Pulsatile Pump System Research Articles

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

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. 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. 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. 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.

A pneumatically controlled microfluidic rectifier enabling zero backflow under pulsatile flow regime

A pulsatile microfluidic pump transports discrete volume to specific target locations. However, backflow in the pulsatile microfluidic pump often decreases the pumping efficiency and causes unwanted sample mixing due to unsteady boundaries. Employing the concept of a transistor, we developed a pneumatically controlled microfluidic rectifier (PCMR) that prevents backflow in the pulsatile flow regime. This PCMR was interconnected with a microfluidic pulsatile pumping system to characterize the functions of PCMR under continuous pumping sequences (CPS) and discrete pumping sequences (DPS) with various gate pressures on the PCMR. In the passive mode (zero gate pressure), 1.07% backflow for a DPS and 0.12% for a CPS were achieved. However, by adjusting the gate pressure on PCMR actively, we were able to achieve zero backflow for both pumping sequences at the cost of pumping efficiency. Interestingly, when the flow passes through the PCMR under the controlled gate-pressure, a fluidic oscillation was observed due to the force balance between the fluidic pressure and the gate-pressure. This microfluidic system successfully demonstrated half-rectification from various pulsatile flow profiles. By incorporating multiple three-microvalve systems in parallel with frequency modulation, a fully rectified flow pattern can be realized to enable steady laminar flow from pulsatile micropumps.

The composition of vulnerable plaque and its effect on arterial waveforms

Carotid plaque composition is a key factor of plaque stability and it carries significant prognostic information. The carotid unstable plaques are characterized by a thin fibrous cap (FC) ≤65μm with large lipid core (LC), while stable plaques have a thicker FC and less LC. Identifying the percentage of plaque compositions could help surgeons to make a precise decision for their patients’ treatment protocol. This study aims to distinguish between stable and unstable plaque by defining the relationship between plaque composition and arterial waveform non-invasively. An in-vitro arterial system, composed of a Harvard pulsatile flow pump and artificial circulation system, was used to investigate the effect of the plaque compositions on the pulsatile arterial waveforms. Five types of arterial plaques, composed of the LC, FC, Collagen (Col) and Calcium (Ca), were implemented into the artificial carotid artery to represent the diseased arterial system with 30% of blockage. The pulsatile pressure, velocity and arterial wall movement were measured simultaneously at the site proximal to the plaque. Non-invasive wave intensity analysis (Non-WIA) was used to separate the waves into forward and backward components. The correlation between the plaque compositions and the reflected waveforms was quantitatively analysed. The experimental results indicate that the reflected waveforms are strongly correlated with the plaque compositions, where the percentages of the Col are linearly correlated with the amplitude of the backward diameter (correlation coefficient, r = 0.74) and the lipid content has a strong negative correlation with the backward diameter (r = 0.82). A slight weak correlation exists between the reflected waveform and the percentage of Ca. The strong correlation between the compositions of the plaques with the backward waveforms observed in this study demonstrates that the components of the arterial plaques could be distinguished by the arterial waveforms. This finding might lead to a potential novel non-invasive clinical tool to determine the composition of the plaques and distinguish between stable and vulnerable arterial plaques at the early stage.

Optimizing the Quality of 4D-DSA Temporal Information.

Quantification of blood flow using a 4D-DSA would be useful in the diagnosis and treatment of cerebrovascular diseases. A protocol optimizing identification of density variations in the time-density curves of a 4D-DSA has not been defined. Our purpose was to determine the contrast injection protocol most likely to result in the optimal pulsatility signal strength. Two 3D-printed patient-specific models were used and connected to a pulsatile pump and flow system, which delivered 250-260 mL/min to the model. Contrast medium (Isovue, 370 mg I/mL, 75% dilution) was injected through a 6F catheter positioned upstream from the inlet of the model. 4D-DSA acquisitions were performed for the following injection rates: 1.5, 2.0, 2.5, 3.0 and 3.5 mL/s for 8 seconds. To determine pulsatility, we analyzed the time-density curve at the inlets using the oscillation amplitude and a previously described numeric metric, the sideband ratio. Vascular geometry from 4D-DSA reconstructions was compared with ground truth and micro-CT measurements of the model. Dimensionless numbers that characterize hemodynamics, Reynolds and Craya-Curtet, were calculated for each injection rate. The strongest pulsatility signal occurred with the 2.5 mL/s injections. The largest oscillation amplitudes were found with 2.0- and 2.5-mL/s injections. Geometric accuracy was best preserved with injection rates of >1.5 mL/s. An injection rate of 2.5 mL/s provided the strongest pulsatility signal in the 4D-DSA time-density curve. Geometric accuracy was best preserved with injection rates above 1.5 mL/s. These results may be useful in future in vivo studies of blood flow quantification.

