{"id":8615,"date":"2023-12-12T21:51:00","date_gmt":"2023-12-13T03:51:00","guid":{"rendered":"https:\/\/shockwavemedical.com\/education\/coronary-ivl-a-paradigm-shift-in-complex-pci\/"},"modified":"2024-12-11T09:26:54","modified_gmt":"2024-12-11T15:26:54","slug":"coronary-ivl-a-paradigm-shift-in-complex-pci","status":"publish","type":"post","link":"https:\/\/shockwavemedical.com\/en-eu\/education\/coronary-ivl-a-paradigm-shift-in-complex-pci\/","title":{"rendered":"Coronary IVL: A Paradigm Shift in Complex PCI"},"content":{"rendered":"\n<section id=\"block_d9cc15e316e45e411a75467349d887eb\" class=\"block block--wysiwyg wysiwyg_styles u-bgColorNone container\">\n\t<div class=\"u-wysiwyg u-animation\">\n\t\t<p><span data-contrast=\"auto\">A new publication titled \u201c<\/span><i><span data-contrast=\"auto\">Use of Calcium Modification during Percutaneous Coronary Intervention after Introduction of Coronary Intravascular Lithotripsy<\/span><\/i><span data-contrast=\"auto\">\u201d details an overall increase in the use of calcium modification tools for percutaneous coronary interventions (PCI) and a rapid uptake in the use of coronary IVL since the U.S. launch of Shockwave C<\/span><span data-contrast=\"auto\">2<\/span><span data-contrast=\"auto\">\u00a0in early 2021. The research, led by Dr. Neel Butala, Assistant Professor, Medicine-Cardiology at the University of Colorado School of Medicine, was recently\u00a0<\/span><a href=\"https:\/\/doi.org\/10.1016\/j.jscai.2023.101254\" target=\"_blank\" rel=\"noopener\"><span data-contrast=\"none\">published in the<\/span><i><span data-contrast=\"none\">\u00a0Journal of the Society for Cardiovascular Angiography and Interventions (JSCAI)<\/span><\/i><\/a><span data-contrast=\"auto\">.<\/span><\/p>\n<p><span data-contrast=\"auto\">The research analyzed data from the ACC\/NCDR\u00ae (National Cardiovascular Data Registry) CathPCI\u00ae Registry from April 2018 to December 2022 and revealed that in less than two years, coronary IVL expanded the appreciation of lesion preparation and use of calcium modification tools more broadly and has rapidly become the most used calcium modification technology in the U.S. Of the PCI cases analyzed during the second quarter of 2018, 8.7% were performed with calcium modification tools, including cutting or scoring balloon angioplasty, rotational and orbital atherectomy. By the fourth quarter of 2020, this number increased to 11.1%. By the fourth quarter of 2022, in conjunction with the U.S. commercial introduction of coronary IVL in early 2021, the use of calcium modification tools increased to 16.0% of PCI cases. In only 18 months of availability in the U.S., coronary IVL was used in 7.8% of PCI cases, while the use of atherectomy decreased from 5.4% to 4.4% of cases during the same timeframe.\u00a0<\/span><span data-ccp-props=\"{\"201341983\":0,\"335559739\":160,\"335559740\":259}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">\u201cOur research shows a rapid uptake in coronary IVL, likely driven by its safety profile and ease of use relative to atherectomy, which makes calcium modification as simple as balloon angioplasty,\u201d said Dr. Butala, the first author on the publication. \u201cI would like to thank SCAI for the opportunity to conduct this research as part of the society\u2019s Early Career Research Grants program and I look forward conducting deeper analyses into the ACC\/NCDR CathPCI Registry, particularly with respect to identifying predictors of calcium modification strategies and their correlated outcomes.\u201d<\/span><\/p>\n<div class=\"video\"><iframe title=\"YouTube video player\" data-src=\"https:\/\/www.youtube.com\/embed\/imj3LfyYhxE?si=sApznwWshoNsUNPj\" frameborder=\"0\" allowfullscreen=\"allowfullscreen\" src=\"data:image\/svg+xml;base64,PHN2ZyB3aWR0aD0iMSIgaGVpZ2h0PSIxIiB4bWxucz0iaHR0cDovL3d3dy53My5vcmcvMjAwMC9zdmciPjwvc3ZnPg==\" data-load-mode=\"1\"><span data-mce-type=\"bookmark\" style=\"display: inline-block; width: 0px; overflow: hidden; line-height: 0;\" class=\"mce_SELRES_start lazyload\">\ufeff<\/span><\/iframe><\/div>\n<p><a href=\"https:\/\/www.jscai.org\/article\/S2772-9303(23)01314-5\/fulltext\" target=\"_blank\" rel=\"noopener\">Read the Publication<\/a><\/p>\n<hr \/>\n<p><span class=\"legal_copy\">Dr. Neel Butala is a paid consultant for Shockwave Medical.