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1.
J Clin Med ; 13(7)2024 Mar 26.
Article in English | MEDLINE | ID: mdl-38610683

ABSTRACT

The proportion of patients with multivessel coronary artery disease in individuals experiencing acute coronary syndrome (ACS) varies based on age and ACS subtype. In patients with ST-segment elevation myocardial infarction (STEMI) without cardiogenic shock, the prognostic benefit of complete revascularization has been demonstrated by several randomized trials and meta-analyses, leading to a strong guideline recommendation. However, similar data are lacking for ACS without ST-segment elevation (NSTE-ACS). Non-randomized data suggesting a benefit from complete revascularization in non-ST-segment elevation myocardial infarction (NSTEMI) are prone to selection bias and should be interpreted with caution. A series of large randomized controlled trials have been initiated recently to address these open questions.

2.
Article in English | MEDLINE | ID: mdl-38430099

ABSTRACT

BACKGROUND: Functional tricuspid regurgitation (TR) can develop either because of right ventricular (RV) remodeling (ventricular functional TR) and/or right atrial dilation (atrial functional TR). OBJECTIVES: This meta-analysis aimed to investigate the association between right heart remodeling and long-term (>1 year) all-cause mortality in patients with significant TR (at least moderate, ≥2+). METHODS: MEDLINE, ISI Web of Science, and SCOPUS databases were searched. Studies reporting data on at least 1 RV functional parameter and long-term all-cause mortality in patients with significant TR were included. This study was designed according to PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) requirements. RESULTS: Out of 8,902 studies, a total of 14 were included, enrolling 4,394 subjects. The duration of follow-up across the studies varied, ranging from a minimum of 15.5 months to a maximum of 73.2 months. Overall, long-term all-cause mortality was 31% (95% CI: 20%-41%; P ≤ 0.001). By means of meta-regression analyses, an inverse relation was found between tricuspid annular plane systolic excursion (11 studies enrolling 3,551 subjects, -6.3% [95% CI: -11.1% to -1.4%]; P = 0.011), RV fractional area change (9 studies, 2,975 subjects, -4.4% [95% CI: -5.9% to -2.9%]; P < 0.001), tricuspid annular dimension (7 studies, 2,986 subjects, -4.1% [95% CI: -7.6% to -0.5%]; P = 0.026), right atrial area (6 studies, 1,920 subjects, -1.9% [95% CI: -2.5% to -1.3%]; P < 0.001) and mortality. CONCLUSIONS: RV dysfunction parameters are associated to worse clinical outcomes in patients with TR, whereas right atrial dilatation is linked to a better prognostic outcome. Further studies are needed to unravel the pathophysiological differences within the functional TR spectrum. (Right heart remodeling and outcomes in patients with tricuspid regurgitation; CRD42023418667).

3.
Eur J Heart Fail ; 26(2): 448-457, 2024 Feb.
Article in English | MEDLINE | ID: mdl-38084483

ABSTRACT

AIMS: Anaemia and iron deficiency (ID) are common comorbidities in cardiovascular patients and are associated with a poor clinical status, as well as a worse outcome in patients with heart failure and acute myocardial infarction (AMI). Nevertheless, data concerning the impact of anaemia and ID on clinical outcomes in patients with cardiogenic shock (CS) are scarce. This study aimed to assess the impact of anaemia and ID on clinical outcomes in patients with CS complicating AMI. METHODS AND RESULTS: The presence of anaemia (haemoglobin <13 g/dl in men and <12 g/dl in women) or ID (ferritin <100 ng/ml or transferrin saturation <20%) was determined in patients with CS due to AMI from the CULPRIT-SHOCK trial. Blood samples were collected in the catheterization laboratory during initial percutaneous coronary intervention. Clinical outcomes were compared in four groups of patients having neither anaemia nor ID, against patients with anaemia with or without ID and patients with ID only. A total of 427 CS patients were included in this analysis. Anaemia without ID was diagnosed in 93 (21.7%), anaemia with ID in 54 study participants (12.6%), ID without anaemia in 72 patients (16.8%), whereas in 208 patients neither anaemia nor ID was present (48.9%). CS patients with anaemia without ID were older (73 ± 10 years, p = 0.001), had more frequently a history of arterial hypertension (72.8%, p = 0.01), diabetes mellitus (47.8%, p = 0.001), as well as chronic kidney disease (14.1%, p = 0.004) compared to CS patients in other groups. Anaemic CS patients without ID presence were at higher risk to develop a composite from all-cause death or renal replacement therapy at 30-day follow-up (odds ratio [OR] 3.83, 95% confidence interval [CI] 2.23-6.62, p < 0.001) than CS patients without anaemia/ID. The presence of ID in CS patients, with and without concomitant anaemia, did not increase the risk for the primary outcome (OR 1.17, 95% CI 0.64-2.13, p = 0.64; and OR 1.01, 95% CI 0.59-1.73, p = 0.54; respectively) within 30 days of follow-up. In time-to-event Kaplan-Meier analysis, anaemic CS patients without ID had a significantly higher hazard ratio (HR) for the primary outcome (HR 2.11, 95% CI 1.52-2.89, p < 0.001), as well as for death from any cause (HR 1.90, 95% CI 1.36-2.65, p < 0.001) and renal replacement therapy during 30-day follow-up (HR 2.99, 95% CI 1.69-5.31, p < 0.001). CONCLUSION: Concomitant anaemia without ID presence in patients with CS at hospital presentation is associated with higher risk for death from any cause or renal replacement therapy and the individual components of this composite endpoint within 30 days after hospitalization. ID has no relevant impact on clinical outcomes in patients with CS.


