Boston Scientific Ivus Manual
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Boston Scientific Ivus Manual
The IVUS Guidance in Left Main Study pooled analysis of four registries involving 1,670 patients with LM disease. 505 patients who underwent IVUS-guided PCI compared to 505 propensity-matched patients where IVUS-guidance was not performed. Clinical Impact of Intravascular Ultrasound Guidance in Drug-Eluting Stent Implantation for Unprotected Left Main Coronary Disease. J Am Coll Cardiol Intv. 2014;7:244-254.CAUTION: The law restricts these devices to sale by or on the order of a physician. Available in 5F and 6F Now with a peripheral use indication. Cases may also be archived as DICOM studies to CD (650 MB), DVD (4.7 GB), removable hard drive (up to 2 TB), and to the network (PACS). SOP Class used for IVUS frames: Ultrasound Multi-frame Image Storage. SOP Class used for Screenshots: Ultrasound Multi-frame Image Storage. Compression schemes supported: JPEG Baseline and JPEG NH-Lossless. C-codes are used for hospital outpatient device reporting for Medicare and some private payers. Note: Boston Scientific Corporation is not responsible for correct use of codes on submitted claims; this information does not constitute reimbursement or legal advice.CAUTION: The law restricts these devices to sale by or on the order of a physician. Sign in Forgot Password. My Bench Close Sign In Not A Member. Sign Up Join MedWrench OK name type Receive Summary Emails. It offers an easy user interface and automatic enhancement of ICE images. The iLAB system is compatible with all Boston Scientific ultrasound catheters: Intracardiac (ICE), Intravascular (IVUS) and Peripheral (PI). The Boston Scientific ULTRA ICE PLUS catheter is designed to provide precise, real-time visualization of both intracardiac anatomy and devices positioned within the heart. Not only does it help you in identifying anatomical structures, it also helps you in visualizing where your devices are relative to those structures.
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FORUMS View All (1) Ask a New Question 2 Replies -KF1 a year ago a year ago Manual and Service Manual Hi All. I am learning about the IVUS, intravascular ultrasound which I stated for both of the models. I was not able to get information via the web to learn more about the 2 units has to offer. By continuing to browse the site you are agreeing to our use of cookies. Please review our Privacy Policy for more details. All Rights Reserved. Other health care professionals should select their country in the top right corner of the website. To the extent this site contains information, reference guides and databases intended for use by licensed medical professionals, such materials are not intended to offer professional medical advice. Prior to use, please consult device labeling for prescriptive information and operating instructions. It is strictly forbidden to make copies, whether partial or total and on whichever media without prior approval. It features exceptional deliverability and accuracy so it’s the optimal wire to diagnose and treat. All cited trademarks are the property of their respective owners. CAUTION: The law restricts these devices to sale by or on the order of a physician. Indications, contraindications, warnings and instructions for use can be found in the product labelling supplied with each device. Information for use only in countries with applicable health authority registrations. This material is not intended for use in France. It can also help measure the effectiveness of balloon angioplasty or stenting during follow ups. Volcano offers two systems, the s5 and s5i, and Boston Scientific's system is the iLab. The systems are available on a cart that can be moved around to different cath labs, or as an integrated system where a controller is permanently mounted table in the lab. Both companies have partnered with GE, Philips, Siemens and Toshiba as part of their cath lab installation packages.
