01 White Paper No. 02/2009 First Experiences with the Ziehm Vision FD Mobile C-Arm with Flat-Panel Detector Leiden University Medical Center (LUMC) in the Netherlands is the first hospital in the world using the Ziehm Vision FD in clinical practice. Since the beginning of 2006, Dr. van der Linden and Dr. Willemssen from the Department of Radiology have been working with this leadingedge C-arm system in a clinical environment. This technologically groundbreaking new product was awarded the Product Innovation Award 2006 by Frost & Sullivan on September 18, 2006. Ziehm Imaging has taken mobile C-arm imaging to a new level by introducing the Ziehm Vision FD, the first mobile C-arm in the world that uses flat-panel detector technology. The Ziehm Vision FD s cutting edge technology paves the way for mobile C-arms to advance from purely fulfilling applications in the operating theater to undertaking the most advanced interventional radiological procedures. The Ziehm Vision FD features a flat-panel detector based on amorphous silicon (a-si) photodiode technology with a field size of 20 cm x 20 cm. The flat-panel detector provides an unmatched dynamic range with an image quality suitable for a wide variety of different interventional radiology procedures. The compact design enables better patient access and increased mobility, so that the unit can easily be brought to the patient instead of the patient to the unit. The system runs with a pulsing generator featuring Vision Pulse technology running at a frame rate of up to 30 frames/sec in Fig.1: Ziehm Vision FD fluoroscopy mode as well as in DSA or cine loop modes. The user interface offers an intuitive workflow and logical guidance using two synchronized TFT touchscreen control panels, one conveniently mounted on a swivel arm of the C-arm, the other one mounted on the monitor cart. Why use a mobile C-arm with digital flat-panel detector? We asked Dr. van der Linden and Dr. Willemssen at LUMC in the Netherlands. We wanted to have a compact, high-quality C-arm for OR procedures such as EVARs and simultaneously a mobile high-quality angiography system as a backup here in our Radiology Department. We also intended to use the unit for CT-guided interventions in combination with X-ray fluoroscopy instead of CT fluoroscopy for biopsies, catheter placements and vertebroplasty in order to lower the dose levels. Besides, we were also very curious to explore further practical applications opened up by this groundbreaking technology. It was our intention to do some research in this area, says Dr. van der Linden.
02 White Paper No. 02/2009 Initial Experiences Dr. Willemssen explains further about the clinical experiences with the Ziehm Vision FD in daily practice. The C-arm has been in our department since January 2006, and we have used it for many vascular and non-vascular examinations with excellent results. The unit provides highquality images with outstanding contrast resolution. We used the C-arm for abdominal EVARs, iliac stent placements, biliary PTAs, catheter placements, biopsies and different skeletal interventions such as arthrographies and vertebroplasties. Normally, we run the unit at a pulse rate of 15 pulses/sec, and at 5-10 pulses/sec during catheter placements for further dose savings. Case 1: Skeletal Intervention A 10-year-old boy presented with pain in the right foot, especially when standing on his right heel. Clinical examination revealed a normal flexion and extension. Pronation and supination, however, were decreased compared to the other foot. An X-ray (Fig. 2) of the foot revealed a large osteolytic lesion in the calcaneus, with sclerotic margins. During the CT examination blood-fluid levels were present. The diagnosis of aneurysmal bone cyst was confirmed. Due to pain and diminished function, treatment was required. Earlier arterial embolization was unsuccessful. Hence direct puncture into the bone tumor was performed under CT guidance (Fig. 3) using Ethibloc for the embolization. The unit is very easy to use and to manoeuvre thanks to its compact detector dimensions and smart touchscreen user interface features that are highly appreciated by our radiographers. The C-arm opening is larger than on a conventional C-arm, thus providing substantially improved patient access. The C-arm movements are not motorized though. This functionality might be taken into consideration for future improvements, although it is not a must, as the C is very easy to position anyhow, adds Dr. Willemssen. From our experiences, there is no disadvantage compared to an X-ray C-arm with image intensifier. On the contrary: the image quality having such excellent contrast resolution particularly in DSA is a great improvement. The field size of 20 cm x 20 cm, however, entails some limitations in the coverage of the lower extremities. Fig. 2: X-ray of the left foot showing large lytic lesion the calcaneus. Case Highlights from LUMC We would like to highlight some cases where the Ziehm Vision FD performed especially well compared to conventional C-arm systems, says Dr. Willemssen. Fig. 3: Axial CT image of the embolization shows the needle placed into the tumor as well as the embolization material.
