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1.
Lancet ; 402(10410): 1338-1346, 2023 10 14.
Article in English | MEDLINE | ID: mdl-37643628

ABSTRACT

BACKGROUND: Venoarterial extracorporeal membrane oxygenation (VA-ECMO) is increasingly used in patients with cardiogenic shock despite the lack of evidence from adequately powered randomised clinical trials. Three trials reported so far were underpowered to detect a survival benefit; we therefore conducted an individual patient-based meta-analysis to assess the effect of VA-ECMO on 30-day death rate. METHODS: Randomised clinical trials comparing early routine use of VA-ECMO versus optimal medical therapy alone in patients presenting with infarct-related cardiogenic shock were identified by searching MEDLINE, Cochrane Central Register of Controlled Trials, Embase, and trial registries until June 12, 2023. Trials were included if at least all-cause death rate 30 days after in-hospital randomisation was reported and trial investigators agreed to collaborate (ie, providing individual patient data). Odds ratios (ORs) as primary outcome measure were pooled using logistic regression models. This study is registered with PROSPERO (CRD42023431258). FINDINGS: Four trials (n=567 patients; 284 VA-ECMO, 283 control) were identified and included. Overall, there was no significant reduction of 30-day death rate with the early use of VA-ECMO (OR 0·93; 95% CI 0·66-1·29). Complication rates were higher with VA-ECMO for major bleeding (OR 2·44; 95% CI 1·55-3·84) and peripheral ischaemic vascular complications (OR 3·53; 95% CI 1·70-7·34). Prespecified subgroup analyses were consistent and did not show any benefit for VA-ECMO (pinteraction ≥0·079). INTERPRETATION: VA-ECMO did not reduce 30-day death rate compared with medical therapy alone in patients with infarct-related cardiogenic shock, and an increase in major bleeding and vascular complications was observed. A careful review of the indication for VA-ECMO in this setting is warranted. FUNDING: Foundation Institut für Herzinfarktforschung.


Subject(s)
Extracorporeal Membrane Oxygenation , Shock, Cardiogenic , Humans , Shock, Cardiogenic/etiology , Shock, Cardiogenic/therapy , Extracorporeal Membrane Oxygenation/adverse effects , Intra-Aortic Balloon Pumping , Logistic Models , Hemorrhage/etiology , Retrospective Studies , Randomized Controlled Trials as Topic
2.
N Engl J Med ; 385(27): 2544-2553, 2021 12 30.
Article in English | MEDLINE | ID: mdl-34459570

ABSTRACT

BACKGROUND: Myocardial infarction is a frequent cause of out-of-hospital cardiac arrest. However, the benefits of early coronary angiography and revascularization in resuscitated patients without electrocardiographic evidence of ST-segment elevation are unclear. METHODS: In this multicenter trial, we randomly assigned 554 patients with successfully resuscitated out-of-hospital cardiac arrest of possible coronary origin to undergo either immediate coronary angiography (immediate-angiography group) or initial intensive care assessment with delayed or selective angiography (delayed-angiography group). All the patients had no evidence of ST-segment elevation on postresuscitation electrocardiography. The primary end point was death from any cause at 30 days. Secondary end points included a composite of death from any cause or severe neurologic deficit at 30 days. RESULTS: A total of 530 of 554 patients (95.7%) were included in the primary analysis. At 30 days, 143 of 265 patients (54.0%) in the immediate-angiography group and 122 of 265 patients (46.0%) in the delayed-angiography group had died (hazard ratio, 1.28; 95% confidence interval [CI], 1.00 to 1.63; P = 0.06). The composite of death or severe neurologic deficit occurred more frequently in the immediate-angiography group (in 164 of 255 patients [64.3%]) than in the delayed-angiography group (in 138 of 248 patients [55.6%]), for a relative risk of 1.16 (95% CI, 1.00 to 1.34). Values for peak troponin release and for the incidence of moderate or severe bleeding, stroke, and renal-replacement therapy were similar in the two groups. CONCLUSIONS: Among patients with resuscitated out-of-hospital cardiac arrest without ST-segment elevation, a strategy of performing immediate angiography provided no benefit over a delayed or selective strategy with respect to the 30-day risk of death from any cause. (Funded by the German Center for Cardiovascular Research; TOMAHAWK ClinicalTrials.gov number, NCT02750462.).