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Angiography is used to guide the IVUS catheter to the area of the vessel to be imaged. It is placed farthest away from the area to be imaged and is then pulled back through the area of stenosis. The IVUS catheters use either a fixed array of mini transducers, or a single rotating transducer. IVUS has several advantages over traditional angiography. It can help better define vessels that are difficult to analyze using angiographic imaging, such as determining the lumen size of ostial lesions or areas with several overlapping vessels. Also, unlike angiography, it visualizes the atheroma and allows measurement of both the lumen and the plaque thickness on the arterial wall. IVUS allows a cross sectional view of the artery that can clearly show the intima, plaque deposits and the remodeled lumen. Millimeter marks can be superimposed on IVUS images to accurately measure the current lumen and the original lumen size to determine the amount of stenosis and to determine what size stent is needed if the vessel will undergo PCI. The tool measures proximal and distal blood pressure around a lesion to help determine if an intervention is needed. The IVUS system can detect variations in sound waves reflected back to the transducer created by different materials in plaque being imaged. Using a method called virtual histology (VH), an IVUS system can create a color-coded cross sectional image of a vessel showing the make-up of the plaque. Volcano said its proprietary VH IVUS technology helps differentiate the four plaque types: fibrous, fibro-fatty, necrotic core and dense calcium. Physicians who spoke at the Transcatheter Cardiovascular Therapeutics (TCT) 2008 said IVUS needs a faster frame rate to overcome this issue. Current IVUS systems use a frame rate of about 30 frames per second, as compared to normal ultrasound systems, which run at rates between 50-750.
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It is integrated into a percutenous coronary intervention (PCI) training app for mobile devices that allows interventional cardiologists to perform streamlined cath lab patient case simulations, including, iFR, angioplasty and stenting. These are activated individually in a r otational fashion in order to generate a rotating ultrasound beam. The resulting echocardiographic information is then routed to a computer system, which in turn generates a cross sectional, real time image. The only commercially available solid-state catheter currently available (Volcano) has 64 separate transducer elements arranged around the catheter tip and uses a 20 MHz scanning frequency. These catheters are 3.5 French in size at the transducer and are compatible with a 5 French guiding catheter over a 0.014-in. guide-wire in a rapid exchange design. Larger devices are also available for use over both 0.018 and 0.035-in. wires and are designed for use in the peripheral vessels and aorta. Aside from conventional IVUS images, the Volcano solid-state catheters also perform radiofrequency IVUS, also known as virtual histology or VH-IVUS which will be discussed in a later section. 2 Rotational ( Mechcanical ) IVUS. With rotational systems, a single transducer element is located at the tip of the catheter that is rotated by an external motor drive attached to the proximal end of the catheter. As the transducer rotates, echocardiographic information is gathered and generated into a circumferential cross sectional image, identical to that generated by solid-state systems. As the rotating transducer sits inside the catheter, there is a very short rapid exchange portion at the tip of the catheters for use with a 0.014 in. guide-wire. Currently, rotational coronary imaging systems are available in three separate platforms (Boston Scientific, Volcano and Infraredx). The Boston Scientific coronary catheter has a 3.
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15 French crossing profile, is compatible through a 5 French catheter, and uses a 40 MHz scanning frequency. The Volcano rotational catheter has a 3.2 French crossing profile and is compatible through a 6 French sheath and uses a scanning frequency of 45 MHz. The Infraredx device has a 3.2 French crossing profile, is compatible through a 6 French sheath and uses a 40 MHz scanning frequency. The main difference in the Infraredx catheter is that it also provides the ability to perform near infrared spectroscopy (NIRS) in addition to IVUS (See Fig. 8.3 ). Fig. 8.3 InfraRedX IVUS images. The yellow in the underlying longitudinal image represents lipid, which can be quantified into a lipid core burden index (LCBI) For coronary imaging, both solid state and rotational systems are performed over a 0.014 in. guide-wire which is placed by the operator across the area of interest and into the distal vessel after fully anticoagulating the patient. The IVUS catheter is then advanced over the guide-wire with the transducer beyond the area of interest. After initiation of the IVUS catheter, baseline circumferential images are obtained. There are two different methods of then proceeding with IVUS, which are manual pull back, or motorized pullback, which can be done with any of the currently available catheters. In manual pull back, the operator will slowly withdraw the transducer across the area of interest. With solid-state catheters, the entire catheter is slowly pulled back while with rotational catheters the internal imaging catheter is slowly withdrawn leaving the outer catheter in place beyond the lesion. With motorized pull back, an external “sled” is attached to the proximal portion of the catheter which when activated will provide a steady withdrawal of the catheter at a standardized speed (See Fig. 8.4 ).
