Impella Use Research Articles

Use of Impella in Patients Listed for Heart Transplantation

<h3>Purpose</h3> The new United Network for Organ Sharing (UNOS) policy has resulted in significantly higher number of temporary mechanical support device use including IMPELLA due to provision of higher priority with its use while on waitlist. We aimed to identify temporal changes in IMPELLA use and its outcomes in patients awaiting heart transplant (HTx). <h3>Methods</h3> The UNOS thoracic organ transplant database was queried between years 2015 and 2019 for patients aged >17 years, listed to undergo HTx. The available dataset was stratified in 2 groups based on implementation of UNOS policy (Oct 18, 2018); new and old era. Basic descriptive statistics were used to analyze the data. <h3>Results</h3> A total of 378 patients had IMPELLA awaiting HTx. The IMPELLA use skyrocketed from 2015 (1%) to 2019 (4%, Cochran-Armitage p <0.01, Figure 1A). The risk profile of IMPELLA patients before and after the policy change in terms of listing age, PA pressure, creatinine and heart failure etiology were comparable. . More patients with IMPELLA directly transplanted (81% vs. 56%, p<.01), had lower waiting time (median 12 vs. 45 days, p<.01), waitlist mortality (24% vs. 12%, p<.01), and converted to a durable support (13% vs. 5%) after policy change (Figure 1B). <h3>Conclusion</h3> The IMPELLA use as a temporary support device for bridge to HTx has significantly increased after UNOS policy change. This increase has resulted in more patients transplanted while supported by Impella on waiting list. This increase in IMPELLA use shows a substantial change in practice patterns of listing and managing patients on the HTx waitlist.

Outcomes of Heart Transplant Recipients Bridged with Percutaneous versus Durable LVADs

<h3>Purpose</h3> The new UNOS heart allocation policy prioritizes patients with percutaneous ventricular support devices over durable LVADs. We examined one-year survival of heart transplant recipients successfully bridged with Impella versus durable LVADs in the most recent era. <h3>Methods</h3> We retrospectively reviewed all primary adult orthotopic heart transplant recipients in the UNOS registry between Jan 1, 2016 to June 12, 2020. Recipients were identified as having an isolated durable LVAD or Impella device at the time of transplant. Those bridged with ECMO, RVAD, BIVAD, or TAH were excluded. One-year survival was examined with the Kaplan Meier method and multivariable Cox proportional hazards regression. <h3>Results</h3> Of 10,492 heart transplant recipients in the study period, 4610(44%) were bridged with a durable LVAD and 158(2%) with Impella. Impella use increased following the UNOS allocation policy change (3% vs 1% of transplants, p<0.01) and a higher proportion were status 1 or 2 compared to those bridged with durable LVADs (96% vs 26%, p<0.01). Median days between listing and transplant were 40, 218, and 13 days for no MCS, durable LVAD, and Impella, respectively (p<0.01). Impella-bridged recipients were less likely to be obese (26% vs 41%, p<0.01), have diabetes (24% vs 31%, p<0.01), ischemic cardiomyopathy (28% vs 35%, p<0.01), prior cardiac surgery (27% vs 73%, p<0.01), and were more likely to be on inotropes at the time of transplant (65% vs 6%, p<0.01). On multivariate analysis, neither bridge with durable LVAD (aHR 1.25, 95% CI 0.97-1.62, p = 0.08) nor Impella (aHR 1.07, 95% CI 0.55-2.08, p=0.84) was associated with a difference in one-year survival following heart transplantation. <h3>Conclusion</h3> Impella utilization as bridge to transplant has tripled in the current era of heart transplantation with no significant difference in one-year survival compared to those bridged with durable LVADs. Percutaneous LVAD platforms can be cautiously considered in the sickest patients requiring LVAD bridge to transplantation.