Subject(s)
Coronary Angiography , Electrocardiography , Out-of-Hospital Cardiac Arrest/diagnostic imaging , Aged , Cardiopulmonary Resuscitation , Cause of Death , Coronary Disease/complications , Coronary Disease/diagnostic imaging , Female , Humans , Kaplan-Meier Estimate , Length of Stay , Male , Middle Aged , Nervous System Diseases/etiology , Out-of-Hospital Cardiac Arrest/complications , Out-of-Hospital Cardiac Arrest/mortality , Out-of-Hospital Cardiac Arrest/therapy , ST Elevation Myocardial Infarction/diagnostic imaging , Time Factors , Time-to-Treatment
3.
Herz ; 49(1): 5-14, 2024 Feb.
Article in German | MEDLINE | ID: mdl-38032511

ABSTRACT

The new guidelines of the European Society of Cardiology (ESC) on the management of acute coronary syndrome (ACS) in 2023 encompass updates for both the guidelines pertaining to ST elevation myocardial infarction (STEMI) and acute coronary syndrome without ST segment elevation (NSTE-ACS). The previously separated guidelines from 2017 and 2020 were therefore revised and summarized. These guidelines address various topics, including diagnostics, acute management, antithrombotic treatment, out-of-hospital cardiac arrest, cardiogenic shock, invasive strategies, and long-term treatment. The notable updates compared to earlier guidelines address the recommendation regarding the timing of invasive diagnostics in NSTE-ACS (Non-ST elevation acute coronary syndrome), the procedure of revascularization in multivessel coronary artery disease and alternative regimens for antithrombotic treatment in patients with a high risk of bleeding.


Subject(s)
Acute Coronary Syndrome , Cardiology , Coronary Artery Disease , ST Elevation Myocardial Infarction , Humans , Acute Coronary Syndrome/therapy , Acute Coronary Syndrome/drug therapy , Fibrinolytic Agents/therapeutic use , Coronary Artery Disease/drug therapy , Shock, Cardiogenic/diagnosis , Shock, Cardiogenic/etiology , Shock, Cardiogenic/therapy , ST Elevation Myocardial Infarction/drug therapy
4.
Catheter Cardiovasc Interv ; 100(3): 330-337, 2022 09.
Article in English | MEDLINE | ID: mdl-35900214

ABSTRACT

OBJECTIVES: To compare early coronary angiography to a delayed or selective approach in out-of-hospital cardiac arrest (OHCA) without ST-segment elevation of possible cardiac cause by means of meta-analysis of available randomized controlled trials (RCTs). METHODS: We searched MEDLINE and the Cochrane Central Register of Controlled Trials for RCTs comparing early with delayed or selective coronary angiography in OHCA patients of possible cardiac origin without ST-segment elevation. The primary endpoint was all-cause short-term mortality (PROSPERO CRD42021271484). RESULTS: The search strategy identified three RCTs enrolling a total of 1167 patients. An early invasive approach was not associated with improved short-term mortality (odds ratio 1.19, 95% confidence interval 0.94-1.52; p = 0.15). Further, no significant differences were shown with respect to the risk of severe neurological deficit, the composite of all-cause mortality or severe neurological deficit, need for renal replacement therapy due to acute renal failure, and significant bleeding at short-term follow-up. CONCLUSION: Early coronary angiography in OHCA without ST-segment elevation is not superior compared to a delayed/selective approach.


Subject(s)
Out-of-Hospital Cardiac Arrest , Percutaneous Coronary Intervention , Coronary Angiography/methods , Humans , Out-of-Hospital Cardiac Arrest/diagnostic imaging , Out-of-Hospital Cardiac Arrest/etiology , Out-of-Hospital Cardiac Arrest/therapy , Percutaneous Coronary Intervention/adverse effects , Randomized Controlled Trials as Topic , Time Factors , Treatment Outcome
5.
Catheter Cardiovasc Interv ; 99(4): 1327-1334, 2022 03.
Article in English | MEDLINE | ID: mdl-35019201

