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1.
Int J Cardiol ; 347: 83-88, 2022 Jan 15.
Artigo em Inglês | MEDLINE | ID: mdl-34767896

RESUMO

BACKGROUND: Cardiac magnetic resonance (CMR) imaging provides valuable prognostic information in patients with ST-elevation myocardial infarction (STEMI). The peri-infarct zone (PIZ) is a potential marker for post-infarction risk stratification. The aim of this study was to assess the prognostic impact of PIZ in a large multicenter STEMI-trial. METHODS: The study population consisted of 704 consecutive patients undergoing CMR within 10 days after STEMI to assess established parameters of myocardial injury and additionally the extent of PIZ. The primary clinical endpoint was major adverse cardiac events (MACE) consisting of death, re-infarction and new congestive heart failure within 1 year after infarction. RESULTS: The median heterogeneous PIZ-volume in the overall population was 14 ml (interquartile range [IQR] 7 to 24 ml). Male sex, infarct size, and left ventricular ejection fraction were identified as independent predictors of larger PIZ alterations. Patients with MACE had a significantly larger PIZ volume compared to patients without adverse events (21 ml [IQR 12 to 35 ml] versus 14 ml [IQR 7 to 23 ml]; p = 0.001). In stepwise multivariable Cox regression analysis, PIZ > median (>14 ml) emerged as an independent predictor of MACE (hazard ratio [HR] 2.84; 95% confidence interval [CI] 1.34 to 6.00; p = 0.006) in addition to the Thrombolysis In Myocardial Infarction (TIMI) risk score (HR 1.53; 95% CI 1.19 to 1.53; p < 0.001). Addition of PIZ to a CMR risk model comprising LVEF, infarct size and microvascular obstruction resulted in net reclassification improvement of 0.46 (0.19-0.73, p < 0.001). CONCLUSION: In this currently largest prospective, multicenter CMR study assessing PIZ, the extent of PIZ emerged as an independent predictor of MACE and a potential novel marker for optimized risk stratification in STEMI patients. ClinicalTrials.gov: NCT00712101.

2.
ESC Heart Fail ; 2021 Nov 15.
Artigo em Inglês | MEDLINE | ID: mdl-34783164

RESUMO

AIMS: To evaluate outcomes of percutaneous left atrial appendage closure (LAAC) in patients with congestive heart failure (CHF) and non-valvular atrial fibrillation (AF) in a consecutive, industry-independent registry associated with periprocedural success and complications during long-term follow-up. METHODS AND RESULTS: For this analysis, we included patients who underwent transcatheter LAAC from January 2014 to December 2019 at the University Heart Center in Lübeck, Germany, and compared patients with presence of CHF defined as patients with a reduced left ventricular ejection fraction (LVEF ≤ 40%), patients with a mid-range LVEF (LVEF 41-49%), patients with diastolic dysfunction and preserved LVEF (LVEF ≥ 50%), and patients with right-sided heart failure and impaired right ventricular function (tricuspid annular plane systolic excursion < 17) to patients undergoing LAAC with no CHF. Primary endpoints were defined as periprocedural complications, and complications during long-term follow-up presented as major adverse cardiac and cerebrovascular events (MACCE). A total of 300 consecutive patients underwent LAAC. Of these, 96 patients in the CHF group were compared with 204 patients in the non-CHF group. Implantation success was lower in CHF group in comparison with non-CHF group (99.5% vs. 96%, P = 0.038); otherwise, there were no differences in periprocedural complications between groups. Patients with CHF showed a significantly higher incidence of MACCE rate (31.9% vs. 15.1%, P = 0.002) and more deaths (24.2% vs. 7%, P ≤ 0.001) during long-term follow-up. In Cox multivariable regression analysis, CHF was an independent predictor of mortality after LAAC implantation at long-term follow-up (hazard ratio 3.23, 95% confidence intervals 1.52-6.86, P = 0.002). CONCLUSIONS: Implantation of LAAC devices in patients with non-valvular AF and CHF is safe. The increased mortality in patients with CHF compared with patients without CHF during the long-term follow-up is mainly attributed to comorbidities associated with CHF.

