Sami Alnasser1, Douglas Lee2, Peter C Austin3, Christopher Labos4, Mark Osten5, David T Lightfoot6, Shelby Kutty7, Ashish Shah8, Lukas Meier5, Lee Benson9, Eric Horlick10. 1. Peter Munk Cardiac Centre, Toronto General Hospital, Canada; Health Sciences North, Sudbury, Ontario, Canada. 2. Peter Munk Cardiac Centre, Toronto General Hospital, Canada; The Institute for Clinical Evaluative Sciences, Canada. 3. The Institute for Clinical Evaluative Sciences, Canada; Department of Health Management, Policy and Evaluation, University of Toronto, Canada. 4. The Institute for Clinical Evaluative Sciences, Canada. 5. Peter Munk Cardiac Centre, Toronto General Hospital, Canada. 6. Scotiabank Health Sciences Library, University of Toronto, Canada. 7. University of Nebraska Medical Center, Children's Hospital and Medical Center, Omaha, United States. 8. Peter Munk Cardiac Centre, Toronto General Hospital, Canada; St Boniface hospital, University of Manitoba, Winnipeg, Canada. 9. Peter Munk Cardiac Centre, Toronto General Hospital, Canada; The Labatt Family Heart Centre, The Hospital for Sick Children, Toronto, Canada. 10. Peter Munk Cardiac Centre, Toronto General Hospital, Canada. Electronic address: Eric.horlick@uhn.on.ca.
Abstract
BACKGROUND: Transcatheter Closure (TC) has become the main stay therapy for many secundum atrial septal defects (ASD) based on short and intermediate term outcome data. Long-term safety and efficacy of this approach among adult patients however, is not well established. METHODS AND RESULTS: A comprehensive search of major electronic databases for studies reporting the long-term (≥5 year) outcomes post TC among adults yielded 114 studies, 9 of which had met the inclusion criteria. This included 1015 patients with a mean age of 45 years ± 5.5 years, two third were female with a mean follow up duration 6.4 years ± 2.7 years. The weighted proportions of long-term mortality and stroke with 95% confidence intervals (CI) were 2.4% (95%CI 0.9%-6.1%) and 2.1% (95%CI 0.7%-5.7%) respectively. Atrial arrhythmia occurred in 6.5% (95%CI 3.5%-11.7%) and atrial fibrillation in 4.9% (95%CI 1.9%-11.7%). ASD related re-interventions were encountered in 2.3% (95%CI 1.0%-5.4%) and residual shunt in 4.2% (95% CI 1.3%-12.4%), with 1 case of suspected device erosion 0.9% (95%CI 0.4-2.2%). Frame fractures and late migrations were observed at 4.2% (95%CI 1.5%-11.5%) and 1.2% (95%CI 0.3%-4%) respectively. No cases of occluder endocarditis or thrombosis were reported. IN CONCLUSION: This is the first study that systematically analyzes the long-term outcomes after TC providing important estimates for various clinical and occluder related outcomes. The analysis suggests preserved long-term safety post TC; however, this is limited due to the variable quality of available evidence and requires further assessment by larger studies with more comprehensive follow-up data.
BACKGROUND: Transcatheter Closure (TC) has become the main stay therapy for many secundum atrial septal defects (ASD) based on short and intermediate term outcome data. Long-term safety and efficacy of this approach among adultpatients however, is not well established. METHODS AND RESULTS: A comprehensive search of major electronic databases for studies reporting the long-term (≥5 year) outcomes post TC among adults yielded 114 studies, 9 of which had met the inclusion criteria. This included 1015 patients with a mean age of 45 years ± 5.5 years, two third were female with a mean follow up duration 6.4 years ± 2.7 years. The weighted proportions of long-term mortality and stroke with 95% confidence intervals (CI) were 2.4% (95%CI 0.9%-6.1%) and 2.1% (95%CI 0.7%-5.7%) respectively. Atrial arrhythmia occurred in 6.5% (95%CI 3.5%-11.7%) and atrial fibrillation in 4.9% (95%CI 1.9%-11.7%). ASD related re-interventions were encountered in 2.3% (95%CI 1.0%-5.4%) and residual shunt in 4.2% (95% CI 1.3%-12.4%), with 1 case of suspected device erosion 0.9% (95%CI 0.4-2.2%). Frame fractures and late migrations were observed at 4.2% (95%CI 1.5%-11.5%) and 1.2% (95%CI 0.3%-4%) respectively. No cases of occluder endocarditis or thrombosis were reported. IN CONCLUSION: This is the first study that systematically analyzes the long-term outcomes after TC providing important estimates for various clinical and occluder related outcomes. The analysis suggests preserved long-term safety post TC; however, this is limited due to the variable quality of available evidence and requires further assessment by larger studies with more comprehensive follow-up data.