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New scoring balloon to treat moderate-to-severe calcified coronary lesions. The first-in-man Naviscore study
Antonio Serra Peñaranda1, Estefanía Fernández Peregrina1, Marcelo Jiménez Kockar1
1Departamento 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.
Insights
The Naviscore scoring balloon (SB) effectively treats calcified coronary lesions, improving lesion crossing and plaque modification. This new device demonstrates a superior safety profile compared to existing cutting balloons (CB) and scoring balloons (SB).
Area of Science:
- Cardiovascular Medicine
- Interventional Cardiology
- Medical Devices
Background:
- Calcified coronary lesions present significant therapeutic challenges due to their prevalence and resistance to treatment.
- Existing devices like cutting balloons (CB) and scoring balloons (SB) can be stiff and bulky, complicating lesion crossing and navigation, especially in tortuous arteries.
- Difficulty in recrossing lesions after initial device inflation necessitates improved device design for complex calcified lesions.
Purpose of the Study:
- To evaluate the safety and efficacy of the novel Naviscore scoring balloon (SB).
- To assess the Naviscore SB's ability to overcome the limitations of conventional balloons in treating calcified coronary lesions.
- To determine the Naviscore SB's performance as a first-line device for percutaneous coronary intervention (PCI) in moderate to severe calcified lesions.
Main Methods:
- A multicenter, prospective, first-in-man trial (Naviscore Registry) involving 85 patients with moderate or severe de novo calcified coronary lesions.
- Patients had stable angina and required percutaneous coronary intervention (PCI).
- The Naviscore SB was used as the initial device for lesion preparation prior to stent implantation.
Main Results:
- The Naviscore SB successfully crossed 76% of treated lesions and was effective in plaque modification in 98% of cases.
- Procedural success was high at 94%, with significant reduction in stenosis from 81% to 33% post-Naviscore and 7.5% post-stenting.
- No major adverse cardiovascular events, perforations, or flow-limiting dissections occurred; device performance was rated superior to conventional CB and SB.
Conclusions:
- The Naviscore SB is a highly effective and safe first-line device for treating severely calcified coronary lesions, facilitating plaque modification and stent expansion.
- It offers improved handling and performance compared to existing scoring balloons (SB) and cutting balloons (CB).
- The Naviscore SB is recommended as a preferred choice for treating significant calcified lesions due to its simplicity and efficacy.
Introduction And Objectives:
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.
Methods:
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.
Results:
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.
Conclusions:
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.
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