3.
J Am Heart Assoc ; 10(20): e021150, 2021 10 19.
Artigo em Inglês | MEDLINE | ID: mdl-34622680

RESUMO

Background Little is known about the impact of center volume on outcomes in acute myocardial infarction complicated by cardiogenic shock. The aim of this study was to investigate the association between center volume, treatment strategies, and subsequent outcome in patients with acute myocardial infarction complicated by cardiogenic shock. Methods and Results In this subanalysis of the randomized CULPRIT-SHOCK (Culprit Lesion Only PCI Versus Multivessel PCI in Cardiogenic Shock) trial, study sites were categorized based on the annual volume of acute myocardial infarction complicated by cardiogenic shock into low-/intermediate-/high-volume centers (<50; 50-100; and >100 cases/y). Subjects from the study/compulsory registry with available volume data were included. Baseline/procedural characteristics, overall treatment, and 1-year all-cause mortality were compared across categories. n=1032 patients were included in this study (537 treated at low-volume, 240 at intermediate-volume, and 255 at high-volume centers). Baseline risk profile of patients across the volume categories was similar, although high-volume centers included a larger number of older patients. Low-/intermediate-volume centers had more resuscitated patients (57.5%/58.8% versus 42.2%; P<0.01), and more patients on mechanical ventilation in comparison to high-volume centers. There were no differences in reperfusion success despite considerable differences in adjunctive pharmacological/device therapies. There was no difference in 1-year all-cause mortality across volume categories (51.1% versus 56.5% versus 54.4%; P=0.34). Conclusions In this study of patients with acute myocardial infarction complicated by cardiogenic shock, considerable differences in adjunctive medical and mechanical support therapies were observed. However, we could not detect an impact of center volume on reperfusion success or mortality.

4.
Int J Cardiol Heart Vasc ; 37: 100893, 2021 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-34712772

RESUMO

Background: Data reporting a head-to-head comparison between Amulet and Watchman devices are scarce. The aim of this study was to compare the Watchman™ versus Amulet™ left atrial appendage closure (LAAC) devices in a consecutive, industry-independent registry. Methods: Patients who underwent LAAC using Watchman or Amulet devices from January 2014 to December 2019 at the University Heart Center Lübeck, Lübeck, Germany were included in the present analysis. Primary endpoints included periprocedural complications (in-hospital death, pericardial tamponade, device embolization, stroke, major bleeding and vascular access complications), and complications during long-term follow-up (ischemic stroke, hemorrhagic stroke, thromboembolism, device thrombus, bleeding and death). Results: After matching the patients for age (±5 years), gender, CHA2DS2Vasc score (±1) and HASBLED score (±1), each of the Watchman and the Amulet groups included 113 patients. Patients in the Amulet group had significantly more periprocedural complications (2.7% vs 10.6%, p = 0.029; respectively) and more major bleeding complications (0% vs 5.3%, p = 0.029; respectively). During long-term follow-up, the rate of events was comparable between the Watchman and Amulet groups (18.3% versus 20.8%, p = 0.729; respectively). Conclusion: Amulet LAAC device was associated with increased periprocedural complications as compared to Watchman LAAC device. On long-term follow-up, both devices showed comparable efficacy and safety.

5.
Eur Heart J Acute Cardiovasc Care ; 10(8): 890-897, 2021 Oct 27.
Artigo em Inglês | MEDLINE | ID: mdl-34529043

RESUMO

AIMS: Several prediction models have been developed to allow accurate risk assessment and provide better treatment guidance in patients with infarct-related cardiogenic shock (CS). However, comparative data between these models are still scarce. The objective of the study is to externally validate different risk prediction models in infarct-related CS and compare their predictive value in the early clinical course. METHODS AND RESULTS: The Simplified Acute Physiology Score (SAPS) II Score, the CardShock score, the IABP-SHOCK II score, and the Society for Cardiovascular Angiography and Intervention (SCAI) classification were each externally validated in a total of 1055 patients with infarct-related CS enrolled into the randomized CULPRIT-SHOCK trial or the corresponding registry. The primary outcome was 30-day all-cause mortality. Discriminative power was assessed by comparing the area under the curves (AUC) in case of continuous scores. In direct comparison of the continuous scores in a total of 161 patients, the IABP-SHOCK II score revealed best discrimination [area under the curve (AUC = 0.74)], followed by the CardShock score (AUC = 0.69) and the SAPS II score, giving only moderate discrimination (AUC = 0.63). All of the three scores revealed acceptable calibration by Hosmer-Lemeshow test. The SCAI classification as a categorical predictive model displayed good prognostic assessment for the highest risk group (Stage E) but showed poor discrimination between Stages C and D with respect to short-term-mortality. CONCLUSION: Based on the present findings, the IABP-SHOCK II score appears to be the most suitable of the examined models for immediate risk prediction in infarct-related CS. Prospective evaluation of the models, further modification, or even development of new scores might be necessary to reach higher levels of discrimination.


Assuntos
Choque Cardiogênico , Humanos , Prognóstico , Sistema de Registros , Medição de Risco , Choque Cardiogênico/diagnóstico , Choque Cardiogênico/etiologia
6.
N Engl J Med ; 2021 Aug 29.
Artigo em Inglês | MEDLINE | ID: mdl-34459570

RESUMO

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.).

