PASC 1354 - Department of Health
1354Final protocol to guide the assessment of intravascular ultrasound guided coronary stent insertionSeptember 2014Table of Contents TOC \o "1-3" \h \z \u MSAC and PASC PAGEREF _Toc390348190 \h 3Purpose of this document PAGEREF _Toc390348191 \h 3Purpose of application PAGEREF _Toc390348192 \h 4Intervention PAGEREF _Toc390348193 \h 4Description PAGEREF _Toc390348194 \h 4Administration, dose, frequency of administration, duration of treatment PAGEREF _Toc390348195 \h 6Co-administered interventions PAGEREF _Toc390348196 \h 8Background PAGEREF _Toc390348197 \h 8Current arrangements for public reimbursement PAGEREF _Toc390348198 \h 10Regulatory status PAGEREF _Toc390348199 \h 11Patient population PAGEREF _Toc390348200 \h 13Proposed MBS listing PAGEREF _Toc390348201 \h 14Clinical place for proposed intervention PAGEREF _Toc390348202 \h 14Comparator PAGEREF _Toc390348203 \h 17Clinical claim PAGEREF _Toc390348204 \h 17Outcomes and health care resources affected by introduction of proposed intervention PAGEREF _Toc390348205 \h 18Outcomes PAGEREF _Toc390348206 \h 18Health care resources PAGEREF _Toc390348207 \h 18Proposed structure of economic evaluation (decision-analytic) PAGEREF _Toc390348208 \h 23Research questions PAGEREF _Toc390348209 \h 26Appendix A: AIHW Hospital morbidity data PAGEREF _Toc390348210 \h 27Appendix B: MBS items for percutaneous coronary stent insertion PAGEREF _Toc390348211 \h 29Appendix C Stents and stent delivery systems listed in the prostheses list PAGEREF _Toc390348212 \h 32References PAGEREF _Toc390348213 \h 33MSAC and PASCThe Medical Services Advisory Committee (MSAC) is an independent expert committee appointed by the Australian Government’s Minister for Health to strengthen the role of evidence in health financing decisions in Australia. MSAC advises the Minister on the evidence relating to the safety, effectiveness, and cost-effectiveness of new and existing medical technologies and procedures and under what circumstances public funding should be supported.The Protocol Advisory Sub-Committee (PASC) is a standing sub-committee of MSAC. Its primary objective is the determination of protocols to guide clinical and economic assessments of medical interventions proposed for public funding.Purpose of this documentThis document is intended to provide a draft protocol that will be used to guide the assessment of an intervention for a particular population of patients. The draft protocol will be finalised after inviting relevant stakeholders to provide input to the protocol. The final protocol will provide the basis for the assessment of the intervention.The protocol guiding the assessment of the health intervention has been developed using the widely accepted “PICO” approach. The PICO approach involves a clear articulation of the following aspects of the research question that the assessment is intended to answer:Patients – specification of the characteristics of the patients in whom the intervention is to be considered for use;Intervention – specification of the proposed interventionComparator – specification of the therapy most likely to be replaced by the proposed interventionOutcomes – specification of the health outcomes and the healthcare resources likely to be affected by the introduction of the proposed interventionPurpose of applicationA proposal for an application requesting Medicare Benefits Schedule (MBS) listing for intravascular ultrasound (IVUS) guided coronary stent insertion for patients undergoing percutaneous coronary intervention (PCI) was received from Boston Scientific Pty Ltd by the Department of Health and Ageing in September 2013.MSAC application 1032 (July 2001) assessed evidence for IVUS as a diagnostic tool, and a therapeutic tool adjunct for interventional coronary procedures. ADDIN EN.CITE <EndNote><Cite><Author>MSAC</Author><Year>2001</Year><RecNum>1</RecNum><DisplayText><style face="superscript">1</style></DisplayText><record><rec-number>1</rec-number><foreign-keys><key app="EN" db-id="eadep9r2s52txne05xsv9adp2efrwfxva5xf">1</key></foreign-keys><ref-type name="Web Page">12</ref-type><contributors><authors><author>MSAC</author></authors></contributors><titles><title>MSAC Application 1032: Intravascular ultrasound </title></titles><volume>2014</volume><number>03/04</number><dates><year>2001</year></dates><pub-location>Canberra</pub-location><publisher>Department of Health and Ageing</publisher><urls><related-urls><url>$File/1032-Intravascular-ultrasound-Assessment-Report.pdf </url></related-urls></urls><access-date>03/03/2014</access-date></record></Cite></EndNote>1 MSAC did not recommend public funding for the service in that instance due to insufficient evidence of effectiveness and cost-effectiveness. The current application pertains to the assessment of evidence for IVUS as a therapeutic tool to assist coronary stent insertion. Use of IVUS as a diagnostic tool is not an intended purpose of the current application.InterventionDescriptionIntravascular ultrasound (IVUS)IVUS is the generic name for any ultrasound technology that provides tomographic, 3-dimensional, 360-degree images from inside the lumen of a blood vessel. During PCI, IVUS may be used to assess the degree of narrowing in the coronary vessels in ischaemic heart disease (IHD). The technology may also be used to guide coronary stent insertion, particularly in cases of left main coronary artery disease of indeterminate severity. ADDIN EN.CITE <EndNote><Cite><Author>Levine</Author><Year>2011</Year><RecNum>14</RecNum><DisplayText><style face="superscript">2</style></DisplayText><record><rec-number>14</rec-number><foreign-keys><key app="EN" db-id="eadep9r2s52txne05xsv9adp2efrwfxva5xf">14</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Levine, G. N.</author><author>Bates, E. R.</author><author>Blankenship, J. C.</author><author>Bailey, S. R.</author><author>Bittl, J. A.</author><author>Cercek, B.</author><author>Chambers, C. E.</author><author>Ellis, S. G.</author><author>Guyton, R. A.</author><author>Hollenberg, S. M.</author><author>Khot, U. N.</author><author>Lange, R. A.</author><author>Mauri, L.</author><author>Mehran, R.</author><author>Moussa, I. D.</author><author>Mukherjee, D.</author><author>Nallamothu, B. K.</author><author>Ting, H. H.</author></authors></contributors><titles><title>2011 ACCF/AHA/SCAI Guideline for Percutaneous Coronary Intervention. A report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines and the Society for Cardiovascular Angiography and Interventions</title><secondary-title>J Am Coll Cardiol</secondary-title></titles><periodical><full-title>J Am Coll Cardiol</full-title></periodical><pages>e44-122</pages><volume>58</volume><number>24</number><edition>2011/11/11</edition><keywords><keyword>Angioplasty, Balloon, Coronary/methods/ standards</keyword><keyword>Humans</keyword></keywords><dates><year>2011</year><pub-dates><date>Dec 6</date></pub-dates></dates><isbn>1558-3597 (Electronic)
0735-1097 (Linking)</isbn><accession-num>22070834</accession-num><urls></urls><electronic-resource-num>10.1016/j.jacc.2011.08.007</electronic-resource-num><remote-database-provider>NLM</remote-database-provider><language>eng</language></record></Cite></EndNote>2 IVUS may be used as an adjunct to angiography in performing stent insertion.An IVUS system consists of an imaging catheter, a mini-transducer connected at the tip of the catheter ( REF _Ref381710657 \h Figure 1), and a console. ADDIN EN.CITE <EndNote><Cite><Author>Nissen</Author><Year>2001</Year><RecNum>22</RecNum><DisplayText><style face="superscript">3</style></DisplayText><record><rec-number>22</rec-number><foreign-keys><key app="EN" db-id="eadep9r2s52txne05xsv9adp2efrwfxva5xf">22</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Nissen, S. E.</author><author>Yock, P.</author></authors></contributors><auth-address>Cleveland Clinic Foundation, Cleveland, Ohio 44195, USA. nissens@</auth-address><titles><title>Intravascular ultrasound: novel pathophysiological insights and current clinical applications</title><secondary-title>Circulation</secondary-title></titles><periodical><full-title>Circulation</full-title></periodical><pages>604-16</pages><volume>103</volume><number>4</number><edition>2001/02/07</edition><keywords><keyword>Blood Vessels/physiopathology/ ultrasonography</keyword><keyword>Coronary Vessels/physiopathology/ultrasonography</keyword><keyword>Humans</keyword><keyword>Ultrasonography/instrumentation/ methods</keyword></keywords><dates><year>2001</year><pub-dates><date>Jan 30</date></pub-dates></dates><isbn>1524-4539 (Electronic)
0009-7322 (Linking)</isbn><accession-num>11157729</accession-num><urls></urls><remote-database-provider>NLM</remote-database-provider><language>eng</language></record></Cite></EndNote>3 Ultrasound transducers generate, transmit and receive sound of an appropriate frequency and pulse rate. Sound is then processed by an ultrasound processor to generate on-screen. The catheter delivers the transducer at the narrowed coronary vessel ( REF _Ref381710676 \h Figure 2). The transducer may be mechanical, consisting of a single rotating transducer driven by a flexible drive cable, or it may be electronic, where the scanning is performed using an array of multiple transducing crystals ( REF _Ref381710676 \h Figure 2).PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5OaXNzZW48L0F1dGhvcj48WWVhcj4yMDAxPC9ZZWFyPjxS
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ADDIN EN.CITE.DATA 3, 4Figure SEQ Figure \* ARABIC 1: Intravascular ultrasound imaging catheterSource: Medical Advisory Secretariat Ontario 2006 ADDIN EN.CITE <EndNote><Cite><Author>Medical Advisory Secretariat</Author><Year>2006</Year><RecNum>2</RecNum><DisplayText><style face="superscript">5</style></DisplayText><record><rec-number>2</rec-number><foreign-keys><key app="EN" db-id="eadep9r2s52txne05xsv9adp2efrwfxva5xf">2</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Medical Advisory Secretariat,</author></authors></contributors><titles><title>Intravescular ultrasound to guide percutaneous coronary interventions: an evidence-based analysis </title><secondary-title>Ontario Health Technology Assessment Series</secondary-title></titles><periodical><full-title>Ontario Health Technology Assessment Series</full-title></periodical><pages>1-97</pages><volume>6</volume><number>12</number><dates><year>2006</year></dates><urls></urls></record></Cite></EndNote>5Figure SEQ Figure \* ARABIC 2: Schematic of an intravascular ultrasound catheter within a blood vesselSource: Medical Advisory Secretariat Ontario 2006 ADDIN EN.CITE <EndNote><Cite><Author>Medical Advisory Secretariat</Author><Year>2006</Year><RecNum>2</RecNum><DisplayText><style face="superscript">5</style></DisplayText><record><rec-number>2</rec-number><foreign-keys><key app="EN" db-id="eadep9r2s52txne05xsv9adp2efrwfxva5xf">2</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Medical Advisory Secretariat,</author></authors></contributors><titles><title>Intravescular ultrasound to guide percutaneous coronary interventions: an evidence-based analysis </title><secondary-title>Ontario Health Technology Assessment Series</secondary-title></titles><periodical><full-title>Ontario Health Technology Assessment Series</full-title></periodical><pages>1-97</pages><volume>6</volume><number>12</number><dates><year>2006</year></dates><urls></urls></record></Cite></EndNote>5The transducer produces high frequency sound waves. Structures such as blood, tissues, and plaques in the artery reflect sound waves differently because of differences in density. The reflected ultrasound waves are processed electronically to reconstruct black and white images that are displayed and recorded on the console. These images are interpreted to obtain information about lumen dimensions, plaque structure, extent and composition, presence of dissection, plaque rupture and thrombus, and to determine lumen area. This may provide physicians with a better understanding of atherosclerotic vessels to determine appropriate treatment strategy, stent selection and placement, and adequate deployment to restore blood flow.For the purposes of this protocol, the intervention is the therapeutic use of IVUS when used for the placement of coronary stents. This excludes the use of IVUS for diagnostic purposes.AngiographyCoronary angiography is an established procedure and is considered the gold standard for diagnosis of IHD. ADDIN EN.CITE <EndNote><Cite><Author>Ryan</Author><Year>2002</Year><RecNum>38</RecNum><DisplayText><style face="superscript">6</style></DisplayText><record><rec-number>38</rec-number><foreign-keys><key app="EN" db-id="eadep9r2s52txne05xsv9adp2efrwfxva5xf">38</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Ryan, T. J.</author></authors></contributors><auth-address>Evans Department of Medicine, Section of Cardiology, Boston University School of Medicine, Boston, Mass, USA. thomas.ryan@</auth-address><titles><title>The coronary angiogram and its seminal contributions to cardiovascular medicine over five decades</title><secondary-title>Circulation</secondary-title></titles><periodical><full-title>Circulation</full-title></periodical><pages>752-6</pages><volume>106</volume><number>6</number><edition>2002/08/07</edition><keywords><keyword>Cardiology/ history</keyword><keyword>Coronary Angiography/ history</keyword><keyword>Coronary Artery Disease/history/radiography</keyword><keyword>History, 20th Century</keyword><keyword>Humans</keyword></keywords><dates><year>2002</year><pub-dates><date>Aug 6</date></pub-dates></dates><isbn>1524-4539 (Electronic)
