Serum Sirolimus Levels After Implantation of Third Generation Drug Eluting Cobalt Chromium Coronary Stent in Ductus Arteriosus in Neonates with Duct-Dependent Pulmonary Circulation

Sivakumar, Kothandam; Pavithran, Sreeja; Sonawane, Bhushan; Rajendran, Monica; Rajeshkumar, Ramasamy

doi:10.1007/s00246-020-02381-4

Cited by 13 publications

(8 citation statements)

References 27 publications

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“…In a study of neonates receiving sirolimus-eluting stents, peak sirolimus levels reached immunosuppressive levels, although no clinically significant adverse outcomes were observed. 46 The level of immunosuppression also correlates with the length and number of stents; Sivakumar et al 47 noted that sirolimus levels did not reach immunosuppressive levels if a single stent of <22 mm was used. Again, however, no clinically significant adverse outcomes were observed for the cases that did reach immunosuppressive levels, and drug levels rapidly decreased within a week.…”

Section: Type Of Stentmentioning

confidence: 99%

Stenting of the Patent Ductus Arteriosus: A Meta-analysis and Literature Review

Bauser‐Heaton¹,

Price²,

Weber³

et al. 2022

Journal of the Society for Cardiovascular Angiography & Int

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Section: Type Of Stentmentioning

confidence: 99%

Stenting of the Patent Ductus Arteriosus: A Meta-analysis and Literature Review

Bauser‐Heaton¹,

Price²,

Weber³

et al. 2022

Journal of the Society for Cardiovascular Angiography & Int

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“…A study using third-generation sirolimus stent demonstrated patency of the stent up to 8-16 months in univentricular lesions and 21-27 months in patients destined for biventricular repair. 9 Limitations This is a prospective study with a small sample size. There were significantly lesser number of patients than expected because of the COVID-19 pandemic and lockdowns imposed.…”

Section: Discussionmentioning

confidence: 98%

“…Another study reported the serum sirolimus levels attained in 12 neonates following ductal stenting using a third-generation cobalt chromium drug-eluting stent. 9 Their cohort involved 11 neonates with duct-dependent pulmonary circulation and one with pulmonary atresia and rhabdomyoma. The sirolimus levels were less than 5 ng/ml in patients who received a single stent or even two stents where the total length was less than 22 mm.…”

Section: Discussionmentioning

confidence: 99%

“…The average age of our cohort was 11.3 days, and the mean weight was 2.8 kg, as compared to 3kg and 3.2 kg in the other series. 7,9 Bare-metal stents are not readily available in our country which limits their application for interventions. It has been established that drug-eluting stents fare much better than bare-metal stents in terms of long-term patency/ luminal loss.…”

Section: Discussionmentioning

confidence: 99%

“…The study by Sivakumar et al on 12 neonates used BioMime stent (Meril Life Sciences, Gujarat, India) which contains sirolimus at a dosage of 1.25 μg per square millimetre of stent surface area and elutes the drug luminally too. 9 Studies involving larger number of patients with head-to-head comparison of abluminal and conformal drug-eluting stents are required to clarify the comparative drug levels after ductal stenting in newborns. Sirolimus levels are considered to be therapeutic (for immunosuppression in renal transplant recipients) when the levels are 4 to 20 ng/ml as estimated by tandem mass spectrometry.…”

Section: Discussionmentioning

confidence: 99%

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

et al. 2022

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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.

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Mammalian target of rapamycin inhibitors: A new‐possible approach for in‐utero medication therapy

Qaderi,

Javinani,

Blumenfeld

et al. 2024

Prenatal Diagnosis

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The mammalian/mechanistic target of rapamycin (mTOR) is a protein kinase that plays a crucial role in regulating cellular growth, metabolism, and survival. Although there is no absolute contraindication for the use of mTOR inhibitors during pregnancy, the specific fetal effects remain unknown. Available data from the past 2 decades have examined the use of mTOR inhibitors during pregnancy in patients with solid organ transplantation, showing no clear link to fetal complications or structural abnormalities. Recently, a handful of case reports and series have described transplacental therapy of mTOR inhibitors to control symptomatic and complicated pathologies in the fetus. The effect of these agents includes a significant reduction in lesion size in the fetus and a reduced need for mechanical ventilation in neonates. In this context, we delve into the potential of mTOR inhibitors as in‐utero therapy for fetal abnormalities, with a primary focus on lymphatic malformation (LM) and cardiac rhabdomyoma (CR). While preliminary reports underscore the efficacy of mTOR inhibitors for the treatment of fetal CR and fetal brain lesions associated with tuberous sclerosis complex, chylothorax, and LMs, additional investigation and clinical trials are essential to comprehensively assess the safety and efficacy of these medications.

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Serum Sirolimus Levels After Implantation of Third Generation Drug Eluting Cobalt Chromium Coronary Stent in Ductus Arteriosus in Neonates with Duct-Dependent Pulmonary Circulation

Cited by 13 publications

References 27 publications

Stenting of the Patent Ductus Arteriosus: A Meta-analysis and Literature Review

Stenting of the Patent Ductus Arteriosus: A Meta-analysis and Literature Review

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

Mammalian target of rapamycin inhibitors: A new‐possible approach for in‐utero medication therapy

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