Rotational atherectomy (RA) is predominantly performed to treat severely calcified lesions in patients with coronary atherosclerotic heart disease (CAD). Studies focusing on the assessment of postoperative coronary microvascular dysfunction (CMD) after RA and related prognosis are scarce.

We investigated the predictive risks of microvascular dysfunction and postoperative major adverse cardiovascular events (MACE) in patients after RA.

This retrospective and multicenter study analyzed the data from patients after RA between January 2019 and November 2022. The coronary microcirculatory function after RA was assessed using angiography-derived microcirculatory resistance (AMR). Patients were categorized into CMD and non-CMD groups depending on a postoperative AMR of ≥2.5 mm Hg-s/cm. Patients were followed up for MACE.

We analyzed data from 532 patients; after RA, the mean AMR, mean QFR, and percentage of CMDs were significantly higher as compared prior to RA (p < 0.001). A total of 143 (26.9 %) patients had AMR ≥2.5 after the procedure. MACE occurred in 117 (22.0 %) patients after 18 months of follow-up. The proportion of patients with MACE was higher in the AMR ≥ 2.5 than in the AMR < 2.5 (32.1 % vs. 18.2 %, p < 0.001) group. Cox regression analysis showed that AMR ≥2.5 mm Hg-s/cm (HR = 2.01, 95 % CI: 1.39-2.92, p < 0.001), EF and renal insufficiency were independent predictors of MACE. Logistic regression analyses revealed that the length of the RA operative area and presence of diabetes mellitus (DM) were related to post-RA CMD.

The operative length of RA and DM were associated with CMD after RA; furthermore, post-RA AMR ≥2.5 mm Hg-s/cm independently predicted post-RA MACE.

Evaluation of calcified lesions by intravascular imaging has revealed that atherectomy devices have only limited impact. However, subsequent use of coronary intravascular lithotripsy (IVL) may increase treatment effectiveness without increasing risk of complications. This study was designed to evaluate the safety and effectiveness of IVL use after atherectomy in severely calcified coronary lesions as pre-treatment for drug-eluting stents (DES). The Dual-Prep registry is a multicenter, prospective registry of consecutive image-guided percutaneous coronary interventions (PCI). The primary effectiveness and safety endpoints were procedural success (residual stenosis < 50% by quantitative coronary angiography) without an in-hospital major adverse cardiac event (MACE) and 30-day freedom from MACE, respectively. Baseline vessel calcification score and final DES expansion were evaluated by optical coherence tomography (OCT). A total of 118 patients with 120 lesions were enrolled at 20 sites. The calcification score of lesions after atherectomy by core-lab assessment was 4.0 in all cases. Rotational atherectomy was applied prior to IVL in 83.9% cases with mean burr size of 1.57 ± 0.20 mm; IVL was subsequently successfully delivered in all cases (mean balloon diameter 3.02 ± 0.45 mm), followed by DES deployment (mean diameter 3.19 ± 0.51 mm, length of 36.3 ± 16.0 mm). The primary efficacy and safety endpoints were met in 98.3% and 98.3% of cases, respectively. A DES expansion index < 0.8 was seen in 42.2%, and an eccentricity index < 0.7 was not observed in any patient. In severely calcified lesions, image-guided atherectomy followed by IVL lesion preparation demonstrated high procedural success rates and satisfactory non-eccentric stent expansion. This approach may be considered for lesions where an 'IVL-first' strategy may not be feasible. jRCT1032230384 (Oct 7, 2023).

Rotational atherectomy (RA) is an effective, mature, and specific treatment for calcified lesions. However, the incidence of RA-related myocardial injury remains high and has not been adequately addressed. To assess the safety and efficacy of low-temperature RA-flush solution versus room-temperature RA-flush solution during RA. A total of 132 patients with moderate-to-severe calcified lesions who underwent RA were randomly assigned to the low-temperature RA-flush solution group or the room-temperature RA-flush solution group. The primary endpoint was RA-related myocardial injury, defined as any increase in myocardial biomarkers within 72 h after percutaneous coronary intervention (PCI). Secondary endpoints included RA-related myocardial infarction (MI), RA-related transient slow/no flow, or transient coronary spasm. A total of 78 patients (59.1%) had increased cardiac troponin I (cTnI) levels, and 60 patients (45.5%) had increased creatine kinase isoenzyme (CK-MB) levels after PCI. The number of patients with myocardial injury (primary endpoint), defined as elevated cTnI (47.0% vs. 71.2%, p = 0.005) or elevated CK-MB (28.8% vs. 62.1%, p < 0.001), was significantly lower in the low temperature group than in the room temperature group. The number of patients with RA-related transient slow/no flow (6.1% vs. 34.8%, p < 0.001) and transient coronary spasm (9.1% vs. 25.8%, p = 0.012) (secondary endpoints) was significantly lower in the low temperature group than in the room temperature group; no significant difference in the incidence of RA-related MI was observed between the two groups. Compared with room-temperature RA-flush solution, low-temperature RA-flush solution is associated with reduced RA-related myocardial injury in patients treated with RA.Registration: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT03701230; first submitted registration date: 09/10/2018.

The ROLLER COASTR-EPIC22 was the first randomized trial to directly compare rotational atherectomy (RA), excimer laser coronary angioplasty (ELCA), and intravascular lithotripsy (IVL) for the treatment of patients with calcified coronary stenosis.

The aim of this study is to report and compare its 1-year clinical outcomes.

The ROLLER COASTR-EPIC22 trial randomized 171 patients with angiographic moderate to severe calcified coronary lesions to PCI with RA (n = 57), IVL (n = 57), or ELCA (n = 57). A pre-specified analysis of clinical events at one year from the index PCI was conducted. The clinical endpoints analyzed at one year were the rate of major adverse cardiovascular events (MACE), defined as the occurrence of cardiac death, target vessel myocardial infarction (TV-MI), target lesion revascularization (TLR), target vessel revascularization (TVR) and stent thrombosis. Furthermore, the rate of all-cause mortality, non-fatal TV-MI, TVR, TLR, and stent thrombosis were analyzed separately. Kaplan-Meier analysis was performed to assess time-to-event outcomes. The adjudication of clinical events was conducted in accordance with the intention-to-treat principle.