ABSTRACT

This study sought to evaluate a new method that uses injection of fibrin sealant under simultaneous balloon occlusion for the treatment of postinterventional access site bleeding complications. With the rising complexity of interventional procedures, iatrogenic false aneurysms and active bleeding has become more common. In general, these complications are associated with increased morbidity and mortality, especially if surgical repair is required. Although high success rates are reported for ultrasound-guided compression and ultrasound-guided thrombin injection, these methods are not always feasible. All procedures of fibrin sealant injection under simultaneous balloon occlusion for the treatment of postinterventional access site bleeding complications or pseudoaneurysm were prospectively collected. Additional data were retrospectively obtained and analyzed for all patients treated by this new method. In total, 53 patients were included from 2018 to 2021. Most of the access site complications were related to transcatheter aortic valve replacement (40%) or percutaneous coronary intervention (21%), but also to a wide variety of other procedures. Of the 53 patients, 30 had to be treated for false aneurysms and 23 for active bleeding. A high primary success rate of 94% was achieved. Recurrences of false aneurysms occurred in six patients, of which only one needed open surgical repair. Regarding complications, two peripheral embolisms, thereof one requiring additional stent implantation occurred. Balloon-assisted thrombin injection seems to be feasible and safe. It provides a new alternative to prevent surgery for patients where common techniques are unavailable or have failed.


Subject(s)
Aneurysm, False , Fibrin Tissue Adhesive , Aneurysm, False/diagnostic imaging , Aneurysm, False/etiology , Aneurysm, False/therapy , Femoral Artery/surgery , Fibrin Tissue Adhesive/adverse effects , Humans , Retrospective Studies , Thrombin , Treatment Outcome
6.
Lipids Health Dis ; 21(1): 47, 2022 May 28.
Article in English | MEDLINE | ID: mdl-35643463

ABSTRACT

BACKGROUND: The preventive effect of cholesterol efflux capacity (CEC) on the progression of atherosclerotic lesions has been confirmed in animal models, but findings in the population are inconsistent. Therefore, this meta-analysis aimed to systematically investigate the relationship of CEC with coronary artery disease (CAD) and cardiovascular mortality in a general population. METHODS: Four electronic databases (PubMed, Embase database, Cochrane Library, Web of Science) were searched from inception to February 1st, 2022 for relevant studies, without any language restriction. For continuous variables, the mean and standard deviation (SD), maximum adjusted odds ratios (ORs), relative risks (RRs), or hazard ratios (HRs) and 95% confidence intervals (CIs) were extracted. The random-effects model was adopted to calculate the pooled results, and dose-response analyses were conducted. All pooled results were expressed by standardized mean difference (SMD) and ORs. RESULTS: Finally, 18 observational studies were included. Compared with the non-CAD group, the CAD group (SMD -0.48, 95% CI - 0.66 to - 0.30; I2 88.9%) had significantly lower CEC. In the high-CEC population, the risks of CAD (OR 0.52, 95% CI 0.37 to 0.71; I2 81%) significantly decreased, and a linear negative dose-response was detected. However, an association between CEC and the risk of cardiovascular mortality was not found (OR 0.44, 95% CI 0.18 to 1.06; I2 83.2%). CONCLUSIONS: This meta-analysis suggests that decreased CEC is strongly associated with the risk of CAD, independent of HDL-C level. However, a decreased CEC seems not to be related to cardiovascular mortality. Meanwhile, CEC is linearly negatively correlated with the risk of CAD.


Subject(s)
Coronary Artery Disease , Animals , Cholesterol, HDL , Humans , Incidence , Odds Ratio , Risk Factors
7.
Eur Heart J ; 42(24): 2344-2352, 2021 06 21.
Article in English | MEDLINE | ID: mdl-33647946