Effects of the UNOS Allocation Policy Change on Impella Use as Bridge in Heart Transplant

<h3>Purpose</h3> Impella is used as a bridge for heart transplantation (HT) in unstable patients. We sought to compare baseline characteristics and 6-month post-transplant survival in patients who utilized impella as a bridge to HT in the one year before and after the UNOS allocation policy change. <h3>Methods</h3> We queried the UNOS database for all adult heart transplant recipients that were bridged to heart transplantation with an Impella device (n=90). Exclusion criteria included patients who were younger than 18 years old, lost to follow-up, or who had multi-organ transplant were excluded. Pre-policy era (n=25) and post-policy era (n=65) baseline characteristics were compared via standard statistical analysis, reported in median and IQR. Kaplan Meier survival analysis and univariate cox regression were performed. Multivariate cox proportional hazard (PH) regression analysis was adjusted for age, donor age, recipient creatinine and bilirubin at the time of heart transplantation, dialysis, and ischemic time. <h3>Results</h3> There was no difference in baseline characteristics between groups. The post policy change was associated with increased ischemic time (3.8 vs 2.8 hours, p=0.01) and increased distance from donor and recipient hospitals (248 vs 36 nautical miles, p=0.01). UNOS policy change was not a significant predictor of post-transplant mortality on either unadjusted (p >0.9) or adjusted (p>0.9) Cox PH modeling. <h3>Conclusion</h3> The distance between donor hospital to transplant center was farther, and ischemic time was longer in the post-era policy change. In spite of this, overall mortality was unchanged.

Impella use in real-world cardiogenic shock patients: Sobering outcomes

BackgroundCritically ill patients with cardiogenic shock could benefit from ventricular assist device support using the Impella microaxial blood pump. However, recent studies suggested Impella not to improve outcomes. We, therefore, evaluated outcomes and predictors in a real-world scenario.MethodsIn this retrospective single-center trial, 125 patients suffering from cardiac arrest/cardiogenic shock between 2008 and 2018 were analyzed. 93 Patients had a prior successful cardiopulmonary resuscitation. The primary endpoint was hospital mortality. Associations of covariates with the primary endpoint were assessed by univariable and multivariable logistic regression. Adjusted odds ratios (aOR) and optimal cut-offs (using Youden index) were obtained.ResultsHospital mortality was high (81%). Baseline lactate was 4.7mmol/L [IQR = 7.1mmol/L]. In multivariable logistic regression, only age (aOR 1.13 95%CI 1.06–1.20; p<0.001) and lactate (aOR 1.23 95%CI 1.004–1.516; p = 0.046) were associated with hospital mortality, and the respective optimal cut-offs were >3.3mmol/L and age >66 years.Patients were retrospectively stratified into three risk groups: Patients aged ≤66 years and lactate ≤3.3mmol (low-risk; n = 22); patients aged >66 years or lactate >3.3mmol/L (medium-risk; n = 52); and patients both aged >66 years and lactate >3.3mmol/L (high-risk, n = 51). Risk of death increased from 41% in the low-risk group, to 79% in the medium risk group and 100% in the high-risk group. The predictive abilities of this model were high (AUC 0.84; 95% 0.77–0.92).ConclusionMortality was high in this real-world collective of severely ill cardiogenic shock patients. Better patient selection is warranted to avoid unethical use of Impella. Age and lactate might help to improve patient selection.

Abstract 14634: Hospital Teaching Status and Variation in Outcomes: Evidence From Patients Undergoing Multi-vessel Percutaneous Coronary Interventions

