Safety, efficacy, and optical coherence tomography insights into intravascular lithotripsy for the modification of non-eruptive calcified nodules: A prospective observational study.

Non-eruptive calcium nodules (CNs) are commonly seen in heavily calcified coronary artery disease. They are the most difficult subset for modification, and may result in stent damage, malapposition and under-expansion. There are only limited options available for non-eruptive CN modification. Intravascular lithotripsy (IVL) is being explored as a potentially safe and effective modality in these lesions. This study aimed to investigate the safety and efficacy of the use of IVL for the modification of non-eruptive CNs. The study also explored the OCT features of calcium nodule modification by IVL. This is a single-center, prospective, observational study in which patients with angiographic heavy calcification and non-eruptive CN on OCT and undergoing PCI were enrolled. The primary safety endpoint was freedom from perforation, no-reflow/slow flow, flow-limiting dissection after IVL therapy, and major adverse cardiac events (MACE) during hospitalization and at 30 days. MACE was defined as a composite of cardiac death, myocardial infarction (MI), and ischemia-driven target lesion revascularization (TLR). The primary efficacy endpoint was procedural success, defined as residual diameter stenosis of <30% on angiography and stent expansion of more than 80% as assessed by OCT. A total of 21 patients with 54 non-eruptive CNs undergoing PCI were prospectively enrolled in the study. Before IVL, OCT revealed a mean calcium score of 3.7 ± 0.5 and a mean MLA at CN of 3.9 ± 2.1 mm2. Following IVL, OCT revealed calcium fractures in 40 out of 54 (74.1%) CNs with an average of 1.05 ± 0.72 fractures per CN. Fractures were predominantly observed at the base of the CN (80%). Post IVL, the mean MLA at CN increased to 4.9 ± 2.3 mm2. After PCI, the mean MSA at the CN was 7.9 ± 2.5 mm2. Optimal stent expansion (stent expansion >80%) at the CN was achieved in 85.71% of patients. All patients remained free from MACE during hospitalization and at the 30-day follow-up. At 1-year follow-up, all-cause death had occurred in 3 (14.3%) patients. This single-arm study demonstrated the safety, efficacy, and utility of the IVL in a subset of patients with non-eruptive calcified nodules. In this study, minimal procedural complications, excellent lesion modifications, and favorable 30-day and 1-year outcomes were observed.

Gupta A ，Shrivastava A ，Chhikara S ，Revaiah PC ，Mamas MA ，Vijayvergiya R ，Seth A ，Singh B ，Bajaj N ，Singh N ，Dugal JS ，Mahesh NK ... -  《-》

Coronary intravascular lithotripsy in contemporary practice: challenges and opportunities in coronary intervention.

Gupta A ，Shrivastava A ，Dugal JS ，Chhikara S ，Vijayvergiya R ，Singh N ，Mehta AC ，Mahesh NK ，Swamy A ... -  《-》

Efficacy of intravascular lithotripsy (IVL) in coronary stenosis with severe calcification: A multicenter systematic review and meta-analysis.

With heavily calcified coronary and peripheral artery lesions, lesion preparation is crucial before stent placement to avoid underexpansion, associated with stent thrombosis or restenosis and patency failure in the long-term. Intravascular lithotripsy (IVL) technology disrupts superficial and deep calcium by using localized pulsative sonic pressure waves, making it to a promising tool for patients with severe calcification in coronary bed. The aim of the study is to systematically review and summarize available data regarding the safety and efficacy of IVL for lesion preparation in severely calcified coronary arteries before stenting. This study was conducted according to the PRISMA guidelines. We systematically searched PubMed, SCOPUS, and Cochrane databases from their inception to February 23, 2023, for studies assessing the characteristics and outcomes of patients undergoing IVL before stent implantation. The diameter of the vessel lumen before and after IVL, as well as stent implantation, were analyzed. The occurrence of major adverse cardiovascular events (MACE) was assessed using a random-effects model. This meta-analysis comprised 38 studies including 2977 patients with heavily calcified coronary lesions. The mean age was 72.2 ± 9.1 years, with an overall IVL clinical success of 93% (95% confidence interval [CI]: 91%-95%, I2 = 0%) and procedural success rate of 97% (95% CI: 95%-98%, I2 = 73.7%), while the in-hospital and 30-days incidence of MACE, myocardial infarction (MI), and death were 8% (95% CI: 6%-11%, I2 = 84.5%), 5% (95% CI: 2%-8%, I2 = 85.6%), and 2% (95% CI: 1%-3%, I2 = 69.3%), respectively. There was a significant increase in the vessel diameter (standardized mean difference [SMD]: 2.47, 95% CI: 1.77-3.17, I2 = 96%) and a decrease in diameter stenosis (SMD: -3.44, 95% CI: -4.36 to -2.52, I2 = 97.5%) immediately after IVL application, while it was observed further reduction in diameter stenosis (SMD: -6.57, 95% CI: -7.43 to -5.72, I2 = 95.8%) and increase in the vessel diameter (SMD: 4.37, 95% CI: 3.63-5.12, I2 = 96.7%) and the calculated lumen area (SMD: 3.23, 95% CI: 2.10-4.37, I2 = 98%), after stent implantation. The mean acute luminal gain following IVL and stent implantation was estimated to be 1.27 ± 0.6 and 1.94 ± 1.1 mm, respectively. Periprocedural complications were rare, with just a few cases of perforations, dissection, or no-reflow phenomena recorded. IVL seems to be a safe and effective strategy for lesion preparation in severely calcified lesions before stent implantation in coronary arteries. Future prospective studies are now warranted to compare IVL to other lesion preparation strategies.

Sagris M ，Ktenopoulos N ，Dimitriadis K ，Papanikolaou A ，Tzoumas A ，Terentes-Printzios D ，Synetos A ，Soulaidopoulos S ，Lichtenberg M ，Korosoglou G ，Honton B ，Tousoulis D ，Tsioufis C ，Toutouzas K ... -  《-》

Safety and Effectiveness of Coronary Intravascular Lithotripsy for Treatment of Severely Calcified Coronary Stenoses: The Disrupt CAD II Study.

Ali ZA ，Nef H ，Escaned J ，Werner N ，Banning AP ，Hill JM ，De Bruyne B ，Montorfano M ，Lefevre T ，Stone GW ，Crowley A ，Matsumura M ，Maehara A ，Lansky AJ ，Fajadet J ，Di Mario C ... -  《-》

Impact of coronary calcium morphology on intravascular lithotripsy.

McInerney A ，Travieso A ，Jerónimo Baza A ，Alfonso F ，Del Val D ，Cerrato E ，Garcia de Lara J ，Pinar E ，Perez de Prado A ，Jimenez Quevedo P ，Tirado-Conte G ，Nombela-Franco L ，Brugaletta S ，Cepas-Guillén P ，Sabaté M ，Cubero Gallego H ，Vaquerizo B ，Jurado A ，Varbella F ，Jimenez M ，Garcia Escobar A ，de la Torre JM ，Amat Santos I ，Jimenez Diaz VA ，Escaned J ，Gonzalo N ... -  《-》