The mean age was 70.9 ± 8.2 years and 77.2% of the patients were men. Clinical presentation was acute coronary syndrome in 35.7% of patients and severe angiographic calcification was observed in 82.5% of lesions by the independent core laboratory unaware to the treatment arm. All patients showed criteria of severe calcification, either angiographic or at optical coherence tomography (OCT). At OCT evaluation, mean calcium arc was 300.8° ± 78.9°, maximum calcium thickness 1.17 ± 0.24 mm, calcification length 30.9 ± 12.9 mm and 30.5% of patients presented calcium nodules. Baseline characteristics were well balanced between groups. At one year, there were no significant differences in MACE incidence among the three arms (RA 5.3%, IVL 5.3%, ELCA 3.5%; p = 0.88). Furthermore, there were no significant differences in all-cause death between groups (p = 0.22), with no events in the IVL group (RA 5.3%, IVL 0%, ELCA 5.3%). No significant differences were observed among the 3 arms in the terms of TV-MI (RA 1.7, IVL 1.7, ELCA 0%; p = 0.61), TVR (RA 3.5%, IVL 5.3%, ELCA 1.7%; p = 0.59), TLR (RA 1.7%, IVL 1.7%, ELCA 1.7%; p = 1.00), or stent thrombosis (RA 1.7%, IVL 0%, ELCA 1.7; p = 0.61).

This is the first randomized trial comparing RA, IVL, and ELCA for the treatment of patients with calcified coronary lesions and reporting long-term clinical outcomes. At one year, no significant differences were observed among the three arms in the composite endpoint of one-year all-cause mortality, AMI, TVR, TLR and stent thrombosis. Similarly, no significant differences were found when analyzing the individual components of the endpoint separately.

As patients increase in age and medical complexity, coronary artery calcification is frequently encountered and its presence portends worse outcomes following percutaneous coronary intervention (PCI) - negatively impacting procedural success and long-term outcomes. This review paper explores available imaging techniques and calcium modification technique that can identify, characterize and modify these lesions to facilitate stent implantation. The data supporting these techniques are explored and an algorithm for decision-making during lesion modification is presented. Current barriers and future directions are additionally discussed.

Coronary artery calcification is common among patients undergoing percutaneous coronary intervention (PCI), and severe coronary artery lesion calcification is associated with increased procedural complexity, stent under-expansion, and high rates of intraprocedural complications and out-of-hospital adverse events. Whether calcium ablation before stent implantation can mitigate these adverse events is not currently established. We aimed to prospectively compare orbital atherectomy with a balloon angioplasty-based strategy before stent implantation for the treatment of severely calcified coronary lesions.

In this multicentre, open-label, randomised controlled trial conducted at 104 medical centres in the USA, patients (aged ≥18 years) with severely calcified coronary lesions were randomly assigned (1:1) to orbital atherectomy or balloon angioplasty before PCI with drug-eluting stents using a web-based system (block sizes of four and six) and stratified by intended treatment of single versus multiple lesions and enrolling site. Randomly assigned lesions were deemed by operators to be eligible for both treatment strategies. Operators and patients were not masked to treatment. The two powered coprimary study endpoints were target vessel failure at 1 year (a composite of cardiac death, target vessel myocardial infarction, or ischaemia-driven target vessel revascularisation) and post-procedural minimal stent area at the site of maximal calcification, as assessed by intravascular optical coherence tomography in an imaging patient cohort. Primary analyses were by intention-to-treat. The trial is registered at ClinicalTrials.govNCT03108456, and 2-year follow-up is ongoing.

From March 27, 2017, to April 13, 2023, 2005 patients with 2492 lesions were randomly assigned to lesion preparation with orbital atherectomy (1008 patients with 1250 lesions) or balloon angioplasty (997 with 1242 lesions) before stent implantation. Median patient age was 70·0 years (IQR 64·0-76·0). 541 (27·0%) of 2005 patients were female and 1464 (73·0%) were male. Angiographically severe calcium was confirmed by the core laboratory in 1088 (97·1%) of 1120 lesions assigned to orbital atherectomy and 1068 (97·0%) of 1101 lesions assigned to balloon angioplasty. PCI was guided by intravascular imaging in 627 (62·2%) of 1008 patients in the orbital atherectomy group and 619 (62·1%) of 997 in the balloon angioplasty group. Target vessel failure events within 1 year occurred in 113 of 1008 patients in the orbital atherectomy group (1-year target vessel failure 11·5% [95% CI 9·7 to 13·7]) and in 97 of 997 patients in the balloon angioplasty group (10·0% [8·3 to 12·1]; absolute difference 1·5% [96% CI -1·4 to 4·4]; hazard ratio 1·16 [96% CI 0·87 to 1·54], p=0·28). Among those in the optical coherence tomography substudy cohort (276 patients with 286 lesions in the orbital atherectomy group and 279 patients with 292 lesions in the balloon angioplasty group), the mean minimal stent area at the site of maximal calcification was 7·67 mm2 (SD 2·27) in the orbital atherectomy group and 7·42 mm2 (2·54) in the balloon angioplasty group (mean difference 0·26 [99% CI -0·31 to 0·82]; p=0·078). Cardiac death events within 1 year occurred in 39 of 1008 patients in the orbital atherectomy group and in 26 of 997 in the balloon angioplasty group.

