Shockwave lithotripsy paves the way for drug coated balloon in calcific in- stent restenosis: a case report

Shockwave lithotripsy paves the way for drug coated balloon in calcific in- stent restenosis: a case report | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Case Report Shockwave lithotripsy paves the way for drug coated balloon in calcific in- stent restenosis: a case report Sedky Zaalouk, Mostafa Elwany This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-4542429/v1 This work is licensed under a CC BY 4.0 License Status: Under Review Version 1 posted 19 You are reading this latest preprint version Abstract Background Drug-coated balloons (DCB) have been well-studied as a modality of percutaneous intervention (PCI) for the management of in-stent restenosis (ISR) in numerous trials. Proper lesion preparation has been the Achilles heel for DCB and is essentially the cornerstone for its proper use. Shockwave intravascular lithotripsy (IVL) is considered one of the safe and effective techniques for cracking heavy coronary artery calcifications (CAC) to allow proper stent expansion. There have been a few reports illustrating the safety and efficacy of the use of IVL technology to achieve satisfactory stent expansion in heavily calcific ISR. Case presentation In this report, we are presenting a resistant calcific ISR in a post coronary artery bypass surgery (CABG) patient which was successfully managed by IVL followed by DCB. Conclusions IVL followed by PCI using DCB has been shown to be safe and effective in cases of ISR with dense CAC. The technique needs to be further assessed by more studies to be adopted on a wider scale. Coronary artery calcification in-stent restenosis intravascular lithotripsy drug-coated balloon case report Figures Figure 1 Background Heavily calcified coronary lesions have always remained a challenge for interventional cardiologists to combat. While several techniques have been studied to counter CAC, the challenge gets harder with calcific ISR. PCI for ISR has been associated with worse outcomes compared with PCI for de novo lesions [5,6]. IVL has been shown to be safe and effective in both de novo CAC and ISR in recent studies, although the use of IVL in ISR is still off-label in the United States, and RCTs are lacking in this regard [2-4]. Limited data are available for guiding case selection for IVL in ISR. Although DCB strategy is recommended in European Society of Cardiology (ESC) Guidelines for management of ISR, it is less effective in cases of heavy CAC because calcium burden can prevent 1:1 lesion preparation and it can also impact drug delivery from the balloon [7]. Case presentation A 75-year-old female patient presented with class III anginal pain despite optimal medical therapy. The patient underwent CABG 15 years prior with a failed venous graft which required stenting 8 years later. Computed tomography – coronary angiography (CTCA) was done revealing patent LIMA-LAD and SVG-OM1 grafts with occluded heavily calcific RCA. Invasive coronary angiography via right radial access confirmed the critical calcific ISR in the mid segment of the RCA. The procedure was performed using Phillips Azurion 3 F15® device. IVUS catheter failed to cross. StentBoost® technology helped clarify the stent status. Repeated attempts with multiple noncompliant balloons were done but to no avail. We performed IVL using C2 Shockwave Medical Coronary® system. The balloon size selected was 4 x 12 mm based on 1:1 sizing protocol. The IVL catheter was delivered using 6Fr guide extension catheter Guidezilla®. The balloon was inflated to 4 atmospheric pressures at the target lesion site. We applied 80 pulses (10 pulses x 8 cycles). We then used Essential Pro® paclitaxel-eluting balloon sized 4.5mm x 30mm, inflated up to 16 atm at the target lesion for 90 seconds. DCB after IVL resulted in complete resolution of ISR (see figure). The patient had an uneventful peri-interventional hospital course and was discharged the next day, free of symptoms. The patient reported no angina at 1 month follow-up. Discussion ISR is a well-recognized clinical and economic burden, increasing the risk of repeated hospitalization due to acute myocardial infarction, as well as overall mortality [5]. There are various classifications for ISR lesions which depend on pathophysiological or mechanical factors, and they have aided in choosing the optimal intervention strategy [8]. According to the latest consensus statement from Society of Cardiovascular Angiography and Interventions (SCAI), there is no clear gold-standard method for the management of all ISR lesions, and classifying