David Lindisch

Paired Comparison of Vascular Wall Reactions to Palmaz Stents, Strecker Tantalum Stents, and Wallstents in Canine Iliac and Femoral Arteries

BACKGROUNDnPalmaz stents, Strecker stents, and Wallstents, all used clinically, differ substantially in their physical characteristics, yet how differently the vascular wall reacts to them has not been demonstrated conclusively. We therefore undertook a side-by-side comparison.nnnMETHODS AND RESULTSnOne stent was implanted into each canine external iliac and/or the flexing portion of the proximal femoral artery. In 9 dogs, Palmaz stents were placed vis-à-vis Strecker stents, with follow-up of 2 and 4 months. In 7 dogs, Palmaz stents were placed vis-à-vis Wallstents, with 4 months of follow-up. Angiographic midstent luminal diameters immediately after placement and at follow-up as well as midstent cross-sectional areas of neointima were compared for significant differences. In addition, neointimal maturation, medial atrophy, and stent-related trauma were assessed. Angiographically, all arteries remained open. The degree of luminal narrowing by recoil and neointima never reached 50% and was modest for Palmaz stents and Wallstents (P = .33) but significantly higher for Strecker stents (P < .0001 compared with Palmaz stents). This corresponded histologically to a significantly thicker neointima (P = .003) over Strecker than over Palmaz stents but not between Palmaz stents and Wallstents (P = .18). Neointimal buildup was generally more pronounced in the femoral artery segments than in the iliac segments. Maturation of the neointima over Palmaz stents was much further advanced than over Strecker stents and slightly more advanced than over Wallstents. Pressure-related atrophy of the tunica media was least for Strecker stents and more pronounced but similar for Wallstents and Palmaz stents. Wallstent wire ends caused some wall trauma; several femoral Palmaz stent struts protruded through the media.nnnCONCLUSIONSnThe lower-hoop-strength, higher-profile tantalum Strecker stent is affected by vascular wall recoil and evokes a greater degree of neointima formation than the lower-profile, higher-hoop-strength Palmaz stent and Wallstent. Medial atrophy is pronounced outside the latter two stents. The rigid Palmaz stent can penetrate through the vascular wall in flexing arteries.

Electromagnetic tracking in the clinical environment

When choosing an electromagnetic tracking system (EMTS) for image-guided procedures several factors must be taken into consideration. Among others these include the systems refresh rate, the number of sensors that need to be tracked, the size of the navigated region, the system interaction with the environment, whether the sensors can be embedded into the tools and provide the desired transformation data, and tracking accuracy and robustness. To date, the only factors that have been studied extensively are the accuracy and the susceptibility of EMTSs to distortions caused by ferromagnetic materials. In this paper the authors shift the focus from analysis of system accuracy and stability to the broader set of factors influencing the utility of EMTS in the clinical environment. The authors provide an analysis based on all of the factors specified above, as assessed in three clinical environments. They evaluate two commercial tracking systems, the Aurora system from Northern Digital Inc., and the 3D Guidance system with three different field generators from Ascension Technology Corp. The authors show that these systems are applicable to specific procedures and specific environments, but that currently, no single system configuration provides a comprehensive solution across procedures and environments.

Precision targeting of liver lesions using a novel electromagnetic navigation device in physiologic phantom and swine.

