Real-World Data on the Intravascular Microaxial Left Ventricular Flow Pump (Impella) in High-Risk Patients.
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SUBMITTER: Rao SV
PROVIDER: S-EPMC8176068 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:BackgroundThe use of an Impella pump catheter has advanced substantially in the last few years due to the simple insertion procedure and smaller device size. However, its use is still associated with some risks and complications. Here, we report a device fracture as a rare complication that occurred during the device extraction a few days after the initial insertion.Case summaryA 74-year-old man with cardiogenic shock due to acute non-ST-segment elevation myocardial infarction presented to our hospital, and he was transferred to the cath lab for emergency percutaneous coronary intervention (PCI). An Impella CP pump was inserted without any complication prior to PCI. After successful PCI, the patient was transferred to the intensive care unit with device left for continued haemodynamic support. After 3 days, as the patient's condition remarkably improved, we tried to remove the device. However, a persistent mechanical resistance hindered the further catheter retraction; therefore, a decision was made to remove the catheter under fluoroscopy. Indeed, the fluoroscopy revealed a broken distal part of the pump at the level of the ascending aorta. The retained catheter tip was eventually snared with a snare catheter and removed without any complication.DiscussionAn Impella microaxial pump may improve the overall outcome by providing haemodynamic support in critically ill patients. However, its application is not without complications. Intravascular device tip fracture, as demonstrated in this case report, is a rarely reported complication. The use of a snare catheter can be an option in retrieving a broken pump.
| S-EPMC9397508 | biostudies-literature
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.
| S-EPMC7042879 | biostudies-literature
Project description:BackgroundCardiac remodeling, after a myocardial insult, often causes progression to heart failure. The relationship between alterations in left ventricular blood flow, including kinetic energy (KE), and remodeling is uncertain. We hypothesized that increasing derangements in left ventricular blood flow would relate to (1) conventional cardiac remodeling markers, (2) increased levels of biochemical remodeling markers, (3) altered cardiac energetics, and (4) worsening patient symptoms and functional capacity. Methods Thirty-four dilated cardiomyopathy patients, 30 ischemic cardiomyopathy patients, and 36 controls underwent magnetic resonance including 4-dimensional flow, BNP (brain-type natriuretic peptide) measurement, functional capacity assessment (6-minute walk test), and symptom quantification. A subgroup of dilated cardiomyopathy and control subjects underwent cardiac energetic assessment. Left ventricular flow was separated into 4 components: direct flow, retained inflow, delayed ejection flow, and residual volume. Average KE throughout the cardiac cycle was calculated.ResultsPatients had reduced direct flow proportion and direct-flow average KE compared with controls ( P<0.0001). The residual volume proportion and residual volume average KE were increased in patients ( P<0.0001). Importantly, in a multiple linear regression model to predict the patient's 6-minute walk test, the independent predictors were age (β=-0.3015; P=0.019) and direct-flow average KE (β=0.280, P=0.035; R2 model, 0.466, P=0.002). In contrast, neither ejection fraction nor left ventricular volumes were independently predictive.ConclusionsThis study demonstrates an independent predictive relationship between the direct-flow average KE and a prognostic measure of functional capacity. Intracardiac 4-dimensional flow parameters are novel biomarkers in heart failure and may provide additive value in monitoring new therapies and predicting prognosis.
| S-EPMC6544522 | biostudies-literature
Project description:Worldwide, the left ventricular assist device Impella® (Abiomed, Danvers, MA, USA) is increasingly implanted in patients with acute cardiogenic shock or undergoing high-risk cardiac interventions. Despite its long history of use, few studies have assessed its safety and possible complications associated with its use. All patients treated with a left-sided Impella® device at the University Hospital of Basel from 1 January 2011 to 31 December 2019 were enrolled. The primary endpoint was the composite rate of mortality and adverse events (bleeding, acute kidney injury, and limb ischemia). Out of 281 included patients, at least one adverse event was present in 262 patients (93%). Rates of in-hospital, 90-day, and one-year mortality were 48%, 47%, and 50%, respectively. BARC type 3 bleeding (62%) and hemolysis (41.6%) were the most common complications. AKI was observed in 50% of all patients. Renal replacement therapy was required in 97 (35%) of all patients. Limb ischemia occurred in 13% of cases. Bleeding and hemolysis are common Impella®-associated complications. Additionally, we found a high rate of AKI. A careful selection of patients receiving microaxial LV support and defining the indication for its use are essential measures to be taken for the benefits to outweigh potential complications.
