Intravascular Lithotripsy for the Treatment of Stent Underexpansion: The Multicenter IVL-DRAGON Registry

Abstract

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.

Intravascular Lithotripsy as a Novel Treatment Method for Calcified Unprotected Left Main Diseases—Comparison to Rotational Atherectomy—Short-Term Outcomes

“…Interestingly, when comparing the RA-LM- PCI and S-IVL-LM-PCI results, we noticed an insignificant trend wherein the MACE rate increased (17.2% vs. 13.3%), with a similar all-cause mortality level. There is a lack of strong evidence supporting the efficiency of S-IVL-LM-PCI; however, our results partially confirm some other trials [ 27 , 28 , 29 , 30 ]. These findings might be linked to the decreased rate of periprocedural complications after S-IVL.…”

Intravascular Lithotripsy for Underexpanded Stent in Heavily Calcified Coronary Artery Disease

“…In multicenter IVL-Dragon Registry, 62 consecutive patients with stent underexpansion were treated with IVL procedural success (72.6% of patients) [8]. Intravascular imaging confirmed increased stent expansion following IVL from 37.5% to 86% by optical coherence tomography and from 57% to 89% by intravascular ultrasound.…”

Rota-Lithotripsy as a Novel Bail-Out Strategy for Highly Calcified Coronary Lesions in Acute Coronary Syndrome

“…On the other hand, the NC balloon dilatation, in terms of eccentric calcium plaque, may direct the dilatation forces toward the non-calcified segments of the artery with a faint effect on calcium nodules. On the other hand, the S-IVL is a bulky device focused on the disruption of deep calcium plaque with the inability to cross through high-grade stenosis lesions [ 35 , 36 , 37 ].…”