the lesions based on the time of stent deployment can reliably predict the mechanism of ISR and thus help in treatment plan. According to the latest classification proposed by SCAI, ISR beyond 1 year is likely due to neo-atherosclerosis, which follows neo-intimal hyperplasia due to chronic inflammation of the intima and media layers of the coronary artery. Neo-atherosclerotic lesions, in the later stages, can be heavily calcific, hindering proper lesion preparation by conventional balloon angioplasty [9]. Rotational atherectomy (RA) has always been the standard of advanced interventions in combating CAC. However, clinical trials of RA in ISR have failed to demonstrate any benefit, with risks of perforation, device entrapment and target lesion revascularization (TLR) [10]. Cutting and scoring balloons have also failed to show benefit when compared to conventional balloon angioplasty in cases of calcific ISR [11]. The limited availability and benefit of excimer laser has also made it far from being a first choice. Although IVL is being increasingly used for CAC, its use in calcific ISR is still under investigation, but the results so far are promising. This case exemplifies the promising potential of IVL, although RCTs are needed. The use of IVUS in our case had been of utmost importance for defining the length and depth of calcification. CTCA confirmed that there is dense calcification at the target lesion, yet IVUS would have been more beneficial in defining the best treatment strategy. The failure of the IVUS catheter to cross made us suspect that conventional balloon angioplasty would fail in preparing the lesion. Although DCB is not yet available for use in the United States, its safety and efficacy have been evident in many trials, especially for paclitaxel-eluting balloons, in cases of ISR. DCB is considered non-inferior to DES in cases of ISR due to stent under-expansion or neo-intimal hyperplasia [1]. Moreover, DCB strategy has the advantage of avoiding long duration of dual antiplatelet therapy. Stenting of the lesion in the above-mentioned case instead of using DCB would increase further the risk of multi-layer ISR given the already challenging vessel status, posing a more difficult subsequent revascularization attempts if needed. Conclusions IVL, as presented in several case reports, is a safe and effective intervention to prepare a heavily calcific ISR lesion. DCB followed by IVL effectively led to optimal results in the diseased RCA, leading to improved symptoms for our case after follow up. RCTs are needed to further assess the reliability of this modality combination in successfully treating calcific ISR. Abbreviations DCB drug-coated balloon; ISR in-stent restenosis; PCI percutaneous coronary intervention; CAC coronary artery calcification; CABG coronary artery bypass graft; RA Rotational atherectomy; CTCA Computed tomography-coronary angiography; RCT randomized controlled trial; TLR target lesion revascularization; LIMA-LAD left internal mammary artery - left anterior descending graft; SVG-OM1 saphenous vein graft – obtuse marginal artery; RCA right coronary artery; ESC European Society of Cardiology; SCAI Society of Cardiovascular Angiography and Interventions Declarations Ethical approval and consent to participate The case has been carried out in accordance with The Code of Ethics of the World Medical Association (Declaration of Helsinki) for experiments involving humans. The report has received approval from the Ethics Committee in Faculty of Medicine, Alexandria University (IRB NO: 00012098). Consent for publication Written informed consent was obtained from the patient for her anonymized information to be published in this article. Availability of data and material Data sharing is not applicable to this article as no datasets were generated or analysed during the current study. Competing Interests All authors declare that they have no competing interests. Funding This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors. Authors’ Contributions ME was the main interventionist for the presented case. SZ is the corresponding author as he wrote and thoroughly revised the manuscript with approval from ME. Acknowledgements Not applicable. References Kufner, S., Joner, M., Schneider, S., Tölg, R., Zrenner, B., Repp, J., Starkmann, A., Xhepa, E., Ibrahim, T., Cassese, S., Fusaro, M., Ott, I., Hengstenberg, C., Schunkert, H., Abdel-Wahab, M., Laugwitz, K. L., Kastrati, A., Byrne, R. A., & ISAR-DESIRE 4 Investigators (2017). Neointimal Modification With Scoring Balloon and Efficacy of Drug-Coated Balloon Therapy in Patients With Restenosis in Drug-Eluting