Impella Device Research Articles

The evolving role of percutaneous ventricular assist devices in high-risk cardiac patients.

The Impella is a mechanical circulatory support device that supports ventricular function. Since 2008, when the first Impella device received Food and Drug Administration clearance, its use has become increasingly prevalent. A variety of Impella devices are available, and are differentiated by size, power, and insertion techniques. These versions of the Impella have been used in a multitude of clinical scenarios, both emergent and elective, including high-risk coronary interventions, acute myocardial infarction complicated by cardiogenic shock, decompensated left and right heart failure, high-risk ventricular tachycardia ablations, and aortic valvuloplasty. However, the available evidence supporting its use is less than robust, primarily consisting of case reports and registries, with a limited number of randomized-controlled trials comparing the Impella with the intra-aortic balloon pump. Although these trials show that the Impella provides better hemodynamic support compared with the intra-aortic balloon pump, they failed to show a survival benefit for the Impella. This finding may have a number of explanations, foremost the inherent difficulty of selecting appropriate patients for trials that are conducted in extreme clinical settings. In this study, we discuss the mechanism of the Impella and the different types of Impella devices available, and review the medical literature for evidence of its efficacy in treating cardiac patients. Although the Impella has become ubiquitous in certain markets, such as in the USA, it has yet to be a part of the standard of care for patients in Israel.

Trends, etiologies, and predictors of 90-day readmission after percutaneous ventricular assist device implantation: A national population-based cohort study.

Percutaneous ventricular assist devices (pVADs) are indicated to provide hemodynamic support in high-risk percutaneous interventions and cardiogenic shock. However, there is a paucity of published data regarding the etiologies and predictors of 90-day readmissions following pVAD use. We studied the data from the US Nationwide Readmissions Database (NRD) for the years 2013 and 2014. Patients with a primary discharge diagnosis of pVAD use were collected by searching the database for International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) procedural code 37.68 (Impella and TandemHeart devices). Amongst this group, we examined 90-day readmission rates. Comorbidities as identified by "CM_" variables provided by the NRD were also extracted. The Charlson Comorbidity Index was calculated using appropriate ICD-9-CM codes, as a secondary diagnosis. A 2-level hierarchical logistic regression model was then used to identify predictors of 90-day readmission following pVAD use. Records from 7074 patients requiring pVAD support during hospitalization showed that 1562 (22%) patients were readmitted within 90 days. Acute decompensated heart failure (22.6%) and acute coronary syndromes (11.2%) were the most common etiologies and heart failure (odds ratio [OR]: 1.39, 95% confidence interval [CI]: 1.17-1.67), chronic obstructive pulmonary disease (OR: 1.26, 95% CI: 1.07-1.49), peripheral vascular disease (OR: 1.305, 95% CI: 1.09-1.56), and discharge into short- or long-term facility (OR: 1.28, 95% CI: 1.08-1.51) were independently associated with an increased risk of 90-day readmission following pVAD use. This study identifies important etiologies and predictors of short-term readmission in this high-risk patient group that can be used for risk stratification, optimizing discharge, and healthcare transition decisions.

Gender disparities with the use of percutaneous left ventricular assist device in patients undergoing percutaneous coronary intervention complicated by cardiogenic shock: From pVAD Working Group

BackgroundHemodynamic support with Impella (Abiomed Inc., Danvers, MA) devices is becoming a more prevalent treatment option for patients with cardiogenic shock (CS) undergoing percutaneous coronary intervention (PCI). There exists only limited published data regarding outcome differences between male and female patients. Therefore, the objective of this paper is to analyze these gender differences between short-term survival and in-hospital outcomes in those undergoing PCI with CS. MethodsBetween January 2011 and July 2016, patients undergoing PCI with simultaneous use of Impella were identified. Only patients presenting with CS were included in the analysis. All-cause in-hospital mortality was the primary outcome. Using SAS 9.4 for propensity score matching, additional secondary outcomes were also compared. ResultsThe primary outcome was comparable between males and females (39.5% vs. 26.3%, p=0.33) in CS patients. Secondary outcomes were also comparable and included: myocardial infarction, stroke, CS, heart failure, dialysis requirement, bleeding within 72h, blood transfusion, dysrhythmia, composite of all complications, major adverse cardiac events. Survival at 30days was equal in both groups. A reduced mortality in males was noted for pre-PCI initiation of Impella. Additionally, both genders who received pre-PCI Impella support, experienced a significant reduction in inotrope use. ConclusionsDespite the small number of cohorts, this study did not reveal any significant differences among gender with the use of percutaneous left ventricular assist devices for PCI in patients with acute myocardial infarction complicated by CS. However, initiation of Impella prior to PCI may be associated with improved mortality and morbidity in both genders.

