Dataset Information

Initial Clinical Experience with the Biodegradable Absnow^TM Device for Percutaneous Closure of Atrial Septal Defect: A 3-Year Follow-Up.

ABSTRACT:

Objective

We reported the 3-year follow-up results of initial clinical experience with the Absnow^TM device, a novel biodegradable occluder for percutaneous closure of atrial septal defect (ASD).

Background

The Absnow^TM device is a total biodegradable septal occluder with double-disc poly-L-lactic acid (PLLA) framework and PLLA membranes intergraded into the device to ensure its biodegradability, clinical safety, and efficacy.

Methods

Five pediatric patients were enrolled from May to June 2018 in our institution and were followed up for 3 years. A clinical evaluation and transthoracic echocardiography were performed at 24 hr, 1 month, 3 months, 6 months, 12 months, and yearly after implantation. Primary endpoints were a composite clinical success, comprising of clinical closure success and safety at the 36-month follow-up evaluation. Secondary endpoints included technical success, procedure success, closure success, and safety at each of the follow-up visits.

Results

The median subject age was 3.6 years (range 3.1-6.5 years). The mean ASD diameter was (13.7 ± 2.9) mm. The median device size was 20 mm (range 14 to 24 mm). Technical and procedure success was achieved in 100% (5/5) of the patients. At 2-year follow-up, 3 of the 5 patients developed new-onset residual shunts and 2 of them reached a moderate degree. At 3-year follow-up, the residual shunt size increased over time in all the 3 patients, and 1 of them had right ventricular enlargement. All of the 5 patients were free from serious adverse events during the 3-year follow-up, with no device embolization, thromboembolization, or reintervention to the target defect.

Conclusion

This 3-year follow-up result of initial experience with the biodegradable Absnow^TM device has demonstrated acceptable safety with no procedural complications. Notably, the high rate of residual shunt significantly affected its efficacy. The long-term safety and efficacy of the device should be further evaluated in a large cohort of patients in future studies.

SUBMITTER: Li Y

PROVIDER: S-EPMC8349294 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:IntroductionChange in migraine headache (MH)-preexisting MH change or development of de novo MH-are known potential complications following percutaneous closure of atrial septal defect (ASD), but consensus on a causal trigger remains elusive.ObjectivesTo expose potential MH triggers linked, mainly by timing and occurrence, to the emergence of de novo MH or change in preexisting MH subsequent to percutaneous ASD closure (pASDC).MethodsThe literature was systematically searched for studies available in English reporting MH status after pASDC published between January 1, 1990 and November 15, 2015. We determined the number and percentage of patients experiencing MH status change within 7 days post procedure and the cumulative total by final follow-up (Mdn = 12 months).ResultsTwenty-five studies met the inclusion criteria, which accounted for a total of 1,646 pASDC patients. Pre-procedure MH prevalence was 8% (126/1,646). Change in preexisting MH occurred in a total of 72% (91/126), 12% (11/91) within 7-days after pASDC; within follow-up MH improved in 14% (18/126), resolved in 37% (47/126), but persisted in 63% (79/126). De novo MH incidence ranged between 10 (153/1,520) and 18.3% (153/836); 34% incipience (52/153) was within 7-days of pASDC; females accounted for 80% (63/79) of gender differentiated cases; of type distinguished cases, 42% (51/122) were MH without aura (MO) and 58% (71/122) were MH with aura (MA); MH improved in 10% (16/153), resolved in 24% (37/153) but persisted beyond final follow-up in 76% (116/153). Antiplatelet agents were effective modulators of MH in 44% (11/25) studies. Possible adverse MH-predisposing traits were scarce: larger ASD size reported in ~2% (39/1,646) of patients experiencing de novo MH or preexisting MH exacerbation; short aortic rim reported in three de novo MH patients; allergic response to occluder nickel alloy in four patients with MH status change from baseline (de novo or preexisting MH change not specified).InterpretationEarly intensification of MH status change but later amelioration (virtually paralleling stages of endothelialization), relatively high efficacy of antiplatelet agents, and the emergence of MA as the dominant de novo MH type favor proinflammatory triggers of MH status change after pASDC.

Dataset Information

Initial Clinical Experience with the Biodegradable Absnow^TM Device for Percutaneous Closure of Atrial Septal Defect: A 3-Year Follow-Up.

Objective

Background

Methods

Results

Conclusion

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OmicsDI is part of the ELIXIR infrastructure

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Dataset Information

Initial Clinical Experience with the Biodegradable AbsnowTM Device for Percutaneous Closure of Atrial Septal Defect: A 3-Year Follow-Up.

Objective

Background

Methods

Results

Conclusion

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets

Initial Clinical Experience with the Biodegradable Absnow^TM Device for Percutaneous Closure of Atrial Septal Defect: A 3-Year Follow-Up.