7.
Clin Res Cardiol ; 110(9): 1493-1503, 2021 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-33999281

RESUMO

AIMS: The aim of this pooled sub-analysis of the Intraaortic Balloon Pump in Cardiogenic Shock II (IABP-SHOCK II) and Culprit Lesion Only PCI versus Multivessel PCI in Cardiogenic Shock (CULPRIT-SHOCK) trial was to compare the clinical outcome of patients with acute myocardial infarction complicated by cardiogenic shock treated either with clopidogrel or the newer, more potent ADP-receptor antagonists prasugrel or ticagrelor. METHODS AND RESULTS: For the current analysis the primary endpoint was 1-year mortality and the secondary safety endpoint was moderate or severe bleedings until hospital discharge with respect to three different ADP-receptor antagonists. 856 patients were eligible for analysis. Of these, 507 patients (59.2%) received clopidogrel, 178 patients (20.8%) prasugrel and 171 patients (20.0%) ticagrelor as acute antiplatelet therapy. The adjusted rate of mortality after 1-year did not differ significantly between prasugrel and clopidogrel (hazard ratio [HR]: 0.81, 95% confidence interval [CI] 0.60-1.09, padj = 0.17) or between ticagrelor and clopidogrel treated patients (HR: 0.86, 95% CI 0.65-1.15, padj = 0.31). In-hospital bleeding events were significantly less frequent in patients treated with ticagrelor vs. clopidogrel (HR: 0.37, 95% CI 0.20 -0.69, padj = 0.002) and not significantly different in patients treated with prasugrel vs. clopidogrel (HR: 0.73, 95% CI 0.43 -1.24, padj = 0.24). CONCLUSION: This pooled sub-analysis is the largest analysis on safety and efficacy of three oral ADP-receptor antagonists and shows that acute therapy with either clopidogrel, prasugrel or ticagrelor is no independent predictor of 1-year mortality. Treatment with ticagrelor seems independently associated with less in-hospital moderate and severe bleeding events compared to clopidogrel. This finding might be due to selection bias and should be interpreted with caution.

8.
J Am Heart Assoc ; 10(9): e018881, 2021 05 04.
Artigo em Inglês | MEDLINE | ID: mdl-33899498

RESUMO

Background Intravenous morphine administration can adversely affect platelet inhibition induced by P2Y12 receptor inhibitors after acute myocardial infarction. In contrast, some evidence suggests that opioid agonists may have cardioprotective effects on the myocardium. The aim of this prospective, randomized MonAMI (Impact of Morphine Treatment With and Without Metoclopramide Coadministration on Platelet Inhibition in Acute Myocardial Infarction) trial was, therefore, to investigate the impact of morphine with or without metoclopramide coadministration on myocardial and microvascular injury. Methods and Results Patients with acute myocardial infarction (n=138) were assigned in a 1:1:1 ratio to ticagrelor 180 mg plus: (1) intravenous morphine 5 mg (morphine group); (2) intravenous morphine 5 mg and metoclopramide 10 mg (morphine+metoclopramide group); or (3) intravenous placebo (control group) administered before primary percutaneous coronary intervention. Cardiac magnetic resonance imaging was performed in 104 patients on day 1 to 4 after the index event. Infarct size was significantly smaller in the morphine only group as compared with controls (percentage of left ventricular mass, 15.5 versus 17.9; P=0.047). Furthermore, the number of patients with microvascular obstruction was significantly lower after morphine administration (28% versus 54%; P=0.022) and the extent of microvascular obstruction was smaller (percentage of left ventricular mass, 0 versus 0.74; P=0.037). In multivariable regression analysis, morphine administration was independently associated with a reduced risk for the occurrence of microvascular obstruction (odds ratio, 0.37; 95% CI, 0.14-0.93 [P=0.035]). There was no significant difference in infarct size (P=0.491) and extent (P=0.753) or presence (P=0.914) of microvascular obstruction when comparing the morphine+metoclopramide group with the control group. Conclusions In this randomized study, intravenous administration of morphine before primary percutaneous coronary intervention resulted in a significant reduction of myocardial and microvascular damage following acute myocardial infarction. This effect was not observed in the morphine plus metoclopramide group. Registration URL: https://www.clinicaltrials.gov; Unique identifier: NCT02627950.


Assuntos
Circulação Coronária/fisiologia , Metoclopramida/administração & dosagem , Microcirculação/efeitos dos fármacos , Morfina/administração & dosagem , Traumatismo por Reperfusão/prevenção & controle , Infarto do Miocárdio com Supradesnível do Segmento ST/tratamento farmacológico , Vasoconstrição/efeitos dos fármacos , Idoso , Analgésicos Opioides/administração & dosagem , Angiografia Coronária , Antagonistas dos Receptores de Dopamina D2/administração & dosagem , Relação Dose-Resposta a Droga , Quimioterapia Combinada , Feminino , Seguimentos , Humanos , Imagem Cinética por Ressonância Magnética/métodos , Masculino , Microcirculação/fisiologia , Pessoa de Meia-Idade , Estudos Prospectivos , Traumatismo por Reperfusão/diagnóstico , Traumatismo por Reperfusão/fisiopatologia , Infarto do Miocárdio com Supradesnível do Segmento ST/diagnóstico , Infarto do Miocárdio com Supradesnível do Segmento ST/fisiopatologia , Método Simples-Cego
9.
Eur Heart J ; 42(24): 2344-2352, 2021 06 21.
Artigo em Inglês | MEDLINE | ID: mdl-33647946

RESUMO

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.


