Design and Haemodynamic Analysis of a Novel Anchoring System for Central Venous Pressure Measurement.

BACKGROUND/OBJECTIVE: In recent years, treatment of heart failure patients has proved to benefit from implantation of pressure sensors in the pulmonary artery (PA). While longitudinal measurement of PA pressure profoundly improves a clinician's ability to manage HF, the full potential of central venous pressure as a clinical tool has yet to be unlocked. Central venous pressure serves as a surrogate for the right atrial pressure, and thus could potentially predict a wider range of heart failure conditions. However, it is unclear if current sensor anchoring methods, designed for the PA, are suitable to hold pressure sensors safely in the inferior vena cava. The purpose of this study was to design an anchoring system for accurate apposition in inferior vena cava and evaluate whether it is a potential site for central venous pressure measurement. MATERIALS AND METHODS: A location inferior to the renal veins was selected as an optimal site based on a CT scan analysis. Three anchor designs, a 10-strut anchor, and 5-struts with and without loops, were tested on a custom-made silicone bench model of Vena Cava targeting the infra-renal vena cava. The model was connected to a pulsatile pump system and a heated water bath that constituted an in-vitro simulation unit. Delivery of the inferior vena cava implant was accomplished using a preloaded introducer and a dilator as a push rod to deploy the device at the target area. The anchors were subjected to manual compression tests to evaluate their stability against dislodgement. Computational Fluid Dynamics (CFD) analysis was completed to characterize blood flow in the anchor's environment using pressure-based transient solver. Any potential recirculation zones or disturbances in the blood flow caused by the struts were identified. RESULTS: We demonstrated successful anchorage and deployment of the 10-strut anchor in the Vena Cava bench model. The 10-strut anchor remained stable during several compression attempts as compared with the other two 5-strut anchor designs. The 10-strut design provided the maximum number of contact points with the vessel in a circular layout and was less susceptible to movement or dislodgement during compression tests. Furthermore, the CFD simulation provided haemodynamic analysis of the optimum 10-strut anchor design. CONCLUSIONS: This study successfully demonstrated the design and deployment of an inferior vena cava anchoring system in a bench test model. The 10-strut anchor is an optimal design as compared with the two other 5-strut designs; however, substantial in-vivo experiments are required to validate the safety and accuracy of such implants. The CFD simulation enabled better understanding of the haemodynamic parameters and any disturbances in the blood flow due to the presence of the anchor. The ability to place a sensor technology in the vena cava could provide a simple and minimally invasive approach for heart failure patients.

Simulation of changes in myocardial tissue properties during left ventricular assistance with a rotary blood pump.

We considered a mathematical model to investigate changes in geometric and hemodynamic indices of left ventricular function in response to changes in myofiber contractility and myocardial tissue stiffness during rotary blood pump support. Left ventricular assistance with a rotary blood pump was simulated based on a previously published biventricular model of the assisted heart and circulation. The ventricles in this model were based on the one-fiber model that relates ventricular function to myofiber contractility and myocardial tissue stiffness. The simulations showed that indices of ventricular geometry, left ventricular shortening fraction, and ejection fraction had the same response to variations in myofiber contractility and myocardial tissue stiffness. Hemodynamic measures showed an inverse relation compared with geometric measures. Particularly, pulse pressure and arterial dP/dtmax increased when myofiber contractility increased, whereas increasing myocardial tissue stiffness decreased these measures. Similarly, the lowest pump speed at which the aortic valve remained closed increased when myofiber contractility increased and decreased when myocardial tissue stiffness increased. Therefore, simultaneous monitoring of hemodynamic parameters and ventricular geometry indirectly reflects the status of the myocardial tissue. The appropriateness of this strategy will be evaluated in the future, based on in vivo studies.

Exercise hemodynamics during extended continuous flow left ventricular assist device support: the response of systemic cardiovascular parameters and pump performance.