Routine treatment with orbital atherectomy before drug-eluting stent implantation did not increase minimal stent area or reduce the rate of target vessel failure at 1 year compared with a balloon angioplasty-based approach in severely calcified lesions deemed eligible for both treatment strategies. These data support a balloon-first approach for most calcified coronary artery lesions that can be crossed and dilated before stent implantation, guided by intravascular imaging.

Abbott Vascular (Abbott).

Relevant calcified coronary artery disease (CCAD) may be present in around 20% of patients undergoing percutaneous coronary interventions, and it is known to add procedural challenges and risks. Careful patient selection and specific expertise in multimodality imaging and plaque modification techniques are required to plan and adopt the most appropriate therapeutic strategy. This review aims to present the contemporary clinical approach and procedural planning for CCAD patients, describing the available tools and strategies in view of the most recent scientific evidence.

Rotational atherectomy (RA) is widely used for the management of calcified coronary stenoses. However, there is limited data on its use, trends, and outcomes. We sought to report our twelve-year experience with RA and explore the trends and outcomes of percutaneous coronary intervention (PCI) with this device.

Our institutional PCI database was queried to identify all cases of RA-PCI performed between January 2009 and December 2020. We analysed peri-procedural outcomes and major adverse cardiovascular events (MACE) during follow-up: cardiovascular death, myocardial infarction, and target lesion revascularization.

Four hundred ten procedures (2.8% of total PCI volume) in 388 patients were included. Mean age was 72.3±9.3 years, 74.0% were male, 53.6% had diabetes, and 33.8% presented with acute coronary syndrome. There was a significant increase in median SYNTAX score (ptrend=0.003) and the proportion of type B2/C lesions (ptrend=0.003). Transradial access was preferred (60.0% overall) with a growing trend over time (ptrend=0.003). Maximum burr size was <1.75 mm in 88.0% of cases (burr-to-artery ratio of 0.49±0.07). Angiographic success rate was consistently high (96.6% overall). Complications were recorded in 9.0% of procedures, with a temporal decline (ptrend=0.029). Clinical follow-up was available for 357 patients (median time of 40 months). At one year, MACE rate was 12.1% with no significant temporal changes.

RA-PCI was a safe and effective procedure with a high rate of angiographic success and few complications, particularly in recent years, in line with significant technical improvements. The MACE incidence is acceptable considering the clinical risk and angiographic complexity.

Percutaneous coronary intervention of severely calcified lesions is limited by inadequate stent expansion and poor clinical outcomes. Over the past decade, several devices and techniques have been developed for calcium modification and lesion preparation. Intravascular lithotripsy (IVL) is a novel tool in this context. Although numerous observational studies have been reported on this technique, randomized trials powered for clinical outcomes on the relative merits of IVL in patients with severely calcified lesions are lacking.

The ISAR-WAVE trial is a multicenter, prospective, randomized, single-blind controlled trial. The aim is to test whether IVL is superior to other calcium-modifying techniques (modified or super high-pressure balloon and atheroablative devices) in de novo severely calcified coronary lesions. The study is planned to enroll 666 patients. The primary endpoint is the composite of major cardiac and cerebrovascular adverse events defined as death, nonfatal myocardial infarction, nonfatal stroke and clinically indicated target vessel revascularization at 12 months. In addition to the individual components of the primary endpoint, secondary endpoints include also safety, quality of life and cost-effectiveness measures.

ISAR-WAVE is a multicenter, randomized trial designed to test the hypothesis that a strategy of IVL confers superior clinical performance compared to other calcium-modifying techniques in patients undergoing percutaneous intervention for a de novo severely calcified coronary artery lesion.

ClilicalTrial.gov, NCT06369142.

Calcified coronary lesions are becoming more prevalent and remain therapeutically challenging. Although a variety of devices can be used in this setting, cutting balloons (CB) and scoring balloons (SB) are powerful and simple tools to treat calcified plaques vs more complex devices. However, there are some drawbacks: these are stiff and bulky balloons that, as a first device, complicate lesion crossing and navigability in the presence of tortuosity, thus making it extremely difficult to recross once the balloon has been inflated. The objective of this study was to evaluate the safety and efficacy profile of the new Naviscore SB designed to overcome these drawbacks.

The first-in-man Naviscore Registry is a multicenter, prospective trial that included 85 patients with moderate (34%) or severe (66%) de novo calcified coronary lesions located in the native arteries, with stable angina and an indication for percutaneous coronary intervention.

Mean age was 71 ± 11 years, with a high prevalence of comorbidities. Used as the first device, the Naviscore was able to cross 76% of the lesions and was used in 98% of the cases effectively modifying the calcified plaque. Procedural success was achieved in 94% of cases. Basal stenosis of 81 ± 12% decreased to 33 ± 8.5% after Naviscore and to 7.5 ± 2.6% after stent implantation. There were no major adverse cardiovascular events during admission. Perforation, device entrapment or flow-limiting dissections did not occur-only type A/B dissections in 13%-which were fixed with stent implantation. Device performance was deemed superior to the usual SB or CB used by the participant centers.

The Naviscore SB is very effective crossing severely calcified lesions as the first device, with effective plaque modification, stent expansion and an excellent safety profile. The Naviscore improves the behavior of current CB and SB. Due to its simplicity of use and performance, the Naviscore can be the first-choice SB to treat significant calcified lesions.

Background: The increasing prevalence of severe calcified coronary artery disease has expanded the role of rotational atherectomy (RA) in percutaneous coronary intervention (PCI). In the drug-eluting stent (DES) era, RA remains a key tool for complex lesion modification. This review focuses on its clinical outcomes and evolving indications. Methods: This review was conducted as a narrative review, focusing on the most relevant clinical studies regarding RA in the DES era. Articles were identified through a systematic PubMed search. Results: Comparing to early-generation DES, new-generation DES (NG-DES) demonstrate superior outcomes due to thinner struts and biocompatible polymers. RA plays a critical role in challenging scenarios, including chronic total occlusions and de novo small vessel lesions. Despite these advances, further randomized controlled trials are needed to validate the long-term safety and efficacy of RA-based strategies. Conclusions: This review highlights the clinical outcomes of RA in the DES era and its evolving role in contemporary cardiology. RA has shown promising potential for broader clinical applications in complex coronary artery disease. However, critical knowledge gaps remain. Further research is needed to refine RA-based strategies.