Analysis of outcomes for 15,259 US patients with acute myocardial infarction cardiogenic shock (AMICS) supported with the Impella device

BackgroundThe Impella percutaneous ventricular assist device (PVAD) rapidly deploys mechanical circulatory support (MCS) in patients with acute myocardial infarction complicated by cardiogenic shock (AMICS). We present findings from a quality improvement (IQ) registry for US patients with AMICS who received Impella devices. Methods and ResultsFrom January 2009 to December 2016, 46,949 patients from 1010US hospitals were entered into the IQ registry; of these, 15,259 had AMICS. Limited de-identified patient information, product performance, and survival to explantation were recorded. Of those with AMICS, 51% survived to explantation of PVAD. There was a significant difference between survival at explantation with quintile volume at hospitals (range: 0–100%; 30% survival rate in lowest quintile vs. 76% in top quintile; P<.0001). Use of the Impella device as first-line treatment pre-PCI was associated with a 59% survival rate, compared with 52% when used as a salvage strategy (P<.001). The survival rate among those who received hemodynamic monitoring with pulmonary artery catheters was 63% as compared with 49% in those who did not (P<.0001). Overall institutional Impella volume was related to survival (56% survival at sites with >7/year vs. 51% at sites with ≤1; P<.001). ConclusionsIn this early clinical experience with Impella support for AMICS, wide variation in outcomes existed across centers. Survival was higher when Impella was used as first support strategy, when invasive hemodynamic monitoring was used, and at centers with higher Impella implantation volume.

Outcomes in Patients Bridged to Long-term Continuous Flow Left Ventricular Assist Devices Using Short-term Impella Device

The number of patients receiving short-term mechanical circulatory support (MCS) devices as a bridge-to-decision has been increasing. However, outcomes in patients bridged with an Impella (Abiomed Inc., Danvers, MA) to long-term, implantable left ventricular assist devices (LVADs) have not been well studied. We analyzed our single-center experience in patients bridged to long-term continuous-flow (CF)-LVADs using an Impella.

Circulatory Support with Extracorporeal Membrane Oxygenation and/or Impella for Cardiogenic Shock During Myocardial Infarction.

Temporary mechanical circulatory support (TCS) is recommended for patients with profound cardiogenic shock (CS). Extracorporeal membrane oxygenation (ECMO) and Impella are possible TCS devices, but the device choice and the implantation timing are not definitely established, specifically during acute myocardial infarction. We have analyzed the respective use of ECMO or Impella (2.5, CP, or 5.0) for CS following acute myocardial infarction, from a cohort of patients who underwent TCS within 72 hours after admission for emergency percutaneous coronary intervention (PCI) from January 2009 to April 2015. Among 88 TCS-treated patients, 42 had early TCS: 23 ECMO and 19 Impella. Cardiac management, including PCI, was similar between the two groups, but ECMO patients were sicker than Impella patients (higher blood lactate level at ICU admission, higher vasoactive-inotroic and ENCOURAGE scores before TCS implantation, p ≤ 0.02). Three patients (7%) have had TCS implantation before admission, but TCS was implanted mostly in cathlab (43%, 1 during PCI, 13 just after PCI) or soon after ICU admission (50%, n = 21). Modification of the initial TCS choice was required in 10 cases (24%) for assistance upgrading in case of Impella (n = 4) or for left ventricle unloading in case of ECMO (n = 6). Extracorporeal membrane oxygenation is the technique of choice in case of profound CS, whereas Impella devices seem more appropriate for less severe hemodynamic compromise. Interestingly, the combination of both techniques may help to overcome the limits inherent to each device.

Pre-close technique of percutaneous closure for delayed hemostasis of large-bore femoral sheaths.