Background and Objectives: Evidence suggests variations in medical services provided by hospital teaching status. However, there is limited data on how it affects hospital outcomes. The aim of this study is to examine differences in outcomes among patients who underwent multi-vessel percutaneous coronary intervention (MVPCI) stratified by hospital teaching status. Methods: We queried the 2016 Nationwide Inpatient Sample database and identified patients who underwent MVPCI using ICD-10 procedure codes. Hospital teaching status was classified as urban teaching vs. non- teaching. Chi-square and Wilcoxon rank-sum tests were used to compare the following outcomes between hospitals: patient demographics, clinical outcomes, in-hospital mortality, length of stay (LOS), and total charges. Results: Among the 15,611 MVPCI procedures performed, 73.5% were done in teaching hospitals. 68.4% of the MVPCI in teaching hospitals were in males and 54.1% in patients aged ≥65 years. Teaching hospitals had a lower proportion of whites (74.1% vs 79.5%, p&lt;0.001). Teaching and non-teaching hospitals did not differ significantly in impella use (1.7% vs 1.7%, p=0.9928), IABP use (2.2% vs. 2.3%, p=0.7156) and in-hospital mortality (2.0% vs 2.2% p=0.3399). The incidence of acute renal failure (14.0% vs 13.5%, p=0.3858), cardiogenic shock (4.5% vs 4.7%, p=0.5969), cardiac tamponade (0.2% vs 0.2% p=0.5769), and ventricular fibrillation (2.6% vs 2.9%, p=0.2570) did not differ significantly. However, the median length of stay (LOS) (3 vs 2 days, p=0.0075) and hemorrhage requiring transfusion (HRT) (5.6% vs 4.7%, p=0.0414) were significantly greater in teaching centers. In contrast, total hospital charges ($96,465 vs. $106,711, p&lt;0.0001) was lower in teaching centers. Conclusion: Our analysis did not show any differences with regards to in-hospital deaths, IABP use, impella use and many of the hospital outcomes in MVPCI. In teaching centers, the occurrence of HRT and the mean LOS was increased, but there was no increased financial costs.

Analysis of Adverse Events Related to Impella Usage (from the Manufacturer and User Facility Device Experience and National Inpatient Sample Databases)

Impella devices are increasingly utilized for hemodynamic support in high-risk percutaneous coronary intervention or cardiogenic shock despite a lack of randomized clinical trial data showing clinical benefit and newer observational data suggesting harm. In this retrospective analysis, our aim was to determine the most common adverse events associated with Impella usage reported annually to the Food and Drug Administration Manufacturer and User Facility Device Experience (MAUDE) database and to estimate via the National Inpatient Sample (NIS) database the number of percutaneous ventricular assist devices utilized and associated with inpatient mortality since introduction of the Impella. Among the 885 complete reports submitted to the MAUDE database from 2008 to 2019 related to Impella usage, there were 1,206 complications coded; 88.2% of reports occurred from 2016 to 2019. Among patients with adverse events reported, bleeding (32.8%), device deployment or retrieval issues (18.2%), vascular complications (15.8%), and death (12.4%) were the most common, and 7.9% of all complications were attributable to operator decision-making or technique. From 2007 to 2017 there was a >100-fold increase in percutaneous ventricular assist devices use with an increase and plateau in in-hospital mortality to 31% from 2012 to 2016 based on NIS data. In conclusion, Impella use has increased substantially over the last decade but remains associated with high inpatient mortality and serious complications based on data from the NIS and MAUDE databases. These findings emphasize the need for high quality randomized controlled trials to determine the clinical utility of Impella in high-risk percutaneous coronary intervention and cardiogenic shock.

TCT CONNECT-181 A Propensity Matched Analysis of Impella Use From a Large-Scale Claims Data: Influence of Analytic Methodology on Clinical Outcomes

TCT CONNECT-181 A Propensity Matched Analysis of Impella Use From a Large-Scale Claims Data: Influence of Analytic Methodology on Clinical Outcomes

