Peñaranda Antonio Serra, Peregrina Estefanía Fernández, Kockar Marcelo Jiménez, Del Blanco Bruno García, Romani Sebastián, Moreiras Javier Martín, Bermúdez Eduardo Pinar, Rodrigues Alberto, Ojeda Soledad, López Nieves Gonzalo, Regueiro Ander, Frutos Ana Serrador
Departamento de Cardiología, Hospital de la Santa Creu i Sant Pau, Barcelona, España Departamento de Cardiología Hospital de la Santa Creu i Sant Pau Barcelona España.
Departamento de Cardiología, Hospital Universitari Vall d'Hebron, Barcelona, España Departamento de Cardiología Hospital Universitari Vall d'Hebron Barcelona España.
REC Interv Cardiol. 2025 Feb 3;7(2):91-98. doi: 10.24875/RECIC.M24000487. eCollection 2025 Apr-Jun.
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.
钙化性冠状动脉病变日益普遍，治疗上仍具挑战性。尽管在此情况下可使用多种器械，但与更复杂的器械相比，切割球囊（CB）和刻痕球囊（SB）是治疗钙化斑块的有力且简单的工具。然而，存在一些缺点：这些球囊坚硬且体积较大，作为首个器械，在存在迂曲的情况下会使病变通过和可操作性变得复杂，因此一旦球囊充气后再次通过极为困难。本研究的目的是评估旨在克服这些缺点的新型Naviscore SB的安全性和有效性。
首次人体Naviscore注册研究是一项多中心前瞻性试验，纳入了85例患有中度（34%）或重度（66%）新发钙化性冠状动脉病变的患者，病变位于自身动脉，患有稳定型心绞痛且有经皮冠状动脉介入治疗指征。
平均年龄为71±11岁，合并症患病率高。作为首个器械使用时，Naviscore能够通过76%的病变，并且在98%的病例中有效用于改变钙化斑块。94%的病例获得了手术成功。基础狭窄率81±12%在使用Naviscore后降至33±8.5%，在植入支架后降至7.5±2.6%。住院期间未发生重大不良心血管事件。未发生穿孔、器械嵌顿或限流性夹层，仅13%发生了A/B型夹层，通过植入支架得以解决。器械性能被认为优于参与中心常用的SB或CB。
Naviscore SB作为首个器械在通过严重钙化病变方面非常有效，具有有效的斑块改变、支架扩张及出色的安全性。Naviscore改善了当前CB和SB的性能。由于其使用简便和性能良好，Naviscore可成为治疗显著钙化病变的首选SB。