ABSTRACT

BACKGROUND: Cardiogenic shock (CS) complicating acute myocardial infarction (AMI) still reaches excessively high mortality rates. This analysis is aimed to develop a new easily applicable biomarker-based risk score. METHODS AND RESULTS: A biomarker-based risk score for 30-day mortality was developed from 458 patients with CS complicating AMI included in the randomized CULPRIT-SHOCK trial. The selection of relevant predictors and the coefficient estimation for the prognostic model were performed by a penalized multivariate logistic regression analysis. Validation was performed internally, internally externally as well as externally in 163 patients with CS included in the randomized IABP-SHOCK II trial. Blood samples were obtained at randomization. The two trials are registered with ClinicalTrials.gov (NCT01927549 and NCT00491036), are closed to new participants, and follow-up is completed. Out of 58 candidate variables, the four strongest predictors for 30-day mortality were included in the CLIP score (cystatin C, lactate, interleukin-6, and N-terminal pro-B-type natriuretic peptide). The score was well calibrated and yielded high c-statistics of 0.82 [95% confidence interval (CI) 0.78-0.86] in internal validation, 0.82 (95% CI 0.75-0.89) in internal-external (temporal) validation, and 0.73 (95% CI 0.65-0.81) in external validation. Notably, it outperformed the Simplified Acute Physiology Score II and IABP-SHOCK II risk score in prognostication (0.83 vs 0.62; P < 0.001 and 0.83 vs. 0.76; P = 0.03, respectively). CONCLUSIONS: A biomarker-only score for 30-day mortality risk stratification in infarct-related CS was developed, extensively validated and calibrated in a prospective cohort of contemporary patients with CS after AMI. The CLIP score outperformed other clinical scores and may be useful as an early decision tool in CS.


Subject(s)
Myocardial Infarction , Shock, Cardiogenic , Cystatin C , Humans , Interleukin-6 , Intra-Aortic Balloon Pumping , Lactic Acid , Myocardial Infarction/complications , Natriuretic Peptide, Brain , Prospective Studies , Risk Factors , Shock, Cardiogenic/etiology
8.
N Engl J Med ; 379(18): 1699-1710, 2018 11 01.
Article in English | MEDLINE | ID: mdl-30145971

ABSTRACT

BACKGROUND: Among patients with acute myocardial infarction, cardiogenic shock, and multivessel coronary artery disease, the risk of a composite of death from any cause or severe renal failure leading to renal-replacement therapy at 30 days was found to be lower with percutaneous coronary intervention (PCI) of the culprit lesion only than with immediate multivessel PCI. We evaluated clinical outcomes at 1 year. METHODS: We randomly assigned 706 patients to either culprit-lesion-only PCI or immediate multivessel PCI. The results for the primary end point of death or renal-replacement therapy at 30 days have been reported previously. Prespecified secondary end points at 1 year included death from any cause, recurrent myocardial infarction, repeat revascularization, rehospitalization for congestive heart failure, the composite of death or recurrent infarction, and the composite of death, recurrent infarction, or rehospitalization for heart failure. RESULTS: As reported previously, at 30 days, the primary end point had occurred in 45.9% of the patients in the culprit-lesion-only PCI group and in 55.4% in the multivessel PCI group (P=0.01). At 1 year, death had occurred in 172 of 344 patients (50.0%) in the culprit-lesion-only PCI group and in 194 of 341 patients (56.9%) in the multivessel PCI group (relative risk, 0.88; 95% confidence interval [CI], 0.76 to 1.01). The rate of recurrent infarction was 1.7% with culprit-lesion-only PCI and 2.1% with multivessel PCI (relative risk, 0.85; 95% CI, 0.29 to 2.50), and the rate of a composite of death or recurrent infarction was 50.9% and 58.4%, respectively (relative risk, 0.87; 95% CI, 0.76 to 1.00). Repeat revascularization occurred more frequently with culprit-lesion-only PCI than with multivessel PCI (in 32.3% of the patients vs. 9.4%; relative risk, 3.44; 95% CI, 2.39 to 4.95), as did rehospitalization for heart failure (5.2% vs. 1.2%; relative risk, 4.46; 95% CI, 1.53 to 13.04). CONCLUSIONS: Among patients with acute myocardial infarction and cardiogenic shock, the risk of death or renal-replacement therapy at 30 days was lower with culprit-lesion-only PCI than with immediate multivessel PCI, and mortality did not differ significantly between the two groups at 1 year of follow-up. (Funded by the European Union Seventh Framework Program and others; CULPRIT-SHOCK ClinicalTrials.gov number, NCT01927549 .).