Calcified nodules (CNs) are increasingly recognized as critical contributors to the pathophysiology of acute coronary syndrome (ACS). This review provides a comprehensive synthesis of the recent literature, focusing on the prevalence of CNs, their underlying mechanisms, and their implications for the clinical management of coronary artery disease (CAD). CNs are characterized by unique pathophysiological processes, and the diagnosis and treatment of CNs during percutaneous coronary interventions (PCIs) underscore the importance of advanced intravascular imaging techniques, such as optical coherence tomography (OCT) and intravascular ultrasound (IVUS), for precise identification and prognostic evaluation. Current therapeutic strategies aim to modulate CN characteristics, enhance arterial wall stability, and reduce the risk of ACS and sudden cardiac death. This review highlights the impact of CNs in ACS, the role of intravascular imaging in diagnosis, and the importance of targeted interventions to improve clinical outcomes, as by bridging diagnostic insights with emerging atherectomy modalities, this review also seeks to advance the understanding and management of CNs in PCI, fostering improved patient outcomes.

Rotational atherectomy (RA) and intravascular lithotripsy (IVL) are well-established technologies for modification of coronary calcification. Given their contrasting mechanisms of action, there has been interest in whether the use of these devices in conjunction could potentially be synergistic and offer improved procedural results. The aim of this study was therefore to evaluate the efficacy, procedural safety and long-term outcomes of combining RA and IVL, termed 'RotaShock' (RSK), for the treatment of severe coronary calcification.

A single- centre retrospective analysis was carried out of consecutive patients treated with an RSK strategy for coronary calcification from January 2019 until September 2022. Baseline demographics, comorbidity details, details of the percutaneous coronary intervention procedure, angiographic and/or intracoronary imaging (ICI) results and presence of target vessel revascularisation or mortality were recorded.

A total of 36 patients were treated with RSK; the majority of patients were male (n=29; 80.6%) and the median age was 75 years (IQR 70-79 years). The majority of cases involved treating the left anterior descending artery (63.4%) but one-third involved percutaneous coronary intervention to the left main coronary artery. The vast majority of cases were guided by ICI (88.9%) and were performed through radial access (80.6%). In patients with ICI available for analysis, the median minimum stent area was 7.7 mm2 (IQR 6.2-10.0 mm2). There were two access site complications but no other periprocedural complications. The median follow-up was 942 days (IQR 645-1,306 days). Despite the high complexity of lesions treated, follow-up identified only two cases of target vessel revascularisation. There were five cases of non-adjudicated all-cause mortality.

RSK is an effective and safe strategy for modification of severe coronary calcification, with long-term results suggesting a highly durable result. Further and randomised data are now mandated to evaluate the relative merits of RSK compared with RA or IVL alone.

Coronary calcification negatively affects the safety and effectiveness of percutaneous coronary intervention. There is a lack of randomized comparisons among different plaque modification techniques.

The aim of this study was to compare rotational atherectomy (RA), excimer laser coronary angioplasty (ELCA), and intravascular lithotripsy (IVL) for the treatment of patients with calcified coronary stenosis.

Patients with moderate to severe calcified coronary lesions were randomly assigned to percutaneous coronary intervention with RA, IVL, or ELCA. The primary endpoint was the percentage of stent expansion by optical coherence tomography. An intention-to-treat, noninferiority analysis was conducted.

A total of 171 patients (77.2% men [n = 132], mean age 70.9 ± 8.2 years) were enrolled, 57 in each treatment arm. Clinical presentation was chronic coronary syndrome in 64.3% of patients (n = 110) and acute coronary syndrome in 35.7% (n = 61). Severe angiographic calcification was observed in 82.5% of lesions (n = 141). Procedural success rate and final minimum stent area (RA, 5.5 ± 2.1 mm2; IVL, 5.4 ± 1.8 mm2; ELCA, 5.1 ± 1.8 mm2) were similar among the 3 arms. IVL proved to be noninferior to RA, with no differences in stent expansion (RA, 86.4% ± 14.1%; IVL, 85.6% ± 13.3%; P = 0.77). ELCA did not reach noninferiority in the intention-to-treat analysis. The rate of complications was low, with no significant differences in the 3 arms but numerically lower with IVL.

In the first randomized trial comparing RA, IVL, and ELCA for the treatment of patients with calcified coronary lesions, IVL was noninferior to RA in terms of stent expansion. ELCA did not reach this noninferiority margin compared with RA. No significant differences were observed among the 3 arms regarding minimum stent area, procedural success rate, and complications, which were numerically lower with IVL.

The 2021 Percutaneous Coronary Intervention guidelines completed by American College of Cardiology/American Heart Association/Society for Cardiovascular Angiography and Interventions provide a set of guidelines regarding revascularization strategies. With emphasis on equity of care, multidisciplinary heart team use, revascularization for acute coronary syndrome, and stable ischemic heart disease, the guidelines create a thorough framework with recommendations regarding therapeutic strategies. In this comprehensive review, our aim is to summarize the 2021 revascularization guidelines and analyze key points regarding each recommendation.

The clinical outcomes of percutaneous coronary intervention (PCI) using drug-coated balloons (DCB) for de novo coronary artery lesions with eruptive calcified nodules remain unclear.