Assuntos
Infarto do Miocárdio , Choque Cardiogênico , Cistatina C , Humanos , Interleucina-6 , Balão Intra-Aórtico , Ácido Láctico , Infarto do Miocárdio/complicações , Peptídeo Natriurético Encefálico , Estudos Prospectivos , Fatores de Risco , Choque Cardiogênico/etiologia
10.
ESC Heart Fail ; 8(2): 953-961, 2021 04.
Artigo em Inglês | MEDLINE | ID: mdl-33560591

RESUMO

AIMS: The mortality in cardiogenic shock (CS) is high. The role of specific mechanical circulatory support (MCS) systems is unclear. We aimed to compare patients receiving Impella versus ECLS (extracorporal life support) with regard to baseline characteristics, feasibility, and outcomes in CS. METHODS AND RESULTS: This is a retrospective cohort study including CS patients over 18 years with a complete follow-up of the primary endpoint and available baseline lactate level, receiving haemodynamic support either by Impella 2.5 or ECLS from two European registries. The decision for device implementation was made at the discretion of the treating physician. The primary endpoint of this study was all-cause mortality at 30 days. A propensity score for the use of Impella was calculated, and multivariable logistic regression was used to obtain adjusted odds ratios (aOR). In total, 149 patients were included, receiving either Impella (n = 73) or ECLS (n = 76) for CS. The feasibility of device implantation was high (87%) and similar (aOR: 3.14; 95% CI: 0.18-56.50; P = 0.41) with both systems. The rates of vascular injuries (aOR: 0.95; 95% CI: 0.10-3.50; P = 0.56) and bleedings requiring transfusions (aOR: 0.44; 95% CI: 0.09-2.10; P = 0.29) were similar in ECLS patients and Impella patients. The use of Impella or ECLS was not associated with increased odds of mortality (aOR: 4.19; 95% CI: 0.53-33.25; P = 0.17), after correction for propensity score and baseline lactate level. Baseline lactate level was independently associated with increased odds of 30 day mortality (per mmol/L increase; OR: 1.29; 95% CI: 1.14-1.45; P < 0.001). CONCLUSIONS: In CS patients, the adjusted mortality rates of both ECLS and Impella were high and similar. The baseline lactate level was a potent predictor of mortality and could play a role in patient selection for therapy in future studies. In patients with profound CS, the type of device is likely to be less important compared with other parameters including non-cardiac and neurological factors.


Assuntos
Coração Auxiliar , Choque Cardiogênico , Humanos , Pontuação de Propensão , Estudos Retrospectivos , Choque Cardiogênico/terapia , Resultado do Tratamento
12.
Am Heart J ; 234: 1-11, 2021 04.
Artigo em Inglês | MEDLINE | ID: mdl-33428901

RESUMO

BACKGROUND: In acute myocardial infarction complicated by cardiogenic shock the use of mechanical circulatory support devices remains controversial and data from randomized clinical trials are very limited. Extracorporeal life support (ECLS) - venoarterial extracorporeal membrane oxygenation - provides the strongest hemodynamic support in addition to oxygenation. However, despite increasing use it has not yet been properly investigated in randomized trials. Therefore, a prospective randomized adequately powered clinical trial is warranted. STUDY DESIGN: The ECLS-SHOCK trial is a 420-patient controlled, international, multicenter, randomized, open-label trial. It is designed to compare whether treatment with ECLS in addition to early revascularization with percutaneous coronary intervention or alternatively coronary artery bypass grafting and optimal medical treatment is beneficial in comparison to no-ECLS in patients with severe infarct-related cardiogenic shock. Patients will be randomized in a 1:1 fashion to one of the two treatment arms. The primary efficacy endpoint of ECLS-SHOCK is 30-day mortality. Secondary outcome measures such as hemodynamic, laboratory, and clinical parameters will serve as surrogate endpoints for prognosis. Furthermore, a longer follow-up at 6 and 12 months will be performed including quality of life assessment. Safety endpoints include peripheral ischemic vascular complications, bleeding and stroke. CONCLUSIONS: The ECLS-SHOCK trial will address essential questions of efficacy and safety of ECLS in addition to early revascularization in acute myocardial infarction complicated by cardiogenic shock.


