First use and limitations of Magmaris® bioresorbable stenting in a low birth weight infant with native aortic coarctation

Abstract

We, herein, report the first use of a Magmaris® magnesium‐based vascular scaffold for native aortic coarctation in a 1,980 g infant with multiple malformations. Due to the low body weight, complex illness, and clinical instability, it was decided to delay surgical correction. After insufficient results had been obtained by balloon angioplasty, Magmaris® implantation was chosen to bridge the patient to surgery by stabilizing left ventricular function and to allow for sufficient growth. Due to significant early stent restenosis and complete loss of radial force, the patient required balloon reangioplasty only 21 days after Magmaris® implantation and early surgical correction. In addition, high systemic sirolimus levels were detected 48 hr after the intervention (5 ng/mL). Although the bioresorbable scaffold was successfully used as a short‐term bridge‐to‐surgery in our case, due to significant early stent failure (loss of radial force), this approach does not seem promising for long‐term bridging of infants with aortic coarctation. In addition, the consequences of sirolimus‐induced systemic immunosuppression may further limit the applicability of Magmaris® scaffolds in infants with congenital heart disease.

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

“…Even months after the degradation, the dissection of the modified Blalock-Taussig shunt and construction of a bidirectional Glenn shunt was not hindered nor was any intervention at the stented site necessary. 19,20 In another centre and similar to earlier results, 2 the new magnesium scaffold has not produced a lasting positive result in coarctations in newborns, 11 where ductal tissue may play a role.…”

“…Rapamycin inhibits activation of T cells and B cells by reducing their sensitivity to interleukin-2 through mechanistic target of rapamycin inhibition, 10 and its immunosuppressive characteristics were considered an obstacle for the use in infants. 11 Following literature review and discussions on the use of rapamycin in transplant medicine, its effect on cell proliferation is considered reversible and severe adverse reactions are seen only at mid-and long-term systemic treatment. [12][13][14][15][16][17] There were no clinical signs of adverse effects connected to the scaffold implantation in this patient group including Pat5 with therapeutic Sirolimus levels for 2 days.…”

In vivo degradation and endothelialization of an iron bioresorbable scaffold

“…As an implantable medical device with high risk, an ideal bioresorbable stents or scaffolds (BRSs) should not only demonstrate safety and effectiveness non-inferior to the current permanent drug-eluting stents [ 1 , 2 ], but also exhibit advantages of decreasing long-term risks, improving very late clinical outcomes [ 3 ], leaving the unrestricted vascular growth of infants or kids [ 4 , 5 ] and allowing the possible re-intervention [ 6 ]. The first BRS – Igaki-Tamai scaffold composed of polylatide (PLA) was implanted into human coronary artery in 1998 [ 7 ], and more than 20 years go through since then.…”

The Future of Paediatric Heart Interventions: Where Will We Be in 2030?

“…Ltd., Vapi, India), a novel second-generation sirolimus-eluting BRS, with up to 3-year follow-up [ 21 ]. Another second-generation BRS named Magmaris (Biotronik AG, Bülach, Switzerland), a newer generation magnesium-based BRS, has reported encouraging results based on a small number of non-RCT studies [ 22 ], and one case was reported as the first use of a Magmaris for native aortic coarctation in a small infant with success as a short-term bridge-to-surgery [ 23 ].…”