This retrospective study analyzed the long-term outcomes of 308 consecutive patients (389 lesions) treated with PCI using DCB under optical coherence tomography guidance for de novo coronary artery lesions between September 2018 and November 2020. Patients were classified into 2 groups: those with an eruptive calcified nodule in the culprit lesion (CN group) and those without (non-CN group). The primary endpoint was major adverse cardiovascular events (MACE), including clinically driven target lesion revascularization (TLR), myocardial infarction (MI), and cardiac death. The median follow-up period was 2.6 years (interquartile range 1.9-3.4 years). The CN group had significantly higher rates of MACE (hazard ratio [HR] 9.2; 95% confidence interval [CI] 4.1-20.2; P<0.0001), TLR (HR 5.0; 95% CI 1.7-15.1; P<0.01), MI (HR 30.5; 95% CI 5.0-184.8; P<0.001), and cardiac death (HR 25.1; 95% CI 8.7-72.6; P<0.0001) than the non-CN group. Results were similar even after adjusting for potential confounding factors using propensity score matching.

This study demonstrated that patients with eruptive calcified nodules who underwent PCI with DCB for de novo coronary artery lesions had worse long-term clinical outcomes than patients without such nodules.

Calcified coronary artery disease is a common clinical finding and is visible angiographically in 25-30% of patients presenting for percutaneous coronary intervention. The presence of coronary calcium, even without coronary artery obstruction, confers an adverse clinical prognosis. Coronary calcium score on CT is additive in predicting risk of cardiovascular events beyond traditional scoring systems. Deposition of calcium in coronary arteries is initiated by the formation of an atherosclerotic plaque. Thereafter, multiple processes and pathways are involved, resulting in initial microcalcifications that coalesce into calcium sheets. Calcified nodules are thought to occur from rupture of these sheets. Calcified coronary stenoses requiring revascularisation result in greater target lesion failure and overall major adverse cardiovascular events than noncalcified lesions, regardless of the mode of revascularisation. Modifying calcium prior to stenting to optimise stent expansion is required and intracoronary imaging can greatly facilitate not only the detection of coronary calcium, but also the confirmation of adequate modification and stent optimisation. In this review, the authors examine the pathophysiology, prevalence, predictors and impact on outcomes of coronary calcium.

Despite the excellent success and safety of intravascular lithotripsy (IVL) in heavily calcified lesions, evidence in acute coronary syndromes (ACS) remains limited.

This study aimed to evaluate the procedural and clinical outcomes of IVL in heavily calcified ACS.

Patients who underwent IVL between 2019 and 2024 from the ongoing prospective BENELUX registry were eligible for inclusion. Patients were therefore classified in ACS and chronic coronary syndrome (CCS) groups. The primary technical endpoint was angiographic success < 30%, defined as the successful delivery of the IVL catheter across the target lesion and delivery of IVL pulses without angiographic complications and residual target lesion less than 30%. The primary clinical endpoint was in-hospital major adverse cardiac events (MACE), including cardiac death, nonfatal myocardial infarction, or target lesion revascularization.

A total of 454 patients underwent IVL, with 251 (55.3%) treated for CCS and 203 (44.7%) for ACS. The median SYNTAX score (p-value 0.17), the need for inotropes (p-value 0.09), and the use of mechanical circulatory support (p-value 0.71) were similar between CCS and ACS groups. Comparable angiographic success (< 30% residual stenosis) was observed between CCS and ACS groups (90.1% vs. 91.1%, p = 0.69). MACE were similar across groups during hospital stays (CCS 1.6% vs. ACS 3.0%, p = 0.33), at 30 days (CCS 3.2% vs. ACS 3.9%, p = 0.86), and at 12-month follow-up (CCS 8.4% vs. ACS 7.9%, p = 0.91).

IVL provides high procedural success and consistent clinical outcomes in both CCS and ACS cases.

Percutaneous coronary intervention (PCI) for thrombotic and heavily calcified coronary artery lesions and occlusions is often hampered by difficulty in wiring the occlusions, restoring antegrade flow, and proceeding to successful stent implantation. Characterization of dynamic anatomical features such as thrombi and the calcium distribution is key to prevent periprocedural complications and long-term adverse events, which are mainly driven by stent underexpansion and malapposition and may prompt in-stent restenosis or stent thrombosis. Therefore, multimodal imaging is a critical step during PCI to better characterize these high-risk lesions and select those in which careful preparation with debulking devices is needed or to guide stent optimization with the aim of improving procedural and long-term clinical outcomes. Hence, obtaining a better understanding of the underlying cause of thrombus formation, imaging the calcium distribution, and thorough planning remain crucial steps in selecting the optimal revascularization strategy for an individual patient. In this review, we summarize current evidence about the prevalence, predictors, and clinical outcomes of "hard-rock" thrombotic lesions treated by PCI, focusing on the value of imaging and physiological assessments performed to guide interventions. Furthermore, we provide an overview of cutting-edge technologies with the aim of facilitating the use of such devices according to specific procedural features.

The presence and severity of calcified coronary plaque negatively impacts angiographic and clinical outcomes following percutaneous coronary intervention (PCI). Severe coronary calcification is associated with suboptimal stent delivery, deployment, apposition and expansion which can lead to in-stent restenosis and/or thrombosis. Severe coronary calcification is associated with incremental hazard for adverse clinical events, including death, during 5-10 years following PCI despite the use of new generation drug- eluting stents. Multiple technologies including high-pressure noncompliant and modified (cutting/scoring) balloons, atheroablative technologies (laser, rotational or orbital atherectomy), and more recently, intravascular lithotripsy have been used to modify calcified plaque and facilitate optimal coronary stent implantation. Intravascular imaging is critically important to determine the extent and distribution (superficial or deep) of coronary calcification and to aid selection and sequence for use of calcium modifying technologies. Unfortunately, large scale randomized comparative trials of calcium modifying technologies are limited and the relative safety and effectiveness of these modalities is poorly defined. Recent mechanistic and clinical data supporting the use of plaque modifying technologies are reviewed to provide insights into their optimal use.

