Intravascular lithotripsy (IVL) facilitates drug-coated balloon (DCB) delivery and leads to favorable results in severely calcified coronary lesions without stenting.

Background/Introduction The adoption of drug coated balloons (DCB) for treatment of coronary lesions is rapidly expanding. Along with this trend comes an increasing lesion complexity being treated with DCBs. In this context, optimal lesion preparation, permitting not only good luminal gain, but also preserving vascular integrity and limiting flow limiting dissection, is key. Yet sufficient information about the safety and efficacy of intravascular lithotripsy (IVL) for management of coronary lesions treated with DCBs is lacking. Purpose To assess the safety and efficacy of intravascular lithotripsy (IVL) in the treatment of coronary lesions managed with drug-coated balloons (DCBs). Material and Methods Consecutive patients undergoing lesion preparation with IVL for treatment of calcified coronary lesions with contemporary DCBs were analyzed from the prospective SIROOP Registry (NCT04988685). Outcomes of interest included, among others, periprocedural complications and target lesion failure (TLF). Angiograms and outcomes were independently adjudicated. Results Overall, 41 patients and 43 lesions underwent DCB-PCI involving Shockwave. The patient’s mean age was 73.2±7 years, 37 patients (90.2%) were males. Regarding lesion characteristics, 26 (60.5%) cases involved instent restenosis (ISR), 4 (9.3%) of which were chronic total occlusions (CTO), and only 17 (39.5%) were native lesions. Hybrid treatment, requiring additional stent implantation, was performed in 15 (35%) lesions, the remainder was treated with a "DCB-only" approach. There were no flow-limiting dissections requiring bail-out stent implantation as well as no coronary artery perforations. After a mean follow-up time of 12±3 months, TLF occurred in 12 (27.9%) lesions, TVR was required in 17 (39.5%) vessels. Of note, TLF and TVR were mostly attributable to recurrent ISR in previously implanted metallic stent. Conclusion IVL seems to be a safe and effective preparation strategy for management of calcified coronary lesions undergoing DCB-PCI. Nonetheless, we also encountered an unexpectedly high rate of recurrent ISR, despite aggressive lesion preparation and use of contemporary DCBs. More research is warranted to define optimal lesion preparation, especially in calcified lesions, undergoing DCB-PCI.

Drug-Coated Balloon After Intravascular Lithotripsy

Introduction: Coronary artery disease (CAD) is typically a chronic, progressive, inflammatory disease of the coronary arteries caused by coronary atherosclerosis. Moderate-to-severe calcification is present in up to 30% of patients undergoing coronary angiography (CA). Calcified coronary artery lesions are one of the most complex and challenging lesion subsets in interventional cardiology. Shockwave intravascular lithotripsy (IVL) is a recently introduced calcium-modifying technique for the treatment of concentric, eccentric and nodular calcifications. Case presentation: We present a clinical case of a 73-year-old male complaining of intermittent chest pain. He was a non-smoker with a positive familiar history for CVD. He had previous myocardial infarction and stenting of the right coronary artery (RCA), previous CVI, paroxysmal atrial fibrillation, insulin-dependent type 2 diabetes, heart failure with mildly reduced ejection fraction (HFmrEF) and chronic kidney disease (CKD) stage II/IIIa. CA revealed heavily calcified CAD. A calcified lesion of the left anterior descending artery (LAD) was treated using a 3.0/12 mm Shockwave IVL balloon; and calcium cracks and fractures were confirmed by optical coherence tomography (OCT). We proceeded with an NC balloon and finally treated the lesion with a 3.5/15 mm drug-coated balloon (DCB). The calcified lesion of the RCA was treated with conventional techniques using guiding catheter extension, NC balloons and drug-eluting stent (DES). Conclusion: Heavily calcified coronary artery lesions remain one of the biggest challenges for interventional cardiologists. Shockwave IVL is designed for treatment of all types of heavily calcified lesions using acoustic waves (shock waves). IVL is safe and effective technique that will definitely strengthen the armamentarium for modern treatment of heavily calcified lesions.

BackgroundCalcified coronary artery disease presents a significant challenge during percutaneous coronary intervention (PCI). Intravascular lithotripsy (IVL) emerges as a ground-breaking modality for the modification of calcific plaques, thereby enhancing stent...