0009-7322 (Linking)</isbn><accession-num>12163439</accession-num><urls></urls><remote-database-provider>NLM</remote-database-provider><language>eng</language></record></Cite></EndNote>6 It provides key information about coronary lesions, allowing clinicians to decide on best management strategies from medical therapy, angioplasty, stenting or coronary artery bypass grafting (CABG). Angiography is also the most commonly used imaging modality to guide percutaneous coronary procedures such as stenting.Angiography involves the insertion of a catheter to administer a contrast agent selectively into the coronary arteries to locate any lesions, assess left ventricular function, and to measure haemodynamic pressures. X-ray monitors the flow of the contrast agent through the arteries. It is a two-dimensional imaging technique, which depicts the cross-sectional coronary anatomy as a planar silhouette of the contrast-filled vessel lumen. Images may be interpreted using direct visual assessment of lesions or by quantitative assessment using computer software. Images of the coronary vasculature depict any narrowing or lesions. ADDIN EN.CITE <EndNote><Cite><Author>SCAI</Author><Year>2014</Year><RecNum>39</RecNum><DisplayText><style face="superscript">7</style></DisplayText><record><rec-number>39</rec-number><foreign-keys><key app="EN" db-id="eadep9r2s52txne05xsv9adp2efrwfxva5xf">39</key></foreign-keys><ref-type name="Web Page">12</ref-type><contributors><authors><author>SCAI</author></authors></contributors><titles><title>Angiogram</title></titles><volume>2014</volume><number>25/03</number><dates><year>2014</year></dates><publisher>The Society for Cardiovascular Angiography and Interventions</publisher><urls><related-urls><url> Application 1032 identifies the following limitations of angiography:provides no information on the composition and structure of atherosclerotic lesionsvisual interpretation can result in clinically significant intra- and inter-observer variabilityin instances of diffuse vessel involvement, the measure of per cent diameter stenosis is likely to underestimate the true disease extentas a result of arterial remodelling, it may not detect plaque burden less than 40—50 per cent of the total vessel cross-sectional area. ADDIN EN.CITE <EndNote><Cite><Author>MSAC</Author><Year>2001</Year><RecNum>1</RecNum><DisplayText><style face="superscript">1</style></DisplayText><record><rec-number>1</rec-number><foreign-keys><key app="EN" db-id="eadep9r2s52txne05xsv9adp2efrwfxva5xf">1</key></foreign-keys><ref-type name="Web Page">12</ref-type><contributors><authors><author>MSAC</author></authors></contributors><titles><title>MSAC Application 1032: Intravascular ultrasound </title></titles><volume>2014</volume><number>03/04</number><dates><year>2001</year></dates><pub-location>Canberra</pub-location><publisher>Department of Health and Ageing</publisher><urls><related-urls><url>$File/1032-Intravascular-ultrasound-Assessment-Report.pdf </url></related-urls></urls><access-date>03/03/2014</access-date></record></Cite></EndNote>1The MSAC Application 1032 was based on the consideration of X-ray angiography. Other available angiographic techniques include computed tomography coronary angiography (CTCA) and magnetic resonance coronary angiography (MRCA). Hybrid imaging catheters are in development, which would allow the cardiologist to inject the contrast material for the angiographic images. The cardiologist would also be able to have the ultrasound transducers in the same catheter to get a cross-sectional view of a coronary vessel. ADDIN EN.CITE <EndNote><Cite><Author>DAIC</Author><Year>2010</Year><RecNum>41</RecNum><DisplayText><style face="superscript">8</style></DisplayText><record><rec-number>41</rec-number><foreign-keys><key app="EN" db-id="eadep9r2s52txne05xsv9adp2efrwfxva5xf">41</key></foreign-keys><ref-type name="Web Page">12</ref-type><contributors><authors><author>DAIC</author></authors></contributors><titles><title>Hybrid IVUS/Angio Navigation Tool Presented at EuroPCR</title></titles><volume>2014</volume><number>25/03</number><dates><year>2010</year></dates><pub-location>IL</pub-location><publisher>Scranton Gillette Communications</publisher><urls><related-urls><url> app="EN" db-id="eadep9r2s52txne05xsv9adp2efrwfxva5xf">41</key></foreign-keys><ref-type name="Web Page">12</ref-type><contributors><authors><author>DAIC</author></authors></contributors><titles><title>Hybrid IVUS/Angio Navigation Tool Presented at EuroPCR</title></titles><volume>2014</volume><number>25/03</number><dates><year>2010</year></dates><pub-location>IL</pub-location><publisher>Scranton Gillette Communications</publisher><urls><related-urls><url>, dose, frequency of administration, duration of treatmentThe eligible population is identified by preliminary screening tests such as exercise stress tests and stress imaging studies. The majority of patients are diagnosed following an episode of angina or myocardial infarction. Coronary angiography is performed in these patients to locate and to define the extent and severity of atherosclerotic lesions. It also provides guidance during PCI procedures.Following the finding of a lesion or narrowed coronary artery through diagnostic angiography, the cardiologist may elect to proceed immediately to insert a stent. In “high-risk” patients, IVUS may be a useful adjunct to coronary angiography. For further information on “high risk” patients, refer to the section on Patient Population (page 13).Where further investigations and additional resources (e.g. a credentialled IVUS specialist) are not immediately available to perform IVUS-guided stent insertion, a follow-up procedure which includes IVUS may be necessary. Consecutive procedures are likely to be required in a substantial proportion of patients, as IVUS expertise is unlikely to be available consistently in all centres and at all times.Surgical management also involves balloon angioplasty, plaque modification procedures such as cutting balloon, or rotational atherectomy. Angioplasty is performed by inserting a catheter with a small balloon at the tip, which is directed to the site of the lesion. The cardiologist inflates the balloon several times to restore blood flow to the heart. The cardiologist will commonly choose to place a stent during the procedure to keep the blood vessel open. ADDIN EN.CITE <EndNote><Cite><Author>SCAI</Author><Year>2014</Year><RecNum>39</RecNum><DisplayText><style face="superscript">7</style></DisplayText><record><rec-number>39</rec-number><foreign-keys><key app="EN" db-id="eadep9r2s52txne05xsv9adp2efrwfxva5xf">39</key></foreign-keys><ref-type name="Web Page">12</ref-type><contributors><authors><author>SCAI</author></authors></contributors><titles><title>Angiogram</title></titles><volume>2014</volume><number>25/03</number><dates><year>2014</year></dates><publisher>The Society for Cardiovascular Angiography and Interventions</publisher><urls><related-urls><url> Australia, angioplasty is performed in approximately 70 per cent, 35 per cent and 15 per cent of ST-segment elevation myocardial infarction (STEMI), non-STEMI (NSTEMI) and unstable angina patients, respectively. Of patients with a STEMI who undergo angioplasty, approximately 95 per cent will receive a stent.PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5DaGV3PC9BdXRob3I+PFllYXI+MjAwODwvWWVhcj48UmVj
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ADDIN EN.CITE.DATA 9 This is due to the high restenosis risk after angioplasty alone (30%) compared to restenosis risk after the addition of a stent (5%).PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5DaGV3PC9BdXRob3I+PFllYXI+MjAwODwvWWVhcj48UmVj
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ADDIN EN.CITE PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5DaGV3PC9BdXRob3I+PFllYXI+MjAwODwvWWVhcj48UmVj
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ADDIN EN.CITE.DATA 9Ultrasonography is a safe, non-invasive imaging procedure that does not produce ionizing radiation. ADDIN EN.CITE <EndNote><Cite><Author>Marhofer</Author><Year>2005</Year><RecNum>9</RecNum><DisplayText><style face="superscript">10</style></DisplayText><record><rec-number>9</rec-number><foreign-keys><key app="EN" db-id="eadep9r2s52txne05xsv9adp2efrwfxva5xf">9</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Marhofer, P.</author><author>Greher, M.</author><author>Kapral, S.</author></authors></contributors><auth-address>Department of Anaesthesia and Intensive Care Medicine, Medical University of Vienna, Waehringer Guertel 18-20, A-1090 Vienna, Austria. peter.marhofer@meduniwien.ac.at</auth-address><titles><title>Ultrasound guidance in regional anaesthesia</title><secondary-title>Br J Anaesth</secondary-title></titles><periodical><full-title>Br J Anaesth</full-title></periodical><pages>7-17</pages><volume>94</volume><number>1</number><edition>2004/07/28</edition><keywords><keyword>Adult</keyword><keyword>Anesthesia, Conduction/ methods</keyword><keyword>Anesthesia, Epidural/methods</keyword><keyword>Anesthetics, Local/administration & dosage</keyword><keyword>Child</keyword><keyword>Humans</keyword><keyword>Nerve Block/methods</keyword><keyword>Peripheral Nerves/ultrasonography</keyword><keyword>Ultrasonography, Interventional/instrumentation/ methods</keyword></keywords><dates><year>2005</year><pub-dates><date>Jan</date></pub-dates></dates><isbn>0007-0912 (Print)
0007-0912 (Linking)</isbn><accession-num>15277302</accession-num><urls></urls><electronic-resource-num>10.1093/bja/aei002</electronic-resource-num><remote-database-provider>NLM</remote-database-provider><language>eng</language></record></Cite></EndNote>10 Sound frequencies used in medical sonography range from 1MHz to 40MHz and are poorly transmitted by air and calcified tissue, but effectively transmitted by fluid and soft tissues. Higher frequencies provide a more detailed image, but are less able to penetrate into deep tissues. As such, IVUS is generally capable of providing precise images of coronary wall structure.IVUS-guided coronary stent insertion is performed in a catheterisation laboratory. The imaging catheter is inserted into the femoral artery, and navigated to the narrowed coronary artery. The Judkins technique is commonly used. ADDIN EN.CITE <EndNote><Cite><Author>Davidson</Author><Year>2012</Year><RecNum>3</RecNum><DisplayText><style face="superscript">11</style></DisplayText><record><rec-number>3</rec-number><foreign-keys><key app="EN" db-id="eadep9r2s52txne05xsv9adp2efrwfxva5xf">3</key></foreign-keys><ref-type name="Book Section">5</ref-type><contributors><authors><author>Davidson, CJ;</author><author>Bonow, RO</author></authors><secondary-authors><author>Bonow, RO; </author><author>Mann, DL; Zipes, DP; et al.</author></secondary-authors></contributors><titles><title>Cardiac catheterization</title><secondary-title>Braunwald’s Heart Disease: A Textbook of Cardiovascular Medicine</secondary-title></titles><edition>9</edition><dates><year>2012</year></dates><publisher>Elsevier</publisher><urls></urls></record></Cite></EndNote>11 The catheter is usually positioned distally to the lesion (or stent), and withdrawn through the lesion (or stent) at a constant speed, manually or with an automatic mechanical pullback device.Cardiologists perform the IVUS during a PCI. In Australia, this would typically be an interventional cardiologist. The Cardiac Society of Australia and New Zealand conduct proctoring programs and credentialling for these specialists.The service may be useful in both elective and emergency PCI procedures. It is provided at a public or private hospital as an inpatient procedure. IVUS imaging takes 10–15 minutes; this is in addition to the stent insertion procedure, which usually takes 10–20 minutes.It is a common practice to perform follow-up angiography post-stenting. The timing and frequency of the follow-up angiography depend on clinical indications. If a patient presents with an unstable condition after stenting, immediate angiography is required to identify the root cause.Co-administered interventionsBare metal stents (BMS) and drug-eluting stents (DES) are deployed at the narrowed part of a coronary vessel. BMS are mesh-like tubes of thin wire. DES are covered with a drug, which is slowly released to reduce cell proliferation. This prevents fibrosis, which together with thrombosis could narrow the stented artery, a process called restenosis.The PCI is generally performed under local anaesthesia. Oral or intravenous sedation is usually administered. ADDIN EN.CITE <EndNote><Cite><Author>Davidson</Author><Year>2012</Year><RecNum>3</RecNum><DisplayText><style face="superscript">11</style></DisplayText><record><rec-number>3</rec-number><foreign-keys><key app="EN" db-id="eadep9r2s52txne05xsv9adp2efrwfxva5xf">3</key></foreign-keys><ref-type name="Book Section">5</ref-type><contributors><authors><author>Davidson, CJ;</author><author>Bonow, RO</author></authors><secondary-authors><author>Bonow, RO; </author><author>Mann, DL; Zipes, DP; et al.</author></secondary-authors></contributors><titles><title>Cardiac catheterization</title><secondary-title>Braunwald’s Heart Disease: A Textbook of Cardiovascular Medicine</secondary-title></titles><edition>9</edition><dates><year>2012</year></dates><publisher>Elsevier</publisher><urls></urls></record></Cite></EndNote>11 Fluoroscopy may be used to locate the femoral artery and to assist insertion of the guidewire. ADDIN EN.CITE <EndNote><Cite><Author>Davidson</Author><Year>2012</Year><RecNum>3</RecNum><DisplayText><style face="superscript">11</style></DisplayText><record><rec-number>3</rec-number><foreign-keys><key app="EN" db-id="eadep9r2s52txne05xsv9adp2efrwfxva5xf">3</key></foreign-keys><ref-type name="Book Section">5</ref-type><contributors><authors><author>Davidson, CJ;</author><author>Bonow, RO</author></authors><secondary-authors><author>Bonow, RO; </author><author>Mann, DL; Zipes, DP; et al.