Page 11 - Journal of Structural Heart Disease Volume 3, Issue 4

Original Research Article
98
Figure 1. Patent foramen ovale and atrial septal defect patient groups (21 patients underwent closure; two declined closure; one not a closure candidate).
had migraine prior to closure, ve (71.4%) report- ed resolution of migraines. There were ve deaths (20.8%); three were due to non-cardiac conditions (one of these patients did not receive a device), one was associated with metastatic pancreatic cancer, and one was due to unknown causes in a 77-year-old woman who did not receive a device. Table 1 shows closure indications and patient outcomes.
Discussion
As patients who are immunocompromised or have an autoimmune disease are at higher risk of develop- ing an infection [4, 5, 6], there is a concern that im- planting a permanent foreign body in the vasculature might increase their risk of developing endocarditis. In addition, the healing process in these patients may be compromised, and some devices could be associ- ated with a higher risk of erosion through a thin atrial wall. However, there are no data published regarding the use of cardiac devices in this patient population because these patients are speci cally excluded from prospective randomized trials of new devices to di- minish the risk of complications that could make the device appear unsafe upon review by the FDA. Nevertheless, clinical indications for closure of ASD
or PFO may arise in immunocompromised patients. Thus, the purpose of this retrospective observation- al study was to determine whether there is increased risk in immunocompromised patients who have an implanted closure device.
Although this was a small patient population (24 out of 1,303 cases) with a relatively rare combination of disorders, it is encouraging to note that there were no severe complications reported, such as increased risk of endocarditis or erosion of the device.
The occurrence of device infection after percuta- neous PFO or ASD closure is extremely uncommon. A few case reports have described the occurrence of endocarditis from a PFO or ASD device, which com- monly necessitates surgical explantation [7, 8, 9]. One case describes successful treatment achieved solely with antibiotics [10]. However, no observational or randomized controlled studies have been performed for infections associated with septal closure devices.
Other implantable therapeutic foreign bodies in patients with normal immune function, such as pace- makers or implantable cardioverter de brillators, are more prone to infections (1–6%), which increases the risk of mortality even after successful treatment of the infection [11, 12, 13]. Pacemaker infection rates from the 1970s to 1980s were even higher (1–19.9%) [14].
Our study patients received medications that are known to suppress the immune system and had var- ious medical conditions that predisposed them to an immunocompromised state (Table 1). Autoimmune disease also may induce a prothrombotic state pro- moting stroke, such as an HIV patient with protein C and protein S de ciency who developed a stroke in the presence of a PFO [15]. The prevalence rates of anti-cardiolipin antibodies in patients with ischemic strokes were 17–21% [16]. A retrospective case series of 40 patients showed that anti-phospholipid antibod- ies and hypercoagulability is common in patients with PFO [17]. A case-controlled study also showed that anti-phospholipid antibodies are strongly associated with PFO and atrial septal aneurysms [18]. Hence, auto- immune diseases with various hypercoagulable factors may increase the risk of stroke, which may be reduced with PFO closure. Of the patients in our study, one had anti-phospholipid antibodies with Sjogren’s syndrome and another had anti-cardiolipin antibodies with sys- temic lupus erythematosus. Both patients developed a
Journal of Structural Heart Disease, [Month 2017]
Volume 3, Issue 4:96-101