Background: Coronary intravascular lithotripsy (IVL) is an emerging therapy for the modification of coronary artery calcification (CAC). Data on its use in several clinical and lesion subsets are limited due to their exclusion from preapproval trials.
Methods: We performed a retrospective review of patients who were excluded from preapproval trials of coronary IVL and underwent CAC modification with the off-label use of a peripheral IVL system. The primary outcome was a composite of procedural success, defined as residual stenosis <10%, and no major adverse cardiac event (MACE), ie, cardiac death, myocardial infarction, or target- vessel revascularization, in hospital and at 30 days.
Results: Between June 2019 and April 2020, a total of 9 patients who underwent off-label coronary IVL were identified. Exclusion criteria from preapproval trials included a target lesion within an unprotected left main coronary artery (ULMCA; n = 3) and/or ostial location (n = 5), a target lesion involving in-stent restenosis (n = 3), a second target-vessel lesion with >50% stenosis (n = 1), and/or New York Heart Association class III/IV heart failure (n = 5). The primary outcome was achieved in 8 patients. MACE rate was 0% in hospital and at 30 days. For ULMCA lesions (n = 3), residual stenosis was 0% in 2 patients and 10% in 1 patient. For right coronary artery lesions (n = 3), residual stenosis was 0% in 2 patients and 40% in 1 patient. For left anterior descending coronary artery lesions (n = 3), residual stenosis was 0% in all patients.
Conclusion: Coronary IVL with a peripheral IVL system may be an effective therapy for CAC modification within ULMCA disease, ostial disease, in-stent restenosis, and New York Heart Association class III/IV heart failure.
Keywords: intravascular lithotripsy; unprotected left main coronary artery.