</author></secondary-authors></contributors><titles><title>Cardiac catheterization</title><secondary-title>Braunwald’s Heart Disease: A Textbook of Cardiovascular Medicine</secondary-title></titles><edition>9</edition><dates><year>2012</year></dates><publisher>Elsevier</publisher><urls></urls></record></Cite></EndNote>11BackgroundIHD, also known as coronary heart disease or atherosclerotic heart disease, is the most common form of cardiovascular disease. ADDIN EN.CITE <EndNote><Cite><Author>AIHW</Author><Year>2014</Year><RecNum>10</RecNum><DisplayText><style face="superscript">12</style></DisplayText><record><rec-number>10</rec-number><foreign-keys><key app="EN" db-id="eadep9r2s52txne05xsv9adp2efrwfxva5xf">10</key></foreign-keys><ref-type name="Web Page">12</ref-type><contributors><authors><author>AIHW</author></authors></contributors><titles><title>What are cardiovascular diseases?</title></titles><volume>2014</volume><number>04/03</number><dates><year>2014</year></dates><pub-location>Canberra</pub-location><publisher>Australian Institute of Health and Welfare</publisher><urls><related-urls><url> High blood pressure and high cholesterol are the largest contributors to IHD in Australia, followed by physical inactivity, high body mass, tobacco use and low fruit and vegetable consumption. ADDIN EN.CITE <EndNote><Cite><Author>ABS</Author><Year>2010</Year><RecNum>4</RecNum><DisplayText><style face="superscript">13</style></DisplayText><record><rec-number>4</rec-number><foreign-keys><key app="EN" db-id="eadep9r2s52txne05xsv9adp2efrwfxva5xf">4</key></foreign-keys><ref-type name="Web Page">12</ref-type><contributors><authors><author>ABS,</author></authors></contributors><titles><title>ABS 2007-08 National Health Survey (NHS)</title></titles><volume>2014</volume><number>04/03</number><dates><year>2010</year></dates><pub-location>Canberra</pub-location><publisher>Australian Bureau of Statistics</publisher><urls><related-urls><url> main underlying pathology in IHD is atherosclerosis, which can lead to occlusion of the coronary arteries and oxygen starvation of the heart, which presents as angina pectoris. Angina is a chronic condition in which short episodes of chest pain occur periodically. When one or more of the coronary arteries are completely blocked, a myocardial infarction may occur. When the cerebral blood flow is compromised, IHD may result in stroke or cerebrovascular accident.PrevalenceBased on self-reports from the 2007–08 National Health Survey, an estimated 3.4 million Australians (16% of the population) had at least one long-term cardiovascular disease. ADDIN EN.CITE <EndNote><Cite><Author>ABS</Author><Year>2010</Year><RecNum>4</RecNum><DisplayText><style face="superscript">13</style></DisplayText><record><rec-number>4</rec-number><foreign-keys><key app="EN" db-id="eadep9r2s52txne05xsv9adp2efrwfxva5xf">4</key></foreign-keys><ref-type name="Web Page">12</ref-type><contributors><authors><author>ABS,</author></authors></contributors><titles><title>ABS 2007-08 National Health Survey (NHS)</title></titles><volume>2014</volume><number>04/03</number><dates><year>2010</year></dates><pub-location>Canberra</pub-location><publisher>Australian Bureau of Statistics</publisher><urls><related-urls><url> Similarly, estimates from the 2007 National Survey of Mental Health and Wellbeing (NSMHWB) show that 3.5 million Australians aged 16–85 years had a chronic cardiovascular condition. About 685,000 people (3% of the population) had IHD. Of those, 353,000 had experienced angina and 449,000 other conditions of IHD or myocardial infarction (note that a person may report more than one disease). ADDIN EN.CITE <EndNote><Cite><Author>AIHW</Author><Year>2010</Year><RecNum>37</RecNum><DisplayText><style face="superscript">14</style></DisplayText><record><rec-number>37</rec-number><foreign-keys><key app="EN" db-id="eadep9r2s52txne05xsv9adp2efrwfxva5xf">37</key></foreign-keys><ref-type name="Government Document">46</ref-type><contributors><authors><author>AIHW</author></authors><secondary-authors><author>Australian Institute of Health and Welfare</author></secondary-authors></contributors><titles><title>Australia's health 2010</title></titles><section>Diseases and injury</section><dates><year>2010</year></dates><pub-location>Canberra</pub-location><publisher>Australian Institute of Health and Welfare</publisher><isbn>12</isbn><urls><related-urls><url> Institute of Health and Welfare</custom1></record></Cite></EndNote>14The prevalence of IHD was higher among males than females in people aged over 35 years. More females than males were likely to have the disease in the age group 25—34. Men and women aged under 25 years had a similar but minimal prevalence of the disease. Overall, after adjusting for age, four per cent of males were estimated to have IHD, compared to two per cent of females. The prevalence of IHD increases markedly with age. In 2007–08, around seven per cent of Australians aged 55–64 years were estimated to have IHD, increasing to 24 per cent among those aged 85 years and over. ADDIN EN.CITE <EndNote><Cite><Author>AIHW</Author><Year>2011</Year><RecNum>5</RecNum><DisplayText><style face="superscript">15</style></DisplayText><record><rec-number>5</rec-number><foreign-keys><key app="EN" db-id="eadep9r2s52txne05xsv9adp2efrwfxva5xf">5</key></foreign-keys><ref-type name="Web Page">12</ref-type><contributors><authors><author>AIHW,</author></authors></contributors><titles><title>Cardiovascular disease: Australian facts 2011</title><secondary-title>Cardiovascular disease series no. 35. Cat. no. CVD 53. </secondary-title></titles><dates><year>2011</year></dates><pub-location>Canberra</pub-location><publisher>Australian Institute of Health and Welfare</publisher><urls><related-urls><url> the 2004–05 National Aboriginal and Torres Strait Islander Heath Survey, it was estimated that one per cent of Indigenous Australians (5,800 people) had IHD. Of these, 48 per cent (2,800) were males and 52 per cent (3,000) were females. When adjusted for age differences, the prevalence rate for Indigenous Australians was approximately twice as high as that for non-Indigenous Australians. ADDIN EN.CITE <EndNote><Cite><Author>AIHW</Author><Year>2011</Year><RecNum>5</RecNum><DisplayText><style face="superscript">15</style></DisplayText><record><rec-number>5</rec-number><foreign-keys><key app="EN" db-id="eadep9r2s52txne05xsv9adp2efrwfxva5xf">5</key></foreign-keys><ref-type name="Web Page">12</ref-type><contributors><authors><author>AIHW,</author></authors></contributors><titles><title>Cardiovascular disease: Australian facts 2011</title><secondary-title>Cardiovascular disease series no. 35. Cat. no. CVD 53. </secondary-title></titles><dates><year>2011</year></dates><pub-location>Canberra</pub-location><publisher>Australian Institute of Health and Welfare</publisher><urls><related-urls><url> 2007–08, overall IHD prevalence was highest in the lowest socioeconomic group and lowest in the highest socioeconomic group. ADDIN EN.CITE <EndNote><Cite><Author>AIHW</Author><Year>2011</Year><RecNum>5</RecNum><DisplayText><style face="superscript">15</style></DisplayText><record><rec-number>5</rec-number><foreign-keys><key app="EN" db-id="eadep9r2s52txne05xsv9adp2efrwfxva5xf">5</key></foreign-keys><ref-type name="Web Page">12</ref-type><contributors><authors><author>AIHW,</author></authors></contributors><titles><title>Cardiovascular disease: Australian facts 2011</title><secondary-title>Cardiovascular disease series no. 35. Cat. no. CVD 53. </secondary-title></titles><dates><year>2011</year></dates><pub-location>Canberra</pub-location><publisher>Australian Institute of Health and Welfare</publisher><urls><related-urls><url> are no national data on the incidence of IHD in Australia. ADDIN EN.CITE <EndNote><Cite><Author>AIHW</Author><Year>2011</Year><RecNum>5</RecNum><DisplayText><style face="superscript">15</style></DisplayText><record><rec-number>5</rec-number><foreign-keys><key app="EN" db-id="eadep9r2s52txne05xsv9adp2efrwfxva5xf">5</key></foreign-keys><ref-type name="Web Page">12</ref-type><contributors><authors><author>AIHW,</author></authors></contributors><titles><title>Cardiovascular disease: Australian facts 2011</title><secondary-title>Cardiovascular disease series no. 35. Cat. no. CVD 53. </secondary-title></titles><dates><year>2011</year></dates><pub-location>Canberra</pub-location><publisher>Australian Institute of Health and Welfare</publisher><urls><related-urls><url> The Australian Institute of Health and Welfare (AIHW) estimates that in 2007 there were 49,391 major coronary events in Australia among 40–90 year olds (31,036 men and 18,355 women)—about 135 incidences per day. Nearly 40 per cent of these events were fatal (18,265 cases). The overall rate of major coronary events was twice as high among males as it was among females. After adjusting for age, there were 703 major coronary events per 100,000 males, compared with 331 per 100,000 females. ADDIN EN.CITE <EndNote><Cite><Author>AIHW</Author><Year>2011</Year><RecNum>5</RecNum><DisplayText><style face="superscript">15</style></DisplayText><record><rec-number>5</rec-number><foreign-keys><key app="EN" db-id="eadep9r2s52txne05xsv9adp2efrwfxva5xf">5</key></foreign-keys><ref-type name="Web Page">12</ref-type><contributors><authors><author>AIHW,</author></authors></contributors><titles><title>Cardiovascular disease: Australian facts 2011</title><secondary-title>Cardiovascular disease series no. 35. Cat. no. CVD 53. </secondary-title></titles><dates><year>2011</year></dates><pub-location>Canberra</pub-location><publisher>Australian Institute of Health and Welfare</publisher><urls><related-urls><url> rate of major coronary events increased with age; rates among persons aged 75–90 years were over 16 times higher than amongst persons aged 40–54 years. The rate was higher among males for every age group. The rate for women aged 65–74 years was similar to that of men aged 55–64 years, indicating that men, on average, suffer from IHD at younger ages than women. ADDIN EN.CITE <EndNote><Cite><Author>AIHW</Author><Year>2011</Year><RecNum>5</RecNum><DisplayText><style face="superscript">15</style></DisplayText><record><rec-number>5</rec-number><foreign-keys><key app="EN" db-id="eadep9r2s52txne05xsv9adp2efrwfxva5xf">5</key></foreign-keys><ref-type name="Web Page">12</ref-type><contributors><authors><author>AIHW,</author></authors></contributors><titles><title>Cardiovascular disease: Australian facts 2011</title><secondary-title>Cardiovascular disease series no. 35. Cat. no. CVD 53. </secondary-title></titles><dates><year>2011</year></dates><pub-location>Canberra</pub-location><publisher>Australian Institute of Health and Welfare</publisher><urls><related-urls><url> and Torres Strait Islander people have considerably higher rates of major coronary events than other Australians; three times as high in 2002–03. ADDIN EN.CITE <EndNote><Cite><Author>Mathur</Author><Year>2006</Year><RecNum>6</RecNum><DisplayText><style face="superscript">16</style></DisplayText><record><rec-number>6</rec-number><foreign-keys><key app="EN" db-id="eadep9r2s52txne05xsv9adp2efrwfxva5xf">6</key></foreign-keys><ref-type name="Web Page">12</ref-type><contributors><authors><author>Mathur, S;</author><author>Moon, L.</author><author>Leigh, S</author></authors></contributors><titles><title>Aboriginal and Torres Strait Islander people with coronary heart disease</title><secondary-title>Cardiovascular disease series no 25</secondary-title></titles><dates><year>2006</year></dates><pub-location>Canberra</pub-location><publisher>Australian Institute of Health and Welfare</publisher><urls><related-urls><url> Higher event rates among Indigenous Australians were also found in more recent studies in Western Australia and the Northern Territory where the incidence of acute myocardial infarction in the Indigenous population was found to have increased by 60 per cent between 1992 and 2004 but to have decreased by 20 per cent in the non-Indigenous population over the same period.PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5CcmFkc2hhdzwvQXV0aG9yPjxZZWFyPjIwMTE8L1llYXI+