In Vitro Evaluation of Balloon-Expandable Chimney Grafts in the Renal Arteries Combined With the Endurant Endograft

Purpose: To compare balloon-expandable covered stents (BECS) available for use as renal chimney grafts to the Advanta V12 approved for use with the Endurant endograft. Materials and Methods: A silicone model was manufactured based on preoperative computed tomography angiography (CTA) scans of a patient with a 7-cm juxtarenal aneurysm treated with an Endurant bifurcated endograft and an Advanta V12 covered stent for the 6-mm-diameter right renal artery. The model was placed in a flow box filled with a 37°C blood-mimicking solution equipped with a pulsatile pumping system (140/60 mm Hg). The tested BECS were the Advanta V12, the VBX, and the BeGraft+. A 36-mm-diameter Endurant II endograft with a 16-mm-diameter contralateral limb and a 6×59-mm BECS chimney graft were used in 9 consecutive tests (3 for each combination). After each implantation, the model was placed in the CT scanner, and 2 radiologists blinded to the test device independently measured the gutter areas and the patent chimney graft lumen at the level of the Endurant’s suprarenal stent, at the level of the chimney’s maximum curvature, and 10 mm inside the renal artery. The intraclass correlation coefficients (ICC) were calculated to assess interreader reliability. Results: The mean gutter areas were 19.3±7, 20.2±8, and 22.3±8 mm2 for the Advanta, VBX, and BeGraft+, respectively (all p>0.05). At the level of the aortic endograft’s suprarenal stent struts, the mean diameter of the Advanta V12, VBX, and BeGraft+ were 4.46±0.3, 4.12±0.4, and 4.12±0.3 mm, respectively (all p>0.05). At the level of the maximum chimney graft angulation, the mean diameters were 3.77±0.3, 4.16±0.1, and 3.74±0.3 mm, respectively (all p>0.05). In the right renal artery, the mean diameters were 3.91±0.2, 4.05±0.9, and 4.3±0.4 mm, respectively (all p>0.05). The ICCs varied between 0.7 and 0.9, indicating good agreement between readers. Conclusion: These in vitro findings showed comparable results between the Advanta V12 and the available BECS used in conjunction with the Endurant endograft according to the instructions for use. Further clinical evaluation is needed to confirm these results.

TAA16. In Vitro Evaluation of Balloon-Expandable Chimney Grafts in a Silicone Model With Pulsatile Pumping System and Use of Computed Tomography Angiography

TAA16. In Vitro Evaluation of Balloon-Expandable Chimney Grafts in a Silicone Model With Pulsatile Pumping System and Use of Computed Tomography Angiography

“Live Cadaver” Model for Internal Carotid Artery Injury Simulation in Endoscopic Endonasal Skull Base Surgery

Intraoperative injury of the internal carotid artery (ICA) is the most dreaded complication in endoscopic endonasal surgery (EES) of skull base. Training for ICA injury is practically impossible in live operative settings. To evaluate a pulsatile perfusion-based live cadaveric model for ICA injury simulation in a laboratory setting. The major emphasis of the study was to evaluate various means of controlling acute bleeding and evaluating the practical utility of this model for training purposes. Five embalmed, uninjected cadaveric heads were prepared for study by connecting to a pulsatile perfusion pump system filled with artificial blood solution. EES approaches were used to evaluate different types of ICA injuries similar to operative scenarios. Various methods of managing ICA injuries such as packing, clipping, and trapping, were evaluated. The educational advantages of the live cadaver model were assessed using questionnaires given to participants in a hands-on dissection course. The trainee was faced with several scenarios similar to those encountered during an actual intraoperative ICA injury. Packing, clipping, and trapping of the ICA injury were successfully achieved in all segments of the ICA. Clip-based reconstruction techniques were successfully developed. All trainees reported gaining new knowledge, learning new techniques. The responses to the questionnaire confirmed the significant educational value of this model. The live cadaver model presented here provides real-life experience with major vessel injury during EES in a laboratory setting. This model could significantly improve current training for the management of intraoperative vascular injuries during EES.

A High Performance Pulsatile Pump for Aortic Flow Experiments in 3-Dimensional Models.

