Gianluca Rigatelli1, Marco Zuin2, Fabio Dell'Avvocata3, Loris Roncon3, Dobrin Vassilev4, Nguyen Nghia5. 1. Section of Adult and Congenital Heart Disease, Cardiovascular Diagnosis and Endoluminal Interventions, Rovigo General Hospital, 45100, Rovigo Italy. Electronic address: jackyheart@libero.it. 2. Section of Adult and Congenital Heart Disease, Cardiovascular Diagnosis and Endoluminal Interventions, Rovigo General Hospital, 45100, Rovigo Italy; University of Ferrara, Faculty of Medicine, Ferrara, Italy. 3. Section of Adult and Congenital Heart Disease, Cardiovascular Diagnosis and Endoluminal Interventions, Rovigo General Hospital, 45100, Rovigo Italy. 4. Department of Cardiology, Alesandrovska University School of Medicine, Sofia, Bulgaria. 5. Department of Interventional cardiology, Cho Ray Hospital, Ho Chi Minh City, Vietnam.
Abstract
AIMS: The optimal antiplatelet therapy after atrial septal defect (ASD) or patent foramen ovale device closure (PFO) remain to be established. We evaluated the safety and effectiveness of 6-month 100 mg Aspirin (ASA) regimen in the very long-term follow up after intracardiac echocardiography (ICE) -aided interatrial shunt closure in a large retrospective cohort. METHODS: Single-center retrospective analysis which included medical and instrumental data of 789 consecutive patients referred to our institution over a 15 years period due interatrial shunt catheter-based closure. RESULTS: Finally, 734 patients were included in the analysis (mean age 46.1 ± 14.6 years, 398 females): ASD and PFO closure were successfully performed in 281 and 453 patients, respectively. Over the follow-up period, no major bleeding events were observed while the rate of minor bleeding events was 0.9%. Tolerance problems were detected in 3.4% of cases (n==28). In 11 patients (1.5%) an abnormal complete blood count was detected and monitored up to normalization. On a mean follow -up of 10.3 ± 3.0 years (range 1-15), 10 patients (1.36%) had a persistent moderate shunt 12 months after closure and maintained Aspirin 100 mg life-long, whereas the remaining 724 suspended the treatment after 6 months. Device thrombosis in ASD and PFO groups were 0% and 0.2%, respectively. A cerebral ischemic event occurred in 0.4% of the entire cohort. CONCLUSIONS: A regimen of 100 mg of ASA for six months after ASD/PFO closure appeared to be both safe and effective in preventing device thrombosis and major bleedings.
AIMS: The optimal antiplatelet therapy after atrial septal defect (ASD) or patent foramen ovale device closure (PFO) remain to be established. We evaluated the safety and effectiveness of 6-month 100 mg Aspirin (ASA) regimen in the very long-term follow up after intracardiac echocardiography (ICE) -aided interatrial shunt closure in a large retrospective cohort. METHODS: Single-center retrospective analysis which included medical and instrumental data of 789 consecutive patients referred to our institution over a 15 years period due interatrial shunt catheter-based closure. RESULTS: Finally, 734 patients were included in the analysis (mean age 46.1 ± 14.6 years, 398 females): ASD and PFO closure were successfully performed in 281 and 453 patients, respectively. Over the follow-up period, no major bleeding events were observed while the rate of minor bleeding events was 0.9%. Tolerance problems were detected in 3.4% of cases (n==28). In 11 patients (1.5%) an abnormal complete blood count was detected and monitored up to normalization. On a mean follow -up of 10.3 ± 3.0 years (range 1-15), 10 patients (1.36%) had a persistent moderate shunt 12 months after closure and maintained Aspirin 100 mg life-long, whereas the remaining 724 suspended the treatment after 6 months. Device thrombosis in ASD and PFO groups were 0% and 0.2%, respectively. A cerebral ischemic event occurred in 0.4% of the entire cohort. CONCLUSIONS: A regimen of 100 mg of ASA for six months after ASD/PFO closure appeared to be both safe and effective in preventing device thrombosis and major bleedings.