulmonary resuscitation and new onset of cardiogenic shock or need for mechanical ventilation. RESULTS: Mortality decreased in all age groups between the initial time period and the most recent one (8.9% vs. 4.5%, p < 0.01), particularly in female patients ≥75 years (18.2% in 2000-2004 vs. 7.9% in 2013-2016, p < 0.01). Revascularization rates differed by gender (68.3% in women vs. 78.1% in men, p < 0.01) and by age (64.2% for ≥75 years vs. 80.9% for <75 years, p < 0.01). PCI rates in elderly female patients increased from 28.7% to 69.8% (p < 0.01) from the initial to the latest period. CONCLUSIONS: The present study demonstrates, that revascularization rates improved in all patient groups over the study period. However, females and elderly patients still remain less likely to be treated according to current guidelines.

The clinical effect of arrhythmia monitoring after myocardial infarction (BIO-GUARD|MI):study protocol for a randomized controlled trial.

BACKGROUND: The increasing use of implantable cardiac monitors (ICMs) allows early documentation of asymptomatic cardiac arrhythmias that would previously have gone unnoticed. The addition of remote monitoring to cardiac devices means that physicians receive an early warning in cases of new-onset arrhythmias. While remote monitoring has been suggested to increase survival in heart failure patients with implantable defibrillators, trials using ICMs for continuous electrocardiographic monitoring of cardiac arrhythmias in the postmyocardial infarction setting have shown that patients who experienced cardiac arrhythmias such as atrial fibrillation, bradycardia, and ventricular tachyarrhythmia have an increased risk of major adverse cardiac events. METHODS: The Biomonitoring in patients with preserved left ventricular function after diagnosed myocardial infarction (BIO-GUARD-MI) study is designed to investigate and clarify whether the incidence of major adverse cardiac events can be decreased by early detection and treatment of cardiac arrhythmias using an ICM in patients after myocardial infarction. In addition, the study will allow us to describe the interplay between baseline characteristics, arrhythmias, and clinical events to improve the treatment of this high-risk patient population. The study will enroll and randomize a cohort of high-risk postmyocardial infarction patients with CHA2DS2-VASc score ≥ 4 and left ventricular ejection fraction > 35% to an ICM or conventional treatment. Physicians are provided with suggestions on how to respond to ICM-documented arrhythmias. An estimated 1400 patients will be enrolled and followed until 372 primary endpoints have occurred. In this paper, we describe the literature and rationale behind the design and interventions towards new-onset arrhythmias, as well as future perspectives and limitations for the use of ICMs. DISCUSSION: Remote monitoring may improve clinical outcome if it uncovers conditions with low symptom burden which cause or indicate an increased risk. A simple and easily implementable response to the information is important. Cardiac arrhythmias frequently start as asymptomatic, shorter lasting, and nightly events. The BIO-GUARD-MI trial represents the first attempt to simplify the response to the rather complex nature of heart arrhythmias. TRIAL REGISTRATION: Clinical Trials, NCT02341534 . Registered on 19 January 2015.

Procedural Success Rates and Mortality in Elderly Patients With Percutaneous Coronary Intervention for Cardiogenic Shock.

OBJECTIVES: The aim of this study was to determine the impact of age on procedural and clinical outcomes in patients with cardiogenic shock (CS). BACKGROUND: The use of early revascularization therapy with percutaneous coronary intervention (PCI) has been shown to improve outcome in patients with acute myocardial infarction (AMI) complicated by CS. METHODS: Data from consecutive patients with AMI and CS treated with PCI enrolled into the prospective ALKK (Arbeitsgemeinschaft Leitende Kardiologische Krankenhausärzte) PCI registry were centrally collected and analyzed. Patients were divided into 4 groups according to their age (<65, 65 to 74, 75 to 84, and >85 years). Patients' characteristics, procedural features, antithrombotic therapies, and in-hospital complications were compared among the 4 groups. RESULTS: Between 2010 and 2015, a total of 2,323 consecutive patients with AMI and CS were treated by PCI in 51 hospitals. TIMI (Thrombolysis In Myocardial Infarction) flow grade 3 patency after PCI decreased with increasing age from 84% to 78%, while in-hospital mortality increased from 32% to 56%. Bleeding rates were low (2.0% to 2.3%) and not different among age groups. In the multivariate analysis, higher age, TIMI flow grade <3 after PCI, 3-vessel disease, and left main PCI were independent predictors of mortality. CONCLUSIONS: PCI in patients with AMI and CS is associated with a high procedural success rate and a low bleeding rate, even in very elderly patients, while mortality increases with increasing age. Because mortality in elderly patients with CS without revascularization therapy is very high, it seems justified to perform PCI in selected patients to reduce mortality.

