Novel ECG-Synchronized Pulsatile ECLS System With Various Heart Rates and Cardiac Arrhythmias: An In Vitro Study

Abstract

The objective of this study is to evaluate electrocardiography (ECG)-synchronized pulsatile flow under varying heart rates and different atrial and ventricular arrhythmias in a simulated extracorporeal life support (ECLS) system. The ECLS circuit consisted of an i-cor diagonal pump and console, an iLA membrane ventilator, and an 18 Fr arterial cannula. The circuit was primed with lactated Ringer's solution and packed red blood cells (hematocrit 35%). An ECG simulator was used to trigger pulsatile flow and to generate selected cardiac rhythms. All trials were conducted at a flow rate of 2.5 L/min at room temperature for normal sinus rhythm at 45-180 bpm under non-pulsatile and pulsatile modes. Various atrial and ventricular arrhythmias were also tested. Real-time pressure and flow data were recorded using a custom-based data acquisition system. The energy equivalent pressure (EEP) generated by pulsatile flow was always higher than the mean pressure. No surplus hemodynamic energy (SHE) was recorded under non-pulsatile mode. Under pulsatile mode, SHE levels increased with increasing heart rates (45-120 bpm). SHE levels under a 1:2 assist ratio were higher than the 1:1 and 1:3 assist ratios with a heart rate of 180 bpm. A similar trend was recorded for total hemodynamic energy levels. There was no statistical difference between the two perfusion modes with regards to pressure drops across the ECLS circuit. The main resistance and energy loss came from the arterial cannula. The i-cor console successfully tracked electrocardiographic signals of 12 atrial and ventricular arrhythmias. Our results demonstrated that the i-cor pulsatile ECLS system can be synchronized with a normal heart rate or with various atrial/ventricular arrhythmias. Further in vivo studies are warranted to confirm our findings.

Impact of Heart Rate on Pulsatile Hemodynamic Performance in a Neonatal ECG‐Synchronized ECLS System

“…Indeed, THE and SHE levels decreased with increasing heart rate and assist ratio with pulsatile amplitudes of 1000-3000 rpm for all flow rates. Our data from previous studies regarding ECG-synchronized pulsatile flow for adult ECLS support this finding (10,15). However, the results of the present study showed that the i-cor pump significantly increased SHE levels under a pulsatile amplitude of 4000 rpm at 200 mL/min and heart rates of 120 bpm (R1:2) and 150 bpm (R1:3), as well as at 400 mL/min and a heart rate of 120 bpm (R1:2).…”

Evaluation and Comparison of Hemodynamic Performance of Three ECLS Systems in a Simulated Adult Cardiogenic Shock Model

“…By syncing a pump's pulsatile waveform with ECG of the patient, it is possible that pulsatile flow pumps, like the i‐cor system, may be able to avoid some of these serious complications. Additionally, other studies have shown improvements in hemodynamic energy transmission, coronary blood flow, and end organ protection when using pulsatile flow ECLS systems . Therefore, there may be specific instances where using pulsatile flow systems may render more physiological benefits, especially for higher risk adult ECLS patients.…”

Evaluation of centrifugal blood pumps in term of hemodynamic performance using simulated neonatal and pediatric ECMO circuits

“…We intentionally did not include the results from this particular diagonal pump in the materials and methods section of this manuscript, as it has not been approved by the FDA for clinical practice in the United States. The i‐Cor DP3 diagonal pump is also capable of providing pulsatile flow in addition to conventional non‐pulsatile flow . In addition, the i‐Cor pump is capable of providing ECG‐synchronized pulsatile flow by syncing the pulses of the pump with the patient’s native heartbeat.…”

“…The use of pulsatile flow during acute or chronic mechanical circulatory support for pediatric or adult patients is one of the major research areas at the Penn State Hershey Pediatric Cardiovascular Research Center. [16][17][18][19] The predecessor of the PediMag centrifugal pump was the Levitronix PediVAS system, which is capable of generating pulsatile flow and has been tested in an experimental setting at our research center. This pulsatile module was intended for experimental use only and has not been approved by the Food and Drug Administration (FDA) for use in clinical practice.…”

“…The i-Cor DP3 diagonal pump is also capable of providing pulsatile flow in addition to conventional non-pulsatile flow. [17][18][19][22][23][24] In addition, the i-Cor pump is capable of providing ECG-synchronized pulsatile flow by syncing the pulses of the pump with the patient's native heartbeat. We evaluated the i-Cor pump under non-pulsatile and pulsatile modes using the identical experimental settings of this particular investigation.…”