Advancement of coronary interventions and portable hemodynamic device requires placement of large bore sheaths. Access for large caliber sheaths, its placement, maintenance, and hemostasis is very challenging and one of the key ailments for successful procedures. Traditional hemostasis method is manual compression, which is unattractive due to its own limitations and subsequent complications. Single closure device for sheath size larger than 8 French (Fr) is not available. We performed retrospective analysis of large cohort of patients with 13, 14 Fr sheaths (Impella device [ABIOMED]) percutaneous closure with the use of two Perclose devices. Two perclose devices were placed in a "Preclose" fashion and hemostasis was obtained few days later once hemodynamic support was weaned off by deployment of perclose sutures.

Bridge to Recovery with Early Mobilisation: The Impella Device via Axillary Artery in Lupus-Associated Acute Cardiomyopathy

A previously healthy 33-year-old woman of South East Asian descent presented with myalgia and petechial leg rash. Acute cardiogenic shock, lactic acidosis, and oligoanuria evolved rapidly over 24 hours, with hypotension refractory to inotropes. Echocardiography demonstrated severe global left ventricular dysfunction with an ejection fraction of 10–15%. She was commenced on femoral veno-arterial extracorporal membrane oxygenation and renal replacement therapy. An endomyocardial biopsy was non–diagnostic, but an anti-dsDNA titre of >800, positive Smith antigen, and marked complement consumption confirmed the diagnosis of systemic lupus erythematosus-associated acute cardiomyopathy, and high-dose corticosteroids were initiated. After 10 days on extracorporal membrane oxygenation, as a potential bridge to transplantation, she was transitioned to an Impella CP device via the right axillary artery to support the left ventricle, allowing her to begin mobilisation. The Impella device remained in situ for 13 days with gradual weaning of inotropes while she started weight-bearing exercises with assistance. Her left ventricular ejection fraction improved to 30% on repeat echocardiogram prior to device removal, and to low-normal on magnetic resonance imaging subsequently. This case highlighted the utility of the Impella device to support the failing left ventricle while facilitating early mobilisation in patients with acute cardiomyopathy of reversible aetiology requiring a protracted course of mechanical support. To our knowledge, this was the first case of an Impella device inserted via the axillary route in Australia. The axillary approach offers a mobilisation friendly, minimally invasive option in the expanding artillery of short-term mechanical circulatory support, either as a bridge to myocardial recovery or cardiac transplant.

Percutaneous Mechanical Circulatory Support Using Impella Devices for Decompensated Cardiogenic Shock: A Pediatric Heart Center Experience.

Cardiogenic shock remains a significant cause of mortality and morbidity in children with heart failure. Percutaneous mechanical circulatory support may be an additional tool to augment left heart support and decompression in addition to conventional therapies. This report aims to review the clinical and hemodynamic outcomes of the Impella device at a pediatric center. A retrospective review of all implants between October 2014 and November 2016 was conducted. Clinical outcomes, device implant techniques, complications, and hemodynamic data were collected. Statistical analysis was performed on hemodynamic and echocardiographic data. There were 10 Impella device placements in 8 patients with a median age of 17 years (6.5-25) and support duration of 8 days (1-21). Implant diagnosis included 5 patients with either posttransplant rejection or allograft vasculopathy, 2 patients with myocarditis, and 1 patient with refractory ventricular tachycardia. Extracorporeal membrane oxygenation support was required in 4 patients. Significant reduction in pulmonary capillary wedge pressures/left atrial pressures (p = 0.031) and increase in near infrared spectroscopy (p = 0.039) was seen pre- and post-Impella implant. All patients survived to discharge from the intensive care unit with one late death. Percutaneous mechanical circulatory support is a viable option in experienced pediatric centers as a mode to augment cardiac output or to decompress the left heart in patients on extracorporeal membrane oxygenation or with cardiogenic shock.

