Session 4: Technical Strategies - Scoring and High-Pressure Balloons – Adnan Kastrati

Cutting and Scoring Balloons in Interventional Cardiology

Introduction to Cutting and Scoring Balloons

• The speaker expresses gratitude for presenting after TCT, noting that their slides would have been outdated otherwise.

• They reference Victor's presentation, which highlighted the importance of cutting and scoring balloon techniques.

• Two types of balloons are discussed: one with knives and another with wire knitting, both aimed at disrupting neointima or plaque.

Clinical Applications

• Recommendations from Antonio Colombo suggest interchangeable use of these balloons in various scenarios, particularly instant restenosis and calcified lesions.

• A study on the additive effect of scored balloons before drug-eluting balloon (DEB) use shows a reduction in binary stenosis from 32% to 18%, indicating significant results despite a small sample size.

Randomized Trials Overview

• The first randomized trial compares scoring balloons against non-compliant balloons for treating calcified lesions, showing benefits in minimal stent area.

• Another trial compared scoring balloons with rotational atherectomy; procedural success was higher with rotational atherectomy but five-year outcomes were similar.

Shortcut Trial Insights

• The Shortcut trial compared cutting balloons versus intravascular lithotripsy (IVL), involving 43 patients with significantly calcified coronary artery disease.

• Patients were stratified based on planned rotational procedures; primary endpoint focused on post-procedural minimal stent area at maximum calcium sites.

Key Findings from the Shortcut Trial

• The trial confirmed non-inferiority of cutting balloons compared to IVL regarding primary endpoints; no significant clinical event differences were observed between groups.

• Cost analysis revealed IVL costs exceeded $13,000 while scoring balloon costs were under $10,000.

Comparison of OPN Balloon vs. Scoring Balloon

• Discussion introduces the OPN balloon characterized by its double-layer design capable of high pressures exceeding 40 atmospheres.

OPN vs IVL Trial Results

Overview of the Trial

• The trial compared OPN (Over-the-Necessary Balloon) and IVL (Intravascular Lithotripsy) in a randomized study involving over 270 patients, all of whom received stent implantations with second-generation drug-eluting stents.

• The primary endpoint was the measurement of final stent expansion, assessed through Optical Coherence Tomography (OCT), alongside clinical follow-up at 30 days post-procedure.

Key Findings

• The trial confirmed the non-inferiority of OPN balloon compared to IVL regarding primary endpoint outcomes related to stent expansion.

• No significant differences were observed in clinical outcomes between the two methods; however, it is important to note that the patient sample size was relatively small.

Future Directions