Optimal plaque preparation of calcified coronary lesions is key to prevent stent failure. The purpose of this study was to determine the strategy success and safety of intravascular lithotripsy (IVL) in calcified lesions of an all-comers cohort. Patients with calcified coronary lesions were screened in 3 centers. Seventy-one patients were eligible for IVL. Patients were assigned to (group A) primary IVL therapy for patients with calcified de-novo lesions (n=39 lesions), (group B) secondary IVL therapy for patients with calcified lesions in which noncompliant balloon dilatation failed (n=22 lesions), and (group C) tertiary IVL therapy in patients with stent underexpansion after previous stenting (n=17 lesions). Primary end point was strategy success (stent expansion with <20% in-stent residual stenosis) and safety outcomes (procedural complications, in-hospital major adverse cardiovascular event). Seventy-eight calcified lesions were treated using the Shockwave C2 balloon. Mean diameter stenosis of calcified lesions was 71.8±13.1% at baseline, decreased to 45.1±17.4% immediately after IVL, and to 17.5±15.2% after stenting. Mean minimal lumen diameter was 1.01±0.49 mm at baseline and increased to 1.90±0.61 after IVL, and to 2.88±0.56 mm after stenting. The primary end point of strategy success was reached in 84.6% (group A), 77.3% (group B), and 64.7% (group C). Device delivery and IVL treatment were possible in all lesions. Four type b dissections were observed without further sequelae. No patient suffered from in-hospital major adverse cardiovascular event. Seven Shockwave balloons ruptured during treatment without any sequelae. IVL provides a valid strategy for lesion preparation in severely calcified coronary lesions with high success rate, low procedural complications, and low major adverse cardiovascular event rates.

Calcium Modification During Peripheral Intervention With a Novel Intravascular Lithotripsy System: An Institutional Experience

Intravascular Lithotripsy for Peripheral Artery Calcification: 30-Day Outcomes From the Randomized Disrupt PAD III Trial.

Introduction Heavily calcified coronary lesions impede appropriate stent deployment and expansion, increasing the risk of complications. Intravascular Lithotripsy (IVL) technology disrupts subendothelial calcification by using localized pulsative sonic pressure waves and is a promising technique for patients with severe coronary calcification. Purpose Our aim was to systematically review and summarize available data regarding the safety and efficacy of IVL in preparing severely calcified plaques in coronary before stenting. Methods 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 peri-procedural complications and major adverse cardiovascular events (MACE) in a 30-day period were assessed using a random-effects model. Results This meta-analysis comprised 38 studies including 2,977 patients with heavily calcified coronary lesions. The mean age was 72.2 ± 9.1 years, with an overall IVL procedural success rate of 98% (95% CI: 96%-99%, I2=69.2%) and clinical success of 96% (95% CI: 93%-98%, I2=72.2%), 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 (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 mm and 1.94 ± 1.1 mm, respectively. Peri-procedural complications were rare, with just a few cases of perforations, dissection, or no-reflow phenomena recorded. Conclusions The present meta-analysis shows that IVL constitutes an effective and safe technique for preparing severely calcified lesions before stent implantation in coronary arteries. These results support the use of IVL in the high procedural risk setting of severe coronary calcification.

Systematic review and updated meta-analysis of the use of drug-coated balloon angioplasty versus plain old balloon angioplasty for femoropopliteal arterial disease

The management of patients with calcified de novo lesions remains a major clinical challenge even in the era of drug-eluting stents (DES). Drug-coated balloon (DCB) therapy has emerged as an alternative to DES to treat de novo lesions. Nevertheless, the management of calcified lesions using intravascular lithotripsy (IVL) combined with DCB to treat de novo lesions has not been investigated. The authors report the short-term results of our preliminary experience with this novel approach. The authors conducted a multicenter retrospective study of 14 patients who underwent percutaneous coronary intervention for de novo lesions treated with IVL followed by DCB in 3 centers between September 2023 and July 2024. The mean age of the patients was 69 years, and 71% were male. At 30 days, 1 patient experienced non-cardiac death. No lesion site thrombosis, target lesion revascularization (TLR), or cardiac death occurred at the 30-day follow-up. At the 6-month follow-up, 2 (14.3%) patients experienced TLR. This real-world data using IVL followed by DCB (in cases of acceptable lesion preparation) in patients with de novo calcified coronary lesions suggest that this strategy is feasible and appears to have an acceptable target lesion failure rate at mid-term follow-up. This proof of concept could be hypothesis-generating for larger studies.

