Assessing Single Ventricle Function in the Fontan Circulation using Wave Intensity Analysis.

Single ventricle hearts palliated with the Fontan operation present complications later in life as a result of increased venous pressures and abnormal ventricle function. Wave intensity analysis uses measurements of blood velocity and pressure to represent arterial hemodynamics as summations of energy waves. This methodology could potentially be a useful tool in assessment of Fontan patients. The clinical value of wave intensity parameters was utilized to evaluate the functional performance of the single ventricle in Fontan patients. A retrospective analysis of invasive hemodynamic data was retrospectively obtained from routine cardiac catheterization of patients with Fontan circulation (n = 20) and comparison to those with biventricular circulation (n = 10) who presented to the catheterization laboratory for closure of small patent ductus arteriosus (PDAs). Wave intensity analysis and wave energy flux was calculated using aortic pressure waveforms and echocardiography aortic Doppler measurements as previously described. Significant differences were seen in the peak forward compression wave (p = 0.013), early systolic energy flux (p = 0.005) and the systolic and diastolic ratio (p = 0.006) in Fontan patients versus controls. Within the Fontan group, there was a positive correlation (0.54, p = 0.02) between the wave speed and pulmonary vascular resistance. Early systolic energy flux was a potential individual indicator of a Fontan patients heart failure classification (AUC = 0.71). Wave intensity analysis could be a useful tool in screening Fontan patients and predicting clinical outcomes and Fontan failure. Future prospective analyses of Fontan hemodynamics and WIA are needed.

In vitro evaluation of an external compression device for fontan mechanical assistance.

While Fontan palliation in the form of the total cavopulmonary connection has improved the management of congenital single ventricle physiology, long-term outcomes for patients with this disease are suboptimal due to the lack of two functional ventricles. Researchers have shown that ventricular assist devices (VADs) can normalize Fontan hemodynamics. To minimize blood contacting surfaces of the VAD, we evaluated the use of an external compression device (C-Pulse Heart Assist System, Sunshine Heart Inc.) as a Fontan assist device. A mock circulation was developed to mimic the hemodynamics of a hypertensive Fontan circulation in a pediatric patient. The Sunshine C-Pulse compression cuff was coupled with polymeric valves and a compressible tube to provide nonblood-contacting pulsatile flow through the Fontan circulation. The effect of the number, one or two, and placement of valves, before or after the compression cuff, on inferior vena cava pressure (IVCP) was studied. In addition, the effect of device inflation volume and compression rate on maintaining low IVCP was investigated. With one valve located before the cuff, the device was unable to maintain an IVCP below 15.5 mm Hg. With two valves, the C-Pulse was able to maintain IVCP as low as 8.5 mm Hg. The C-Pulse provided pulsatile flow and pressure through the pulmonary branch of the mock circulation with a pulse pressure of 16 mm Hg and 180 mL/min additional flow above unassisted flow. C-Pulse compression reduced IVCP below 12 mm Hg with 13 cc inflation volume and compression rates above 105 bpm. This application of an external compression device combined with two valves has potential for use as an artificial right ventricle by maintaining low IVCP and providing pulsatile flow through the lungs.

Graphical User Interface for Calculating Wave Intensity from Cardiac Catheterization Measurements.

Wave intensity analysis (WIA) as a framework to assess cardiovascular hemodynamics has been successfully used in many clinical applications. Typically, wave intensity calculations require the simultaneous acquisition of blood velocity and blood pressure at the same vascular site. Unfortunately, many hemodynamic parameters that are used to monitor pre-operative patient hemodynamic state use both invasively acquired blood pressure measurements in catheterization laboratory and non-invasively acquired blood velocity measurements. To utilize wave intensity analysis to assess patients undergoing cardiac interventional procedures, we have developed a graphical user interface (GUI) that uses standard clinical measurements which include invasive blood pressure waveforms and Doppler echocardiography images to calculate wave intensity parameters. The GUI consists of three main subroutines that allow clinicians to import raw data and extract and analyze the blood pressure and blood velocity signals separately. Using the electrocardiogram signals as an alignment marker, the re-formatted signals are aligned, and wave intensity is calculated. Wave intensity features such as forward compression wave (FCW), forward expansion wave (FEW) and wave speed are calculated and output in a table for statistical analysis. The GUI represents the first attempt to create a program that encourages clinicians to use WIA for hemodynamic assessment in patients undergoing cardiac catheterization procedures with the data they have already procured.