<\/span><\/p>\n<p><strong><span class=\"legal_copy\">Coronary Important Safety Information:<\/span><\/strong><\/p>\n<p><span class=\"legal_copy\"> In the United States: Rx only.<\/span><\/p>\n<p><span class=\"legal_copy\"> Indications for Use\u2014The Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave C2\u00a0Coronary IVL Catheter is indicated for lithotripsy-enabled, low-pressure balloon dilatation of severely calcified, stenotic\u00a0de novo\u00a0coronary arteries prior to stenting. <\/span><\/p>\n<p><span class=\"legal_copy\">Contraindications\u2014The Shockwave C2\u00a0Coronary IVL System is contraindicated for the following: This device is not intended for stent delivery. This device is not intended for use in carotid or cerebrovascular arteries. <\/span><\/p>\n<p><span class=\"legal_copy\">Warnings\u2014 Use the IVL Generator in accordance with recommended settings as stated in the Operator\u2019s Manual. The risk of a dissection or perforation is increased in severely calcified lesions undergoing percutaneous treatment, including IVL. Appropriate provisional interventions should be readily available. Balloon loss of pressure was associated with a numerical increase in dissection which was not statistically significant and was not associated with MACE.\u00a0 Analysis indicates calcium length is a predictor of dissection and balloon loss of pressure.\u00a0 IVL generates mechanical pulses which may cause atrial or ventricular capture in bradycardic patients. In patients with implantable pacemakers and defibrillators, the asynchronous capture may interact with the sensing capabilities. Monitoring of the electrocardiographic rhythm and continuous arterial pressure during IVL treatment is required.\u00a0 In the event of clinically significant hemodynamic effects, temporarily cease delivery of IVL therapy. <\/span><\/p>\n<p><span class=\"legal_copy\">Precautions\u2014 Only to be used by physicians trained in angiography and intravascular coronary procedures. Use only the recommended balloon inflation medium. Hydrophilic coating to be wet only with normal saline or water and care must be taken with sharp objects to avoid damage to the hydrophilic coating.\u00a0Appropriate anticoagulant therapy should be administered by the physician.\u00a0Precaution should be taken when treating patients with previous stenting within 5mm of target lesion. <\/span><\/p>\n<p><span class=\"legal_copy\">Potential adverse effects consistent with standard based cardiac interventions include\u2013 Abrupt vessel closure \u2013 Allergic reaction to contrast medium, anticoagulant and\/or antithrombotic therapy-Aneurysm-Arrhythmia-Arteriovenous fistula-Bleeding complications-Cardiac tamponade or pericardial effusion-Cardiopulmonary arrest-Cerebrovascular accident (CVA)-Coronary artery\/vessel occlusion, perforation, rupture or dissection-Coronary artery spasm-Death-Emboli (air, tissue, thrombus or atherosclerotic emboli)-Emergency or non-emergency coronary artery bypass surgery-Emergency or non-emergency percutaneous coronary intervention-Entry site complications-Fracture of the guide wire or failure\/malfunction of any component of the device that may or may not lead to device embolism, dissection, serious injury or surgical intervention-Hematoma at the vascular access site(s)-Hemorrhage-Hypertension\/Hypotension-Infection\/sepsis\/fever-Myocardial Infarction-Myocardial Ischemia or unstable angina-Pain-Peripheral Ischemia-Pseudoaneurysm-Renal failure\/insufficiency-Restenosis of the treated coronary artery leading to revascularization-Shock\/pulmonary edema-Slow flow, no