Predictors for Calcium Fracture With a Novel Cutting Balloon

Kurata, Naoya; Ishihara, Takayuki; Iida, Osamu; Tsujimura, Takuya; Ito, Kazutoshi; Hata, Yutaka; Toyoshima, Taku; Higashino, Naoko; Nakao, Sho; Mano, Toshiaki

doi:10.1016/j.jcin.2022.02.017

Cited by 6 publications

(6 citation statements)

References 4 publications

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“…A recent, elegant study based on optical coherence tomography in severely calcified lesions has demonstrated that although NCB, orbital, and rotational atherectomy does not generate cracks within the calcium, CB is able to create fractures in 43.3% of cases with more than one crack observed in more than 76% cases. The receiver‐operating curves identified that the best predictors of CB efficacy were a maximum calcium arch of 198°, a minimum calcium thickness of 0.445 mm, and a balloon‐artery ratio of 2.1 15 . Another large series of 261 de novo‐calcified lesions treated with only NCB found the presence of calcium fracture in 10.7% 16 .…”

Section: Discussionmentioning

confidence: 99%

“…In the modern PCI era, a number of calcium modification techniques have been introduced with variable success, with the aim to improve acute and long‐term outcomes of PCI. Recent data suggest that the use of the novel cutting balloon (CB) offers a good safety and efficacy profile in CAC 3 . The actual recommendation for the usage of CB suggest inflations at nominal pressures.…”

Section: Introductionmentioning

confidence: 99%

“…Recent data suggest that the use of the novel cutting balloon (CB) offers a good safety and efficacy profile in CAC. 3 The actual recommendation for the usage of CB suggest inflations at nominal pressures. This strategy may lower the efficacy of this device.…”

Section: Introductionmentioning

confidence: 99%

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Cutting balloon to optimize predilation for stent implantation: The COPS randomized trial

Mangieri

Nerla

Castriota

et al. 2023

Cathet Cardio Intervent

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Objectives: The objective of this study is to investigate the use of cutting balloon (CB) inflated at high pressure compared with noncompliant balloon (NCB) for the treatment of calcified coronary lesions.Background: No data are available regarding the safety and efficacy of CB inflated at high pressure in coronary artery calcifications.Methods: Patients with calcified lesions (more than 100°of calcium demonstrated at baseline intravascular ultrasound) were randomized. Primary endpoint of the study was the final minimal stent area (MSA) and stent symmetry in the calcific segment.Secondary endpoints included rate of device failure and the 1-year rate of target lesion revascularization, target vessel revascularization, and major adverse cardiovascular events.Results: From September 2019 to June 2021, a total of 100 patients were included and randomized; 13 patients were excluded for major protocol deviations. Lesions were complex (type B2/C n = 61 [71.2%]) with a mean arch of calcium of 266 ± 84°, a calcium length of 12 ± 6.6 mm. CB was inflated at comparable atmospheres when compared with NCB (18.3 ± 5 vs. 19 ± 4.5, p = 0.46). In the per-protocol population, the final MSA at the level of the calcium site was significantly higher in the CB group (8.1 ± 2 vs. 7.3 ± 2.1, p = 0.035) with a higher eccentricity index achieved in the CB group (0.84 ± 0.07 vs. 0.8 ± 0.08, p = 0.013). Three device failure occurred in the CB group. One-year follow-up outcomes were comparable.Conclusions: Treatment of calcified lesions with high-pressure CB has a good safety profile and is associated with a larger MSA and higher eccentricity of the stent at the level of the calcium site compared with NCB.

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Cutting balloon to optimize predilation for stent implantation: The COPS randomized trial

Mangieri

Nerla

Castriota

et al. 2023

Cathet Cardio Intervent

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“…Our findings suggest that, for severely calcified FP lesions assessed by IVUS, a preballoon dilatation diameter ≥1.9 mm eter is a known factor contributing to sufficient vessel preparation in coronary lesions with calcification. 13,14 In this study, the factor contributing to sufficient vessel preparation for severely calcified FP lesion sites was the preballoon dilatation diameter, and the cutoff value was 1.9 mm for severely calcified FP lesion sites (AUC, 0.80; 95% CI, 0.71-0.89; sensitivity, 74%; specificity, 76%) (Figure 3). Torii et al reported that calcification associated with lowerextremity arteries has various patterns and is thicker than that associated with coronary artery lesion.…”

Section: Discussionmentioning

confidence: 76%

Factors in Sufficient Endovascular Vessel Preparation for Severely Calcified Femoropopliteal Lesions

Kurata

Iida

Asai

et al. 2023

Circ J

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Study ParticipantsThis was a single-center retrospective observational study conducted in accordance with the Declaration of Helsinki and approved by the Ethics Committee of Kansai Rosai Hospital (reference no. 19 16D008g). From July 2012 to April 2021, intravascular ultrasound (IVUS)-supported EVT under a provisional stenting strategy was performed for 955 de novo FP lesions in 773 patients with symptomatic LEAD. Of them, 849 lesions were excluded for the following reasons: (1) no calcification (n=275); (2) not total circumferential calcification (n=499); (3) lack of IVUS data after preballoon dilatation (n=72); and (4) lack of postprocedural IVUS data (n=3). The remaining 106 de novo FP lesions in 97 patients were analyzed in this study. The study flowchart is shown in Figure 1. Because this was an noninvasive observational study without intervention Approximately half of all symptomatic patients with lower extremity arterial disease (LEAD) have femoropopliteal (FP) lesions, 1 with half of such cases complicated by vessel calcification (2). The presence of vessel calcification affects the occurrence of restenosis after endovascular therapy (EVT) with stents, 2-4 mainly due to insufficient dilation and consequent recoil during the initial treatment. 3,4 Although atherectomy devices can effectively treat severely calcified FP lesions, they are not routinely used in contemporary FP practice because of their high cost, risk of complications including distal embolization, and insufficient results of combined use. 5-7 Although the importance of vessel preparation was recently reported, 8,9 the factors contributing to sufficient vessel preparation for severely calcified FP lesions have not been elucidated, which became the aim of our study.

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“…In the intention‐to‐treat analysis, there is only a strong trend ( p = 0.61) toward larger MSA with CB angioplasty rather than a statistically significant result. Nevertheless, in the context of prior trials of CB, 3,4 it would be very reasonable to accept this trial as contemporary evidence that high‐pressure, undersized CB angioplasty is relatively safe and effective in maximizing MSA.…”

Section: Figurementioning

confidence: 99%

Cut, score, press, shock, or ablate?

Seto

2023

Cathet Cardio Intervent

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Key Points Cutting balloon angioplasty can modify fibrous or mildly calcified plaques before stent implantation. The present randomized study shows that high‐pressure cutting balloon angioplasty provides for a larger minimal stent area than standard noncompliant balloons, at the cost of a small risk of perforation. At a time when multiple plaque modification technologies are available, the simplicity and lower cost of cutting balloon angioplasty may ensure a continued role in percutaneous coronary intervention.

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Predictors for Calcium Fracture With a Novel Cutting Balloon

Cited by 6 publications

References 4 publications

Cutting balloon to optimize predilation for stent implantation: The COPS randomized trial

Cutting balloon to optimize predilation for stent implantation: The COPS randomized trial

Factors in Sufficient Endovascular Vessel Preparation for Severely Calcified Femoropopliteal Lesions

Cut, score, press, shock, or ablate?

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