This first-in-man (FIM) study evaluated the feasibility and safety of a new peripheral plaque atherectomy system in patients with symptomatic lower extremity artery disease (LEAD). Ten patients with symptomatic LEAD (Rutherford class 2-5) were enrolled in a prospective, single-center study from March to April 2024. Patients aged 18-85 years with target lesions showing ≥70% stenosis and reference vessel diameters ≥1.8 mm underwent treatment using a novel atherectomy device with a "shaving" mechanism to excise calcified plaques. Outcomes included post-procedural stenosis improvement, 6-month primary patency rate, and safety endpoints such as thrombosis, vasospasm, acute occlusion, and distal embolization. Statistical analysis used SPSS 23.0. Ten male patients (mean age: 61.4 ± 9.2 years) were treated. Most had diabetes (80%), hypertension (70%), and hyperlipidemia (80%). Pre-procedural ankle-brachial index (ABI) averaged 0.50 ± 0.14. Angiographic analysis showed 60% of lesions in the femoral artery and 40% as chronic total occlusions. No major adverse events occurred, with 100% technical success. Post-procedural ABI improved to 0.92 ± 0.12 (p < 0.05). At 6 months, the primary patency rate was 100%, with no clinically-driven revascularization or adverse cardiovascular events. Mortality was 0%. All patients reported significant improvement in symptoms and walking distance, as well as enhanced quality of life and reduced pain during physical activity. The novel atherectomy device showed promising safety and efficacy for treating calcified LEAD. Larger-scale trials are needed to confirm these outcomes.

The optical coherence tomography (OCT)-based calcium scoring system was developed to guide optimal lesion preparation strategies for percutaneous coronary intervention (PCI) of calcified lesions. However, the score was derived retrospectively, and a prospective investigation is lacking. The CORAL (UMIN000053266) study was a single-arm, prospective, multicenter study that included patients with calcified lesions with OCT-calcium score of 1-2 to investigate whether these lesions could be optimally treated with a balloon-only preparation strategy using a non-compliant/scoring/cutting balloon. The primary endpoint was strategy success (successful stent placement with a final percent diameter stenosis [%DS] < 20% and Thrombolysis In Myocardial Infarction flow grade III without crossover to rotational atherectomy/orbital atherectomy/intravascular lithotripsy [RA/OA/IVL]). A superiority analysis for the primary endpoint was performed by comparing the study cohort with a performance goal of 83.3%. One hundred and eighteen patients with 130 lesions were enrolled. The mean age was 79.0 ± 10.3 years, and 79 patients (66.9%) were male. The OCT-calcium score was 1 for 81 lesions (62.3%) and 2 for 49 lesions (37.7%). The %DS improved from 47.0 ± 14.8% preprocedure to 11.1 ± 5.6% postprocedure. Stent expansion ≥ 70% was achieved in 90.2%. The strategy success rate was 93.1% (95% confidence interval: 87.3-96.8), and superiority against the performance goal was achieved without any crossover to RA/OA/IVL (P = 0.0027). The OCT-calcium score could identify mild/moderately calcified lesions treatable by PCI with the balloon-first strategy using a non-compliant/scoring/cutting balloon for predilatation, with a high strategy success rate. These results support the intravascular imaging-based treatment algorithm for calcified lesions proposed by CVIT.

Limited data is available regarding in-hospital outcomes of patients undergoing high-risk percutaneous coronary intervention (HR-PCI) with Impella with and without a prior history of coronary artery bypass grafting (CABG).

We performed a retrospective study from the Nationwide Inpatient Sample from year 2016 to 2020. We identified patients who underwent Impella and percutaneous coronary intervention on the same day and excluded those with cardiogenic shock. Subsequently, we stratified them into those with and without prior CABG.

During the study period, 18 925 patients underwent HR-PCI. Among these, 2043 (10.8%) patients had prior CABG. Patients without prior CABG had a higher percentage of acute coronary syndrome at presentation (62.7 vs 56.1%, P = 0.008). The proportion of females was significantly higher in those without prior CABG (32.4 vs 21.7%, P < 0.001). On multivariate analysis, there was no statistically significant difference in the in-hospital mortality (5.8% in CABG vs 8.5% in non-CABG, P = 0.52). Patients without prior CABG had higher rates of acute kidney injury, major bleeding, and blood transfusions. There were no significant differences in rates of cardiac arrest, ventricular arrhythmias, acute stroke, coronary dissections, and coronary perforations. Those without prior CABG had a longer duration of hospitalization (6.8 vs 9.3 days, P < 0.001) and higher hospital charges ($292 267 vs $322 206, P < 0.035).

Our study highlights that a history of previous CABG does not increase the risk of in-hospital mortality in patients undergoing Impella-assisted HR-PCI but is associated with reduced rates of complications.

Percutaneous coronary intervention (PCI) of severely calcified lesions is associated with a higher risk of procedural complications, suboptimal stent expansion, and in-stent restenosis. Lesion preparation with orbital atherectomy (OA) in severely calcified lesions has been shown to increase procedural success and decrease reintervention rates. In this study, we sought to report the procedural safety and efficacy of our initial experience with OA in a non-surgical center in Portugal.

Patients with severely calcified coronary lesions who were treated with intended intravascular ultrasound (IVUS) guided OA were included in a prospective single-center registry. We evaluated several endpoints, including: debulking success, defined <50% residual stenosis severity after OA; procedural success, defined as stent implantation according to Optimal-IVUS PCI criteria; use of additional calcium debulking strategies; and procedural complications, including coronary no-reflow, dissection, perforation or side branch occlusion. Patients were followed up for 30 days to assess early cardiovascular or procedure-related death, myocardial infarction, myocardial injury and reintervention.

Between January 2023 and September 2023, 37 patients and 53 coronary arteries underwent OA. IVUS imaging was used in all cases. Debulking and procedural success were achieved in 90.5% and 97.3% of cases, respectively. In 26 (49.1%) lesions, additional calcium debulking techniques were needed. Procedural complications occurred in three cases and one patient died during hospitalization.

