Novel Hertz Contact Intravascular Lithotripsy: Could We Achieve More in Balloon-Based Calcium Modification?

Abstract: Background: Severe coronary artery calcification (CAC) poses a major challenge during percutaneous coronary intervention (PCI) and increases the likelihood of in-stent restenosis (ISR). Rotational atherectomy (RA) and intravascular lithotripsy (IVL) are widely used plaque-modifying strategies, yet clear guidance on selecting between them remains limited. This systematic review compares the efficacy of RA and IVL in the management of ISR, focusing on patient characteristics, lesion morphology, procedural performance, and clinical outcomes. Methods: A systematic search was conducted in PubMed, the Cochrane Library, and Google Scholar for studies published from January 2020 to April 2025. The review adhered to PRISMA 2020 guidelines. Inclusion criteria comprised angiographically confirmed coronary ISR treated with RA or IVL and reported angiographic or clinical outcomes. Both randomized and observational studies were eligible. Data extraction encompassed study characteristics, procedural parameters, complications, and short- to mid-term outcomes. A qualitative synthesis was performed due to heterogeneity in study design and reported endpoints. Results: Nine studies involving 1,250 patients met the eligibility criteria. Procedural success was consistently high (95–100%) for both modalities. IVL demonstrated numerically fewer procedural complications in several reports, particularly vessel perforation and slow/no-reflow (RA 3–13% vs. IVL 0–3%), although pooled results did not reach statistical significance. Rates of major adverse cardiac events (MACE) during follow-up were comparable between groups (RA 6–18% vs. IVL 5–17%). RA was more frequently employed in densely calcified lesions requiring substantial plaque debulking, whereas IVL tended to be favored in cases prioritizing procedural safety. Conclusion: RA and IVL are effective strategies for treating calcified ISR after PCI. Selection should be individualized based on lesion complexity, plaque morphology, and procedural risk. Additional high-quality studies are needed to refine modality-specific indications and establish long-term comparative outcomes.

Severe coronary artery calcification (CAC) remains a significant challenge in interventional cardiology, especially in elderly and comorbid patients, such as diabetes or chronic kidney disease. CAC often leads to complications such as stent thrombosis and restenosis, therefore leading to bad clinical outcomes and increased major adverse cardiovascular events (MACE) rates. Traditional approaches, including rotational atherectomy (RA), are commonly used to treat calcified plaques; however, are limited by procedural complexity, length of procedures, and risk of vascular injury. In contrast, intravascular lithotripsy (IVL) has emerged as a novel therapy using acoustic pressure waves to break calcified plaques with minimal vascular trauma. Despite its increasing use, direct comparisons between IVD and RA in the context of severe CAC are scant and leave critical evidence gaps for therapy optimization. This study compares IVL and RA outcomes to improve strategies for severe CAC management. This study aims at comparing the clinical outcomes such as procedural success, safety evaluations and clinical efficacy of IVL with RA in the treatment of severe CAC. A systematic review and meta-analysis were conducted following PRISMA 2020 guidelines and registered in PROSPERO (CRD42024626551). Searches were performed in PubMed, ScienceDirect, Embase, and Scopus databases using the descriptors "Rotablator," "Lithotripsy," and "Coronary Disease" combined with Boolean operators ("AND" and "OR"). Eligible studies directly compared IVL and RA, assessing outcomes such as procedural success, safety, and efficacy. Inclusion criteria were directed to retrospective cohorts and randomized studies with at least 6 months of follow-up, excluding case reports, reviews, and conference abstracts. Two independent reviewers performed data extraction with a third resolving discrepancies. The ROBINS-I tool was used to assess the risk of bias in non-randomized studies, while statistical analyses were done using R software (version 4.3.2). Eleven studies with a total of 2120 patients were included. IVL demonstrated significant benefits over RA, such as reduced use of contrast (MD: -17.45 mL; 95% CI: -32.79 to -2.11) and lower procedural time (MD: -27.90 min; 95% CI: -30.11 to -25.68; I² = 92.3%). IVL also effectively treated complex lesions, such as bifurcations and calcified left main arteries, by fragmenting plaques with minimal vascular trauma and reduced procedural risks. While luminal gain showed no differences between groups (MD: -0.07 mm²; 95% CI: -0.34 to 0.35), IVL provided higher rates of stent deployment success and lower target lesion revascularization, indicating better long-term vessel patency. The meta-analysis for mortality outcome showed a pooled OR of 0.55 (95% CI: 0.28-1.06; I² = 1%; p = 0.42) under the common-effect model and 0.70 (95% CI: 0.35-1.42) under the random-effects model, with negligible heterogeneity (I² = 1%). These consistent findings across studies reinforce IVL as a safer and effective strategy for severe CAC and warrant further trials to establish long-term benefits. IVL showed slight advantages over RA in severe CAC, including reduced contrast use, shorter procedure times, and fewer complications. Further trials are needed to confirm these findings and to reduce the heterogeneity of the studies.