Patients on continuous flow left ventricular assist devices (cf-LVADs) are able to return to an active lifestyle and perform all sorts of physical activities. This study aims to evaluate exercise hemodynamics in patients with a HeartMate II cf-LVAD (HM II). Thirty (30) patients underwent a bicycle exercise test. Along with exercise capacity, systemic cardiovascular responses and pump performance were evaluated at 6 and 12 months after HM II implantation. From rest to maximum exercise, heart rate increased from 87 ± 14 to 140 ± 32 beats/minute (bpm) (P<0.01), while systolic arterial blood pressure increased from 93 ± 12 to 116 ± 21 mm Hg (P<0.01). Total cardiac output (TCO) increased from 4.1 ± 1.1 to 8.5 ± 2.8 L/min (P<0.01) while pump flow increased less, from 5.1 ± 0.7 to 6.4 ± 0.6 L/min (P<0.01). Systemic vascular resistance (SVR) decreased from 1776 ± 750 to 1013 ± 83 dynes.s/cm(5) (P<0.001) and showed the strongest correlation with TCO (r= -0.72; P<0.01). Exercise capacity was affected by older age, while blood pressure increased significantly in men compared with women. Exercise capacity remained consistent at 6 and 12 months after HM II implantation, 51% ± 13% and 52% ± 13% of predicted VO2 max for normal subjects corrected for age and gender. In conclusion, pump flow of the HM II may contribute partially to TCO during exercise, while SVR was the strongest determinant of TCO.

A Procedural Guide for Implanting the Cordella Pulmonary Artery Pressure Sensor.

BACKGROUND: The Cordella pulmonary artery (PA) pressure sensor (Endotronix, Inc) is an investigational, wireless, microelectromechanical system (MEMS) sensor that allows remote monitoring of PA pressures. Understanding the implantation procedure and technical nuances is key to safe, efficient, and effective implantation to allow for successful use of the PA pressure sensor over the long term. We provide a summary of the implantation procedure and present a series of cases detailing the Cordella PA pressure sensor implantation in the United States and Europe.

Noninvasive continuous arterial blood pressure monitoring with Nexfin®.

BACKGROUND: If invasive measurement of arterial blood pressure is not warranted, finger cuff technology can provide continuous and noninvasive monitoring. Finger and radial artery pressures differ; Nexfin® (BMEYE, Amsterdam, The Netherlands) measures finger arterial pressure and uses physiologic reconstruction methodologies to obtain values comparable to invasive pressures. METHODS: Intra-arterial pressure (IAP) and noninvasive Nexfin arterial pressure (NAP) were measured in cardiothoracic surgery patients, because invasive pressures are available. NAP-IAP differences were analyzed during 30 min. Tracking was quantified by within-subject precision (SD of individual NAP-IAP differences) and correlation coefficients. The ranges of pressure change were quantified by within-subject variability (SD of individual averages of NAP and IAP). Accuracy and precision were expressed as group average ± SD of the differences and considered acceptable when smaller than 5 ± 8 mmHg, the Association for the Advancement of Medical Instrumentation criteria. RESULTS: NAP and IAP were obtained in 50 (34-83 yr, 40 men) patients. For systolic, diastolic, mean arterial, and pulse pressure, median (25-75 percentiles) correlation coefficients were 0.96 (0.91-0.98), 0.93 (0.87-0.96), 0.96 (0.90-0.97), and 0.94 (0.85-0.98), respectively. Within-subject precisions were 4 ± 2, 3 ± 1, 3 ± 2, and 3 ± 2 mmHg, and within-subject variations 13 ± 6, 6 ± 3, 9 ± 4, and 7 ± 4 mmHg, indicating precision over a wide range of pressures. Group average ± SD of the NAP-IAP differences were -1 ± 7, 3 ± 6, 2 ± 6, and -3 ± 4 mmHg, meeting criteria. Differences were not related to mean arterial pressure or heart rate. CONCLUSION: Arterial blood pressure can be measured noninvasively and continuously using physiologic pressure reconstruction. Changes in pressure can be followed and values are comparable to invasive monitoring.

A novel wireless implant for central venous pressure measurement: First animal experience.