Subject(s)
Myocardial Infarction/complications , Percutaneous Coronary Intervention/methods , Shock, Cardiogenic/therapy , Aged , Female , Follow-Up Studies , Heart Failure/epidemiology , Heart Failure/etiology , Humans , Kaplan-Meier Estimate , Male , Middle Aged , Patient Readmission , Recurrence , Renal Insufficiency/etiology , Renal Insufficiency/therapy , Renal Replacement Therapy , Shock, Cardiogenic/etiology , Shock, Cardiogenic/mortality
9.
Herz ; 46(1): 3-13, 2021 Feb.
Article in German | MEDLINE | ID: mdl-33236199

ABSTRACT

The European Society of Cardiology (ESC) guidelines for the management of acute coronary syndrome without persistent ST-segment elevation (NSTE-ACS) published in August 2020, replace the former NSTE-ACS guidelines published in 2015. These updated guidelines have some relevant changes for the clinical practice, which include the diagnostic work-up, risk stratification, antithrombotic therapy, invasive or noninvasive coronary diagnostics and also long-term treatment. New sections deal with spontaneous coronary artery dissection (SCAD), myocardial infarction with nonobstructive coronary arteries (MINOCA) and also newly introduced quality indicators for NSTE-ACS treatment. The diagnostic work-up using highly sensitive cardiac troponin (hs-cTn) assays is emphasized with the recommendation to use fast triage decisions that enable an early rule-in (no STEMI) or rule-out (NSTEMI probable) in the emergency room or chest pain unit. In antiplatelet therapy a greater individualization of the treatment concept is recommended based on the individual ischemic/thrombotic events and bleeding complications. Some new aspects were introduced for timing of invasive coronary angiography; however, principally the very high-risk group should still immediately undergo coronary angiography and the high-risk group should undergo an invasive angiography within 24 h. In risk stratification, the former intermediate risk group has been removed, instead it is now emphasized that low-risk patients should be treated similarly to patients with chronic coronary syndrome.


Subject(s)
Acute Coronary Syndrome , Cardiology , Myocardial Infarction , Non-ST Elevated Myocardial Infarction , Acute Coronary Syndrome/diagnosis , Acute Coronary Syndrome/therapy , Coronary Angiography , Humans
10.
Circulation ; 139(4): 448-457, 2019 01 22.
Article in English | MEDLINE | ID: mdl-30026282

ABSTRACT

BACKGROUND: Experimental trials suggest improved outcome by mild therapeutic hypothermia for cardiogenic shock after acute myocardial infarction. The objective of this study was to investigate the hemodynamic effects of mild therapeutic hypothermia in patients with cardiogenic shock complicating acute myocardial infarction. METHODS: Patients (n=40) with cardiogenic shock undergoing primary percutaneous coronary intervention without classic indications for mild therapeutic hypothermia underwent randomization in a 1:1 fashion to mild therapeutic hypothermia for 24 hours or control. The primary end point was cardiac power index at 24 hours; secondary end points included other hemodynamic parameters and serial measurements of arterial lactate. RESULTS: No relevant differences were observed for the primary end point of cardiac power index at 24 hours (mild therapeutic hypothermia versus control: 0.41 [interquartile range, 0.31-0.52] versus 0.36 [interquartile range, 0.31-0.48] W/m2; P=0.50; median difference, -0.025 W/m2; 95% CI, -0.12 to 0.06). Similarly, all other hemodynamic measurements were not statistically different. Arterial lactate levels at 6, 8, and 10 hours were significantly higher in patients in the mild therapeutic hypothermia group with a slower decline ( P for interaction=0.03). There were no differences in 30-day mortality (60% versus 50%; hazard ratio, 1.27; 95% CI, 0.55-2.94; P=0.55). CONCLUSIONS: In this randomized trial, mild therapeutic hypothermia failed to show a substantial beneficial effect on cardiac power index at 24 hours in patients with cardiogenic shock after acute myocardial infarction. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov . Unique identifier: NCT01890317.