Coronary Stents: A Randomized Controlled Trial. JACC. Cardiovascular interventions , 10 (13), 1332–1340. https://doi.org/10.1016/j.jcin.2017.04.024 Tovar Forero, M. N., Sardella, G., Salvi, N., Cortese, B., di Palma, G., Werner, N., Aksoy, A., Escaned, J., Salazar, C. H., Gonzalo, N., Ugo, F., Cavallino, C., Sheth, T. N., Kardys, I., Van Mieghem, N. M., & Daemen, J. (2022). Coronary lithotripsy for the treatment of underexpanded stents: the international & multicentre CRUNCH registry. EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology , 18 (7), 574–581. https://doi.org/10.4244/EIJ-D-21-00545 Wańha, W., Tomaniak, M., Wańczura, P., Bil, J., Januszek, R., Wolny, R., Opolski, M. P., Kuźma, Ł., Janas, A., Figatowski, T., Gąsior, P., Milewski, M., Roleder-Dylewska, M., Lewicki, Ł., Kulczycki, J., Włodarczak, A., Tomasiewicz, B., Iwańczyk, S., Sacha, J., Koltowski, Ł., … Wojakowski, W. (2022). Intravascular Lithotripsy for the Treatment of Stent Underexpansion: The Multicenter IVL-DRAGON Registry. Journal of clinical medicine , 11 (7), 1779. https://doi.org/10.3390/jcm11071779 Yap, L. B., Choy, C. N., Navin, S., Koh, K. W., Jeyamalar, R., & Balachandran, K. (2022). Treatment of severe coronary artery calcification with intravascular lithotripsy: Initial experience of a prospective single centre registry. The Medical journal of Malaysia , 77 (4), 500–505. Moussa, I. D., Mohananey, D., Saucedo, J., Stone, G. W., Yeh, R. W., Kennedy, K. F., Waksman, R., Teirstein, P., Moses, J. W., & Simonton, C. (2020). Trends and Outcomes of Restenosis After Coronary Stent Implantation in the United States. Journal of the American College of Cardiology , 76 (13), 1521–1531. https://doi.org/10.1016/j.jacc.2020.08.002 Palmerini, T., Della Riva, D., Biondi-Zoccai, G., Leon, M. B., Serruys, P. W., Smits, P. C., von Birgelen, C., Ben-Yehuda, O., Généreux, P., Bruno, A. G., Jenkins, P., & Stone, G. W. (2018). Mortality Following Nonemergent, Uncomplicated Target Lesion Revascularization After Percutaneous Coronary Intervention: An Individual Patient Data Pooled Analysis of 21 Randomized Trials and 32,524 Patients. JACC. Cardiovascular interventions , 11 (9), 892–902. https://doi.org/10.1016/j.jcin.2018.01.277 Neumann, F. J., Sousa-Uva, M., Ahlsson, A., Alfonso, F., Banning, A. P., Benedetto, U., Byrne, R. A., Collet, J. P., Falk, V., Head, S. J., Jüni, P., Kastrati, A., Koller, A., Kristensen, S. D., Niebauer, J., Richter, D. J., Seferovic, P. M., Sibbing, D., Stefanini, G. G., Windecker, S., … ESC Scientific Document Group (2019). 2018 ESC/EACTS Guidelines on myocardial revascularization. European heart journal , 40 (2), 87–165. https://doi.org/10.1093/eurheartj/ehy394 Shlofmitz, E., Iantorno, M., & Waksman, R. (2019). Restenosis of Drug-Eluting Stents: A New Classification System Based on Disease Mechanism to Guide Treatment and State-of-the-Art Review. Circulation. Cardiovascular interventions , 12 (8), e007023. https://doi.org/10.1161/CIRCINTERVENTIONS.118.007023 Klein, L. W., Nathan, S., Maehara, A., Messenger, J., Mintz, G. S., Ali, Z. A., Rymer, J., Sandoval, Y., Al-Azizi, K., Mehran, R., Rao, S. v., & Lotfi, A. (2023). SCAI Expert Consensus Statement on Management of In-Stent Restenosis and Stent Thrombosis. Journal of the Society for Cardiovascular Angiography and Interventions, 2(4). https://doi.org/10.1016/j.jscai.2023.100971 Sharma, S. K., Kini, A., Mehran, R., Lansky, A., Kobayashi, Y., & Marmur, J. D. (2004). Randomized trial of Rotational Atherectomy Versus Balloon Angioplasty for Diffuse In-stent Restenosis (ROSTER). American heart journal , 147 (1), 16–22. https://doi.org/10.1016/j.ahj.2003.07.002 Park, S. J., Kim, K. H., Oh, I. Y., Shin, D. H., Park, K. I., Seo, M. K., Chung, J. W., Park, K. W., Lee, H. Y., Kang, H. J., Koo, B. K., Youn, T. J., & Kim, H. S. (2010). Comparison of plain balloon and cutting balloon angioplasty for the treatment of restenosis with drug-eluting stents vs bare metal stents. Circulation journal : official journal of the Japanese Circulation Society , 74 (9), 1837–1845. https://doi.org/10.1253/circj.cj-09-1041 Additional Declarations No competing interests reported. Cite Share Download PDF Status: Under Review Version 1 posted Editorial decision: Revision requested 02 Nov, 2024 Reviews received at journal 01 Nov, 2024 Reviews received at journal 30 Oct, 2024 Reviews received at journal 28 Oct, 2024 Reviews received at journal 22 Oct, 2024 Reviewers agreed at journal 21 Oct, 2024 Reviewers agreed at journal 21 Oct, 2024 Reviewers agreed at journal 20 Oct, 2024 Reviewers agreed at journal 20 Oct, 2024 Reviewers agreed at journal 20 Oct, 2024 Reviewers agreed at journal 20 Oct, 2024 Reviewers agreed at journal 18 Oct, 2024 Reviews received at journal 05 Jul, 2024 Reviewers agreed at journal 23 Jun, 2024 Reviewers agreed at journal 23 Jun, 2024 Reviewers invited by journal 18 Jun, 2024 Editor assigned by journal 07 Jun, 2024 Submission checks completed at journal 07 Jun, 2024 First submitted to journal 06 Jun, 2024 You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. 