Jan-Willem Hinnen

The Proximal Fixation Strength of Modern EVAR Grafts in a Short Aneurysm Neck. An In Vitro Study

OBJECTIVES The study aims to measure the strength of the proximal fixation of endografts in short and long necks. DESIGN Three types of endografts were compared: Gore Excluder, Vascutek Anaconda and Medtronic Endurant. MATERIALS AND METHODS The proximal part of the stent grafts was inserted in bovine arteries and the graft was then attached to a tensile testing machine. The force to obtain dislodgement (DF) from the aorta was recorded for each graft at proximal seal lengths of 10 and 15 mm. RESULTS The median DF (interquartile range, IQR) for the Excluder, the Anaconda and the Endurant with a seal length of 15 mm was: 11.8 (10.5-12.0) N, 20.8 (18.0-30.1) N and 10.7 (10.4-11.3) N. With the shorter proximal seal of 10mm, DF was, respectively: 6.0 (4.5-6.6) N, 17.0 (11.2-36.6) N and 6.4 (6.1-12.0) N. CONCLUSIONS The proximal fixation of the Anaconda is superior to the Excluder and the Endurant at short necks of 10 and 15 mm in an experimental set-up. There is a statistically significant decrease of proximal fixation for the Excluder stent graft, when decreasing the length of the proximal neck from 15 to 10 mm.

Aortic customize: a new alternative endovascular approach to aortic aneurysm repair using injectable biocompatible elastomer. An in vitro study.

PURPOSE Aortic Customize is a new concept for endovascular aortic aneurysm repair in which a non polymerized elastomer is injected to fill the aneurysm sac around a balloon catheter. The aim of this in vitro study was to investigate the extent of aneurysm wall stress reduction by the presence of a noncompliant elastomer cuff. METHODS A thin-walled latex aneurysm (inner radius sac 18 mm, inner radius neck 8 mm), equipped with 12 tantalum markers, was attached to an in vitro circulation model. Fluoroscopic roentgenographic stereo photogrammetric analysis (FRSA) was used to measure marker movement during six cardiac cycles. The radius of three circles drawn through the markers was measured before and after sac filling. Wall movement was measured at different systemic pressures. Wall stress was calculated from the measured radius (sigma = pr/2t). RESULTS The calculated wall stress was 7.5-15.6 N/cm(2) before sac filling and was diminished to 0.43-1.1 N/cm(2) after sac filling. Before sac filling, there was a clear increase (P < .001) in radius of the proximal (range, 7.9%-33.5%), middle (range, 3.3%-25.2%), and distal (range, 10.5%-184.3%) rings with increasing systemic pressure. After sac filling with the elastomer, there remained a small, significant (P < .001) increase in the radius of the circles (ranges: 6.8%-8.8%; 0.7%-1.1%; 5.3%-6.7%). The sac filling reduced the extent of radius increase. The treated aneurysm withstood systemic pressures up to 220/140 mm Hg without noticeable wall movement. After the sac filling, there was no pulsation visible in the aneurysm wall. CONCLUSIONS Filling the aneurysm sac of a simplified in vitro latex model with a biocompatible elastomer leads to successful exclusion of the aneurysm sac from the circulation. Wall movement and calculated wall stress are diminished noticeably by the injection of biocompatible elastomer.

Effect of Stent-Graft Compliance on Endotension after EVAR

Purpose: To investigate whether, and to which extent, the type of graft has influence on the pressure in the aneurysm sac. Methods: The study consisted of a dynamic and a static experiment. In the dynamic experiment, a latex aneurysm was inserted into an in-vitro circulation model, with variable (80–180 mmHg) systemic systolic pressure and a pulse pressure of 40 mmHg. Seven types of devices were used to exclude the aneurysm: a latex reference graft, 3 stentless grafts made of different fabrics, and 3 different types of commercially produced stented grafts used for endovascular aneurysm repair (EVAR). The systolic and diastolic intra-aneurysm pressures (IAP) were measured, along with the pulse pressure. The mean IAP and pulse pressures were compared for each category of graft (stented/stentless) and for each graft. In the static experiments, the compliance of each graft and the latex aneurysm were determined by measuring the change in volume necessary to obtain a change in pressure. Furthermore, the IAP with each graft was measured in a nonpulsatile situation under systolic pressures varying between 60 and 140 mmHg. Results: The experiments showed that, with increasing systemic pressures, there was a small pressure (<5 mmHg) increase in the aneurysm, but there was no significant difference among grafts in the dynamic or the static experiments (p=0.12 and p=0.17, respectively). With the 3 stented EVAR grafts, there was less pressure transmission than with the 3 stentless grafts, but this difference was not significant (p>0.05). Conclusion: This in-vitro study demonstrated that there is a clinically irrelevant pressure transmission through the graft wall and no significant difference in the pressure transmission between stented and stentless grafts.

