Midterm Results from the Prospective Multicenter Post Marketing Clinical Follow-up Study (PMCF) with Lifetech CeraFlex Occluder for Transcatheter Closure of Atrial Septal Defect (ASD), Patent Foramen Ovale (PFO), and Patent Ductus Arteriosus (PDA)

Background: The aim of this multicenter prospective study was to evaluate the safety, efficacy, procedural success, and short-term results of transcatheter closure of secundum type atrial septal defect (ASD), patent foramen ovale (PFO) and patent ductus arteriosus (PDA) with Lifetech CeraFlexTM occluders.

Method: A total of 120 pediatric and adult patients were prospectively enrolled in 7 centers as an intention-to-treat (ITT) cohort for transcatheter closure of ASD, PFO, or PDA with the CeraFlexTM occluders during November 2015 to January 2019. Of these, 117/120 (97.5%) were further evaluated in an attempted treatment (AT) cohort. Primary endpoints were successful deployment and procedural success, defined as a composite of: absence of periprocedural stroke/TIA, device embolization, cardiac or vascular perforation or death. Secondary endpoints were the rate of device- or procedure-related adverse and serious adverse events (AEs, SAEs), residual shunt at discharge and during follow-up, and, the probability of freedom from re-hospitalization during midterm follow-up period of 12 months.

Results: A total of 117 patients in the AT cohort were scheduled for transcatheter closure of ASD (n = 55), PFO (n = 45), and PDA (n = 17) using CeraFlex occluders. Successful deployment of the occluder device could be achieved in 51/55 (93%) ASD patients, in 43/45 (95.6%) PFO patients, and in 10/17 (58.8%) PDA patients. Twelve-month FU was achieved in the following groups: ASD (40/55) 73%, PFO 37/47 (79%), and PDA 8/17 (47%). Closure rate at 12 months was high in all groups: ASD 95%, PFO 97.6%, and PDA 100%. No mortality occurred during the procedure or during documented follow-up in either patient group during 12-month FU. SAEs were reported in 2/51 (3.9%) ASD patients, in 2/45 (4.4%) PFO patients, and in no PDA patient; all SAEs were resolved by adequate medical treatment. During FU, significant residual shunt (>mild) was only seen in 2/41 (4.8%) after ASD closure, 1 patient after PFO closure, and none after PDA closure. The probability of freedom from re-hospitalization at 12 months was 92% after ASD closure, 93.3% after PFO closure, and 100% after PDA closure.

Conclusion: This study confirmed the safety and the efficacy of the CeraFlex occluder devices in patients with ASD, PFO and PDA. While procedural success and closure rates were excellent for the ASD and PFO occluders, results were limited due to the lower number for implanted PDA occluder. According to the current problems of EU Medical Device Regulation, it is important to share clinical data and experience for especially pediatric cardiac intervention.

Publication History

Article published online:
28 January 2023