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. 2025 Feb 6;4(3):160–169. doi: 10.1016/j.cjcpc.2025.01.004

A Canadian Experience With a Percutaneous Microaxial Ventricular Assist Device in Children With Cardiogenic Shock

Bhavikkumar D Langanecha a,b,∗, Alyssa Power a, Rachel D Vanderlaan c, Osami Honjo c, Oshri Zaulan a,b, Andrea Maurich a, Rajiv Chaturvedi a, Aamir Jeewa a
PMCID: PMC12418258  PMID: 40933776

Abstract

Background

The experience of a percutaneous microaxial (Impella) left ventricular assist device in children with cardiogenic shock is limited. The primary objective of this study was to review our institutional clinical outcomes of Impella use in children with cardiogenic shock.

Methods

This is a single-center retrospective study of all adult-sized children who underwent Impella implantation from June 2019 to December 2024. Clinical outcomes, hemodynamics, and device complication data were collected.

Results

A total of 7 patients (female = 4) with a median (interquartile range [IQR]) age of 15 years (14.5, 16.5 years) and a median weight of 50.9 kg (46.5, 59.85 kg) underwent Impella insertion during the study period. Five patients underwent Impella insertion for hemodynamic support and 2 for left ventricular decompression while on extracorporeal membrane oxygenation (ECMO) support. The underlying cardiac diagnoses were dilated cardiomyopathy (4 of 7), myocarditis (2 of 6), and hypertrophic cardiomyopathy with presumed myocarditis (1 of 7). The median (IQR) duration of support was 5 days (2, 7 days). The median (IQR) duration of intensive care unit and hospital stay was 13 days (10.5, 19 days) and 23 days (15, 54 days), respectively. Three patients were ultimately bridged to a durable ventricular assist device, and 2 patients had recovery of myocardial function. One patient developed significant aortic regurgitation, which necessitated device explantation and conversion to central ECMO after 38 hours of support, and one patient had withdrawal of life-sustaining measures due to significant brain injury unrelated to Impella.

Conclusions

There is increasing use of percutaneous microaxial pumps for supporting children in cardiogenic shock and left ventricle decompression on ECMO support. This report identifies the initial Canadian experience as an addition to the mechanical circulatory support armamentarium.

The common etiologies for cardiogenic shock in children without systemic outflow obstruction are dilated cardiomyopathy (DCM), myocarditis, graft dysfunction after heart transplant, and heart failure in complex congenital heart disease.1 Treatment with inotrope and/or vasopressor support, diuresis, and mechanical ventilation may be insufficient for the management of cardiogenic shock, and rapid escalation of advanced cardiac therapies in the form of mechanical circulatory support (MCS) may be necessary. There has been significant progress in the field of pediatric MCS in the last 2 decades along with an increase in its use and improved outcomes.2, 3, 4, 5, 6, 7, 8

One-fourth of the children who present with cardiogenic shock require MCS in the first 24 hours of hospitalization, and the majority of these are supported with a temporary MCS configuration.1,9 The primary aim of MCS in cardiogenic shock is early hemodynamic stabilization and better end-organ perfusion, with the ultimate goal of explantation after myocardial functional recovery or evaluation and implementation of other long-term therapies including a bridge to durable ventricular assist device (VAD) or heart transplant. Extracorporeal membrane oxygenation (ECMO) and Impella are less invasive and can be initiated faster compared with durable VAD. The most commonly used short-term MCS in children is ECMO.1,7,9,10 The use of ECMO can improve end-organ perfusion and function. However, ECMO support is associated with a significant increase in left ventricular (LV) afterload and ventricular loading and it may impede myocardial recovery.11,12 This leads to high myocardial oxygen consumption and in some patients left atrial hypertension with pulmonary edema needing invasive left atrial/LV decompression.

The Impella (Abiomed, Danvers, MA) is a catheter-based microaxial left VAD that can be implanted percutaneously via the femoral or axillary artery. The use of Impella in adults with heart failure or requiring high-risk percutaneous coronary interventions has significantly increased in recent years.13,14 It can be used in isolation for circulatory support or along with ECMO for LV unloading.13, 14, 15 Currently, this form of temporary MCS can be used for both left and right heart support. Because of the device size, it is more suitable for bigger children and adolescents, usually greater than 25 kg.16 The direct LV unloading by an Impella may help ventricular recovery by reducing myocardial oxygen demand, LV wall tension, and improving coronary perfusion compared with ECMO support.17 However, it is associated with its own complications including bleeding, hemolysis, and the potential for limb ischemia.18,19

The primary objective of this study was to report on the institutional experience of Impella use in children presenting with acute decompensated heart failure.