Roentgen Stereophotogrammetric Analysis: An Accurate Tool to Assess Stent-Graft Migration

Purpose: To evaluate in an in vitro model the feasibility and accuracy of Roentgen stereophotogrammetric analysis (RSA) versus computed tomography (CT) for the ability to detect stent-graft migration. Methods: An aortic model was constructed from a 22-mm-diameter Plexiglas tube with 6-mm polytetrafluoroethylene inlays to mimic the renal arteries. Six tantalum markers were placed in the wall of the aortic tube proximal to the renal arteries. Another 6 markers were added to a Gianturco stent, which was cast in Plexiglas and placed inside the aorta and fixed to a micromanipulator to precisely control displacement of the stent along the longitudinal axis. Sixteen migrations were analyzed with RSA software and compared to the micromanipulator. Thirty-two migrations were measured by 3 observers from CT images acquired with 16X0.5-mm beam collimation and reconstructed with a 0.5-mm slice thickness and a 0.4-mm reconstruction interval. Measurements were made with Vitrea postprocessing software using a standard clinical protocol and central lumen line reconstruction. Results of CT were also compared to the micromanipulator. Results: The mean RSA measurement error compared to the micromanipulator was 0.002±0.044 mm, and the maximum error was 0.10 mm. There was no statistically significant interobserver variability for CT (p=0.17). The pooled mean (maximum) measurement error of CT was 0.14±0.29 (1.00) mm, which was significantly different from the RSA measurement error (p<0.0001). Conclusion: Detection of endograft migration by RSA is feasible and was significantly more accurate than CT in this nonpulsatile in vitro model.

Aneurysm sac pressure monitoring: effect of pulsatile motion of the pressure sensor on the interpretation of measurements.

Purpose: To determine the effect of pulsatile motion of graft-attached pressure sensors on the accuracy of aneurysm sac pressure measurement. Methods: Pressure inside a pressure box was measured with a sensor attached to a stent-graft (Sensorgraft) facing a sensor in fixed position (Sensorbox). Maximum inter-sensor variation of Sensorgraft and Sensorbox was determined in static experiments. Experiments with pulsatile circulation were performed with a compliant and a noncompliant stent-graft at 120/80 mmHg and 160/95 mmHg. Pressure measurements in the box were repeated after the box pressure was increased from 0 to 120 mmHg. Sensorgraft motion was measured by ultrasound. Measurements with Sensorgraft were compared to those with Sensorbox using Pearson correlation coefficients to determine the concordance between the sensors. Results: The maximum inter-sensor variation was 4 mmHg. Increased box pressure induced progressive pulsatile graft and sensor motion during all experiments. During the experiments with the compliant graft at systemic pressures of 120/80 and 160/95 mmHg, the maximum inter-sensor variation was exceeded at box pressures of 65 and 75 mmHg, respectively. The sensor motion at these box pressures was 214±2.70 μm and 210±0.93 μm, respectively. Measurements of Sensorgraft were higher than Sensorbox, up to 13 mmHg at a box pressure of 120 mmHg. The Pearson correlation coefficients during these experiments were 0.99 and 1.00 (p<0.001), respectively. In the experiments with the noncompliant graft, the maximum inter-sensor variation was not exceeded, and sensor motion was only 7±0.46 μm and 26±1.48 μm, respectively. The Pearson correlation coefficient during these experiments was 1.00 (p<0.001). Conclusion: Pulsatile sensor motion can influence the accuracy of pressure measurement. More compliant grafts are more susceptible to this phenomenon. Despite false high pressure measurements, stent-graft-attached pressure sensors seem appropriate to follow pressure trends in the aneurysm sac.

