{"id":8330,"date":"2020-12-18T18:59:00","date_gmt":"2020-12-19T00:59:00","guid":{"rendered":"https:\/\/shockwavemedical.com\/education\/q-and-a-with-basavarajaiah-ielasi\/"},"modified":"2024-12-11T08:24:57","modified_gmt":"2024-12-11T14:24:57","slug":"q-and-a-with-basavarajaiah-ielasi","status":"publish","type":"post","link":"https:\/\/shockwavemedical.com\/de\/education\/q-and-a-with-basavarajaiah-ielasi\/","title":{"rendered":"IVL in Real-World European Population: Q&A with Dr. Sandeep Basavarajaiah & Dr. Alfonso Ielasi"},"content":{"rendered":"\n
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Dr. Sandeep Basavarajaiah,\u00a0consultant cardiologist at Heartlands Hospital in Birmingham, UK, and other\u00a0leading UK and Italian cardiologists\u00a0published their initial real-world experience with\u00a0Intravascular Lithotripsy (IVL)<\/a>\u00a0in a real-world population, in\u00a0Catheter Cardiovasc Interv<\/em>: \u201cIntravascular lithotripsy in calcified-coronary lesions: A real-world observational, European multicenter study\u201d.<\/p>\n

We had the privilege of connecting with Dr. Sandeep Basavarajaiah and with Dr. Alfonso Ielasi, from Milan, Italy, to learn more about the publication and its key takeaways.<\/p>\n

Read the publication<\/a>\u00a0and enjoy their Q&A:<\/p>\n

What does this study add to interventionalists\u2019 daily practice?<\/strong><\/p>\n

Dr. Basavarajaiah:\u00a0<\/strong>This study provides the safety data on IVL use in real-world population from six-high volume centres that undertake complex coronary intervention. In addition, it also demonstrates the high success rate in completing the procedure with very low event rates during this short-term follow-up.<\/p>\n

\u00a0<\/p>\n

How will you describe the baseline demographics of patients included in this study and how does it compare with DISRUPT CAD trials already published?<\/strong><\/p>\n

Dr. Ielasi:<\/strong>\u00a0From a clinical point of view our study reflects a different nature compared to the DISRUPT CAD studies. Typical clinical predictors of events, such diabetes and CKD, were more represented in our \u201call-comers\u201d registry as well as the more aggressive interventional approaches, e.g. \u201crotatripsy\u201d. The lack of a systematic use of intracoronary imaging in our study reflects a real-world practice according to country and regional reimbursement. However, this aspect did not influence the clinical outcome.<\/p>\n

\u00a0<\/p>\n

From your perspective what are the key takeaways from this publication?<\/strong><\/p>\n

Dr.\u00a0<\/strong>Basavarajaiah<\/strong>:<\/strong>\u00a0Our study from a real-world practice has shown that the use of IVL in complex calcified coronary lesions appears safe with low rates of complications and high rates of procedural success. In addition, the clinical outcomes are promising with low even rates. This should encourage operators to embrace this novel technology in their daily clinical practice.<\/p>\n

\u00a0<\/p>\n

Intravascular imaging was only used in ~1\/4 of the cases. What drives the need of use intravascular imaging in this group of patients? Do you think that using intracoronary imaging is mandatory in a real-world setting in order to attain good results with IVL?<\/strong><\/p>\n

Dr. Ielasi:<\/strong>\u00a0In our study, the use of intravascular imaging was left to operator\u2019s discretion and it was mostly performed in the initial IVL experience (led by the curiosity to assess the IVL effect on calcified lesions) and in case of intra-stent lesions (off label use). Although intravascular imaging is of paramount importance to appreciate the type and extension of the calcifications in the vessel wall, in our experience not using intracoronary imaging to guide PCI did not result in poorer clinical outcomes.<\/p>\n

\u00a0<\/p>\n

When intravascular imaging isn\u2019t available how do you decide to use IVL based on angio alone?<\/strong><\/p>\n