Radiofrequency ablation of primary and metastatic liver tumors is becoming a potential alternative to surgical resection. We propose a novel system that uses real-time electromagnetic position sensing of the needle tip to help with precision guidance into a liver tumor. The purpose of this study was to evaluate this technology in phantom and animal models. Using an electromagnetic navigation device, instrumented 18 g needles were advanced into radioopaque tumor targets in a respiratory liver phantom. The phantom featured a moving liver target that simulated cranio-caudal liver motion due to respiration. Skin-to-target path planning and real-time needle guidance were provided by a custom-designed software interface based on pre-operative 1 mm CT data slices. Needle probes were advanced using only the electromagnetic navigation device and software display. No conventional real-time imaging was used to assist in advancing the needle to the target. Two experienced operators (interventional radiologists) and two inexperienced ones (residents) used the system. The same protocol was then also used in two anesthetized 45 kg Yorkshire swine where radioopaque agar nodules were injected into the liver to serve as targets. A total of 76 tumor targeting attempts were performed in the liver phantom, and 32 attempts were done in the swine. The average time for path planning was 30 s in the phantom, and 63 s in the swine. The median time for the actual needle puncture to reach the desired target was 33 s in the phantom, and 42 s in the swine. The average registration error between the CT coordinate system and electromagnetic coordinate system was 1.4 mm (SD 0.3 mm) in the phantom, and 1.9 mm (SD 0.4 mm) in the swine. The median distance from the final needle tip position to the center of the tumor was 6.4 mm (SD 3.3 mm, n=76) in the phantom, and 8.3 mm (SD 3.7 mm, n=32) in the swine. There was no statistical difference in the planning time, procedure time, or accuracy of needle placement between experienced and inexperienced operators. The novel electromagnetic navigation system allows probe delivery into hepatic tumors of a physiologic phantom and live anesthetized swine. The system allows less experienced operators to perform equally well as experienced radiologists in terms of procedure time and accuracy of needle probe delivery.

Electromagnetic tracking for abdominal interventions in computer aided surgery

Electromagnetic tracking has great potential for assisting physicians in precision placement of instruments during minimally invasive interventions in the abdomen, since electromagnetic tracking is not limited by the line-of-sight restrictions of optical tracking. A new generation of electromagnetic tracking has recently become available, with sensors small enough to be included in the tips of instruments. To fully exploit the potential of this technology, our research group has been developing a computer aided, image-guided system that uses electromagnetic tracking for visualization of the internal anatomy during abdominal interventions. As registration is a critical component in developing an accurate image-guided system, we present three registration techniques: 1) enhanced paired-point registration (time-stamp match registration and dynamic registration); 2) orientation-based registration; and 3) needle shape-based registration. Respiration compensation is another important issue, particularly in the abdomen, where respiratory motion can make precise targeting difficult. To address this problem, we propose reference tracking and affine transformation methods. Finally, we present our prototype navigation system, which integrates the registration, segmentation, path-planning and navigation functions to provide real-time image guidance in the clinical environment. The methods presented here have been tested with a respiratory phantom specially designed by our group and in swine animal studies under approved protocols. Based on these tests, we conclude that our system can provide quick and accurate localization of tracked instruments in abdominal interventions, and that it offers a user-friendly display for the physician.

Liver Tumor Biopsy in a Respiring Phantom with the Assistance of a Novel Electromagnetic Navigation Device

The purpose of this study was to evaluate our ability to insert magnetically tracked needles into liver phantom tumors which move simulating physiologic respiration. First, a novel image-guided platform based on a new magnetic tracking device (AURORA?) was constructed. Second, an accuracy evaluation of a compatible magnetically tracked needle (MagTrax) was performed. Finally, 16 liver tumor punctures were attempted using only the image-guided platform for guidance. The inherent MagTrax needle positional error was 0.71?0.43 mm in the non-surgical laboratory setting. Successful puncture of liver tumors was achieved in 14 of 16 attempts (87.5%) by two users. The average time of each procedure was short (163?57 seconds.) The system adequately displayed the moving liver allowing for tumor target visualization and targeting. The AURORA based navigation platform and the compatible MagTrax needle appear promising for more rigorous phantom accuracy studies and in vivo tumor puncture testing in a respiring animal.