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ADDIN EN.CITE.DATA 17, 18HospitalisationsRelevant AIHW hospital morbidity data are provided in Appendix A. In 2009—10, there were 153,833 hospitalisations with a principal diagnosis of IHD, 32 per cent of hospitalisations for diseases of the circulatory system. Of hospitalisations for IHD, angina accounted for 65,158 (42%) and acute myocardial infarction for 55,033 (36%) ( REF _Ref381779597 \h \* MERGEFORMAT Table 11). ADDIN EN.CITE <EndNote><Cite><Author>AIHW</Author><Year>2014</Year><RecNum>12</RecNum><DisplayText><style face="superscript">19</style></DisplayText><record><rec-number>12</rec-number><foreign-keys><key app="EN" db-id="eadep9r2s52txne05xsv9adp2efrwfxva5xf">12</key></foreign-keys><ref-type name="Web Page">12</ref-type><contributors><authors><author>AIHW</author></authors></contributors><titles><title>Hospital data: Australian refined diagnosis-related groups (AR-DRG) data cubes </title></titles><volume>2014</volume><number>03/03</number><dates><year>2014</year></dates><publisher>Australian Institute of Health and Welfare </publisher><urls><related-urls><url> During the same year, 14,499 PCI with acute myocardial infarction, and 19,037 PCI without acute myocardial infarction with stent implantation were performed ( REF _Ref382984304 \h Table 12). ADDIN EN.CITE <EndNote><Cite><Author>AIHW</Author><Year>2014</Year><RecNum>11</RecNum><DisplayText><style face="superscript">20</style></DisplayText><record><rec-number>11</rec-number><foreign-keys><key app="EN" db-id="eadep9r2s52txne05xsv9adp2efrwfxva5xf">11</key></foreign-keys><ref-type name="Web Page">12</ref-type><contributors><authors><author>AIHW</author></authors></contributors><titles><title>Hospital data: principal diagnosis data cubes </title></titles><volume>2014</volume><number>03/03</number><dates><year>2014</year></dates><pub-location>Canberra</pub-location><publisher>Australian Institute of Health and Welfare </publisher><urls><related-urls><url> In total, 182,654 coronary artery procedures were conducted over this period, which included 37,038 transluminal coronary angioplasty procedures. The majority, 94 per cent of the transluminal coronary angioplasty procedures, involved stent insertion ( REF _Ref381780578 \h \* MERGEFORMAT Table 13). ADDIN EN.CITE <EndNote><Cite><Author>AIHW</Author><Year>2014</Year><RecNum>12</RecNum><DisplayText><style face="superscript">19</style></DisplayText><record><rec-number>12</rec-number><foreign-keys><key app="EN" db-id="eadep9r2s52txne05xsv9adp2efrwfxva5xf">12</key></foreign-keys><ref-type name="Web Page">12</ref-type><contributors><authors><author>AIHW</author></authors></contributors><titles><title>Hospital data: Australian refined diagnosis-related groups (AR-DRG) data cubes </title></titles><volume>2014</volume><number>03/03</number><dates><year>2014</year></dates><publisher>Australian Institute of Health and Welfare </publisher><urls><related-urls><url> For stent insertion during transluminal coronary angioplasty procedures, 68 per cent involved a single stent inserted into a single coronary artery ( REF _Ref381780981 \h \* MERGEFORMAT Table 14). ADDIN EN.CITE <EndNote><Cite><Author>AIHW</Author><Year>2014</Year><RecNum>12</RecNum><DisplayText><style face="superscript">19</style></DisplayText><record><rec-number>12</rec-number><foreign-keys><key app="EN" db-id="eadep9r2s52txne05xsv9adp2efrwfxva5xf">12</key></foreign-keys><ref-type name="Web Page">12</ref-type><contributors><authors><author>AIHW</author></authors></contributors><titles><title>Hospital data: Australian refined diagnosis-related groups (AR-DRG) data cubes </title></titles><volume>2014</volume><number>03/03</number><dates><year>2014</year></dates><publisher>Australian Institute of Health and Welfare </publisher><urls><related-urls><url> In Australia, approximately 75—80 per cent of transluminal stent insertion procedures currently use a DES.Burden of diseaseCardiovascular disease was responsible for approximately 34 per cent of all deaths in 2008 and its health and economic burdens exceed that of any other disease. ADDIN EN.CITE <EndNote><Cite><Author>AIHW</Author><Year>2011</Year><RecNum>5</RecNum><DisplayText><style face="superscript">15</style></DisplayText><record><rec-number>5</rec-number><foreign-keys><key app="EN" db-id="eadep9r2s52txne05xsv9adp2efrwfxva5xf">5</key></foreign-keys><ref-type name="Web Page">12</ref-type><contributors><authors><author>AIHW,</author></authors></contributors><titles><title>Cardiovascular disease: Australian facts 2011</title><secondary-title>Cardiovascular disease series no. 35. Cat. no. CVD 53. </secondary-title></titles><dates><year>2011</year></dates><pub-location>Canberra</pub-location><publisher>Australian Institute of Health and Welfare</publisher><urls><related-urls><url> Approximately half of IHD deaths resulted from acute myocardial infarction. Between 1987 and 2007, the age-standardised IHD death rate more than halved in Australia, falling from 251 deaths per 100,000 population to 98 per 100,000. The decline is attributed to a number of factors including the decline in levels of tobacco smoking, and the availability of better medical care. ADDIN EN.CITE <EndNote><Cite><Author>AIHW</Author><Year>2011</Year><RecNum>5</RecNum><DisplayText><style face="superscript">15</style></DisplayText><record><rec-number>5</rec-number><foreign-keys><key app="EN" db-id="eadep9r2s52txne05xsv9adp2efrwfxva5xf">5</key></foreign-keys><ref-type name="Web Page">12</ref-type><contributors><authors><author>AIHW,</author></authors></contributors><titles><title>Cardiovascular disease: Australian facts 2011</title><secondary-title>Cardiovascular disease series no. 35. Cat. no. CVD 53. </secondary-title></titles><dates><year>2011</year></dates><pub-location>Canberra</pub-location><publisher>Australian Institute of Health and Welfare</publisher><urls><related-urls><url> comorbidities associated with cardiovascular disease include diabetes and chronic kidney disease. They have common risk factors such as tobacco smoking, physical inactivity, high blood pressure, high blood cholesterol, and being overweight or obese. Each disease is itself a risk factor for the other disease. In 2007–08, nearly a third of hospitalisations with any diagnosis of IHD had a co-existing diagnosis of diabetes or chronic kidney disease, and six per cent had a diagnosis of all three. ADDIN EN.CITE <EndNote><Cite><Author>AIHW</Author><Year>2014</Year><RecNum>11</RecNum><DisplayText><style face="superscript">20</style></DisplayText><record><rec-number>11</rec-number><foreign-keys><key app="EN" db-id="eadep9r2s52txne05xsv9adp2efrwfxva5xf">11</key></foreign-keys><ref-type name="Web Page">12</ref-type><contributors><authors><author>AIHW</author></authors></contributors><titles><title>Hospital data: principal diagnosis data cubes </title></titles><volume>2014</volume><number>03/03</number><dates><year>2014</year></dates><pub-location>Canberra</pub-location><publisher>Australian Institute of Health and Welfare </publisher><urls><related-urls><url> IHD and stroke account for a considerable proportion of the public health expenditure. Thirty-one per cent ($1,813 million) of CVD expenditure was spent on IHD, while a further nine per cent ($546 million) was spent on stroke. In 2004–05, prescription pharmaceuticals represented 16 per cent of total IHD expenditure, with the comparable figure for stroke being 11 per cent. However, it is likely that the amount spent on prescription pharmaceuticals for CVD is greatly underestimated. ADDIN EN.CITE <EndNote><Cite><Author>AIHW</Author><Year>2011</Year><RecNum>5</RecNum><DisplayText><style face="superscript">15</style></DisplayText><record><rec-number>5</rec-number><foreign-keys><key app="EN" db-id="eadep9r2s52txne05xsv9adp2efrwfxva5xf">5</key></foreign-keys><ref-type name="Web Page">12</ref-type><contributors><authors><author>AIHW,</author></authors></contributors><titles><title>Cardiovascular disease: Australian facts 2011</title><secondary-title>Cardiovascular disease series no. 35. Cat. no. CVD 53. </secondary-title></titles><dates><year>2011</year></dates><pub-location>Canberra</pub-location><publisher>Australian Institute of Health and Welfare</publisher><urls><related-urls><url> current guidelines on management of IHD recommend the following strategies: ADDIN EN.CITE <EndNote><Cite><Author>Qaseem</Author><Year>2012</Year><RecNum>13</RecNum><DisplayText><style face="superscript">21</style></DisplayText><record><rec-number>13</rec-number><foreign-keys><key app="EN" db-id="eadep9r2s52txne05xsv9adp2efrwfxva5xf">13</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Qaseem, A.</author><author>Fihn, S. D.</author><author>Dallas, P.</author><author>Williams, S.</author><author>Owens, D. K.</author><author>Shekelle, P.</author></authors></contributors><auth-address>American College of Physicians, 190 N. Independence Mall West, Philadelphia, PA 19106, USA. aqaseem@</auth-address><titles><title>Management of stable ischemic heart disease: summary of a clinical practice guideline from the American College of Physicians/American College of Cardiology Foundation/American Heart Association/American Association for Thoracic Surgery/Preventive Cardiovascular Nurses Association/Society of Thoracic Surgeons</title><secondary-title>Ann Intern Med</secondary-title></titles><periodical><full-title>Ann Intern Med</full-title></periodical><pages>735-43</pages><volume>157</volume><number>10</number><edition>2012/11/21</edition><keywords><keyword>Angina Pectoris/therapy</keyword><keyword>Exercise Therapy</keyword><keyword>Humans</keyword><keyword>Myocardial Infarction/mortality/prevention & control</keyword><keyword>Myocardial Ischemia/complications/mortality/ therapy</keyword><keyword>Myocardial Revascularization</keyword><keyword>Patient Education as Topic</keyword><keyword>Risk Factors</keyword><keyword>Risk Reduction Behavior</keyword></keywords><dates><year>2012</year><pub-dates><date>Nov 20</date></pub-dates></dates><isbn>1539-3704 (Electronic)
0003-4819 (Linking)</isbn><accession-num>23165665</accession-num><urls></urls><electronic-resource-num>10.7326/0003-4819-157-10-201211200-00011</electronic-resource-num><remote-database-provider>NLM</remote-database-provider><language>eng</language></record></Cite></EndNote>21behavioural modification – weight control, pressure control and healthy lifestylemedical/pharmaceuticals (e.g. beta-blockers, angiotensin-converting enzyme inhibitors, angiotensin receptor blockers, aldosterone antagonists)surgical/revascularisation – CABG, PCI (e.g. stenting) ADDIN EN.CITE <EndNote><Cite><Author>Qaseem</Author><Year>2012</Year><RecNum>13</RecNum><DisplayText><style face="superscript">21</style></DisplayText><record><rec-number>13</rec-number><foreign-keys><key app="EN" db-id="eadep9r2s52txne05xsv9adp2efrwfxva5xf">13</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Qaseem, A.</author><author>Fihn, S. D.</author><author>Dallas, P.</author><author>Williams, S.</author><author>Owens, D. K.</author><author>Shekelle, P.</author></authors></contributors><auth-address>American College of Physicians, 190 N. Independence Mall West, Philadelphia, PA 19106, USA. aqaseem@</auth-address><titles><title>Management of stable ischemic heart disease: summary of a clinical practice guideline from the American College of Physicians/American College of Cardiology Foundation/American Heart Association/American Association for Thoracic Surgery/Preventive Cardiovascular Nurses Association/Society of Thoracic Surgeons</title><secondary-title>Ann Intern Med</secondary-title></titles><periodical><full-title>Ann Intern Med</full-title></periodical><pages>735-43</pages><volume>157</volume><number>10</number><edition>2012/11/21</edition><keywords><keyword>Angina Pectoris/therapy</keyword><keyword>Exercise Therapy</keyword><keyword>Humans</keyword><keyword>Myocardial Infarction/mortality/prevention & control</keyword><keyword>Myocardial Ischemia/complications/mortality/ therapy</keyword><keyword>Myocardial Revascularization</keyword><keyword>Patient Education as Topic</keyword><keyword>Risk Factors</keyword><keyword>Risk Reduction Behavior</keyword></keywords><dates><year>2012</year><pub-dates><date>Nov 20</date></pub-dates></dates><isbn>1539-3704 (Electronic)
0003-4819 (Linking)</isbn><accession-num>23165665</accession-num><urls></urls><electronic-resource-num>10.7326/0003-4819-157-10-201211200-00011</electronic-resource-num><remote-database-provider>NLM</remote-database-provider><language>eng</language></record></Cite></EndNote>21 (the decision regarding whether to perform CABG or PCI with stenting is at the discretion of the treating specialist and will be made considering the patient’s comorbidities and circumstances;PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5IYW1tPC9BdXRob3I+PFllYXI+MjAxMTwvWWVhcj48UmVj
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ADDIN EN.CITE.DATA 22 other surgical procedures include balloon angioplasty, rotational atherectomy and laser thrombectomy). ADDIN EN.CITE <EndNote><Cite><Author>Levine</Author><Year>2011</Year><RecNum>19</RecNum><DisplayText><style face="superscript">2</style></DisplayText><record><rec-number>19</rec-number><foreign-keys><key app="EN" db-id="eadep9r2s52txne05xsv9adp2efrwfxva5xf">19</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Levine, G. N.</author><author>Bates, E. R.</author><author>Blankenship, J. C.</author><author>Bailey, S. R.</author><author>Bittl, J. A.</author><author>Cercek, B.</author><author>Chambers, C. E.</author><author>Ellis, S. G.</author><author>Guyton, R. A.</author><author>Hollenberg, S. M.</author><author>Khot, U. N.</author><author>Lange, R. A.</author><author>Mauri, L.</author><author>Mehran, R.</author><author>Moussa, I. D.</author><author>Mukherjee, D.</author><author>Nallamothu, B. K.</author><author>Ting, H. H.</author></authors></contributors><titles><title>2011 ACCF/AHA/SCAI Guideline for Percutaneous Coronary Intervention. A report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines and the Society for Cardiovascular Angiography and Interventions</title><secondary-title>J Am Coll Cardiol</secondary-title></titles><periodical><full-title>J Am Coll Cardiol</full-title></periodical><pages>e44-122</pages><volume>58</volume><number>24</number><edition>2011/11/11</edition><keywords><keyword>Angioplasty, Balloon, Coronary/methods/ standards</keyword><keyword>Humans</keyword></keywords><dates><year>2011</year><pub-dates><date>Dec 6</date></pub-dates></dates><isbn>1558-3597 (Electronic)