Transmission and loss of ECG snapshots: Remote monitoring in implantable cardiac monitors.

INTRODUCTION: Remote monitoring including transmission of electrocardiogram (ECG) strips has been implemented in implantable cardiac monitors (ICM). We appraise whether the physician can rely on remote monitoring to be informed of all possibly significant arrhythmias. METHODS: We analyzed remote monitoring transmissions of patients in the ongoing BIO|GUARD-MI study, in which Biotronik devices are used. Once per day, the devices automatically transmit messages with up to six ECG snapshots to the Home Monitoring Service Center. If more than one type of arrhythmia is recorded during a day, at least one ECG of each arrhythmia type is transmitted. RESULTS: 212 study patients were registered at the service center. The mean age of the patients was 70 ±â€¯8 years, and 74% were male. Patients were followed for an average of 13 months. The median time from device implantation until the first message receipt in the service center was 2 days. The median patient-individual transmission success was 98.0% (IQR 93.6-99.8) and remained stable in the second and third year. The most frequent arrhythmias were atrial fibrillation, bradycardia and high ventricular rate. 17.3% of the messages with ECG snapshots contained more than one arrhythmia type. DISCUSSION: Our analysis confirms that the physician can rely on Home Monitoring to be informed of all possibly significant arrhythmias during long-term follow-up. We have found hints that the transmission of only one episode per day may lead to the loss of clinically relevant information if patients with ICMs are followed by remote monitoring only.

Effect of renal insufficiency and diabetes mellitus on in-hospital mortality after acute coronary syndromes treated with primary PCI. Results from the ALKK PCI Registry.

BACKGROUND: It is known that patients with acute coronary syndromes (ACS) and diabetes mellitus (DM) are at higher risk for in-hospital adverse events. However, we hypothesized that the higher event rate is due to the patients' subgroup with renal failure (RF), a common sequel of DM. METHODS AND RESULTS: We used data of the prospective ALKK-PCI registry including all consecutive percutaneous coronary interventions (PCI) for ACS of 48 hospitals between 2008 and 2013. We divided 69,651 patients in four groups according to their history of DM and RF (GFR < 60 ml/min). All-cause, in-hospital mortality of the following four groups: noDM/noRF, DM/noRF, DM/RF, RF/noDM, was: 3.5%, 6.6%, 21.9%, and 14.1% for STEMI and 1.5%, 2.1%, 7.2%, and 5.4% for NSTE-ACS. In a multivariate analysis we looked for independent mortality-predictors. Odds ratios with confidence intervals for the following variables: DM without RF, DM with RF, RF without DM were: 1.62 (1.37-1.90), 3.02 (2.43-3.76), and 2.13 (1.80-2.52) for STEMI and 1.20 (0.99-1.45), 2.72 (2.18-3.88), and 2.08 (1.69-2.56) for NSTE-ACS. We also calculated mortality in four groups (60-90, 45-60, 45-30, <30 ml/min) according to the estimated glomerular filtration rate (eGFR). Mortality rates were: 5.0%, 12.8%, 17.7%, and 31.5% for STEMI and 2.1%, 3.8%, 7.1%, and 12.0% for NSTE-ACS (p for trend <0.0001 for both). CONCLUSIONS: In-hospital death after PCI in patients with ACS and DM is mainly observed in the subgroup with co-existing RF. In a multivariate analysis, DM without RF was a significant mortality-predictor in STEMI, but not in NSTE-ACS. RF, irrespective of co-existent DM, was a stronger predictor than DM alone for both ACS-types (OR > 3) and mortality increased with decreasing eGFR.

[Regional Aspects in Treatment of Patients with Acute Myocardial Infarction in the North-East of Germany]. / Regionale Versorgungsaspekte des akuten Myokardinfarktes im Nordosten Deutschlands.