Safety of long-distance transfers of patients on acute mechanical circulatory support

BackgroundAcute mechanical circulatory support (aMCS) can be a lifesaving therapy for patients with refractory cardiogenic shock. As device safety and technology improve, so will the ability to extend aMCS to patients at remote hospitals. The Intermountain West is unique because of the large geographical area, making transport of critically ill patients a logistical challenge. MethodsWe reviewed our experience of transporting patients in cardiogenic shock over long distances who had already been placed on aMCS: Impella and extracorporeal membrane oxygenator devices. Survival data was compared to international benchmark data published by the Extracorporeal Life Support Organization. ResultsA total of 11 patients (91% male; mean age 56 ± 5.4 y) were transported via fixed-wing aircraft to our center. The etiology of cardiogenic shock was ST-elevation myocardial infarction (n = 4), acutely decompensated chronic systolic heart failure (n = 4), postcardiotomy shock (n = 2), and acute myocarditis (n = 1). Average transport distance was 364 ± 139 miles (585 ± 264 km) and flight time was 170 ± 29 min. All patients were safely transported with no in-transit adverse events. The average duration of aMCS was 6.4 ± 3.3 d. Six patients (54.5%) survived to device explantation and 3 (27.2%) survived to hospital discharge. For comparison, Extracorporeal Life Support Organization benchmark data for adult cardiogenic shock patients report 56% survival to device explantation and 41% to hospital discharge. ConclusionsPatient transport with aMCS over long distances can be done safely without serious adverse events using good protocols and well-trained personnel. Although survival data are slightly below benchmark data, they appear reasonable, given the severity of illness and challenges of transferring critically ill patients to an expert center.

Single-centre experience with the Impella CP, 5.0 and RP in 109 consecutive patients with profound cardiogenic shock.

Short-term mechanical circulatory support is increasingly used in the management of cardiogenic shock, but data from controlled studies are sparse. Thus, real-life data on complication rates and predictors of adverse outcome are important. The objective of this study was to analyse the experience with Impella devices in the management of profound cardiogenic shock. A retrospective study of 109 consecutive patients with severe shock after myocardial infarction, acute heart failure, or cardiac surgery. Possible device-related complications were registered and predictors of death while on Impella support and within 180 days were identified. In 79 patients (72%) cardiogenic shock was caused by myocardial infarction, acute heart failure in 16 (15%) and post-cardiotomy shock in 14 patients (13%). Thirty-five patients (32%) were comatose after cardiac arrest and in seven, the Impella was placed during chest compression. Mean age was 62±12 years, mean arterial pressure was 57±13 mmHg, pH 7.19±0.17 and lactate 7.5±5.7 mmol/l (range 1.8-30.0 mmol/l) at placement. During Impella therapy, 26 patients (28%) died among patients with myocardial infarction or acute heart failure. Of data available prior to placement lactate (hazard ratio 1.14, 95% confidence interval 1.04-1.25, P=0.004) was the only predictor of death on support. During support, five patients (5%) developed leg ischaemia requiring intervention. Bleeding from the Impella insertion site was seen in 14 patients (13%). Impella treatment is feasible in profound cardiogenic shock at an acceptable rate of complications. Despite an aggressive approach to restore cardiac output, mortality was high. Besides the severity of lactic acidosis there were no strong predictors of early death.

The effectiveness and safety of the Impella ventricular assist device for high-risk percutaneous coronary interventions: A systematic review.

Small randomized controlled trials (RCTs) and observational studies have examined the effectiveness and safety of the Impella device, a percutaneous left ventricular assist device, in the setting of high-risk percutaneous coronary intervention (PCI). However, data are sparse and results are conflicting. Our objective was to evaluate the effectiveness and safety of the Impella device in high-risk patients undergoing PCI via a systematic review of the literature. We searched Medline, EMBASE, and the Cochrane Library for RCTs and observational studies that evaluated the Impella device in high-risk patients undergoing PCI. Inclusion was restricted to studies in which ≥10 patients received the Impella device; both uncontrolled and controlled (versus intra-aortic-balloon pump [IABP]) studies were included. A total of 20 studies (4 RCTs, 2 controlled observational studies, and 14 uncontrolled observational studies; 1,287 patients) were included, with follow-up ranging from 1 to 42 months. The use of Impella resulted in improved procedural and hemodynamic characteristics in controlled and uncontrolled studies. In controlled studies, the 30-day rates of all-cause mortality and MACE were similar across groups. In most uncontrolled studies, the 30-day rates of all-cause mortality were generally low (range: 3.7%-10%), though rates of MACE were slightly higher (range: 5%-20%). The Impella device was found to improve procedural and hemodynamic parameters, but only limited randomized data are available regarding clinical outcomes associated with its use. Large, multicenter RCTs are needed to definitively establish the effectiveness of the Impella device among high-risk PCI patients.