Aortic pathologies such as coarctation, dissection, and aneurysm represent a particularly emergent class of cardiovascular diseases. Computational simulations of aortic flows are growing increasingly important as tools for gaining understanding of these pathologies, as well as for planning their surgical repair. In vitro experiments are required to validate the simulations against real world data, and the experiments require a pulsatile flow pump system that can provide physiologic flow conditions characteristic of the aorta. We designed a newly capable piston-based pulsatile flow pump system that can generate high volume flow rates (850mL/s), replicate physiologic waveforms, and pump high viscosity fluids against large impedances. The system is also compatible with a broad range of fluid types, and is operable in magnetic resonance imaging environments. Performance of the system was validated using image processing-based analysis of piston motion as well as particle image velocimetry. The new system represents a more capable pumping solution for aortic flow experiments than other available designs, and can be manufactured at a relatively low cost.

Development of the ex vivo laryngeal model of phonation.

The direct study of human phonation is limited by the invasive and painful nature of human laryngeal neuromuscular manipulation. As a platform for the study of human phonation, indirect models have been utilized for decades such as animal, cadaveric, and computational. We sought to develop a research method allowing direct scientific control of virtually living larynges to expand our ability to understand human phonation. Canine and porcine models. Nineteen canine larynges were surgically removed and reperfused with progressively adapting methodologies to create ex vivo phonation. Full neuromuscular stimulation and phonation were ultimately achieved in the ex vivo larynx. As compared with alternative perfusate solutions, heparinized whole blood was found to result in the most robust neuromuscular response. Modification of the reperfusion technique from a continuous flow to a pulsatile pump system resulted in dramatic increases in neuromuscular response and longevity of the organ. The experimental findings were repeated to demonstrate reliability of the ex vivo model. The ex vivo larynx model is demonstrated to be a repeatable platform for phonatory research. The process of development has been comprehensively described in the present report. Although the described experimental model was designed for phonatory research, this model can be readily adapted for investigations of organ transplant preservation techniques, effects of organ ischemia, and neuromuscular reinnervation capabilities. NA.

Closed circuit MR compatible pulsatile pump system using a ventricular assist device and pressure control unit

The aim of this study was to evaluate the performance of a closed circuit MR compatible pneumatically driven pump system using a ventricular assist device as pulsatile flow pump for in vitro 3D flow simulation. Additionally, a pressure control unit was integrated into the flow circuit. The performance of the pump system and its test-retest reliability was evaluated using a stenosis phantom (60% lumen narrowing). Bland-Altman analysis revealed a good test-retest reliability (mean differences = -0.016 m/s, limits of agreement = ±0.047 m/s) for in vitro flow measurements. Furthermore, a rapid prototyping in vitro model of a normal thoracic aorta was integrated into the flow circuit for a direct comparison of flow characteristics with in vivo data in the same subject. The pneumatically driven ventricular assist device was attached to the ascending aorta of the in vitro model to simulate the beating left ventricle. In the descending part of the healthy aorta a flexible stenosis was integrated to model an aortic coarctation. In vivo and in vitro comparison showed significant (P = 0.002) correlations (r = 0.9) of mean velocities. The simulation of increasing coarctation grade led to expected changes in the flow patterns such as jet flow in the post-stenotic region and increased velocities.

Flow pumping system for physiological waveforms

A pulsatile flow pumping system is developed to replicate flow waveforms with reasonable accuracy for experiments simulating physiological blood flows at numerous points in the body. The system divides the task of flow waveform generation between two pumps: a gear pump generates the mean component and a piston pump generates the oscillatory component. The system is driven by two programmable servo controllers. The frequency response of the system is used to characterize its operation. The system has been successfully tested in vascular flow experiments where sinusoidal, carotid, and coronary flow waveforms are replicated.

A cell culturing system that integrates the cell loading function on a single platform and evaluation of the pulsatile pumping effect on cells

In this paper, we present a novel microfluidic system with pulsatile cell storing, cell-delivering and cell culturing functions on a single PDMS platform. For this purpose, we have integrated two reservoirs, a pulsatile pumping system containing two soft check valves, which were fabricated by in situ photopolymerization, six switch valves, and three cell culture chambers all developed through a simple and rapid fabrication process. The sample volume delivered per stroke was 120 nl and the transported volume was linearly related to the pumping frequency. We have investigated the effect of the pulsatile pneumatic micropumping on the cells during transport. For this purpose, we pumped two types of cell suspensions, one containing human breast adenocarcinoma cells (MCF-7) and the other mesenchymal stem cells (hMSCs) derived from bone marrow. The effect of pulsatile pumping on both cell types was examined by short and long-term culture experiments. Our results showed that the characteristics of both cells were maintained; they were not damaged by the pumping system. Evaluations were carried out by morphological inspection, viability assay and immunophenotyping analysis. The delivered MCF-7 cells and hMSCs spread and proliferated onto the gelatin coated cell culture chamber. This total micro cell culture system can be applied to cell-based high throughput screening and for co-culture of different cells with different volume.