Assuntos
Oxigenação por Membrana Extracorpórea , Infarto do Miocárdio/terapia , Revascularização Miocárdica/métodos , Ponte de Artéria Coronária/métodos , Oxigenação por Membrana Extracorpórea/efeitos adversos , Oxigenação por Membrana Extracorpórea/métodos , Fibrinolíticos/uso terapêutico , Humanos , Infarto do Miocárdio/complicações , Infarto do Miocárdio/mortalidade , Prognóstico , Estudos Prospectivos , Qualidade de Vida , Tamanho da Amostra , Choque Cardiogênico/etiologia , Choque Cardiogênico/mortalidade
13.
Am Heart J ; 232: 185-193, 2021 02.
Artigo em Inglês | MEDLINE | ID: mdl-33253678

RESUMO

BACKGROUND: The impact of coronary artery chronic total occlusion (CTO) and its management with percutaneous coronary intervention (PCI) in the setting of myocardial infarction (MI) related cardiogenic shock (CS) remains unclear. METHODS: This is a pre-specified analysis from the culprit-lesion-only PCI vs multivessel PCI in CS (CULPRIT-SHOCK) trial which randomized patients presenting with MI and multivessel disease complicated by CS to a culprit-lesion-only or immediate multivessel PCI strategy. CTO was defined by central core-laboratory evaluation. The independent associations between the presence of CTO and adverse outcomes at 30 days and 1 year were assessed using multivariate logistics models. RESULTS: A noninfarct related CTO was present in 157 of 667 (23.5%) analyzed patients. Patients presenting with CTO had more frequent diabetes mellitus or prior PCI but less frequently presented with ST segment elevation MI as index event. The presence of CTO was associated with higher rate of death at 30 days (adjusted Odds ratio 1.63; 95% confidence interval [CI] 1.01-2.60). Rate of death at 1 year was also increased but did not reach statistical significance (adjusted Odds ratio 1.62; 95%CI 0.99-2.66). Compare to immediate multivessel PCI, a strategy of culprit-lesion-only PCI was associated with lower rates of death or renal replacement therapy at 30 days in patients with and without CTO (Odds ratio 0.79 95%CI 0.42-1.49 and Odds ratio 0.67 95%CI 0.48-0.96, respectively), without significant interaction (P = .68). CONCLUSIONS: In patients with MI-related CS and multivessel disease, the presence of CTO is associated with adverse outcomes while a strategy of culprit-lesion-only PCI seems beneficial regardless of the presence of CTO.


Assuntos
Oclusão Coronária/cirurgia , Estenose Coronária/cirurgia , Infarto do Miocárdio/cirurgia , Intervenção Coronária Percutânea/métodos , Choque Cardiogênico/terapia , Idoso , Idoso de 80 Anos ou mais , Causas de Morte , Doença Crônica , Oclusão Coronária/complicações , Estenose Coronária/complicações , Feminino , Humanos , Modelos Logísticos , Masculino , Pessoa de Meia-Idade , Mortalidade , Análise Multivariada , Infarto do Miocárdio/complicações , Prognóstico , Terapia de Substituição Renal/estatística & dados numéricos , Choque Cardiogênico/etiologia , Resultado do Tratamento
14.
JACC Cardiovasc Interv ; 13(19): 2208-2216, 2020 10 12.
Artigo em Inglês | MEDLINE | ID: mdl-33032708

RESUMO

OBJECTIVES: This study sought to compare single lactate values at admission (L1) and after 8 h (L2) with lactate clearance (LC) for mortality prediction in cardiogenic shock (CS). BACKGROUND: Early estimation of prognosis in CS complicating acute myocardial infarction is crucial for tailored treatment selection. Arterial lactate is the most widely used point-of-care parameter in CS. In septic shock, lactate reduction over time-LC-has been extensively investigated. However, in CS, only limited data exist, and the prognostic value of LC is unknown. METHODS: This study is a subanalysis of the IABP-SHOCK II (Intraaortic Balloon Pump in Cardiogenic Shock II) trial and the corresponding registry. Lactate levels were prospectively collected. All-cause mortality at 30 days was assessed as primary endpoint. RESULTS: For 671 of 783 (85.7%) patients, L1 and L2 values were available. The area under the receiver-operating characteristic curve (L1: 0.69; L2: 0.76; LC: 0.59) showed no difference between L1 and LC (p = 0.20). In contrast, L2 was a significantly better predictive parameter than L1 or LC (p < 0.001 for both). In multivariable stepwise Cox regression analysis, L2 ≥3.1 mmol/l (best cutoff value by Youden index) and LC <-3.45%/h remained independently predictive for time to death (p < 0.001 for both), with L2 showing the highest chi-square test score (42.1) and hazard ratio (2.89; 95% confidence interval: 2.10 to 3.97). CONCLUSIONS: Arterial lactate after 8 h is superior in mortality prediction in comparison with baseline lactate and LC. A cutoff value of 3.1 mmol/l for lactate after 8 h showed the best discrimination for assessing early prognosis in CS and may serve as new treatment goal. (Intraaortic Balloon Pump in Cardiogenic Shock II [IABP-SHOCK II]; NCT00491036).