| S-EPMC8396891 | biostudies-literature
Project description:AimsMortality in cardiogenic shock patients remains high. Short-term mechanical circulatory support with Impella can be used to support the circulation in these patients, but data from randomised controlled studies and 'real-world' data are sparse. The aim is to describe real-life data on outcomes and complications of our 12 years of clinical experience with Impella in patients with cardiogenic shock after acute myocardial infarction and to identify predictors of 6-month mortality.MethodsWe describe a single-centre registry from October 2004 to December 2016 including all patients treated with Impella for cardiogenic shock after acute myocardial infarction. We report outcomes and complications and identify predictors of 6-month mortality.ResultsOur overall clinical experience consists of 250 patients treated with Impella 2.5, Impella CP or Impella 5.0. A total of 172 patients received Impella therapy for cardiogenic shock, of which 112 patients had cardiogenic shock after acute myocardial infarction. The mean age was 60.1±10.6 years, mean arterial pressure was 67 (56-77) mmHg, lactate was 6.2 (3.6-9.7) mmol/L, 87.5% were mechanically ventilated and 59.6% had a cardiac arrest before Impella placement. Overall 30-day mortality was 56.2% and 6-month mortality was 60.7%. Complications consisted of device-related vascular complications (17.0%), non-device-related bleeding (12.5%), haemolysis (7.1%) and stroke (3.6%). In a multivariate analysis, pH before Impella placement is a predictor of 6-month mortality.ConclusionsOur registry shows that Impella treatment in cardiogenic shock after acute myocardial infarction is feasible, although mortality rates remain high and complications occur.
| S-EPMC6616211 | biostudies-literature
Project description:The Impella (Abiomed, Danvers, MA, USA) is a novel percutaneous heart pump device for left ventricular (LV) assistance; however, LV thrombus is a notable contraindication for this device. Contrast computed tomography assessment is useful for detecting LV thrombus and preventing thromboembolism in patients recommended for Impella use. <Learning objective: The Impella (Abiomed, Danvers, MA, USA) is a heart pump device which aspirates blood from a left ventricular (LV) cavity and ejects it into an ascending aorta. Therefore, LV thrombus should be explored before the Impella insertion to prevent systemic embolism. Generally, echocardiography is the first choice to detect LV thrombus. Given limited diagnostic sensitivity for detecting LV thrombus in echocardiography, contrast computed tomography might be a useful strategy for the patient targeting Impella insertion.>.
| S-EPMC7718521 | biostudies-literature
Project description:Mechanical circulatory support (MCS) devices are effective tools in managing refractory cardiogenic shock (CS). Data comparing veno-arterial extracorporeal membrane oxygenation (VA-ECMO) and IMPELLA® are however scarce. We aimed to assess outcomes of patients implanted with these two devices and eligible to both systems. From 2004 to 2020, we retrospectively analyzed 128 patients who underwent VA-ECMO or IMPELLA® in our institution for refractory left ventricle (LV) dominant CS. All patients were eligible to both systems: 97 patients were first implanted with VA-ECMO and 31 with IMPELLA®. The primary endpoint was 30-day all-cause death. VA-ECMO patients were younger (52 vs. 59.4, p = 0.006) and had a higher lactate level at baseline than those in the IMPELLA® group (6.84 vs. 3.03 mmol/L, p < 0.001). Duration of MCS was similar between groups (9.4 days vs. 6 days in the VA-ECMO and IMPELLA® groups respectively, p = 0.077). In unadjusted analysis, no significant difference was observed between groups in 30-day mortality: 43.3% vs. 58.1% in the VA-ECMO and IMPELLA® groups, respectively (p = 0.152). After adjustment, VA-ECMO was associated with a significant reduction in 30-day mortality (HR = 0.25, p = 0.004). A higher rate of MCS escalation was observed in the IMPELLA® group: 32.3% vs. 10.3% (p = 0.003). In patients eligible to either VA-ECMO or IMPELLA® for LV dominant refractory CS, VA-ECMO was associated with improved survival rate and a lower need for escalation.