Dr.\u00a0<\/strong>Basavarajaiah<\/strong>:<\/strong>\u00a0Degree of calcium can be analysed on the angiogram, although not as accurately as from intra-vascular imaging. If intra-vascular imaging is not available, we would suggest considering IVL only if conventional devices failed to expand the lesion (bailout use of IVL).<\/p>\n

\u00a0<\/p>\n

In this paper you present a very simplified algorithm. With the current algorithms previously developed, what compelled you to develop this straightforward and imaging-free algorithm?<\/strong><\/p>\n

Dr. Ielasi<\/strong>:<\/strong>\u00a0This algorithm provides a simple and practical decision making approach, to treat resistant coronary lesions without the need of intracoronary imaging, while providing some suggestion on when IVL usage should be considered.<\/p>\n

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Dr. Sandeep Basavarajaiah and Dr. Alfonso Ielasi are paid consultants of Shockwave Medical.<\/span><\/p>\n

Coronary Important Safety Information:<\/span><\/strong><\/p>\n

In the United States: Rx only.<\/span><\/p>\n

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

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

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

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

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

Prior to use, please reference the Instructions for Use for more information on warnings, precautions and adverse events.\u00a0\u00a0https:\/\/shockwavemedical.com\/IFU <\/a><\/span><\/p>\n

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":"

Dr. Sandeep Basavarajaiah and other leading cardiologists published their initial real-world experience with IVL in a real-world population.<\/p>\n","protected":false},"author":2,"featured_media":3632,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":[207],"meta":{"_acf_changed":true,"content-type":"","footnotes":""},"categories":[3],"tags":[],"disease-state":[161],"education-topic":[185,189,197],"product-tag":[],"specialty":[297,330,334,346],"technology":[318],"class_list":["post-8330","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-unkategorisiert","disease-state-coronary-artery-disease-de","education-topic-best-practices-de","education-topic-case-reviews-de","education-topic-peer-to-peer-de","format-article-de","specialty-fellows-residents-de","specialty-interventional-cardiologists-de","specialty-interventional-radiologists-de","specialty-vascular-surgeons-de","technology-coronary-ivl-de"],"acf":[],"_links":{"self":[{"href":"https:\/\/shockwavemedical.com\/de\/wp-json\/wp\/v2\/posts\/8330","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/shockwavemedical.com\/de\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/shockwavemedical.com\/de\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/shockwavemedical.com\/de\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/shockwavemedical.com\/de\/wp-json\/wp\/v2\/comments?post=8330"}],"version-history":[{"count":0,"href":"https:\/\/shockwavemedical.com\/de\/wp-json\/wp\/v2\/posts\/8330\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/shockwavemedical.com\/de\/wp-json\/wp\/v2\/media\/3632"}],"wp:attachment":[{"href":"https:\/\/shockwavemedical.com\/de\/wp-json\/wp\/v2\/media?parent=8330"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/shockwavemedical.com\/de\/wp-json\/wp\/v2\/categories?post=8330"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/shockwavemedical.com\/de\/wp-json\/wp\/v2\/tags?post=8330"},{"taxonomy":"disease-state","embeddable":true,"href":"https:\/\/shockwavemedical.com\/de\/wp-json\/wp\/v2\/disease-state?post=8330"},{"taxonomy":"education-topic","embeddable":true,"href":"https:\/\/shockwavemedical.com\/de\/wp-json\/wp\/v2\/education-topic?post=8330"},{"taxonomy":"format","embeddable":true,"href":"https:\/\/shockwavemedical.com\/de\/wp-json\/wp\/v2\/format?post=8330"},{"taxonomy":"product-tag","embeddable":true,"href":"https:\/\/shockwavemedical.com\/de\/wp-json\/wp\/v2\/product-tag?post=8330"},{"taxonomy":"specialty","embeddable":true,"href":"https:\/\/shockwavemedical.com\/de\/wp-json\/wp\/v2\/specialty?post=8330"},{"taxonomy":"technology","embeddable":true,"href":"https:\/\/shockwavemedical.com\/de\/wp-json\/wp\/v2\/technology?post=8330"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}