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Acute treatment of critical vascular stenoses with a bioabsorbable magnesium scaffold in infants with CHDs

Published online by Cambridge University Press:  21 February 2020

Peter A. Zartner*
Affiliation:
Department of Cardiology, German Paediatric Heart Centre, University Hospital, Bonn, Germany
Dietmar Schranz
Affiliation:
Department of Cardiology, Hessian Paediatric Heart Centre, University Giessen and Marburg, Giessen, Germany
Nathalie Mini
Affiliation:
Department of Cardiology, German Paediatric Heart Centre, University Hospital, Bonn, Germany
Martin B. Schneider
Affiliation:
Department of Cardiology, German Paediatric Heart Centre, University Hospital, Bonn, Germany
Katja Schneider
Affiliation:
Department of Neonatology, Marienhospital, Bonn, Germany
*
Author for correspondence: Dr P. Zartner, Department of Cardiology, German Paediatric Heart Centre, University Hospital of Bonn, Venusberg Campus 1, 53127Bonn, Germany. Tel: +49 228 287-37482; Fax: +49 228 287-14603; E-mail: [email protected]

Abstract

Background:

Post-operative severe vascular stenosis and proliferating endothelial tissue lead to severe circulatory disorders and impair organ perfusion. Bioabsorbable magnesium scaffolds may help to overcome these obstructions without leaving obstructing stent material. We analyse their role in the treatment of vascular stenosis in infants.

Methods:

Since 2016, 15 magnesium scaffolds with a diameter of 3.5 mm were implanted in 9 patients aged 15 days to 7.6 years. Eight scaffolds were implanted in pulmonary venous restenoses, five in pulmonary arterial stenosis including one in-stent stenosis, one into a stenotic brachiocephalic artery, and one in a recurrent innominate vein thrombosis.

Results:

All patients clinically improved after the implantation of a scaffold. The magnesium scaffolds lost integrity after 30–48 days (mean 42 days). The innominate vein thrombosed early, while all other vessels remained open. Two patients died after 1.3 and 14 weeks not related to the scaffolds. Five patients needed further balloon dilations or stent implantations after the scaffold had fractured. At first recatheterisation after in mean 2.5 months, the mean minimum/maximum diameter in relation to the scaffold’s original diameter was 89%/99% in the arterial implantations (n = 6) and 66%/77% in the pulmonary venous implantations.

Conclusions:

The magnesium scaffolds can be used as a bridging solution to treat severe vascular stenosis in different locations. Restenosis can occur after degradation and make further interventions necessary, but neither vessel growth nor further interventions are hindered by stent material. Larger diameters may improve therapeutic options.

Type
Original Article
Copyright
© The Author(s) 2020. Published by Cambridge University Press