Wave Intensity Analysis of Right Ventricular Function during Pulsed Operation of Rotary Left Ventricular Assist Devices.

Changing the speed of left ventricular assist devices (LVADs) cyclically may be useful to restore aortic pulsatility; however, the effects of this pulsation on right ventricular (RV) function are unknown. This study investigates the effects of direct ventricular interaction by quantifying the amount of wave energy created by RV contraction when axial and centrifugal LVADs are used to assist the left ventricle. In 4 anesthetized pigs, pressure and flow were measured in the main pulmonary artery and wave intensity analysis was used to identify and quantify the energy of waves created by the RV. The axial pump depressed the intensity of waves created by RV contraction compared with the centrifugal pump. In both pump designs, there were only minor and variable differences between the continuous and pulsed operation on RV function. The axial pump causes the RV to contract with less energy compared with a centrifugal design. Diminishing the ability of the RV to produce less energy translates to less pressure and flow produced, which may lead to LVAD-induced RV failure. The effects of pulsed LVAD operation on the RV appear to be minimal during acute observation of healthy hearts. Further study is necessary to uncover the effects of other modes of speed modulation with healthy and unhealthy hearts to determine if pulsed operation will benefit patients by reducing LVAD complications.

Quantification of Pulsed Operation of Rotary Left Ventricular Assist Devices with Wave Intensity Analysis.

The current generation of left ventricular assist devices (LVADs) provides continuous flow and has the capacity to reduce aortic pulsatility, which may be related to a range of complications associated with these devices. Pulsed LVAD operation using speed modulation presents a mechanism to restore aortic pulsatility and potentially mitigate complications. We sought to investigate the interaction of axial and centrifugal LVADs with the LV and quantify the effects of continuous and pulsed LVAD operations on LV generated wave patterns under different physiologic conditions using wave intensity analysis (WIA) method. The axial LVAD created greater wave intensity associated with LV relaxation. In both LVADs, there were only minor and variable differences between the continuous and pulsed operations. The response to physiologic stress was preserved with LVAD implantation as wave intensity increased marginally with volume loading and significantly with infusion of norepinephrine. Our findings and a new approach of investigating aortic wave patterns based on WIA are expected to provide useful clinical insights to determine the ideal operation of LVADs.

Feasibility of a Post-Auricle Wireless Power System for Pediatric Mechanical Circulatory Support Pumps.

Heart failure (HF) affects approximately 12,000-35,000 children each year in the United States. The development of blood pumps has provided circulatory support for many adults suffering with HF until they receive a heart transplant. However, while the development of blood pumps for adults has led to fullyimplantable continuous flow devices, blood pump technology for children has lagged significantly behind. One area for improving blood pump implantability in children is the use of wireless powering transfer systems (WPTS). These systems eliminate the power cord connecting the implanted blood pump to the external power supply. In adults, WPTS have decreased the number of power cord-related infections and have improved patient outcomes after pump implantation. Unfortunately, the components of these wireless systems are too large for children. In this paper we describe the preliminary work to develop a fully implantable WPTS specifically designed to power the Jarvik 2000 Child. Specifically, we design planar coils 36 um in thickness to be implanted in behind-the-ear fashion. An amplifier and rectifier circuit were also built to provide 15.7V and 0.5A of voltage and current to the pump.

Electrical power to run ventricular assist devices using the Free-range Resonant Electrical Energy Delivery system.

