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Complications from percutaneous-left ventricular assist devices versus intra-aortic balloon pump in acute myocardial infarction-cardiogenic shock.

ABSTRACT: BACKGROUND:There are limited data on the complications with a percutaneous left ventricular assist device (pLVAD) vs. intra-aortic balloon pump (IABP) in acute myocardial infarction-cardiogenic shock (AMI-CS). OBJECTIVE:To assess the trends, rates and predictors of complications. METHODS:Using a 17-year AMI-CS population from the National Inpatient Sample, AMI-CS admissions receiving pLVAD and IABP support were evaluated for vascular, lower limb amputation, hematologic, neurologic and acute kidney injury (AKI) complications. In-hospital mortality, hospitalization costs and length of stay in pLVAD and IABP cohorts with complications was studied. RESULTS:Of 168,645 admissions, 7,855 (4.7%) receiving pLVAD support. The pLVAD cohort had higher comorbidity, cardiac arrest (36.1% vs. 29.7%) and non-cardiac organ failure (74.7% vs. 56.9%) rates. Complications were higher in pLVAD compared to IABP cohort-overall 69.0% vs. 54.7%; vascular 3.8% vs. 2.1%; lower limb amputation 0.3% vs. 0.3%; hematologic 36.0% vs. 27.7%; neurologic 4.9% vs. 3.5% and AKI 55.4% vs. 39.1% (all p<0.001 except for amputation). Non-White race, higher comorbidity, organ failure, and extracorporeal membrane oxygen use were predictors of complications for both cohorts. The pLVAD cohort with complications had higher in-hospital mortality (45.5% vs. 33.1%; adjusted odds ratio 1.65 [95% confidence interval 1.55-1.75]), shorter duration of hospital stay, and higher hospitalization costs compared to the IABP cohort with complications (all p<0.001). These results were consistent in propensity-matched pairs. CONCLUSIONS:AMI-CS admissions receiving pLVAD had higher rates of complications compared to the IABP, with worse in-hospital outcomes in the cohort with complications.

SUBMITTER: Vallabhajosyula S

PROVIDER: S-EPMC7444810 | biostudies-literature | 2020

REPOSITORIES: biostudies-literature

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Complications from percutaneous-left ventricular assist devices versus intra-aortic balloon pump in acute myocardial infarction-cardiogenic shock.

Vallabhajosyula Saraschandra S Subramaniam Anna V AV Murphree Dennis H DH Patlolla Sri Harsha SH Ya'Qoub Lina L Kumar Vinayak V Verghese Dhiran D Cheungpasitporn Wisit W Jentzer Jacob C JC Sandhu Gurpreet S GS Gulati Rajiv R Shah Nilay D ND Gersh Bernard J BJ Holmes David R DR Bell Malcolm R MR Barsness Gregory W GW

PloS one 20200824 8

<h4>Background</h4>There are limited data on the complications with a percutaneous left ventricular assist device (pLVAD) vs. intra-aortic balloon pump (IABP) in acute myocardial infarction-cardiogenic shock (AMI-CS).<h4>Objective</h4>To assess the trends, rates and predictors of complications.<h4>Methods</h4>Using a 17-year AMI-CS population from the National Inpatient Sample, AMI-CS admissions receiving pLVAD and IABP support were evaluated for vascular, lower limb amputation, hematologic, neu ...[more]