Introduction Coronary artery calcification (CAC) is commonly encountered by interventional cardiologists. Severe CAC may impair stent delivery or result in stent underexpansion, stent thrombosis and/or in-stent restenosis (ISR). Multiple tools have been developed to help overcome the challenges associated with CAC and improve outcomes for these patients. Intravascular shockwave lithotripsy (IVL) is a novel therapy that uses acoustic pressure waves for the modification of CAC. Areas covered This review discusses the growing body of evidence to support the safety and efficacy of IVL in the setting of de novo severely calcified coronary arteries prior to stenting. We also discuss international real-world experience with the coronary IVL system. This includes the use of IVL in the setting of acute coronary syndrome (ACS), ISR and in combination with other tools for calcium modification. Expert opinion IVL is a safe and effective therapy that results in the fracture of coronary calcium and facilitates optimal stent delivery and expansion. Longer term follow-up is essential to shed light on the durability and late outcomes of an IVL strategy. Randomized control trials are warranted to compare IVL to alternative methods of calcium modification and to explore further the use of IVL for ACS.

Severe coronary artery calcification (CAC) remains challenging during percutaneous coronary intervention (PCI) and often requires 1 or more advanced calcium modification tools. We describe the combination use of rotational (RA) or orbital atherectomy (OA), with intravascular lithotripsy (IVL), termed rotatripsy and orbital-tripsy, respectively, for modifying CAC prior to stent implantation during PCI. We performed a retrospective analysis of patients treated with rotatripsy or orbital-tripsy at our center between July 2019 and March 2022. The primary efficacy endpoint was procedural success (successful stent implantation, <30% residual stenosis visually, Thrombolysis in Myocardial Infarction 3 flow; absence of types C to F dissection/perforation or loss of side branch ≥2.0mm visually) without in-hospital major adverse cardiovascular event (MACE, defined as cardiovascular death, myocardial infarction [MI], target-vessel revascularization). A total of 25 patients (14 rotatripsy and 11 orbital-tripsy) were included in our study. The mean age was 72.2 ± 7.6 years and 76% were men. PCI was guided by intravascular imaging in 24 patients (96%). All cases were treated with either RA or OA before utilization of IVL. Procedural success was achieved in 22 cases (88%) with 1 sidebranch loss without periprocedural MI (4%) and 2 in-patient deaths (8%) unrelated to the procedure (1 intracerebral hemorrhage and 1 cardiac arrest). We describe efficacious use of both rotatripsy and orbital-tripsy to modify severe CAC during PCI in a real-world setting. Intravascular imaging can guide appropriate use of these devices to complement each other to modify severe CAC to achieve optimal outcomes.

<h3>Introduction</h3> Severe coronary artery calcification (CAC) in patients undergoing percutaneous coronary intervention (PCI) is a common cause of procedural complications, lack of success, and stent failure. In this study we examine the utility of a novel technique to deal with this problem: intravascular lithotripsy (IVL) using the ‘Shockwave’ device. <h3>Methods</h3> A retrospective single centre study was conducted of consecutive patients treated with coronary IVL between January and October 2020. Baseline demographics were obtained from electronic patient records and SYNTAX scores were calculated from index coronary angiograms. Procedural success was verified by independent review of the angiogram and defined as (1) adequate stent expansion, (2) no significant residual stenosis and (3) TIMI III flow in all major branches. Target lesion revascularisation (TLR) was defined as any unplanned repeat PCI of the target lesion or bypass of the target vessel performed for in-stent restenosis (ISR) or other complication of the target lesion. Clinical outcomes including Canadian Cardiovascular Society (CCS) angina classification were assessed at virtual clinical follow-up. <h3>Results</h3> 47 patients were treated with IVL during the study period. Baseline demographics and procedural characteristics are seen in tables 1 and 2, respectively. All patients had circumferential or near-circumferential calcium as determined by coronary angiography ± intracoronary imaging. 57% had treatment of a de novo lesion, 32% had PCI to a previously placed under-expanded stent and 11% had severely calcified ISR. Procedural success was high (94%), however, reasons for failure/abandonment included: (i) intra-procedural ischaemia with significant residual stenosis, (ii) prolonged procedural time, ischaemia and resistant stent under-expansion and (iii) prolonged procedural time, dissection with no-reflow, in the setting of a chronic total occlusion (CTO). <h3>Complications Included</h3> Coronary dissection (13%) of which the majority were successfully treated with conservative measures and coronary perforation (2%) which was treated with prolonged balloon inflation. At a mean follow up of 10 months, 23% underwent planned/staged-PCI, 4% underwent CABG and there were 2 (4%) deaths. There was a 51% reduction in CCS angina class from 2.9 (prior to IVL) to 1.4 (post IVL), p&lt;0.00001. <h3>Conclusions</h3> The use of coronary IVL is a very effective percutaneous therapy for severe CAC. This cohort shows high procedural success with IVL and a significant reduction in CCS angina class at follow-up.

