Intravascular Lithotripsy in Calcified Coronary Lesions

Abstract

Background: Optimal plaque preparation of calcified coronary lesions is key to prevent stent failure. The purpose of this study was to determine the strategy success and safety of intravascular lithotripsy (IVL) in calcified lesions of an all-comers cohort. Methods: Patients with calcified coronary lesions were screened in 3 centers. Seventy-one patients were eligible for IVL. Patients were assigned to (group A) primary IVL therapy for patients with calcified de-novo lesions (n=39 lesions), (group B) secondary IVL therapy for patients with calcified lesions in which noncompliant balloon dilatation failed (n=22 lesions), and (group C) tertiary IVL therapy in patients with stent underexpansion after previous stenting (n=17 lesions). Primary end point was strategy success (stent expansion with <20% in-stent residual stenosis) and safety outcomes (procedural complications, in-hospital major adverse cardiovascular event). Results: Seventy-eight calcified lesions were treated using the Shockwave C 2 balloon. Mean diameter stenosis of calcified lesions was 71.8±13.1% at baseline, decreased to 45.1±17.4% immediately after IVL, and to 17.5±15.2% after stenting. Mean minimal lumen diameter was 1.01±0.49 mm at baseline and increased to 1.90±0.61 after IVL, and to 2.88±0.56 mm after stenting. The primary end point of strategy success was reached in 84.6% (group A), 77.3% (group B), and 64.7% (group C). Device delivery and IVL treatment were possible in all lesions. Four type b dissections were observed without further sequelae. No patient suffered from in-hospital major adverse cardiovascular event. Seven Shockwave balloons ruptured during treatment without any sequelae. Conclusions: IVL provides a valid strategy for lesion preparation in severely calcified coronary lesions with high success rate, low procedural complications, and low major adverse cardiovascular event rates.

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

“…Recently introduced IVL seems to be promising and safe and is considered by many as the next big leap in coronary intervention. Although there are some reports in the literature, there is currently scarcity of data from a real‐world population 21‐30 . There are two reports from the real world, but their numbers were small ranging from 26 to 78 patients.…”

“…The IVL system transmits electrical energy into mechanical energy during low‐pressure inflation from the balloon surface 21 . Although, there are a few reported studies on this novel technology, data from the real world is scarce 22‐30 . In this study, we report the initial IVL experience from six centers (United Kingdom and Italy) that undertake high‐volume complex coronary interventions.…”

Intravascular imaging–guided intracoronary lithotripsy: First real‐world experience

“…Our results were compared very favorably to a prospective registry of 78 IVL cases in Germany, which demonstrated a successful PCI strategy (residual stenosis <20%) in 84.6% of calcified de novo lesions, 77.3% of lesions in which noncompliant balloon dilatation failed, and 64.7% of patients with stent underexpansion. 12 Our results also were compared well to clinical success rates (defined as residual stenosis <50% and no periprocedural complications) for rotablation in a large (966 patients) contemporary European registry (91.9%). 13 Utilizing intracoronary imaging, our results establish the efficacy of IVL in treating highly calcified coronary lesions in a range of real‐world patients (Figure 2 ), comprising many lesions (eg, LMS, ISR, unstable lesions in ACS) that were not included in the original DISRUPT‐CAD trials of IVL.…”

Repeated intracoronary lithotripsy as a treatment for rebel stent underexpansion

“…Despite this, the presence of calcification that is not appreciably visible on angiographies can result in the occurrence of said complication. Although IVL has shown very good results in the treatment of calcified de novo lesions, according to recent studies, in the specific scenario of stent underexpansion the results have been much worse, with success rates between 64.7% 2 and 25% 3 in different published series, and some isolated cases of stent thrombosis due to underexpansion treated with this therapy. 4 …”