Real-world outcomes in treatment of highly calcified coronary lesions with intravascular shockwave lithotripsy

Abstract

Real-world data regarding the efficacy and safety of coronary intravascular lithotripsy (IVL) are lacking. We conducted a study of 50 consecutive patients (64 lesions) who underwent IVL. 3 patients suffered in-hospital mortality unrelated to the IVL; there was no other occurrence of MACE up to 30 days. Angiographic success was nearly universal (98% of patients with residual stenosis <50%, 96% of patients with TIMI 3 flow) and complication was rare, including among patients undergoing IVL for in-stent restenosis or left main coronary artery lesions. In a high-risk real-world cohort, IVL was a safe and effective treatment for highly-calcified coronary lesions.

Intravascular Lithotripsy for Treatment of Severely Calcified Coronary Lesions: 1-Year Results From the Disrupt CAD III Study

“…with acute coronary syndromes and IVL treatment of in-stent restenosis have also reported favorable safety and effectiveness outcomes of coronary IVL with low rates of adverse clinical events at 1 year. 26,27 Thus, the relative 1-year benefits of IVL were sustained in both indirect comparisons with orbital atherectomy 28,29 and with historical cohorts of patients with moderate or severe target lesion calcification undergoing PCI with other lesion preparation techniques. 6,30,31 Nonetheless, adequately powered randomized trials are required to further evaluate the relative safety and effectiveness of different types of calcium-modifying therapies for calcified lesions.…”

“…[37][38][39] The safety and effectiveness of coronary IVL as an adjunct to stenting has been observed by others in smaller, initial "real-world" clinical experiences with limited 1-year follow-up. 26,27 Additionally,…”

Intravascular imaging in coronary stent restenosis: Prevention, characterization, and management

“…In a recent retrospective study of 50 patients who underwent IVL, 13 patients had ISR as the target lesion. Angiographic success occurred in 100% and none experienced death, MACE, or major bleeding at 30 days ( 152 ). Most recently, a prospective multicenter observational study of IVL in calcified coronary lesions included ISR with stent underexpansion in almost 30% ( n = 40) of the enrolled procedures.…”

One-year outcomes in patients who underwent coronary intravascular shockwave lithotripsy for highly-calcified coronary lesions

“… 2 , 3 IVL has been shown to have excellent angiographic and short-term clinical results in patients with heavily calcified lesions who require percutaneous coronary intervention in both randomized and observational studies. 2 , 5 , 8 , 9 , 10 However, limited data exist regarding long-term outcomes. A recently published follow-up study of the Disrupt CAD III clinical trial cohort showed low rates of major adverse cardiac events (MACE), target vessel revascularization (TVR), and stent thrombosis at one year.…”

“…We previously published a study examining the immediate periprocedural and 30-day outcomes in a real-world IVL cohort; this study found nearly 100% angiographic success and low complications rates at 30 days. 10 In order to help better define long-term outcomes, we conducted a follow-up of the same high-risk cohort over a 1-year period following IVL.…”