Coronary Lithotripsy as Elective or Bail-Out Strategy After Rotational Atherectomy in the Rota-Shock Registry

The feasibility of intravascular lithotripsy (IVL) for modification of severe coronary artery calcification (CAC) was demonstrated in the Disrupt CAD I study (Disrupt Coronary Artery Disease). We next sought to confirm the safety and effectiveness of IVL for these lesions. The Disrupt CAD II study was a prospective multicenter, single-arm post-approval study conducted at 15 hospitals in 9 countries. Patients with severe CAC with a clinical indication for revascularization underwent vessel preparation for stent implantation with IVL. The primary end point was in-hospital major adverse cardiac events (cardiac death, myocardial infarction, or target vessel revascularization). An optical coherence tomography substudy was performed to evaluate the mechanism of action of IVL, quantifying CAC characteristics and calcium plaque fracture. Independent core laboratories adjudicated angiography and optical coherence tomography, and an independent clinical events committee adjudicated major adverse cardiac events. Between May 2018 and March 2019, 120 patients were enrolled. Severe CAC was present in 94.2% of lesions. Successful delivery and use of the IVL catheter was achieved in all patients. The post-IVL angiographic acute luminal gain was 0.83±0.47 mm, and residual stenosis was 32.7±10.4%, which further decreased to 7.8±7.1% after drug-eluting stent implantation. The primary end point occurred in 5.8% of patients, consisting of 7 non-Q-wave myocardial infarctions. There was no procedural abrupt closure, slow or no reflow, or perforations. In 47 patients with post-percutaneous coronary intervention optical coherence tomography, calcium fracture was identified in 78.7% of lesions with 3.4±2.6 fractures per lesion, measuring 5.5±5.0 mm in length. In patients with severe CAC who require coronary revascularization, IVL was safely performed with high procedural success and minimal complications and resulted in substantial calcific plaque fracture in most lesions. URL: https://www.clinicaltrials.gov. Unique identifier: NCT03328949.

Background:Coronary artery calcification (CAC) is a strong predictor of long-term adverse outcomes in patients with coronary artery disease (CAD). Meanwhile, insulin resistance (IR) is a key metabolic disorder that accelerates CAC progression through multiple pathways. Fibroblast growth factor 21 (FGF21) improves glucolipid metabolism and has been associated with vascular calcification. However, the relationship between serum FGF21 level and CAC severity in patients with varying degrees of IR remains unclear.Methods:A total of 128 patients with CAD who underwent preprocedural coronary computed tomography angiography and percutaneous coronary intervention were enrolled. Patients were stratified by triglyceride–glucose (TyG) index into high (TyG >8.62, n = 62) and low (TyG ≤8.62, n = 66) groups. Associations between FGF21 levels and severe CAC were analyzed under varying degrees of IR.Results:In patients with a TyG index >8.62, serum FGF21 levels were significantly lower in those with severe CAC, and were negatively correlated with CAC scores. Multivariable analysis revealed that serum FGF21 levels were independently associated with severe CAC (odds ratio (OR) per 1-standard deviation (SD) increase: 0.261; 95% confidence interval (CI): 0.073, 0.933; p < 0.05). In contrast, serum FGF21 levels among patients with a TyG index ≤8.62 did not differ significantly between the severe and non-severe CAC groups, and no independent association between serum FGF21 level and severe CAC was observed after adjustment. Importantly, a significant interaction was observed between the TyG index and FGF21 level (p for interaction = 0.035). Moreover, the protective association between FGF21 and CAC was primarily observed in patients with a high TyG index.Conclusions:Lower serum FGF21 levels in patients with CAD can identify individuals at increased risk of severe CAC, particularly among those with a higher degree of IR. Serum FGF21 levels may serve as a novel biomarker for CAC risk stratification in metabolically susceptible patients.

