2017 Barcelona. Acute Cardiac Unloading and Recovery Working Group Meeting. The Impella ventricular assist device support experience at Texas Children's Hospital.

1. § PVAD is feasible as an adjunctive therapy to
VA-ECMO support in children.
§ The risk profiles of the combined support are
not substantially higher than those for ECMO
alone.
§ Potential advantages of PVAD include
ventricular decompression, and facilitation of
ECMO weaning process.
§ Further studies are warranted to clarify the
safety and efficacy of such an approach in the
pediatric population.
PERCUTANEOUS VAD IN CHILDREN SUPPORTED WITH
ECMO FOR CARDIOGENIC SHOCK
BACKGROUND
§ Standard therapy for acute cardiogenic shock
primarily involves volume management,
inotropic and vasoactive support to modulate
cardiac output and vascular tone.
§ Patients in acute cardiogenic shock who fail to
respond to standard medical therapies might
require extracorporeal membrane support
(ECMO).
§ Veno-arterial (VA) ECMO increases afterload,
which can result in pulmonary edema and/or
ventricular distention if used in a heart with
diminished systolic function.
§ Impella is a catheter-based percutaneous
ventricular assist device (PVAD) that has
recently emerged as an option for ventricular
decompression during ECMO support.
§ Patients with progressive cardiogenic shock
on PVADsupport might also require additional
support with ECMO.
§ Experience with combined PVAD and ECMO
support in children is limited.
§ We aimed to define the role of PVAD in the
setting of VA-ECMO in management of
cardiogenic shock at a pediatric
cardiovascular intensive care unit (CVICU) at
a freestanding children’s hospital.
Sebastian C. Tume MD1, Athar Qureshi MD2Dhaval Parekh MD2,Marc Anders MD2, Ricardo Pignatelli MD1
Antonio Cabrera MD2, Carlos M. Mery MD, MPH3, Henri Justino MD2, Iki Adachi MD3.
1. Section of Critical Care Medicine, Baylor College of Medicine and Texas Children’s Hospital, Houston, TX; 2. Section of Cardiology, Baylor College of Medicine and
Texas Children’s Hospital, Houston, TX; 3. Section of Congenital Heart Surgery, Baylor College of Medicine and Texas Children’s Hospital, Houston TX
RESULTS
Table 2. Demographic features
METHODS
§ All patients supported with Impella PVAD on
VA-ECMO support at Texas Children’s
Hospital from September 2014 through May
2017 were included.
§ Demographic, hemodynamic and laboratory
data were reviewed and reported using
descriptive statistics.
§ Hemolysis was defined as plasma free
hemoglobin (PFH) >40 mg/dL on two
occasions or presence of hematuria.
§ Non-lethal arrhythmias included non-
sustained arrhythmias and lethal arrhythmias
included sustained episodes of ventricular or
atrial arrhythmias during device support.
§ All patients were anticoagulated with systemic
heparin infusion per ECMO protocol in
addition to purge heparin (goal ACT 180 - 200
s).
§ Pre and post clinical variables were compared
using Student t-test with significance at
p<0.05.
Table 3: Circulatory support and device characteristics
RESULTS
Patient Characteristics (Table 1 & 2):
§ 6 PVAD devices were implanted in 6 patients
with median BSA 1.46 m2
(0.91-1.97).
§ In 4 patients, peripheral ECMO was added at
median of 6 hours (0- 15) after PVAD
initiation to optimize systemic perfusion.
§ 2 patients had PVAD support added after
peripheral ECMO support due to concern for
poor left heart unloading and pulmonary
edema.
§ 2 patients had LV long diameter < 7 cm and
required device pigtail modification to
accommodate the Impella 2.5.
DEVICE CHARACTERISTICS n = 6
Type of PVAD
Impella 2.5, n (%) 2 (33)
Impella CP, n (%) 4 (67)
Site of Implantation
Femoral, n (%) 6 (100.0)
Cath Implant Time, (minutes) median (min-max ) 37 (5-52)
Duration of PVAD support (days), median (min-max ) 7.5 (5-18)
Duration of ECMO support (days), median (min-max ) 6.5 (5-12)
Reason for Explantation
Clinical Recovery, n (%) 6 (100)
PVAD Malfunction, n (%) 1 (17)
Death on device, n (%) none
Death before hospital discharge, n (%) 2 (33)
RESULTS
PATIENT CHARACTERISTICS n = 6
Weight (kg), median (min-max ) 51 (22 -74)
Age at implant (yrs), median (min-max ) 13 (6.5 - 19)
SEX
Female, n (%) 4 (67)
Male, n (%) 2 (33)
RACE/ETHNICITY
Non-Hispanic White, n (%) 1 (17)
Hispanic, n (%) 2 (33)
Non-Hispanic Black, n (%) 3 (50)
ETIOLOGY OF HEART FAILURE
Myocarditis, n (%) 2 (33)
Rejection after Heart Transplant, n (%) 3 (50)
Congenital Heart Disease, n (%) 1 (17)
Table 1. Patient specific clinical data
RESULTS
CONCLUSIONS
Serious bleeding: bleeding requiring blood trans fus ion; Lethalarrhy thmia: s us tained non-perfusing
arrhy thmia; Hemoly s is : defined as PFH>40mg/dL on more than 2 oc c as ions or pres ence of
hematuria.
Table 4: Complications related to device support
Characteristics of PVADsupport (Table 3):
§ 1 patient (BSA 0.91 m2
) required ECMO to
arterial jump graft to preserve perfusion of
distal lower extremity after PVAD insertion.
§ ECMO was weaned off at median of 6.5 days
(5 - 12) of support, with PVAD remaining in
place.
§ Subsequently, PVAD support was discontinued
at median of 0.5 days (0.5-5) after ECMO
decannulation.
§ In two patients in whom PVADwas added after
ECMO support for LV decompression a
reduction in left ventricular end diastolic
diameter and pulmonary capillary wedge
pressure was observed.
§ None of the devices required exchange.
§ Hemolysis markers at 5 days of combined
support remained in clinically acceptable
ranges: LDH 1632 U/L (559 - 10274) and PFH
33 mg/dL (30 - 150).
§ Site bleeding and arrhythmias were the most
common patient related side effects (Table 4).
§ Lethal arrhythmia occurred in 1 patient with
severe refractory rejection (Table 4).
§ Purge failure and suction were most common
device malfunctions (Table 4). None required
removal of the device.
§ LDH and PFHdid not change significantly after
initiation of support (p >0.05).
§ All patients decannulated from ECMO had
recovery of clinical status and cardiac function.
§ All patients survived until PVAD and ECMO
explantation however 2 patients expired at day
7 and day 23 after support.
OHT; orthotropic heart trans plant, EC NF Fontan: ex tra c ardiac non-fenes tratedFontan,
n = 6
PATIENT COMPLICATIONS
Serious bleeding, n (%) 0
Site bleeding, n (%) 4 (67)
Arterial thrombosis, n (%) 0
Lethal arrhythmia, n (%) 1 (17)
Non lethal arrhythmia, n (%) 2 (33)
Stroke, n (%) 0
DEVICE REALTED COMPLICATIONS
Suction, n (%) 1 (17)
Device thrombus, n (%) 0
Monitor/Purge failure, n (%) 2 (33)
Motor failure, n (%) 0
Device repositioning, n (%) 0