BACKGROUND: In recent decades, guideline-based therapy of myocardial infarction has led to a considerable reduction in myocardial infarction mortality. However, there are relevant differences in acute care and the extent of infarction mortality. The objective of this survey was to analyze the current care situation of patients with acute myocardial infarction in the region of northeast Germany (Berlin, Brandenburg and Mecklenburg-Vorpommern). METHODS: Based on pseudonymized data from a statutory health insurance of 1 387 084 persons, a total of 6733 patients with inpatient admission at MI were filtered using the ICD10 code I21 and I22 for 2012. Total inhospital mortality and 1-year mortality and prognostic parameters were evaluated and analyzed in country comparisons. RESULTS: Both the hospital mortality rate and the 1-year mortality rate of the individual countries (Berlin 13.6 resp. 27.5 %, respectively, BRB 13.9 and 27.9 %, MV 14.4 and 29.0 %, respectively) were comparable to the overall rate (13.9 % or 28.0 %) and in the country comparison. In the multiple analysis, the 1-year mortality was determined by the invasive strategy (OR 0.42, 95 % CI 0.35 - 0.51, p < 0.001) as well as by the implementation of the guidelines-based secondary prevention (OR 0.14, 95 % CI 0.12 - 0.17, p < 0.001). There were no statistical differences between the three federal states. CONCLUSION: The investigated population of patients with acute MI in Berlin, Brandenburg and Mecklenburg-Vorpommern demonstrated a comparable inpatient and post-hospital care and 1-year prognosis regardless of the federal state assignment. Referral to coronary angiography and adequate implementation of evidence-based medication demonstrated a significant prognostic impact.

Comparing routine administrative data with registry data for assessing quality of hospital care in patients with myocardial infarction using deterministic record linkage.

BACKGROUND: Assessment of quality of care in patients with myocardial infarction (MI) should be based on data that effectively enable determination of quality. With the need to simplify measurement techniques, the question arises whether routine data can be used for this purpose. We therefore compared data from a German sickness fund (AOK) with data from the Berlin Myocardial Infarction Registry (BMIR). METHODS: We included patients hospitalised for treatment of MI in Berlin from 2009-2011. We matched 2305 patients from AOK and BMIR by using deterministic record linkage with indirect identifiers. For matched patients we compared the frequency in documentation between AOK and BMIR for quality assurance variables and calculated the kappa coefficient (KC) as a measure of agreement. RESULTS: There was almost perfect agreement in documentation between AOK and BMIR data for matched patients for: catheter laboratory (KC: 0.874), ST elevation MI (KC: 0.826), diabetes (KC: 0.818), percutaneous coronary intervention (KC: 0.860) and hospital mortality (KC: 0.952). The remaining variables compared showed moderate or less than moderate agreement (KC < 0.6), and were grouped in Category II with less frequent documentation in AOK for risk factors and aspects of patients' history; in Category III with more frequent documentation in AOK for comorbidities; and in Category IV for medication at and after hospital discharge. CONCLUSIONS: Routine data are primarily collected and defined for reimbursement purposes. Quality assurance represents merely a secondary use. This explains why only a limited number of variables showed almost perfect agreement in documentation between AOK and BMIR. If routine data are to be used for quality assessment, they must be constantly monitored and further developed for this new application. Furthermore, routine data should be complemented with registry data by well-established methods of record linkage to realistically reflect the situation - also for those quality-associated variables not collected in routine data.

The Emergency Medical Care of Patients With Acute Myocardial Infarction.

BACKGROUND: Optimizing the emergency medical care chain might shorten the time to treatment of patients with ST-elevation myocardial infarction (STEMI). The initial care by a physician, and, in particular, correct ECG interpretation, are critically important factors. METHODS: From 1999 onward, data on the care of patients with myocardial infarction have been recorded and analyzed in the Berlin Myocardial Infarction Registry. In the First Medical Contact Study, data on initial emergency medical care were obtained on 1038 patients who had been initially treated by emergency physicians in 2012. Their pre-hospital ECGs were re-evaluated in a blinded fashion according to the criteria of the European Society of Cardiology. RESULTS: The retrospective re-evaluation of pre-hospital ECGs revealed that 756 of the 1038 patients had sustained a STEMI. The emergency physicians had correctly diagnosed STEMI in 472 patients (62.4%), and they had correctly diagnosed ventricular fibrillation in 85 patients (11.2%); in 199 patients (26.3%), the ECG interpretation was unclear. The pre-hospital ECG interpretation was significantly associated with the site of initial hospitalization and the ensuing times to treatment. In particular, the time from hospital admission to cardiac catheterization was longer in patients with an unclear initial ECG interpretation than in those with correctly diagnosed STEMI (121 [54; 705] vs. 36 [19; 60] minutes, p <0.001). After multivariate adjustment, this corresponded to a hazard ratio* of 2.67 [2.21; 3.24]. CONCLUSION: Pre-hospital ECG interpretation in patients with STEMI was a trigger factor with a major influence on the time to treatment in the hospital. The considerable percentage of pre-hospital ECGs whose interpretation was unclear implies that there is much room for improvement.