Subject(s)
Anemia, Iron-Deficiency , Anemia , Heart Failure , Myocardial Infarction , Percutaneous Coronary Intervention , Male , Humans , Female , Shock, Cardiogenic/etiology , Shock, Cardiogenic/therapy , Shock, Cardiogenic/diagnosis , Heart Failure/complications , Treatment Outcome , Myocardial Infarction/complications , Myocardial Infarction/therapy , Anemia/complications , Anemia, Iron-Deficiency/etiology , Percutaneous Coronary Intervention/adverse effects
4.
Clin Res Cardiol ; 113(4): 533-545, 2024 Apr.
Article in English | MEDLINE | ID: mdl-37421436

ABSTRACT

BACKGROUND: The GRACE risk score is generically recommended by guidelines for timing of invasive coronary angiography without stating which score should be used. The aim was to determine the diagnostic performance of different GRACE risk scores in comparison to the ESC 0/1 h-algorithm using high-sensitivity cardiac troponin (hs-cTn). METHODS: Prospectively enrolled patients presenting with symptoms suggestive of myocardial infarction (MI) in two large studies testing biomarker diagnostic strategies were included. Five GRACE risk scores were calculated. The amount of risk reclassification and the theoretical impact on guideline-recommended timing of invasive coronary angiography was studied. RESULTS: Overall, 8,618 patients were eligible for analyses. Comparing different GRACE risk scores, up to 63.8% of participants were reclassified into a different risk category. The proportion of MIs identified (i.e., sensitivity) dramatically differed between GRACE risk scores (range 23.8-66.5%) and was lower for any score than for the ESC 0/1 h-algorithm (78.1%). Supplementing the ESC 0/1 h-algorithm with a GRACE risk score slightly increased sensitivity (P < 0.001 for all scores). However, this increased the number of false positive results. CONCLUSION: The substantial amount of risk reclassification causes clinically meaningful differences in the proportion of patients meeting the recommended threshold for pursuing early invasive strategy according to the different GRACE scores. The single best test to detect MIs is the ESC 0/1 h-algorithm. Combining GRACE risk scoring with hs-cTn testing slightly increases the detection of MIs but also increases the number of patients with false positive results who would undergo potential unnecessarily early invasive coronary angiography.


Subject(s)
Acute Coronary Syndrome , Myocardial Infarction , Humans , Troponin , Acute Coronary Syndrome/diagnosis , Coronary Angiography , Risk Assessment/methods , Myocardial Infarction/diagnosis
5.
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
6.
JAMA Cardiol ; 8(9): 827-834, 2023 09 01.
Article in English | MEDLINE | ID: mdl-37556123

