1. A meta-analysis of percutaneous versus surgical closure of ostium secundum atrial septal defects Butera G, Biondi-Zoccai G, Abella R, Piazza L, Chessa M, Micheletti A, Negura D, Giamberti A, Frigiola A, Carminati M. Negura D, Giamberti A, Frigiola A, Carminati M. Departement Of Pediatric Cardiology And GUCH Unit San Donato Milanese, Italy

2. Background  Percutaneous atrial septal defect closure has became available in the last ten years  In literature there are studies comparing surgical and percutaneous closure Departement Of Pediatric Cardiology And GUCH Unit San Donato Milanese, Italy

3. Background  Large data set comparing these two techniques are lacking  No meta-analysis studies are reported in the field of pediatric cardiology/cardiac surgery Departement Of Pediatric Cardiology And GUCH Unit San Donato Milanese, Italy

4. Clinical Question & Objectives  Clinical Question Is there any difference in early post-procedural results between surgical and percutaneous secundum ASD closure?  Objectives to perform a meta-analysis of all relevant studies comparing results of surgical and percutaneous ASD closure Departement Of Pediatric Cardiology And GUCH Unit San Donato Milanese, Italy

5. Methods  Databases: Pubmed, Google Scholar, Biomed Central  Search updated April 07  Search terms: ‘atrial septal defect’, ‘closure’, ‘percutaneous’, ‘surgery’, ‘device’  Inclusion criteria for studies: Comparison of surgical versus percutaneous ASD closure Reporting on > 20 pts

6. Methods  Data collection - Pre-specified forms used to collect data on baseline characteristics and outcomes - Data abstracted by two independente and unblinded reviewers (GB, GBZ) - We abstracted: authors, journal, years of conduct and publication, study design, sample size, patient characteristics, raw numbers for death, total complication and major adverse cardiovascular events, length of hospital stay

7. Methods  Statistical methods -performed using Review Manager 4.2.4 - Pooled estimated for odds ratiuos computed according to random effect methods - Continuous variables compared using random effect inverse variance weighting method -Statistical inconsistency appraised with I2 - Reported values were two-tailed and results were considered statistically significant at the 0.05 level. - Quality of included studies was appraised according to the Cochrane Collaboration methods

8. Methods Methods  Primary outcome: - Death -Total complications -Major complications  Secondary outcomes: - Major complications excluding device embolization -Length of hospital stay Departement Of Pediatric Cardiology And GUCH Unit San Donato Milanese, Italy

9. Results 320 citations from initial search 13 articles retrieved 1 study excluded 12 studies selected Total of 2821 patients 1144 pts with surgical ASD closure 1677 pts with percutaneous ASD closure 307 excluded as non-relevant at citation level Departement Of Pediatric Cardiology And GUCH Unit San Donato Milanese, Italy

10. Results: Study characteristics AutAuthor(journal,yr) Study type Numbers of ptsAge Berger (JTCVS 1999)ProspectiveSurg:61 kt: 61 20 (0.5-74) 12 (0.8-77) Bettencourt (Rev Port Cardiol 2002)RetrospectiveSurg: 25 Kt: 38 38 (13-67) 40 (15-72) Bialkowksi (Tex heart Int J 2004)Retyrospective Children (< 18 yrs) Surg: 44 Kt: 47 6.5 (2.3-16.9) 9.9 (2.3-17) Butera (Am H J 2006)RetrospectiveSurg: 533 Kt: 751 22.4  18.9 29  19.8 Cowley (Am J Cardio 2001)RetrospectiveSurg:44 kt:45 10.5±11.7 22.9±20.8 Du (JACC 2002)Prospective, non-randomized Multicenter Surg: 155 Kt: 459 4.1 9.8 Durongpsittikul (Ped Cardiol 2002)Prospective x kt. Retrospective x surgery Surg: 64 Kt: 39 25 (2.3-64) 11.7 (2-69) Formigari (JACC 1999)RetrospectiveSurg:121 Kt: 52 5.1 7 Hugues (Heart 2002)ProspectiveSurg: 19 Kt 43 3.3 (2.2-5.4) 6.1 (3.3-10) Kim (Med Sci Monit 2002)RetrospectiveSurg: 32 Kt: 48 19..9  19 37.9  23 Thomson (Heart 2002)ProspectiveSurg: 16 Kt: 27 5.5 (2.7-15.2) 9.7 (2.1-44.6) Vida (JACC 2006)RetrospectiveSurg: 28 Kt: 83 7.14  5.5 18.3  15.5

11. Results: Primary outcomes Death No death was reported with any of the two methods Departement Of Pediatric Cardiology And GUCH Unit San Donato Milanese, Italy

12. Results: Primary outcomes Total complication rate 31 % (95 % CI: 21-41%) 6.6% (95% CI: 3.9-9.2) (p<0.0001) Departement Of Pediatric Cardiology And GUCH Unit San Donato Milanese, Italy

13. Results: Primary outcomes Total complication rate Departement Of Pediatric Cardiology And GUCH Unit San Donato Milanese, Italy

14. Results: Primary outcomes Major complication rate 6,8 % (95 % CI: 4-9,5%) 1,9% (95% CI:0,9-2,9) (p<0.0001) Departement Of Pediatric Cardiology And GUCH Unit San Donato Milanese, Italy

15. Results: Primary outcomes Major complication rate Departement Of Pediatric Cardiology And GUCH Unit San Donato Milanese, Italy

16. Results: Primary outcomes Major complications Surgery Redo surgery (major bleeding, patch dehiescence, repeat sternal closure), Cardiac Tamponade, Wound Infection, Stroke, Major arrhythmias, Seizures, Intracardiac thrombus formation, Pneumothorax/Pericardial effusion/pleural effusion needing Drainage, Heart failure, Carotid artery dissection Device closure Embolization/malposition needing surgery, Pericardial tamponade, Vascular injury of femoral veins/artery needing surgical repair, Thrombus formation, Device erosion, Major arrhythmias Departement Of Pediatric Cardiology And GUCH Unit San Donato Milanese, Italy

17. Results: Secondary outcomes Major complication rate excluding device embolization Departement Of Pediatric Cardiology And GUCH Unit San Donato Milanese, Italy

18. Results: Secondary outcomes Length of hospital stay Departement Of Pediatric Cardiology And GUCH Unit San Donato Milanese, Italy

19. Additional analyses  Testing for publication bias yielded non- significant results (P=0.107 at Egger test)  Excluding one study at a time, did not determine major changes in direction or magnitude of statistical findings Departement Of Pediatric Cardiology And GUCH Unit San Donato Milanese, Italy

20. Limitations Inherent limitations of individual studies within meta-analysis impact on overall result  Retrospective, unblinded, non-randomized  Single center studies  Quite wide range of publication dates (1999---2006) Departement Of Pediatric Cardiology And GUCH Unit San Donato Milanese, Italy

21. Conclusions The largest cohort to date of patients with secundum ASD shows that: - percutaneous closure has a significantly lower rate of either total or major complications - shorter hospital stay Departement Of Pediatric Cardiology And GUCH Unit San Donato Milanese, Italy

22. Thank you for your attention

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