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Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-4542429","acceptedTermsAndConditions":true,"allowDirectSubmit":false,"archivedVersions":[],"articleType":"Case Report","associatedPublications":[],"authors":[{"id":316975502,"identity":"07fae04d-4d87-4dc6-8c26-249b70027e51","order_by":0,"name":"Sedky Zaalouk","email":"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAZAAAAAyAQMAAABI0h/eAAAABlBMVEX///8AAABVwtN+AAAACXBIWXMAAA7EAAAOxAGVKw4bAAABAUlEQVRIiWNgGAWjYHACYwbGf0CKnYGBsaECyGBmbiCshYENpBKk5QyIwUiKlsY2kAABLfLtzZuNeXjq5PmbmY9JzpxXG83fDtTyo2IbTi0GZ44VJ/NIsBnOOMyWJrlx2/HcGYcZGxh7ztzGrUUix/gwjwEPY8NhHjPJh9uO5TYAtTAztuHWIj//DVBLgoT9fLCWOcdy5xPSwnCDxziZ54BB4gaQlo0NNbkbCGkxOJNWbDi3ISF542G2ZMsZxw7kbgRqOYjPL/LthzdLvG2os513vPngzZ6autx55w8ffPCjAo/DgICJB8E+DCYP4FUPBIw/EOw6QopHwSgYBaNgBAIAvaJapjuovY0AAAAASUVORK5CYII=","orcid":"","institution":"Alexandria University","correspondingAuthor":true,"prefix":"","firstName":"Sedky","middleName":"","lastName":"Zaalouk","suffix":""},{"id":316975503,"identity":"4aafd4e9-3a6b-4c11-adcc-8000d21979f5","order_by":1,"name":"Mostafa Elwany","email":"","orcid":"","institution":"Alexandria University","correspondingAuthor":false,"prefix":"","firstName":"Mostafa","middleName":"","lastName":"Elwany","suffix":""}],"badges":[],"createdAt":"2024-06-06 21:03:25","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-4542429/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-4542429/v1","draftVersion":[],"editorialEvents":[],"editorialNote":"","failedWorkflow":false,"files":[{"id":59215299,"identity":"eeb10f62-bb3b-44eb-a4c7-ccb2d13c8c13","added_by":"auto","created_at":"2024-06-27 18:55:36","extension":"png","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":400523,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cem\u003eFigure \u003c/em\u003eImages \u003cstrong\u003eA \u003c/strong\u003eand \u003cstrong\u003eB\u003c/strong\u003e are reproduced by StentBoost® technology for the RCA stent showing significant calcific in-stent restenosis. \u003cstrong\u003eA \u003c/strong\u003eshows the extent of the ISR before an attempt of balloon angioplasty. \u003cstrong\u003eB \u003c/strong\u003eshows the effect of IVL in combatting the existing calcium which resulted in better results with the PCI procedure. \u003cstrong\u003eC \u003c/strong\u003eis the final image of the RCA after DCB.\u003c/p\u003e","description":"","filename":"1.png","url":"https://assets-eu.researchsquare.com/files/rs-4542429/v1/bde81553aaa3b53a610c7350.png"},{"id":59215300,"identity":"d90af45c-ecd2-4dc1-8987-f95458c0fdaa","added_by":"auto","created_at":"2024-06-27 18:55:41","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":836741,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-4542429/v1/5a0a5196-e8c2-4842-8e68-9d6351ee9709.pdf"}],"financialInterests":"No competing interests reported.","formattedTitle":"Shockwave lithotripsy paves the way for drug coated balloon in calcific in- stent restenosis: a case report","fulltext":[{"header":"Background","content":"\u003cp\u003eHeavily calcified coronary lesions have always remained a challenge for interventional cardiologists to combat. While several techniques have been studied to counter CAC, the challenge gets harder with calcific ISR. PCI for ISR has been associated with worse outcomes compared with PCI for de novo lesions [5,6]. IVL has been shown to be safe and effective in both de novo CAC and ISR in recent studies, although the use of IVL in ISR is still off-label in the United States, and RCTs are lacking in this regard [2-4]. Limited data are available for guiding case selection for IVL in ISR. Although DCB strategy is recommended in European Society of Cardiology (ESC) Guidelines for management of ISR, it is less effective in cases of heavy CAC because calcium burden can prevent 1:1 lesion preparation and it can also impact drug delivery from the balloon [7].