Assuntos
Choque Cardiogênico , Humanos , Balão Intra-Aórtico , Ácido Láctico , Prognóstico , Resultado do Tratamento
15.
Circ Cardiovasc Interv ; 13(9): e009562, 2020 09.
Artigo em Inglês | MEDLINE | ID: mdl-32883104

RESUMO

BACKGROUND: The management of patients with acute myocardial infarction complicated by cardiogenic shock is highly complex, and outcomes may depend on the time of hospital admission and subsequent intervention (ie, ON-hours versus OFF-hours). The CULPRIT-SHOCK trial (Culprit Lesion Only PCI Versus Multivessel PCI in Cardiogenic Shock) demonstrated superior outcome for culprit-lesion-only versus immediate multivessel percutaneous coronary intervention in patients presenting with acute myocardial infarction, multivessel disease, and cardiogenic shock. However, it is unknown whether the time of hospital admission affects the overall outcome of these high-risk patients. METHODS: We analyzed patients from the CULPRIT-SHOCK trial with respect to the time of hospital admission. We divided patients in ON-hours and OFF-hours groups and further stratified them according to their individual revascularization strategy. Outcome measures consisted of a composite end point of death or renal-replacement therapy within 30 days and mortality within 1 year. RESULTS: Out of 686 patients randomized in the CULPRIT-SHOCK trial, 444 patients (64.7%) presented during ON-hours, whereas 242 patients (35.3%) presented during OFF-hours. Death or renal-replacement therapy at 30 days occurred to a similar extent in patients admitted during ON-hours (51.0%) and OFF-hours (50.0%; P=0.80). Similarly, 1-year mortality was not affected by the time of hospital admission (54.4% ON-hours versus 51.7% OFF-hours, P=0.49). Regardless of admission time, patients had a benefit from culprit-lesion-only as compared to immediate multivessel percutaneous coronary intervention. The composite end point at 30 days occurred in 45.1% versus 57.6% of patients admitted ON-hours and in 47.7% versus 51.9% of patients admitted OFF-hours (Pinteraction=0.29). Death within 1 year occurred in 49.4% versus 60.0% of patients admitted during ON-hours and in 51.4% versus 51.9% of patients admitted OFF-hours (Pinteraction=0.20). CONCLUSIONS: Among patients with myocardial infarction and cardiogenic shock, the risk of death or renal-replacement therapy at 30 days, and mortality at 1 year did not differ significantly according to the time of hospital admission. Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT01927549.


Assuntos
Plantão Médico , Infarto do Miocárdio/terapia , Admissão do Paciente , Intervenção Coronária Percutânea , Choque Cardiogênico/terapia , Idoso , Idoso de 80 Anos ou mais , Europa (Continente) , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio/complicações , Infarto do Miocárdio/diagnóstico , Infarto do Miocárdio/mortalidade , Intervenção Coronária Percutânea/efeitos adversos , Intervenção Coronária Percutânea/mortalidade , Medição de Risco , Fatores de Risco , Choque Cardiogênico/diagnóstico , Choque Cardiogênico/etiologia , Choque Cardiogênico/mortalidade , Fatores de Tempo , Tempo para o Tratamento , Resultado do Tratamento
16.
JAMA Cardiol ; 5(12): 1329-1337, 2020 Dec 01.
Artigo em Inglês | MEDLINE | ID: mdl-32845312

RESUMO

Importance: Myocardial infarction with a culprit lesion located in the left main or proximal left anterior descending artery compared with other coronary segments is associated with more myocardium at risk and worse clinical outcomes. Objective: To evaluate the association of culprit lesion location with outcomes of culprit-lesion-only percutaneous coronary intervention with optional staged revascularization vs immediate multivessel percutaneous coronary intervention in patients with multivessel disease, myocardial infarction, and cardiogenic shock. Design, Setting, and Participants: Post hoc analysis of the Culprit Lesion Only Coronary Intervention vs Multivessel Coronary Intervention in Cardiogenic Shock (CULPRIT-SHOCK), an investigator-initiated randomized, open-label clinical trial. Patients with multivessel disease, acute myocardial infarction, and cardiogenic shock were enrolled at 83 European centers from April 2013 through April 2017. Interventions: Patients were randomized to culprit-lesion-only percutaneous coronary intervention with optional staged revascularization or immediate multivessel percutaneous coronary intervention (1:1). For this analysis, patients were stratified by culprit lesion location in the left main or proximal left anterior descending artery group and other-culprit-lesion location group. Main Outcomes and Measures: End points included a composite of death or kidney replacement therapy at 30 days and death at 1 year. Results: The median age of the study population was 70 (interquartile range, 60-78 years) and 524 of the study participants were men (76.4%). Of the 685 patients, 33.4% constituted the left main or proximal left anterior descending artery group and 66.6% the other-culprit-lesion location group. The left main or proximal left anterior descending artery group had worse outcomes compared with the other-culprit-lesion location group (56.8% vs 47.5%; P = .02 for the composite end point at 30 days and 59.8% vs 50.1%; P = .02 for death at 1 year). In both groups, culprit-lesion-only vs immediate multivessel percutaneous coronary intervention was associated with a reduced risk of the composite end point at 30 days (49.1% vs 64.3% and 44.1% vs 50.9%; P for interaction = .27). At 1 year, culprit-lesion-only vs immediate multivessel percutaneous coronary intervention was associated with a significantly reduced risk of death in the left main or proximal left anterior descending artery but not the other-culprit-lesion location group (50.0% vs 69.6%; P = .003 and 49.8% vs 50.4%; P = .89; P for interaction = 0.02). Conclusions and Relevance: In patients with multivessel disease with myocardial infarction and cardiogenic shock, a culprit lesion located in the left main or proximal left anterior descending artery vs other coronary segments was associated with worse outcomes. These patients may especially benefit from culprit-lesion-only percutaneous coronary intervention with optional staged revascularization, although further investigation is needed to confirm this finding. Trial Registration: ClinicalTrials.gov Identifier: NCT01927549.