Materials and Methods

Study design and population

This is a retrospective cohort study of all patients who underwent Impella device implantation at the Hospital for Sick Children (Toronto, Canada) from June 2019 to December 2024. Patients were identified from the VAD database. The study was approved by the institutional research ethics board, and informed consent was waived due to the retrospective nature of the study design. The types of devices used in this cohort were Impella CP and Impella 2.5. Patients who underwent Impella insertion for LV unloading during ECMO support were also included in this cohort. Baseline characteristics, diagnoses, and clinical and hemodynamics parameters were collected from the chart review. Echocardiographic data were collected for ventricular size, ventricular function assessment, and aortic valve regurgitation before Impella implantation.

Procedure

All patients underwent preimplantation echocardiogram to assess systemic ventricle length (ensure systemic ventricle apex to aortic valve ≥7.5 cm), assess systemic semilunar valve function (rule out significant stenosis or regurgitation), rule out ventricular or aortic thrombus, and assess right ventricle function. Patient clinical history and echocardiogram images were discussed in multidisciplinary meeting including a cardiac intensivist, a heart failure cardiologist, and an interventional cardiologist to determine candidacy for Impella support. All patients underwent percutaneous Impella insertion in the cardiac catheterization laboratory with a therapeutic activated clotting time target of 250 or more. After vascular access, an appropriate size peel-away sheath was placed in the vessel. The Impella device was inserted under fluoroscopic and echocardiographic guidance. Following optimal Impella position, the peel-away sheath was peeled away. The Impella reposition sheath was inserted and fixed with a suture. Impella support was started, and the P level was adjusted under echocardiographic guidance to optimize LV unloading and hemodynamic support. A higher P level represents increased rotational speed of the microaxial pump and therefore higher blood flow.

Postimplantation management

All patients were admitted to a cardiac critical care unit after Impella implantation. Patients were started on therapeutic heparin infusion with a target activated clotting time of 160-180. No antiplatelet or direct thrombin inhibitors were used routinely. Daily chest radiograph was performed to assess device position. An echocardiogram was performed as needed to assess device position, ventricular unloading, and recovery of ventricular function. Inotropic support was titrated according to hemodynamics and right ventricle function. We monitored periodic plasma-free hemoglobin (Hgb) as a marker of hemolysis.

In cases with improvement in ventricular function, we weaned the P level by 2 every few hours until the P level of 2 was reached. If the patient remained hemodynamically stable, then the Impella could be removed.

For weaning of Impella support used for LV unloading with ECMO, we first decannulated ECMO support after myocardial functional recovery. If the patient remained stable after ECMO decannulation, then we weaned and explanted the Impella.

Statistical analysis

Descriptive statistics were used for analysis. Continuous data were presented as median with interquartile range (IQR) and categorical data as a percentage.

Results

During the study period, a total of 7 patients (females = 4 [57%]) underwent Impella insertion. Table 1 describes the baseline clinical characteristics at the time of implantation. All patients had functionally normal aortic valves with no significant aortic valve stenosis or regurgitation on their preimplantation echocardiogram. The median age (IQR) at the time of Impella implantation was 15 years (IQR: 14.5, 16.5 years). The median weight and body surface area were 50.9 kg (IQR: 46.5, 59.85 kg) and 1.56 m2 (IQR: 1.45, 1.67 m2), respectively. The final underlying diagnosis was DCM in 4 patients including 1 patient with anthracycline-induced cardiomyopathy. Two patients had myocarditis, and one had Friedreich’s ataxia with hypertrophic LV with presumed myocarditis. The median Pediatric Sequential Organ Failure Assessment score was 5 (IQR: 6, 8). All patients who underwent Impella insertion for primary hemodynamic support underwent the procedure within 24 hours of admission to critical care.

Table 1.