\u003c/p\u003e"},{"header":"Case presentation","content":"\u003cp\u003eA 75-year-old female patient presented with class III anginal pain despite optimal medical therapy. The patient underwent CABG 15 years prior with a failed venous graft which required stenting 8 years later. Computed tomography \u0026ndash; coronary angiography (CTCA) was done revealing patent LIMA-LAD and SVG-OM1 grafts with occluded heavily calcific RCA. Invasive coronary angiography via right radial access confirmed the critical calcific ISR in the mid segment of the RCA. The procedure was performed using Phillips Azurion 3 F15\u0026reg; device. IVUS catheter failed to cross. StentBoost\u0026reg; technology helped clarify the stent status. Repeated attempts with multiple noncompliant balloons were done but to no avail. We performed IVL using C2 Shockwave Medical Coronary\u0026reg; system. The balloon size selected was 4 x 12 mm based on 1:1 sizing protocol. The IVL catheter was delivered using 6Fr guide extension catheter Guidezilla\u0026reg;. The balloon was inflated to 4 atmospheric pressures at the target lesion site. We applied 80 pulses (10 pulses x 8 cycles). We then used Essential Pro\u0026reg;\u003csup\u003e\u0026nbsp;\u003c/sup\u003epaclitaxel-eluting balloon sized 4.5mm x 30mm, inflated up to 16 atm at the target lesion for 90 seconds. DCB after IVL resulted in complete resolution of ISR (see figure). The patient had an uneventful peri-interventional hospital course and was discharged the next day, free of symptoms. The patient reported no angina at 1 month follow-up.\u003c/p\u003e"},{"header":"Discussion","content":"\u003cp\u003eISR is a well-recognized clinical and economic burden, increasing the risk of repeated hospitalization due to acute myocardial infarction, as well as overall mortality [5]. There are various classifications for ISR lesions which depend on pathophysiological or mechanical factors, and they have aided in choosing the optimal intervention strategy [8]. According to the latest consensus statement from Society of Cardiovascular Angiography and Interventions (SCAI), there is no clear gold-standard method for the management of all ISR lesions, and classifying the lesions based on the time of stent deployment can reliably predict the mechanism of ISR and thus help in treatment plan. According to the latest classification proposed by SCAI, ISR beyond 1 year is likely due to neo-atherosclerosis, which follows neo-intimal hyperplasia due to chronic inflammation of the intima and media layers of the coronary artery. Neo-atherosclerotic lesions, in the later stages, can be heavily calcific, hindering proper lesion preparation by conventional balloon angioplasty [9].\u003c/p\u003e\n\u003cp\u003eRotational atherectomy (RA) has always been the standard of advanced interventions in combating CAC. However, clinical trials of RA in ISR have failed to demonstrate any benefit, with risks of perforation, device entrapment and target lesion revascularization (TLR) [10]. Cutting and scoring balloons have also failed to show benefit when compared to conventional balloon angioplasty in cases of calcific ISR [11]. The limited availability and benefit of excimer laser has also made it far from being a first choice. Although IVL is being increasingly used for CAC, its use in calcific ISR is still under investigation, but the results so far are promising. This case exemplifies the promising potential of IVL, although RCTs are needed.\u003c/p\u003e\n\u003cp\u003eThe use of IVUS in our case had been of utmost importance for defining the length and depth of calcification. CTCA confirmed that there is dense calcification at the target lesion, yet IVUS would have been more beneficial in defining the best treatment strategy. The failure of the IVUS catheter to cross made us suspect that conventional balloon angioplasty would fail in preparing the lesion.\u003c/p\u003e\n\u003cp\u003eAlthough DCB is not yet available for use in the United States, its safety and efficacy have been evident in many trials, especially for paclitaxel-eluting balloons, in cases of ISR. DCB is considered non-inferior to DES in cases of ISR due to stent under-expansion or neo-intimal hyperplasia [1]. Moreover, DCB strategy has the advantage of avoiding long duration of dual antiplatelet therapy. Stenting of the lesion in the above-mentioned case instead of using DCB would increase further the risk of multi-layer ISR given the already challenging vessel status, posing a more difficult subsequent revascularization attempts if needed. \u0026nbsp;\u003c/p\u003e"},{"header":"Conclusions","content":"\u003cp\u003eIVL, as presented in several case reports, is a safe and effective intervention to prepare a heavily calcific ISR lesion. DCB followed by IVL effectively led to optimal results in the diseased RCA, leading to improved symptoms for our case after follow up. RCTs are needed to further assess the reliability of this modality combination in successfully treating calcific ISR.