17.
J Clin Med ; 9(6)2020 Jun 24.
Artigo em Inglês | MEDLINE | ID: mdl-32599815

RESUMO

OBJECTIVES: To analyze the use and prognostic impact of active mechanical circulatory support (MCS) devices in a large prospective contemporary cohort of patients with cardiogenic shock (CS) complicating acute myocardial infarction (AMI). BACKGROUND: Although increasingly used in clinical practice, data on the efficacy and safety of active MCS devices in patients with CS complicating AMI are limited. METHODS: This is a predefined subanalysis of the CULPRIT-SHOCK randomized trial and prospective registry. Patients with CS, AMI and multivessel coronary artery disease were categorized in two groups: (1) use of at least one active MCS device vs. (2) no active MCS or use of intra-aortic balloon pump (IABP) only. The primary endpoint was a composite of all-cause death or renal replacement therapy at 30 days. RESULTS: Two hundred of 1055 (19%) patients received at least one active MCS device (n = 112 Impella®; n = 95 extracorporeal membrane oxygenation (ECMO); n = 6 other devices). The primary endpoint occurred significantly more often in patients treated with active MCS devices compared with those without active MCS devices (142 of 197, 72% vs. 374 of 827, 45%; p < 0.001). All-cause mortality and bleeding rates were significantly higher in the active MCS group (all p < 0.001). After multivariable adjustment, the use of active MCS was significantly associated with the primary endpoint (odds ratio (OR) 4.0, 95% confidence interval (CI) 2.7-5.9; p < 0.001). CONCLUSIONS: In the CULPRIT-SHOCK trial, active MCS devices were used in approximately one fifth of patients. Patients treated with active MCS devices showed worse outcome at 30 days and 1 year.

18.
J Invasive Cardiol ; 32(11): 422-426, 2020 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-32653865

RESUMO

INTRODUCTION: Patients after cardiac arrest (CA) treated with extracorporeal cardiopulmonary resuscitation (eCPR) evidence high mortality. Recently, women were reported to evidence even worse outcomes after CA. However, sex-specific data on CA patients treated with eCPR are lacking. We therefore aimed to evaluate potential sex differences in risk distribution, management, and outcomes in patients treated with eCPR. METHODS: Sixty-four patients - 16 females (25%) and 48 males (75%) - were included in this retrospective analysis. Two propensity scores were calculated on sex using multivariable logistic regression. Propensity score 1 included baseline characteristics only, and propensity score 2 included the previous variables plus pH as well as lactate concentration. Univariable and multivariable logistic regression models were used to assess associations with the endpoints. RESULTS: The distribution of risk factors and baseline characteristics showed no sex-specific differences. Sex was neither associated with mortality nor with bad neurological outcomes, and remained so after adjustment for both propensity scores. Baseline lactate (adjust odds ratio [aOR], 1.18; 95% confidence interval [CI], 1.02-1.38; P=.03), lactate after 6 hours (aOR, 1.23; 95% CI, 1.04-1.45; P=.01), and lactate clearance at 6 hours (aOR, 0.979; 95% CI, 0.959-0.999; P=.04) were independently associated with 30-day mortality. Higher lactate clearance after 6 hours was associated with lower rates of bad Glasgow Outcomes Scale both in univariable (OR, 0.967; 95% CI, 0.941-0.991; P=.02) and multivariable logistic regression models (aOR, 0.967; 95% CI, 0.941-0.994; P=.02). CONCLUSION: There were no sex-specific outcome differences in patients treated with eCPR. Both lactate concentration and lactate clearance could help with the selection of patients for inclusion in eCPR trials.