ABSTRACTBackgroundCoronary artery calcification is strongly linked to factors such as advanced age, dyslipidemia, and chronic kidney disease. Severe coronary artery calcification significantly elevates the complexity and risk of percutaneous coronary intervention (PCI), potentially giving rise to complications such as incomplete stent expansion, restenosis, and thrombosis. Intravascular lithotripsy (IVL), a novel approach, can break up calcified plaques and facilitate stent delivery and expansion. Nevertheless, its comprehensive safety and efficacy in pretreating severe coronary artery calcification lesions remain uncertain, and research data is relatively scarce compared to traditional techniques, especially in the large hospital setting of Henan with a considerable population base.AimsTo retrospectively analyze the safety and efficacy of IVL in the treatment of severe coronary artery calcification in 261 cases.MethodsFrom January 2022 to March 2024, 261 patients with at least one coronary artery lesion diagnosed as severe calcification and undergoing PCI based on IVL in Fuwai Central China Cardiovascular Hospital and Henan Provincial People's Hospital were selected for the study. A retrospective analysis was conducted on 272 diseased vessels treated with IVL for PCI. The primary endpoint was procedural success, while the main safety endpoints were no cardiac death, myocardial infarction, and target vessel revascularization within 30 days.ResultsAmong the 261 patients, 234 (89.7%) had acute coronary syndrome (ACS), including 195 (74.7%) with non‐ST‐segment elevation myocardial infarction (NSTEMI). Various techniques like noncompliant balloon, cutting balloon, and orbital grinding were employed for IVL preparation, and the proportion of direct IVL treatment was 8.8% (24 cases). The minimum lumen area significantly increased from (1.5 ± 0.6) mm² before treatment to (7.2 ± 1.8) mm² after treatment, with an acute gain rate of (243 ± 105)%, (p < 0.001), indicating a statistically significant difference. The primary efficacy endpoint was achieved 100%, and the primary safety endpoint was 2.6%. Perioperative complications were infrequent and were managed successfully.ConclusionsAs a new technology for modifying calcified plaques, the IVL system proves to be safe, effective, and straightforward to operate, offering a new and preferred option for patients with severe coronary calcified lesions, particularly those with ACS.

IntroductionCoronary artery disease (CAD) is a progressive, inflammatory disorder with calcification forming as plaque heals. Coronary artery calcification (CAC) is thus a biomarker of CAD. The 2020 BSCI/BSTI guidelines recommended,...

There is limited information on the clinical relevance and procedural impact of coronary artery calcification (CAC) in the contemporary percutaneous coronary intervention (PCI) setting. This study sought to determine the incidence and clinical significance of procedural techniques on the outcomes in 'real-world' patients with CAC undergoing PCI with drug-eluting stents (DESs). Using patient-level data from seven stent-specific, prospective DES registries, we evaluated 17 084 patients who underwent PCI with various DES types between July 2007 and July 2015. The primary outcome was target-vessel failure (TVF), defined as a composite of cardiac death, target-vessel myocardial infarction, or target-vessel revascularization. Outcomes through 3 years (and between 0-1 and 1-3 years) were assessed according to CAC status (none/mild vs. moderate/severe) and stenting technique (predilation or post-dilation). Among 17 084 patients with 22 739 lesions included in the pooled dataset, moderate to severe CAC was observed in 11.3% of patients (10.1% of lesions). Older age, lower BMI, diabetes, hypertension, family history of coronary artery disease, and renal failure were independent predictors of moderate/severe CAC. The presence of moderate/severe CAC was significantly associated with an adjusted risk of TVF at 3 years [hazard ratio, 1.37; 95% confidence interval (CI), 1.19-1.58; P < 0.001]. For severe CAC, optimal lesion preparation with predilation was associated with a lower 3-year rate of TVF (no vs. yes, 22.3 vs. 12.8%), in which the effect of predilation was prominent at the late period of 1-3 years (hazard ratio, 0.28; 95% CI, 0.12-0.69; P = 0.003) than at the early period through 1 year (hazard ratio, 1.16; 95% CI, 0.37-3.71; P = 0.80). However, post-dilation (with a high-pressure noncompliant balloon) had no effect on the outcome. In this study, moderate/severe CAC was common (~10%) and strongly associated with TVF during 3 years of follow-up. For severe CAC, optimal lesion preparation with pre-balloon dilation has a significant effect on long-term outcomes, especially during the late period beyond 1 year. Clinical Trial Registration - URL: http://www.clinicaltrials.gov. Unique identifier: NCT01186133.

CALCIFIED CORONARY LESION: IS IT STILL THE ACHILLES’ HEAL OF PERCUTANEOUS CORONARY INTERVENTIONS?