Needle-Based Interventions With the Image-Guided Surgery Toolkit (IGSTK): From Phantoms to Clinical Trials

We present three image-guided navigation systems developed for needle-based interventional radiology procedures, using the open source image-guided surgery toolkit (IGSTK). The clinical procedures we address are vertebroplasty, RF ablation of large lung tumors, and lung biopsy. In vertebroplasty, our system replaces the use of fluoroscopy, reducing radiation exposure to patient and physician. We evaluate this system using a custom phantom and compare the results obtained by a medical student, an interventional radiology fellow, and an attending physician. In RF ablation of large lung tumors, our system provides an automated interventional plan that minimizes damage to healthy tissue and avoids critical structures, in addition to accurate guidance of multiple electrode insertions. We evaluate the systems performance using an animal model. Finally, in the lung biopsy procedure, our system replaces the use of computed tomographic (CT) fluoroscopy, reducing radiation exposure to patient and physician, while at the same time enabling oblique trajectories which are considered challenging under CT fluoroscopy. This system is currently being used in an ongoing clinical trial at Georgetown University Hospital and was used in three cases.

A hardware and software protocol for the evaluation of electromagnetic tracker accuracy in the clinical environment: a multi-center study

This paper proposes an assessment protocol that incorporates both hardware and analysis methods for evaluation of electromagnetic tracker accuracy in different clinical environments. The susceptibility of electromagnetic tracker measurement accuracy is both highly dependent on nearby ferromagnetic interference sources and non-isotropic. These inherent limitations combined with the various hardware components and assessment techniques used within different studies makes the direct comparison of measurement accuracy between studies difficult. This paper presents a multicenter study to evaluate electromagnetic devices in different clinical environments using a common hardware phantom and assessment techniques so that results are directly comparable. Measurement accuracy has been shown to be in the range of 0.79-6.67mm within a 180mm3 sub-volume of the Aurora measurement space in five different clinical environments.

A Buyer's Guide to Electromagnetic Tracking Systems for Clinical Applications

When choosing an Electromagnetic Tracking System (EMTS) for image-guided procedures, it is desirable for the system to be usable for different procedures and environments. Several factors influence this choice. To date, the only factors that have been studied extensively, are the accuracy and the susceptibility of electromagnetic tracking systems to distortions caused by ferromagnetic materials. In this paper we provide a holistic overview of the factors that should be taken into account when choosing an EMTS. These factors include: the systems refresh rate, the number of sensors that need to be tracked, the size of the navigated region, system interaction with the environment, can the sensors be embedded into the tools and provide the desired transformation data, and tracking accuracy and robustness. We evaluate the Aurora EMTS (Northern Digital Inc., Waterloo, Ontario, Canada) and the 3D Guidance EMTS with the flat-panel and the short-range field generators (Ascension Technology Corp., Burlington, Vermont, USA) in three clinical environments. We show that these systems are applicable to specific procedures or in specific environments, but that, no single system is currently optimal for all environments and procedures we evaluated.

Robotically Assisted Interventions: Clinical Trial for Spinal Blocks

Percutaneous interventions are performed by freehand passages of instruments, such as needles, from the skin surface to the anatomy of interest. The main problem with this approach is that the physician can be inaccurate in aligning the instrument and staying on course. A joystick-controlled robotic needle driver may allow the physician to more precisely target the anatomy. This paper describes our experience with a robotic needle driver in a 20-patient clinical trial of nerve and facet blocks. Our next stage of research in robotically assisted lung biopsy is also mentioned.

Robotically assisted spine needle placement: program plan and cadaver study

Gives an overview of our program plan in robotically assisted spine procedures and details an initial cadaver study. Low back pain is a common medical problem, and minimally invasive procedures such as nerve blocks are rapidly growing in popularity as a potential method of treatment. To assist the physician in needle placement during these procedures, we have investigated using a needle-driver robot developed at the Johns Hopkins Urology Robotics Laboratory. Robotic systems such as these have great potential as physician-assisting devices for improving the precision of needle placement and enabling the development of the next generation of precision guidance systems for interventional techniques.