Outcomes with Impella in Cardiogenic Shock

Background The Impella (ABIOMED, Danvers, MA) is a temporary left ventricular support device, intended for short-term cardiac support for percutaneous procedures and cardiac shock. The Impella device is available in several sizes capable of producing different flows. It is FDA approved for up to 6 days of support. The device can provide significantly higher blood flow than an intra-aortic balloon pump and can be implanted percutaneously. We sought to describe potential complications and outcomes associated with extended Impella use for cardiogenic shock. Methods We retrospectively evaluated patients who underwent implantation of either the Impella CP (Impella 3.5) or Impella 5.0 from September 1, 2017 to September 1, 2019 at our institution. Hemolysis was defined as plasma free hemoglobin level > 50 mg/dL, a lactate dehydrogenase (LDH) level > 500 units/L, and bilirubin increase > 1 mg/dL. Results 58 patients underwent percutaneous insertion of an Impella device, with the indication of cardiogenic shock in 32 patients (55%). In these 32 patients, only one had an Impella 2.5 device, 21 had an Impella CP (66%), and 10 (31%) had an Impella 5.0. The average age at time of implantation was 55 ± 17 years, and 25 patients were male (78%). Ejection fraction was 17 ± 11.7%. The average duration of Impella support was 5.5 days (1, 16 days). Complications included hematoma at the time of insertion (3 patients), leg ischemia (2 patients), improper positioning (7 patients), acute renal failure (28 patients), and hemolysis (20 patients). Hemolysis developed in 12 patients (57%) with the Impella CP and in 8 patients (80%) with the Impella 5.0, with an average LDH of 1452 units/L. 8 patients were transitioned to veno-arterial (VA) extracorporeal membrane oxygenation (ECMO), with the Impella utilized for left ventricular venting. 9 patients (28%) eventually underwent durable left ventricular assist device (LVAD) implantation on average 7 ± 6.1 days after Impella, and two patients underwent heart transplantation, both 9 days following Impella insertion. 23 patients (72%) did not survive past the initial hospitalization. Conclusion The Impella is a percutaneous temporary left ventricular support device used to provide additional cardiac output in patients with cardiogenic shock. Serious complications can occur with extended support, including hemolysis, acute renal failure, and high mortality. Of our 28 patients who received an Impella, 11 were able to be successfully bridged to either LVAD or heart transplantation with the Impella.

Percutaneous large-bore axillary access is a safe alternative to surgical approach: A systematic review.

To systematically review relevant literature regarding cardiovascular outcomes of large-bore axillary arterial access via percutaneous and surgical approaches. In patients with severe peripheral arterial disease (PAD) undergoing cardiac interventions, large-bore femoral access may be prohibitive. The axillary artery provides an alternative vascular access for transcatheter aortic valve replacement (TAVR) or mechanical circulatory support. There have been limited comparisons of percutaneous transaxillary (pTAX) approach with the more traditional surgical transaxillary (sTAX) approach. Pubmed and Medline databases were queried through January 2019 for studies describing pTAX or sTAX approaches with TAVR or Impella insertion. Primary outcomes were access-related mortality, 30-day mortality, stroke, major vascular complications, and major bleeding. One hundred and fifty five studies were reviewed, with additional unpublished data from 1 institution. Twenty-two studies met the inclusion criteria. Patient data was heterogeneous, with 69% TAVR and 31% Impella use in the pTAX group, and 96% TAVR and 4% Impella use in the sTAX group. There was more cardiogenic shock in the pTAX group. When compared to surgical approach, the percutaneous approach had similar 30-day mortality for TAVR (5.6% vs 4.6%, OR non-significant) and Impella (43.4% vs 38.6%, OR non-significant), similar stroke rates (4.3% vs 4.2%, OR non-significant), similar major vascular complications (2.8% vs 2.3%, OR non-significant) and less major bleeding (2.7% vs 17.9%, OR significant). Data suggests large-bore pTAX access has similar 30-day mortality, stroke rates, and major vascular complications as sTAX access, with less major bleeding. Additional studies are needed to validate results.

Impella in cardiogenic shock following acute myocardial infarction: a systematic review and meta-analysis.