reflow, or abrupt closure of coronary artery-Stroke-Thrombus-Vessel closure, abrupt-Vessel injury requiring surgical repair-Vessel dissection, perforation, rupture, or spasm. Risks identified as related to the device and its use:\u00a0Allergic\/immunologic reaction to the catheter material(s) or coating-Device malfunction, failure, or balloon loss of pressure leading to device embolism, dissection, serious injury or surgical intervention-Atrial or ventricular extrasystole-Atrial or ventricular capture. <\/span><\/p>\n<p><span class=\"legal_copy\">Prior to use, please reference the Instructions for Use for more information on warnings, precautions and adverse events.\u00a0\u00a0<a href=\"https:\/\/shockwavemedical.com\/en-eu\/ifu\/\">https:\/\/shockwavemedical.com\/IFU <\/a><\/span><\/p>\n<p><span class=\"legal_copy\">Please contact your local Shockwave representative for specific country availability and refer to the Shockwave C2\u00a0instructions for use containing important safety information.<\/span><\/p>\n\t<\/div>\n\t<\/section>","protected":false},"excerpt":{"rendered":"<p>Dr. Neel Butala breaks down his findings in his article &#8220;Use of Calcium Modification during Percutaneous Coronary Intervention after Introduction of Coronary IVL&#8221;.<\/p>\n","protected":false},"author":2,"featured_media":3719,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":[203,204],"meta":{"_acf_changed":true,"content-type":"","footnotes":""},"categories":[17],"tags":[],"disease-state":[159],"education-topic":[183],"product-tag":[255],"specialty":[295,328,332,336,344],"technology":[316],"class_list":["post-8615","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-uncategorized-en-uk","disease-state-coronary-artery-disease-en-uk","education-topic-best-practices-en-uk","format-article-en-uk","format-video-en-uk","product-tag-shockwave-c2-en-uk-2","specialty-fellows-residents-en-uk","specialty-interventional-cardiologists-en-uk","specialty-interventional-radiologists-en-uk","specialty-nurses-technologists-en-uk","specialty-vascular-surgeons-en-uk","technology-coronary-ivl-en-uk"],"acf":[],"_links":{"self":[{"href":"https:\/\/shockwavemedical.com\/en-eu\/wp-json\/wp\/v2\/posts\/8615","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/shockwavemedical.com\/en-eu\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/shockwavemedical.com\/en-eu\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/shockwavemedical.com\/en-eu\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/shockwavemedical.com\/en-eu\/wp-json\/wp\/v2\/comments?post=8615"}],"version-history":[{"count":0,"href":"https:\/\/shockwavemedical.com\/en-eu\/wp-json\/wp\/v2\/posts\/8615\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/shockwavemedical.com\/en-eu\/wp-json\/wp\/v2\/media\/3719"}],"wp:attachment":[{"href":"https:\/\/shockwavemedical.com\/en-eu\/wp-json\/wp\/v2\/media?parent=8615"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/shockwavemedical.com\/en-eu\/wp-json\/wp\/v2\/categories?post=8615"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/shockwavemedical.com\/en-eu\/wp-json\/wp\/v2\/tags?post=8615"},{"taxonomy":"disease-state","embeddable":true,"href":"https:\/\/shockwavemedical.com\/en-eu\/wp-json\/wp\/v2\/disease-state?post=8615"},{"taxonomy":"education-topic","embeddable":true,"href":"https:\/\/shockwavemedical.com\/en-eu\/wp-json\/wp\/v2\/education-topic?post=8615"},{"taxonomy":"format","embeddable":true,"href":"https:\/\/shockwavemedical.com\/en-eu\/wp-json\/wp\/v2\/format?post=8615"},{"taxonomy":"product-tag","embeddable":true,"href":"https:\/\/shockwavemedical.com\/en-eu\/wp-json\/wp\/v2\/product-tag?post=8615"},{"taxonomy":"specialty","embeddable":true,"href":"https:\/\/shockwavemedical.com\/en-eu\/wp-json\/wp\/v2\/specialty?post=8615"},{"taxonomy":"technology","embeddable":true,"href":"https:\/\/shockwavemedical.com\/en-eu\/wp-json\/wp\/v2\/technology?post=8615"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}