Background/Objective: Central venous pressure (CVP) serves as a surrogate for right atrial pressure, and thus could potentially predict a wider range of heart failure conditions. The purpose of this work is to assess CVP, through an implantable sensor incorporated with a novel anchor design, in the inferior and superior vena cava of an animal model. Methods: Two animals (Dorset sheep) were implanted with sensors at 3 different locations: inferior vena cava (IVC), superior vena cava (SVC), and pulmonary artery (PA). Two sensors with distinct anchor designs considering anatomical requirements were used. A standard PA sensor (trade name Cordella) was deployed in the PA and SVC, whereas a sensor with a modified cylindrical anchor with various struts was designed to reside in the IVC. Each implant was calibrated against a Millar catheter reference sensor. The ability of the central venous sensors to detect changes in pressure was evaluated by modifying the fluid volume of the animal. Results: The sensors implanted in both sheep were successful, which provided an opportunity to understand the relationship between PA and CVP via simultaneous readings. The mapping and implantation in the IVC took less than 15 minutes. Multiple readings were taken at each implant location using a hand-held reader device under various conditions. CVP recorded in the IVC (6.49 mm Hg) and SVC (6.14 mm Hg) were nearly the same. PA pressure (13-14 mm Hg) measured was higher than CVP, as expected. The SVC waveforms showed clear beats and respiration. Respiration could be seen in the IVC waveforms, but not all beats were easily distinguishable. Both SVC and IVC readings showed increases in pressure (3.7 and 2.7 mm Hg for SVC and IVC, respectively) after fluid overload was induced via extra saline administration. Conclusion: In this work, the feasibility of measuring CVP noninvasively was demonstrated. The established ability of wireless PA pressure sensors to enable prevention of decompensation events weeks ahead can now be explored using central venous versions of such sensors.

Noninvasive arterial blood pressure waveforms in patients with continuous-flow left ventricular assist devices.

Arterial blood pressure and echocardiography may provide useful physiological information regarding cardiac support in patients with continuous-flow left ventricular assist devices (cf-LVADs). We investigated the accuracy and characteristics of noninvasive blood pressure during cf-LVAD support. Noninvasive arterial pressure waveforms were recorded with Nexfin (BMEYE, Amsterdam, The Netherlands). First, these measurements were validated simultaneously with invasive arterial pressures in 29 intensive care unit patients. Next, the association between blood pressure responses and measures derived by echocardiography, including left ventricular end-diastolic dimensions (LVEDDs), left ventricular end-systolic dimensions (LVESDs), and left ventricular shortening fraction (LVSF) were determined during pump speed change procedures in 30 outpatients. Noninvasive arterial blood pressure waveforms by the Nexfin monitor slightly underestimated invasive measures during cf-LVAD support. Differences between noninvasive and invasive measures (mean ± SD) of systolic, diastolic, mean, and pulse pressures were -7.6 ± 5.8, -7.0 ± 5.2, -6.9 ± 5.1, and -0.6 ± 4.5 mm Hg, respectively (all <10%). These blood pressure responses did not correlate with LVEDD, LVESD, or LVSF, while LVSF correlated weakly with both pulse pressure (r = 0.24; p = 0.005) and (dP(art)/dt)max (r = 0.25; p = 0.004). The dicrotic notch in the pressure waveform was a better predictor of aortic valve opening (area under the curve [AUC] = 0.87) than pulse pressure (AUC = 0.64) and (dP(art)/dt)max (AUC = 0.61). Patients with partial support rather than full support at 9,000 rpm had a significant change in systolic pressure, pulse pressure, and (dP(art)/dt)max during ramp studies, while echocardiographic measures did not change. Blood pressure measurements by Nexfin were reliable and may thereby act as a compliment to the assessment of the cf-LVAD patient.

Analysis of aortic valve commissural fusion after support with continuous-flow left ventricular assist device.

OBJECTIVES: Continuous-flow left ventricular assist devices (cf-LVADs) may induce commissural fusion of the aortic valve leaflets. Factors associated with this occurrence of commissural fusion are unknown. The aim of this study was to examine histological characteristics of cf-LVAD-induced commissural fusion in relation to clinical variables. METHODS: Gross and histopathological examinations were performed on 19 hearts from patients supported by either HeartMate II (n = 17) or HeartWare (n = 2) cf-LVADs and related to clinical characteristics (14 heart transplantation, 5 autopsy). RESULTS: Eleven of the 19 (58%) aortic valves showed fusion of single or multiple commissures (total fusion length 11 mm [4-20] (median [interquartile range]) per valve), some leading to noticeable nodular displacements or considerable lumen diameter narrowing. Multiple fenestrations were observed in one valve. Histopathological examination confirmed commissural fusion, with varying changes in valve layer structure without evidence of inflammatory infiltration at the site of fusion. Commissural fusion was associated with continuous aortic valve closure during cf-LVAD support (P = 0.03). LVAD-induced aortic valve insufficiency developed in all patients with commissural fusion and in 67% of patients without fusion. Age, duration of cf-LVAD support and aetiology of heart failure (ischaemic vs dilated cardiomyopathy) were not associated with the degree of fusion. CONCLUSIONS: Aortic valve commissural fusion after support with cf-LVADs is a non-inflammatory process leading to changes in valve layer structure that can be observed in >50% of cf-LVAD patients. This is the first study showing that patients receiving full cf-LVAD support without opening of the valve have a significantly higher risk of developing commissural fusion than patients on partial support.