Subject(s)
Hypothermia, Induced/methods , Myocardial Infarction/therapy , Percutaneous Coronary Intervention , Shock, Cardiogenic/therapy , Aged , Aged, 80 and over , Biomarkers/blood , Female , Germany , Hemodynamics , Humans , Hypothermia, Induced/adverse effects , Hypothermia, Induced/mortality , Lactic Acid/blood , Male , Myocardial Infarction/diagnosis , Myocardial Infarction/mortality , Myocardial Infarction/physiopathology , Percutaneous Coronary Intervention/adverse effects , Percutaneous Coronary Intervention/mortality , Prospective Studies , Recovery of Function , Shock, Cardiogenic/diagnosis , Shock, Cardiogenic/mortality , Shock, Cardiogenic/physiopathology , Time Factors , Treatment Outcome
11.
Circulation ; 140(13): 1061-1069, 2019 09 24.
Article in English | MEDLINE | ID: mdl-31466479

ABSTRACT

BACKGROUND: Atrial arrhythmias are common in patients with implantable cardioverter-defibrillator (ICD). External shocks and internal cardioversion through commanded ICD shock for electrical cardioversion are used for rhythm-control. However, there is a paucity of data on efficacy of external versus internal cardioversion and on the risk of lead and device malfunction. We hypothesized that external cardioversion is noninferior to internal cardioversion for safety, and superior for successful restoration of sinus rhythm. METHODS: Consecutive patients with ICD undergoing elective cardioversion for atrial arrhythmias at 13 centers were randomized in 1:1 fashion to either internal or external cardioversion. The primary safety end point was a composite of surrogate events of lead or device malfunction. Conversion of atrial arrhythmia to sinus rhythm was the primary efficacy end point. Myocardial damage was studied by measuring troponin release in both groups. RESULTS: N=230 patients were randomized. Shock efficacy was 93% in the external cardioversion group and 65% in the internal cardioversion group (P<0.001). Clinically relevant adverse events caused by external or internal cardioversion were not observed. Three cases of pre-existing silent lead malfunction were unmasked by internal shock, resulting in lead failure. Troponin release did not differ between groups. CONCLUSIONS: This is the first randomized trial on external vs internal cardioversion in patients with ICDs. External cardioversion was superior for the restoration of sinus rhythm. The unmasking of silent lead malfunction in the internal cardioversion group suggests that an internal shock attempt may be reasonable in selected ICD patients presenting for electrical cardioversion. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov. Unique identifier: NCT03247738.


Subject(s)
Arrhythmias, Cardiac/therapy , Atrial Fibrillation/therapy , Defibrillators, Implantable , Electric Countershock/methods , Aged , Aged, 80 and over , Equipment Failure , Female , Humans , Male , Middle Aged , Risk
12.
Herz ; 45(6): 542-547, 2020 Sep.
Article in English | MEDLINE | ID: mdl-32430519

ABSTRACT

The optimal treatment of non-infarct-related coronary arteries in patients presenting with ST-elevation myocardial infarction (STEMI) has been a subject of debate for many years. Earlier medium-sized randomized controlled trials reported a benefit of multivessel percutaneous coronary intervention (PCI) primarily due to a reduction of subsequent revascularizations. Recently, the well-powered COMPLETE trial showed a reduction in the composite endpoint of cardiovascular mortality and myocardial reinfarction through complete revascularization. The present review summarizes the current evidence regarding revascularization strategies in STEMI patients.


Subject(s)
Coronary Artery Disease , Percutaneous Coronary Intervention , ST Elevation Myocardial Infarction , Coronary Artery Disease/surgery , Humans , ST Elevation Myocardial Infarction/surgery , Treatment Outcome
13.
Am Heart J ; 209: 20-28, 2019 03.
Article in English | MEDLINE | ID: mdl-30639610

ABSTRACT

Patients experiencing out-of-hospital cardiac arrest (OHCA) without ST-segment elevation are a heterogenic group with a variety of underlying causes. Up to one-third of patients display a significant coronary lesion compatible with myocardial infarction as OHCA trigger. There are no randomized data on patient selection and timing of invasive coronary angiography after admission. METHODS AND RESULTS: The TOMAHAWK trial randomly assigns 558 patients with return of spontaneous circulation after OHCA with no obvious extracardiac origin of cardiac arrest and no ST-segment elevation/left bundle-branch block on postresuscitation electrocardiogram to either immediate coronary angiography or initial intensive care assessment with delayed/selective angiography in a 1:1 ratio. The primary end point is 30-day all-cause mortality. Secondary analyses will be performed with respect to initial rhythm, electrocardiographic patterns, myocardial infarction as underlying cause, neurological outcome, as well as clinical and laboratory markers. Clinical follow-up will be performed at 6 and 12 months. Safety end points include bleeding and stroke. CONCLUSION: The TOMAHAWK trial will address the unresolved issue of timing and general indication of angiography after OHCA without ST-segment elevation.


