{"id":8209,"date":"2024-01-17T11:07:00","date_gmt":"2024-01-17T17:07:00","guid":{"rendered":"https:\/\/shockwavemedical.com\/?p=8209"},"modified":"2024-12-16T10:29:06","modified_gmt":"2024-12-16T16:29:06","slug":"empower-cad-study-unveiling-the-first-european-patients-journey","status":"publish","type":"post","link":"https:\/\/shockwavemedical.com\/en-eu\/education\/empower-cad-study-unveiling-the-first-european-patients-journey\/","title":{"rendered":"EMPOWER CAD Study: Unveiling the First European Patient&#8217;s Journey"},"content":{"rendered":"\n<section id=\"block_833ad3ea684bb314dbc76e7094d298bb\" 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\">Enrollments in the EMPOWER CAD study are picking up pace! Dr Nieves Gonzalo (Hospital Cl\u00ecnico San Carlos, Madrid), the study\u2019s European lead, recently shared with the medical community the journey of her first patient included in the study.\u202f\u202f<\/span><span data-ccp-props=\"{\"134233117\":true,\"134233118\":true,\"201341983\":0,\"335551550\":6,\"335551620\":6,\"335559738\":0,\"335559739\":0,\"335559740\":240}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">In this first case, Dr Gonzalo treated an 81-year-old woman with a severely calcified LAD stenosis. The treatment decision was supported by intravascular imaging: the OCT run showed diffuse disease with more eccentric calcium in the proximal area. The lesion was treated with a 2.5mm Shockwave C2+ achieving very good balloon expansion already after 70 pulses.\u202f\u202f<\/span><span data-ccp-props=\"{\"134233117\":true,\"134233118\":true,\"201341983\":0,\"335551550\":6,\"335551620\":6,\"335559738\":0,\"335559739\":0,\"335559740\":240}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">For those not familiar with the study, EMPOWER CAD is the first prospective clinical study in the interventional space that is completely dedicated to female patients. The study wants to bridge the PCI inequality gap between females and males, with a dedicated focus on calcium modification with\u00a0IVL. The objective of the study is to provide robust data with longer-term outcomes in a larger, all-comers patient cohort. It is designed to determine whether coronary IVL should be considered the front-line calcium modification approach in female patients.\u202f<\/span><span data-ccp-props=\"{\"134233117\":true,\"134233118\":true,\"201341983\":0,\"335551550\":6,\"335551620\":6,\"335559738\":0,\"335559739\":0,\"335559740\":240}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">Watch this 7-minute video if you want to find out the outcome of this case (spoiler alert: it goes very well!). \u202f<\/span><span data-ccp-props=\"{\"134233117\":true,\"134233118\":true,\"201341983\":0,\"335551550\":6,\"335551620\":6,\"335559738\":0,\"335559739\":0,\"335559740\":240}\">\u00a0<\/span><\/p>\n<div class=\"video\"><iframe title=\"YouTube video player\" data-src=\"https:\/\/www.youtube.com\/embed\/3wMIBFULHDo?si=i15dOAqtQOqNY5mn\" 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<hr \/>\n<p><span class=\"legal_copy\">Dr Nieves Gonzalo is a paid consultant for Shockwave Medical. <span class=\"legal_copy\">See Important Safety information below.<\/span><\/span><\/p>\n<p><strong><span class=\"legal_copy\">Coronary Important Safety Information:<\/span><\/strong><\/p>\n<p><span class=\"legal_copy\"><span class=\"legal_copy\">In the United States: Rx only <\/span><\/span><\/p>\n<p><span class=\"legal_copy\"><span class=\"legal_copy\">Indications for Use\u2014\u00a0The Shockwave Intravascular Lithotripsy (IVL) System with the\u00a0Shockwave C2\u00a0and 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><\/span><\/p>\n<p><span class=\"legal_copy\"><span class=\"legal_copy\">Contraindications\u2014\u00a0The Shockwave\u00a0C2\u00a0and 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><\/span><\/p>\n<p><span class=\"legal_copy\"><span class=\"legal_copy\">Warnings\u2014\u00a0Use 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. Analysis indicates calcium length is a predictor of dissection and balloon loss of pressure. 