Premium
Initial experiences with a novel biodegradable device for percutaneous closure of atrial septal defects: From preclinical study to first‐in‐human experience
Author(s) -
Li YiFan,
Xie YuMei,
Chen Jun,
Li BoNing,
Xie ZhaoFeng,
Wang ShuShui,
Zhang ZhiWei
Publication year - 2020
Publication title -
catheterization and cardiovascular interventions
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.988
H-Index - 116
eISSN - 1522-726X
pISSN - 1522-1946
DOI - 10.1002/ccd.28529
Subject(s) - medicine , percutaneous , shunt (medical) , adverse effect , implant , surgery , cardiology
Objective To evaluate the feasibility, safety, and effectiveness of a novel, absorbable atrial septal defect (ASD) closure device made of poly‐ l ‐lactic acid (PLLA) in a swine model of ASD and for the first time in humans. Methods A preclinical safety study was conducted using a swine model of ASD. In a clinical setting, five pediatric patients underwent ASD closure with the PLLA device with fluoroscopic and transthoracic echocardiography guidance. The procedural results and clinical outcomes at 1 day, 30 days, 3 months, and 6 months after closure were analyzed. Results The 24‐ and 36‐month follow‐up results of the preclinical study demonstrated that the PLLA device exhibited good endothelialization and degradability in the swine model. In the clinical study, successful device implantation was achieved in all five patients (median age, 3.6 years; range, 3.1–6.5 years). The mean defect size was (13.6 ± 2.7) mm. Follow‐up at 30 days, 3 months, and 6 months was completed in all five cases. The complete defect closure rates with no residual shunt at 30 days, 3 months, and 6 months follow‐up were 60% (3/5), 80% (4/5), and 80% (4/5), respectively. No device dislodgement, significant aortic valve or mitral valve regurgitation, new onset cardiac arrhythmia, or other adverse events were reported. Conclusion The study results demonstrated that it is feasible to implant the PLLA device for closure of small to medium sized ASDs without significant residual shunts or severe adverse events in humans. The PLLA device exhibited good endothelialization and degradability in the swine model at 24 and 36 months. Further studies to evaluate long‐term safety and effectiveness with the device in a large cohort of patients are warranted.