Background: The recently introduced intravascular lithotripsy (IVL) appears promising and relatively safer than conventional approaches when dealing with calcified lesions. Although there are published reports on this novel technology, data from the real world are limited. In this study, we aim to report on the experience of IVL from a real-world population derived from six European centers that undertake high-volume complex coronary interventions.
Methods And Results: We enrolled all patients treated with IVL between November 2018 and February 2020 at six centers. Procedural success and complications were assessed along with clinical outcomes, which included: cardiac death, target vessel myocardial infarction (TVMI), target lesion revascularisation (TLR), and major adverse cardiac event (MACE) (composite of cardiac death, TVMI, and TLR). Hundred and ninety patients (200 lesions) with a mean age of 72 years were treated using IVL. Diabetes and chronic kidney disease were present in 50% (n = 95) and 16% (n = 30) of cases, respectively. Acute-coronary syndromes accounted for 91 (48%) of the cases. Most were de-novo lesions (77%; n = 154). Upfront use of IVL occurred in 26% of cases, while the rest were bail-out procedures due to inadequate predilatation with conventional balloons. Adjuvant rotational atherectomy was needed in 17% of cases. Procedural success was achieved in 99% of cases with a complication rate of 3%. During the median follow-up of 222 days, there was two cardiac deaths (1%), one case of TVMI (0.5%), 3 TLR (1.5%) taking the MACE rate to 2.6%.
Conclusion: Use of IVL appears to be safe and effective in dealing with calcified-coronary lesions. A high success rate was observed with low procedural complications and event rates.
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http://dx.doi.org/10.1002/ccd.29263 | DOI Listing |
Catheter Cardiovasc Interv
January 2025
Department of Cardiology, Ageo Central General Hospital, Saitama, Japan.
Background: Intravascular lithotripsy (IVL), that generates shockwaves through spark gap discharge between emitters, has been increasingly used to treat severely calcified coronary artery lesions. However, there is a question as to whether IVL has no electrical effects on endocardial tissues or cardiac implantable devices (CIEDs).
Aims: The aim of this study was to investigate the effects of IVL-induced intracardiac potentials on cardiac electrophysiology and CIEDs.
J Vasc Surg Cases Innov Tech
April 2025
Vascular Surgery Unit, S. Chiara Hospital, APSS Trento, Trento, Italy.
This case report presents the use of intravascular lithotripsy (IVL) in a 68-year-old woman with disabling bilateral claudication owing to a heavily calcified subocclusive stenosis of the infrarenal aorta. The patient had a history of tobacco use, dyslipidemia, and chronic obstructive pulmonary disease, with absent femoral pulses and severe arterial calcification. A 12-mm Shockwave L6 lithotripsy catheter was employed to treat the aortic lesion, resulting in a significant decrease in the aortic pressure gradient without the need for stenting.
View Article and Find Full Text PDFBackground: The Centers for Medicare and Medicaid Services (CMS) New Technology Add-on Payment (NTAP) program supports adoption of new, costly medical technologies demonstrating substantial clinical improvement. In 2021, CMS waived the "substantial clinical improvement" criterion for devices designated under the FDA Breakthrough Devices Program (BDP). This study characterized risk-standardized payments associated with hospitalizations in which Medicare beneficiaries received calcium modification during PCI for acute myocardial infarction (AMI) following the adoption of the Shockwave C Coronary Intravascular Lithotripsy (IVL) Catheter (Shockwave Medical) with BDP designation.
View Article and Find Full Text PDFInt J Cardiol
January 2025
Department of Cardiology, Leiden University Medical Center, Leiden, The Netherlands.
Background: Intravascular lithotripsy (IVL) has an excellent efficacy and safety profile in the treatment of calcified coronary lesions during percutaneous coronary intervention (PCI). However, data regarding its use on left main (LM) lesions are still limited.
Objective: We aimed to analyze the technical success and 1-year clinical outcomes in calcified LM lesions treated with IVL.
J Vasc Surg Cases Innov Tech
April 2025
Department of Surgery, Westchester Medical Center, Valhalla, NY.
We present a case of an 86-year-old female with chronic mesenteric ischemia secondary to long-segment flush occlusion of the superior mesenteric artery and near-total occlusion of the celiac artery. The superior mesenteric artery was unable to be revascularized by conventional antegrade approaches. Successful transcollateral crossing of the occluded superior mesenteric artery and body-flossing, followed by antegrade balloon angioplasty, shockwave lithotripsy, and stent implantation were performed.
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