Three-dimensional balloon catheter sizing identifies significant underdeployed stents using conventional methods in...

Area of Science:

• Interventional Cardiology
• Medical Device Technology
• Vascular Surgery

Background:

• Renal artery stent restenosis is a major challenge, often linked to suboptimal stent placement.
• The Metricath (MC) system, a balloon-catheter sizing device, was investigated for its potential to optimize stent deployment.

Purpose of the Study:

• To test the hypothesis that the MC system can achieve optimal stent deployment during renal artery interventions.
• To evaluate the effectiveness of the MC system in improving stent expansion and minimizing restenosis.

Main Methods:

• The MC system uses a low-pressure balloon to derive accurate vessel lumen dimensions via 3D reconstruction of fluid volume and pressure.
• A systematic comparison was made between final visual assessment of renal artery interventions and subsequent MC minimal lumen diameter (MLD) measurements.

Main Results:

• MC guidance led to adjunctive intervention in 90% of 20 renal artery lesions across 16 patients.
• Adjunctive intervention increased MLD from 4.40 mm to 5.17 mm (p < 0.001), improving MC MLD to nominal stent diameter ratio from 76.2% to 90.0% (p < 0.001).
• The proportion of lesions achieving an MC MLD-to-nominal stent diameter ratio >= 85% increased from 10% to 65% after adjunctive balloon post-dilatation.

Conclusions:

• MC guidance during renal interventions identified a significant proportion of underdeployed stents.
• Adjunctive intervention, guided by the MC system, effectively optimized stent deployment and expansion.