Our initial experience with OA for heavily calcified coronary lesions demonstrated high procedural success and overall favorable clinical outcomes.

Background/Objectives: Calcified coronary lesions require plaque modification techniques for optimal stent apposition, of which rotational atherectomy (RA) is the most commonly used one. Challenging cases require the use of additional dedicated devices (such as modified balloons, MB); however, data available for evidence-based device selection are limited. The aim of this study is to determine the impact of the balloon-based technology used after successful RA treatment on outcomes. Methods: This study was carried out according to the PRISMA guidelines. MEDLINE, CENTRAL and Embase databases were systematically searched for eligible randomized and non-randomized studies. Results: A total of nine studies and 1024 patients were included in the analysis. Patients were treated with RA followed by either plain balloon angioplasty (RA + BA) or modified balloon (RA + MB) treatment prior to stent implantation. There was no significant difference in MACE (major adverse cardiovascular events; OR: 0.53; 95% CI: 0.21-1.34; p = 0.153), all-cause mortality (OR: 0.68; 95% CI: 0.33-1.42; p = 0.265), and target lesion revascularization (OR: 0.64; 95% CI: 0.27-1.55; p = 0.264) between the two groups. However, a sensitivity analysis demonstrated a significant decrease in MACE for patients with severely calcified lesions (OR: 0.42; 95% CI: 0.25-0.70; p = 0.009) in the RA + MB group. The analyses of the safety outcomes of slow flow/no reflow (OR: 0.59; 95% CI: 0.29-1.22; p = 0.128) and coronary artery perforation (OR: 1.18; 95% CI: 0.70-1.99; p = 0.480) showed no difference between the two groups. Conclusions: Our meta-analysis suggests that the benefit of the more invasive RA + MB treatment is statistically significant for severely calcified lesions, but is not associated with additional procedural complications.

The optimal treatment for coronary calcified nodules (CNs) is still unclear. The aim of this study was to compare the modification of these lesions by coronary intravascular lithotripsy (IVL) and rotational atherectomy (RA) using optical coherence tomography (OCT).

ROTA.shock was a 1:1 randomized, prospective, double-arm multi-center non-inferiority trial that compared the use of IVL and RA with percutaneous coronary intervention (PCI) in severely calcified lesions. In 19 of the patients out of this study CNs were detected by OCT in the target lesion and were treated by either IVL or RA.

The mean angle of CNs was significantly larger in final OCT scans than before RA (92 ± 17° vs. 68 ± 7°; p = 0.01) and IVL (89 ± 18° vs. 60 ± 10°; p = 0.03). The CNs were thinner upon final scans than in initial native scans (RA: 17.8 ± 7.8 mm vs. 38.6 ± 13.1 mm; p = 0.02; IVL: 16.5 ± 9.0 mm vs. 37.2 ± 14.3 mm; p = 0.02). Nodule volume did not differ significantly between native and final OCT scans (RA: 0.66 ± 0.12 mm3 vs. 0.61 ± 0.33 mm3; p = 0.68; IVL: 0.64 ± 0.19 mm3 vs. 0.68 ± 0.22 mm3; p = 0.74). Final stent eccentricity was high with 0.62 ± 0.10 after RA and 0.61 ± 0.09 after IVL.

RA or IVL are unable to reduce the volume of the calcified plaque. CN modulation seems to be mainly induced by the stent implantation and not by RA or IVL.

Progress in coronary angioplasty has enabled outpatients treatment with rates of immediate complications below 1%. This shows a clear improvement in patient's comfort and it represents an important medical and economic gain. Considering the demographic evolution of the population, there is an increasing number of calcified coronary lesions which represent, according to the series, up to a quarter of angioplasties. However, their care is more delicate with a greater risk of complications and procedural failure. In fact, with the difficulties of crossing and with the vascular intrusions related to pre-dilation or sub-dilation stent deployment, the complication risk increases by almost 10% in these cases of angioplasties. Similarly, the death rate at 30 days goes from 4.7% in angioplasty in general up to 24.4% in calcified lesions. Several devices for atherectomy and plaque preparation have been developed in order to better overcome the lesions and better prepare the stent installation at the cost of a risk of complications between 2 and 10%. The three most frequent complications are dissection (1.8 to 7%), slow/no-flow (0.1 to 3%) and coronary perforation (0.2 to 4%). Nevertheless, despite this procedural increased risk, ambulatory angioplasty of calcified complex lesions can become a reality subject to 4-6 hours monitoring in a specialized unit with dedicated protocols.

Coronary artery disease remains the leading cause of morbidity and mortality worldwide despite advancements in percutaneous coronary intervention (PCI). With an increasing ageing population, there is a significant challenge in addressing severe calcification in atherosclerotic plaque during angioplasty. This review article focuses on atherectomy strategies such as rotational atherectomy (RA), orbital atherectomy (OA) and excimer laser coronary angioplasty (ELCA) aimed at modifying calcified lesions and improving PCI outcomes. RA modifies plaque through rotational ablation, OA uses eccentrically mounted diamond-coated crown and has a reduced entrapment risk compared to RA. ELCA uses pulsatile laser energy to precisely ablate plaque tissue. This review provides insights into the mechanisms, procedural techniques and clinical outcomes associated with these calcium modification techniques. The selection of appropriate devices and adequate training are crucial for optimising lesion modification and enhancing procedural success. Further research and standardised protocols are required to overcome challenges associated with using these devices and expand their usage in clinical practice.

Rotational atherectomy (RA) remains an integral tool for the treatment of severe coronary calcified lesions despite emergence of newer techniques. We aimed to evaluate the contemporary clinical practices and outcomes of RA in China.