Cardiogenic shock (CS) conveys ahigh mortality risk. Acardiac assist device may serve as bridge to patient recovery. We aimed to provide apooled estimate on mortality and complications from studies evaluating the use of the left ventricular assist device Impella in CS following acute myocardial infarction. In addition, we evaluated whether mortality risk differed with device placement before or after percutaneous coronary intervention (PCI). We searched Medline, Embase and Web of Science from 2005 until July 2019 for observational studies or clinical trials on this specific patient group. Studies were required to report on 30-day all-cause mortality and device-related complications. We calculated pooled proportions with 95% confidence intervals (CI) using random effects models and the inverse variance method. Overall, 671 patients from 11studies (2randomized and 9observational) were included. Pooled proportions showed a30-day mortality of 54.6% (95% CI 47.3-61.8; P = 0.22; I2 = 65.8%). Among complications, major bleeding was found in 19.9% (95% CI 14.2-27.3; P < 0.05; I2 = 69.1%), hemolysis in 10.5% (95% CI 7.2-15.0; P < 0.05; I2 = 52.1%), limb ischemia in 5.0% (95% CI 2.6-9.5; P < 0.05; I2 = 48.3%) and stroke in 3.8% of patients (95% CI 2.4-5.9; P < 0.05; I2 = 0%). Sensitivity analysis demonstrated astatistically significant risk reduction in 30-day mortality when Impella was implanted prior to PCI as compared to after PCI, risk ratio (RR): 0.71, CI 0.58-0.86, P = 0.001, I2 = 0%. Pooled estimates of Impella use in myocardial infarction with CS revealed a high 30-day mortality; however, as compared to post-PCI, Impella initiation prior to PCI was associated with a survival benefit.

IN-HOSPITAL OUTCOMES OF IMPELLA VERSUS IABP IN ST ELEVATED MYOCARDIAL INFARCT: WHAT THE REAL WORLD LOOKS LIKE

Previous studies showed inconsistent outcomes of using Impella and intra-aortic balloon pump (IABP) in complex revascularization and myocardial infarction (MI) with shock. We compared in-hospital outcomes associated with Impella and IABP use in patients with ST-elevation MI (STEMI). In a

Management of spontaneous coronary artery dissection complicated by cardiogenic shock using mechanical circulatory support with the Impella device.

The aim is to evaluate the feasibility of using mechanical circulatory support, specifically the Impella device, in spontaneous coronary artery dissection (SCAD) patients with cardiogenic shock. The therapeutic options for managing SCAD complicated by cardiogenic shock are limited. Risky revascularization procedures are often necessary. This was a multicenter case series in the United States. Approximately 20 cases of Impella implantation in patients with SCAD are known. The implanting physician for each of these cases was contacted and de-identified records were requested. The records were analyzed for Impella indications, outcomes, and complications. Records from four cases were received. All patients survived to hospital discharge and no major complications were observed. In two cases, cardiogenic shock developed in the absence of ongoing ischemia, suggesting a Takotsubo-like cardiomyopathy. In these cases, the Impella provided hemodynamic support until the patient's cardiac function recovered. Although a small case series, given the scarcity of SCAD cases complicated by cardiogenic shock and the limited therapies available to treat these patients, these data are of clinical value in highlighting the feasibility of Impella use in SCAD. The Impella can be valuable for procedural support and in cardiogenic shock, especially in cases without evidence of ongoing ischemia.

The Evolving Landscape of Impella Use in the United States Among Patients Undergoing Percutaneous Coronary Intervention With Mechanical Circulatory Support.