\u003c/p\u003e"},{"header":"Abbreviations","content":"\u003cp\u003e\u003cem\u003eDCB\u0026nbsp;\u003c/em\u003edrug-coated balloon; \u003cem\u003eISR\u0026nbsp;\u003c/em\u003ein-stent restenosis; \u003cem\u003ePCI\u0026nbsp;\u003c/em\u003epercutaneous coronary intervention; \u003cem\u003eCAC\u0026nbsp;\u003c/em\u003ecoronary artery calcification; \u003cem\u003eCABG\u003c/em\u003e coronary artery bypass graft; \u003cem\u003eRA\u0026nbsp;\u003c/em\u003eRotational atherectomy; \u003cem\u003eCTCA\u0026nbsp;\u003c/em\u003eComputed tomography-coronary angiography; \u003cem\u003eRCT\u0026nbsp;\u003c/em\u003erandomized controlled trial; \u003cem\u003eTLR\u0026nbsp;\u003c/em\u003etarget lesion revascularization; \u003cem\u003eLIMA-LAD\u0026nbsp;\u003c/em\u003eleft internal mammary artery - left anterior descending graft; \u003cem\u003eSVG-OM1\u0026nbsp;\u003c/em\u003esaphenous vein graft \u0026ndash; obtuse marginal artery;\u003cem\u003e\u0026nbsp;RCA\u0026nbsp;\u003c/em\u003eright coronary artery; \u003cem\u003eESC\u0026nbsp;\u003c/em\u003eEuropean Society of Cardiology; \u003cem\u003eSCAI\u0026nbsp;\u003c/em\u003eSociety of Cardiovascular Angiography and Interventions\u003c/p\u003e"},{"header":"Declarations","content":"\u003cp\u003e\u003cstrong\u003e\u003cem\u003eEthical approval and consent to participate\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eThe case\u0026nbsp;\u003c/strong\u003e\u003cstrong\u003ehas been carried out in accordance with The Code of Ethics of the World Medical Association (Declaration of Helsinki) for experiments involving humans.\u0026nbsp;\u003c/strong\u003e\u003cstrong\u003eThe report has received approval from the Ethics Committee in Faculty of Medicine, Alexandria University (IRB NO: 00012098).\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003eConsent for publication\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eWritten informed consent was obtained from the patient for her anonymized information to be published in this article.\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003eAvailability of data and material\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eData sharing is not applicable to this article as no datasets were generated or analysed during the current study.\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003eCompeting Interests\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAll authors declare that they have no competing interests.\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003eFunding\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eThis research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors.\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003eAuthors\u0026rsquo; Contributions\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eME was the main interventionist for the presented case. SZ is the corresponding author as he wrote and thoroughly revised the manuscript with approval from ME.\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003eAcknowledgements\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eNot applicable.\u003c/strong\u003e\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\n\u003cli\u003eKufner, S., Joner, M., Schneider, S., T\u0026ouml;lg, R., Zrenner, B., Repp, J., Starkmann, A., Xhepa, E., Ibrahim, T., Cassese, S., Fusaro, M., Ott, I., Hengstenberg, C., Schunkert, H., Abdel-Wahab, M., Laugwitz, K. L., Kastrati, A., Byrne, R. A., \u0026amp; ISAR-DESIRE 4 Investigators (2017). Neointimal Modification With Scoring Balloon and Efficacy of Drug-Coated Balloon Therapy in Patients With Restenosis in Drug-Eluting Coronary Stents: A Randomized Controlled Trial. \u003cem\u003eJACC. Cardiovascular interventions\u003c/em\u003e, \u003cem\u003e10\u003c/em\u003e(13), 1332\u0026ndash;1340. https://doi.org/10.1016/j.jcin.2017.04.024\u003c/li\u003e\n\u003cli\u003eTovar Forero, M. N., Sardella, G., Salvi, N., Cortese, B., di Palma, G., Werner, N., Aksoy, A., Escaned, J., Salazar, C. H., Gonzalo, N., Ugo, F., Cavallino, C., Sheth, T. N., Kardys, I., Van Mieghem, N. M., \u0026amp; Daemen, J. (2022). Coronary lithotripsy for the treatment of underexpanded stents: the international \u0026amp; multicentre CRUNCH registry. \u003cem\u003eEuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology\u003c/em\u003e, \u003cem\u003e18\u003c/em\u003e(7), 574\u0026ndash;581. https://doi.org/10.4244/EIJ-D-21-00545\u003c/li\u003e\n\u003cli\u003eWańha, W., Tomaniak, M., Wańczura, P., Bil, J., Januszek, R., Wolny, R., Opolski, M. P., Kuźma, Ł., Janas, A., Figatowski, T., Gąsior, P., Milewski, M., Roleder-Dylewska, M., Lewicki, Ł., Kulczycki, J., Włodarczak, A., Tomasiewicz, B., Iwańczyk, S., Sacha, J., Koltowski, Ł., \u0026hellip; Wojakowski, W. (2022). Intravascular