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Safety of drug-eluting stents for stenting patent arterial duct in neonates

Published online by Cambridge University Press:  05 May 2022

Harikrishnan K.N. Kurup Open the ORCID record for Harikrishnan K.N. Kurup [Opens in a new window] ,
Arun Gopalakrishnan Open the ORCID record for Arun Gopalakrishnan [Opens in a new window] ,
Deepa Sasikumar Open the ORCID record for Deepa Sasikumar [Opens in a new window]  and
Kavassery M. Krishnamoorthy Open the ORCID record for Kavassery M. Krishnamoorthy [Opens in a new window]
Harikrishnan K.N. Kurup
Affiliation:
Department of Cardiology, Sree Chitra Tirunal Institute for Medical Sciences and Technology, Thiruvananthapuram, Kerala 695011, India
Arun Gopalakrishnan*
Affiliation:
Department of Cardiology, Sree Chitra Tirunal Institute for Medical Sciences and Technology, Thiruvananthapuram, Kerala 695011, India
Deepa Sasikumar
Affiliation:
Department of Cardiology, Sree Chitra Tirunal Institute for Medical Sciences and Technology, Thiruvananthapuram, Kerala 695011, India
Kavassery M. Krishnamoorthy
Affiliation:
Department of Cardiology, Sree Chitra Tirunal Institute for Medical Sciences and Technology, Thiruvananthapuram, Kerala 695011, India
*
Author for correspondence: Dr Arun Gopalakrishnan, DM, Associate Professor, Department of Cardiology, Sree Chitra Tirunal Institute for Medical Sciences and Technology, Thiruvananthapuram, Kerala 695011, India. E-mail: arungopalakrishnan99@gmail.com
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Abstract

Objectives:

The primary objective was to evaluate the trend of blood sirolimus concentrations in neonates following ductal stenting. The long-term outcomes and incidence of infections were also evaluated.

Methods:

Prospective open-label observational study in a tertiary referral centre over a 1-year period. Serum sirolimus levels were estimated at 1 hour and 24hrs post-stent insertion followed by 7 days in neonates who underwent ductal stenting. The trend in sirolimus levels, incidence of infections, complications and outcomes following ductal stenting were studied.

Results:

Seven neonates with duct-dependent pulmonary circulation underwent ductal stenting at median age of 8.5 days and weight of 2.83kg. The average stent size was 3.5±0.4 mm, and average stent length was 16.3±5.1 mm. The mean sirolimus concentrations at 1 hour, 24 hours and 7 days were 41.3±6.9ng/ml, 15.4±7.1ng/ml and 3.1±0.85ng/ml respectively. Levels fell below therapeutic range for all patients by 7 days. Three patients had sepsis or necrotising enterocolitis, but responded well to antibiotics; 1 patient had aspiration related sudden death. There were no further events at a mean follow-up of 207 days, and 4 patients underwent elective surgery at 238 ± 81 days after ductal stenting.

Conclusions:

This study demonstrates applicability of drug-eluting stents for ductal stenting in newborns. Drug-eluting stents with abluminal drug delivery are associated with high sirolimus levels in initial hours but rapidly taper to negligible levels within a week of implantation. Neonates with high pre-procedure likelihood of infection developed sepsis but responded well to conservative management. The patency of drug-eluting ductal stents is preserved over long-term follow-up.

Keywords

PDA Stentingneonatessafetyductal stenting
Type
Original Article
Information
Cardiology in the Young , Volume 33 , Issue 3 , March 2023 , pp. 437 - 443
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Copyright
© The Author(s), 2022. Published by Cambridge University Press

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