Early Malfunction of Polyvinyl Alcohol Membrane–Covered Atrial Septal Defect Closure Devices

Abstract

A 77-year-old man was referred for treatment of a secundum type atrial septal defect (ASD). Transthoracic echocardiography and transesophageal echocardiography showed a 20-mm atrial ASD (Figure [A]) with important enlargement of the right ventricle. A 24-mm ASD Ultrasept II (Cardia Inc, Eagan, MN) closure device was successfully implanted (Figure [B]) after the first attempt with no residual shunt. The Ultrasept II device was loaded and deployed in a similar manner to Amplatzer devices. The nickel-titanium frame of the Ultrasept II device has 2 discs covered with a polyvinyl alcohol (PVA) membrane ( . In follow-up at 8 months the patient was well. Thereafter, a routine transthoracic echocardiography was performed at 3 months of all patients (n=9) implanted with the ASD Ultrasept II device in our institution. One other similar case was diagnosed: a 41-year-old woman referred for treatment of an ASD associated with moderate enlargement of the right ventricle. Transesophageal echocardiography showed a 19-mm defect associated with thin margins. A 32-mm ASD Ultrasept II closure device was implanted successfully with no residual shunt. One-week and one-month echocardiographic followup were unremarkable. A routine transthoracic echocardiography performed at 3 months revealed a recurrent significant left-to-right shunt. Transesophageal echocardiography, intraoperative, and explanted images were similar to those described as in the first case. Surgical device removal and Gore-Tex patch repair were performed with an uneventful follow-up at 6 months. DiscussionTwo early malfunctions of the PVA membrane were observed in a series of 9 consecutive patients treated with ASD Ultrasept II closure device in our institution. Implantation of a second device within the defective device was discussed, but surgery repair was preferred because of the unclear mechanism of the malfunction. Two similar cases were previously reported 1 with the ASD Atriasept II (Cardia Inc, Eagan, MN) closure device, a previous generation of the device used in the current cases, which also uses a PVA-based material. The mechanism of PVA membrane disappearance was not reported. PVA is a water-soluble polymer, which becomes insoluble for medical purposes with formaldehyde or glutaraldehyde cross links. The biocompatibility of PVA is recognized as good.2 Intolerance reactions to PVA are not known. A recent literature review did not indicate unexpected biodegradability of PVA membranes in ASD closure devices.3 An usual procedure followed for our 2 cases included soaking of the device in sterile saline before loading in the delivery sheath. A severe adverse event notification form was sent to the manufacturer. The 2 devices were not from the same manufacturing lot. The explanted devices were macroscopically and microscopically examined. The metallic frame and all sutures used to attach the PVA membrane to the frame were intact. Examination of the residual PVA membrane was unremarkable. All processes used to create the PVA membranes were reviewed. Several chemic...

Early malfunction of polyvinyl alcohol membrane of septal occluder

“…Bartel reported similar device failure in two cases in which an older version of this device with PVA‐based material (Atriasept II, Cardia Inc, Eagan, MN) was used . Early malfunctions of the PVA membrane in two patients were also reported in a series of nine consecutive patients treated with ASD Ultrasept II closure device . In the latter two cases, similar to ours, the PVA membrane had disappeared but the nitinol frame was intact and no definitive reason for PVA membrane degradation was identified.…”

Delayed spontaneous perforation of polyvinyl alcohol membrane—Covered atrial septal defect closure devices

“…Bartel et al reported two cases of devices failure 5 and 6 weeks after transcatheter closure in patients treated with the ASD Atriasept II (Cardia Inc, Eagan, MN), a previous generation of the device used in our series . Aubry et al and Ramoglu et al reported early disappearance of the PVA membrane in two and one patients respectively treated with the Ultrasept II device . The degradation of the PVA membrane was asymptomatic in most reported cases, although it might be revealed by dyspnea as in our first case, or multiple stroke .…”

“…The possibility of covering the damaged membrane with a second device has been reported and may be considered as an alternative to surgery . Operators have to be aware of this apparently rare complication that is likely to be underestimated, associated with such device. The device has been excluded from our institution as well as some other institutions in France institution.…”

Device‐in‐device: A transcatheter alternative to surgical explantation of a failing atrial septal defect intracardiac prosthesis

“…Others have previously described early failure of the PVA sail in CARDIA ASD devices . In their patients, the failing devices were surgically explanted, showing varying degrees of missing PVA sails.…”