Assuntos
Reanimação Cardiopulmonar , Oxigenação por Membrana Extracorpórea , Parada Cardíaca , Feminino , Parada Cardíaca/diagnóstico , Parada Cardíaca/terapia , Humanos , Masculino , Estudos Retrospectivos , Resultado do Tratamento
19.
Artif Organs ; 44(12): 1259-1266, 2020 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-32592601

RESUMO

The frequency of mechanical circulatory support (MCS) device application has increased in recent years. Besides implantation in the emergency setting, such as circulatory arrest, MCS is also increasingly used electively to ensure hemodynamic stability in high-risk patients, for example, during percutaneous coronary interventions (PCI), valve interventions or off-pump coronary bypass surgery. Lifebridge (Zoll Medical GmbH, Germany) is a compact percutaneous MCS device widely used in daily clinical routine. The present study aimed to investigate the indications, feasibility, and outcomes after use of Lifebridge in cardiac interventions, evaluating a large-scale multicenter database. A total of 60 tertiary cardiovascular centers were questioned regarding application and short-term outcomes after the use of the Lifebridge system (n = 160 patients). Out of these 60 centers, eight consented to participate in the study (n = 39 patients), where detailed data were collected using standardized questionnaires. Demographic and clinical characteristics of the patient population, procedural as well as follow-up data were recorded and analyzed. In 60 interrogated centers, Lifebridge was used in 74% of emergency cases and 26% in the setting of planned interventions. The subcohort interrogated in detail displayed the same distribution of application scenarios, while the main cardiovascular procedure was high-risk PCI (82%). All patients were successfully weaned from the device and 92% (n = 36) of the patients studied in detail survived after 30 days. As assessed 30 days after insertion of the device, bleeding requiring red blood cell (RBC) transfusion constituted the main complication, occurring in 49% of cases. In our analysis of clinical data, the use of Lifebridge in cardiac intervention was shown to be feasible. Further prospective studies are warranted to identify patients who benefit from hemodynamic MCS support despite the increased rate of RBC transfusion due to challenges in access sites during cardiovascular procedures.


Assuntos
Perda Sanguínea Cirúrgica/prevenção & controle , Oxigenação por Membrana Extracorpórea/estatística & dados numéricos , Cuidados Intraoperatórios/métodos , Hemorragia Pós-Operatória/epidemiologia , Idoso , Perda Sanguínea Cirúrgica/estatística & dados numéricos , Ponte de Artéria Coronária sem Circulação Extracorpórea/efeitos adversos , Ponte de Artéria Coronária sem Circulação Extracorpórea/estatística & dados numéricos , Transfusão de Eritrócitos/estatística & dados numéricos , Oxigenação por Membrana Extracorpórea/efeitos adversos , Oxigenação por Membrana Extracorpórea/instrumentação , Estudos de Viabilidade , Feminino , Seguimentos , Alemanha/epidemiologia , Implante de Prótese de Valva Cardíaca/efeitos adversos , Implante de Prótese de Valva Cardíaca/estatística & dados numéricos , Mortalidade Hospitalar , Humanos , Cuidados Intraoperatórios/efeitos adversos , Cuidados Intraoperatórios/estatística & dados numéricos , Masculino , Pessoa de Meia-Idade , Intervenção Coronária Percutânea/efeitos adversos , Hemorragia Pós-Operatória/etiologia , Hemorragia Pós-Operatória/terapia , Estudos Prospectivos , Sistema de Registros/estatística & dados numéricos , Centros de Atenção Terciária/estatística & dados numéricos , Resultado do Tratamento
20.
Eur Heart J Acute Cardiovasc Care ; : 2048872620930509, 2020 Jun 10.
Artigo em Inglês | MEDLINE | ID: mdl-32517482

RESUMO

BACKGROUND: Conflicting results exist on whether initiation of intraaortic balloon pumping (IABP) before percutaneous coronary intervention (PCI) has an impact on outcome in this setting. Our aim was to assess the outcome of patients undergoing IABP insertion before versus after primary PCI in acute myocardial infarction complicated by cardiogenic shock. METHODS: The IABP-SHOCK II-trial randomized 600 patients with acute myocardial infarction and cardiogenic shock to IABP-support versus control. We analysed the outcome of patients randomized to the intervention group regarding timing of IABP implantation before or after PCI. RESULTS: Of 600 patients included in the IABP-SHOCK II trial, 301 were randomized to IABP-support. We analysed the 275 (91%) patients of this group undergoing primary PCI as revascularization strategy surviving the initial procedure. IABP insertion was performed before PCI in 33 (12%) and after PCI in 242 (88%) patients. There were no differences in baseline arterial lactate (p = 0.70), Simplified Acute Physiology Score-II-score (p = 0.60) and other relevant baseline characteristics. No differences were observed for short- and long-term mortality (pre vs. post 30-day mortality: 36% vs. 37%, odds ratio 0.99, 95% confidence interval (CI) 0.47-2.12, p = 0.99; one-year mortality: 56% vs. 48%, hazard ratio 1.08, 95% CI 0.65-1.80, p = 0.76; six-year-mortality: 64% vs. 65%, hazard ratio 1.00, 95% CI 0.63-1.60, p = 0.99). In multivariable Cox regression analysis timing of IABP-implantation was no predictor for long-term outcome (hazard ratio 1.08, 95% CI 0.66-1.78, p = 0.75). CONCLUSIONS: Timing of IABP-implantation pre or post primary PCI had no impact on outcome in patients with acute myocardial infarction complicated by cardiogenic shock.

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