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  • Ovid Technologies (Wolters Kluwer Health)  (23)
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  • Ovid Technologies (Wolters Kluwer Health)  (23)
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Fachgebiete(RVK)
  • 1
    In: Circulation, Ovid Technologies (Wolters Kluwer Health), Vol. 142, No. 15 ( 2020-10-13), p. 1437-1447
    Kurzfassung: In clinical practice, local anesthesia with conscious sedation (CS) is performed in roughly 50% of patients undergoing transcatheter aortic valve replacement. However, no randomized data assessing the safety and efficacy of CS versus general anesthesia (GA) are available. Methods: The SOLVE-TAVI (Comparison of Second-Generation Self-Expandable Versus Balloon-Expandable Valves and General Versus Local Anesthesia in Transcatheter Aortic Valve Implantation) trial is a multicenter, open-label, 2×2 factorial, randomized trial of 447 patients with aortic stenosis undergoing transfemoral transcatheter aortic valve replacement comparing CS versus GA. The primary efficacy end point was powered for equivalence (equivalence margin 10% with significance level 0.05) and consisted of the composite of all-cause mortality, stroke, myocardial infarction, infection requiring antibiotic treatment, and acute kidney injury at 30 days. Results: The primary composite end point occurred in 27.2% of CS and 26.4% of GA patients (rate difference, 0.8 [90% CI, −6.2 to 7.8]; P equivalence =0.015). Event rates for the individual components were as follows: all-cause mortality, 3.2% versus 2.3% (rate difference, 1.0 [90% CI, −2.9 to 4.8]; P equivalence 〈 0.001); stroke, 2.4% versus 2.8% (rate difference, −0.4 [90% CI, −3.8 to 3.8]; P equivalence 〈 0.001); myocardial infarction, 0.5% versus 0.0% (rate difference, 0.5 [90% CI, −3.0 to 3.9]; P equivalence 〈 0.001), infection requiring antibiotics 21.1% versus 22.0% (rate difference, −0.9 [90% CI, −7.5 to 5.7]; P equivalence =0.011); acute kidney injury, 9.0% versus 9.2% (rate difference, −0.2 [90% CI, −5.2 to 4.8]; P equivalence =0.0005). There was a lower need for inotropes or vasopressors with CS (62.8%) versus GA (97.3%; rate difference, −34.4 [90% CI, −41.0 to −27.8]). Conclusions: Among patients with aortic stenosis undergoing transfemoral transcatheter aortic valve replacement, use of CS compared with GA resulted in similar outcomes for the primary efficacy end point. These findings suggest that CS can be safely applied for transcatheter aortic valve replacement. Registration: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT02737150.
    Materialart: Online-Ressource
    ISSN: 0009-7322 , 1524-4539
    Sprache: Englisch
    Verlag: Ovid Technologies (Wolters Kluwer Health)
    Publikationsdatum: 2020
    ZDB Id: 1466401-X
    Standort Signatur Einschränkungen Verfügbarkeit
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  • 2
    In: Circulation, Ovid Technologies (Wolters Kluwer Health), Vol. 139, No. 4 ( 2019-01-22), p. 448-457
    Kurzfassung: 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/m 2 ; P =0.50; median difference, −0.025 W/m 2 ; 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.
    Materialart: Online-Ressource
    ISSN: 0009-7322 , 1524-4539
    Sprache: Englisch
    Verlag: Ovid Technologies (Wolters Kluwer Health)
    Publikationsdatum: 2019
    ZDB Id: 1466401-X
    Standort Signatur Einschränkungen Verfügbarkeit
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  • 3
    In: Shock, Ovid Technologies (Wolters Kluwer Health), Vol. 53, No. 1 ( 2020-01), p. 58-62
    Kurzfassung: Reperfusion strategies in acute myocardial infarction (AMI) may result in ischemia reperfusion injury characterized by increased oxidative stress, inflammation, and ultimately death of myocardial tissue which may be of particular importance in infarct-related cardiogenic shock (CS). Many anti-oxidative and immune regulatory processes depend on selenium which in large proportions is bound to circulating selenoprotein P (SelP). Individual SelP patterns may therefore be associated with inflammatory response and possibly mortality in patients with CS post AMI. Methods: In the randomized Intra-Aortic Balloon Pump in cardiogenic Shock II (IABP-SHOCK II)-trial, 600 patients with CS complicating AMI were assigned to therapy with or without IABP. In a predefined biomarker substudy of 147 patients, we analyzed SelP levels 1 and 3 days following randomization. Samples were compared with healthy controls and associations with the unspecific inflammatory marker C-reactive protein (CRP) were analyzed. Results: Compared with controls SelP levels in patients with infarct-related CS were markedly higher (2.7-fold at day 1 and 5.7-fold at day 3 following AMI, all P   〈  0.001). Thirty-day mortality was significantly higher in patients with SelP levels above the 75th percentile at day 3 following AMI (26% vs. 46%, P  = 0.045). SelP was significantly proportionally correlated with CRP 1 (R 2  = 0.762, P   〈  0.0001) and 3 days (R 2  = 0.777 P   〈  0.0001) following AMI. Conclusion: SelP levels are significantly increased post AMI with CS. Higher SelP levels are associated with increased CRP levels indicative for inflammatory processes. Future studies should focus on the characterization of SelP profiles following AMI and the identification of pathomechanisms affected by SelP.