Baseline clinical characteristics at the time of Impella insertion

ID Age (y) Gender Weight (kg) BSA (m2) Diagnosis LVEDD (cm) LVEDD z score EF (%) MR RV function Hemodynamic support (mcg/kg/min) Intubated ECMO support pSOFA score
1 15 F 50.9 1.5 First presentation of DCM with cardiogenic shock (VUS in TNNT2) 6.4 5.19 26 No Severe Epi 0.1
Milri 0.5		 Yes Yes 7
2 15 F 53.1 1.58 Influenza A myocarditis with cardiogenic shock 4.26 –1.3 39 Trivial Good Epi 0.06 Yes Yes 6
3 14 F 50 1.56 Parainfluenza myocarditis with cardiogenic shock NA NA 14 No Mild Epi 0.2 Yes No 11
4 11 M 26.9 1 Known DCM. New immigrant and presented with cardiogenic shock and intermittent second degree AV block with ventricular escape rhythm (likely pathogenic mutation in FLNC) 6.03 6.2 29 Moderate Moderate to severe Epi 0.04 No No 4
5 17 M 66.6 1.77 First presentation of DCM with cardiogenic shock with out-of-hospital VF cardiac arrest. Ongoing ventricular ectopy and nonsustain VT (pathogenic mutation in LMNA) 6.58 4.4 25 Mild Mild Epi 0.06
Norepi 0.04		 Yes No 5
6 16 M 69.4 1.85 Anthracycline-induced cardiomyopathy with single kidney with cardiogenic shock 6.89 3.9 19 Severe Severe Epi 0.06 No No 9
7 17 F 43 1.4 LV hypertrophy with severe biventricular dysfunction and cardiogenic shock. Later diagnosed with Friedreich’s ataxia 3.52 –3.2 21 Mild Severe Epi 0.2 No No 5
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AV, atrioventricular; BSA, body surface area; DCM, dilated cardiomyopathy; ECMO, extra corporeal membrane oxygenation; EF, ejection fraction; Epi, epinephrine; FLNC, filamin-C; LMNA, lamin-A; LV, left ventricle; LVEDD, left ventricular end-diastolic diameter; Milri, milrinone; MR, mitral regurgitation; NA, not available; Norepi, norepinephrine; pSOFA, Pediatric Sequential Organ Failure Assessment; RV, right ventricle; TNNT2, cardiac muscle troponin T2; VF, ventricular fibrillation; VT, ventricular tachycardia; VUS, variant of unknown significance.

Table 2 describes the indication, complications, and outcomes for Impella support. All patients underwent percutaneous implantation through the femoral artery in the cardiac catheterization laboratory. Two patients underwent Impella insertion for LV decompression on ECMO, whereas 5 patients underwent insertion as the primary form of hemodynamic support. The Impella 2.5 was used for LV decompression, whereas Impella CP was used for hemodynamic support. A 13 F sheath was used for the Impella 2.5, and a 14 F sheath was used for the Impella CP device. The median duration of the Impella insertion procedure was 86 minutes (IQR: 60, 100.5 minutes). The median fluoroscopy time was 6.36 minutes (IQR: 4.26, 7.55 minutes), and the total area dose radiation exposure was 498.06 μGy m2 (IQR: 387.7, 930.29 μGy m2). There were no complications during the Impella insertion procedure.

Table 2.

Indications, complications, and outcomes after Impella insertion

ID Indication Device type Access Procedure duration (min) Total area dose radiation exposure (μGy m2) Fluoroscopy time (min) Flow (L/min) Support days Complications ICU stay Hospital stay Outcomes
1 LV decompression 2.5 Femoral artery 66 474.56 04:03 1.1-1.9 2 Moderate to severe AI 19 54 Conversation to central ECMO and later to HeartWare LVAD
2 LV decompression 2.5 Femoral artery 50 498.06 08:10 0.5-1.7 6 None 13 20 Myocardial functional recovery
3 Hemodynamic support CP Femoral artery 54 205.15 04:50 2.7-3.9 1 Ventricular ectopy and bleeding from access site 1 1 Withdrawal of care due to severe HIE
4 Hemodynamic support CP Femoral artery 122 300.79 07:00 2.5-3 5 Rt external iliac artery occlusive clot. No distal perfusion issue 19 60 Conversation to HM3 LVAD
5 Hemodynamic support CP Femoral artery 112 8906.1 11:55 2.8-3.5 10 Hemolysis requiring device repositioning and reduction in the P level 10 10 Conversation to HM3 LVAD
6 Hemodynamic support CP Femoral artery 86 1011.73 03:21 3.4-3.7 2 Hemolysis requires device repositioning and reduction in the P level. Acute kidney injury in setting of isolated kidney, required RRT 23 54 Conversation to HM3 LVAD
7 Hemodynamic support CP Femoral artery 89 848.85 06:36 NA 8 Bleeding at access site 11 23 Myocardial functional recovery
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AI, aortic insufficiency; ECMO, extra corporeal membrane oxygenation; HIE, hypoxic ischemic encephalopathy; HM3, heart mate 3; ICU, intensive care unit; LV, left ventricle; LVAD, left ventricular assist device; NA, not available; RRT, renal replacement therapy; Rt, right.