0735-1097 (Linking)</isbn><accession-num>22070834</accession-num><urls></urls><electronic-resource-num>10.1016/j.jacc.2011.08.007</electronic-resource-num><remote-database-provider>NLM</remote-database-provider><language>eng</language></record></Cite></EndNote>2PCI is the most commonly employed coronary revascularization procedure worldwide. It is a primary management strategy in patients with STEMI. It may be indicated in the treatment of NSTMI and angina. Patients with single- and multi-vessel coronary artery disease can receive PCI. ADDIN EN.CITE <EndNote><Cite><Author>Leopold</Author><Year>2011</Year><RecNum>28</RecNum><DisplayText><style face="superscript">23</style></DisplayText><record><rec-number>28</rec-number><foreign-keys><key app="EN" db-id="eadep9r2s52txne05xsv9adp2efrwfxva5xf">28</key></foreign-keys><ref-type name="Book Section">5</ref-type><contributors><authors><author>Leopold, JA;</author><author>Bhatt, DL;</author><author>Faxon, DP;</author></authors><secondary-authors><author>Longo, DL;</author><author>Kasper, DL;</author><author>Jameson, JL;</author><author>Fauci, AS;</author><author>Hauser, SL;</author><author>Loscalzo, J</author></secondary-authors></contributors><titles><title>Atlas of Percutaneous Revascularization</title><secondary-title>Harrison's Principles of Internal Medicine, 18 edition</secondary-title></titles><section>33</section><dates><year>2011</year></dates><publisher>McGraw-Hill Professional</publisher><isbn>978-0071748896 </isbn><urls></urls></record></Cite></EndNote>23Current arrangements for public reimbursementCoronary angiography is performed prior to stent insertion to acquire diagnostic information to decide on the strategy for management. Patients, who are indicated for and consent to PCI with stenting, receive BMS or DES at the narrowed coronary artery segment to relieve the effects of myocardial ischemia and to improve symptoms and prognosis. Balloon dilatation may be used during the procedure.Coronary angiography and stenting are well established in current Australian practice. Coronary angiography is claimed via MBS item 38246. Angiography involves the placement of a catheter and the injection of opaque materials (MBS items 38215 and 38243). MBS item 38306 covers PCI with stenting. MBS items 38312 and 38318 are used when rotational atherectomy is considered prior to stenting. Their descriptors are provided in REF _Ref389561561 \h Appendix B.IVUS is not routinely used in Australia during percutaneous coronary stent insertion and is not listed on the MBS.Regulatory statusA list of ARTG-listed IVUS transducers and delivery catheters intended to be used during a percutaneous coronary stent insertion is provided in REF _Ref372205688 \h Table 1. This submission does not pertain to a specific trademarked device. No new devices are proposed.Table SEQ Table \* ARABIC 1: TGA registered intravascular ultrasound devicesARTG numberApproval dateManufacturerProduct nameIntended purpose126936b11/04/2006Boston Scientific Pty LtdAtlantis SR Pro - Transducer assembly, ultrasound, diagnostic, intracorporeal, intravascularIntended for ultrasound examination of coronary intravascular pathology in patients who are candidates fortransluminal coronary interventional procedures.144141b3/09/2007Johnson & Johnson Medical Pty LtdACUNAV Ultrasound Catheter - Transducer assembly, ultrasound, diagnostic, intracorporeal, intravascularFor intracardiac and intra-luminal visualisation of cardiac and great vessel anatomy and physiology as well as visualisation of other devices in the heart.153370b30/06/2008Johnson & Johnson Medical Pty LtdSoundStar 3D Ultrasound Catheter - Transducer assembly, ultrasound, diagnostic, intracorporeal, intravascularIndicated for intra-cardiac and intra-luminal visualisation of cardiac and great vessel anatomy and physiology as well as visualisation of other devices in the heart. Provides location information when used with a CARTO Navigation System.153484b7/07/2008Medical Vision Aust Cardiology & Thoracic Pty LtdRevolution 45 MHz Rotational Intravascular Ultrasound Imaging Catheter - Transducer assembly, ultrasound, diagnostic, intracorporeal, intravascularTo enable intravascular ultrasound images of coronary arteries by insertion into the vascular system when attached to an ultrasound system operator console. Indicated for patients who are candidates for transluminal interventional procedures.153485b7/07/2008Medical Vision Aust Cardiology & Thoracic Pty LtdVisions PV 0.018 Intravascular Ultrasound Imaging Catheter - Transducer assembly, ultrasound, diagnostic, intracorporeal, intravascularFor use in the evaluation of vascular morphology in blood vessels of the coronary and peripheral vasculature by providing a cross-sectional image of such vessels. It is designed for use as an adjunct to conventional angiographic procedures to provide an image of the lumen and wall structures.179135b13/01/2011Medical Vision Aust Cardiology & Thoracic Pty LtdEagle Eye Platinum Digital IVUS Catheter - Transducer assembly, ultrasound, diagnostic, intracorporeal, intravascularFor use in the evaluation of vascular morphology in blood vessels of the coronary and peripheral vasculature by providing a cross-sectional image of such vessels. This device is not currently indicated for use in cerebral vessels. It is designed for use as an adjunct to conventional angiographic procedures to provide an image of the vessel lumen and wall structures.217814a28/11/2013Boston Scientific Pty LtdEagle Eye Platinum Digital IVUS Catheter - Transducer assembly, ultrasound, diagnostic, intracorporeal, intravascularThis catheter is intended for ultrasound examination of coronary intravascular pathology only. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal coronary interventional procedures.219096b10/01/2014Boston Scientific Pty LtdOptiCross Coronary Imaging Catheter - Transducer assembly, ultrasound, diagnostic, intracorporeal, intravascularThis catheter is intended for ultrasound examination of coronary intravascular pathology only. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal coronary interventional procedures. The Catheter is packaged with a Sterile Bag, extension tube, 3 cm3 (cc) and 10 cm3 (cc) syringes and a 4-way stopcock.219543b24/01/2014Medical Vision Aust Cardiology & Thoracic Pty LtdVisions PV .035 - Transducer assembly, ultrasound, diagnostic, intracorporeal, intravascular, single-useIntended for use in the evaluation of vascular morphology in blood vessels of the peripheral vasculature by providing a cross-sectional image of such vessels. It is designed for use as an adjunct to conventional angiographic procedures to provide an image of the vessel lumen and wall structures and dimensional measurements from the image.221253b13/03/2014Johnson & Johnson Medical Pty LtdSoundStar eco Diagnostic Ultrasound Catheter - Transducer assembly, ultrasound, diagnostic, intracorporeal, intravascularIndicated for intra-cardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart. When used with compatible CARTO? 3 EP NavigationSystems, the SOUNDSTAR? eco Catheter provides location information.a Medical device class Ib Medical device class IIINote: MBS items 144151, 153370, 153484, 153485, 179135, 217814, 219096, 219543 and 221253 were added by the assessment group.Source: , accessed March 2014Catheters for IVUS systems were not identified on the prostheses list. Other technologies, stents and stent delivery systems used in association with the proposed service are listed in the prostheses list ( REF _Ref382385570 \h Table 19). Various trade names fall under the general categories of BMS, DES and stent delivery systems. ADDIN EN.CITE <EndNote><Cite><Author>DoH</Author><Year>2014</Year><RecNum>15</RecNum><DisplayText><style face="superscript">24</style></DisplayText><record><rec-number>15</rec-number><foreign-keys><key app="EN" db-id="eadep9r2s52txne05xsv9adp2efrwfxva5xf">15</key></foreign-keys><ref-type name="Web Page">12</ref-type><contributors><authors><author>DoH</author></authors></contributors><titles><title>Prostheses List</title></titles><volume>2014</volume><number>04/03</number><dates><year>2014</year></dates><pub-location>Canberra</pub-location><publisher>Australian Government Department of Health</publisher><urls><related-urls><url> populationThe intervention is proposed for patients eligible for coronary revascularisation undergoing PCI with coronary stent insertion. This includes patients undergoing initial stent insertion, or re-stenting or assessment for other interventions if there are complications or failure of the stent. 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ADDIN EN.CITE.DATA 26 Higher risk patients, such as those with a difficult anatomical lesion or type 1 diabetes, commonly receive a DES while patients with heavily calcified plaques commonly receive BMS. Usually, the choice of stent is decided before insertion of an IVUS catheter.PCI with coronary stenting is not recommended if the patient is not likely to be able to tolerate and comply with dual antiplatelet therapy for an appropriate duration. ADDIN EN.CITE <EndNote><Cite><Author>Qaseem</Author><Year>2012</Year><RecNum>13</RecNum><DisplayText><style face="superscript">21</style></DisplayText><record><rec-number>13</rec-number><foreign-keys><key app="EN" db-id="eadep9r2s52txne05xsv9adp2efrwfxva5xf">13</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Qaseem, A.</author><author>Fihn, S. D.</author><author>Dallas, P.</author><author>Williams, S.</author><author>Owens, D. K.</author><author>Shekelle, P.</author></authors></contributors><auth-address>American College of Physicians, 190 N. Independence Mall West, Philadelphia, PA 19106, USA. aqaseem@</auth-address><titles><title>Management of stable ischemic heart disease: summary of a clinical practice guideline from the American College of Physicians/American College of Cardiology Foundation/American Heart Association/American Association for Thoracic Surgery/Preventive Cardiovascular Nurses Association/Society of Thoracic Surgeons</title><secondary-title>Ann Intern Med</secondary-title></titles><periodical><full-title>Ann Intern Med</full-title></periodical><pages>735-43</pages><volume>157</volume><number>10</number><edition>2012/11/21</edition><keywords><keyword>Angina Pectoris/therapy</keyword><keyword>Exercise Therapy</keyword><keyword>Humans</keyword><keyword>Myocardial Infarction/mortality/prevention & control</keyword><keyword>Myocardial Ischemia/complications/mortality/ therapy</keyword><keyword>Myocardial Revascularization</keyword><keyword>Patient Education as Topic</keyword><keyword>Risk Factors</keyword><keyword>Risk Reduction Behavior</keyword></keywords><dates><year>2012</year><pub-dates><date>Nov 20</date></pub-dates></dates><isbn>1539-3704 (Electronic)
0003-4819 (Linking)</isbn><accession-num>23165665</accession-num><urls></urls><electronic-resource-num>10.7326/0003-4819-157-10-201211200-00011</electronic-resource-num><remote-database-provider>NLM</remote-database-provider><language>eng</language></record></Cite></EndNote>21 If dual antiplatelet therapy is discontinued prematurely, the risk of stent thrombosis is increased dramatically. Stent thrombosis is associated with a mortality rate of 20—45 per cent.PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5GaWhuPC9BdXRob3I+PFllYXI+MjAxMjwvWWVhcj48UmVj
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ADDIN EN.CITE.DATA 27Patients with diabetes, impaired renal function, and acute coronary syndrome are known to be at higher risk of cardiac events post-PCI; therefore, these patients may constitute a subpopulation.Proposed MBS listingThe proposed MBS item descriptor is provided in REF _Ref283284346 \h Table 2. The proposed schedule fee is based on MBS item 38241 (use of a coronary pressure wire during selective coronary angiography to measure fractional flow reserve (FFR) and coronary flow reserve in one or more intermediate coronary artery or graft lesions…) which most closely resembles IVUS in terms of complexity and time. The fee for item 38241 is $469.70 as of March 2014.Table SEQ Table \* ARABIC 2:Proposed MBS item descriptor for Intravascular Ultrasound-guided PCI with stent insertionCategory 3 – Therapeutic ProceduresMBS xxxxxSelective Coronary Intravascular Ultrasound (IVUS), placement of IVUS catheter into the native coronary arteries, associated with the service to which item 38306 appliesMultiple Services Rule(Anaes.)Fee: $469.70 Benefit: 75% = $352.30 85% = $399.25[Relevant explanatory notes]Fee only payable when the service is provided in association with insertion of coronary stent/s (item 38306)The number of coronary stent insertions performed using MBS item 38306 in the period 2008—2012 is provided in REF _Ref389561528 \h Appendix B. The proposed service is not expected to impact the natural growth in utilisation for coronary stent insertion.PASC agreed that the creation of two MBS items may be warranted: one item for the initial insertion of a stent under guidance of IVUS; and a second item a subgroup of patients who will require stent insertion at a subsequent occasion under guidance of IVUS. This should be resolved at the assessment stage. Clinical place for proposed interventionThe current clinical pathway up to the point at which the intervention is provided is generally accepted in Australian clinical practice and is not expected to change with the introduction of IVUS. The rationale for the use of IVUS at the time of stenting arises from limitations of coronary angiography in terms of assessing the severity of coronary stenosis. ADDIN EN.CITE <EndNote><Cite><Author>Lotfi</Author><Year>2014</Year><RecNum>21</RecNum><DisplayText><style face="superscript">28</style></DisplayText><record><rec-number>21</rec-number><foreign-keys><key app="EN" db-id="eadep9r2s52txne05xsv9adp2efrwfxva5xf">21</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Lotfi, A.</author><author>Jeremias, A.</author><author>Fearon, W. F.</author><author>Feldman, M. D.</author><author>Mehran, R.</author><author>Messenger, J. C.</author><author>Grines, C. L.</author><author>Dean, L. S.</author><author>Kern, M. J.</author><author>Klein, L. W.</author></authors></contributors><auth-address>Baystate Medical Center, Springfield, Massachusetts.</auth-address><titles><title>Expert consensus statement on the use of fractional flow reserve, intravascular ultrasound, and optical coherence tomography: A consensus statement of the society of cardiovascular angiography and interventions</title><secondary-title>Catheter Cardiovasc Interv</secondary-title></titles><periodical><full-title>Catheter Cardiovasc Interv</full-title></periodical><pages>509-18</pages><volume>83</volume><number>4</number><edition>2013/11/15</edition><dates><year>2014</year><pub-dates><date>Mar 1</date></pub-dates></dates><isbn>1522-726X (Electronic)