Pulsatile Flow Phantom for Ultrasound Image-Guided HIFU Treatment of Vascular Injuries

A pulsatile flow phantom was developed for studies of ultrasound image-guided high intensity focused ultrasound (HIFU) application in transcutaneous hemostasis of injured blood vessels. The flow phantom consisted of a pulsatile pump system with instrumented excised porcine carotid artery, which was imbedded in a transparent agarose gel to model structural configuration of in vivo tissues. Heparinized porcine blood was circulated through the phantom. The artery was injured using an 18-gauge needle to model a penetrating injury in human peripheral vasculature. A HIFU transducer with the diameter of 7 cm, focal length of 6.3 cm and frequency of 3.4 MHz was used to seal the puncture. Ultrasound imaging was used to localize and target the puncture site and to monitor the HIFU treatment. Triphasic blood flows present in the human arteries were reproduced, with flow rates of 50 to 500 mL/min, pulse rates of 62 to 138 beats/min and peak pressures of 100 to 250 mm Hg. The penetrating injury of an artery was mimicked successfully in the flow phantom setting and was easily visualized both optically through the transparent gel and with power Doppler ultrasound imaging. Hemostasis was achieved in 55 ± 31 s ( n = 9) of HIFU application. Histologic observations showed that a HIFU-sealed puncture was filled with clotted blood and covered with a fibrin cap. The pulsatile flow phantom provides a controlled and repeatable environment for studies of transcutaneous image-guided HIFU application in hemostasis of a variety of blood vessel injuries. (E-mail: adasi@u.washington.edu)

Pulsatile ECMO and VAD: a dual use of a new device in pediatric cardiac patients

The purpose of this investigation was to present the first European clinical experience with the new MEDOS DELTASTREAM DP1 used in pulsatile extracorporeal membrane oxygenation (ECMO) or ventricular assist device (VAD) options in the pediatric population. Between January 2002 and April 2006, 11 patients required ECMO and 5 patients received a left VAD (LVAD) in the San Vincenzo Hospital. Indications were postcardiotomy heart failure in 15 patients and fulminant myocarditis in one patient. ECMO was established in all patients by cannulation of the right atrium and ascending aorta. LVAD was instituted by cannulation of the left atrium and ascending aorta. The DP1, an extracorporeal rotary blood pump, was used as an ECMO and an LVAD device. The pump features a diagonal-flow impeller and can be used for both continuous and pulsatile modes of perfusion. Priming volume of the pump was approximately 30 ml, with a flow rate of up to 8 l/min. Ten patients were discharged from ECMO and four from VAD. In the ECMO group, one patient died of peritonitis while on ECMO and two patients died on days 3 and 4 after weaning because of persistent pulmonary hypertension and major neurologic complications. In the VAD group, one patient died of low output syndrome 9 days after weaning. A 12-year-old patient was successfully given transplantation on day 8 of ECMO support and discharged on day 30 after heart transplant. All other patients were discharged. Three pumps were changed for pump failure and one pump was electively replaced because of improper anticoagulation management. No other thromboembolic adverse events occurred. Our results suggest that the MEDOS DELTASTREAM DP1 pulsatile pump system can be used as an ECMO or a VAD support. The opportunity to utilize pulsatile flow in postcardiotomy cardiogenic shock significantly improved the outcomes by producing more physiologic hemodynamics and superior end organ function. Easy implantation and simple management of this device represents the major advantage.

Initial European Clinical Experience With Pulsatile Extracorporeal Membrane Oxygenation

Extracorporeal membrane oxygenation (ECMO) for post-cardiotomy heart failure in neonates and infants still carries high mortality and morbidity rates. In this study we present the first European clinical experience with the Medos DeltaStream DP1, a new pulsatile flow pump, in neonates and infants. The DP1 is an extracorporeal rotary blood pump. The pump features a diagonal flow impeller, and can be used for both continuous and pulsatile output. Special characteristics include its small priming volume of approximately 30 ml and a high pumping capacity. A temperature sensor and speed sensors are integrated into the pump. The pump has a delivery rate of up to 8 liters/min and a speed range of 100 to 10,000 rpm. Two patients being assisted with the pulsatile pump system were successfully weaned after 36 and 53 hours, respectively. Based on our limited experience with 2 patients, we believe that pulsatile DP1 device is a reasonable alternative to current conventional non-pulsatile systems.