Pharmacologic Considerations in the Management of Patients Receiving Left Ventricular Percutaneous Mechanical Circulatory Support.

Percutaneous mechanical circulatory support (MCS) devices, including the intraaortic balloon pump, Impella, and TandemHeart, are often used for hemodynamic support in the setting of refractory cardiogenic shock. The thrombotic and bleeding complications associated with these devices is well recognized, and the Impella and TandemHeart devices have unique anticoagulation considerations that may influence patient outcomes. Both devices typically require use of a heparinized purge solution in combination with intravenous unfractionated heparin, thereby providing multiple sources of heparin exposure. Each device also has specific monitoring requirements and goal ranges. This review provides an overview of percutaneous MCS devices commonly used in the acute management of left ventricular failure, with an emphasis on pharmacologic considerations. We review recent evidence and guidelines and provide recommendations for appropriate use of anticoagulation during device support. Approaches to managing heparinized purge solutions, monitoring, and the utility of nonheparin anticoagulants are also provided because high-quality evidence in the literature is limited.

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.

Real‐world supported unprotected left main percutaneous coronary intervention with impella device; data from the USpella registry

Patients with left main (LM) coronary artery disease are increasingly being treated with percutaneous revascularization (PCI). The safety, feasibility, and efficacy of unprotected LM intervention (ULMI) with hemodynamic support by Impella device have not been evaluated previously. Using a large retrospective single center database from the USpella registry, we evaluated the safety, feasibility, and potential benefits of periprocedural left ventricular assist with axial flow Impella 2.5 and Impella CP (Abiomed Inc. Danvers, Mass) during ULMI. We analyzed a total of 127 consecutive patients who received hemodynamic support with Impella (2.5 or CP) for ULMI from August 2008 to July 2015. Safety, feasibility and efficacy end points included procedural success rates, in-hospital and 30-day major adverse cardiovascular event (MACE) rates. Among 127 patients who received hemodynamic support for ULMI (mean age 69.98 ± 10.7 years, 71% men, and mean left ventricular ejection fraction 28.74 ± 15.55%, Society of Thoracic Surgeons' mortality/morbidity 4/23%) the in-hospital and 30 days mortality rates were 1.43% (2/140) and 2.1% (3/141), respectively. The average baseline and post PCI (residual) syntax scores were 31.4 and 7.86, respectively, (P < 0.001). Only one patient (0.8%) had vascular complication that required surgery; 2.36% (3/127) had hematoma and 3.9% (5/127) had bleeding that required transfusion. This large singe center retrospective evaluation of USpella registry substantiates and strongly supports the feasibility, safety, and hemodynamic usefulness of Impella device for ULMI with acceptable in-hospital and 30-day MACE rates. © 2017 Wiley Periodicals, Inc.

(352) - Clinical Outcomes of Impella Microaxillary Pumps When Used in Patients with Cardiogenic Shock Bridged Successfully to Durable Mechanical Circulatory Support and Cardiac Transplantation

For pts presenting with severe cardiogenic shock who are otherwise eligible for durable mechanical circulatory support (MCS) or transplant, temporary MCS can be a lifesaving therapy. Outcomes with Impella (ABIOMED, Danvers, MA) devices used to salvage severe shock in the end stage heart failure population are not well established.

Left Ventricular Unloading by Impella Device Versus Surgical Vent During Extracorporeal Life Support

