Safety and efficacy of a novel calcified plaque modification device — Shockwave Intravascular Lithotripsy — in all-commers with Coronary Artery Disease: Mid-term outcomes

Background: Coronary interventions in calcified lesions are associated with a higher rate of clinical adverse events. Initial aggressive plaque modification along with post-implantation optimization is pivotal for achieving a favorable effect of the percutaneous coronary intervention (PCI). Recently, the Shockwave C2 Intravascular Lithotripsy (S-IVL), a novel acoustic wave-based device designed to modify calcified plaque, has been introduced into clinical practice. Aims: We evaluated the mid-term safety and efficiency of S-IVL in an all-comers cohort with severely calcified coronary lesions. Methods: We retrospectively analyzed a total 131 consecutive S-IVL PCI procedures. The study had two main inclusion criteria the presence of: calcified, resistant lesion (defined by an inadequate non-complaint balloon catheter inflation) or a significantly under-expanded stent (more than 20% of reference diameter). The study had two primary endpoints – successful clinical outcome and safety concerns. Clinical success was defined as effective stent deployment or optimization of a previously under-expanded stent (with less than <20% in-stent residual stenosis). Safety outcomes were defined as periprocedural complications, such as device failure, and major adverse cardiac and cerebrovascular events (MACCE). Clinical follow-up was performed at the end of hospitalization and 6 months after the index procedure. Results: In-hospital MACCE was 4.6% with 1.5% target lesion revascularization (TLR) and one case of subacute fatal stent thrombosis. At the 6-month-follow-up, the MACCE rate was 7.9% with a concomitant TLR rate of 3.8%. Conclusion: Our mid-term data confirm an acceptable safety and efficacy of intravascular lithotripsy as a valuable strategy for lesion preparation and stent optimization in an all-comers cohort with severely calcified coronary lesions