RODIN-CUT: Successive Cutting Balloon Technique in Calcified Lesions

Moderate or severe coronary calcification can be a marker of poor prognosis in coronary artery disease, as it significantly increases the risk of failure in stent implantation. Therefore, proper lesion preparation is essential to ensure correct expansion. However, there is no universal percutaneous transluminal coronary angioplasty (PTCA) technique suitable for all scenarios involving calcified lesions.

A cutting balloon (CB) is a specialized balloon equipped with microblades or atherotomes that generate microfractures and controlled endovascular incisions. This device has shown superior results in terms of luminal gain and mean stent area (MSA) compared to conventional balloon angioplasty. Factors such as calcium arc, calcification length and thickness, inflation pressure, and blade positioning influence the effectiveness of plaque preparation.

This study evaluated the RODIN-CUT technique, which involves performing multiple successive inflations with a CB and assessing the results with intravascular ultrasound (IVUS, Opticross HD 60 MHz) after each inflation. The aim was to assess the applicability of this technique in the first treated cases.

Methodology

Researchers used a 7-Fr guidewire catheter (GC) that allowed for simultaneous IVUS and CB use. Initially, they conducted a pullback with IVUS, retracting it to the GC. The CB was then positioned at the target lesion, while the distal tip of the IVUS was placed near the CB. The CB was inflated at a pressure of 16–18 atm for 5–10 seconds per cycle (with a minimum of five consecutive inflations). IVUS images were obtained after each inflation.

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Procedural success was defined as residual stenosis <30% and a distal TIMI 3 flow.

In Case 1, PTCA was performed in the ostial circumflex artery with a minimal lumen area (MLA) of 2.34 mm² and a 340° arc. After each inflation, the MLA increased from 2.34 to 2.42, 4.56, and 6.32 mm², with a reduction in the calcium arc from 340° to 180°, 160°, and finally 120°. Post-stenting MSA was 11.75 mm², with excellent flow.

Case 2 involved restenosis with concentric calcification, an MLA of 4.47 mm², and a length of 2.5 mm. The MLA increased from 4.47 to 5.91, 5.56, 6.04, and 6.61 mm², with a calcium arc reduction from 340° to 200°, 160°, and 120°. Additionally, operators treated a nodular calcium lesion with an MLA of 3.73 mm², which increased from 3.73 to 5.14, 5.76, and 7.48 mm². Its post-stenting MSA was 10.51 mm² and the eccentricity index, 0.85.

Lastly, researchers describe an ostial right coronary artery lesion with an MLA of 2.04 mm² and a 310° arc. The MLA increased to 6.98 mm² without major dissections. After stenting, the MSA was 14.88 mm², with an eccentricity index of 0.86.

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The effectiveness observed through intravascular imaging positions the RODIN-CUT technique as a promising alternative for the management of complex coronary calcifications. Researchers emphasize the importance of performing at least five CB inflations, with continuous IVUS evaluation, as this is what allowed for optimal CB rotation during each inflation.

Conclusions

Multiple inflations at higher-than-usual pressures (while respecting the balloon-to-lumen ratio) showed a significant increase in MLA and a reduction in the calcium arc in these initial cases. The controlled dissections generated by the blades did not cause major adverse events. These findings need to be validated in randomized studies to confirm the benefits.

Original Title: Enhanced Efficiency of Sequential Cutting Balloon Angioplasty in Calcified Coronary Artery Disease: The RODIN‐CUT Technique.

Reference: Ungureanu C, Leibundgut G, Cocoi M, Gasparini G, Colletti G, Avran A, Poletti E, Moroni A, Mangieri A, Dumitrascu S, Mozid A, Boukhris M, Achim A, Zivelonghi C, Bentakhou E, Agostoni P. Enhanced Efficiency of Sequential Cutting Balloon Angioplasty in Calcified Coronary Artery Disease: The RODIN-CUT Technique. Catheter Cardiovasc Interv. 2025 Jan 5. doi: 10.1002/ccd.31387. Epub ahead of print. PMID: 39757754.