Intravascular lithotripsy in calcified‐coronary lesions: A real‐world observational, European multicenter study

Abstract

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.

Type E coronary artery dissection caused by intravascular lithotripsy balloon rupture; vessel anatomy and characteristics in a lithoplasty complication case as detailed by optical coherence tomography: a case report

“…Published real-world data from the several registries worldwide including the SING-IVL registry, 5 a European Multicentre registry 6 and a German multicentre registry by Aksoy et al , 7 all demonstrated similarly low complication rates. In the latter registry, there was a 9% balloon rupture rate.…”

Feasibility of intravascular lithotripsy for calcific coronary lesions: A multi‐institutional experience

“…In the study presented by Aziz et al MACE was 2.6%, including two cardiac deaths (1%), one TVMI (0.5%) and three cases of TLR (1.5%). 14 The mean follow-up was 222 days.…”

Intravascular Lithotripsy in Calcified Coronary Lesions: A Single-Center Experience in “Real-World” Patients

“…Several technological developments have been introduced to aid in the treatment of severely calcified coronary lesions. Recently, intravascular lithotripsy (IVL), a balloon-based calcium-modifying technique, has been introduced as a promising strategy, which is simple to use, with a high rate of procedural success and a low rate of complications (3)(4)(5)(6). Nevertheless, data regarding IVL use in distinctive anatomical settings and different clinical indications are scarce and longterm data using this therapeutic approach are lacking.…”