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. In the event of clinically significant hemodynamic effects, temporarily cease delivery of IVL therapy. <\/span><\/span><\/p>\n<p><span class=\"legal_copy\"><span class=\"legal_copy\">Precautions\u2014\u00a0Only 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. Appropriate anticoagulant therapy should be administered by the physician. Precaution should be taken when treating patients with previous stenting within 5mm of target lesion. <\/span><\/span><\/p>\n<p><span class=\"legal_copy\"><span class=\"legal_copy\">Potential adverse effects consistent with standard based cardiac interventions include\u2013\u00a0Abrupt 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 nonemergency coronary artery bypass surgery-Emergency or nonemergency 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. <\/span><\/span><\/p>\n<p><span class=\"legal_copy\"><span class=\"legal_copy\">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><\/span><\/p>\n<p><span class=\"legal_copy\"><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=\"https:\/\/shockwavemedical.com\/en-eu\/ifu\/\">www.shockwavemedical.com\/IFU<\/a>.<\/span><\/span><\/p>\n\t<\/div>\n\t<\/section>","protected":false},"excerpt":{"rendered":"<p>Dr Nieves Gonzalo (Hospital Cl\u00ecnico San Carlos, Madrid), the study\u2019s European lead, recently shared with the medical community the journey of her first patient included in the EMPOWER CAD study.\u202f\u202f<\/p>\n","protected":false},"author":15,"featured_media":8215,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":[203,204],"meta":{"_acf_changed":false,"content-type":"","footnotes":""},"categories":[1],"tags":[],"disease-state":[159],"education-topic":[183,187],"product-tag":[255,251],"specialty":[295,328,332,336,344],"technology":[316],"class_list":["post-8209","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-uncategorized","disease-state-coronary-artery-disease-en-uk","education-topic-best-practices-en-uk","education-topic-case-reviews-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\/8209","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\/15"}],"replies":[{"embeddable":true,"href":"https:\/\/shockwavemedical.com\/en-eu\/wp-json\/wp\/v2\/comments?post=8209"}],"version-history":[{"count":0,"href":"https:\/\/shockwavemedical.com\/en-eu\/wp-json\/wp\/v2\/posts\/8209\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/shockwavemedical.com\/en-eu\/wp-json\/wp\/v2\/media\/8215"}],"wp:attachment":[{"href":"https:\/\/shockwavemedical.com\/en-eu\/wp-json\/wp\/v2\/media?parent=8209"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/shockwavemedical.com\/en-eu\/wp-json\/wp\/v2\/categories?post=8209"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/shockwavemedical.com\/en-eu\/wp-json\/wp\/v2\/tags?post=8209"},{"taxonomy":"disease-state","embeddable":true,"href":"https:\/\/shockwavemedical.com\/en-eu\/wp-json\/wp\/v2\/disease-state?post=8209"},{"taxonomy":"education-topic","embeddable":true,"href":"https:\/\/shockwavemedical.com\/en-eu\/wp-json\/wp\/v2\/education-topic?post=8209"},{"taxonomy":"format","embeddable":true,"href":"https:\/\/shockwavemedical.com\/en-eu\/wp-json\/wp\/v2\/format?post=8209"},{"taxonomy":"product-tag","embeddable":true,"href":"https:\/\/shockwavemedical.com\/en-eu\/wp-json\/wp\/v2\/product-tag?post=8209"},{"taxonomy":"specialty","embeddable":true,"href":"https:\/\/shockwavemedical.com\/en-eu\/wp-json\/wp\/v2\/specialty?post=8209"},{"taxonomy":"technology","embeddable":true,"href":"https:\/\/shockwavemedical.com\/en-eu\/wp-json\/wp\/v2\/technology?post=8209"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}