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

Chamié, Fscai Francisco; Maia, Julio P.; Giuliano, Luiz Carlos

doi:10.1002/ccd.26456

Cited by 6 publications

(10 citation statements)

References 12 publications

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“…5,6 However, It has been revealed that the CARDIA ASD prostheses show multiple PVA membrane perforations from 1 week to 24 months following postimplantation. [7][8][9][10][11][12] This malfunction was found independent from device size and noticed in the last two generations. The purpose of the study was to investigate retrospectively all ASD patients with CARDIA Ultrasept ASD occluder (an older version of the Ultrasept II) in our centre and examine whether spontaneous PVA membrane perforation developed in the long term.…”

Section: Introductionmentioning

confidence: 76%

“…Covering the damaged membrane with a second device can be considered as an alternative to surgery. [8][9][10][11] The space between the nitinol struts made it possible to cross the long sheath for implanting the second device. Chamié et al applied 'device in device technique' to four patients and showed that implanting a second nitinol symmetrical double disk over the first one was technically feasible.…”

Section: Discussionmentioning

confidence: 99%

“…1,2 However, it has been reported in several publications that PVA membrane with many versions of the CARDIA ASD prostheses have early or delayed malfunctions. [7][8][9][10][11][12] Bartel et al reported two cases, including devices failure in patients treated with the Atriasept II (Cardia Inc, Eagan, MN), an older version of the device that we used. 7 Bhattacharyya et al also revealed disintegration of PVA with the same version device that we have.…”

Section: Discussionmentioning

confidence: 99%

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Spontaneous Perforation of Polyvinyl Alcohol Membrane: A Rare Cause of Atrial Septal Occluder Failure

Parlar

Bozyel

2019

Kocaeli Üniversitesi Sağlık Bilimleri Dergisi

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Objective: Percutaneous closure of atrial septal defect is a well-established procedure and has evolved to become the standard of care due to its many advantages. However, atrial septal defect closure devices covered with polyvinyl alcohol membrane could cause recurrent significant shunts due to a spontaneous polyvinyl alcohol membrane perforation. To investigate whether spontaneous polyvinyl alcohol membrane perforation developed in our patients who had implanted with CARDIA Ultrasept atrial septal defect occluder (Eagan, Minnesota, USA) that covered with Polyvinyl Alcohol membrane. Methods: We retrospectively rewieved all patients with a diagnosis of secundum type atrial septal defect who underwent percutanoues closure with CARDIA Ultrasept prosthesis. Results: Ten patients aged 4 to 56 years who underwent atrial septal defect closure with UItrasept device were included. During a median 26 months follow up period, we detected a four cases of polyvinyl alcohol membrane failure. In 3 patients, perforation of polyvinyl alcohol membrane caused significant left to right shunt that required re-intervention, while in one patient it caused minimal residual shunt. The devices were used were 14 mm (two patients), 16 mm (one patient) and 30 mm (one patient). Two patients underwent surgical device removal and pericardial patch closure. One patient underwent device in device procedure. Residual shunts were not occured in after reinterventions. Conclusion: Polyvinyl alcohol membrane perforation is rare and can require reintervention. Operators have to be aware of this malfunction.

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Section: Introductionmentioning

confidence: 76%

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

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Spontaneous Perforation of Polyvinyl Alcohol Membrane: A Rare Cause of Atrial Septal Occluder Failure

Parlar

Bozyel

2019

Kocaeli Üniversitesi Sağlık Bilimleri Dergisi

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“…They reported a total of four relatively early malfunctions of the polyvinyl alcohol membrane observed in a series of six consecutive patients treated with atrial septal defect Ultrasept II™ closure device from January to December 2014. Chamié et al 11 informed about four cases of early failure of the polyvinyl alcohol membrane and, in fact, they proposed a new and less invasive treatment for patients who present with early to mid-term failure of the polyvinyl alcohol sail-based devices. After 2015, Cardia Inc. developed a new version of this same device -Ultrasept II™in which a Goretex patch has been interposed between both discs.…”

Section: Discussionmentioning

confidence: 99%

Atrial septal defect closure with the new Cardia Ultrasept II™ device with interposed Goretex patch: Mexican experience – has the perforation of Ivalon’s membrane been solved?

et al. 2018

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“…Chamié et al [76] , 2016 -case series 4 4 out of 70 developed early fabric erosion, treated with device in device Nit Occlude ASD-R PFM Medical Mepro CE Mark Peirone et al [77] , 2014 -prospective observational 73 98.6% closure at 11 mo, no adverse events…”

Section: Asd Characteristics Amenable For Percutaneous Closurementioning

confidence: 99%

Atrial septal defect repair in the age of transcatheter devices

Zimmermann¹,

Hussain²,

Worku³

et al. 2019

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The aim of this review is to discuss the management of atrial septal defects (ASD) in the adult patient paying special attention to the elderly population and the most recent transcatheter advancements. ASDs are characterized by the following categories: ostium secundum, ostium primum, sinus venosus, and coronary sinus defects; though multiple defects may exist concurrently. Intervention for closure of ASDs are indicated with the development of right ventricular volume overload, or in the clinical context of paradoxical embolic stroke. Previously, there was significant disagreement regarding the timing of ASD closure in adult patients, but there is now general consensus that adult patients with clinical evidence of right ventricular overload should undergo closure of ASDs at the time of presentation. The present review describes the typical presentation of patients with symptomatic ASD's, medical management, and whether surgical or percutaneous approach should be pursued. We will also discuss other important considerations for patient selection and potential early and late complications of transcatheter ASD closure such as congestive heart failure, device embolization, and tissue erosion. At the time of this writing, there are currently three FDA-approved devices for percutaneous VSD closure including the Amplatzer TM Septal Occluder (ASO, St. Jude Medical, St. Paul, MN), Gore HELEX TM Septal Occluder (W.L. Gore and Associates, Newark, NJ), and Gore CARDIOFORM TM Septal occluder (GCSO, W.L. Gore and Associates, Newark, NJ) devices. Many premarket approvals were granted for devices that never went to market due to poor investigational study performance. Likewise, the HELEX device has since been discontinued upon bringing the GCSO device to market. We will focus primarily on the ASO device with a brief review of current investigations into the GCSO device, both of which carry an indication for closure small to medium sized ASDs in the ostium secundum position. Additionally, this review covers the safety of transcatheter closure of ASDs with currently available devices, review studies associated with devices available outside the United States, and perioperative considerations for transcatheter Page 2 of 18 Zimmermann et al. Vessel Plus 2019;3:31 I http://dx.intervention. Obstacles to device employment and countermeasures to overcome operational challenges will also be discussed. To this end, variations or similarities of currently approved devices will be emphasized throughout this discussion where possible. Lastly, we will offer insights into device evolution trends with the expectation of new device developments on the horizon. We will briefly discuss up and coming areas of active research, including the emerging fields of novel biomaterials and gene therapy. MORPHOLOGY AND CLINICAL FEATURES OF ASDS Location, Morphology, and suitability for surgery vs. transcatheter interventionIt is important to note that morphological variations of different types of ASDs, which determines whether a particular defect is amenabl...

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

Cited by 6 publications

References 12 publications

Spontaneous Perforation of Polyvinyl Alcohol Membrane: A Rare Cause of Atrial Septal Occluder Failure

Spontaneous Perforation of Polyvinyl Alcohol Membrane: A Rare Cause of Atrial Septal Occluder Failure

Atrial septal defect closure with the new Cardia Ultrasept II™ device with interposed Goretex patch: Mexican experience – has the perforation of Ivalon’s membrane been solved?

Atrial septal defect repair in the age of transcatheter devices

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