PMID: 32833995

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Project description:BackgroundCardiogenic shock (CS) is a state of critical end-organ hypoperfusion due to a primary cardiac disorder. For people with refractory CS despite maximal vasopressors, inotropic support and intra-aortic balloon pump, mortality approaches 100%. Mechanical assist devices provide mechanical circulatory support (MCS) which has the ability to maintain vital organ perfusion, to unload the failing ventricle thus reduce intracardiac filling pressures which reduces pulmonary congestion, myocardial wall stress and myocardial oxygen consumption. This has been hypothesised to allow time for myocardial recovery (bridge to recovery) or allow time to come to a decision as to whether the person is a candidate for a longer-term ventricular assist device (VAD) either as a bridge to heart transplantation or as a destination therapy with a long-term VAD.ObjectivesTo assess whether mechanical assist devices improve survival in people with acute cardiogenic shock.Search methodsWe searched CENTRAL, MEDLINE (Ovid), Embase (Ovid) and Web of Science Core Collection in November 2019. In addition, we searched three trials registers in August 2019. We scanned reference lists and contacted experts in the field to obtain further information. There were no language restrictions.Selection criteriaRandomised controlled trials on people with acute CS comparing mechanical assist devices with best current intensive care management, including intra-aortic balloon pump and inotropic support.Data collection and analysisWe performed data collection and analysis according to the published protocol. Primary outcomes were survival to discharge, 30 days, 1 year and secondary outcomes included, quality of life, major adverse cardiovascular events (30 days/end of follow-up), dialysis-dependent (30 days/end of follow-up), length of hospital stay and length of intensive care unit stay and major adverse events. We used the five GRADE considerations (study limitations, consistency of effect, imprecision, indirectness, and publication bias) to assess the quality of a body of evidence as it relates to the studies which contribute data to the meta-analyses for the prespecified outcomes Summary statistics for the primary endpoints were risk ratios (RR), hazard ratios (HRs) and odds ratios (ORs) with 95% confidence intervals (CIs).Main resultsThe search identified five studies from 4534 original citations reviewed. Two studies included acute CS of all causes randomised to treatment using TandemHeart percutaneous VAD and three studies included people with CS secondary to acute myocardial infarction who were randomised to Impella CP or best medical management. Meta-analysis was performed only to assess the 30-day survival as there were insufficient data to perform any further meta-analyses. The results from the five studies with 162 participants showed mechanical assist devices may have little or no effect on 30-day survival (RR of 1.01 95% CI 0.76 to 1.35) but the evidence is very uncertain. Complications such as sepsis, thromboembolic phenomena, bleeding and major adverse cardiovascular events were not infrequent in both the MAD and control group across the studies, but these could not be pooled due to inconsistencies in adverse event definitions and reporting. We identified four randomised control trials assessing mechanical assist devices in acute CS that are currently ongoing.Authors' conclusionsThere is no evidence from this review of a benefit from MCS in improving survival for people with acute CS. Further use of the technology, risk stratification and optimising the use protocols have been highlighted as potential reasons for lack of benefit and are being addressed in the current ongoing clinical trials.

Project description:AimsPercutaneous left ventricular assist devices (pVADs) are used to haemodynamically stabilize patients with cardiogenic shock (CS) caused by acute myocardial infarction (AMI). One out of every two patients has a non-ischaemic cause of CS, and these patients differ profoundly from patients with AMI-related CS. We assessed the usefulness of pVAD support for patients with non-ischaemic CS.Methods and resultsWe analysed 106 patients with CS and Impella® support between 2015 and 2018. CS was non-ischaemic in 36 patients and AMI-related in 70 patients. Compared with the AMI group, those in the non-ischaemic group were significantly younger [median age 62 (50.8, 70.8) years vs. 68 (58.0, 75.5) years, P = 0.007] and had more patients with severely reduced left ventricular function (94% vs. 79%, P = 0.035) and worse glomerular filtration rate [45 (27, 57) mL/min vs. 60 (44, 78) mL/min]. Propensity score matching yielded 31 patients with non-ischaemic CS and 31 patients with AMI-related CS, without a difference in baseline laboratory values or comorbidities. In both groups, pVAD support was performed along with haemodynamic stabilization, reduction of catecholamines and normalization of lactate levels. In 7 days, systolic blood pressure increased from 91 (80, 101) mmHg at baseline to 100 (100, 120) mmHg in the non-ischaemic CS group (P = 0.001) and 89 (80, 100) mmHg at baseline to 112 (100, 128) mmHg in the AMI-related CS group (P = 0.001). Moreover, in 7 days, the need of catecholamines (calculated as vasoactive-inotropic score) decreased from 32.0 (11.1, 47.0) at baseline to 5.3 (0, 16.1) in the non-ischaemic group (P = 0.001) and from 35.2 (18.11, 67.0) to zero (0, 0) in the AMI-related CS group (P = 0.001). Lactate level decreased from 3.8 (2.8, 5.9) mmol/L at baseline to 1.0 (0.8, 2.1) mmol/L (P = 0.001) in the non-ischaemic CS group and from 3.8 (2.6, 6.5) mmol/L to 1.2 (1.0, 2.0) mmol/L in the AMI-related group (P = 0.001). In the non-ischaemic CS group, eight patients (25.8%) were upgraded to veno-arterial extracorporeal membrane oxygenation (VA-ECMO) or long-term mechanical circulatory support. Two of these upgraded patients received heart transplantation. In the AMI group, eight patients (25.8%) were upgraded to VA-ECMO or long-term mechanical circulatory support. Ninety-day survival did not significantly differ between the groups (non-ischaemic CS group 48.4%, AMI-related CS group 45.2%, P = 0.799).ConclusionspVAD support is useful for haemodynamic stabilization of patients with non-ischaemic CS and is valuable as a bridge to patients' recovery or long-term left ventricular support and heart transplantation.

