Evidence on the impact on clinical outcome of active mechanical circulatory support (MCS) devices in cardiogenic shock (CS) is scarce. This collaborative meta-analysis of randomized trials thus aims ...to investigate the efficacy and safety of percutanzeous active MCS vs. control in CS.
Randomized trials comparing percutaneous active MCS to control in patients with CS were identified through searches of medical literature databases. Risk ratios (RR) and 95% confidence intervals (95% CI) were calculated to analyse the primary endpoint of 30-day mortality and device-related complications including bleeding and leg ischaemia. Mean differences (MD) were calculated for mean arterial pressure (MAP), cardiac index (CI), pulmonary capillary wedge pressure (PCWP), and arterial lactate. Four trials randomizing 148 patients to either TandemHeart™ or Impella® MCS (n = 77) vs. control (n = 71) were identified. In all four trials intra-aortic balloon pumping (IABP) served as control. There was no difference in 30-day mortality (RR 1.01, 95% CI 0.70 to 1.44, P = 0.98, I2 = 0%) for active MCS compared with control. Active MCS significantly increased MAP (MD 11.85 mmHg, 95% CI 3.39 to 20.31, P = 0.02, I2 = 32.7%) and decreased arterial lactate (MD - 1.36 mmol/L, 95% CI - 2.52 to - 0.19, I2 = 0%, P = 0.02) at comparable CI (MD 0.32, 95% CI - 0.24 to 0.87, P = 0.14, I2 = 44.1%) and PCWP (MD - 5.59, 95% -15.59 to 4.40, P = 0.14, I2 = 81.1%). No significant difference was observed in the incidence of leg ischaemia (RR 2.64, 95% CI 0.83 to 8.39, P = 0.10, I2 = 0%), whereas the rate of bleeding was significantly increased in MCS compared to IABP (RR 2.50, 95% CI 1.55 to 4.04, P < 0.001, I2 = 0%).
Results of this collaborative meta-analysis do not support the unselected use of active MCS in patients with CS complicating AMI.
Despite advances in treatment, mortality in acute myocardial infarction (AMI) complicated by cardiogenic shock (CS) remains high. Short-term mechanical circulatory support devices acutely improve ...hemodynamic conditions.
The aim of this study was to determine whether a new percutaneous mechanical circulatory support (pMCS) device (Impella CP, Abiomed, Danvers, Massachusetts) decreases 30-day mortality when compared with an intra-aortic balloon pump (IABP) in patients with severe shock complicating AMI.
In a randomized, prospective, open-label, multicenter trial, 48 patients with severe CS complicating AMI were assigned to pMCS (n = 24) or IABP (n = 24). Severe CS was defined as systolic blood pressure <90 mm Hg or the need for inotropic or vasoactive medication and the requirement for mechanical ventilation. The primary endpoint was 30-day all-cause mortality.
At 30 days, mortality in patients treated with either IABP or pMCS was similar (50% and 46%, respectively; hazard ratio with pMCS: 0.96; 95% confidence interval: 0.42 to 2.18; p = 0.92). At 6 months, mortality rates for both pMCS and IABP were 50% (hazard ratio: 1.04; 95% confidence interval: 0.47 to 2.32; p = 0.923).
In this explorative randomized controlled trial involving mechanically ventilated patients with CS after AMI, routine treatment with pMCS was not associated with reduced 30-day mortality compared with IABP. (IMPRESS in Severe Shock; NTR3450)
Display omitted
Objective
Catecholamines have been the mainstay of pharmacological treatment of cardiogenic shock (CS). Recently, use of epinephrine has been associated with detrimental outcomes. In the present ...study we aimed to evaluate the association between epinephrine use and short-term mortality in all-cause CS patients.
Design
We performed a meta-analysis of individual data with prespecified inclusion criteria: (1) patients in non-surgical CS treated with inotropes and/or vasopressors and (2) at least 15% of patients treated with epinephrine administrated alone or in association with other inotropes/vasopressors. The primary outcome was short-term mortality.
Measurements and results
Fourteen published cohorts and two unpublished data sets were included. We studied 2583 patients. Across all cohorts of patients, the incidence of epinephrine use was 37% (17–76%) and short-term mortality rate was 49% (21–69%). A positive correlation was found between percentages of epinephrine use and short-term mortality in the CS cohort. The risk of death was higher in epinephrine-treated CS patients (OR CI = 3.3 2.8–3.9) compared to patients treated with other drug regimens. Adjusted mortality risk remained striking in epinephrine-treated patients (
n
= 1227) (adjusted OR = 4.7 3.4–6.4). After propensity score matching, two sets of 338 matched patients were identified and epinephrine use remained associated with a strong detrimental impact on short-term mortality (OR = 4.2 3.0–6.0).
Conclusions
In this very large cohort, epinephrine use for hemodynamic management of CS patients is associated with a threefold increase of risk of death.
