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Original Research Article
100
Table 1 (Continued). PFO and ASD closure indications and outcomes (n = 24)
22 Pulmonary Helex 30 None embolism with right
No (TEE) N/A
No (TEE)
None
N/A (died, unknown etiology)
Migraine resolved
1 None 3
Patient
Closure Indication
Device
Size (mm)
Complications
Residual Shunt (TEE/ TCD/ICE)
Post-Procedure Symptoms
Post- Procedure Follow-Up (months)
heart failure
23 Right atrial and right ventricular
No closure (patient N/A N/A declined)
enlargement
24 Migraine with aura Amplatzer 10 None
PFO = patent foramen ovale; ASD = atrial septal defect; TEE = transesophageal echocardiography; TCD = trans-cranial Doppler; ICE = intracardiac echocardi- ography; PHTN = pulmonary hypertension; N/A = non-applicable; TIA = transient ischemic attack
stroke in the presence of a PFO. Conversely, the PFO in Cryptogenic Stroke Study and the Anti-Phospholipid Antibodies and Stroke study (PICSS-APASS) post-hoc retrospective analysis did not show an increased risk of stroke in patients with anti-phospholipid antibodies and PFO [19].
Our study has some limitations. This was a retro- spective observational study of a complex but small patient population, which limits the generalizability of the results and prohibits adequate power for sta- tistical analysis. Also, 10 out of the 21 patients (47.6%) underwent closure with the Helex device, which has not been associated with erosions. This fact may have diminished the risk of erosions even in an autoim- mune population. Nevertheless, this study provides a small database on the use of device closure in these vulnerable patients, as no prior studies describe their treatment. This study was set at tertiary care centers with highly experienced operators who routinely per- form PFO or ASD closures.
In conclusion, this small observational study shows the safety of PFO or ASD closure in patients who are immunocompromised or have autoimmune disorders. Patients reported an improvement or res- olution of debilitating migraine, and there was no recurrence of stroke after closure. In this high-risk pa- tient population, there were no procedural complica- tions, local or systemic infection, endocarditis on the implanted device, or complications such as erosion across a follow-up period of up to 8 years (mean of 21 months).
Con ict of Interest
The authors have no con ict of interest relevant to this publication.
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Journal of Structural Heart Disease, [Month 2017]
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