The median duration of Impella support was 5 days (IQR: 2, 7 days). The median duration of intensive care unit and hospital stay was 13 days (IQR: 10.5, 19 days) and 23 days (IQR: 15, 54 days), respectively. Three patients were bridged to a durable VAD, and 2 had an explantation for myocardial recovery. There was 1 death while on Impella support after withdrawal of life-sustaining therapies due to severe brain injury. This patient presented with altered sensorium, seizure, and cardiogenic shock with severe LV dysfunction due to parainfluenza myocarditis. Impella was inserted for hemodynamic support. Despite hemodynamic stabilization with Impella support, this patient demonstrated ongoing neurologic dysfunction, which was likely related to the acute presentation and shock.

One patient with DCM, who presented with cardiogenic shock, underwent Impella insertion for LV decompression during ECMO support. The patient developed hemodynamically significant aortic regurgitation after Impella implantation, requiring device removal after 38 hours and conversion to central venoarterial ECMO. There was no significant aortic regurgitation or residual damage to the aortic valve after device removal. Two patients required Impella repositioning and P level adjustment due to hemolysis. One patient developed an acute kidney injury requiring renal replacement therapy in the setting of single kidney, elevated serum creatinine at the time of admission, and hemolysis. His renal function normalized after 2 weeks of renal replacement therapy. An occlusive femoral arterial clot after explant was seen in 1 patient and required anticoagulation therapy, but with adequate limb perfusion throughout. One patient developed ventricular ectopy and a few runs of nonsustained ventricular tachycardia, which did not require any medical management. Two patients had initial bleeding from the access sites that required application of local pressure. One patient required local suture application and the other required transfusion of blood product.

With respect to the hemometabolic changes while on Impella support, Figure 1 shows the clearance of lactate in the first 24 hours after device insertion. Figure 2 shows mean arterial blood pressure during the first 48 hours after the insertion of the device. Figure 3 shows a reduction in N-terminal pro–B-type natriuretic peptide after Impella support. Figure 4 shows the plasma-free Hgb as a marker for hemolysis after Impella insertion. Four patients had a plasma-free Hgb higher than 200 mg/L. The initial elevated plasma-free Hgb was reduced in 24-48 hours in all 4 patients. All the patients who underwent Impella implantation for circulatory support remained on some inotropic agents along with Impella support.

Figure 1.

Figure 1

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Trend of blood lactate clearance after initiation of Impella support in first 24 hours.

Figure 2.

Figure 2

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Mean arterial blood pressure (BP) during first 48 hours after initiation of Impella support.

Figure 3.

Figure 3

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NT-proBNP level before and after Impella insertion. NT-proBNP, N-terminal pro–brain natriuretic peptide.

Figure 4.

Figure 4

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Trend of plasma-free hemoglobin (Hb) on Impella support.

Figure 5 shows a chest radiograph depicting the pre- and postimplant changes in pulmonary congestion/edema on device support in a patient who presented with myocarditis with cardiogenic shock and pulmonary congestion/edema.

Figure 5.

Figure 5

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Chest radiograph (A) before and (B) after Impella insertion.

Discussion

This is an initial experience of Impella use in children with severe acute decompensated heart failure in Canada. Impella is a less invasive temporary MCS option than ECMO. In our cohort, 71% (5 of 7) reached the intended outcome of either myocardial recovery (2 of 5) or a bridge to durable VAD (3 of 5) with an acceptable risk profile. When it was used for circulatory support, it provided adequate circulatory support and lactate clearance in the first 24 hours.