Introduction: The combination of intravascular lithotripsy (IVL) and drug-coated balloon (DCB) angioplasty for calcified peripheral lesions is associated with promising short-term results. However, data regarding the 12 months performance of this treatment option is missing. This study reports on the outcomes of IVL and DCB angioplasty for calcified femoropopliteal disease. Methods: Patients treated with IVL and DCB for calcified femoropopliteal lesions between February 2017 and September 2020 were included into this study. The primary outcome measure of this analysis was primary patency. Secondary patency, freedom from target lesion revascularization (TLR) and overall mortality were additionally analyzed. Results: Fifty-five (n = 55) patients and 71 lesions were analyzed. Most patients presented with long-term limb-threatening ischemia (n = 31, 56%), 47% (n = 26) were diabetics, and 66% (n = 36) had long-term kidney disease. The median lesion length was 77 mm (interquartile range: 45-136), and 20% (n = 14) of the lesions were chronic total occlusions (CTOs). Eccentric calcification was found in 23% of the vessels (n = 16), and circumferential calcium (peripheral arterial calcium scoring system [PACSS] Class 3 and 4) was present in 78% (n = 55) of the treated lesions. The technical success after IVL amounted to 87% (n = 62) and the procedural success to 97% (n = 69). A flow-limiting dissection was observed in 2 cases (3%). Both the rates of target lesion perforation and distal embolization were 1% (n = 1). A bail-out scaffold was deployed in 5 lesions (7%). At 12 months the Kaplan-Meier estimate of primary patency was 81%, the freedom from TLR was 92% and the secondary patency 98%. The overall survival amounted to 89%, while the freedom from major amputation to 98%. The presence of eccentric disease, CTOs, or PACSS Class 4 did not increase the risk for loss of patency or TLR. Conclusions: In this challenging cohort of patients, the use of IVL and DCB for calcified femoropopliteal lesions was associated with promising 12 months outcomes and an excellent safety profile.

Objectives: Intravascular lithotripsy (IVL) followed by drug-coated balloon (DCB) angioplasty might be a valuable alternative to surgery for calcified common femoral artery (CFA) atherosclerotic disease. Nonetheless, the 12 months performance of this treatment strategy remains unknown. This study reports on the 12 months outcomes of IVL with adjunctive DCB angioplasty for calcified CFA lesions. Methods: This is a retrospective single-center, single-arm study. Consecutive patients treated by IVL and DCB for calcified CFA disease between February 2017 and September 2020 were evaluated. The primary measure outcome of this analysis was primary patency. Procedural technical success (<30% stenosis), freedom from target lesion revascularization (TLR), secondary patency, and overall mortality were additionally analyzed. Results: Thirty-three (n=33) patients were included in this study. The majority presented with lifestyle limiting claudication (n=20, 61%), 52% (n=17) of the patients had chronic kidney disease (CKD) and 33% (n=11) had diabetes. The procedural technical success was 97% (n=32). A flow-limiting dissection post IVL was observed in 2 patients (6%) and a peripheral embolization in a single patient (3%), while the bail-out stenting rate amounted to 12% (n=4). No perforation was observed. The median length of hospital stay was 2 days (interquartile range 2–3). At 12 months, the primary patency was 72%. The freedom from TLR and the secondary patency rates were 94% and 88%, respectively. The 12-month survival amounted to 100% and 75% (n=25) of the patients were asymptomatic or presented with mild claudication. The presence of chronic limb-threatening ischemia (CLTI) (hazard ratio [HR], 0.92; confidence interval (CI); 0.18–4.8, p=0.7) or CKD (HR, 1.30; 95% CI, 0.29–5.8; p=0.72), as well as the use of a 7 mm IVL catheter (HR, 0.59; 95% CI, 0.13–2.63; p=0.49) or of high-dose DCB (HR, 0.68; 95% CI, 0.13–3.53; p=0.65) did not influence the primary patency. Conclusions: In this study, the combination of IVL and DCB angioplasty for calcified CFA disease was associated with low risk for periprocedural complications, acceptable 12 months clinical outcomes, and low rates of reinterventions. Clinical Impact Intravascular lithotripsy in combination with DCB angioplasty can be an alternative to surgery in highly selected patients with CFA atherosclerotic disease. In this Cohort the combination therapy lead to acceptable clinical results and low reintervention rates at 12 months.