Pulsatile ECMO in Neonates and Infants: First European Clinical Experience with a New Device

This study presents the first European clinical experience with the Medos DeltaStream DP1, a new pulsatile flow pump, in neonates and infants. Between January 2002 and December 2004, 420 patients at our institution underwent congenital heart surgery on cardiopulmonary bypass. During this period, 10 patients required extracorporeal membrane oxygenation (ECMO) support for acute postcardiotomy heart failure. Seven patients (median age 7 days, range 1-70 days), were supported by a nonpulsatile Biomedicus centrifugal pump, whereas three patients (aged 1 month, 1 year, and 12 years) were supported by a pulsatile Medos DP1. The DP1 is an extracorporeal rotary blood pump. The pump features a diagonal-flow impeller, and can be used for both continuous and pulsatile output. Special characteristics include a small priming volume of approximately 30 ml and a high pumping capacity. A temperature sensor and speed sensors are integrated in the pump. The pump has a delivery rate of up to 8 l/min and a speed range of 100-10,000 rpm. Overall mortality was 40% (4 of 10 patients), and all four deaths were in the nonpulsatile Biomedicus group. In the nonpulsatile group, the median support duration was 95 hours with a range of 48-140 hours. Two patients assisted with the pulsatile pump system were successfully weaned after 36 and 53 hours, respectively; the 12-year-old patient was successfully transplanted on the eighth postimplant day and discharged from the hospital on the 32nd posttransplant day. Although this preliminary experience doesn't allow for statistical analysis, clinically it was possible to observe a better performance in pulsatile flow recipients with faster lactate recovery, reduced need for inotropic support, reduced assistance duration in bridge-to-recovery settings, and smoother intensive care management. ECMO for postcardiotomy heart failure in neonates and infants still carries high mortality and morbidity rates. Pulsatile flow with the Medos DeltaStream DP1 pump system improves results by producing more physiologic hemodynamics, reducing the duration of support in the case of bridge to recovery, and improving end-organ function.

Effect of „physiological“ pulsatile perfusion on renal blood flow during cardiopulmonary bypass

Objectives: Data on the benefit of pulsatile perfusion during cardiopulmonary bypass are still controversial. One reason for the divergent results is the non „physiological“ pulsatile perfusion of a modified roller-pump. Therefore we developed a new physiological pulsatile pump system for cardiopulmonary bypass to examine the effect of non-pulsatile perfusion, pulsatile perfusion induced by a roller-pump and „physiological“ pulsatile perfusion generated by the new device on renal blood flow.

Distribution of Sac Pressure in an Experimental Aneurysm Model After Endovascular Repair:The Effect of Endoleak Types I and II

Purpose To study in an experimental aneurysm model the differential distribution of strain/pressure (S/P) on the aneurysm wall before and after endograft exclusion and in the presence of individual type I and type II endoleaks. Methods Two tapered elliptical Gore-Tex patches were sutured to an anterior and posterior longitudinal arteriotomy of an 8-mm Gore-Tex tube graft, thus creating a fusiform aneurysm. Two S/P transducers were placed at the proximal sac adjacent to the proximal neck, 2 at the site of the widest sac diameter, and 2 at the sac adjacent to the distal neck. The aneurysm, which was connected to a pulsatile pump system, was excluded using a 10-mm endograft. Type I and type II endoleaks were created and tested individually. S/P measurements were obtained at systemic systolic pressures (BP) of 80, 110, and 150 mmHg. Thrombosis of the sac contents was induced by injection of thrombin and calcium in the sac. Angiography was used to verify presence or absence of flow in the sac. Results Aneurysm exclusion resulted in significant S/P reductions at all 3 BP levels versus prior to exclusion (p 0.05 for all 3 BP levels). In the presence of a proximal type I endoleak, S/P distribution was not uniform, and S/P at the proximal neck was close to S/P prior to exclusion (p>0.05 no graft versus type I endoleak for all 3 BP levels). This was also true in the presence of thrombus. With a type II endoleak, S/P was more evenly distributed and was not significantly elevated compared to the pressure without an endoleak (p>0.05, graft versus type II endoleak for all 3 BP levels). Thrombus had no effect on intrasac S/P with a type II endoleak. Intrasac S/P was significantly higher in the presence of a type I endoleak compared to a type II endoleak when BP=150 mmHg (p=0.008). Conclusions Endovascular exclusion of an aneurysm results in uniform S/P reduction in the aneurysm sac. Type I endoleak, but not type II endoleak, results in significantly higher S/P in an area of the sac adjacent to the proximal neck. Thrombus does not result in significantly different S/P distribution in the aneurysm sac.

