Preclinical comparative assessment of a dedicated pediatric poly-L-lactic-acid-based bioresorbable scaffold with a low-profile bare metal stent

Kamel Shibbani; Luiza De Lima e Silva Bagno; Marie-France Poulin; Thomas Matella; Karim Diab; Clifford Kavinsky; Nagarajan Ramesh; Vinayak Bhat; Ziyad M. Hijazi; Damien Kenny

doi:10.1002/ccd.28893

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Preclinical comparative assessment of a dedicated pediatric poly-L-lactic-acid-based bioresorbable scaffold with a low-profile bare metal stent

Kamel Shibbani, Luiza De Lima e Silva Bagno, Marie-France Poulin, Thomas Matella, Karim Diab, Clifford Kavinsky, Nagarajan Ramesh, Vinayak Bhat, Ziyad M. Hijazi and Damien Kenny

Catheterization and cardiovascular interventions, Vol.96(4), pp.878-888

10/01/2020

DOI: 10.1002/ccd.28893

PMCID: PMC7737646

PMID: 32294303

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https://www.ncbi.nlm.nih.gov/pmc/articles/7737646View

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Abstract

Background Polymer-based bioresorbable scaffolds (PBBS) have been assessed for coronary revascularization with mixed outcomes. Few studies have targeted pediatric-specific scaffolds. We sought to assess safety, efficacy, and short-term performance of a dedicated drug-free PBBS pediatric scaffold compared to a standard low-profile bare metal stent (BMS) in central and peripheral arteries of weaned piglets. Methods Forty-two devices (22 Elixir poly-L-lactic-acid-based pediatric bioresorbable scaffolds [BRS] [6 x 18 mm] and 20 control BMS Cook Formula 418 [6 x 20 mm]) were implanted in the descending aorta and pulmonary arteries (PAs) of 14 female Yucatan piglets. Quantitative measurements were collected on the day of device deployment and 30 and 90 days postimplantation to compare device patency and integrity. Results The BRS has a comparable safety profile to the BMS in the acute setting. Late lumen loss (LLL) and percent diameter stenosis (%DS) were not significantly different between BRS and BMS in the PA at 30 days. LLL and %DS were greater for BRS versus BMS in the aorta at 30 days postimplantation (LLL difference: 0.96 +/- 0.26; %DS difference: 16.15 +/- 4.51; p < .05). At 90 days, %DS in the aortic BRS was less, and PA BRS LLL was also less than BMS. Histomorphometric data showed greater intimal proliferation and area stenosis in the BRS at all time points and in all vessels. Conclusions A dedicated PBBS pediatric BRS has a favorable safety profile in the acute/subacute setting and demonstrates characteristics that are consistent with adult BRSs.

Cardiac & Cardiovascular Systems

Cardiovascular System & Cardiology

Life Sciences & Biomedicine

Science & Technology

Details

Title: Subtitle: Preclinical comparative assessment of a dedicated pediatric poly-L-lactic-acid-based bioresorbable scaffold with a low-profile bare metal stent
Creators: Kamel Shibbani - University of Iowa Hospitals and Clinics
Luiza De Lima e Silva Bagno - University of Miami
Marie-France Poulin - Beth Israel Deaconess Med Ctr, Boston, MA 02215 USA
Thomas Matella - Rush University Medical Center
Karim Diab - Rush University Medical Center
Clifford Kavinsky - Rush University Medical Center
Nagarajan Ramesh - Elixir Medical (United States)
Vinayak Bhat - Elixir Medical (United States)
Ziyad M. Hijazi - Sidra Med, Doha, Qatar
Damien Kenny - Children's Health Ireland at Crumlin
Resource Type: Journal article
Publication Details: Catheterization and cardiovascular interventions, Vol.96(4), pp.878-888
DOI: 10.1002/ccd.28893
PMID: 32294303
PMCID: PMC7737646
NLM abbreviation: Catheter Cardiovasc Interv
ISSN: 1522-1946
eISSN: 1522-726X
Publisher: Wiley
Number of pages: 11
Grant note: UL1TR002537 / University of Iowa Clinical and Translational Science Award Giving Heart Foundation
Language: English
Date published: 10/01/2020
Academic Unit: Cardiology; Stead Family Department of Pediatrics
Record Identifier: 9984702821802771

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