The advantages of manual pullback are simplicity of operation and ability to “fine tune” the catheter to the area of interest for more detailed and prolonged investigations. The main advantage of motorized pullback is ability to provide information not only on vessel diameter, but also provide longitudinal information as the length of the area visualized is reported as well. This allows physicians to accurately determine lesion length in order to tailor not only the diameter of stents, but the length as well. With manual pullback one is not able to determine length or gather longitudinal information. Fig. 8.4 Mechanical, or rotational, imaging system with overlying catheter. Because solid-state catheters have a zone of “ ring down ” artifact around the catheter, an additional step to mask this artifact is performed once the catheter is advanced into the coronary, which is done, on the computer console. Other advantages of the solid-state catheters include the lack of moving parts, lack of guide-wire artifact, and lack of “NURD” which is a type of artifact with rotational systems which will be further explained in upcoming sections. Historically, the solid-state catheters were smaller in size, however with further advances in technology the crossing profiles of both the solid-state and rotational systems are essentially identical. In addition, due to a longer monorail segment there is less “buckling” of the catheter across tight stenoses leading to improved crossibility. Finally, one of the major disadvantages of the solid-state systems is the use of 20 MHz frequencies which allow imaging of larger vessels as well as increased penetration, however has less axial resolution and are felt by many interventionalists to provide less clear images. However, predominantly due to the simplified set-up and use there is still a very strong role for these catheters. However, the set-up for rotational systems is more cumbersome.
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The catheter is removed from its packaging and its associated stop-cocks and lines are attached. The motor drive is then handed over and placed in sterile bagging as it is a re-usable part. The catheter is then connected to the motor drive followed by flushing of the catheter in both the distal and proximal positions in order to remove all air from between the inner and outer catheters. The catheter, which has a very short monorail at the distal tip, is then placed on a 0.014 in. guide-wire and advanced through the catheter beyond the area of interest. If manual pullback is to be performed, it is important to only pull back the inner catheter during imaging leaving the stationary outer sheath in place, as opposed to pulling back the entire system as a unit. As the guide-wire runs alongside the transducer (rather than through the catheter as with solid-state systems), an imaging artifact inherent to all rotational systems is “guidewire artifact.” This is important to recognize in order to avoid misinterpretation of images. Regardless of the type of system used, the generated axial image is essentially the same and interpretation and measurement relies upon the ability to correctly identify the different portions of the blood vessel as well as identify diseased and healthy appearing vessels. The three basic histologic layers and composition of the blood vessels provide the basis for image interpretation and result in the classic trilaminar appearance of IVUS. These layers are the intima, media, and adventitia (See Fig. 8.5 ). The innermost layer, the intima, is in direct contact with the intraluminal space and is typically only one to two cell layers thick in healthy arteries. Therefore, in truly normal coronaries, as seen in young individuals, the intima will not be able to be seen by IVUS because of the limits of the axial resolution.
However, due to age as well as due to remodeling and deposition of atherosclerotic plaque from CAD, the majority of adults evaluated in the cath lab have a much thicker intima allowing its visualization by IVUS which appears echogenic. The intima is separated from the media by the internal elastic membrane which is composed predominantly of homogenous layers of smooth muscle cells in the coronaries. As the smooth muscle cells do not reflect sound waves well and there is less elastin and collagen as compared to the intima and adventitia, the media appears as a thin echolucent strip surrounding the vessel and separating the adventitia from the intima. The media is separated from the adventitia by the external elastic membrane. It is composed of fibrous connective tissue with a high amount of elastin and collagen and therefore appears echogenic. The imaged vessel wall therefore has, almost invariably, a classic trilaminar appearance (bright-dark-bright) providing important land marks for measurement (See Figs. 8.6 and 8.7 ). Fig. 8.5 Trilaminar structure of the blood vessels (Courtesy of Boston Scientific) Fig. 8.6 Healthy vessel. Note the trilaminar appearance with a thin echogenic intima, echolucent media bounded by the internal and external elastic lamina, and echogenic adventitia (Courtesy of Boston Scientific) Fig. 8.7 Cross-sectional and longitudinal images generated by IVUS. Note the calcified stenosis in the center of the longitudinal image (Courtesy of Boston Scientific) As stated, the major strength of IVUS is its ability to see both the intraluminal as well as extra-luminal portions of the vascular bed in order to provide a more complete picture. It is also a very useful tool for the accurate and reproducible measurement of many parts of the blood vessel.