BACKGROUND: Models of power delivery within an intact organism have been limited to ionizing radiation and, to some extent, sound and magnetic waves for diagnostic purposes. Traditional electrical power delivery within the intact human body relies on implanted batteries that limit the amount and duration of delivered power. The efficiency of current battery technology limits the substantial demands required, such as continuous operation of an implantable artificial heart pump within a human body. METHODS: The fully implantable, miniaturized, Free-range Resonant Electrical Energy Delivery (FREE-D) system, compatible with any type of ventricular assist device (VAD), has been tested in a swine model (HVAD) for up to 3 hours. Key features of the system, the use of high-quality factor (Q) resonators together with an automatic tuning scheme, were tested over an extended operating range. Temperature changes of implanted components were measured to address safety and regulatory concerns of the FREE-D system in terms of specific absorption rate (SAR). RESULTS: Dynamic power delivery using the adaptive tuning technique kept the system operating at maximum efficiency, dramatically increasing the wireless power transfer within a 1-meter diameter. Temperature rise in the FREE-D system never exceeded the maximum allowable temperature deviation of 2°C (but remained below body temperature) for an implanted device within the trunk of the body at 10 cm (25% efficiency) and 50 cm (20% efficiency), with no failure episodes. CONCLUSIONS: The large operating range of FREE-D system extends the use of VAD for nearly all patients without being affected by the depth of the implanted pump. Our in-vivo results with the FREE-D system may offer a new perspective on quality of life for patients supported by implanted device.

Novel techniques of mechanical circulatory support for the right heart and Fontan circulation.

BACKGROUND: Currently available ventricular assist devices are designed primarily for use in patients with left sided heart failure. This study evaluated the efficacy of the Jarvik 2000 ventricular assist device (VAD) as a pulmonary pump to power a Fontan circuit in a large animal model. METHODS: Without the use of cardiopulmonary bypass, Fontan circulations were surgically created in 4 pigs (50 kg) using synthetic grafts from the inferior and superior vena cavas to the main pulmonary artery. Subsequently, the VAD was implanted within the common Fontan graft to provide a pulmonary pump. Direct chamber pressures and epicardial Doppler images were taken during the various phases of the experiment. Heart rate, femoral artery blood pressure, oxygen saturation, and aortic flow rate were continuously recorded. The outflow cannula of the VAD was then partially banded by 50% and then 75% to mimic increased afterload. RESULTS: Fontan and VAD implantation was successfully performed in all 4 animals. Arterial pressure and aortic flow decreased dramatically with institution of the Fontan but were restored to baseline upon activation of the VAD. The pressure within the systemic venous circulation rose precipitously with institution of the Fontan circulation and improved appropriately with activation of the VAD. Adequate perfusion was maintained during increased afterload. CONCLUSIONS: An axial flow VAD can restore normal hemodynamics and cardiac output when used as a pulmonary pump in a Fontan circulation. A VAD can rescue a failing Fontan as a bridge to transplant or recovery, even in the setting of high pulmonary resistance.

Feasibility of using piezohydraulic pumps as motors for pediatric ventricular assist devices.

The feasibility of using piezohydraulic pumps in drivers for pediatric ventricular assist devices is presented in this article. In this study a 0.5 kg piezohydraulic pump is incorporated into a ventricular assist device driver to drive a pulsatile pediatric 30 mL stroke ventricular assist device (VAD). The driver consists of a piezoelectric-hydraulic hybrid actuator and volume amplification section. Mechanical tests were performed on the pump and the hybrid actuator and a maximum power output of 5.4 W and 1.6 W were recorded respectively. The driver was tested running at multiple heart rates from 50-80 beats per minute (BPM) in an in-vitro bench top mock circulation to characterize the performance of the driver under a circulatory load. The maximum drive pressure output by the driver was 35 kPa. Peak flow rate from the VAD driven by the new driver was 6 L/min against a 10 kPa back pressure. Mean flow rate from the VAD outlet was 2.35 L/min for 80 BPM operation.