{"id":8303,"date":"2022-10-12T00:09:09","date_gmt":"2022-10-12T05:09:09","guid":{"rendered":"https:\/\/shockwavemedical.com\/education\/does-calcium-morphology-matter-coronary-ivl-real-world-experience-from-europe\/"},"modified":"2024-12-11T08:23:07","modified_gmt":"2024-12-11T14:23:07","slug":"does-calcium-morphology-matter-coronary-ivl-real-world-experience-from-europe","status":"publish","type":"post","link":"https:\/\/shockwavemedical.com\/en-eu\/education\/does-calcium-morphology-matter-coronary-ivl-real-world-experience-from-europe\/","title":{"rendered":"Does Calcium Morphology Matter? Coronary IVL Real World Experience from Europe"},"content":{"rendered":"\n<section id=\"block_b093e9bfbb64ff8b8202e55abfe7e307\" class=\"block block--wysiwyg wysiwyg_styles u-bgColorNone container\">\n\t<div class=\"u-wysiwyg u-animation\">\n\t\t<p>In this webcast recorded at TCT 2022, Prof. Javier Escaned and Dr. Nieves Gonzalo from Clinico San Carlos Madrid, and Dr. Angela McInerney, from University Hospital Galway, share their experience with IVL and the results from their most recent studies.<\/p>\n<p>Dr. Mclnerney discusses about the results of a multicentre prospective study conducted within 14 centres in Spain to evaluate IVL in real-world scenarios and to compare MSA post IVL in different calcium morphologies. The results show that IVL is very effective across all calcium morphologies as there was no significant difference in MSE across concentric, eccentric and nodular calcium.<\/p>\n<p>Dr. Gonzalo speaks about a multicentre study conducted in 2 large centres in Spain, with the objective of evaluating the long-term angiographic results following IVL, assess changes in MSA and study patterns of vessel healing after IVL treatment and understand the durability of the therapy. Results from this study showed that MLD and MSA are both maintained at follow up, with a low percentage of restenosis, no signs of recoil, and complete healing of the IVL-induced cracks.<\/p>\n<div class=\"video\"><iframe title=\"YouTube video player\" data-src=\"https:\/\/www.youtube.com\/embed\/68QQq4ifPD8?si=x6m5FjlR0C3b_kHH\" 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<div>\n<hr \/>\n<p><span class=\"legal_copy\">Prof. Javier Escaned, Dr. Nieves Gonzalo, and Dr. Angela Mclnerney are paid consultants for Shockwave Medical. <\/span><\/p>\n<p><span class=\"legal_copy\"><strong>Important Safety Information<\/strong> <\/span><\/p>\n<p><span class=\"legal_copy\"><strong>Coronary Important Safety Information:<\/strong> <\/span><\/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<a href=\"https:\/\/shockwavemedical.com\/IFU\">\u00a0https:\/\/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<p>\u00a0<\/p>\n<p><span class=\"legal_copy\"><strong>Peripheral Important Safety Information:<\/strong> <\/span><\/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 Medical Intravascular Lithotripsy (IVL) System is intended for lithotripsy-enhanced balloon dilatation of lesions, including calcified lesions, in the peripheral vasculature, including the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries. Not for use in the coronary or cerebral vasculature. <\/span><\/p>\n<p><span class=\"legal_copy\">Contraindications\u2014Do not use if unable to pass 0.014 guidewire across the lesion\u2014Not intended for treatment of in-stent restenosis or in coronary, carotid, or cerebrovascular arteries. Warnings\u2014Only to be used by physicians who are familiar with interventional vascular procedures\u2014Physicians must be trained prior to use of the device\u2014Use the generator in accordance with recommended settings as stated in the Operator\u2019s Manual. <\/span><\/p>\n<p><span class=\"legal_copy\">Precautions\u2014use only the recommended balloon inflation medium\u2014Appropriate anticoagulant therapy should be administered by the physician\u2014Decision regarding use of distal protection should be made based on physician assessment of treatment lesion morphology. <\/span><\/p>\n<p><span class=\"legal_copy\">Adverse effects\u2013Possible adverse effects consistent with standard angioplasty include \u2013 Access site complications \u2013 Allergy to contrast or blood thinner \u2013 Arterial bypass surgery \u2014 Bleeding complications \u2014 Death \u2014 Fracture of guidewire or device \u2014 Hypertension\/Hypotension \u2014 Infection\/sepsis \u2014 Placement of a stent \u2014 renal failure \u2014 Shock\/pulmonary edema \u2014 target vessel stenosis or occlusion \u2014 Vascular complications. Risks unique to the device and its use \u2014 Allergy to catheter material(s) \u2014 Device malfunction or failure \u2014 Excess heat at target site. <\/span><\/p>\n<p><span class=\"legal_copy\">Prior to use, please reference the Instructions for Use for more information on indications, contraindications, warnings, precautions and adverse events.\u00a0<a href=\"http:\/\/www.shockwavemedical.com\">www.shockwavemedical.com <\/a><\/span><\/p>\n<p><span class=\"legal_copy\">Please contact your local Shockwave representative for specific country availability and refer to the Shockwave S4,\u00a0Shockwave M5, and Shockwave M5+\u00a0instructions for use containing important safety information.<\/span><\/p>\n<\/div>\n<div>\n<p>\u00a0<\/p>\n<\/div>\n<p>\u00a0<\/p>\n\t<\/div>\n\t<\/section>","protected":false},"excerpt":{"rendered":"<p>Shockwave International Roundtable at TCT 2022 discussing calcium morphology.<\/p>\n","protected":false},"author":2,"featured_media":3630,"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":[183,187,195],"product-tag":[255,251],"specialty":[295,328,332,336,344],"technology":[316],"class_list":["post-8303","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","education-topic-case-reviews-en-uk","education-topic-peer-to-peer-en-uk","format-article-en-uk","format-video-en-uk","product-tag-shockwave-c2-en-uk-2","product-tag-shockwave-c2-en-uk","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\/8303","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=8303"}],"version-history":[{"count":0,"href":"https:\/\/shockwavemedical.com\/en-eu\/wp-json\/wp\/v2\/posts\/8303\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/shockwavemedical.com\/en-eu\/wp-json\/wp\/v2\/media\/3630"}],"wp:attachment":[{"href":"https:\/\/shockwavemedical.com\/en-eu\/wp-json\/wp\/v2\/media?parent=8303"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/shockwavemedical.com\/en-eu\/wp-json\/wp\/v2\/categories?post=8303"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/shockwavemedical.com\/en-eu\/wp-json\/wp\/v2\/tags?post=8303"},{"taxonomy":"disease-state","embeddable":true,"href":"https:\/\/shockwavemedical.com\/en-eu\/wp-json\/wp\/v2\/disease-state?post=8303"},{"taxonomy":"education-topic","embeddable":true,"href":"https:\/\/shockwavemedical.com\/en-eu\/wp-json\/wp\/v2\/education-topic?post=8303"},{"taxonomy":"format","embeddable":true,"href":"https:\/\/shockwavemedical.com\/en-eu\/wp-json\/wp\/v2\/format?post=8303"},{"taxonomy":"product-tag","embeddable":true,"href":"https:\/\/shockwavemedical.com\/en-eu\/wp-json\/wp\/v2\/product-tag?post=8303"},{"taxonomy":"specialty","embeddable":true,"href":"https:\/\/shockwavemedical.com\/en-eu\/wp-json\/wp\/v2\/specialty?post=8303"},{"taxonomy":"technology","embeddable":true,"href":"https:\/\/shockwavemedical.com\/en-eu\/wp-json\/wp\/v2\/technology?post=8303"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}