Page 10 - Journal of Structural Heart Disease Volume 3, Issue 4

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Original Research Article
clinical trials. Therefore, this study was a retrospective observational analysis of percutaneous PFO or ASD closure in immunocompromised patients to deter- mine safety with respect to infective endocarditis or erosion.
Materials and Methods
We conducted a retrospective observational study of patients at two tertiary care centers in the United States that perform a high volume of percutaneous closure procedures. The centers’ databases were re- viewed to identify any immunocompromised or au- toimmune disease patients who had received a PFO or ASD closure device.
Patients were informed of the investigational and non-FDA-approved indication for PFO closure, and they desired closure for prevention of future strokes, complex migraine with transient visual neurologic de cit, or recurrence of migraine headaches. In- formed and written consent was obtained from all patients.
Based upon operator preference, all patients re- ceived pre- or post-procedural antibiotics (cefazolin, clindamycin, levo oxacin, or vancomycin as the sole agent) up to 48 hours after closure. Patient outcomes were assessed via 3–6-month clinical follow-up or phone questionnaire up to eight years later (mean 21 ± 28 months) consisting of questions pertaining to migraines, palpitations, chest pain, infections, clo- sure complications post-procedure, worsening or improvement in migraines, post-closure stroke, and general health condition post-closure. For patients who were unreachable for phone interview, mortality status was veri ed by the social security death index.
Results
Our total patient population (n = 1,303) consisted of 908 PFO (69.7%) and 395 ASD (30.3%) patients, of which only 24 patients (1.8%) met our inclusion cri- teria. These 24 immunocompromised patients were identi ed from October 2002 to September 2014 and had systemic lupus erythematosus, rheumatoid ar- thritis, mixed connective tissue disease, non-speci c connective tissue disease, scleroderma, end-stage re- nal disease post-renal transplant, Sjogren’s syndrome,
hepatitis A, hepatitis C, or human immunode ciency virus (HIV). They were treated with various immuno- suppressants and had a PFO or ASD. PFO or ASD were documented by transesophageal echocardiography, transthoracic echocardiography, or transcranial dop- pler evaluation. Patients were referred for PFO or ASD closure due to a history of previous stroke, complex mi- graine with transient visual neurologic de cit, desatu- ration, or migraines (with or without aura) in isolation or as a combination of events (n = 21, 87.5%). Other closure indications included chest pain (n = 1, 4.2%), pre-liver transplant work-up (n = 3, 12.5%), and pulmo- nary embolism with right heart failure (n = 1, 4.2%). Im- munosuppressant medications included prednisone, mycophenolate mofetil, methotrexate, leucovorin, cyclophosphamide, azathioprine, hydroxychloroquine sulfate, le unomide, rituximab, chemotherapeutic agents (fol rinox, gemcitabine, and other unspeci ed agents), ritonavir, emtricitabine/tenofovir disoproxil (HIV combination medication), elvitegravir/cobicistat/ emtricitabine/tenofovir/disoproxil (HIV combination medication), or darunavir as sole agents or in various combination regimens.
Of the 24 patients (53 ± 14 years of age), 19 had a PFO (79.1%), 5 had an ASD (20.8%), and 21 under- went closure (87.5%). Two patients (8.3%) declined percutaneous closure and were lost to follow-up. Both had obstructive sleep apnea with hypersomnia, which is associated with increased risk of right-to-left shunting in the presence of a PFO [2, 3]. During car- diac catheterization, one patient (4.2%) was deemed an inappropriate candidate for closure secondary to pulmonary hypertension from scleroderma and was referred for lung transplant evaluation. All PFO or ASD closure procedures were successful. Figure 1 shows the proportion of PFO and ASD patient groups. All patients with autoimmune disorders were treated with single or combination immunosuppressive drug regimens, leading to an immunocompromised state.
No periprocedural complications occurred during closure. One patient (4.2%) experienced a transient neurologic de cit during follow-up associated with lightheadedness, scintillating scotoma, and severe headache, which was diagnosed as complex mi- graine with visual aura. No patient reported endo- carditis, device erosion, exacerbation of migraine, or recurrent stroke. Of the seven patients (29.2%) who
Kar, S. et al.
PFO/ASD Closure in Compromised Patients