OR4-1 | In-hospital Results with Intravascular Lithotripsy in the Real-World: Outcomes from the ACC NCDR® CathPCI Registry®

Intravascular lithotripsy (IVL) has shown promising safety and effectiveness in the treatment of calcified coronary artery disease (CAD) in large trials and small 'real-world' observational studies. Evidence from a larger more complex cohort is lacking. We therefore aimed to evaluate the all-comer real-world performance of the Shockwave C2 coronary IVL using the ACC NCDR® CathPCI Registry®. Patients treated with IVL in the CathPCI Registry were categorized according to key eligibility criteria from the Disrupt CAD III post-approval study (PAS) alongside a Non-PAS cohort, representing more complex patients and procedures. Subgroups of interest (left main, bifurcation procedures, and patients with acute coronary syndromes [ACS]) were studied. Procedural outcomes and observed versus predicted risks of in-hospital mortality using the NCDR-derived Castro-Dominguez Bedside Risk Score model were evaluated. 18,893 IVL procedures were performed between March 2021 and March 2022, with most (n=17,681; 93.6%) not meeting PAS criteria. All lesions (n=20,832) were treated with IVL; 4,521 (21.7%) were also treated with atherectomy. 6,811 (36.1%) of patients had ACS; procedures included treatment of in-stent-restenosis (19.5%), bifurcations (18.1%), and left main lesions (14.5%). Baseline mean diameter stenosis was 86.5 ± 11.1% and lesion length was 32.3 ± 20.4 mm. Post-procedure residual stenosis was 4.0 ± 12.%. Major procedural complications, including 0.7% perforations and 0.9% grade ≥C dissections, were infrequent. Observed and expected in-hospital mortality rates were similar in the PAS cohort: 0.25% vs. E:0.31% and the non-PAS cohort: O:2.38% vs. E:2.37%, respectively. Detailed outcomes in complex subgroups will be presented. Most patients treated with IVL in the CathPCI Registry were excluded from the formal Disrupt CAD III PAS and are at substantially increased risk. In this first IVL all-comer analysis from CathPCI in a real-world setting, IVL resulted in low rates of major procedural complications, and in-hospital mortality was aligned with predicted rates by current risk models.