Patients supported with extracorporeal life support (ECLS) can experience severe complications from increased left ventricular (LV) afterload. The Impella (Abiomed, Danvers, MA) percutaneous ventricular assist device (PVAD) may offer an attractive option for unloading the LV in these patients. This study describes the efficacy and outcomes of PVAD use during ECLS compared with surgically placed LV vent. In this retrospective study, we reviewed patients supported by ECLS with PVAD or surgical LV vent for cardiogenic shock between April 2010 and May 2016. Included were 23 patients with PVADs and 22 with surgical vents. Patients' baseline characteristics, hemodynamic data, and outcomes were collected immediately preceding combined support initiation, at 48 hours, intensive care unit discharge, and 30 days. After 48 hours, pulmonary artery diastolic pressure was significantly reduced in the PVAD (23.3 ±8.4 vs 15.6 ± 4.2, p= 0.02) and surgical vent groups (20.1 ± 5.9 vs 15.6 ± 5.4, p= 0.01), and radiographic evidence of pulmonary edema was reduced or unchanged in 90% of PVAD patients and in 76% of surgical vent patients. The primary end points of survival to 30 days (43% vs 32%, p=0.42) and intensive care unit discharge (35% vs 23%, p= 0.37) were not different between the two methods of support. The PVAD and surgical vent groups were also not significantly different in the rate of vascular complications or in the number decannulated from ECLS and transitioned to durable LV assist device. PVAD use in ECLS patients is an effective means of LV unloading and preventing worsened pulmonary edema, with outcomes and complications that are comparable to surgical LV vent.

A multicenter study of the impella device for mechanical support of the systemic circulation in pediatric and adolescent patients.

The objective was to review the use of Impella devices (Abiomed Inc, Danvers, MA) for temporary circulatory support in pediatric and adolescent patients (age ≤ 21 yrs). Options for minimally invasive circulatory support in children are limited, and published data are confined to case reports and small case series. This was a retrospective, multicenter review of Impella implants in pediatric and adolescent patients from 2009-15, using standardized data collection and INTERMACS definitions. A total of 39 implants were performed in 38 patients from 16 centers. Median age and weight were 16 yrs (4-21 yrs) and 62 kg (15-134 kg). The primary indication for implant was cardiogenic shock in 28 patients (72%). Cardiac allograft rejection, myocarditis, or cardiomyopathy were the underlying diagnosis in 23 patients (59%); 11 patients had congenital heart disease. The median duration of support was 45 hr (1-1224 hr). Indications for explant included ventricular recovery in 16 patients, transition to another device in 12, death in 5, and transplant in 1. Survival was 85% at 7 days and 68% at 30 days. Major adverse events occurred in 8 patients: hemolysis in 3, bleeding in 2, stroke in 1 (unclear if related to Impella), sepsis in 1, and critical leg ischemia in 1. An increase in aortic regurgitation was noted in three patients, with no evidence of valve injury. Temporary circulatory support with Impella devices is feasible in pediatric and adolescent patients, with acceptable risk profiles. More experience and follow up is needed to improve technical performance and patient selection. © 2017 Wiley Periodicals, Inc.

Acute Mitral Regurgitation After Removal of an Impella Device

Acute mitral regurgitation is a very rare complication of an Impella device. We report a case of a 52-year-old man who had an Impella CP device placed for cardiogenic shock and developed acute mitral regurgitation after removal of the Impella. This was managed with the placement of TandemHeart device.

Circulatory support using the impella device in fontan patients with systemic ventricular dysfunction: A multicenter experience.

There are limited mechanical circulatory support options for patients with single ventricle (SV) anatomy. This is a multicenter, retrospective study of the Impella pump to support the systemic ventricle in a cohort of SV patients with Fontan circulation. Patients with SV anatomy supported with an Impella device from 2012 to 2015 were included. Demographic information, indication for support, adverse events and short-term outcome data were collected. Ten patients were included. The median age and weight at implant was 26 years (4-38 years) and 64 kg (15-102 kg). Indications for support were systemic ventricular failure with cardiogenic shock (n = 8) or high-risk electrophysiology (EP) procedures (n = 2). The median duration of support was 49 hr (2.7-264 hr). Support was discontinued for ventricular recovery in five patients, transition to another device in two patients, completion of EP procedure in two patients and death in one patient. Survival to hospital discharge was 80%. Adverse events occurred in 4 patients. There were two cases of hemolysis, one case of increasing aortic valve insufficiency with implant and one asymptomatic access site thrombus. There were no bleeding or thromboembolic events. Impella devices can provide temporary support for the systemic ventricle in SV patients as a bridge to recovery or additional device. Procedural survival and adverse event profiles are favorable. © 2017 Wiley Periodicals, Inc.