Use and impact of thrombectomy in primary percutaneous coronary intervention for acute myocardial infarction with persistent ST-segment elevation: results of the prospective ALKK PCI-registry.

BACKGROUND: Data about the impact of thrombectomy in primary percutaneous coronary intervention (PCI) are inconsistent. The aim of our study was an evaluation of both the real-world use of thrombectomy and the impact of thrombectomy on outcome in unselected patients treated with primary PCI for ST-elevation myocardial infarction (STEMI). METHODS AND RESULTS: We used the data of the prospective ALKK PCI-registry of 35 hospitals from January 2010 to December 2013. A total of 10,755 patients receiving single-vessel primary PCI for acute STEMI were included. In 2176 patients (20.2 %) thrombectomy was performed. There was a wide range of use of thrombectomy in the different ALKK hospitals from 1.1 to 61.7 % (median 18.6 %, quartiles 6.0 and 40.3 %) with a general increase of use over the first years of the study period. In patients with and without thrombectomy there was TIMI 0 flow present before PCI in 6010 patients, TIMI 1 in 1338, TIMI 2 in 2002, and TIMI 3 in 1405. Patients with acute heart failure or cardiogenic shock received significantly more often thrombectomy. Fluoroscopy time (8.1 vs. 7.3 min, p < 0.0001) and dose area product (5373 cGy × cm(2) vs. 4802 cGy × cm(2), p < 0.0001) were significantly higher in patients treated with thrombectomy. The subgroup of patients with TIMI 0 flow before PCI had significantly higher rates of TIMI 3 flow after PCI when treated with thrombectomy (87.1 vs. 84.1 %, p < 0.01), while there was no difference in post-PCI TIMI 3 flow in patients with TIMI 1, 2 or 3 flow before PCI. Rates of major adverse cardiac and cerebrovascular events were similar in both groups in general and in all subgroups of TIMI flow. CONCLUSIONS: The use of thrombectomy in patients with STEMI is heterogenous between hospitals. Overall, there was no impact of thrombectomy on TIMI 3 patency or mortality after PCI. In the subgroup of STEMI patients with TIMI 0 flow before PCI individualized thrombectomy had a positive impact on restoration of normal blood flow.

Antithrombotic therapy in patients with atrial fibrillation and acute coronary syndrome in the real world: Data from the Berlin AFibACS Registry.

BACKGROUND: Guidelines for the management of atrial fibrillation (AFib) recommend antithromboembolic treatment strategies for patients with AFib and acute coronary syndrome (AFibACS). Our study assessed how current guidelines are implemented in the metropolitan area of Berlin and which therapeutic options were chosen in light of stroke and bleeding riskin everyday practice. METHODS AND RESULTS: Between April 2008 and January 2012, we included 1,295 AFibACS patients in the AFibACS Registry, as part of the Berlin Myocardial Infarction Registry. Meanage of the patients was 76 years with numerous comorbidities (15.4% former stroke, 35.0% renal failure, 43.5% diabetes, 92.8% hypertension). Of all the patients, 888 were treated with stent implantation, 91 with balloon angioplasty, and 316 conservatively. Overall mortality was 11.6%, and 8.3% in stented patients. At hospital discharge, triple therapy was administered to 49.9% of stented cases. After adjustment, odds of receiving triple therapy were lower within creasing age and renal failure. Odds were higher after stent implantation, with a higher CHA2DS2-VASc score, and with any AFib category compared to initially diagnosed AFib. Between 2008 and 2011, triple therapy increased from 33.3% to 49.8% for stented patients and did not change significantly for those treated conservatively or with balloon angioplasty. CONCLUSIONS: These data suggest that in AFibACS patients, antithrombotic treatment focused on dual antiplatelet therapy for ACS, rather than on anticoagulation therapy for stroke prevention. Factors influencing therapy at discharge were age, renal failure, stent implantation, AFib category, and CHA2DS2-VASc score. During the study period, triple therapy increased for stented patients.

Long-term prognostic value of restitution slope in patients with ischemic and dilated cardiomyopathies.

