Intravascular lithotripsy in heavily calcified chronic total occlusion: procedural and one-year clinical outcomes.

BACKGROUND: Calcification within chronic total occlusions (CTO) is strongly associated with worse outcomes. Despite the excellent success and safety of intravascular lithotripsy (IVL) in heavily calcified lesions, evidence in CTO remains scarce. AIM: This study aimed to evaluate the procedural and long-term clinical outcomes of IVL in heavily calcified CTO. METHODS: Patients who underwent IVL between 2019 and 2024 from an ongoing prospective multicenter registry were eligible for inclusion. Patients were therefore classified in CTO and non-CTO groups. The efficacy and safety endpoints of CTO percutaneous coronary interventions were defined according to the CTO-ARC consensus. In-hospital major adverse cardiovascular events (MACE) included cardiac death, nonfatal myocardial infarction and target lesion revascularization (TVR). RESULTS: A total of 404 patients underwent IVL, of which the treated lesion was a CTO in 33 (8.2%). The mean J-CTO score was 2.3 ± 1.1. Device success showed no significant difference between CTO and non-CTO groups (100% vs 98.4%; p = 0.35). Comparable technical success with residual stenosis <30% was observed in both groups (90.1% in CTO vs 89.2% in non-CTO, p = 0.83). The incidence of MACE was similar across groups during hospital stays (CTO 6.0% vs. non-CTO 1.9%, p = 0.12), at 30-day (CTO 9.1% vs. non-CTO 3.0%, p = 0.07), and at 12-month follow-up (CTO 9.1% vs. non-CTO 7.3%, p = 0.70). CONCLUSION: IVL provides high procedural success and consistent clinical outcomes in both CTO and non-CTO cases, reinforcing its role in managing heavily calcified coronary lesions.

Procedural and clinical impact of intracoronary lithotripsy in heavily calcified aorto-ostial coronary lesions.

BACKGROUND: Percutaneous coronary intervention of calcified aorto-ostial lesions (AOL) pose unique challenges due to anatomical propensity for recoil, leading to poorer outcomes compared to non-AOL. Although intravascular lithotripsy (IVL) has shown excellent success and safety in heavily calcified plaques, evidence specific to AOL is limited. This study aims to evaluate the efficacy and safety of IVL in AOL versus non-AOL. METHODS: Patients treated with IVL between 2019 and 2023 from an ongoing prospective multicenter registry were eligible for inclusion. Patients were therefore classified in AOL and non-AOL groups, based on anatomical location. The primary technical endpoint was device success, defined as the ability to deliver the IVL catheter and pulses at the target lesion, without angiographic complications. Secondary technical endpoint encompassed procedural success <30%, consisting of device success with residual stenosis <30%, final thrombolysis in myocardial infarction grade 3 flow, and no in-hospital major adverse cardiovascular events (MACE). The primary clinical endpoint was in-hospital MACE, including cardiac death, nonfatal myocardial infarction, or target lesion revascularization. RESULTS: A total of 321 patients underwent IVL, including 48 with AOL. Device success showed no significant difference between AOL and non-AOL groups (100% vs. 98.2%; p = 0.35). A nonsignificant trend toward worse procedural success with residual stenosis <30% was observed in the AOL arm (AOL 81.3% vs. non-AOL 90.5%, p = 0.06). In-hospital MACE was significantly higher in AOL (4.2% vs. 0.7%, p = 0.048), attributed entirely to cardiac deaths. At 6-month follow-up, the incidence of MACE (AOL 8.3% vs. non-AOL 4.0%, p = 0.19), and cardiac deaths (AOL 4.2% vs non-AOL1.1%, p = 0.11) were comparable between groups. CONCLUSION: IVL treatment for heavily calcified AOL demonstrates comparable procedural and 6-month clinical outcomes when compared to non-AOL, despite a higher incidence of in-hospital MACE.

Current applications, procedural and 1-year outcomes of Rotatripsy for the treatment of calcified coronary lesions.

BACKGROUND: Intravascular lithotripsy (IVL) combined with rotational atherectomy (RA), known as Rotatripsy, is used to treat severe coronary artery calcification (CAC), though data on efficacy, midterm safety and use sequence is limited. We aimed to identify indicators for Rotatripsy use and to assess its safety and success rates, both acutely and at 1-year follow-up. METHODS: Patients undergoing Rotatripsy for severe CAC across six centers from May 2019 to December 2023 were included. Demographic, clinical, procedural and follow-up data were collected. Efficacy endpoints included device success (delivery of the RA-burr and IVL-balloon across the target lesion and administration of therapy without related complications), technical success (TIMI 3 flow and residual stenosis <30% by quantitative coronary analysis) and procedural success [composite of technical success with absence of in-hospital major adverse cardiovascular events (MACE: cardiac death, myocardial infarction or target vessel revascularization). Safety endpoints comprised Rotatripsy-related complications and MACE at 1-year follow-up. RESULTS: A total of 114 patients (75 ± 9 years, 78% male) underwent Rotatripsy for 120 lesions. In the majority of procedures RA was followed by IVL, mostly electively (n = 68, 57%) but also for balloon underexpansion (n = 37, 31%) and stent crossing failure (n = 1, 1%). Diverse and complex target lesions were addressed with an average SYNTAX score of 24.6 ± 13.0. Device, technical and procedural success were 97%, 94% and 93%, respectively. Therapy-related complications included two (2%) coronary perforations, one (1%) coronary dissection and one (1%) burr entrapment. At 1-year follow-up(present in 77(67%) patients), MACE occurred in 7(9%) cases. CONCLUSIONS: Over a 1-year follow-up period, Rotatripsy was safe and effective, predominantly using RA electively before IVL.