Lithotripsy for the Treatment of Stent Underexpansion: The Multicenter IVL-DRAGON Registry. \u003cem\u003eJournal of clinical medicine\u003c/em\u003e, \u003cem\u003e11\u003c/em\u003e(7), 1779. https://doi.org/10.3390/jcm11071779\u003c/li\u003e\n\u003cli\u003eYap, L. B., Choy, C. N., Navin, S., Koh, K. W., Jeyamalar, R., \u0026amp; Balachandran, K. (2022). Treatment of severe coronary artery calcification with intravascular lithotripsy: Initial experience of a prospective single centre registry. \u003cem\u003eThe Medical journal of Malaysia\u003c/em\u003e, \u003cem\u003e77\u003c/em\u003e(4), 500\u0026ndash;505.\u003c/li\u003e\n\u003cli\u003eMoussa, I. D., Mohananey, D., Saucedo, J., Stone, G. W., Yeh, R. W., Kennedy, K. F., Waksman, R., Teirstein, P., Moses, J. W., \u0026amp; Simonton, C. (2020). Trends and Outcomes of Restenosis After Coronary Stent Implantation in the United States. \u003cem\u003eJournal of the American College of Cardiology\u003c/em\u003e, \u003cem\u003e76\u003c/em\u003e(13), 1521\u0026ndash;1531. https://doi.org/10.1016/j.jacc.2020.08.002\u003c/li\u003e\n\u003cli\u003ePalmerini, T., Della Riva, D., Biondi-Zoccai, G., Leon, M. B., Serruys, P. W., Smits, P. C., von Birgelen, C., Ben-Yehuda, O., G\u0026eacute;n\u0026eacute;reux, P., Bruno, A. G., Jenkins, P., \u0026amp; Stone, G. W. (2018). Mortality Following Nonemergent, Uncomplicated Target Lesion Revascularization After Percutaneous Coronary Intervention: An Individual Patient Data Pooled Analysis of 21 Randomized Trials and 32,524 Patients. \u003cem\u003eJACC. 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Cardiovascular interventions\u003c/em\u003e, \u003cem\u003e12\u003c/em\u003e(8), e007023. https://doi.org/10.1161/CIRCINTERVENTIONS.118.007023\u003c/li\u003e\n\u003cli\u003eKlein, L. W., Nathan, S., Maehara, A., Messenger, J., Mintz, G. S., Ali, Z. A., Rymer, J., Sandoval, Y., Al-Azizi, K., Mehran, R., Rao, S. v., \u0026amp; Lotfi, A. (2023). SCAI Expert Consensus Statement on Management of In-Stent Restenosis and Stent Thrombosis. Journal of the Society for Cardiovascular Angiography and Interventions, 2(4). https://doi.org/10.1016/j.jscai.2023.100971 \u003c/li\u003e\n\u003cli\u003eSharma, S. K., Kini, A., Mehran, R., Lansky, A., Kobayashi, Y., \u0026amp; Marmur, J. D. (2004). Randomized trial of Rotational Atherectomy Versus Balloon Angioplasty for Diffuse In-stent Restenosis (ROSTER). \u003cem\u003eAmerican heart journal\u003c/em\u003e, \u003cem\u003e147\u003c/em\u003e(1), 16\u0026ndash;22. https://doi.org/10.1016/j.ahj.2003.07.002\u003c/li\u003e\n\u003cli\u003ePark, S. J., Kim, K. H., Oh, I. Y., Shin, D. H., Park, K. I., Seo, M. K., Chung, J. W., Park, K. W., Lee, H. Y., Kang, H. J., Koo, B. K., Youn, T. J., \u0026amp; Kim, H. S. (2010). Comparison of plain balloon and cutting balloon angioplasty for the treatment of restenosis with drug-eluting stents vs bare metal stents. \u003cem\u003eCirculation journal : official journal of the Japanese Circulation Society\u003c/em\u003e, \u003cem\u003e74\u003c/em\u003e(9), 1837\u0026ndash;1845. https://doi.org/10.1253/circj.cj-09-1041\u003c/li\u003e\n\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":false,"highlight":"","institution":"","isAcceptedByJournal":true,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"journal-of-cardiothoracic-surgery","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"jcts","sideBox":"Learn more about [Journal of Cardiothoracic Surgery](http://cardiothoracicsurgery.biomedcentral.com)","snPcode":"13019","submissionUrl":"https://submission.nature.com/new-submission/13019/3","title":"Journal of Cardiothoracic Surgery","twitterHandle":"@BioMedCentral","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"em","reportingPortfolio":"BMC/SO AJ","inReviewEnabled":true,"inReviewRevisionsEnabled":true},"keywords":"Coronary artery calcification, in-stent restenosis, intravascular lithotripsy, drug-coated balloon, case report","lastPublishedDoi":"10.21203/rs.3.rs-4542429/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-4542429/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003e\u003cem\u003e\u003cstrong\u003eBackground\u003c/strong\u003e\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eDrug-coated balloons (DCB) have been well-studied as a modality of percutaneous intervention (PCI) for the management of in-stent restenosis (ISR) in numerous trials. Proper lesion preparation has been the Achilles heel for DCB and is essentially the cornerstone for its proper use. Shockwave intravascular lithotripsy (IVL) is considered one of the safe and effective techniques for cracking heavy coronary artery calcifications (CAC) to allow proper stent expansion. There have been a few reports illustrating the safety and efficacy of the use of IVL technology to achieve satisfactory stent expansion in heavily calcific ISR.