Purpose
Veno-arterial extracorporeal life support (ECLS) is increasingly used in patients during cardiac arrest and cardiogenic shock, to support both cardiac and pulmonary function. We performed a ...systematic review and meta-analysis of cohort studies comparing mortality in patients treated with and without ECLS support in the setting of refractory cardiac arrest and cardiogenic shock complicating acute myocardial infarction.
Methods
We systematically searched MEDLINE, EMBASE, the Cochrane Central Register of Controlled Trials and the publisher subset of PubMed updated to December 2015. Thirteen studies were included of which nine included cardiac arrest patients (
n
= 3098) and four included patients with cardiogenic shock after acute myocardial infarction (
n
= 235). Data were pooled by a Mantel-Haenzel random effects model and heterogeneity was examined by the
I
2
statistic.
Results
In cardiac arrest, the use of ECLS was associated with an absolute increase of 30 days survival of 13 % compared with patients in which ECLS was not used 95 % CI 6–20 %;
p
< 0.001; number needed to treat (NNT) 7.7 and a higher rate of favourable neurological outcome at 30 days (absolute risk difference 14 %; 95 % CI 7–20 %;
p
< 0.0001; NNT 7.1). Propensity matched analysis, including 5 studies and 438 patients (219 in both groups), showed similar results. In cardiogenic shock, ECLS showed a 33 % higher 30-day survival compared with IABP (95 % CI, 14–52 %;
p
< 0.001; NNT 13) but no difference when compared with TandemHeart/Impella (−3 %; 95 % CI −21 to 14 %;
p
= 0.70; NNH 33).
Conclusions
In cardiac arrest, the use of ECLS was associated with an increased survival rate as well as an increase in favourable neurological outcome. In the setting of cardiogenic shock there was an increased survival with ECLS compared with IABP.
All trials were underpowered to adequately evaluate mortality. ...we pooled the data from these trials to compare Impella with IABP on 30-day and 6-month all-cause mortality and left ventricular ...ejection fraction (LVEF) during follow-up. ...although there is only limited data available, this meta-analysis shows no difference in mortality or LVEF in cardiogenic shock patients who are treated with Impella compared with IABP.
Pulse (PPV) and systolic pressure variation (SPV) quantify variations in arterial pressure related to heart-lung interactions and have been introduced as biomarkers of preload dependency to guide ...fluid treatment in mechanically ventilated patients. However, respiratory intra-thoracic pressure changes during spontaneous breathing are considered too small to affect preload and stroke volume sufficiently for the detection by PPV and/or SPV. This study addressed the effects of paced breathing and/or an external respiratory resistance on PPV and SPV in detecting preload dependency in spontaneously breathing subjects.
In 10 healthy subjects, hemodynamic and respiratory parameters were evaluated during progressive central hypovolemia (head-up tilt). Breathing conditions were varied by manipulating breathing frequency and respiratory resistance. Subjects responding with a reduction in stroke volume index ≥15% were classified as having developed preload dependency. The ability for PPV and SPV to predict preload dependency was expressed by the area under the ROC curve (AUC).
A breathing frequency at 6/min increased the PPV (16±5% vs. 10±3%, p<0.001) and SPV (9±3% vs. 5±2%, p<0.001) which was further enhanced by an expiratory resistance (PPV: 19±3%, p = 0.025 and SPV: 10±2%, p = 0.047). These respiratory modifications, compared to free breathing, enhanced the predictive value of PPV with higher accuracy (AUC: 0.92 vs. 0.46).
Under conditions of progressive central hypovolemia, the application of an external respiratory resistance at a breathing frequency of 6/min enhanced PPV and SPV and is worth further study for detection of preload dependency from arterial pressure variations in non-ventilated subjects.
Purpose
This study aimed to concisely describe the current standards of care, major recent advances, common beliefs that have been contradicted by recent trials, areas of uncertainty, and clinical ...studies that need to be performed over the next decade and their expected outcomes with regard to extracorporeal membrane oxygenation (ECMO).
Methods
Narrative review based on a systematic analysis of the medical literature, national and international guidelines, and expert opinion.
Results
The use of venovenous ECMO (VV-ECMO) is increasing in the most severe forms of acute lung injury. In patients with cardiogenic shock, short-term veno-arterial ECMO (VA-ECMO) provides both pulmonary and circulatory support. Technological improvements and recently published studies suggest that ECMO is able to improve patients’ outcomes. There are, however, many uncertainties regarding the real benefits of this technique both in hemodynamic and respiratory failure, the territorial organization to deliver ECMO, the indications and the use of concomitant treatments.
Conclusions
Although there have been considerable advances regarding the use of ECMO in critically ill patients, the risk/benefit ratio remains underinvestigated. ECMO indications, organization of ECMO delivery, and use of adjuvant therapeutics need also to be explored. Ongoing and future studies may be able to resolve these issues.
