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      Initial experiences with a novel biodegradable device for percutaneous closure of atrial septal defects: From preclinical study to first‐in‐human experience

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          Abstract

          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.

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          Most cited references21

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          Incidence and clinical course of thrombus formation on atrial septal defect and patient foramen ovale closure devices in 1,000 consecutive patients.

          The purpose of this study was to investigate the incidence, morphology, and clinical course of thrombus formation after catheter closure of intra-atrial shunts. Post-procedure detailed information about thrombotic material on different devices for transcatheter closure is missing. A total of 1,000 consecutive patients were investigated after patent foramen ovale (PFO) (n = 593) or atrial septal defect (ASD) (n = 407) closure. Transesophageal echocardiography (TEE) was scheduled after four weeks and six months. Additional TEEs were performed as clinically indicated. Thrombus formation in the left atrium (n = 11), right atrium (n = 6), or both (n = 3) was found in 5 of the 407 (1.2%) ASD patients and in 15 of the 593 (2.5%) PFO patients (p = NS). The thrombus was diagnosed in 14 of 20 patients after four weeks and in 6 of 20 patients later on. The incidence was: 7.1% in the CardioSEAL device (NMT Medical, Boston, Massachusetts); 5.7% in the StarFLEX device (NMT Medical); 6.6% in the PFO-Star device (Applied Biometrics Inc., Burnsville, Minnesota); 3.6% in the ASDOS device (Dr. Ing, Osypka Corp., Grenzach-Wyhlen, Germany); 0.8% in the Helex device (W.L. Gore and Associates, Flagstaff, Arizona); and 0% in the Amplatzer device (AGA Medical Corp., Golden Valley, Minnesota). The difference between the Amplatzer device on one hand and the CardioSEAL device, the StarFLEX device, and the PFO-Star device on the other hand was significant (p < 0.05). A pre-thrombotic disorder as a possible cause of the thrombus was found in two PFO patients. Post-procedure atrial fibrillation (n = 4) and persistent atrial septal aneurysm (n = 4) had been found as significant predictors for thrombus formation (p < 0.05). In 17 of the 20 patients, the thrombus resolved under anticoagulation therapy with heparin or warfarin. In three patients, the thrombus was removed surgically. The incidence of thrombus formation on closure devices is low. The thrombus usually resolves under anticoagulation therapy.
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            Polylactic acid (PLA): research, development and industrialization.

            Polylactide (PLA) is a biodegradable, aliphatic polyester derived from lactic acid. It has similar mechanical properties to polyethylene terephthalate, but has a significantly lower maximum continuous use temperature. PLA products can be recycled after use either by remelting and processing the material a second time or by hydrolyzing to lactic acid, the basic chemical. In this review, the technologies for polymerization of the lactic acid and the comparison of physical, thermal and mechanical properties, biodegradability, and biocompatibility of the PLA and copolymers with other similar polymers are described.
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              Transcatheter closure of secundum atrial septal defects using the new self-centering amplatzer septal occluder: initial human experience.

              Transcatheter closure of secundum atrial septal defect (ASD) using clamshell or buttoned devices is accompanied by a high incidence of residual shunt. Recently, a new self-centering device, the Amplatzer septal occluder (ASO), has been evaluated in an animal model with very good results. Therefore, our purpose is to report on our initial clinical experience with this device. Thirty patients underwent an attempt at catheter closure of their ASDs at a median age of 6.1 yr (range, 2.9-62.4 yr) and median weight of 22 kg (range, 13-69 kg) using the ASO. The median ASD diameter measured by transesophageal echocardiography (TEE) was 12.5 mm (range, 5-21 mm), and the median ASD balloon stretched diameter was 14 mm (range, 7-19 mm). All patients had right atrial and ventricular volume overload with a mean +/- SD Qp/Qs of 2.3 +/- 0.6. A 7F catheter was used for delivery of the device in all patients. The device was placed correctly in all patients. There was immediate and complete closure (C) in 17/30 patients, 10 patients had trivial residual shunt (TS), and 3 had moderate residual shunt (MS). The median fluoroscopy time was 15 min (range, 8-35 min), and the median total procedure time was 92.5 min (range, 40-135 min). There was no episode of device embolization or any other complication. Follow-up was performed using transthoracic echocardiography (TTE) 1 day, 1 mo, 3 mo, and yearly thereafter. At 1 day, there was C of the ASD in 24/30 patients, 3 had TS, 1 had small shunt (SS), and 2 had MS. At a median follow-up interval of 6 mo, there have been no episodes of endocarditis, thromboembolism, or wire fracture. We conclude that the use of the new ASO is safe and effective in complete closure of secundum ASDs up to a diameter of 21 mm in the majority of patients. Further clinical trials are underway.
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                Author and article information

                Contributors
                xymay@126.com
                drzhangzw@sohu.com
                Journal
                Catheter Cardiovasc Interv
                Catheter Cardiovasc Interv
                10.1002/(ISSN)1522-726X
                CCD
                Catheterization and Cardiovascular Interventions
                John Wiley & Sons, Inc. (Hoboken, USA )
                1522-1946
                1522-726X
                12 November 2019
                February 2020
                : 95
                : 2 ( doiID: 10.1002/ccd.v95.2 )
                : 282-293
                Affiliations
                [ 1 ] Department of Pediatric Cardiology, Guangdong Cardiovascular Institute, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences Guangdong Provincial Key Laboratory of South China Structural Heart Disease Guangzhou China
                [ 2 ] The Second School of Clinical Medicine Southern Medical University Guangzhou China
                [ 3 ] Department of Pediatric Cardiology Shenzhen Children's Hospital Shenzhen China
                Author notes
                [*] [* ] Correspondence

                Zhi‐Wei Zhang, PhD and Yu‐Mei Xie, PhD, Department of Pediatric Cardiology, Guangdong Cardiovascular Institute, Guangdong Provincial Key Laboratory of South China Structural Heart Disease, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, Guangzhou 510100, China. Email: drzhangzw@ 123456sohu.com (Z.‐W. Z.) and Email: xymay@ 123456126.com (Y.‐M. X.)

                Author information
                https://orcid.org/0000-0003-3217-8893
                https://orcid.org/0000-0003-3338-9385
                Article
                CCD28529
                10.1002/ccd.28529
                7027946
                31714687
                cf8efcaf-5f43-4afa-85fd-92c9f51d59cc
                © 2019 The Authors. Catheterization and Cardiovascular Interventions published by Wiley Periodicals, Inc.

                This is an open access article under the terms of the http://creativecommons.org/licenses/by-nc/4.0/ License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes.

                History
                : 08 April 2019
                : 09 September 2019
                : 18 September 2019
                Page count
                Figures: 11, Tables: 3, Pages: 12, Words: 6833
                Funding
                Funded by: National Key R&D Program of China
                Award ID: 2016YFC1100305
                Funded by: Shenzhen Sanming Medical Project of China
                Award ID: SZSM201612057
                Categories
                Pediatric and Congenital Heart Disease
                PEDIATRIC AND CONGENITAL HEART DISEASE
                Original Studies
                Custom metadata
                2.0
                February 2020
                Converter:WILEY_ML3GV2_TO_JATSPMC version:5.7.5 mode:remove_FC converted:18.02.2020

                absorbable implants,catheterization closure,congenital heart defect,device

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