Pump flow estimation from pressure head and power uptake for the HeartAssist5, HeartMate II, and HeartWare VADs.

The use of long-term mechanical circulatory support (MCS) for heart failure by means of implanted continuous-flow left ventricular assist devices (cf-LVADs) will increase, either to enable recovery or to provide a destination therapy. The effectiveness and user-friendliness of MCS will depend on the development of near-physiologic control strategies for which accurate estimation of pump flow is essential. To provide means for the assessment of pump flow, this study presents pump models, estimating pump flow (Q(lvad)) from pump speed (n) and pressure difference across the LVAD (Δp(lvad)) or power uptake (P). The models are evaluated for the axial-flow LVADs HeartAssist5 (HA5) and HeartMate II (HMII), and for a centrifugal pump, the HeartWare (HW). For all three pumps, models estimating Q(lvad) from Δp(lvad) only is capable of describing pump behavior under static conditions. For the axial pumps, flow estimation from power uptake alone was not accurate. When assuming an increase in pump flow with increasing power uptake, low pump flows are overestimated in these pumps. Only for the HW, pump flow increased linearly with power uptake, resulting in a power-based pump model that estimates static pump flow accurately. The addition of pressure head measurements improved accuracy in the axial cf-LVAD estimation models.

Single-centre experience of 85 patients with a continuous-flow left ventricular assist device: clinical practice and outcome after extended support.

OBJECTIVES: We evaluated our single-centre clinical experience with the HeartMate II (HM II) left ventricular assist device (LVAD) as a bridge to transplantation (BTT) in end-stage heart failure (HF) patients. METHODS: Survival rates, echocardiographic parameters, laboratory values and adverse events of 85 consecutive patients supported with a HM II were evaluated. RESULTS: Overall, mean age was 45 ± 13 years, 62 (73%) were male and non-ischaemic dilatated cardiomyopathy was present in 60 (71%) patients. The median duration of mechanical support was 387 days (IQR 150-600), with a range of 1-1835 days. The 6-month, 1-, 2-, 3- and 4-year survival rates during HM II LVAD support were 85, 81, 76, 76 and 68%, respectively. Echocardiographic parameters demonstrated effective left ventricular unloading, while laboratory results reflected adequate organ perfusion. However, HM II support was associated with adverse events, such as infections in 42 patients (49%; 0.67 events/patient-year), cardiac arrhythmia in 44 (52%; 0.86 events/patient-year), bleeding complications in 32 (38%; 0.43 events/patient-year) and neurological dysfunction in 17 (20%; 0.19 events/patient-year). CONCLUSIONS: In view of the increasing shortage of donor hearts, HM II LVAD support may be considered a life-saving treatment in end-stage HF patients, with good survival. However, it is still associated with some serious adverse events, of which neurological complications are the most critical.

Noninvasive blood pressure measurement by the Nexfin monitor during reduced arterial pulsatility: a feasibility study.

Noninvasive blood pressure measurements are difficult when arterial pulsations are reduced, as in patients supported by continuous flow left ventricular assist devices (cf-LVAD). We evaluated the feasibility of measuring noninvasive arterial blood pressure with the Nexfin monitor during conditions of reduced arterial pulsatility. During cardiopulmonary bypass(CPB) in which a roller pump based or a centrifugal pump based heart-lung machine generated arterial blood pressure with low pulsatility, noninvasive arterial pressures (NAP)measured by the Nexfin Monitor were recorded and compared with invasively measured radial artery pressures (IAP).We also evaluated NAP in 10 patients with a cf-LVAD during a pump speed change procedure (PSCP). During CPB in 18 patients, the NAP-IAP average difference was -1.3 +/- 6.5 mmHg. The amplitude of pressure oscillations were 4.3 +/- 3.8 mmHg measured by IAP. Furthermore, in the cf-LVAD patients, increase in pump speed settings led to an increase in diastolic and mean arterial pressures (MAP) while the NAP acquired a sinusoidal shape as the aortic valve become permanently closed. In conclusion, NAP was similar to IAP under conditions of reduced arterial pulsatility. The device also measured the blood pressure waveform noninvasively in patients supported by a cf-LVAD.