Although the Impella is a percutaneous microaxial pump, it may not be feasible in all children due to device and sheath sizes required during implantation. Although there is a report of a patient as young as 4 years with a body weight of 15 kg supported with an Impella, the majority of patients have been adolescents closer to adult size in the published literature.20, 21, 22 The 2 important factors are the LV length and the arterial diameter of vascular access. Morray et al.16 studied the patient size and LV length from echo (before surgical VAD implantation) and computed tomography/magnetic resonance imaging (patient with no prior cardiovascular disease). There is a positive correlation between patient size and LV length. Regression analysis from both echo and computed tomography/magnetic resonance imaging data predicts a low weight limit of approximately 23 kg, height of approximately 120 cm, and a body surface area of 0.89 m2 for the LV length of 7.5 cm.16 Although not a routine practice in Impella placement, banding of the pigtail shortens the distance from the end of the catheter to the radiopaque annular marker, creating the potential usage of the device in those with shorter LV lengths.21 The other important limiting factor is the vascular access size. A vessel diameter of ≥5 mm is preferred for the 14 F introducer sheath of the Impella CP. The measurement of vessel size by imaging modalities may underestimate the actual baseline size during cardiogenic shock due to high vascular tone, low cardiac output, and vasopressor infusion. This may be of particular importance in children as the margin between “fit” and too small will be narrow. The size of vessels may increase with improvement in shock state and reduction or cessation of vasopressors.

In addition to hemodynamic support, Impella support may provide the potential for greater myocardial recovery than ECMO by direct LV unloading with reduction in myocardial oxygen consumption and improvement in coronary perfusion pressure.17 There is limited published literature for use and outcomes of Impella in a pediatric heart center. Tume et al.20 reported the pediatric single-center experience of Impella use for hemodynamic support. The common underlying etiologies were post-transplant graft failure/rejection (43%) and cardiomyopathy (19%). Sixty percent of patients had a myocardial functional recovery, and 19% of patients were bridged to a durable VAD. The reported overall survival was excellent with 95% at 1 month and 88% at 6 months when censored at death, transplant, or implant of durable VAD.20 The Impella was also used in older children supported with ECMO as a means of LV decompression or as an exit strategy for ECMO to recovery, transition to durable VAD, or heart transplantation. The Advanced Cardiac Therapies Improving Outcomes Network (ACTION) registry report revealed that 90% patients were successfully supported for a bridge to recovery, durable VAD, or heart transplantation.23 Most common adverse events seen in this study were hemolysis and bleeding. There is a growing population of congenital heart disease including single ventricular lesions. Morray et al.24 published the multicenter study of Impella use in patients with Fontan circulation. From the total cohort of 10 patients, 8 were supported for cardiogenic shock with ventricular failure and 2 for a high-risk electrophysiology procedure. The median duration of support was 49 hours (2.7-264 hours). The support was discontinued for recovery in 5 patients, transitioned to another device in 2, completion of the electrophysiological procedure in 2, and death in 1 patient. The survival to hospital discharge was 80%.

Similar to the previous reports, our Canadian experience resulted in overall feasible device implantations and support for both cardiogenic shock and left heart decompression on ECMO. The likelihood of native myocardial functional recovery is unlikely with Impella support in cases of chronic systolic heart failure as compared with acute decompensation secondary to etiologies like myocarditis. But the placement of a durable VAD in cardiogenic shock may result in inferior outcomes, as suggested by INTERMACS and Pedimacs registry reports. Temporizing MCS may be required to achieve hemodynamic stability and reversal of end-organ dysfunction before making decisions about advanced heart failure therapies such as heart transplantation or a durable VAD.25,26 This short-term stability may also allow for additional time for patients and their family to make appropriate decisions around their goals of care. Recently, the Food and Drug Administration expanded the use of Impella in pediatric patients with symptomatic acute decompensated heart failure and cardiogenic shock.

Limitations

The small sample size and retrospective nature of this study are the important limitations. This study showed adequate hemodynamic support with Impella in children, but there was no direct comparison with other types of MCS such as ECMO.

Conclusions

This initial Canadian experience for a microaxial flow device (Impella) demonstrated that it can be used in older children and adolescents for hemodynamic support in cardiogenic shock and LV decompression during ECMO runs. With ongoing experience, the potential exists to expand the use to right heart support or biventricular support and/or in patients with congenital heart disease. Future directions will depend on the ongoing research in device miniaturization of microaxial pumps to expand the use of this less-invasive device to younger children with acute heart failure.

Acknowledgments

Ethics Statement

The study was approved by the institutional research ethics board and had adhered to the relevant ethical guidelines (REB Approval Number: 1000075631).

Patient Consent

Patient consent was waived due to the retrospective design of the study.

Funding Sources

No funding was received for this study.

Disclosures

AJ reports a relationship with Abbott Industries that includes an unrestricted educational grant and also reports a relationship with Berlin Heart Inc and Merck & Co, Inc sponsored trial that includes consulting or advisory. The other authors have no conflicts of interest to disclose.

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