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OPTILOW: A Low-Profile Approach for Implanting Optimus-L Stents in Infants and Children
Katarzyna Gendera1, James R Bentham2, Stanimir Georgiev1
1Department of Pediatric Cardiology and Congenital Heart Disease, German Heart Center Munich Technical University of Munich Munich Germany.
Insights
Optimus-L stents are safe and effective for treating stenosis in small children. This low-profile approach demonstrated successful stent implantation and good outcomes in pediatric patients.
Area of Science:
- Pediatric Cardiology
- Interventional Cardiology
- Vascular Surgery
Background:
- Stent implantation in pediatric patients presents unique challenges due to small vessel size and rapid growth.
- The Optimus-L stent system was developed to address these limitations in pediatric interventions.
Purpose of the Study:
- To evaluate the in vivo efficacy and safety of Optimus-L stent implantation in infants and small children.
- To assess the feasibility of a low-profile approach for stent delivery in this patient population.
Main Methods:
- Retrospective review of 28 pediatric patients (≤20 kg) with congenital heart stenotic lesions.
- Optimus-L stents were implanted using small-sized balloon catheters (≤12 mm) and sheaths (≤8 Fr).
- Stent performance and procedural outcomes were assessed post-implantation.
Main Results:
- Successful stent implantation in all patients without immediate complications.
- Significant increase in median vessel diameter (4.6 mm to 8.8 mm, P<0.001) with high stent expansion (95%).
- Favorable outcomes observed with a median follow-up of 8 months, with only two patients requiring re-intervention.
Conclusions:
- Optimus-L stents are safe and effective for treating arterial and venous stenosis in infants and small children.
- The low-profile implantation approach facilitates successful treatment in this challenging pediatric population.
- The study supports the use of Optimus-L stents for pediatric cardiovascular interventions.
Background:
Stent implantation poses challenges in small children due to their limited vessel size and rapid growth. This multicenter study evaluates in vivo efficacy of implanting Optimus-L stents in small patients using a low-profile approach.
Methods:
We retrospectively reviewed data from children weighing ≤20 kg with congenital heart stenotic lesions who received Optimus-L stents manually mounted on small-sized balloon catheters (diameter ≤12 mm) using a hand-actuated compression tool and implanted through small-sized sheaths (≤8 Fr) at our institutions between May 2022 and January 2024. Stent performance was assessed.
Results:
We identified 28 patients (67.8% male) with median age and weight of 3.4 years (interquartile range [IQR], 1.5-5.5) and 12.9 kg (IQR, 9.1-16.4). Six (21.4%) were infants, 11 (39.3%) ≤10 kg. Stenotic lesions included 16 branch pulmonary arteries, 9 aortic isthmus, 2 right ventricular outflow tracts, and 1 Glenn anastomosis. Percentage of stenosis was 50% (IQR, 36%-58%). All implantations were successful without complications. The procedures mostly used 7 Fr sheaths for stents on 6, 7, and 8 mm balloons and 8 Fr sheaths for 9, 10, 12 mm balloons. Median stent expansion percentage was 95% (IQR, 90%-96%). Median vessel diameters increased from 4.6 mm (IQR, 3.8-5.1) to 8.8 mm (IQR, 7.5-9.5) (P<0.001), with median stenosis expansion at 103% (IQR, 51%-146%). Median stent shortening was 1.9% (IQR, 0%-3.9%). Two patients required redo stent balloon dilation after 18 and 20 months. Median follow-up was 8 months (IQR, 3.2-13.2). Median last recorded Doppler velocity on implanted stents was 1.6 m/s (IQR, 1.2-2).
Conclusions:
Optimus-L stents can safely treat arterial and venous stenosis in infants and small children via a low-profile approach with good outcomes.
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