Impella was approved for mechanical circulatory support (MCS) in 2008, but large-scale, real-world data on its use are lacking. Our objective was to describe trends and variations in Impella use, clinical outcomes, and costs across US hospitals in patients undergoing percutaneous coronary intervention (PCI) treated with MCS (Impella or intra-aortic balloon pump). From the Premier Healthcare Database, we analyzed 48 306 patients undergoing PCI with MCS at 432 hospitals between January 2004 and December 2016. Association analyses were performed at 3 levels: time period, hospital, and patient. Hierarchical models with propensity adjustment were used for association analyses. We examined trends and variations in the proportion of Impella use, and associated clinical outcomes (in-hospital mortality, bleeding requiring transfusion, acute kidney injury, stroke, length of stay, and hospital costs). Among patients undergoing PCI treated with MCS, 4782 (9.9%) received Impella; its use increased over time, reaching 31.9% of MCS in 2016. There was wide variation in Impella use across hospitals (>5-fold variation). Specifically, among patients receiving Impella, there was a wide variation in outcomes of bleeding (>2.5-fold variation), and death, acute kidney injury, and stroke (all ≈1.5-fold variation). Adverse outcomes and costs were higher in the Impella era (years 2008-2016) versus the pre-Impella era (years 2004-2007). Hospitals with higher Impella use had higher rates of adverse outcomes and costs. After adjustment for the propensity score, and accounting for clustering of patients by hospitals, Impella use was associated with death: odds ratio, 1.24 (95% CI, 1.13-1.36); bleeding: odds ratio, 1.10 (95% CI, 1.00-1.21); and stroke: odds ratio, 1.34 (95% CI, 1.18-1.53), although a similar, nonsignificant result was observed for acute kidney injury: odds ratio, 1.08 (95% CI, 1.00-1.17). Impella use is rapidly increasing among patients undergoing PCI treated with MCS, with marked variability in its use and associated outcomes. Although unmeasured confounding cannot be ruled out, when analyzed by time periods, or at the hospital level or the patient level, Impella use was associated with higher rates of adverse events and costs. More data are needed to define the appropriate role of MCS in patients undergoing PCI.

P1710Risk of Mortality associated with use of mechanical support devices among comatose cardiac arrest patients

Abstract Background The impact of mechanical circulatory assist devices (MCS) has not been well studied in cardiac arrest survivors. We examined that association of MCS with risk of mortality among comatose cardiac arrest survivors Purpose Compare the survival between different MCS and non MCS groups Methods This is a retrospective cohort study of 1417 comatose adult cardiac arrest survivors that survived for at least 1 day post cardiopulmonary resuscitation. Cox proportional hazard models adjusted for demographics, resuscitation parameters, comorbidities and medications were used to compute hazard ratios for extracorporeal membrane oxygenation (ECMO), ECMO + Impella/intraaortic balloon pump (IABP), IABP and Impella associated with risk of short term 60 day mortality. Kaplan meier's curves were used to demonstrate cumulative survival rate. Results Among 1417 cardiac arrest survivors, MCS was used among 553 (39.1%) patients. After 60 days of follow up, mortality rate was 49.4% in non MCS group, 58.6% in IABP group, 22.9% in Impella group, 40.0% in ECMO only group, 50.0% in ECMO + Impella/IABP group. When compared with no MCS use, only Impella use was associated with decrease risk of short term mortality (HR 0.37; 95% CI 0.16–0.83, p=0.02) while there was no significant association of other forms of MCS with short term mortality. There was no significant association of any MCS with long term mortality. Kaplan-Meier curves demonstrate early benefit of Impella and very early benefit of ECMO (figure 1). Conclusions This is the first large study to report various types of MCS use among comatose cardiac arrest survivors and has shown an indication of benefit with Impella use only in first 60 days post cardiac arrest. Future prospective study may be needed to validate this association Acknowledgement/Funding None

Hemodynamic support with Impella ventricular assist device in patients undergoing TAVI: A single center experience.