    Materialart: Online-Ressource
    ISSN: 1073-2322 , 1540-0514
    Sprache: Englisch
    Verlag: Ovid Technologies (Wolters Kluwer Health)
    Publikationsdatum: 2020
    ZDB Id: 2011863-6
    Standort Signatur Einschränkungen Verfügbarkeit
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  • 4
    In: Journal of the American Heart Association, Ovid Technologies (Wolters Kluwer Health), Vol. 10, No. 9 ( 2021-05-04)
    Kurzfassung: Intravenous morphine administration can adversely affect platelet inhibition induced by P2Y 12 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.
    Materialart: Online-Ressource
    ISSN: 2047-9980
    Sprache: Englisch
    Verlag: Ovid Technologies (Wolters Kluwer Health)
    Publikationsdatum: 2021
    ZDB Id: 2653953-6
    Standort Signatur Einschränkungen Verfügbarkeit
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  • 5
    In: Circulation: Cardiovascular Interventions, Ovid Technologies (Wolters Kluwer Health), Vol. 12, No. 6 ( 2019-06)
    Kurzfassung: It is unclear whether atrial fibrillation (AF) influences prognosis in patients with cardiogenic shock and multivessel disease. We aimed to investigate the prognostic impact of AF in patients with cardiogenic shock complicating acute myocardial infarction. Methods and Results: In a subanalysis of the CULPRIT-SHOCK trial (Culprit Lesion Only PCI versus Multivessel PCI in Cardiogenic Shock), patients were grouped according to the presence of AF during index hospital stay. The primary end point was all-cause death at 30 days, and the key secondary end point was all-cause death at 1 year. AF was documented in 142 (21%) of 686 patients. AF was not a significant predictor of 30-day (adjusted odds ratio, 1.01; 95% CI 0.67–1.54; P =0.95) and 1-year (adjusted odds ratio, 0.80; 95% CI, 0.52–1.22; P =0.30) all-cause mortality. Patients with AF already on admission showed higher all-cause mortality at 30 days (52 of 90, 58% versus 19 of 52, 37%; P =0.02) and 1 year (57 of 90, 63% versus 20 of 52, 39%; P =0.004) compared with patients with newly detected AF during hospital stay. AF was associated with a longer time to hemodynamic stabilization (4, interquartile range, 1–8 days versus 3, interquartile range, 1–6 days; P =0.04) at 30 days. Conclusions: In cardiogenic shock complicating acute myocardial infarction, all-cause mortality is similar in patients with and without AF. Adverse outcome was detected in the subgroup of patients showing AF already on hospital admission. Clinical Trial Registration: URL: https://www.clinicaltrials.gov . Unique identifier: NCT01927549.
    Materialart: Online-Ressource
    ISSN: 1941-7640 , 1941-7632
    Sprache: Englisch
    Verlag: Ovid Technologies (Wolters Kluwer Health)
    Publikationsdatum: 2019
    ZDB Id: 2450801-9
    Standort Signatur Einschränkungen Verfügbarkeit
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  • 6
    In: Journal of the American Heart Association, Ovid Technologies (Wolters Kluwer Health), Vol. 9, No. 18 ( 2020-09-15)
    Kurzfassung: Cardiovascular magnetic resonance imaging is considered the reference methodology for cardiac morphology and function but requires manual postprocessing. Whether novel artificial intelligence–based automated analyses deliver similar information for risk stratification is unknown. Therefore, this study aimed to investigate feasibility and prognostic implications of artificial intelligence–based, commercially available software analyses. Methods and Results Cardiovascular magnetic resonance data (n=1017 patients) from 2 myocardial infarction multicenter trials were included. Analyses of biventricular parameters including ejection fraction (EF) were manually and automatically assessed using conventional and artificial intelligence–based software. Obtained parameters entered regression analyses for prediction of major adverse cardiac events, defined as death, reinfarction, or congestive heart failure, within 1 year after the acute event. Both manual and uncorrected automated volumetric assessments showed similar impact on outcome in univariate analyses (left ventricular EF, manual: hazard ratio [HR], 0.93 [95% CI 0.91–0.95] ; P 〈 0.001; automated: HR, 0.94 [95% CI, 0.92–0.96]; P 〈 0.001) and multivariable analyses (left ventricular EF, manual: HR, 0.95 [95% CI, 0.92–0.98]; P =0.001; automated: HR, 0.95 [95% CI, 0.92–0.98]; P =0.001). Manual correction of the automated contours did not lead to improved risk prediction (left ventricular EF, area under the curve: 0.67 automated versus 0.68 automated corrected; P =0.49). There was acceptable agreement (left ventricular EF: bias, 2.6%; 95% limits of agreement, −9.1% to 14.2%; intraclass correlation coefficient, 0.88 [95% CI, 0.77–0.93]) of manual and automated volumetric assessments. Conclusions User‐independent volumetric analyses performed by fully automated software are feasible, and results are equally predictive of major adverse cardiac events compared with conventional analyses in patients following myocardial infarction. Registration URL: https://www.clinicaltrials.gov ; Unique identifiers: NCT00712101 and NCT01612312.
