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

Objective: We sought to determine the safety and performance of intravascular lithotripsy in the treatment of severe calcified atherosclerotic lesions.

Background: The modification of severe calcified atherosclerotic lesions with noncompliant or specialty balloons, as well as orbital or rotational atherectomy has limitations and may be ineffective, increasing the risk of periprocedural complications and worsening long-term results. Intravascular lithotripsy has recently been shown to be a safe and feasible alternative to the above methods.

Methods: All consecutive patients treated with Shockwave Medical Intravascular Lithotripsy (S-IVL) between May 2019 and June 2020 were included in current analysis. Device safety and efficacy were the critical endpoints of the study. The primary safety endpoint was 30-day major adverse cardiac events (MACE). In turn, device and clinical success were the primary performance endpoints.

Results: In total, 46 patients undergoing percutaneous coronary intervention were treated with S-IVL before stent deployment (65% male; age, 71 ± 7 years). Device success was achieved in 45 (97.8%) patients with reduction of diameter stenosis from 80% to 5.2% with an acute gain of 2.5 mm. Clinical success was demonstrated in 95.6% of cases. During the 30-day follow-up, one sudden death was recorded, regarded as probable subacute stent thrombosis. During 6-month follow up one target lesion and target vessel revascularizations occurred. The rate of MACE after 6 month was 6.2%.

Conclusions: S-IVL appears to be a safe and effective treatment modality in coronary calcium modification to optimize stent expansion. In selected cases this device obviates the need for more complex lesion preparation strategies such as atherectomy.