ADVERTORIAL: A step forward in scoring balloon catheter design

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This advertorial is sponsored by iVascular

Antoni Serra

A new coronary scoring balloon dilatation catheter—Naviscore (iVascular)—features a hybrid design combining the benefits of scoring and cutting balloons to turn the page on calcified lesions. Cardiovascular News explores the features of this innovative device, and details insights from its deployment in a first-in-man study.

To interventional cardiologists, coronary artery calcification is a well-known and widely-acknowledged challenge in the cath lab—a major marker for poor outcomes in patients and an added layer of complexity when it comes to performing percutaneous coronary intervention (PCI) procedures.

According to figures published by Robert S Copeland-Halperin (Icahn School of Medicine at Mount Sinai, New York, USA) and colleagues in the journal Catheterization & Cardiovascular Interventions, as many as 10% of patients undergoing PCI present with moderately calcified lesions, whilst a further 8% have more extensive—severe—calcification. Copeland-Halperin et al found that among the risk factors for moderate or severe calcification were older age and more complex target lesions. Therefore, it is a reasonable assumption that, with an ageing Western population and a higher number of PCI procedures being performed in patients with wide-ranging comorbidities, the challenge of calcific lesions will persist or even become greater into the future.

With these factors in mind, it is important for interventional cardiologists to have access to an array of tools with features that are tailored to address the demands posed by coronary calcium. Currently, options at hand include the use of mechanical devices, such as rotational atherectomy, orbital atherectomy or intravascular lithotripsy (IVL), as well as a less complex option—scoring and cutting balloons.

Though commonly used for the treatment of coronary plaques, contemporary scoring balloons come with various limitations. “One common complaint about these balloons is that they are bulky and stiff devices, the complaint is that it is very difficult to cross a tight lesion,” Antoni Serra (Hospital Sant Pau, Barcelona, Spain) told attendees of Turin CTO & CHIP Live 2022 (4–6 May, Turin, Italy). According to Serra, the bulkiness and stiffness of the devices can make tracking through calcific and tortuous vessels challenging, as it is difficult to cross the lesion and difficult to recross once inflated.

Introducing Naviscore

“Can we improve this?” Serra asked the audience at Turin CTO & CHIP Live 2022, where he delivered an emphatic answer: Yes we can! He then introduced Naviscore, a new coronary scoring balloon dilatation catheter from iVascular that looks to overcome these existing drawbacks through a unique construction and innovative hybrid design, which is intended to combine the favourable elements of both cutting and scoring balloons.

The device features a nitinol structure placed over a high-pressure balloon and has a rated burst pressure of 20atm, with an average burst pressure up to 26atm. The nitinol lattice is laser-cut for precision, with struts measuring 125μm without welding, ensuring better navigability and a low perforation risk while modifying plaque. The tip of the device features a platinum-iridium ring that serves as a marker of penetration of the scoring balloon in the calcified lesion, a feature that is designed to assist with its positioning.

The device boasts a nylon compensation tube in the shaft, which assists with re-wrapping after the balloons have been deflated—a unique feature that cannot be found on any other device currently on the market. Importantly, Naviscore incorporates an axial filament orientation designed to ensure greater cross capacity and 90-degree axial plaque modification. The axial distribution of filaments allows for more push against the calcific lesions, and enables easier navigation of the device through tortuous and calcified vessels as a result of its favourable crossing profile.

In addition, and in counterpoint to other scoring balloons currently available on the market which have a relatively small filament surface area in contact with the calcific vessel, the axial design of the Naviscore device enables a larger contact area with the vessel. This enables a larger scoring surface, as well as a uniform score, parallel to the balloon itself. Compared to other contemporary devices with a helical design, the Naviscore features a scoring surface area that is up to six times greater.

Naviscore also compares favourably across numerous features when measured against competitor devices. This includes its crossing profile at 1.07mm—which is between five–31% smaller than other scoring and cutting balloons on the market—whilst the device also has a smaller diameter, with balloons available in diameters from 1.5mm to 6mm and 6mm to 15mm in length, meaning that Naviscore can be deployed in smaller, tighter vessels than would previously have been open to scoring or cutting.

At Turin CTO & CHIP Live 2022 Serra detailed findings from the first-in-man, FIM NAVISCORE study, which gives the first real-world insights into the use of Naviscore from 10 centres in Spain and Portugal. The study included a total of 85 patients with moderate or severely calcified lesions in whom the Naviscore was intended for use as the first device in the PCI procedure. If this was unsuccessful, a small balloon could be used for predilatation. Each centre participating in the study carried out a minimum of five cases, having previously completed a handful of cases to gain experience with the device.

Outside of the requirement for calcified lesions, there were no exclusion criteria for the study. Serra noted that patients enrolled in the study had a mean age of 71 years, were predominantly male (80%), and had a range of comorbidities (44% diabetes, 70% dyslipidaemia; 75% hypertension, 18% chronic kidney disease), whilst 43% had previously undergone PCI or coronary artery bypass graft (CABG) surgery. In terms of angiographic characteristics, he noted that the vast majority (87%) had type B2/C lesions, with around two-thirds (66%) comprising severe calcification. Chronic total occlusion (CTO) was present in 10% of cases. In almost half of cases (41%), the lesion was presenting in the left anterior descending (LAD) artery.

Turning to the procedural characteristics, Serra noted that in 76% of patients treated, the first attempt at crossing the lesion with Naviscore was successful. Of the 18 cases in which Naviscore was unable to cross at the first attempt, a small balloon was deployed, and following this, the Naviscore achieved successful crossing in 89% of the patients. Furthermore, in the 10 patients who were treated using an alternative to Naviscore at the first attempt—either rotational atherectomy or a small balloon—all 10 subsequently had the lesion successfully crossed using Naviscore.

Outlining the clinical results from the 85 cases, Serra told Turin CTO & CHIP Live 2022 attendees that, in the study, the device achieved a 94% procedural success rate comprising of a residual stenosis of <30% after stenting, no major complications and thrombolysis in myocardial infarction (TIMI) 3 flow. Additionally, angiography showed that the proportion of stenosis seen prior to the Naviscore procedure stood at 81%, falling to 33% post-Naviscore, and 7.5% post-stenting, suggesting, according to Serra, that Naviscore plays an important role in facilitating the opening of the stent. There were no reported incidences of in-hospital major adverse cardiovascular events (MACE), death, myocardial infarction (MI) or emergency CABG, or device entrapment. Type A or B dissection was seen in 13% of cases, though this was not flow-limiting in any of the patients.

“Naviscore is a very powerful device with more pushability than the other competitors, easier entry into the lesions, and greater plaque modification,” adds Serra, considering the merits of the device in sum. “Naviscore should be the first-choice device for the treatment of these difficult and complex lesions thanks to its crossing capacity of severely calcified lesions at the first attempt and the effectiveness of opening the vessel.”


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