1522-1946 (Linking)</isbn><accession-num>24227282</accession-num><urls></urls><electronic-resource-num>10.1002/ccd.25222</electronic-resource-num><remote-database-provider>NLM</remote-database-provider><language>eng</language></record></Cite></EndNote>28The current and proposed decision-making algorithms are shown in Figures 3 and 4.Figure SEQ Figure \* ARABIC 3: The current clinical decision algorithm for patients indicated for coronary stent insertionPatients indicated for PCI with stent insertion?Diagnostic angiography?Stent insertion at a separate occasion under guidance of angiographyStent insertion at a separate occasion under guidance of angiography Simultaneous stent insertion under guidance of angiography “High-risk” patients§Low/medium risk patientsSimultaneous stent insertion under guidance of angiography Patients indicated for PCI with stent insertion?Diagnostic angiography?Stent insertion at a separate occasion under guidance of angiographyStent insertion at a separate occasion under guidance of angiography Simultaneous stent insertion under guidance of angiography “High-risk” patients§Low/medium risk patientsSimultaneous stent insertion under guidance of angiography ? Patients with acute coronary syndrome – STEMI, NSTEMI with higher risk of a cardiac event, unstable angina, stable angina who fail medical therapy or who have silent myocardial ischemia may be indicated for PCI/stenting as an elective, ad hoc or emergency procedure. Patients may undergo initial stent insertion, or re-stenting or assessment for other interventions if there are complications or failure of the stent.? Diagnostic angiography may be performed in addition to the functional assessments (e.g. fractional flow reserve) of coronary arteries. § “High-risk” patients are identified based on their coronary anatomy, and the type and complexity of coronary lesions. They may include patients with coronary lesions that are intermediate in severity, especially when located in the left main coronary stem, patients undergoing complex coronary interventional procedures of ostial, coronary bifurcation, chronic total occlusions and lesions that are moderate to severely calcified, patients with challenging coronary anatomy, and patients who previously received a stent/s to identify underlying pathology for complications.Figure SEQ Figure \* ARABIC 4: The proposed clinical decision algorithm for patients indicated for coronary stent insertionStent insertion at a separate occasion under guidance of angiography and IVUSStent insertion at a separate occasion under guidance of angiographySimultaneous stent insertion under guidance of angiography and IVUS“High-risk” patients§Patients indicated for PCI with stent insertion?Diagnostic angiography?Low/medium risk patientsSimultaneous stent insertion under guidance of angiographyStent insertion at a separate occasion under guidance of angiography and IVUSStent insertion at a separate occasion under guidance of angiographySimultaneous stent insertion under guidance of angiography and IVUS“High-risk” patients§Patients indicated for PCI with stent insertion?Diagnostic angiography?Low/medium risk patientsSimultaneous stent insertion under guidance of angiography? Patients with acute coronary syndrome – STEMI, NSTEMI with higher risk of a cardiac event, unstable angina, stable angina who fail medical therapy or who have silent myocardial ischemia may be indicated for PCI/stenting as an elective, ad hoc or emergency procedure. Patients may undergo initial stent insertion, or re-stenting or assessment for other interventions if there are complications or failure of the stent.? Diagnostic angiography may be performed in addition to the functional assessments (e.g. fractional flow reserve) of coronary arteries.§ “High-risk” patients are identified based on their coronary anatomy, and the type and complexity of coronary lesions. They may include patients with coronary lesions that are intermediate in severity, especially when located in the left main coronary stem, patients undergoing complex coronary interventional procedures of ostial, coronary bifurcation, chronic total occlusions and lesions that are moderate to severely calcified, patients with challenging coronary anatomy, and patients who previously received a stent/s to identify underlying pathology for paratorInvasive coronary angiography without IVUS is the comparator for the proposed intervention, because angiography is predominantly used in Australian clinical practice to guide PCI with stenting.PASC acknowledged that whilst CTCA and MRCA may be used to diagnose coronary stenosis, coronary interventions are guided only by invasive coronary X-ray angiography which should be used as the comparator. The types of angiography reported in the evidence and the types of angiography in use in Australia should be provided in the assessment.Other imaging modalities, for example FFR and optical coherence tomography (OCT), are sometimes used when conducting PCI. FFR provides a functional assessment of stenosis significance. ADDIN EN.CITE <EndNote><Cite><Author>Christou</Author><Year>2007</Year><RecNum>24</RecNum><DisplayText><style face="superscript">29</style></DisplayText><record><rec-number>24</rec-number><foreign-keys><key app="EN" db-id="eadep9r2s52txne05xsv9adp2efrwfxva5xf">24</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Christou, M. A.</author><author>Siontis, G. C.</author><author>Katritsis, D. G.</author><author>Ioannidis, J. P.</author></authors></contributors><auth-address>Clinical and Molecular Epidemiology Unit, Department of Hygiene and Epidemiology, University of Ioannina School of Medicine, Ioannina, Greece.</auth-address><titles><title>Meta-analysis of fractional flow reserve versus quantitative coronary angiography and noninvasive imaging for evaluation of myocardial ischemia</title><secondary-title>Am J Cardiol</secondary-title></titles><periodical><full-title>Am J Cardiol</full-title></periodical><pages>450-6</pages><volume>99</volume><number>4</number><edition>2007/02/13</edition><keywords><keyword>Blood Flow Velocity</keyword><keyword>Coronary Angiography/ methods</keyword><keyword>Coronary Circulation</keyword><keyword>Diagnostic Imaging</keyword><keyword>Humans</keyword><keyword>Myocardial Ischemia/ radiography</keyword><keyword>ROC Curve</keyword><keyword>Sensitivity and Specificity</keyword></keywords><dates><year>2007</year><pub-dates><date>Feb 15</date></pub-dates></dates><isbn>0002-9149 (Print)
0002-9149 (Linking)</isbn><accession-num>17293182</accession-num><urls></urls><electronic-resource-num>10.1016/j.amjcard.2006.09.092</electronic-resource-num><remote-database-provider>NLM</remote-database-provider><language>eng</language></record></Cite></EndNote>29 It is useful as a diagnostic modality to identify whether a lesion should be treated with stent placement due to restricted blood flow. It does not assist with stent selection or placement and is not useful following stent placement to confirm stent position or apposition. OCT provides high resolution images but has limited depth penetration through the vessel wall, and is an emerging imaging modality with limited clinical evidence ADDIN EN.CITE <EndNote><Cite><Author>Lotfi</Author><Year>2014</Year><RecNum>21</RecNum><DisplayText><style face="superscript">28</style></DisplayText><record><rec-number>21</rec-number><foreign-keys><key app="EN" db-id="eadep9r2s52txne05xsv9adp2efrwfxva5xf">21</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Lotfi, A.</author><author>Jeremias, A.</author><author>Fearon, W. F.</author><author>Feldman, M. D.</author><author>Mehran, R.</author><author>Messenger, J. C.</author><author>Grines, C. L.</author><author>Dean, L. S.</author><author>Kern, M. J.</author><author>Klein, L. W.</author></authors></contributors><auth-address>Baystate Medical Center, Springfield, Massachusetts.</auth-address><titles><title>Expert consensus statement on the use of fractional flow reserve, intravascular ultrasound, and optical coherence tomography: A consensus statement of the society of cardiovascular angiography and interventions</title><secondary-title>Catheter Cardiovasc Interv</secondary-title></titles><periodical><full-title>Catheter Cardiovasc Interv</full-title></periodical><pages>509-18</pages><volume>83</volume><number>4</number><edition>2013/11/15</edition><dates><year>2014</year><pub-dates><date>Mar 1</date></pub-dates></dates><isbn>1522-726X (Electronic)
1522-1946 (Linking)</isbn><accession-num>24227282</accession-num><urls></urls><electronic-resource-num>10.1002/ccd.25222</electronic-resource-num><remote-database-provider>NLM</remote-database-provider><language>eng</language></record></Cite></EndNote>28, and not routinely used in Australian clinical practice. For the purposes of this protocol, OCT and FFR are not comparators.Clinical claimUse of IVUS to guide PCI with coronary stents insertion is expected to enhance post-procedure clinical outcomes. The intervention is expected to be superior in terms of effectiveness, and non-inferior in terms of safety compared to guidance with angiography without IVUS ( REF _Ref283288109 \h Table 3).In an unknown proportion of (elective) stent insertions an IVUS assisted intervention may be considered to be necessary following angiography by a non-IVUS cardiologist. This will involve additional consultation and procedure costs to the MBS for an IVUS cardiologist at a later time to perform IVUS guided stent insertion. PASC agreed that the economic evaluation should consider stenting during a single procedure and during a second procedure, for example when the initial stent insertion is attempted by a non-IVUS credentialled cardiologist.Table SEQ Table \* ARABIC 3:Classification of an intervention for determination of economic evaluation to be presentedComparative effectiveness versus comparatorSuperiorNon-inferiorInferiorComparative safety versus comparatorSuperiorCEA/CUACEA/CUANet clinical benefitCEA/CUANeutral benefitCEA/CUA*Net harmsNone^Non-inferiorCEA/CUACEA/CUA*None^InferiorNet clinical benefitCEA/CUANone^None^Neutral benefitCEA/CUA*Net harmsNone^Abbreviations: CEA = cost-effectiveness analysis; CUA = cost-utility analysis*May be reduced to cost-minimisation analysis. Cost-minimisation analysis should only be presented when the proposed service has been indisputably demonstrated to be no worse than its main comparator(s) in terms of both effectiveness and safety, so the difference between the service and the appropriate comparator can be reduced to a comparison of costs. In most cases, there will be some uncertainty around such a conclusion (i.e. the conclusion is often not indisputable). Therefore, when an assessment concludes that an intervention was no worse than a comparator, an assessment of the uncertainty around this conclusion should be provided by presentation of cost-effectiveness and/or cost-utility analyses.