ABSTRACT

Importance: Myocardial infarction is a frequent cause of out-of-hospital cardiac arrest (OHCA). The long-term effect of early coronary angiography on patients with OHCA with possible coronary trigger but no ST-segment elevation remains unclear. Objective: To compare the clinical outcomes of early unselective angiography with the clinical outcomes of a delayed or selective approach for successfully resuscitated patients with OHCA of presumed cardiac origin without ST-segment elevation at 1-year follow-up. Design, Setting, and Participants: The TOMAHAWK trial was a multicenter, international (Germany and Denmark), investigator-initiated, open-label, randomized clinical trial enrolling 554 patients between November 23, 2016, to September 20, 2019. Patients with stable return of spontaneous circulation after OHCA of presumed cardiac origin but without ST-segment elevation on the postresuscitation electrocardiogram were eligible for inclusion. A total of 554 patients were randomized to either immediate coronary angiography after hospital admission or an initial intensive care assessment with delayed or selective angiography after a minimum of 24 hours. All 554 patients were included in survival analyses during the follow-up period of 1 year. Secondary clinical outcomes were assessed only for participants alive at 1 year to account for the competing risk of death. Interventions: Early vs delayed or selective coronary angiography and revascularization if indicated. Main Outcomes and Measures: Evaluations in this secondary analysis included all-cause mortality after 1 year, as well as severe neurologic deficit, myocardial infarction, and rehospitalization for congestive heart failure in survivors at 1 year. Results: A total of 281 patients were randomized to the immediate angiography group and 273 to the delayed or selective group, with a median age of 70 years (IQR, 60-78 years). A total of 369 of 530 patients (69.6%) were male, and 268 of 483 patients (55.5%) had a shockable arrest rhythm. At 1 year, all-cause mortality was 60.8% (161 of 265) in the immediate angiography group and 54.3% (144 of 265) in the delayed or selective angiography group without significant difference between the treatment strategies, trending toward an increase in mortality with immediate angiography (hazard ratio, 1.25; 95% CI, 0.99-1.57; P = .05). For patients surviving until 1 year, the rates of severe neurologic deficit, myocardial infarction, and rehospitalization for congestive heart failure were similar between the groups. Conclusions and Relevance: This study found that a strategy of immediate coronary angiography does not provide clinical benefit compared with a delayed or selective invasive approach for patients 1 year after resuscitated OHCA of presumed coronary cause and without ST-segment elevation. Trial Registration: ClinicalTrials.gov Identifier: NCT02750462.


Subject(s)
Heart Failure , Myocardial Infarction , Out-of-Hospital Cardiac Arrest , Humans , Male , Middle Aged , Aged , Female , Coronary Angiography/adverse effects , Out-of-Hospital Cardiac Arrest/diagnostic imaging , Out-of-Hospital Cardiac Arrest/therapy , Hospitalization , Myocardial Infarction/complications , Heart Failure/complications
7.
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
9.
Clin Res Cardiol ; 112(7): 923-941, 2023 Jul.
Article in English | MEDLINE | ID: mdl-36884078

ABSTRACT

The German Centre for Cardiovascular Research (DZHK) is one of the German Centres for Health Research and aims to conduct early and guideline-relevant studies to develop new therapies and diagnostics that impact the lives of people with cardiovascular disease. Therefore, DZHK members designed a collaboratively organised and integrated research platform connecting all sites and partners. The overarching objectives of the research platform are the standardisation of prospective data and biological sample collections among all studies and the development of a sustainable centrally standardised storage in compliance with general legal regulations and the FAIR principles. The main elements of the DZHK infrastructure are web-based and central units for data management, LIMS, IDMS, and transfer office, embedded in a framework consisting of the DZHK Use and Access Policy, and the Ethics and Data Protection Concept. This framework is characterised by a modular design allowing a high standardisation across all studies. For studies that require even tighter criteria additional quality levels are defined. In addition, the Public Open Data strategy is an important focus of DZHK. The DZHK operates as one legal entity holding all rights of data and biological sample usage, according to the DZHK Use and Access Policy. All DZHK studies collect a basic set of data and biosamples, accompanied by specific clinical and imaging data and biobanking. The DZHK infrastructure was constructed by scientists with the focus on the needs of scientists conducting clinical studies. Through this, the DZHK enables the interdisciplinary and multiple use of data and biological samples by scientists inside and outside the DZHK. So far, 27 DZHK studies recruited well over 11,200 participants suffering from major cardiovascular disorders such as myocardial infarction or heart failure. Currently, data and samples of five DZHK studies of the DZHK Heart Bank can be applied for.


Subject(s)
Biological Specimen Banks , Humans , Prospective Studies
10.
Clin Res Cardiol ; 112(5): 614-625, 2023 May.
Article in English | MEDLINE | ID: mdl-36749418

ABSTRACT

BACKGROUND: Large-bore arteriotomies can be percutaneously closed with suture-based or plug-based vascular closure device (VCD) strategies. The efficacy of both techniques remains controversial. AIMS: We conducted a meta-analysis of comparative studies between both VCD strategies, focusing on the most commonly applied VCDs (MANTA and ProGlide). METHODS: We searched MEDLINE, the Cochrane Central Register of Controlled Trials and Google scholar for observational studies (OS) and randomized controlled trials (RCT) comparing vascular closure with the MANTA-based and the ProGlide-based technique. The principal endpoint of this analysis was access-site related vascular complications. Both study types were analyzed separately. RESULTS: Access-site related vascular complications were less frequent after vascular closure with the MANTA technique in the analysis of OS (RR 0.61 [95%CI 0.43-0.89], p = 0.01, I2 = 0%), but more frequent in the analysis of RCT data (RR 1.70 [95%CI 1.16-2.51], p = 0.01, I2 = 0%). Both data sets provided no significant difference between the VCD techniques in terms of overall bleeding events (OS: RR 0.57 [95%CI 0.32-1.02], p = 0.06, I2 = 70%; and RCT: RR 1.37 [95%CI 0.82-2.28], p = 0.23, I2 = 30%). RCT data showed that endovascular stenting or vascular surgery due to VCD failure occurred more often after MANTA application (RR 3.53 [95%CI 1.07-11.33], p = 0.04, I2 = 0%). CONCLUSIONS: While OS point to favorable outcomes for large-bore vascular closure with the MANTA-based technique, RCT data show that this strategy is associated with more access-site related vascular complications as well as endovascular stenting or vascular surgery due to device failure compared with the ProGlide-based technique.