BACKGROUND: An action potential duration (APD) restitution curve with a steep slope ≥1 has been associated with increased susceptibility for malignant ventricular arrhythmias. We aimed to evaluate the "restitution hypothesis" and tested ventricular APD restitution slope as well as effective refractory period (ERP)/APD ratio for long-term prognostic value in patients with ischemic (ICM) or dilated cardiomyopathy (DCM). METHODOLOGY/PRINCIPAL FINDINGS: Monophasic action potentials were recorded in patients with ICM (n = 32) and DCM (n = 42) undergoing routine programmed ventricular stimulation (PVS). Left ventricular ejection fraction was 32±7% and 28±9%, respectively. APD and ERP were measured at baseline stimulation (S(1)) and upon introduction of one to three extrastimuli (S(2)-S(4)). ERP/APD ratios and the APD restitution curve were calculated and the maximum restitution slope was determined. After a mean follow-up of 6.1±3.0 years, the combined end-point of mortality and and/or implantable cardioverter-defibrillator shock was not predicted by restitution slope or ERP/APD ratios. Comparing S(2) vs. S(3) vs. S(4) extrastimuli for restitution slope (1.5±0.6 vs. 1.4±0.4 vs. 1.3±0.5; p = NS), additional extrastimuli did not lead to a steepening restitution slope. ERP/APD ratio decreased with additional extrastimuli (0.98±0.09 [S(1)] vs. 0.97±0.10 [S(2)] vs. 0.93±0.11 [S(3)]; p = 0.03 S(1) vs. S(3)). Positive PVS was strongly predictive of outcome (p = 0.006). CONCLUSIONS/SIGNIFICANCE: Neither ventricular APD restitution slope nor ERP/APD ratios predict outcome in patients with ICM or DCM.

Age-related differences in diagnosis, treatment and outcome of acute coronary syndromes: results from the German ALKK registry.

AIMS: The elderly constitute an increasing proportion of all patients with acute coronary syndromes (ACS). However, increased age has been identified as an important risk factor for adverse events and complications of ACS and treatment. The purpose of this study was to investigate age-related differences in presentation and diagnostics, as well as contemporary treatment and outcome in a large series of elderly patients receiving an invasive strategy for ACS. METHODS AND RESULTS: The present study is an analysis of all patients, who were enrolled in the German Arbeitsgemeinschaft Leitende Kardiologische Krankenhausärzte (ALKK) registry in 2008. To assess age-related differences, subjects were divided into three groups: (<75 yrs, 75 to 85 yrs and >85 yrs). Out of 19,708 consecutive patients who were admitted for the treatment of ACS and enrolled in the ALKK registry, 14,174 (71.9%) were <75 yrs, 4,685 (23.8%) were between 75 and 84 yrs and 849 (4.3%) patients were >85 yrs. Therapy recommendation after diagnostic angiography was conservative in 24.6% of the youngest, in 25.1% of the elderly, and in 25.3% of the very elderly patients. Interventional success rates were 95.2% in the youngest vs. 93.1% in the elderly and very elderly patient group (p<0.001). Overall in-hospital event rate increased significantly with age (3.4% vs. 7.4% vs. 8.3%, respectively; p<0.001). CONCLUSIONS: Our analysis shows that there is a high success rate among the large proportion of elderly patients who are treated for ACS by an intervention. Complication rates increased significantly, however, with age.

Routine early invasive strategy and in-hospital mortality in women with non-ST-elevation myocardial infarction: results from the Berlin Myocardial Infarction Registry (BMIR).

BACKGROUND: It is under discussion whether female patients with non-ST-elevation myocardial infarction (NSTEMI) benefit from routine invasive treatment strategy. We accordingly applied our data from the Berlin Myocardial Infarction Registry (BMIR) to analyze the association between early percutaneous coronary intervention (PCI) and hospital mortality in NSTEMI patients. METHODS: Data prospectively collected in the BMIR between 2004 and 2008 from 2808 patients (m=1820/w=988) directly admitted to hospitals with 24-h PCI facilities were included in the analysis. After adjustment for confounding variables, we compared in-hospital mortality for patients of both sexes with vs. without early PCI. RESULTS: Women with NSTEMI were, on average, 7years older than men and demonstrated significantly more comorbidities. A GPIIb/IIIa antagonist was applied in women less often than in men (31.4% vs. 38.4%, p=0.001), and an early PCI was also performed less often in women than in men (64.0% vs. 76.2%, p<0.001). In-hospital mortality was higher in women than in men (5.4% vs. 3.6%, p=0.027). In female patients with NSTEMI, after adjustment for differences in patients' characteristics, hospital mortality did not differ between those treated with early PCI and those managed conservatively (OR: 1.24, 95% CI 0.53-2.91). In contrast, hospital mortality in male patients was lower in those treated with an early PCI (OR: 0.41, 95% CI 0.21-0.78). CONCLUSION: In our clinical registry, early PCI in female patients with NSTEMI was not associated with lower hospital mortality. Further randomized-controlled trials are needed to better understand which women may benefit from early invasive therapy, and under which conditions such benefits are possible.