^No economic evaluation needs to be presented; MSAC is unlikely to recommend government subsidy of this intervention.Outcomes and health care resources affected by introduction of proposed interventionOutcomesEffectivenessPrimary effectiveness outcomelate stent thrombosis/restenosisSecondary effectiveness outcomeshealth-related quality of lifesurvivalmajor adverse cardiac events (MACE (e.g. revascularisation, myocardial infarction, sudden cardiac death)target lesion/vessel revascularisation (TLR/TVR)anginaWhere data permits, the clinical outcomes should be assessed separately for left main coronary artery (LMCA) disease and non-LMCA disease.PASC acknowledged that there is no standard definition for MACE, which may compromise comparison and interpretation of MACE endpoints across trials. The assessment should assess and report the relevance of MACE endpoints.SafetyAny adverse events or complications that occur as a result of the use of the intervention should be considered a safety concern. They include any untoward medical condition that results in mortality, was life threatening, required hospitalisation, or prolongation of existing hospitalisation, or resulted in persistent or significant disability.Health care resourcesA patient is likely to require IVUS only once during their lifetime. Approximately 4,500 patients would utilise the proposed service during the first fully funded provisional year. Currently, 3,000 patients are being treated using IVUS. With physician reimbursement to provide the service, an increase of approximately 50 per cent is expected in the number of patients who are treated using IVUS. This population is not expected to grow, as the PCI rate in Australia is currently steady.Various capital and incremental cost components are involved. Capital costs associated with IVUS include purchase price of IVUS Generator and its maintenance. Currently, a portable IVUS machine costs approximately $150,000. Associated incremental costs are associated with the cost of consumables, staff, hospitalisation and medication ( REF _Ref382400247 \h Table 4).Consumables and prosthesesThe cost of consumables associated with an IVUS procedure is between $1,000 and $1,500, which includes the IVUS catheter. Use of IVUS is not expected to change the other consumables and prostheses (e.g. stents, catheters, wires) used in the stent placement procedure. Details of these costs are available at the Department of Health’s National Hospital Cost Data Collection. A more detailed breakdown of capital costs associated with the proposed medical service will be required at the assessment phase.Table SEQ Table \* ARABIC 4: Calculation of average capital costs per procedureItemCost $AUSLifeAnnual cost $AUS/machine (range)Generator150,000818,750Forgone capital return4% of $150,000Annual$6,000Maintenance$1,940Annual$1,940Total opportunity cost of capital--$26,690Average cost based on current procedures/machines/year-3,000$9Average cost based on expected procedures/machines/year-4,500$6StaffThe same health professionals who insert coronary stents would perform the IVUS service. This would typically be an interventional cardiologist who is also credentialled to perform IVUS. Where the need for IVUS guidance is identified after a stent insertion attempted by a non-IVUS credentialled cardiologist, additional consultation and procedure costs to the MBS would be incurred by an additional procedure undertaken by an IVUS accredited cardiologist. The typical time taken to perform the service by an experienced cardiologist is 10–15 minutes (intra-operative component). No pre-service or post-service components are involved. The proposed service does not change the current standard of care.Other personnel involved include a circulating nurse, scrub nurse, technician (registrar), radiographer and radiologist. The attendance of an anaesthetist is required for the duration of the procedure ( REF _Ref382400217 \h Table 5).Table SEQ Table \* ARABIC 5: Staff costsItemDescriptionFeeCirculating nurseNurse assistant – experienced – $724.50 per week$19.07 per hourTheatre/scrub nurseRegistered theatre nurse (RN) – Level 4 Grade 3 – $1366.70 per week$35.97 per hourTechnician (registrar)Queensland Health registrar – Level 4 – $105,148 per annum$53.21 per hourRadiographerNSW Health Employees' Medical Radiation Scientists (State) Award – Level 4 – $1,964.90 per week$51.69 per hourResources: APNA ADDIN EN.CITE <EndNote><Cite><Author>APNA</Author><Year>2014</Year><RecNum>25</RecNum><DisplayText><style face="superscript">30</style></DisplayText><record><rec-number>25</rec-number><foreign-keys><key app="EN" db-id="eadep9r2s52txne05xsv9adp2efrwfxva5xf">25</key></foreign-keys><ref-type name="Web Page">12</ref-type><contributors><authors><author>APNA</author></authors></contributors><titles><title>APNA Salary and Conditions </title></titles><dates><year>2014</year></dates><publisher>Australian Primary Health Care Nurses Association </publisher><urls><related-urls><url>, Queensland Health ADDIN EN.CITE <EndNote><Cite><Author>Queensland Health</Author><Year>2014</Year><RecNum>26</RecNum><DisplayText><style face="superscript">31</style></DisplayText><record><rec-number>26</rec-number><foreign-keys><key app="EN" db-id="eadep9r2s52txne05xsv9adp2efrwfxva5xf">26</key></foreign-keys><ref-type name="Web Page">12</ref-type><contributors><authors><author>Queensland Health,</author></authors></contributors><titles><title>Queensland Health Medical Officers’ Classification Structure</title></titles><volume>2014</volume><number>05/03</number><dates><year>2014</year></dates><publisher>Queensland Health,</publisher><urls><related-urls><url>, NSW Government Health ADDIN EN.CITE <EndNote><Cite><Author>NSW Government</Author><Year>2013</Year><RecNum>27</RecNum><DisplayText><style face="superscript">32</style></DisplayText><record><rec-number>27</rec-number><foreign-keys><key app="EN" db-id="eadep9r2s52txne05xsv9adp2efrwfxva5xf">27</key></foreign-keys><ref-type name="Web Page">12</ref-type><contributors><authors><author>NSW Government,</author></authors></contributors><titles><title>NSW Radiographer Award Wages </title></titles><volume>2013</volume><number>02/02</number><dates><year>2013</year></dates><publisher>NSW Government,
</publisher><urls><related-urls><url> </url></related-urls></urls><custom1>2013</custom1><custom2>02/02</custom2></record></Cite></EndNote>32Hospitalisation related costs Hospital admission and medication related costs can be calculated based on TGA, PBS and MBS data ( REF _Ref381883337 \h Table 6 and REF _Ref381883428 \h Table 7).Table SEQ Table \* ARABIC 6: Hospital admissionsResourceReferencesInitial PCI with AngiographyAR-DRGRevascularisation with PCI (no MI)AR-DRGRevascularisation with CABG (no MI)AR-DRGMyocardial infarction (no revascularisation)AR-DRGMyocardial infarction with PCIAR-DRGMyocardial infarction with CABGAR-DRGTable SEQ Table \* ARABIC 7: Medical managementResourceReferencesMedical treatment post-MIPharmaceutical Benefits Schedule and Medicare Benefits ScheduleOther direct costs include:ward medical - $30 (estimated from DRG F15Z)ward nursing - $214 (estimated from DRG F15Z)non clinical salaries - $81 (estimated from DRG F15Z)pathology - $5 (estimated from DRG F15Z)imaging (X-ray) - $6 (estimated from DRG F15Z)allied health - $12 (estimated from DRG F15Z) pharmacy - $71 (estimated from DRG F15Z)critical care unit - $1,008 (estimated from DRG F15Z)operating room - $564 (estimated from DRG F15Z)emergency department - $36 (estimated from DRG F15Z)supplies - $51 (estimated from DRG F15Z)specialist procedure suites - $1,190 (estimated from DRG F15Z)prostheses - $5,291 (estimated from DRG F15Z) BMS and DES will be modelled separatelyon-costs - $282 (estimated from DRG F15Z)hotel - $352 (estimated from DRG F15Z)depreciation - $406 (estimated from DRG F15Z)payroll tax - $23 (estimated from DRG F15Z)no of hospitals - $41 (estimated from DRG F15Z).The following MBS items are appropriate for use during the procedure and will be considered in the cost-effectiveness analysis for IVUS in addition to angiography:MBS Item 22025: intra-arterial cannulation when performed in association with the administration of anaesthesia.MBS Item 11600: blood pressure monitoring.MBS Item 38246: coronary angiography.Table SEQ Table \* ARABIC 8:Healthcare resources to be considered in the decision analysisProviderSettingResourceDetails / Cost?UnitsPre-procedure resources used to for the current and proposed interventionInitial consultationCardiologistSurgery or hospitalMBS item 110Fee: $150.90 Benefits: 75%=$113.20 85%=$128.30112 lead ECGCardiologistSurgery or hospitalMBS item 11700Fee: $31.25 Benefits: 75%=$23.45 85%=$26.601Chest X-rayCardiologistSurgery or hospitalMBS Item 58503Fee: $47.15 Benefit: 75%=$35.40 85%=$40.101PathologyPathologistSurgery or hospitalMBS item 65070Fee: $16.95 Benefit: 75%=12.75 85%=$14.451Pathology – quantitationPathologistSurgery or hospitalMBS item 66512Fee: $17.70 Benefit: 75%=13.30 85%=$15.051Resources used to deliver the current and proposed interventionSubsequent consultationCardiologistHospitalMBS item 116Fee: $75.50 Benefit: 75%=$56.651Initial consultationAnaesthetistHospitalMBS item 110Fee: $150.90 Benefit: 75%=$113.20112 lead ECGCardiologistHospitalMBS item 11700Fee: $31.25 Benefit: 75%=$23.451Blood pressure monitoringAnaesthetistHospitalMBS Item 11600Fee: $69.30 Benefit: 75%=$52.001Intraarterial cannulationAnaesthetistHospitalMBS Item 22025Fee: $79.20 Benefit: 75%=$59.401Initiation of anaesthesiaAnaesthetistHospitalMBS item 21941Fee: $138.60 Benefit: 75%=$103.951Anaesthesia (1 hour)AnaesthetistHospitalMBS item 23043Fee: $79.20 Benefit: 75%=$59.401AngiographyCardiologistHospitalMBS item 38246Fee: $887.20 Benefit: 75%=$665.401FluoroscopyCardiologistHospitalMBS item 59925Fee: $362.45 Benefit: 75%=$271.851Stent insertionCardiologistHospitalMBS item 38306Fee: $762.35 Benefit: 75%=$571.801Hospital costsHospitalHospital EpisodeAR-DRG Weighted AveAccommodation, nursing, allied health1Additional resources used to deliver the proposed interventionProposed item fee for IVUSCardiologistHospitalBased on item 38241 coronary pressure wireFee: $460.95 Benefit: 75%=352.301EquipmentCapital costHospitalLife: 8 years$150,0001IVUS CatheterConsumableHospitalList Price$1,000 - $1,5001Follow-up resources used to for the current and proposed interventionSubsequent consultationCardiologistPre-dischargeMBS item 116Fee: $75.50 Benefit: 75%=$56.651Chest X-rayCardiologistPre-dischargeMBS Item 58503Fee: $47.15 Benefit: 75%=$35.40 85%=$40.101Incident cost of MI without revascularisationHospitalAdverse EventAR-DRG Weighted AveTBDIncident cost of MI with PCIHospitalAdverse EventAR-DRG Weighted AveTBDIncident cost of MI with CABGHospitalAdverse EventAR-DRG Weighted AveTBDIncident cost of revascularisation with PCIHospitalAdverse EventAR-DRG Weighted AveTBDIncident cost of revascularisation with CABGHospitalAdverse EventAR-DRG Weighted AveTBDPost-MI medical costsPharmacyAdverse EventPBS and MBSTBDAR-DRG: Australian refined diagnosis-related groups; MBS: Medicare Benefits Schedule; TBD: to be determined; PCI: percutaneous coronary intervention; CABG: coronary artery bypass graft; MI: myocardial infarction: IVUS: intravascular ultrasound.? MBS fees and benefits as at 1 March 2014Proposed structure of economic evaluation (decision-analytic)Given the chronic nature of the condition under study and the impact of patient attributes on the model output, an individual-based model is recommended.. Two extended PICOs are proposed: the first for patients undergoing initial stent placement (Table 9); the second for patients requiring re-stenting or other interventions following a complication or failure of the initial stent ( REF _Ref398624867 \h Table 10). Table SEQ Table \* ARABIC 9: Summary of extended PICO to define research questions that assessment will investigate – PCI with stent placementPatientsInterventionComparatorOutcomes to be assessedHealthcare resources to be consideredPatients eligible for coronary revascularisation and undergoing PCI with coronary stent insertion at the time of initial stent placement.Sub-population: Patients deemed “high-risk” based on their coronary anatomy, lesion type and complexity.a They may include patients with: intermediate left main coronary stenoses; complex coronary lesions (e.g. ostial or bifurcation lesions, calcified lesions, chronic total occlusions); challenging coronary anatomy (e.g. coronary artery ectasia, giant coronary arteries, hazy coronary lesions).Coronary stent insertion guided by IVUS and invasive coronary angiographybCoronary stent insertion guided by invasive coronary angiographyb without IVUSEffectivenessPrimary effectivenessLate stent thrombosis/ restenosisSecondary effectivenessHealth-related quality of lifeSurvivalMACEc (e.g. revascularisation, myocardial infarction, sudden cardiac death)Target lesion/vessel revascularisation (TLR/TVR)AnginaSafetyAny adverse events or complications that occur as a result of the use of the intervention should be considered as a safety concern.Where data permits, the clinical outcomes should be assessed separately:- for left main coronary artery (LMCA) disease and non-LMCA disease,- for types of stents (e.g. BMS, DES)dSee Table 8BMS: bare metal stent; DES: drug-eluting stent; MACE: major adverse cardiac events; PCI: percutaneous coronary intervention; IVUS: intravascular ultrasounda Patients with diabetes, impaired renal function, and acute coronary syndrome may also be at higher risk of cardiac events post-PCI. b The assessment should report the type of angiography used (e.g. X-ray, CT, MRI, hybrid) and explain its relevance to Australian clinical practice.c There is no standard definition for MACE, which may compromise comparison and interpretation of MACE endpoints across trials. The assessment should assess the relevance of MACE endpoints. d Typically BMS and DES are used in specific patient populations with different risks and clinical indications.Table SEQ Table \* ARABIC 10: Summary of extended PICO to define research questions that assessment will investigate – following a complication or failure of the stent requiring re-stenting or other interventionsPatientsInterventionComparatorOutcomes to be assessedHealthcare resources to be consideredPatients eligible for coronary revascularisation and undergoing PCI with coronary stent insertion following a complication or failure of the stent requiring re-stenting or other interventions.Sub-population: Patients deemed “high-risk” based on their coronary anatomy, lesion type and complexity.a They may include patients with: intermediate left main coronary stenoses; complex coronary lesions (e.g. ostial or bifurcation lesions, calcified lesions, chronic total occlusions); challenging coronary anatomy (e.g. coronary artery ectasia, giant coronary