The Rota China Registry (NCT03806621) was an investigator-initiated, prospective, multicenter registry based on China Rota Elite Group. Consecutive patients treated with RA were recruited. A pre-designed, standardized protocol was recommended for the RA procedure. The primary safety endpoint was major adverse cardiovascular events (MACE: composite of cardiac death, myocardial infarction, or ischemia-driven target lesion revascularization) at 30 days. The primary efficacy endpoint was procedural success.

Between July 2018 and December 2020, 980 patients were enrolled at 19 sites in China. Mean patient age was 68.4 years, and 61.4% were men. Radial access was used in 79.1% patients, and 32.7% procedures were guided by intravascular imaging. A total of 22.6% procedures used more than 1 burr, and the maximal burr size was ≥1.75 mm in 24.4% cases, with burr upsizing in 19.3% cases, achieving a final burr-to-artery ratio of 0.52. Procedural success was achieved in 91.1% of patients, and the rate of 30-day and 1-year MACE was 4.9% and 8.2%, respectively. Multivariable analysis identified the total lesion length (HR 1.014, 95% CI: 1.002-1.027; p = 0.021) as predictor of 30-day MACE, and renal insufficiency (HR 1.916, 95% CI: 1.073-3.420; p = 0.028) as predictor of 1-year MACE.

In this contemporary prospective registry in China, the use of RA was effective in achieving high procedural success rate with good short- and long-term outcomes in patients with severely calcified lesions.

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.

Modified balloon (MB) treatment in severely calcified coronary artery lesions is an established technique. However, some lesions require Rotablation (RA) as bailout strategy.

This study aimed to assess predictors of switch from MB to RA and its impact on procedural and midterm outcomes.

Four hundred and eighty-three consecutive patients were included undergoing MB treatment (n = 204) with a scoring or cutting balloon, or upfront RA treatment (n = 279) serving as control cohort. Strategy switch from MB to RA was performed in 19 of 204 patients. Procedural success was defined as successful stent implantation and TIMI III flow.

In the MB cohort, median age was 72 [63-78] years, 75.5% were male and 42.1% had acute coronary syndrome. Procedure success was achieved in 89.4% of the switch group versus 98.4% of the MB only group (p < 0.001) and in 96.4% of the RA cohort. In the switch group, periprocedural complications (31.6% vs. 8.1% vs. 11.8%, p = 0.007), radiation dose (149 [126-252] vs. 59 [30-97] vs. 102 [59-156] Gcm2; p < 0.001) and contrast volume (250 [190-250] vs. 190 [150-250] vs. 195 [190--250] mL; p < 0.001) were significantly higher. Diabetes (OR 3.8, 95% CI 1.1-13.9, p = 0.042), chronic kidney disease stage 4 or 5 (OR 19.0, 95% CI 3.3-108.6, p < 0.001) and pronounced calcification resulting in higher angiographic diameter stenosis (OR 1.13, 95% CI 1.1-1.2, p = 0.001) independently predicted strategy switch. Midterm results were not affected by strategy switch regarding 1-year target lesion revascularization rates (86% vs. 89% vs. 89%; log-rank p = 0.95).

Primary RA strategy might be considered in patients with severely calcified coronary artery lesions with high angiographic diameter stenosis, diabetes or impaired renal function due to increased periprocedural complication rates, radiation dose, and contrast volume following strategy switch.

Coronary artery calcification is frequently encountered during percutaneous coronary intervention and its presence is associated with a higher risk of stent under-expansion which has been associated with long-term risk of stent failure. There are several different calcium modification strategies available, whether they be balloon-based devices (cutting/scoring and intravascular lithotripsy) or atherectomy devices (orbital atherectomy, rotational atherectomy, excimer laser coronary atherectomy) that are established for the modification of coronary calcification. Each strategy applies a different mechanism of action for calcium modulation and consequently the potential to combine modifying tools may offer synergistic advantages over device monotherapy. This article will focus on reviewing the evidence for the use of multiple calcium modification techniques and examine whether there really is any such synergistic effect of combining these tools.

Modified balloons (MB) and rotational atherectomy (RA) are recommended tools for treatment of coronary plaques with superficial calcium. Knowledge about in-hospital safety is limited.

Patients with coronary artery disease who underwent coronary angiography with RA or MB angioplasty in Germany were identified via ICD and OPS codes from 2017 to 2020. Acute coronary syndromes were excluded. Since patients were not randomized toward MB or RA, potential confounding factors were taken into account using the propensity score methods. Thereby, inverse probability weighting was applied.

Ten thousand.ninety-twopatients underwent RA with an increasing trend from 1817 in 2017 toward 3166 in 2020. MBs were used in 22,378 patients also with an increasing trend from 4771 in 2017 toward 6078 in 2020. Patients receiving RA were older (74.23 ± 8.68 vs. 71.86 ± 10.02, p < 0.001), had a higher Charlson Comorbidity Index (2.07 ± 1.75 vs. 1.99 ± 1.76, p = 0.001) and more frequently left main (17.96% vs. 12.91%, p < 0.001) or three vessel disease (66.25% vs. 58.10%, p < 0.001). Adjusted procedural risk of major adverse cardiac and cerebrovascular events (MACCE) was similar in both groups, while pericardial effusion (RR 2.69; 95% CI 1.88-3.86, p < 0.001), pericardial puncture/pericardiotomy/pericardial tamponade (RR 2.66; 95% CI 1.85-3.81, p < 0.001) and bleeding (RR 1.65; 95% CI 1.12-2.43, p < 0.011) occurred more frequently in patients receiving RA. Patients treated with RA at high volume centers were hospitalized shorter (p = 0.005) and had a lower rate of acute cerebrovascular events (p < 0.001). Rate of MACCE, bleeding and pericardial puncture were not influenced by the annual RA numbers per center.

MBs had a lower risk of bleeding and pericardial puncture. Patients treated at centers with high annual RA procedure numbers had a lower risk of acute cerebrovascular events and were hospitalized shorter.