Distribution of sac pressure in an experimental aneurysm model after endovascular repair: the effect of endoleak types I and II.

To study in an experimental aneurysm model the differential distribution of strain/pressure (S/P) on the aneurysm wall before and after endograft exclusion and in the presence of individual type I and type II endoleaks. Two tapered elliptical Gore-Tex patches were sutured to an anterior and posterior longitudinal arteriotomy of an 8-mm Gore-Tex tube graft, thus creating a fusiform aneurysm. Two S/P transducers were placed at the proximal sac adjacent to the proximal neck, 2 at the site of the widest sac diameter, and 2 at the sac adjacent to the distal neck. The aneurysm, which was connected to a pulsatile pump system, was excluded using a 10-mm endograft. Type I and type II endoleaks were created and tested individually. S/P measurements were obtained at systemic systolic pressures (BP) of 80, 110, and 150 mmHg. Thrombosis of the sac contents was induced by injection of thrombin and calcium in the sac. Angiography was used to verify presence or absence of flow in the sac. Aneurysm exclusion resulted in significant S/P reductions at all 3 BP levels versus prior to exclusion (p<0.05). Thrombus in the sac did not alter S/P in the excluded sac (p>0.05 for all 3 BP levels). In the presence of a proximal type I endoleak, S/P distribution was not uniform, and S/P at the proximal neck was close to S/P prior to exclusion (p>0.05 no graft versus type I endoleak for all 3 BP levels). This was also true in the presence of thrombus. With a type II endoleak, S/P was more evenly distributed and was not significantly elevated compared to the pressure without an endoleak (p>0.05, graft versus type II endoleak for all 3 BP levels). Thrombus had no effect on intrasac S/P with a type II endoleak. Intrasac S/P was significantly higher in the presence of a type I endoleak compared to a type II endoleak when BP=150 mmHg (p=0.008). Endovascular exclusion of an aneurysm results in uniform S/P reduction in the aneurysm sac. Type I endoleak, but not type II endoleak, results in significantly higher S/P in an area of the sac adjacent to the proximal neck. Thrombus does not result in significantly different S/P distribution in the aneurysm sac.

Endotension distribution and the role of thrombus following endovascular AAA exclusion.

To determine the pattern of strain and pressure transmitted to an aortic aneurysm wall before and after endovascular exclusion and to evaluate the role of sac thrombus on the conduction of pressure and wall strain. Three canine thoracic aortas were used to create abdominal aortic aneurysms (AAA). The segments were placed on a pulsatile pump system, and 8 strain transducers were positioned in the aneurysm sac. Baseline strain/pressure (S/P) was recorded in 1 animal, then the AAA was excluded with a stent-graft. Thrombin was injected into the sac, and strain/pressure was recorded at 7 systemic pressures (35 to 120 mmHg) over 6 hours. The thrombus was replaced with fibrin glue, and S/P was recorded over 4 hours. Additional trials using whole and 50% diluted unclotted blood were performed prior to sac thrombosis. Computed tomography and angiography were performed before and after aneurysm exclusion. Pressure transmitted to the aneurysm wall decreased following stent-graft placement (p<or=0.001). Strain/pressure was not distributed evenly in the sac (p<or=0.05), and varying systemic pressures did not affect this distribution. Pressures near the stent-graft were higher than those laterally (p<or=0.001) in all trials with interposed fresh thrombus and fibrin thrombus. The fibrin group had elevated baseline measurements, but correction for the elevated values did not influence the statistical significance (p<or=0.001). Blood and fibrin thrombus reduced transmitted wall pressure to a similar degree. Overall S/P in the fluid-filled nonclotted sac was significantly lower (p<or=0.001) than in the thrombus groups. Endovascular AAA exclusion reduced strain and pressure conducted to the aneurysm wall, and the distribution of transmitted pressure in the excluded sac without endoleak differed regardless of the sac contents. Fresh thrombus reduced transmittedS/P in all trials at all systemic pressures, as did fibrin thrombus but in a less predictable fashion.