Transcatheter aortic valve implantation (TAVI) has become a well-established therapeutic option for patients with severe aortic stenosis (AS) at high to intermediate surgical risk. Although TAVI is associated with low mortality of 1.2-6.5%, cardiogenic shock (CS) as a peri-interventional complication remains a challenging problem with very high morbidity and mortality. This study evaluated the clinical outcome of the use of Impella ventricular assist device in patients undergoing TAVI. Between 11/2015 and 08/2018, all patients undergoing TAVI requiring temporary circulatory during the same index hospitalization were included. Primary endpoint was 30-day all-cause mortality. Secondary endpoints were peri-interventional mortality and 30-day stroke rate. Of the 390 patients undergoing TAVI, 13 (3%) required hemodynamic support with an Impella device. Of these, 3 (23%) underwent protected high-risk PCI before TAVI and 10 patients (77%) needed emergency periprocedural hemodynamic support due to cardiogenic shock. Mortality at 30 days was 0% in Impella-protected PCI and 40% with Impella use for periprocedural CS. No stroke occurred in the cohort up to 30 days. Insertion of the Impella device in the setting of TAVI was fast with a mean insertion time of 10 min. Eight patients (80%) in the periprocedural CS group required cardiopulmonary resuscitation prior to Impella use. There was only one device-related complication. Temporary hemodynamic support with the Impella device in patients with severe aortic valve stenosis or in CS secondary to complicated TAVI was technically doable and allowed stabilization and treatment of salvageable patients.

Predictors of Mortality and Outcomes of Acute Severe Cardiogenic Shock Treated with the Impella Device

The Impella (Abiomed, Danvers, Massachusetts) device is increasingly used for mechanical circulatory support (MCS) to treat acute severe cardiogenic shock (CS). Initial and continued determination of the appropriate degree of MCS is challenging. This study evaluates predictors of mortality in patients treated with the Impella for acute severe CS and outcomes associated with prolonged Impella use. This retrospective single-center study included 204 patients treated with the Impella 2.5, Impella CP, or Impella 5.0 from 2011 to 2018 for acute severe CS. The primary end point was all-cause in-hospital mortality. All-cause in-hospital mortality was 45.1%. Nonsurvivors had a lower initial pH (7.24 vs 7.32, hazard ratio [HR] 1.03, p <0.0001), lower serum CO2 (19.1 vs 21.3 mmol/L, HR 1.08, p = 0.002), higher lactate (6.8 vs 3.3 mmol/L, HR 1.17, p <0.0001), and used a greater number of vasopressors and inotropes (4.3 vs 2.6, HR 1.44, p <0.0001). Patients with the Impella >4 days (n = 45) had a longer intensive care unit stay (12.6 vs 6.9 days, p <0.001), longer total hospital stay (16.4 vs 11.6 days, p = 0.03), longer mechanical ventilation use (7.8 vs 4.4 days, p = 0.002), and trend toward increased mortality (57.8 vs 41.5%, p = 0.051). In conclusion, in patients treated with the Impella for acute severe CS, initial biochemical parameters and need for vasopressors and inotropes are significant predictors of mortality that can serve as valuable indicators of whether the Impella or higher level of MCS is more appropriate. Patients treated with the Impella beyond 4 days have poorer outcomes and may benefit from escalation of care.

Impella use in acute myocardial infarction complicated by cardiogenic shock and cardiac arrest: Analysis of 10 years registry data

AimsTo assess characteristics and outcome of patients treated with Impella for acute myocardial infarction (AMI) complicated by severe cardiogenic shock (CS) or cardiac arrest (CA). Methods and resultsFrom 2008 through 2017, 92 patients with AMI complicated by CS were treated with Impella. Survival varied according to clinical presentation. Patients in cardiogenic shock without CA had a 75% 30-day survival. Patients with CA and return of spontaneous circulation (ROSC) had a 43% survival and those with CA and ongoing cardio-pulmonary resuscitation (CPR) had a 6% 30-day survival. Age, pre-existing hypertension, coronary disease, ventilatory support and use of adrenergic agents were associated with worse prognosis. Complications were predominantly access site related. ConclusionsIn this registry of patients with AMICS treated with Impella, hypertension and older age were found to be negatively predictive for survival. Patients without CA had the highest 30-day survival. In patients with ROSC, survival was strongly related to age and comorbidity. Patients with ongoing CPR had very high mortality.