This provides many obvious uses such as comparison of vessel diameter across a coronary stenosis and the reference vessel segment and the ability to accurately determine the size and length of coronary stents and balloons to be used during interventions. However, there are many other measurements which are commonly used in major clinical trials as cut points to guide interventions and therefore knowledge of how to determine these measurements is important. The following is a brief list of many of the commonly used measurements and terms which are thought be important for the practicing interventionalist. Later, discussions on clinical utility of many of these measurements will be covered. While determination of measures such as plaque burden and remodeling index are not routinely performed in every day clinical practice, the nomenclature is important as many of these have been used in previous studies. Proximal Reference Vessel: The site with the largest lumen proximal to a stenosis but within the same segment, usually Distal Reference Vessel: The site with the largest lumen distal to a stenosis but within the same segment, usually Maximal Lumen Diameter: Maximal diameter of the lumen, from leading edge of intima on each side of vessel Minimal Lumen Diameter: Minimal diameter of the lumen, from leading edge of intima on each side of vessel Lumen Eccentricity: Cross Sectional Area ( CSA ): Circumferential area bounded by the luminal border Area Stenosis: External Elastic Membrane Cross Sectional Area ( EEM CSA ): Circumferential area bounded by the leading edge of the external elastic membrane (EEM) Atheroma or Plaque Area: Atheroma or Plaque Burden: Remodeling Index ( RI ): Artifacts and Pitfalls Calcium IVUS depends on differential absorption and reflection of sound waves from tissues in order to generate a grayscale image.
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Tissues that reflect large amounts of sound waves are termed echogenic and appear brighter relative to tissues that do not reflect sound waves as well, which are termed echolucent and appear darker. Calcium is an exceptional reflector of sound waves and therefore appears very echogenic. In addition, as the majority of sound waves are reflected and do not penetrate to the underlying tissue; calcium has significant shadowing making it difficult or impossible to see beyond the calcium, this is also knows as shadowing (See Figs. 8.8 and 8.9 ). Fig. 8.8 (a) Calcified vessel with wire artifact in the 5 o’clock position (Courtesy of Boston Scientific) (b) Calcium artifact. This is typically due to things which result in increased friction on the drive cable such as tortuous vessels or guide catheters, excessive tightening of the hemostatic valve on the guide, kinking of the imaging sheath, or too small a guide catheter lumen (See Fig. 8.10 ). Fig. 8.10 Calcified vessel with wire artifact in the 5 o’clock position (Courtesy of Boston Scientific) Wire Artifact Similar to calcium, guide wires are very echogenic resulting in shadowing and difficulty seeing the vessel wall beyond the artifact. For those not familiar with this type of artifact misdiagnosis of thrombus or dissection is possible (See Fig. 8.11 ). Fig. 8.11 (a and b) NURD artifact which is unique to rotational systems. Secondary to non-uniform rotation of the transducer due to increased friction on the catheter. Ringdown This type of artifact refers to disorganization of the image closet to the transducer or catheter. While present in all types of IVUS catheters it is more common in solid state, or phased array IVUS catheters which attempt to minimize these artifacts by performing a “ringdown” on placement of the catheter into the vessel, which is simply a mask or digital subtraction over this area in the center of the image.