arteries, hazy coronary lesions); andprevious stents.Coronary stent insertion guided by IVUS and invasive coronary angiographybCoronary stent insertion guided by invasive coronary angiographyb without IVUSEffectivenessPrimary effectivenessLate stent thrombosis/ restenosisSecondary effectivenessHealth-related quality of lifeSurvivalMACEc (e.g. revascularisation, myocardial infarction, sudden cardiac death)Target lesion/vessel revascularisation (TLR/TVR)AnginaSafetyAny adverse events or complications that occur as a result of the use of the intervention should be considered as a safety concern.Where data permits, the clinical outcomes should be assessed separately: - for left main coronary artery (LMCA) disease and non-LMCA disease, - for types of stents (e.g. BMS, DES).dSee Table 8BMS: bare metal stent; DES: drug-eluting stent; MACE: major adverse cardiac events; PCI: percutaneous coronary intervention; IVUS: intravascular ultrasounda Patients with diabetes, impaired renal function, and acute coronary syndrome may also be at higher risk of cardiac events post-PCI.b The assessment should report the type of angiography used (e.g. X-ray, CT, MRI, hybrid) and explain its relevance to Australian clinical practice.c There is no standard definition for MACE, which may compromise comparison and interpretation of MACE endpoints across trials. The assessment should assess the relevance of MACE endpoints. d Typically BMS and DES are used in specific patient populations with different risks and clinical indications.Research questionsPrimary research questionsFor patients undergoing PCI with stent insertion, what is the safety of IVUS in addition to angiography compared with angiography without IVUS?For patients undergoing PCI with stent insertion, what is the effectiveness of IVUS in addition to angiography compared with angiography without IVUS?For patients undergoing PCI with stent insertion, what is the cost-effectiveness of IVUS in addition to angiography compared with angiography without IVUS?The assessment should address these questions in line with the two populations defined in Table 9 and Table 10.Fee, cost and financial impact modelling: In an unknown proportion of (elective) stent insertions an IVUS assisted intervention may be considered to be necessary following angiography by a non-IVUS cardiologist. This will involve additional consultation and procedure costs to the MBS for an IVUS cardiologist at a later time to perform IVUS guided stent insertion. The assessment should test the impact of this in the economic modelling.Appendix A: AIHW Hospital morbidity dataTable SEQ Table \* ARABIC 11:Annual growth rate in hospital separations for ischemic heart diseases ADDIN EN.CITE <EndNote><Cite><Author>AIHW</Author><Year>2014</Year><RecNum>11</RecNum><DisplayText><style face="superscript">20</style></DisplayText><record><rec-number>11</rec-number><foreign-keys><key app="EN" db-id="eadep9r2s52txne05xsv9adp2efrwfxva5xf">11</key></foreign-keys><ref-type name="Web Page">12</ref-type><contributors><authors><author>AIHW</author></authors></contributors><titles><title>Hospital data: principal diagnosis data cubes </title></titles><volume>2014</volume><number>03/03</number><dates><year>2014</year></dates><pub-location>Canberra</pub-location><publisher>Australian Institute of Health and Welfare </publisher><urls><related-urls><url> of separations2004—052005—062006—072007—082008—092009—10I20 Angina pectoris80,22977,24275,10971,80166,31265,158I21 Acute myocardial infarction47,63349,53451,66755,67655,23355,003I22 Subsequent myocardial infarction290294310321197216I23 Certain current complications following acute myocardial infarction22232845173112I24 Other acute ischemic heart disease376391363307340351I 25 Chronic ischemic heart disease33,73333,88334,85133,26732,55332,993Total1,62,2831,61,3671,62,3281,61,4171,54,8081,53,833Change from previous year--0.56%0.60%-0.56%-4.09%-0.63%ICD-10-AM: Australian modification of the WHO International classification of diseases – version 2010Source: AIHW ADDIN EN.CITE <EndNote><Cite><Author>AIHW</Author><Year>2014</Year><RecNum>11</RecNum><DisplayText><style face="superscript">20</style></DisplayText><record><rec-number>11</rec-number><foreign-keys><key app="EN" db-id="eadep9r2s52txne05xsv9adp2efrwfxva5xf">11</key></foreign-keys><ref-type name="Web Page">12</ref-type><contributors><authors><author>AIHW</author></authors></contributors><titles><title>Hospital data: principal diagnosis data cubes </title></titles><volume>2014</volume><number>03/03</number><dates><year>2014</year></dates><pub-location>Canberra</pub-location><publisher>Australian Institute of Health and Welfare </publisher><urls><related-urls><url> SEQ Table \* ARABIC 12:Hospital separations for surgical procedures of the cardiovascular system, classified using the Australian refined diagnosis-related groups AR-DRGNumber of separations2004—052005—062006—072007—082008—092009—10F10Z Percutaneous coronary intervention with acute myocardial infarction10,72111,84912,86313,55313,76514,499F15Z Percutaneous coronary intervention (without acute myocardial infarction), with stent implantation20,41720,68220,13618,84218,92819,037Source: AIHW ADDIN EN.CITE <EndNote><Cite><Author>AIHW</Author><Year>2014</Year><RecNum>11</RecNum><DisplayText><style face="superscript">19, 20</style></DisplayText><record><rec-number>11</rec-number><foreign-keys><key app="EN" db-id="eadep9r2s52txne05xsv9adp2efrwfxva5xf">11</key></foreign-keys><ref-type name="Web Page">12</ref-type><contributors><authors><author>AIHW</author></authors></contributors><titles><title>Hospital data: principal diagnosis data cubes </title></titles><volume>2014</volume><number>03/03</number><dates><year>2014</year></dates><pub-location>Canberra</pub-location><publisher>Australian Institute of Health and Welfare </publisher><urls><related-urls><url> app="EN" db-id="eadep9r2s52txne05xsv9adp2efrwfxva5xf">12</key></foreign-keys><ref-type name="Web Page">12</ref-type><contributors><authors><author>AIHW</author></authors></contributors><titles><title>Hospital data: Australian refined diagnosis-related groups (AR-DRG) data cubes </title></titles><volume>2014</volume><number>03/03</number><dates><year>2014</year></dates><publisher>Australian Institute of Health and Welfare </publisher><urls><related-urls><url>, 20Table SEQ Table \* ARABIC 13:Hospital separations for coronary artery procedures, classified using the Australian Classification of Health Interventions ACHINumber of separations2004—052005—062006—072007—082008—092009—10667 cardiac catheterisation1,1001,0781,0571,1051,1281,262670 Transluminal coronary angioplasty2,1622,2162,1742,2752,4182,333671 Transluminal coronary angioplasty with stenting32,52933,84934,04733,32533,88434,705Source: AIHW ADDIN EN.CITE <EndNote><Cite><Author>AIHW</Author><Year>2014</Year><RecNum>12</RecNum><DisplayText><style face="superscript">19</style></DisplayText><record><rec-number>12</rec-number><foreign-keys><key app="EN" db-id="eadep9r2s52txne05xsv9adp2efrwfxva5xf">12</key></foreign-keys><ref-type name="Web Page">12</ref-type><contributors><authors><author>AIHW</author></authors></contributors><titles><title>Hospital data: Australian refined diagnosis-related groups (AR-DRG) data cubes </title></titles><volume>2014</volume><number>03/03</number><dates><year>2014</year></dates><publisher>Australian Institute of Health and Welfare </publisher><urls><related-urls><url> SEQ Table \* ARABIC 14: Hospital separations for transluminal coronary angioplasty with stenting, classified using the Australian Classification of Health Interventions ACHINumber of separations2004—052005—062006—072007—082008—092009—10Percutaneous insertion of 1 transluminal stent into single coronary artery21,22721,69522,27322,40022,75423,618Percutaneous insertion of >= 2 transluminal stents into single coronary artery6,2696,8126,7676,7126,6806,717Percutaneous insertion of >= 2 transluminal stents into multiple coronary arteries5,0195,3274,9954,2074,4334,347Open insertion of 1 transluminal stent into single coronary arteryNRNRNRNR1012NR: not reported.Source: AIHW ADDIN EN.CITE <EndNote><Cite><Author>AIHW</Author><Year>2014</Year><RecNum>12</RecNum><DisplayText><style face="superscript">19</style></DisplayText><record><rec-number>12</rec-number><foreign-keys><key app="EN" db-id="eadep9r2s52txne05xsv9adp2efrwfxva5xf">12</key></foreign-keys><ref-type name="Web Page">12</ref-type><contributors><authors><author>AIHW</author></authors></contributors><titles><title>Hospital data: Australian refined diagnosis-related groups (AR-DRG) data cubes </title></titles><volume>2014</volume><number>03/03</number><dates><year>2014</year></dates><publisher>Australian Institute of Health and Welfare </publisher><urls><related-urls><url> B: MBS items for percutaneous coronary stent insertionTable SEQ Table \* ARABIC 15: MBS item descriptors for percutaneous stent insertion, MBS item 38306Category 3 – Therapeutic ProceduresMBS 38306TRANSLUMINAL INSERTION OF STENT OR STENTS into 1 occlusional site, including associated balloon dilatation for coronary artery, percutaneous or by open exposure, excluding associated radiological services and preparation, and excluding aftercare Multiple Services Rule(Anaes.) (Assist.)Fee: $762.35Explanatory notesRefer to T8.63 (see below)T8.63 Transluminal insertion of stent or stentsItem 38306 should only be billed once per occlusional site. It is not appropriate to bill item 38306 multiple times for the insertion of more than one stent at the same occlusional site in the same artery. However, it would be appropriate to claim this item multiple times for insertion of stents into the same artery at different occlusional sites or into another artery or occlusional site. It is expected that the practitioner will note the details of the artery or site into which the stents were placed, in order for the Department of Human Services to process the claims.Table SEQ Table \* ARABIC 16: MBS item descriptors for percutaneous stent insertion, MBS item 38312Category 3 – Therapeutic ProceduresMBS 38312PERCUTANEOUS TRANSLUMINAL ROTATIONAL ATHERECTOMY of 1 coronary artery, including balloon angioplasty with insertion of 1 or more stents, where: - no lesion of the coronary artery has been stented; and - each lesion of the coronary artery is complex and heavily calcified; and - balloon angioplasty with or without stenting is not suitable; excluding associated radiological services or preparation, and excluding aftercare.Multiple Services Rule(Anaes.) (Assist.)Fee: $1,132.35Explanatory notesRefer to T8.42 (see below)Table SEQ Table \* ARABIC 17: MBS item descriptors for percutaneous stent insertion, MBS item 38318Category 3 – Therapeutic ProceduresMBS 38318PERCUTANEOUS TRANSLUMINAL ROTATIONAL ATHERECTOMY of more than 1 coronary artery, including balloon angioplasty, with insertion of 1 or more stents, where:- no lesion of the coronary arteries has been stented; and- each lesion of the coronary arteries is complex and heavily calcified; and- balloon angioplasty with or without stenting is not suitable,excluding associated radiological services or preparation, and excluding aftercareMultiple Services Rule(Anaes.) (Assist.)Fee: $1,586.35Explanatory notesRefer to T8.42 (see below)T8.42 Percutaneous Transluminal Coronary AngioplastyA coronary artery lesion is considered to be complex when the lesion is a chronic total occlusion, located at an ostial site, angulated, tortuous or greater than 1cm in length. Percutaneous transluminal coronary rotational atherectomy is suitable for revascularisation of complex and heavily calcified coronary artery stenoses in patients for whom coronary artery bypass graft surgery is contraindicated.Each of the items 38309, 38312, 38315 and 38318 describes an episode of service. As such, only one item in this range can be claimed in a single episode.Table SEQ Table \* ARABIC 18: Use of coronary stent insertion services, MBS item 38306, during 2008—2012YearTotal ServiceTotal Growth200820,780200922,3838%201022,193-1%201123,1594%201223,5142%201324,1973%Appendix C Stents and stent delivery systems listed in the prostheses list Table SEQ Table \* ARABIC 19: Stents and stent delivery systems listed in the prostheses list Billing codeProduct nameAC030Cinatra Cobalt Chromium Coronary Stent SystemAY012JoStent Coronary Stent GraftAY023Xience Everolimus Eluting Stent SystemAY028Multilink Coronary Stent System - VisionAY037 Xience PRIME LL Everolimus Eluting Coronary Stent; Xience PRIME Everolimus Eluting Coronary Stent; Xience PRIME SV Everolimus Eluting Coronary StentAY039MULTI-LINK 8 Coronary Stent System, MULTI-LINK 8 SV Coronary Stent System and MULTI-LINK 8 LL Coronary Stent SystemBE001Gazelle Coronary StentBS069Liberte Coronary Stent SystemBS175PROMUS ElementBS176Taxus ElementBS211OMEGA Bare Metal StentBS224PROMUS Element PlusBT082PRO-KineticBT107PRO-Kinetic EnergyDY534Presillion Plus CoCr Coronary Stent on RX SystemIX001Amazonia CroCoIX002Nile CroCoIX003Minvasys Nile Delta Coronary Stent SystemMC329Medtronic Driver, Micro Driver Coronary Stent SystemMC732Endeavour Drug Eluting Coronary Stent SystemMC769Endeavor Sprint Drug Eluting Stent SystemMC816Endeavor Resolute Drug Eluting Coronary Stent SystemMC932Driver Sprint Coronary Stent SystemMC956Integrity Coronary Stent SystemMI037Resolute Integrity Zotarolimus-Eluting Coronary Stent SystemNM004Azule Coronary Stent Delivery SystemTU001Tsunami GoldTU044Kaname Coronary Stent SystemReferences ADDIN EN.REFLIST 1.MSAC. 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