Subject(s)
Cardiopulmonary Resuscitation/methods , Coronary Angiography/methods , Electrocardiography , Out-of-Hospital Cardiac Arrest/diagnosis , Time-to-Treatment , Triage/methods , Cause of Death/trends , Europe/epidemiology , Follow-Up Studies , Humans , Out-of-Hospital Cardiac Arrest/mortality , Out-of-Hospital Cardiac Arrest/therapy , Prospective Studies , Survival Rate/trends , Time Factors
14.
Lancet ; 390(10096): 737-746, 2017 Aug 19.
Article in English | MEDLINE | ID: mdl-28778541

ABSTRACT

BACKGROUND: A routine invasive strategy is recommended for patients with non-ST-elevation acute coronary syndromes (NSTE-ACS). However, optimal timing of invasive strategy is less clearly defined. Individual clinical trials were underpowered to detect a mortality benefit; we therefore did a meta-analysis to assess the effect of timing on mortality. METHODS: We identified randomised controlled trials comparing an early versus a delayed invasive strategy in patients presenting with NSTE-ACS by searching MEDLINE, Cochrane Central Register of Controlled Trials, and Embase. We included trials that reported all-cause mortality at least 30 days after in-hospital randomisation and for which the trial investigators agreed to collaborate (ie, providing individual patient data or standardised tabulated data). We pooled hazard ratios (HRs) using random-effects models. This meta-analysis is registered at PROSPERO (CRD42015018988). FINDINGS: We included eight trials (n=5324 patients) with a median follow-up of 180 days (IQR 180-360). Overall, there was no significant mortality reduction in the early invasive group compared with the delayed invasive group HR 0·81, 95% CI 0·64-1·03; p=0·0879). In pre-specified analyses of high-risk patients, we found lower mortality with an early invasive strategy in patients with elevated cardiac biomarkers at baseline (HR 0·761, 95% CI 0·581-0·996), diabetes (0·67, 0·45-0·99), a GRACE risk score more than 140 (0·70, 0·52-0·95), and aged 75 years older (0·65, 0·46-0·93), although tests for interaction were inconclusive. INTERPRETATION: An early invasive strategy does not reduce mortality compared with a delayed invasive strategy in all patients with NSTE-ACS. However, an early invasive strategy might reduce mortality in high-risk patients. FUNDING: None.


Subject(s)
Acute Coronary Syndrome/surgery , Non-ST Elevated Myocardial Infarction/surgery , Acute Coronary Syndrome/mortality , Adult , Aged , Biomarkers/blood , Coronary Angiography/mortality , Coronary Angiography/statistics & numerical data , Female , Humans , Male , Middle Aged , Non-ST Elevated Myocardial Infarction/mortality , Percutaneous Coronary Intervention/mortality , Percutaneous Coronary Intervention/statistics & numerical data , Randomized Controlled Trials as Topic , Time-to-Treatment , Treatment Outcome
15.
Eur Heart J ; 38(47): 3523-3531, 2017 Dec 14.
Article in English | MEDLINE | ID: mdl-29020341