Short-term mechanical circulatory support devices are increasingly used in cardiogenic shock after acute myocardial infarction. As no randomised evidence is available, the choice between high-output ...Impella or extra-corporeal membrane oxygenation (ECMO) is still a matter of debate. Real-life data are necessary to assess adverse outcomes and to help guide the treatment decision between the different devices. The purpose of this study was to compare characteristics and clinical outcomes of Impella CP/5.0 with ECMO support in patients with cardiogenic shock from myocardial infarction.
A retrospective, two-centre study was performed on all cardiogenic shock from myocardial infarction patients with Impella CP/5.0 or ECMO support, from 2006 until 2018. The primary outcome was 30-day mortality. Potential baseline imbalance between the groups was adjusted using inverse probability treatment weighting, and survival analysis was performed with an adjusted log-rank test. Secondarily, the occurrence of device-related complications (limb ischaemia, access site-related bleeding, access site-related infection) was evaluated.
A total of 128 patients were included (Impella,
=90; ECMO,
=38). The 30-day mortality was similar for both groups (53% vs. 49%,
=0.30), also after adjustment for potential baseline imbalance between the groups (weighted log-rank
=0.16). Patients with Impella support had significantly fewer device-related complications than patients treated with ECMO (respectively, 17% vs. 40%,
<0.01).
Patients treated with Impella CP/5.0 or ECMO for cardiogenic shock after myocardial infarction did not differ in 30-day mortality. More device-related complications occurred with ECMO compared to Impella support.
The Evaluating Xience and left ventricular function in PCI on occlusiOns afteR STEMI (EXPLORE) trial did not show a significant benefit of percutaneous coronary intervention (PCI) of the concurrent ...chronic total occlusion (CTO) in ST-segment elevation myocardial infarction (STEMI) patients on global left ventricular (LV) systolic function. However a possible treatment effect will be most pronounced in the CTO territory. Therefore, we aimed to study the effect of CTO PCI compared to no-CTO PCI on the recovery of regional LV function, particularly in the CTO territory.
Using cardiovascular magnetic resonance (CMR) we studied 180 of the 302 EXPLORE patients with serial CMR (baseline and 4 months follow-up). Segmental wall thickening (SWT) was quantified on cine images by an independent core laboratory. Dysfunctional segments were defined as SWT < 45%. Dysfunctional segments were further analyzed by viability (transmural extent of infarction (TEI) ≤50%.). All outcomes were stratified for randomization treatment.
In the dysfunctional segments in the CTO territory recovery of SWT was better after CTO PCI compared to no-CTO PCI (ΔSWT 17 ± 27% vs 11 ± 23%, p = 0.03). This recovery was most pronounced in the dysfunctional but viable segments(TEI < 50%) (ΔSWT 17 ± 27% vs 11 ± 22%, p = 0.02). Furthermore in the CTO territory, recovery of SWT was significantly better in the dysfunctional segments in patients with Rentrop grade 2-3 collaterals compared to grade 0-1 collaterals to the CTO (16 ± 26% versus 11 ± 24%, p = 0.04).
CTO PCI compared with no-CTO PCI is associated with a greater recovery of regional systolic function in the CTO territory, especially in the dysfunctional but viable segments. Further research is needed to evaluate the use of CMR in selecting post-STEMI patients for CTO PCI and the effect of regional LV function recovery on clinical outcome.
Trialregister.nl NTR1108 , Date registered NTR: 30-okt-2007.
Background In selected patients with an acute myocardial infarction (AMI) complicated by Cardiogenic shock (CS), mechanical circulatory support with Impella may be beneficial, although conclusive ...evidence is still lacking. Nevertheless, it has been suggested that Impella initiation prior to primary PCI might improve survival. Objective To investigate the effect pre-PCI versus immediate post-PCI Impella initiation on short term mortality. Methods A prospective, single center, observational study, was performed including all patients with STEMI complicated by CS, treated with primary PCI and Impella. Thirty day mortality was compared between patients with Impella initiation pre-PCI and immediately post-PCI. Results A total of 88 patients were included. In the pre-PCI group (n = 21), admission heart rate was lower (84 versus 94 bpm, p = 0.04) and no IABP was implanted before Impella initiation, versus 17.9% in post-PCI group (n = 67), p = 0.04. Total 30-day all-cause mortality was 58%, and was lower in pre-PCI group, 47.6% versus 61.2% in the post-PCI group, however not statistically significant (HR 0.7, 95% CI 0.3-1.3, p = 0.21). Thirty-day cardiac mortality was significantly lower in the pre-PCI group, 19% versus 44.7% in the post-PCI group (HR 0.3, 95% CI 0.09-0.96, p = 0.042). Conclusion Pre-PCI Impella initiation in AMICS patients was not associated with a statistically significant difference in 30-day all-cause mortality, compared to post-PCI Impella initiation.
PDF