Project description:ImportanceAcute myocardial infarction (AMI) complicated by cardiogenic shock is associated with substantial morbidity and mortality. Although intravascular microaxial left ventricular assist devices (LVADs) provide greater hemodynamic support as compared with intra-aortic balloon pumps (IABPs), little is known about clinical outcomes associated with intravascular microaxial LVAD use in clinical practice.ObjectiveTo examine outcomes among patients undergoing percutaneous coronary intervention (PCI) for AMI complicated by cardiogenic shock treated with mechanical circulatory support (MCS) devices.Design, setting, and participantsA propensity-matched registry-based retrospective cohort study of patients with AMI complicated by cardiogenic shock undergoing PCI between October 1, 2015, and December 31, 2017, who were included in data from hospitals participating in the CathPCI and the Chest Pain-MI registries, both part of the American College of Cardiology's National Cardiovascular Data Registry. Patients receiving an intravascular microaxial LVAD were matched with those receiving IABP on demographics, clinical history, presentation, infarct location, coronary anatomy, and clinical laboratory data, with final follow-up through December 31, 2017.ExposuresHemodynamic support, categorized as intravascular microaxial LVAD use only, IABP only, other (such as use of a percutaneous extracorporeal ventricular assist system, extracorporeal membrane oxygenation, or a combination of MCS device use), or medical therapy only.Main outcomes and measuresThe primary outcomes were in-hospital mortality and in-hospital major bleeding.ResultsAmong 28 304 patients undergoing PCI for AMI complicated by cardiogenic shock, the mean (SD) age was 65.0 (12.6) years, 67.0% were men, 81.3% had an ST-elevation myocardial infarction, and 43.3% had cardiac arrest. Over the study period among patients with AMI, an intravascular microaxial LVAD was used in 6.2% of patients, and IABP was used in 29.9%. Among 1680 propensity-matched pairs, there was a significantly higher risk of in-hospital death associated with use of an intravascular microaxial LVAD (45.0%) vs with an IABP (34.1% [absolute risk difference, 10.9 percentage points {95% CI, 7.6-14.2}; P < .001) and also higher risk of in-hospital major bleeding (intravascular microaxial LVAD [31.3%] vs IABP [16.0%]; absolute risk difference, 15.4 percentage points [95% CI, 12.5-18.2]; P < .001). These associations were consistent regardless of whether patients received a device before or after initiation of PCI.Conclusions and relevanceAmong patients undergoing PCI for AMI complicated by cardiogenic shock from 2015 to 2017, use of an intravascular microaxial LVAD compared with IABP was associated with higher adjusted risk of in-hospital death and major bleeding complications, although study interpretation is limited by the observational design. Further research may be needed to understand optimal device choice for these patients.

Project description:OBJECTIVES:To review temporary percutaneous mechanical circulatory support devices for the treatment of cardiogenic shock, including current evidence, contraindications, complications, and future directions. DATA SOURCES:A MEDLINE search was conducted with MeSH terms: cardiogenic shock, percutaneous mechanical circulatory support, extracorporeal membrane oxygenation, Impella, and TandemHeart. STUDY SELECTION:Selected publications included randomized controlled trial data and observational studies describing experience with percutaneous mechanical circulatory support in cardiogenic shock. DATA EXTRACTION:Studies were chosen based on strength of association with and relevance to cardiogenic shock. DATA SYNTHESIS:Until recently, there were few options if cardiogenic shock was refractory to vasopressors or intra-aortic balloon pump counterpulsation. Now, several percutaneous mechanical circulatory support devices, including Impella (Abiomed, Danvers, MA), TandemHeart (CardiacAssist, Pittsburgh, PA), and extracorporeal membrane oxygenation, are more accessible. Compared with intra-aortic balloon pump, Impella provides greater hemodynamic support but no reduction in mortality. Similarly, TandemHeart improves hemodynamic variables but not survival. Comparative studies have been underpowered for mortality because of small sample size. Veno-arterial extracorporeal membrane oxygenation offers the advantage of biventricular circulatory support and oxygenation, but there are significant vascular complications. Comparative studies with extracorporeal membrane oxygenation have not been completed. Despite lack of randomized controlled data, there has been a substantial increase in use of percutaneous mechanical circulatory support. Several ongoing prospective studies with larger sample sizes may provide answers, and newer devices may become smaller, easier to insert, and more effective. CONCLUSIONS:Mortality from cardiogenic shock remains unacceptably high despite early coronary revascularization or other therapies. Although evidence is lacking and complications rates are high, improvements and experience with percutaneous mechanical circulatory support may offer the prospect of better outcomes.

Dataset Information

Complications from percutaneous-left ventricular assist devices versus intra-aortic balloon pump in acute myocardial infarction-cardiogenic shock.

Publications

Complications from percutaneous-left ventricular assist devices versus intra-aortic balloon pump in acute myocardial infarction-cardiogenic shock.

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