ABSTRACT

AIMS: Evidence on the impact on clinical outcome of active mechanical circulatory support (MCS) devices in cardiogenic shock (CS) is scarce. This collaborative meta-analysis of randomized trials thus aims to investigate the efficacy and safety of percutanzeous active MCS vs. control in CS. METHODS AND RESULTS: Randomized trials comparing percutaneous active MCS to control in patients with CS were identified through searches of medical literature databases. Risk ratios (RR) and 95% confidence intervals (95% CI) were calculated to analyse the primary endpoint of 30-day mortality and device-related complications including bleeding and leg ischaemia. Mean differences (MD) were calculated for mean arterial pressure (MAP), cardiac index (CI), pulmonary capillary wedge pressure (PCWP), and arterial lactate. Four trials randomizing 148 patients to either TandemHeart™ or Impella® MCS (n = 77) vs. control (n = 71) were identified. In all four trials intra-aortic balloon pumping (IABP) served as control. There was no difference in 30-day mortality (RR 1.01, 95% CI 0.70 to 1.44, P = 0.98, I2 = 0%) for active MCS compared with control. Active MCS significantly increased MAP (MD 11.85 mmHg, 95% CI 3.39 to 20.31, P = 0.02, I2 = 32.7%) and decreased arterial lactate (MD - 1.36 mmol/L, 95% CI - 2.52 to - 0.19, I2 = 0%, P = 0.02) at comparable CI (MD 0.32, 95% CI - 0.24 to 0.87, P = 0.14, I2 = 44.1%) and PCWP (MD - 5.59, 95% -15.59 to 4.40, P = 0.14, I2 = 81.1%). No significant difference was observed in the incidence of leg ischaemia (RR 2.64, 95% CI 0.83 to 8.39, P = 0.10, I2 = 0%), whereas the rate of bleeding was significantly increased in MCS compared to IABP (RR 2.50, 95% CI 1.55 to 4.04, P < 0.001, I2 = 0%). CONCLUSION: Results of this collaborative meta-analysis do not support the unselected use of active MCS in patients with CS complicating AMI.


Subject(s)
Heart-Assist Devices , Shock, Cardiogenic/therapy , Cause of Death , Female , Heart Failure/mortality , Heart Failure/physiopathology , Heart Failure/therapy , Hemodynamics/physiology , Hemorrhage/etiology , Humans , Intra-Aortic Balloon Pumping/instrumentation , Intra-Aortic Balloon Pumping/methods , Ischemia/etiology , Leg/blood supply , Male , Middle Aged , Randomized Controlled Trials as Topic , Risk Factors , Shock, Cardiogenic/mortality , Shock, Cardiogenic/physiopathology
16.
Heart Vessels ; 32(7): 856-864, 2017 Jul.
Article in English | MEDLINE | ID: mdl-28116486

ABSTRACT

Inferior vena cava (IVC) diameter can be used to approximate right atrial pressure in patients admitted for acute decompensated heart failure (ADHF). Recent studies linked IVC dilation to an increased risk of early re-admission and short-term mortality. Moreover, renal insufficiency (RI) is an established risk factor for mortality in ADHF and is associated with congestion. We hypothesized that the IVC diameter is a marker of all-cause mortality but its prognostic impact may be influenced by kidney function. We analyzed data of 1101 patients admitted for ADHF with available echocardiography of the IVC by chart review and death registry linkage. Patients were dichotomized according to a cut-off value of 21 mm. Cox proportional hazards model was used to identify mortality predictors. A dilated IVC was detected in 474 (43.1%) patients. Overall, 400 (36.3%) patients died within 3 years. All-cause mortality was significantly higher in patients with dilated IVC [hazard ratio 1.45 (confidence interval 1.21-1.74); p < 0.001]. However, a dilated IVC was only associated with all-cause mortality in patients with RI function [hazard ratio 1.60 (confidence interval 1.26-2.03); p < 0.001] but not in patients with a preserved kidney function [hazard ratio 1.04 (confidence interval 0.72-1.50); P = 0.84]. IVC diameter was identified as an independent predictor for all-cause mortality in a Cox proportional hazards model with a significant interaction between IVC diameter and baseline kidney function. In conclusion, IVC dilation is a marker of high mortality risk in patients admitted for ADHF. However, this observation was confined to patients with RI.


Subject(s)
Heart Failure/physiopathology , Mortality , Renal Insufficiency/physiopathology , Vena Cava, Inferior/diagnostic imaging , Vena Cava, Inferior/pathology , Aged , Aged, 80 and over , Biomarkers , Echocardiography , Female , Germany/epidemiology , Glomerular Filtration Rate , Heart Failure/complications , Hospitalization/statistics & numerical data , Humans , Male , Multivariate Analysis , Prognosis , Renal Insufficiency/complications , Risk Factors , Survival Analysis
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