Atrial septal defect closure: rethinking device vs surgery

Although atrial septal defect (ASD) closure devices have evolved in terms of design and technique of deployment, to make device closure a safe and efficacious alternative to surgery, the catastrophic mechanical complications, even though the rate is low, do occur, and may require explantation. Recently, complications due to nickel allergy, requiring explantation of ASD devices, have been highlighted. Thus, the role of device closure for ASD needs more critical scrutiny, especially when minimally invasive approaches are emerging as an alternative to device closure in terms of invasiveness and cosmetic superiority.

The case report by Nair et al. in the current issue of this journal describes the debilitating symptoms of migraine after ASD closure by nickel-containing device (Figulla ® Flex 2 Occlutech ASD occluder) implantation, which got resolved after explant of device [1]. A few comments seem pertinent about this article as well as about usage of devices for ASD closure, which implies some concerns.

Surgical closure of ASD was a historical procedure, as it ushered the new era of open-heart surgery, when John Gibbon performed the first successful ASD closure under cardiopulmonary bypass (CPB) in 1953. Since then, it has been a phenomenally successful operation with negligible operative mortality, extremely low morbidity and excellent long-term survival [2].

In 1976, King and Mills originally described, and subsequently demonstrated, feasibility of closing ASD using a device. Although there have been various technical advancements in transcatheter ASD closure devices, several catastrophic complications occur: device embolization, cardiac perforation with tamponade, obstruction to systemic and pulmonary venous drainage and late erosion of the atrial wall. DiBardino and colleagues compared the US Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience database for adverse events involving Amplatzer septal occluder devices with the Society of Thoracic Surgery (STS) congenital cardiac surgery database. Although they found similar overall mortality for device and surgical closure of ASD, the complications from device closure, usually requiring emergency rescue operation and its mortality, were higher than those of elective surgical ASD closure. Furthermore, they noticed that the mortality during surgical management of a device adverse event was 20-fold higher in comparison to primary elective ASD closure. The requirement of operation was also more common in patients undergoing device closure than in the case of reoperation in patients undergoing surgical closure [3]. Sarris et al. derived almost similar conclusions from the analysis of surgery for complications resulting from trans-catheter closure of ASDs in 56 patients, the collective experience of 19 participating European Congenital Heart Surgeons Association centres over a 10-year period (1997–2007) [4].

Nair et al., in this case report, have highlighted another debilitating complication (migraine) due to nickel hypersensitivity necessitating explant of device to resolve migraine [1].

After exploring the concerned literature of nickel allergy due to ASD closure device, the problem of nickel allergy is not so uncommon and attracts the attention of not only cardiologists but also neurologists, dermatologists and, of course, cardiac surgeons in this context. Nickel is a ubiquitous metal, found in many implanted medical devices, as well as everyday products such as jewellery. In fact, the prevalence of dermatitis due to nickel is up to 20%, particularly among women and a subset of these patients may have systemic symptoms. Nickel was labelled with the title of “allergen of the year” in 2008 and was envisaged a growing health concern [5]. The potential for harm from implanted medical devices that contain nickel, however, is less known and it is the subject of the current case report.

Contact hypersensitivity, secondary to the Amplatzer (St. Jude Medical, Inc., St. Paul, Minnesota), PFO Star (Cardia Inc., Burnsville, MN) and Gore Helex devices, has been described previously. GORE CARDIOFORM septal occluder (GSO) device (W.L. Gore, Flagstaff, AZ) was found to have in vitro nickel release comparable to placebo and was thought to be a better device for ASD closure in patients with nickel hypersensitivity, but recently Resor et al. have reported explantation of even this device for resolution of contact dermatitis [6].

The authors of case report under reference have discussed an interesting study by Sharma and colleagues, where ASD device removal was performed in 58 patients for refractory symptoms of nickel allergy. This interesting study provides insight into a likely allergic process to occluder devices that contain higher proportions of nickel. Verma et al. in a retrospective analysis found that 38 of 13,736 (0.28%) patent foramen ovale (PFO)/ASD occluder devices required explantation, out of which 7 were due to nickel allergy [7].

Even though, the complication rate appears to be low, the patients, as well as the physicians, should be aware of risks involved with device-related major adverse events. Unfortunately, it seems that few patients know much about the potential risks of transcatheter device closure. Awareness of the patient about catastrophic complications and nickel hypersensitivity, however, might lead to a change in preference of treatment approach. However, most patients might not choose surgery as an option due to prevalent conception of transcatheter therapy as a safe and less invasive approach, which can be done without CPB, having cosmetic superiority in comparison to surgery. On the other hand, there have been various advancements in CPB methodology, making it safe and suitable for minimally invasive approaches, emerging as an alternative to device closure in terms of invasiveness and cosmetic superiority and also avoiding the potential complications of device closure [8].

Although both American Heart Association (AHA)/American College of Cardiology (ACC) (2018) and European Cardiology Society (ECS) (2020) guidelines recommended transcatheter device closure for ASD closure, they are silent on surgical closure of ASD with a minimally invasive approach [9, 10]. Furthermore, patients are seen by the cardiologists first, underlining their specific role as “gatekeepers” for further referral, while keeping their own interests of device closure in mind. Highlighting of the device-related allergic manifestations like migraine in addition to other catastrophic mechanical complications may lead the opinion makers to rethink, before recommending clinical practice guidelines, keeping in mind the best appropriate approach to management of ASD, i.e., minimally invasive surgery has almost similar cosmetic superiority, avoiding potential mechanical and hypersensitivity complications of device closure (no device: no problem).

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Not relevant being an invited commentary.

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Conflict of interest

The authors declare no competing interests.