03 White Paper No. 02/2009 Since one compartment was not embolized, a second needle was placed into the tumor. The injection of the embolization material was monitored using the Ziehm Vision FD (Fig. 4). The system s pulsed fluoroscopy mode ensured lowdose radiation. Fig. 4: Ziehm Vision FD image: the tumor is clearly visible with good detail, as is the needle and the embolization material. Fig. 5: Lateral fluoroscopic image shows the collapsed third lumbar vertebra with 2 needles placed in it. The small needle is the RFA needle and placed in the center of the tumor. Case 2: Skeletal Intervention A 61-year-old woman presented with pain in the lumbar spine. The medical history revealed invasive bladder carcinoma. X-ray of the lumbar spine showed a collapsed third lumbar vertebra with a fracture, highly suspicious of a pathologic fracture. Histological biopsy confirmed the diagnosis of vertebral metastasis. Since the patient experienced a great deal of pain, she was referred to the Radiology Department for radio frequency ablation and vertebroplasty of the collapsed metastasis vertebra. We use the Ziehm Vision FD in our single-plane angiography room to create a biplane system with simultaneous antero-posterior and lateral projections. Such a combination is very convenient and time-saving for this type of procedures, eliminating the need for rotating the X-ray tube assembly constantly from the A.P. to lateral position and vice versa. The Ziehm Vision FD is ideally suited for this task. Due to its compact dimensions and wide C-arm opening, the surgeon benefits from ample space to perform the procedure. The Ziehm Vision FD is used for obtaining the lateral fluoroscopic images. We also use this system for CT-guided vertebroplasty. The images obtained using lateral fluoroscopy are the most crucial, and are perfectly visualized with the Ziehm Vision FD (Fig. 5, 6, 7). Fig. 6: Lateral fluoroscopic image shows the distribution of cement into the fracture of the vertebra.
04 White Paper No. 02/2009 Fig. 7: Lateral fluoroscopic image shows the cement placed into the vertebra at the end of the procedure, located in the center of the vertebra. No leakage is noted. Case 3. Vascular Intervention A 68-year-old male with diabetes (type II) had presented with an aneurysm of the infrarenal abdominal aorta and right iliac artery for more than 10 years. The dilation of the aneurysm had been only slightly progressive in those years. However, an operation or intervention became necessary this year. The patient underwent an endovascular aortic aneurysm repair in the OR under radiological control using the Ziehm Vision FD. A compact and powerful mobile X-ray C-arm is of vital importance when procedures like these are performed in the OR, where no stationary angiography equipment is available. The stent-graft is placed just below the renal arteries, in this case with suprarenal fixation (Fig. 8). Excellent image quality is essential for precise placement of the stent-graft, and the proximal placement is most critical. With adipose patients, however, it may become difficult to obtain the required image quality level. Even then the Ziehm Vision FD produced images of fine quality, thus avoiding possible complications caused by lack of visibility. Fig. 8: Angiogram during placement of the stentgraft. Highlighted the marker indicating the beginning of the covered part of the stent-graft. This marker must be placed below the renal arteries. Conclusion Based on the various clinical experiences we have had in the past few months, we find the Ziehm Vision FD to be a powerful mobile C-arm with high performance and superior image quality. It is a valuable tool as a mobile C-arm and can be used beneficially for a wide range of both vascular and non-vascular applications, summarizes Dr. Willemssen. Fig. 9: Coronal contrast-enhanced CT MIP image 2 days after placement of the stent-graft: the covered part of the stent-graft is placed below the renal arteries, with normal enhancement of the kidneys.
05 White Paper No. 02/2009 Product Innovation Award 2006 Frost & Sullivan, a renowned European analyst and consulting house, honoured Ziehm Imaging`s pioneering mobile C-arm Ziehm Vision FD with the Frost & Sullivan Product Innovation Award 2006 on September 18, 2006. The system features a groundbreaking digital flat-panel detector that replaces the image intensifier traditionally found on this type of X-ray equipment. The high-dynamic detector enables distortion-free digital capture of the finest bone and soft tissue structures required, for instance, in the area of neurosurgery or tumor localization for radiation therapy. Entirely new fields of application for mobile C-arms will open up when combining the unit with navigation or Computer Aided Surgery (CAS) systems. With the introduction of the Vision FD, Ziehm Imaging has taken a major leap forward in setting the direction for the future of mobile C-arms, says Frost & Sullivan Medical Imaging Team Leader, Karthik Arun B. The Vision FD is expected to set new standards for image quality and patient safety as well as to expand the number of applications where mobile C-arms can be used. In presenting this award to Ziehm, the renowned market research organization has recognized the trend setting technology which, within a few more years, will be standard equipment in every high-tech OR.