Ringdown artifacts are observed as bright halos of variable thickness surrounding the catheter. Blood Speckle Signals from blood cells can be imaged on IVUS catheters. This “blood speckle” artifact increases as transducer frequency increases and as blood flow decreases. Therefore areas where the catheter is across a tight stenosis with resultant limitations in blood flow, blood speckle artifact increases. This can result in decreased ability to differentiate lumen from tissue, especially with soft plaque and thrombus. Flushing the catheter with saline helps to clear the lumen and reduce blood speckle, which in turn may aid in identification of tissue borders (See Fig. 8.12 ). Fig. 8.12 Blood speckle artifact noted in the image on the ( a ) secondary to slow flow. This is improved in the image on the ( b ) after flushing of the catheter (Courtesy of Boston Scientific) Patient Populations Assessment of Intermediate Non-left Main Coronary Lesions Because angiography is the planar 2D representation of a 3D structure, there are multiple potential pitfalls in accurate interpretation. Diffuse reference vessel disease, foreshortening, tortuous vessels, overlapped segments, calcification, lesion eccentricity, and poor contrast opacification all can contribute to inaccurate assessment of lesion severity. IVUS evaluation demonstrates extensive plaque with 95 area stenosis ( b ) (Courtesy of Boston Scientific) Currently, the gold standard for identification of physiologically significant stenosis in the cath lab is fractional flow reserve assessment (FFR). Much of the data done with FFR has demonstrated ischemic lesions that were angiographically assessed as only 50 stenosis, and non-ischemic lesions that appeared to be 80 by angiography. This clearly demonstrates that angiography alone is not adequate in patients where the lesion is “intermediate.
” As with FFR, research with IVUS has been done in an attempt to stratify intermediate lesions as flow or non-flow limiting stenoses. In addition, there are multiple factors aside from lesion severity which contribute to overall functional significance such as length, eccentricity, and the myocardium which is subtended by the vessel. While FFR is currently considered by most the gold standard for invasive assessment of intermediate coronary lesions, significant work has been aimed at evaluating anatomic measurements by IVUS to predict significant coronary lesions. Early work with IVUS suggested a MLA cut point of ? 4.0 mm 2 for prediction of hemodynamically significant non-left main stenoses, in particular of proximal epicardial vessels. While a MLA of ?4.0 mm 2 for non-left main stenosis has been used by many as a potentially reliable marker for determination of significance, there have been many other studies which have suggested different MLA values in addition to other vessel measurements in order to predict hemodynamically significant indeterminate lesions. In a group of 42 patients with 51 lesions that were evaluated by both FFR and IVUS the best determinant of an FFR 60 (sensitivity 92 , specificity 89 ). For the mid LAD, a MLA of 2 was also found to have a reasonable diagnostic accuracy for ischemic lesions by FFR. However, IVUS measurements of the right coronary and circumflex arteries were not found to correlate well with prediction of ischemic lesions. The diagnostic impact of the vessel being studied was also noted in a recent trial of 236 lesions evaluated by both IVUS and FFR. The independent determinants of FFR 2 however the diagnostic accuracy was only 68 . However, in patients with small body habitus or diffuse coronary artery disease such as diabetics, many of the intermediate lesions occur in vessels with smaller luminal diameters.
In the IDEAS (Intravascular Ultrasound-Derived Anatomic Criteria for Defining Functionally Significant Stenoses in Small Coronary Arteries) trial, 94 intermediate coronary lesions were evaluated by both IVUS and FFR. When taken together, the above data demonstrate a large amount of variability in specific cutoff values for determination of ischemic causing indeterminate coronary lesions. What is clear however is that measurements associated with significant coronary stenoses are MLA, lesion length, plaque burden, and area stenosis. While absolute cutoffs for these measurements is not feasible or reasonable for the vast majority of patients evaluated in the catheterization lab progressive reduction in MLA, longer lesions, high plaque burden, and increased area stenosis correlate with reductions in FFR particularly in proximal epicardial vessels, and ideally the left anterior descending. At this time FFR will likely remain the de facto stratifying test for intermediate lesions, however in patients where FFR is not feasible due to significant distal disease or intolerance of adenosine, IVUS remains an option for the interventional operator. Angiographic assessment of the left main is historically very difficult with high inter- and intra-observer variability due to significant foreshortening, ostial angulation, and streaming of contrast medium from the catheter tip in standard angiographic projections. Additionally, the typically diffuse nature of coronary artery disease in the left main limits the comparison of a diseased-free reference segment. With qualitative coronary angiography, the left main has been shown to be the least reproducible of any of the coronary segments. However, most patients with left main disease have additional coronary artery disease in their left anterior descending and circumflex arteries that may make performance of FFR inaccurate due to “protection” of the distal circulation from induced hyperemia.