    Materialart: Online-Ressource
    ISSN: 2047-9980
    Sprache: Englisch
    Verlag: Ovid Technologies (Wolters Kluwer Health)
    Publikationsdatum: 2020
    ZDB Id: 2653953-6
    Standort Signatur Einschränkungen Verfügbarkeit
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  • 7
    In: Journal of the American Heart Association, Ovid Technologies (Wolters Kluwer Health), Vol. 8, No. 16 ( 2019-08-20)
    Kurzfassung: Despite limitations as a stand‐alone parameter, left ventricular (LV) ejection fraction is the preferred measure of myocardial function and marker for postinfarction risk stratification. LV myocardial uniformity alterations may provide superior prognostic information after acute myocardial infarction, which was the subject of this study. Methods and Results Consecutive patients with acute myocardial infarction (n=1082; median age: 63 years; 75% male) undergoing cardiac magnetic resonance at a median of 3 days after infarction were included in this multicenter observational study. Circumferential and radial uniformity ratio estimates were derived from cardiac magnetic resonance feature tracking as markers of mechanical uniformity alterations (values between 0 and 1 with 1 reflecting perfect uniformity). The clinical end point was the 12‐month rate of major adverse cardiac events, consisting of all‐cause death, reinfarction, and new congestive heart failure. Patients with major adverse cardiac events (n=73) had significantly impaired circumferential uniformity ratio estimates (0.76 [interquartile range: 0.67–0.86] versus 0.84 [interquartile range: 0.76–0.89] ; P 〈 0.001) and radial uniformity ratio estimates (0.69 [interquartile range: 0.60–0.79] versus 0.76 [interquartile range: 0.67–0.83] ; P 〈 0.001) compared with patients without events. Although uniformity estimates did not provide independent prognostic information in the overall cohort, a circumferential uniformity ratio estimate below the median of 0.84 emerged as an independent predictor of outcome in postinfarction patients with LV ejection fraction 〉 35% (n=959), even after adjustment for established risk factors (hazard ratio: 1.99; 95% CI, 1.06–3.74; P =0.033 in multivariable Cox regression analysis). In contrast, LV ejection fraction was not associated with adverse events in this subgroup of patients with acute myocardial infarction. Conclusions Cardiac magnetic resonance–derived estimates of mechanical uniformity alterations are novel markers for risk assessment after acute myocardial infarction, and the circumferential uniformity ratio estimate provides independent prognostic information for patients with preserved or only moderately reduced LV ejection fraction.