Procedural and clinical impact of intravascular lithotripsy for the treatment of peri-stent calcification.

BACKGROUND: Use of intravascular lithotripsy (IVL) for treating peri-stent calcification is increasing. However, this indication remains 'off-label'. We aimed to investigate the efficacy and clinical outcomes of in-stent IVL. METHODS: Patients from five European centers who underwent in-stent IVL were included between 2019 and 2023. Demographic, clinical, procedural and follow-up data were collected from electronic hospital records. Angiographic and intracoronary imaging (ICI) data were analyzed in a centralized core-laboratory. RESULTS: Of 101 patients (71.2 ± 9.2 years), 56(55 %) received in-stent IVL for late stent failure (median 109 days post-PCI) due to calcific neoatherosclerosis or extra-stent calcification(late-IVL), while 45(45 %) underwent bail-out IVL due to stent infraexpasion (immediate-IVL). Both late-IVL and immediate-IVL significantly improved angiographic %diameter stenosis (73.7[59.6-89.8]% to 16.4 [10.4-26.9]%;p < 0.0001 and 28.6[22.5-43.3]% to 14.1[10.3-29.4]%;p < 0.0001, and minimum lumen area (MLA) (3.4 ± 1.2 to 8.6 ± 2.5 mm2;p < 0.002 and 5.4 ± 1.9 to 7.3 ± 1.9;p < 0.0001).Device(98 %) and procedural success(80 %) were high. MACE rates in-hospital (2 %), 30-days (3 %),6-months(5 %) and 1-year(7 %) were low and comparable in both groups. Acute diameter gain was lower in immediate-IVL (2.1 ± 0.7 mm vs. 0.5 ± 0.4 mm;p < 0.0001). This, however, was explained by significant differences in pre-IVL angiographic and ICI parameters (%diameter stenosis 73.7[59.6-89.8] vs. 28.6[22.5-43.3]%; p < 0.0001 and MLA (3.4 ± 1.2 vs 5.4 ± 1.9 mm2; p < 0.0001), whereas post-IVL percentage diameter stenosis (16.4(10.4-26.9) vs. 14.1(10.3-29.4);p = 0.914) and MLA (8.6 ± 2.5vs. 7.4 ± 1.9 mm2;p = 0.064) in late- and immediate-IVL were comparable. CONCLUSIONS: IVL in-stent due to peri-stent calcification is an effective strategy, both late and immediately after stent implantation. Overall, MACE rates at short- and mid-term were low and comparable in both groups, although clinical findings should be taken with caution.

Intravascular lithotripsy for the treatment of peri-stent calcific lesions in saphenous vein grafts: A case series report.

BACKGROUND: Coronary artery bypass grafting (CABG) is a cornerstone treatment for coronary artery disease, with the use of saphenous vein grafts (SVGs) being prevalent. However, SVGs are susceptible to high failure rates due to graft inflammation, intimal hyperplasia, and atherosclerosis, leading to a substantial number of patients requiring revascularization. Percutaneous coronary intervention (PCI) of SVGs poses unique challenges, including increased risk of distal embolization and perforation due to the grafts' structure and atherosclerotic nature. The role of intravascular lithotripsy (IVL) in calcific SVG lesions has not been elucidated. METHODS: We retrospectively analyzed four cases of patients treated with IVL for SVG stenosis at Leiden University Medical Centre between May 2019 and December 2023. Quantitative coronary analysis and intravascular ultrasound were utilized to assess procedural success and mid- to long-term clinical outcomes were reported as well. RESULTS: In all 4 cases, IVL was performed in stent (2 due to calcific in-stent neoatherosclerosis; 2 bail-out due to extrinsic stent calcification). No major adverse cardiovascular events (MACE) were reported during mid- to long-term follow-up. The procedure demonstrated effective calcium cracking, leading to optimal stent expansion and minimal residual stenosis with a low risk of procedural complications. CONCLUSIONS: IVL represents a promising approach for managing calcified peri-stent SVG lesions, showing potential for safe and effective revascularization with minimal complications. These findings suggest that IVL could be incorporated into the treatment paradigm for calcified peri-stent SVG stenosis, warranting further investigation in larger, prospective studies to validate its efficacy and safety.