Long-Term Outcomes of Extent of Revascularization in Complex High Risk and Indicated Patients Undergoing Impella-Protected Percutaneous Coronary Intervention: Report from the Roma-Verona Registry.

Objective To investigate the effect of extent of revascularization in complex high-risk indicated patients (CHIP) undergoing Impella-protected percutaneous coronary intervention (PCI). Background Complete revascularization has been shown to be associated with improved outcomes. However, the impact of more complete revascularization during Impella-protected PCI in CHIP has not been reported. Methods A total of 86 CHIP undergoing elective PCI with Impella 2.5 or Impella CP between April 2007 and December 2016 from 2 high volume Italian centers were included. Baseline, procedural, and clinical outcomes data were collected retrospectively. Completeness of coronary revascularization was assessed using the British Cardiovascular Intervention Society myocardial jeopardy score (BCIS-JS) derived revascularization index (RI). The primary end-point was all-cause mortality. A multivariate regression model was used to identify independent predictors of mortality. Results All patients had multivessel disease and were considered unsuitable for surgery. At baseline, 44% had left main disease, 78% had LVEF ≤ 35%, and mean BCIS-JS score was 10±2. The mean BCIS-JS derived RI was 0.7±0.2 and procedural complications were uncommon. At 14-month follow-up, all-cause mortality was 10.5%. At follow-up, 67.4% of CHIP had LVEF ≥ 35% compared to 22.1% before Impella protected-PCI. Higher BCIS-JS RI was significantly associated with LVEF improvement (p=0.002). BCIS-JS RI of ≤ 0.8 (HR 0.11, 95% CI 0.01- 0.92, and p = 0.042) was an independent predictor of mortality. Conclusions These results support the practice of percutaneous Impella use for protected PCI in CHIP. A more complete revascularization was associated with significant LVEF improvement and survival.

TCT-451 Incidence, Correlates and impact of left ventricular ejection fraction improvement on short- and long-term clinical outcome of patients undergoing high-risk percutaneous coronary intervention. A single center experience

The use of a percutaneous mechanical support device such as Impella (Abiomed Inc. Danvers, Massachusetts) facilitates high-risk percutaneous coronary interventions (HRPCI), particularly in the setting of reduced left-ventricular ejection fraction (LVEF). The extent to which Impella use in this

A retrospective analysis of Impella use in all-comers: 1-year outcomes.

There are non-randomized data about the benefits of Impella use in the setting of cardiogenic shock. However, limited data exist to help guide clinicians about whether in the context of the intervention the device should be implanted early or late; how long the device should stay in; and how the mode of explant should be. This is a retrospective, single center registry over 5 years comparing in-hospital outcomes and 1-year mortality in all-comers who had the Impella device placed early versus those who had the device placed late as a bailout. The primary endpoint was a composite of in-hospital all-cause mortality, major vascular, bleeding complications, and stroke. A secondary endpoint was 1-year mortality. Of 262 total patients, 181 (69.1%) had early and 81 (30.9%) had late Impella placement. Patients in the early group had a lower combined MACCE (17.1% vs 59.3%, P < 0.001) and in-hospital mortality (8.8% vs 48.1%, P < 0.001) compared to the late group. Major vascular (3.3% vs 2.5%, P = 1.0), bleeding complications (5.0% vs 7.4%, P = 0.57), and stroke (3.3% vs 7.4%, P = 0.20) were not significant between groups. Early Impella placement had lower 6 month (17.7% vs 53.1%, P < 0.001) and 1-year mortality rates (21.5% vs 53.1%, P < 0.001) compared to those in the late group. For patients with need for an Impella device, regardless of the indication, early implantation is associated with better in-hospital and 1-year outcomes as compared to when the device is implanted late as a bailout.