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

BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.

Initial Experience With the Pediatric Impella Device: A Feasibility Study in a Porcine Model.

OBJECTIVE: This study's objective was to evaluate insertion techniques and device fit of the pediatric version of the Impella ventricular assist device in swine which had similar sized carotids and left ventricles (LVs) as children weighing 10-20 kg. BACKGROUND: Options for minimally invasive circulatory support in children are limited. A modified device based on the current Impella 2.5 platform was created in an effort to provide minimally invasive circulatory support for children. METHODS: Animal studies (n = 10) were performed to determine technical feasibility of device implant via the right common carotid artery (RCCA) in swine with a carotid and LV size similar to children with a BSA < 1 m2 and weight 10-20 kg. The RCCA diameter was measured on pre-implant ultrasound and the LV length was measured at necropsy. The animals were supported for 4 hr and the device explanted. Blood samples and post-explant necropsy was performed to evaluate for device related complications. RESULTS: All animals underwent successful device insertion. Mean carotid artery diameter by ultrasound was 3.5 ± 0.3 mm. There was no LV or aortic/mitral valve damage with a minimum LV length of 5.4 cm. CONCLUSIONS: Minimally invasive circulatory support is needed in small children. Limitations are primarily related to vessel and chamber size. The Impella Pediatric catheter was safely and successfully implanted in carotid arteries similar in size to children weighing 10-20 kg with minimal complications. © 2016 Wiley Periodicals, Inc.

Vasopressin rescue for in-pediatric intensive care unit cardiopulmonary arrest refractory to initial epinephrine dosing: a prospective feasibility pilot trial.

OBJECTIVES: To assess the feasibility of a large, randomized controlled trial of combination epinephrine-arginine vasopressin for in-pediatric intensive care unit cardiopulmonary arrest refractory to initial epinephrine dosing. DESIGN: Prospective, pilot, matched controlled clinical trial using exception from informed consent. SETTING: Pediatric intensive care unit in a university-affiliated tertiary care children's hospital. PATIENTS: All patients <18 yrs of age admitted to the pediatric intensive care unit with cardiopulmonary arrest requiring chest compressions and epinephrine (0.01 mg/kg) were eligible. INTERVENTIONS: Patients who remained in cardiopulmonary arrest despite an initial dose of epinephrine received arginine vasopressin (0.8 U/kg) rescue as the second vasopressor, followed by additional epinephrine if needed. MEASUREMENTS AND MAIN RESULTS: Outcome variables included return of spontaneous circulation (≥20 min), survival at 24 hrs, survival to hospital discharge, and neurologic status at discharge. Favorable neurologic status was defined as Pediatric Cerebral Performance Categories 1, 2, and 3, or no change from admission. Data were compared to a retrospective, matched cohort of patients who experienced cardiopulmonary arrest requiring ≥ two doses of vasopressor, and did not receive arginine vasopressin (n = 20). Of 2,654 patients admitted to the pediatric intensive care unit, 29 (1.1%) had refractory cardiopulmonary arrest: five patients were excluded, 14 missed for inclusion, and ten were enrolled. There was increased 24-hr survival (80% vs. 30%, odds ratio 9.33, 95% confidence interval 1.51-57.65) in arginine vasopressin patients. There was no significant difference in return of spontaneous circulation, survival to hospital discharge, or favorable neurologic status at discharge. CONCLUSIONS: These pilot data provide support for a larger randomized controlled trial of arginine vasopressin therapy during cardiopulmonary resuscitation for in-hospital pediatric cardiac arrest.