Background: Whereas the efficacy and safety of intravascular lithotripsy (IVL) have been confirmed in de novo calcified coronary lesions, little is known about its utility in treating stent underexpansion. This study aimed to investigate the impact of IVL in treating stent underexpansion. Methods and Results: Consecutive patients with stent underexpansion treated with IVL entered the multicenter IVL-Dragon Registry. The procedural success (primary efficacy endpoint) was defined as a relative stent expansion >80%. Thirty days device-oriented composite endpoint (DOCE) (defined as a composite of cardiac death, target lesion revascularization, or target vessel myocardial infarction) was the secondary endpoint. A total of 62 patients were enrolled. The primary efficacy endpoint was achieved in 72.6% of patients. Both stent underexpansion 58.5% (47.5–69.7) vs. 11.4% (5.8–20.7), p < 0.001, and the stenotic area 82.6% (72.4–90.8) vs. 21.5% (11.1–37.2), p < 0.001, measured by quantitative coronary angiography improved significantly after IVL. Intravascular imaging confirmed increased stent expansion following IVL from 37.5% (16.0–66.0) to 86.0% (69.2–90.7), p < 0.001, by optical coherence tomography and from 57.0% (31.5–77.2) to 89.0% (85.0–92.0), p = 0.002, by intravascular ultrasound. Secondary endpoint occurred in one (1.6%) patient caused by cardiac death. There was no target lesion revascularization or target vessel myocardial infarction during the 30-day follow-up. Conclusions: In this real-life, largest-to-date analysis of IVL use to manage underexpanded stent, IVL proved to be an effective and safe method for facilitating stent expansion and increasing luminal gain.
Background: Diabetes mellitus (DM) is one of the major risk factors contributing to Acute Coronary Syndromes (ACS) and is associated with an increased risk of adverse clinical outcomes following percutaneous coronary intervention (PCI), even when the second generation of drug-eluting stents (DES) is used. In order to overcome the disadvantages of permanent caging of a vessel with metallic DES, bioresorbable scaffold (BRS) technology has been recently developed. However, the prognosis of patients with DM and ACS treated with PCI via subsequent implantation of Magmaris (Biotronik, Berlin, Germany)—a novel magnesium-bioresorbable scaffold—is poorly investigated. Methods: A total of 193 consecutive subjects with non-ST elevation acute coronary syndrome (NSTE-ACS) who, from October 2016 to March 2020, received one or more Magmaris scaffolds were enrolled in this study. The diabetic group was compared with non-diabetic subjects. Results: There were no significant differences in the occurrence of primary endpoints (cardiovascular death, myocardial infarction, and in-stent thrombosis) and principal secondary endpoints (target-lesion failure, scaffold restenosis, death from any reason, and other cardiovascular events) between the two compared groups in a 1-year follow-up period. Conclusions: The early 1-year-outcome of magnesium bioresorbable scaffold (Magmaris) seems to be favorable and suggests that this novel BRS is safe and effective in subjects with NSTE-ACS and co-existing DM.
Introduction: Left main (LM) disease is associated with a large myocardial ischemic territory. Calcification with co-existing undilatable lesions is a predictor of poor clinical outcomes following LM percutaneous coronary interventions (PCI).Aim: To evaluate the safety and efficiency of shockwave intravascular lithotripsy (S-IVL) in highly calcified LM diseases.Material and methods: The study population consisted of sixteen patients qualified for PCI -mainly males (81.3%) with coronary artery disease (CAD) treated with left main S-IVL PCI due to unsuccessful attempts of plaque modification with a non-compliant (NC) balloon catheter, or rotational devices. Clinical success was defined as effective stent delivery and deployment (with less than < 20% in-stent residual stenosis) with preserved coronary flow TIMI-3 (Thrombolysis in Myocardial Infarction) at the end of the procedure.Results: The most frequent indication for PCI was acute coronary syndrome (ACS) (62.5%). In these high-risk (average Syntax score 24) patients, clinical success of PCI was achieved in 100% of cases. In the short-term observation, we recorded two major adverse cardiac and cerebrovascular events (MACCE) including one fatal, acute stent thrombosis.Conclusions: Our data suggest that the use of S-IVL is safe and effective as a bail-out strategy to manage LM lesions resistant to high-pressure NC balloon inflation. Despite encouraging initial results, future large studies with long-term observation are required to evaluate the safety and efficacy of S-IVL in LM stenosis.
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