Subject(s)
Cardiovascular Diseases , Vascular Closure Devices , Humans , Cardiovascular Diseases/complications , Femoral Artery/surgery , Hemorrhage/epidemiology , Hemorrhage/etiology , Hemorrhage/prevention & control , Hemostatic Techniques/adverse effects , Treatment Outcome , Vascular Closure Devices/adverse effects , Vascular Surgical Procedures , Observational Studies as Topic , Randomized Controlled Trials as Topic
11.
Clin Res Cardiol ; 112(1): 75-86, 2023 Jan.
Article in English | MEDLINE | ID: mdl-35648271

ABSTRACT

BACKGROUND: Hospitalizations for acute decompensated heart failure (ADHF) are commonly associated with congestion-related signs and symptoms. Objective and quantitative markers of congestion have been identified, but there is limited knowledge regarding the correlation between these markers. METHODS: Patients hospitalized for ADHF irrespective of left ventricular ejection fraction were included in a prospective registry. Assessment of congestion markers (e.g., NT-proBNP, maximum inferior vena cava diameter, dyspnea using visual analogue scale, and a clinical congestion score) was performed systematically on admission and at discharge. Telephone interviews were performed to assess clinical events, i.e., all-cause death or readmission for cardiovascular cause, after discharge. Missing values were handled by multiple imputation. RESULTS: In total, 130 patients were prospectively enrolled. Median length of hospitalization was 9 days (interquartile range 6 to 16). All congestion markers declined from admission to discharge (p < 0.001). No correlation between the congestion markers could be identified, neither on admission nor at discharge. The composite endpoint of all-cause death or readmission for cardiovascular cause occurred in 46.2% of patients. Only NT-proBNP at discharge was predictive for this outcome (hazard ratio 1.48, 95% confidence interval 1.15 to 1.90, p = 0.002). CONCLUSION: No correlation between quantitative congestion markers was observed. Only NT-proBNP at discharge was significantly associated with the composite endpoint of all-cause death or readmission for cardiovascular cause. Findings indicate that the studied congestion markers reflect different aspects of congestion.


Subject(s)
Heart Failure , Ventricular Function, Left , Humans , Stroke Volume , Prospective Studies , Heart Failure/diagnosis , Hospitalization , Natriuretic Peptide, Brain , Peptide Fragments , Prognosis , Biomarkers
12.
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
13.
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
14.
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
15.
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
18.
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
19.
EuroIntervention ; 16(16): 1359-1365, 2021 Mar 19.
Article in English | MEDLINE | ID: mdl-33046436

ABSTRACT

AIMS: The aim of this meta-analysis was to compare general anaesthesia (GA) and deep sedation (DS) with regard to safety and length of intensive care unit (ICU) stay in patients undergoing percutaneous edge-to-edge mitral valve repair (PMVR). METHODS AND RESULTS: Four studies comparing GA and DS in patients undergoing PMVR were included in an individual patient data meta-analysis. Data were pooled after multiple imputation. The composite safety endpoint of all-cause death, stroke, pneumonia, or major to life-threatening bleeding occurred in 87 of 626 (13.9%) patients with no difference between patients treated with DS as compared to GA (56 and 31 events in 420 and 206 patients, respectively). In this regard, the odds ratio (OR) was 1.27 (95% confidence interval [CI]: 0.78 to 2.09; p=0.338) and 1.26 (95% CI: 0.49 to 3.22; p=0.496) following the one-stage and two-stage approach, respectively. Length of ICU stay was longer after GA as compared to DS (ratio of days 3.08, 95% CI: 2.18 to 4.36, p<0.001, and 2.88, 95% CI: 1.45 to 5.73, p=0.016, following the one-stage and two-stage approach, respectively). CONCLUSIONS: Both DS and GA might offer a similar safety profile. However, ICU stay seems to be shorter after DS.


Subject(s)
Deep Sedation , Mitral Valve , Anesthesia, General/adverse effects , Humans , Length of Stay , Mitral Valve/surgery , Time Factors , Treatment Outcome
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