A Warm Welcome to The First Issue of JSCAI

Introduction: Coronary artery calcification (CAC), a hallmark of advanced atherosclerosis, is driven by inflammatory cytokines like TNF-α, IL-6, and ICAM-1, worsening outcomes Post-Per Cutaneous Coronary Intervention (PCI). Drug-coated balloons (DCBs) offer a stent-free alternative to drug-eluting stents (DES) in CAC, but their anti-inflammatory mechanisms remain unclear. This study evaluates DCB-induced TNF-α suppression and its link to clinical and angiographic outcomes. Hypothesis: DCBs reduce inflammation-driven calcification via TNF-α modulation, improving procedural success and lowering major adverse cardiac events (MACE). Methods: A systematic review (2020–2025) of PubMed, EMBASE, and Cochrane Library identified studies evaluating DCB use in CAC. Inclusion criteria required reporting pre- and post-procedural inflammatory markers (TNF-α, IL-6, ICAM-1) or MACE (cardiac death, myocardial infarction, target lesion revascularization). Three studies (n=1,218) were analyzed using random-effects models and mixed regression. Results: DCBs significantly reduced TNF-α in calcified lesions (41.78±6.21 vs. 37.91±5.89 pg/mL; p =0.018), with greater reductions in severe calcification (Δ=−6.3 vs. −2.1 pg/mL; p =0.03). No changes in IL-6 (2.55±1.02 vs. 3.11±1.34 pg/mL; p =0.18) or ICAM-1 (14.11±3.45 vs. 13.91±3.12 ng/mL; p =0.62) were observed. MACE rates in calcified lesions (11.3%; 95% CI:8.2–14.4%) matched non-calcified lesions (9.8%; p =0.24). Angiographic success was 92%, with lower stent deformation vs. DES (4% vs. 12%; p =0.01). DCBs showed non-inferior late lumen loss to DES (0.24±0.18 vs. 0.27±0.21 mm; p =0.15). Subgroup analysis linked baseline TNF-α &gt;50 pg/mL to higher 12-month TLR (18.7% vs. 8.9%; p =0.004). Conclusions: DCBs selectively suppress TNF-α in CAC, correlating with reduced restenosis and high procedural success. While IL-6/ICAM-1 remained unaffected, TNF-α modulation positions DCBs as viable DES alternatives in complex CAC. Limitations include short follow-up and protocol heterogeneity. Future studies should standardize lesion preparation and extend cytokine monitoring.

Some clinical trials have verified the efficacy and safety of paclitaxel drug-coated balloon (DCB) for small vessel coronary artery disease. However, nonsmall vessel and calcified lesions received less attention. This study aimed to investigate the efficacy of DCB treatment for various types of coronary artery lesions, including not only small vessel disease but also nonsmall vessel disease and calcified lesions. In this real-world clinical practice study, in-stent restenosis was excluded. This study consecutively included 934 patients with 1751 nonstented lesions who received DCB at a cardiovascular center in Kyoto Katsura Hospital in Japan between 2009 and 2012 and 2014 to 2019. This study enrolled and retrospectively analyzed all of the patients. Eligible patients routinely underwent follow-up angiography at 6-8 months after percutaneous coronary intervention. The primary endpoint includes target lesion revascularization (TLR) during follow-up. Further, this study calculated the predictor of TLR using multivariate analysis. This study included the lesions involving 46.4% of type B2/C, 26.9% with severe calcification, and 6.0% with DCB restenosis. Mean DCB diameter and length were 2.75 ± 0.51 mm and 24.2 ± 9.6 mm, respectively. The median follow-up duration was 18 months. Follow-up angiography revealed a TLR rate of 9% and a restenosis rate of 9%. This study identified hemodialysis and current smoking as independent TLR predictors. In routine clinical practice, the effectiveness of DCB was observed consistently across various types of coronary artery disease.