Accurate Detection of Stent-Graft Migration in a Pulsatile Aortic Model Using Roentgen Stereophotogrammetric Analysis

Purpose: To evaluate the feasibility and accuracy of Roentgen stereophotogrammetric analysis (RSA) versus computed tomography (CT) for detecting stent-graft migration in an in vitro pulsatile circulation model and to study the feasibility of a nitinol endovascular clip (NEC) as an aortic wall reference marker for RSA. Methods: An aortic model with stent-graft was constructed and connected to an artificial circulation with a physiological flow and pressure profile. Tantalum markers and NECs were used as aortic reference markers for RSA analysis. Stent-graft migrations were measured during pulsatile circulation with RSA and CT. CT images acquired with 64times0.5-mm beam collimation were analyzed with Vitrea postprocessing software using a standard clinical protocol and central lumen line reconstruction. RSA in the model with the circulation switched off was used as the reference standard to determine stent-graft migration. The measurement errors of RSA and CT were determined during pulsatile circulation. Results: The mean measurement error ± standard deviation (maximum) of RSA during pulsatile circulation using the tantalum markers was −0.5±0.16 (0.7) mm. Using the NEC, the mean (maximum) measurement error was −0.4±0.25 (1.1) mm. The mean (maximum) measurement error of CT was −1.1±1.17 (2.8) mm. Conclusion: RSA is an accurate and feasible tool to measure stent-graft migration in a pulsatile environment. Migration measurement with RSA was more accurate than CT in this experimental setup. The nitinol clip tested in this study is potentially feasible as an aortic reference marker in patients after endovascular repair.

Treatment of types II-IV endoleaks by injecting biocompatible elastomer (PDMS) in the aneurysm sac: an in vitro study.

Purpose To investigate if an elastomer [polydimethylsiloxane (PDMS)] can be used to effectively treat endoleaks after endovascular aneurysm repair. Methods A latex aneurysm (36-mm inner diameter sac, 15-mm inner diameter neck) was attached to an in vitro circulation model. The aneurysm was excluded from the circulation by placing an unstented polyester graft. Endoleak types II–IV were created using different setups. While the circulation setup running, the aneurysm was filled with contrast medium and then the biocompatible PDMS elastomer was injected to exclude the endoleaks and the perigraft area. The sac was considered full when all contrast was pushed out of the sac and the elastomer flowed into the proximal efferent lumbar artery. Treatment was successful when the aneurysm was free of endoleak after control angiography. Results The endoleaks were created successfully in the latex aneurysm models, with contrast present in the sac before “treatment.” After elastomer sac filling, all endoleaks were successfully excluded on angiography; there was no leakage of contrast outside the graft lumen in any of the setups. With the type III endoleak, the disruption in the graft material was sealed by the elastomer, while the entire porous graft was encased in elastomer in the type IV endoleak setup. There was no elastomer within the graft lumen in either case. Conclusions This concept of filling the aneurysm sac with PDMS may lead to a percutaneous treatment for endoleaks. While the results of this study show that PDMS may be used to treat endoleaks in vitro, further tests are required to determine if this approach is suitable in vivo.

Influence of aneurysm wall stiffness and the presence of intraluminal thrombus on the wall movement of an aneurysm - an in vitro study.

The purpose of this in vitro study was to investigate the influence of aneurysm wall stiffness and of the presence of intraluminal thrombus (ILT) on aneurysm wall movement. Three latex aneurysms were used with different wall stiffness. The aneurysms, equipped with 20 tantalum markers, were attached to an in vitro circulation model. Fluoroscopic roentgenographic stereo photogrammetric analysis was used to measure marker movement during six cardiac cycles at three different systemic pressures. To investigate the influence of ILT on wall movement, we repeated the same experiment with one of the aneurysms. The aneurysm sac was then filled with one of two E-moduli differing thrombus analogues (Novalyse 8 and 20) or with perfusate as a control. It was noted that the amplitude of the wall movement (mm) increased significantly (P < 0.05) as the compliance of the wall increased. The mean amplitude of the wall movement decreased (P < 0.05) as the stiffness (E-modulus) of the ILT increased. In conclusion, ILT has a ‘cushioning effect’. Wall movement (and theoretically wall stress) diminishes when the stiffness of the ILT increases. Compliance of the aneurysm wall influences wall movement. When the stiffness of the wall increases, the wall movement diminishes.