\u003c/p\u003e\n\u003cp\u003e\u003cem\u003e\u003cstrong\u003eCase presentation\u003c/strong\u003e\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eIn this report, we are presenting a resistant calcific ISR in a post coronary artery bypass surgery (CABG) patient which was successfully managed by IVL followed by DCB.\u003c/p\u003e\n\u003cp\u003e\u003cem\u003e\u003cstrong\u003eConclusions\u003c/strong\u003e\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eIVL followed by PCI using DCB has been shown to be safe and effective in cases of ISR with dense CAC. The technique needs to be further assessed by more studies to be adopted on a wider scale.\u003c/p\u003e","manuscriptTitle":"Shockwave lithotripsy paves the way for drug coated balloon in calcific in- stent restenosis: a case report","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2024-06-27 18:55:32","doi":"10.21203/rs.3.rs-4542429/v1","editorialEvents":[{"type":"communityComments","content":0},{"type":"decision","content":"Revision requested","date":"2024-11-02T08:41:10+00:00","index":"","fulltext":""},{"type":"editorInvitedReview","content":"","date":"2024-11-01T16:00:54+00:00","index":"hide","fulltext":""},{"type":"editorInvitedReview","content":"","date":"2024-10-30T15:43:54+00:00","index":"hide","fulltext":""},{"type":"editorInvitedReview","content":"","date":"2024-10-28T21:21:47+00:00","index":"hide","fulltext":""},{"type":"editorInvitedReview","content":"","date":"2024-10-22T15:42:03+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"277297394132994526054457652883811325408","date":"2024-10-21T14:55:23+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"158416117852971009164364068218266814756","date":"2024-10-21T12:24:49+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"96228291579443262163369374686598459722","date":"2024-10-20T20:53:38+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"296698594184863236195044072128288278293","date":"2024-10-20T20:40:15+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"37294552006185172530198593747042367526","date":"2024-10-20T11:57:52+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"56596341063290774142765980486166307864","date":"2024-10-20T10:48:40+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"229296485088378821081086662571994507029","date":"2024-10-18T11:19:26+00:00","index":"hide","fulltext":""},{"type":"editorInvitedReview","content":"","date":"2024-07-05T16:05:35+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"139020974228568088571876651444223928154","date":"2024-06-23T15:20:07+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"194399051216274922879442910682090553578","date":"2024-06-23T08:40:42+00:00","index":"hide","fulltext":""},{"type":"reviewersInvited","content":"","date":"2024-06-18T14:45:01+00:00","index":"","fulltext":""},{"type":"editorAssigned","content":"","date":"2024-06-07T08:56:58+00:00","index":"","fulltext":""},{"type":"checksComplete","content":"","date":"2024-06-07T08:56:12+00:00","index":"","fulltext":""},{"type":"submitted","content":"Journal of Cardiothoracic Surgery","date":"2024-06-06T21:02:17+00:00","index":"","fulltext":""}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"journal-of-cardiothoracic-surgery","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"jcts","sideBox":"Learn more about [Journal of Cardiothoracic Surgery](http://cardiothoracicsurgery.biomedcentral.com)","snPcode":"13019","submissionUrl":"https://submission.nature.com/new-submission/13019/3","title":"Journal of Cardiothoracic Surgery","twitterHandle":"@BioMedCentral","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"em","reportingPortfolio":"BMC/SO AJ","inReviewEnabled":true,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"54f8521c-9c1e-483f-b615-52cfa38a9538","owner":[],"postedDate":"June 27th, 2024","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"under-review","subjectAreas":[],"tags":[],"updatedAt":"2024-12-24T14:23:33+00:00","versionOfRecord":[],"versionCreatedAt":"2024-06-27 18:55:32","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-4542429","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-4542429","identity":"rs-4542429","version":["v1"]},"buildId":"qtupq5eGEP_6zYnWcrvyt","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}