    Materialart: Online-Ressource
    ISSN: 2047-9980
    Sprache: Englisch
    Verlag: Ovid Technologies (Wolters Kluwer Health)
    Publikationsdatum: 2019
    ZDB Id: 2653953-6
    Standort Signatur Einschränkungen Verfügbarkeit
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  • 8
    In: Circulation Research, Ovid Technologies (Wolters Kluwer Health), Vol. 124, No. 10 ( 2019-05-10), p. 1482-1491
    Kurzfassung: Remote ischemic conditioning (RIC) or ischemic postconditioning (PostC) may protect the myocardium from ischemia-reperfusion injury in patients with ST-segment–elevation myocardial infarction. Objective: To determine whether combined intrahospital RIC and PostC or PostC alone in addition to primary percutaneous coronary intervention (PCI) reduce long-term clinical events after ST-segment–elevation myocardial infarction. Methods and Results: The present study is a post hoc analysis of a prospective trial which randomized 696 ST-segment–elevation myocardial infarction patients with symptoms 〈 12 hours 1:1:1 to either combined RIC and PostC in addition to primary PCI, PostC alone in addition to primary PCI, or conventional PCI (control). Three cycles of RIC were performed by inflation of an upper arm blood pressure cuff for 5 minutes followed by deflation for 5 minutes. PostC was performed after primary PCI via 4 cycles of 30 seconds balloon occlusions followed by 30 seconds of reperfusion. Major adverse cardiac events consisting of cardiac death, reinfarction, and new congestive heart failure were assessed during long-term follow-up. Follow-up data were obtained in 97% of patients in median 3.6 years after the index event (interquartile range, 2.9–4.2 years). Major adverse cardiac events occurred in 10.2% of patients in the combined RIC and PostC group and in 16.9% in the control group (odds ratio, 0.56; 95% CI, 0.32–0.97; P =0.04). The difference was driven by a significantly reduced rate of new congestive heart failure in the RIC and PostC group (2.7% versus 7.8%; odds ratio, 0.32; 95% CI, 0.13–0.84; P =0.02). In contrast, PostC alone did not reduce major adverse cardiac events compared with controls (14.1% versus 16.9%; odds ratio, 0.81; 95% CI, 0.48–1.35; P =0.41), and the reduction of new congestive heart failure was not statistically significant (3.5% versus 7.8%; odds ratio, 0.43; 95% CI, 0.18–1.03; P =0.05). Conclusions: Cardioprotection by combined intrahospital RIC and PostC in addition to primary PCI significantly reduced the rate of major adverse cardiac events and new congestive heart failure after ST-segment–elevation myocardial infarction. Clinical Trial Registration: URL: http://www.clinicaltrials.gov . Unique identifier: NCT02158468.
    Materialart: Online-Ressource
    ISSN: 0009-7330 , 1524-4571
    RVK:
    Sprache: Englisch
    Verlag: Ovid Technologies (Wolters Kluwer Health)
    Publikationsdatum: 2019
    ZDB Id: 1467838-X
    Standort Signatur Einschränkungen Verfügbarkeit
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  • 9
    In: Circulation, Ovid Technologies (Wolters Kluwer Health), Vol. 139, No. 3 ( 2019-01-15), p. 395-403
    Kurzfassung: The role of intraaortic balloon counterpulsation (IABP) in cardiogenic shock is still a subject of intense debate despite the neutral results of the IABP-SHOCK II trial (Intraaortic Balloon Pump in Cardiogenic Shock II) with subsequent downgrading in international guidelines. So far, randomized data on the impact of IABP on long-term clinical outcomes in patients with cardiogenic shock complicating acute myocardial infarction are lacking. Furthermore, only limited evidence is available on general long-term outcomes of patients with cardiogenic shock treated by contemporary practice. Methods: The IABP-SHOCK II trial is a multicenter, randomized, open-label trial. Between 2009 and 2012, 600 patients with cardiogenic shock complicating acute myocardial infarction undergoing early revascularization were randomized to IABP versus control. Results: Long-term follow-up was performed 6.2 years (interquartile range 5.6–6.7) after initial randomization. Follow-up was completed for 591 of 600 patients (98.5%). Mortality was not different between the IABP and the control group (66.3% versus 67.0%; relative risk, 0.99; 95% CI, 0.88–1.11; P =0.98). There were also no differences in recurrent myocardial infarction, stroke, repeat revascularization, or rehospitalization for cardiac reasons (all P 〉 0.05). Survivors’ quality of life as assessed by the EuroQol 5D questionnaire and the New York Heart Association class did not differ between groups. Conclusions: IABP has no effect on all-cause mortality at 6-year long-term follow-up. Mortality is still very high, with two thirds of patients with cardiogenic shock dying despite contemporary treatment with revascularization therapy. Clinical Trial Registration: URL: https://www.clinicaltrials.gov/ . Unique identifier: NCT00491036.
    Materialart: Online-Ressource
    ISSN: 0009-7322 , 1524-4539
    Sprache: Englisch
    Verlag: Ovid Technologies (Wolters Kluwer Health)
    Publikationsdatum: 2019
    ZDB Id: 1466401-X
    Standort Signatur Einschränkungen Verfügbarkeit
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  • 10
    In: Circulation, Ovid Technologies (Wolters Kluwer Health), Vol. 141, No. 16 ( 2020-04-21), p. 1354-1356
    Materialart: Online-Ressource
    ISSN: 0009-7322 , 1524-4539
    Sprache: Englisch
    Verlag: Ovid Technologies (Wolters Kluwer Health)
    Publikationsdatum: 2020
    ZDB Id: 1466401-X
    Standort Signatur Einschränkungen Verfügbarkeit
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