The use of IVUS is uniquely suited for evaluation of ambiguous left main lesions in order to stratify patients that may need revascularization from those that can be safely deferred to medical management. Before proceeding, it is important to recognize that angiographic evaluation of the left main is poor, particularly when an intermediate lesion is identified. Because of the poor prognosis associated with obstructive LMCA disease and the relatively normal survival of patient’s without obstructive LMCA disease, it is imperative that an additional modality other than angiography be used to stratify patients prior to revascularization. Because LMCA disease is most often encountered in association with disease in the remaining coronary tree, non-invasive stress tests may not accurately discriminate ischemia caused by the left main versus other coronary disease. Therefore, when making management decisions regarding the left main, angiography is often not enough. The question however is what IVUS parameters should be used in order to determine functional significance. Because the left main is typically a short vessel, presence of disease in a single segment often predicts diffuse disease during IVUS interrogation. Because of this, it is difficult, if not impossible, to determine a “normal” vessel to use as a distal or proximal reference segment. In addition, positive and negative remodeling in the left main tends to be pronounced, again making identification of reference vessels difficult. For this reason, most of the studies evaluating IVUS parameters in comparison to FFR and SPECT have found MLA and MLD to be the two most predictive measurements correlating to ischemia. The initial investigation of IVUS for stratification of intermediate or ambiguous LMCA lesions initially looked at patients with angiographically normal or minimally diseased LMCA in order to establish a “lower range of normal.
” A total of 121 patients underwent IVUS evaluation of their LMCA and MLA were measured for all. These values were then plotted and a standard bell shaped, or Gaussian distribution, was plotted. The mean MLA for these patients with angiographically normal or minimally diseased LMCA was 16.25 mm 2 with a standard deviation of 4.30 mm 2. The “lower range of normal” was set at two standards deviations below the mean which was defined as a MLA of 7.5 mm 2. Using this value as the cut point, 214 patients with intermediate angiographic left main lesions were then evaluated by IVUS. Of these patients, 39 had an MLA of 2. A significant stenosis was seen in 44 of lesions by IVUS but in only 13 of lesions by QCA. This study again highlights the inherent inaccuracies of angiographic evaluation alone. In addition, when using a MLA cut point of 2 to determine functional significance, less than half of patients evaluated by IVUS in this real world population were found to have significant disease suggesting that the majority of patients with angiographic ambiguous LMCA lesions were not severe by IVUS. A prospective study to validate the use of a MLA of 6 mm 2 as the cutoff value for revascularization was published in 2011. The LITRO (Prospective Application of Pre-Defined Intravascular Ultrasound Criteria for Assessment of Intermediate Left Main Coronary Artery Lesions) Study remains the largest prospective study evaluating an IVUS determined MLA to guide revascularization. A total of 354 patients were evaluated. Of the 168 patients with an MLA of 2, 90.5 were revascularized, while 96 of the 186 patients with MLA ?6 mm 2 were deferred to medical management. Based upon this study, using a MLA cut point of 2 is safe, with little adverse events in patients deferred to medical management. It should not be surprising that there is no clear cutoff for IVUS derived LMCA cutoff values as vessels, like patients, come in a variety of shapes and sizes.
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