BACKGROUND. Coronary artery calcification (CAC) on lung cancer screening low-dose chest CT (LDCT) is a cardiovascular risk marker. South Korea was the first Asian country to initiate a national LDCT lung cancer screening program, although CAC-related outcomes are poorly explored. OBJECTIVE. The purpose of this article is to evaluate CAC prevalence and severity using visual analysis and artificial intelligence (AI) methods and to characterize CAC's association with major adverse cardiovascular events (MACEs) in patients undergoing LDCT in Korea's national lung cancer screening program. METHODS. This retrospective study included 1002 patients (mean age, 62.4 ± 5.4 [SD] years; 994 men, eight women) who underwent LDCT at two Korean medical centers between April 2017 and May 2023 as part of Korea's national lung cancer screening program. Two radiologists independently assessed CAC presence and severity using visual analysis, consulting a third radiologist to resolve differences. Two AI software applications were also used to assess CAC presence and severity. MACE occurrences were identified by EMR review. RESULTS. Interreader agreement for CAC presence and severity, expressed as kappa, was 0.793 and 0.671, respectively. CAC prevalence was 53.4% by consensus visual assessment, 60.1% by AI software I, and 56.6% by AI software II. CAC severity was mild, moderate, and severe by consensus visual analysis in 28.0%, 10.3%, and 15.1%; by AI software I in 39.9%, 14.0%, and 6.2%; and by AI software II in 34.9%, 14.3%, and 7.3%. MACEs occurred in 36 of 625 (5.6%) patients with follow-up after LDCT (median, 1108 days). MACE incidence in patients with no, mild, moderate, and severe CAC for consensus visual analysis was 1.1%, 5.0%, 2.9%, and 8.6%, respectively (p < .001); for AI software I, it was 1.3%, 3.0%, 7.9%, and 11.3% (p < .001); and for AI software II, it was 1.2%, 3.4%, 7.7%, and 9.6% (p < .001). CONCLUSION. For Korea's national lung cancer screening program, MACE occurrence increased significantly with increasing CAC severity, whether assessed by visual analysis or AI software. The study is limited by the large sex imbalance for Korea's national lung cancer screening program. CLINICAL IMPACT. The findings provide reference data for health care practitioners engaged in developing and overseeing national lung cancer screening programs, highlighting the importance of routine CAC evaluation.

BackgroundCalcified lesions are one of the most challenging cases for PCI, where optimal angiographic results and satisfying outcomes are hard to achieve.MethodsWe evaluated the baseline clinical, procedures characteristics and outcomes of patients with severe coronary artery calcification (CAC) who underwent coronary intravascular lithotripsy (IVL) and rotational atherectomy (RA).ResultsRespectively 152 and 238 patients who underwent IVL and RA are enrolled from January 2023 to November 2023. Regarding demographic characteristics, the gender proportion, medical history of PCI and smoke history among groups reach statistical significance. Left anterior descending and right coronary artery were the main vessels treated in both groups. The 2.5 and 3.0 mm IVL balloons and 1.5 mm burr were the most commonly used. 99.3% cases were successfully implanted drug-eluting stents after IVL balloon pre-treatment, which was higher than in the group treated with RA. During hospitalization, there were no serious adverse events in the IVL group, but there were two adverse events in the RA group. Procedural complications were higher in the RA group than the IVL group (5.5% vs. 0.7%, P = 0.027).ConclusionsIVL appears to be safe and effective for the treatment of severe CAC lesions compared to RA.

Coronary artery calcification is strongly associated with adverse cardiac events and can impede the success of percutaneous coronary intervention (PCI) due to challenges with delivery of equipment and expansion of stents. Current treatment modalities for mitigation of coronary calcification have limitations and inherent risk of complications. Coronary intravascular lithotripsy (IVL) is a novel technique to modify coronary artery calcification via acoustic pressure waves. IVL utilizes an easy-to-use device, which does not require a steep learning curve. Prospective studies have shown this technique to be safe and effective and can be used to adequately modify calcified coronary stenoses in preparation for PCI and stent deployment and optimization. IVL has unique features that can be used alone or as an adjunctive therapy to other available calcium modification tools. As compared to the currently established modalities of calcium modification, IVL has the potential to facilitate successful PCI with fewer serious procedural complications. In this review article, we discuss the importance of coronary artery calcification, the role of IVL, its mechanism, the current clinical data behind its use and future directions. Overall, coronary IVL is a promising technology for the treatment of severely calcified coronary stenoses, with a need for, long-term clinical outcome data of IVL-facilitated PCI.