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References

McMahon, CJ, Oslizlok, P, Walsh, KP. Early restenosis following biodegradable stent implantation in an aortopulmonary collateral of a patient with pulmonary atresia and hypoplastic pulmonary arteries. Catheter Cardiovasc Interv 2007; 69: 735738.CrossRefGoogle Scholar
Schranz, D, Zartner, P, Michel-Behnke, I, Akinturk, H. Bioabsorbable metal stents for percutaneous treatment of critical recoarctation of the aorta in a newborn. Catheter Cardiovasc Interv 2006; 67: 671673.CrossRefGoogle Scholar
Zartner, P, Cesnjevar, R, Singer, H, Weyand, M. First successful implantation of a biodegradable metal stent into the left pulmonary artery of a preterm baby. Catheter Cardiovasc Interv 2005; 66: 590594.CrossRefGoogle ScholarPubMed
Zartner, P, Buettner, M, Singer, H, Sigler, M. First biodegradable metal stent in a child with congenital heart disease: evaluation of macro and histopathology. Catheter Cardiovasc Interv 2007; 69: 443446.CrossRefGoogle Scholar
Haude, M, Ince, H, Abizaid, A, et al. Safety and performance of the second-generation drug-eluting absorbable metal scaffold in patients with de-novo coronary artery lesions (BIOSOLVE-II): 6 months results of a prospective, multicentre, non-randomised, first-in-man trial. Lancet 2016; 387: 3139.CrossRefGoogle ScholarPubMed
Haude, M, Ince, H, Abizaid, A, et al. Sustained safety and performance of the second-generation drug-eluting absorbable metal scaffold in patients with de novo coronary lesions: 12-month clinical results and angiographic findings of the BIOSOLVE-II first-in-man trial. Eur Heart J 2016; 37: 27012709.CrossRefGoogle ScholarPubMed
Haude, M, Ince, H, Kische, S, et al. Sustained safety and clinical performance of a drug-eluting absorbable metal scaffold up to 24 months: pooled outcomes of BIOSOLVE-II and BIOSOLVE-III. EuroIntervention 2017; 13: 432439.Google ScholarPubMed
Canpolat, M, Per, H, Gumus, H, et al. Rapamycin has a beneficial effect on controlling epilepsy in children with tuberous sclerosis complex: results of 7 children from a cohort of 86. Childs Nerv Syst 2014; 30: 227240.CrossRefGoogle Scholar
Hammill, AM, Wentzel, M, Gupta, A, et al. Sirolimus for the treatment of complicated vascular anomalies in children. Pediatr Blood Cancer 2011; 57: 10181024.CrossRefGoogle ScholarPubMed
Mukherjee, S, Mukherjee, U. A comprehensive review of immunosuppression used for liver transplantation. J Transplant 2009; 2009: 701464.CrossRefGoogle ScholarPubMed
Sallmon, H, Berger, F, Cho, MY, Opgen-Rhein, B. First use and limitations of Magmaris(R) bioresorbable stenting in a low birth weight infant with native aortic coarctation. Catheter Cardiovasc Interv 2019; 93: 13401343.Google Scholar
Dambrin, C, Klupp, J, Birsan, T, et al. Sirolimus (rapamycin) monotherapy prevents graft vascular disease in non-human primate recipients of orthotopic aortic allografts. Circulation 2003; 107: 23692374.CrossRefGoogle Scholar
Di, BF, Di, SS, De, RN, et al. Sirolimus monotherapy in liver transplantation. Transplant Proc 2007; 39: 19301932.Google Scholar
Di, BF, Di, SS, De, RN, et al. Sirolimus monotherapy effectiveness in liver transplant recipients with renal dysfunction due to calcineurin inhibitors. J Clin Gastroenterol 2009; 43: 280286.Google Scholar
Diekmann, F, Gutierrez-Dalmau, A, Torregrosa, JV, Oppenheimer, F, Campistol, JM. Sirolimus monotherapy: feasible immunosuppression for long-term follow-up of kidney transplantation--a pilot experience. Transplantation 2005; 80: 13441348.CrossRefGoogle ScholarPubMed
Pinto, JR, Arellano Torres, EM, Franco, A, et al. Sirolimus monotherapy as maintenance immunosuppression: a multicenter experience. Transpl Int 2010; 23: 307312.CrossRefGoogle ScholarPubMed
Uhlmann, D, Weber, T, Ludwig, S, et al. Long-term outcome of conversion to sirolimus monotherapy after liver transplant. Exp Clin Transplant 2012; 10: 3038.CrossRefGoogle ScholarPubMed
Lipinski, MJ, Acampado, E, Cheng, Q, et al. Comparison of acute thrombogenicity for magnesium versus stainless steel stents in a porcine arteriovenous shunt model. EuroIntervention 2018; 14: 14201427.CrossRefGoogle Scholar
Brandt-Wunderlich, C, Ruppelt, P, Zumstein, P, et al. Mechanical behavior of in vivo degraded second generation resorbable magnesium scaffolds (RMS). J Mech Behav Biomed Mater 2019; 91: 174181.CrossRefGoogle Scholar
Hideo-Kajita, A, Garcia-Garcia, HM, Haude, M, et al. First report of edge vascular response at 12 months of magmaris, a second-generation drug-eluting resorbable magnesium scaffold, assessed by grayscale intravascular ultrasound, virtual histology, and optical coherence tomography. A Biosolve-II Trial Sub-Study. Cardiovasc Revasc Med 2019; 20: 392398.CrossRefGoogle Scholar