Effective techniques for performing DCB angioplasty

A problem-solving step by step tutorial

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Summary

In recent years, interest in and use of drug-coated balloons (DCBs) have significantly increased in interventional cardiology. Long-term follow-up from registries and randomised trials has reported a 2 to 4 % annual rate of target lesion failure beyond the first year with second-generation drug-eluting stents (DES), largely due to the presence of a permanent metal scaffold. This scaffold impairs vasomotion, prevents late lumen gain, and triggers inflammation and neo-atherosclerosis.

Landmark randomised trials have shown the effectiveness of DCBs in specific populations, such as those with de novo lesions in small coronary vessels or in-stent restenosis (ISR) of DES. Several ongoing randomised trials are now investigating the safety and efficacy of DCBs for de novo lesions in comparison to DES^1,2.

The problem

Drug-coated balloons (DCBs) are semi-compliant balloons coated with an active drug embedded in a matrix. Upon inflation, the drug is transferred to the vessel wall, where it exerts its anti-proliferative effect. DCBs deliver the drug acutely within minutes through direct contact between the balloon surface and the arterial lumen.

However, one limitation of current DCBs is the significant drug loss during preparation and delivery, with first-generation paclitaxel-coated balloons losing up to 80 % of the initial loading dose. Several procedural factors, such as lesion preparation, transit time, inflation duration, and the DCB-to-artery ratio, influence the efficiency of drug transfer and retention within the vessel wall.

Principal idea

Proper lesion preparation, following a step-by-step approach to achieve ≤ 30 % residual stenosis, has become a crucial factor in the success of DCB angioplasty³. Simple techniques to minimize drug loss and optimize drug transfer and retention are also key to enhancing treatment outcomes.

Material needed

• Guiding catheter
• 0.014’’ guidewire
• Semi-compliant balloon
• Non-compliant balloon
• Drug-coated balloon

Step-by-step method

Step 1

In the first phase, pre-dilatation is performed using semi-compliant or non-compliant balloons (vessel/device diameter ratio = 0.8-1) at nominal pressure.
A semi-compliant balloon 2.5 x 15 mm and a non-compliant balloon 3.0 x 15 were inflated up to 10 ATM and 12 ATM, respectively, to prepare the vessel.

Step 2

In case of a sub-optimal result, further dilatations can be performed at higher pressures (16-18 ATM), or other devices such as scoring or cutting balloons, lithotripsy, and atherectomy may be used.

Step 3

Once a satisfactory result is achieved in lesion preparation (similar to stent-like outcomes), DCB angioplasty can be performed.

It is essential to handle the device carefully during preparation, avoiding contact with the balloon surface to prevent drug loss.

After positioning the device at the target lesion, inflate it to 6-8 ATM and maintain inflation for at least 1 minute.

In this case, a sirolimus drug-coated balloon catheter 3.0 x2 5mm was inflated for 1 min at 10 ATM.

If chest pain or ST-segment changes arise, consider performing two inflations of 30 seconds each, rather than a single inflation.

It's important to note that the DCB angioplasty phase is intended only for drug delivery, not for lesion dilation.

Therefore, the device should not be inflated at high pressures for dilating the lesion.

Step 4

If the outcome is satisfactory, with no flow-limiting dissections, the procedure can be considered complete. However, if there is flow reduction and/or a significant dissection (type C or higher), vessel recoil > 30 % or fractional flow reserve ≤ 0.80, bailout stenting is recommended.

Points of specific attention

• The primary goal of DCBs is to deliver the drug to the affected vessel segment, making it essential to avoid drug loss during balloon preparation. It is important to prevent wetting, touching, or contact with other materials.
• To ensure optimal drug delivery to the lesion, the DCB should be the final device used. Avoid performing any post-dilatations after DCB angioplasty.
• The DCB is not designed to dilate the lesion. Inflate it to 4-6 ATM and maintain inflation for 1 minute, carefully avoiding dissections or other complications.
• Type A and B dissections generally indicate good lesion preparation and are typically not flow-limiting. However, a Type C or higher dissection should be treated with stent implantation.

References

1. Greco A, Sciahbasi A, Abizaid A, Mehran R, Rigattieri S, de la Torre Hernandez JM, Alfonso F, Cortese B. Sirolimus-coated balloon versus everolimus-eluting stent in de novo coronary artery disease: Rationale and design of the TRANSFORM II randomized clinical trial. Catheter Cardiovasc Interv. 2022;100:544-552. doi: 10.1002/ccd.30358
2. Spaulding C, Krackhardt F, Bogaerts K, Urban P, Meis S, Morice MC, Eccleshall S. Comparing a strategy of sirolimus-eluting balloon treatment to drug-eluting stent implantation in de novo coronary lesions in all-comers: Design and rationale of the SELUTION DeNovo Trial. Am Heart J. 2023;258:77-84. doi: 10.1016/j.ahj.2023.01.007
3. Jeger RV, Eccleshall S, Wan Ahmad WA, Ge J, Poerner TC, Shin ES, Alfonso F, Latib A, Ong PJ, Rissanen TT, et al. Drug-Coated Balloons for Coronary Artery Disease: Third Report of the International DCB Consensus Group. JACC Cardiovasc Interv. 2020;13:1391-1402. doi: 10.1016/j.jcin.2020.02.043

A word from the reviewer - Ali Nazmi Calik

The Essentials - Drug-Coated Balloon