| S-EPMC7918655 | biostudies-literature
Project description:Many descriptive epidemiological and comparative studies using big data have been reported recently from outside Japan. Within Japan, diagnosis procedure combination (DPC) data and medical receipt data are being stored in electronic media, and real‐world evidence in various fields has started to be reported. We reviewed clinical studies on disseminated intravascular coagulation (DIC) using DPC data obtained from an insurance database with large numbers of cases and a related commercially available dataset including DPC and laboratory data. After DPC was introduced in 2003, 19 studies on DIC using Japanese national DPC data and two studies using the Medical Data Vision database were reported. Epidemiological findings in seven studies showed that the proportion of drugs administered for each underlying disease differed, with antithrombin and recombinant thrombomodulin (rTM) being used more frequently in clinical settings. In 14 comparative studies on anti‐DIC agents, antithrombin for severe pneumonia, postoperative intestinal perforation, and severe burn, and rTM for acute cholangitis were associated with improved survival rates. Large‐scale observational studies using big data can show results similar to those of randomized control trials if the quality of individual research is high. Real‐world data analysis will be increasingly necessary to complement the evidence gap unfilled by randomized control trials. Within Japan, diagnosis procedure combination (DPC) data and medical receipt data are being stored in electronic media, and real‐world evidence in various fields has started to be reported. We reviewed clinical studies on disseminated intravascular coagulation using DPC data obtained from an insurance database with large numbers of cases and a related commercially available dataset including DPC and laboratory data. Real‐world data analysis will be increasingly necessary to complement the evidence gap unfilled by randomized control trials.
| S-EPMC10083461 | biostudies-literature
Project description:The Impella percutaneous mechanical circulatory support device is designed to augment cardiac output and reduce left ventricular wall stress and aims to improve survival in cases of cardiogenic shock. In this meta-analysis we investigated the haemodynamic effects of the Impella device in a clinical setting. We systematically searched all articles in PubMed/Medline and Embase up to July 2019. The primary outcomes were cardiac power (CP) and cardiac power index (CPI). Survival rates and other haemodynamic data were included as secondary outcomes. For the critical appraisal, we used a modified version of the U.S. Department of Health and Human Services quality assessment form. The systematic review included 12 studies with a total of 596 patients. In 258 patients the CP and/or CPI could be extracted. Our meta-analysis showed an increase of 0.39 W [95% confidence interval (CI): 0.24, 0.54], (p = 0.01) and 0.22 W/m2 (95% CI: 0.18, 0.26), (p < 0.01) for the CP and CPI, respectively. The overall survival rate was 56% (95% CI: 0.50, 0.62), (p = 0.09). The quality of the studies was moderate, mostly due to the presence of confounders. Our study suggests that in patients with cardiogenic shock, Impella support seems effective in augmenting CP(I). This study merely investigates the haemodynamic effectiveness of the Impella device and does not reflect the complete clinical impact for the patient.
| S-EPMC7113339 | biostudies-literature
Project description:Background The Impella 5.5® was approved by the FDA for use for mechanical circulatory support up to 14 days in late 2019 at limited centers in the United States. Our single center’s experience with Impella 5.5® can expand the overall understanding for achieving successful patient outcomes as well as provide support for the expansion of its FDA-approved use. Methods This study is an IRB-approved single-center retrospective cohort analysis of hospitalized adult patient characteristics and outcomes in cases where the Impella 5.5® was utilized for mechanical circulatory support. Results A total of 26 implanted Impella 5.5® devices were identified in 24 hospitalized patients at our institution from January 2020 to January 2021. The overall survival rate during index hospitalization was 75%. Eleven Impella 5.5® devices were identified in 10 patients with an average device implantation greater than 14 days. Average device implantation for this subgroup was 27 days with a range of 15–80 days. Survival rate for Impella 5.5® use greater than 14 days was 67%. In the entire cohort and subgroup of device implantation > 14 days, evidence of end organ damage improved with Impella 5.5® use. Complications in our cohort and subgroup of device implantation > 14 days were similar to previously reported complication incidence of axillary inserted LVAD devices. Conclusions Our institution’s experience with the Impella 5.5® has been strongly positive with favorable outcomes and helps to establish the Impella 5.5® as a viable option for mechanical circulatory support beyond 14 days. Supplementary Information The online version contains supplementary material available at 10.1186/s13019-022-01871-1.
| S-EPMC9128113 | biostudies-literature