A meta-analysis of percutaneous versus surgical closure of ostium secundum atrial septal defects Butera G, Biondi-Zoccai G, Abella R, Piazza L, Chessa

A meta-analysis of A meta-analysis of percutaneous versus percutaneous versus

surgical closure of ostium surgical closure of ostium secundum atrial septal secundum atrial septal

defectsdefectsButera G, Biondi-Zoccai G, Abella R, Butera G, Biondi-Zoccai G, Abella R,

Piazza L, Chessa M, Micheletti A,Piazza L, Chessa M, Micheletti A, Negura D, Giamberti A, Frigiola A, Negura D, Giamberti A, Frigiola A,

Carminati M.Carminati M.

Departement Of Pediatric Cardiology And GUCH Unit

San Donato Milanese, Italy

BackgroundBackground

Percutaneous atrial septal defect Percutaneous atrial septal defect closure has became available in the closure has became available in the last ten yearslast ten years

In literature there are studies In literature there are studies comparing surgical and percutaneous comparing surgical and percutaneous closureclosure



BackgroundBackground

Large data set comparing these Large data set comparing these two techniques are lackingtwo techniques are lacking

No meta-analysis studies are No meta-analysis studies are reported in the field of pediatric reported in the field of pediatric cardiology/cardiac surgerycardiology/cardiac surgery



Clinical Question & Clinical Question & ObjectivesObjectives

Clinical QuestionClinical QuestionIs there any difference in early post-Is there any difference in early post-procedural results between surgical and procedural results between surgical and percutaneous secundum ASD closure?percutaneous secundum ASD closure?

ObjectivesObjectivesto perform a meta-analysis of all to perform a meta-analysis of all relevant studies comparing results of relevant studies comparing results of surgical and percutaneous ASD closuresurgical and percutaneous ASD closure



MethodsMethods Databases: Pubmed, Google Scholar, Biomed Databases: Pubmed, Google Scholar, Biomed

CentralCentral

Search updated Search updated April 07 April 07

Search terms: Search terms: ‘‘atrial septal defect’, ‘closure’, ‘percutaneous’, ‘surgery’, atrial septal defect’, ‘closure’, ‘percutaneous’, ‘surgery’,

‘device’ ‘device’

Inclusion criteria for studies: Inclusion criteria for studies: Comparison of surgical versus percutaneous ASD closureComparison of surgical versus percutaneous ASD closure

Reporting on > 20 ptsReporting on > 20 pts

MethodsMethods Data collectionData collection

- Pre-specified forms used to collect data on Pre-specified forms used to collect data on baselinebaseline

characteristics and outcomescharacteristics and outcomes- Data abstracted by two independente and Data abstracted by two independente and

unblinded reviewers (GB, GBZ)unblinded reviewers (GB, GBZ)- We abstracted: We abstracted: authors, journal, years of authors, journal, years of

conduct and publication, study design, conduct and publication, study design, sample size, patient characteristics, raw sample size, patient characteristics, raw numbers for death, total complication and numbers for death, total complication and major adverse cardiovascular events, major adverse cardiovascular events, length of hospital staylength of hospital stay

MethodsMethods Statistical methodsStatistical methods

-- performed using Review Manager 4.2.4performed using Review Manager 4.2.4- Pooled estimated for odds ratiuos computed Pooled estimated for odds ratiuos computed

according to random effect methods according to random effect methods - Continuous variables compared using Continuous variables compared using

random effect inverse variance weighting random effect inverse variance weighting methodmethod

-- Statistical inconsistency appraised with I2Statistical inconsistency appraised with I2- Reported values were two-tailed and results Reported values were two-tailed and results

were considered statistically significant at were considered statistically significant at the 0.05 level. the 0.05 level.

- Quality of included studies was appraised Quality of included studies was appraised according to the Cochrane Collaboration according to the Cochrane Collaboration methodsmethods

MethodsMethods Primary outcome: Primary outcome:

-- DeathDeath-- Total complicationsTotal complications-- Major complicationsMajor complications

Secondary outcomes:Secondary outcomes:-- Major complications excluding device Major complications excluding device

embolizationembolization-- Length of hospital stayLength of hospital stay



ResultsResults320 citations from initial search

13 articles retrieved307 excluded as non-

relevant at citation level

1 study excluded 12 studies selected

Total of 2821 patients

1144 pts with surgical ASD closure

1677 pts with percutaneous ASD

closure



Results: Study Results: Study characteristicscharacteristicsAutAuthor(journal,yr) Study typeStudy type Numbers of pts Age

Berger (JTCVS 1999) Prospective Surg:61kt: 61

20 (0.5-74)12 (0.8-77)

Bettencourt (Rev Port Cardiol 2002) Retrospective Surg: 25Kt: 38

38 (13-67)40 (15-72)

Bialkowksi (Tex heart Int J 2004) RetyrospectiveChildren (< 18 yrs)

Surg: 44Kt: 47

6.5 (2.3-16.9)9.9 (2.3-17)

Butera (Am H J 2006) Retrospective Surg: 533Kt: 751

22.418.92919.8

Cowley (Am J Cardio 2001) Retrospective Surg:44 kt:45

10.5±11.722.9±20.8

Du (JACC 2002) Prospective, non-randomizedMulticenter

Surg: 155Kt: 459

4.19.8

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) Retrospective Surg:121Kt: 52

5.17

Hugues (Heart 2002) Prospective Surg: 19Kt 43

3.3 (2.2-5.4)6.1 (3.3-10)

Kim (Med Sci Monit 2002) Retrospective Surg: 32Kt: 48

19..91937.923

Thomson (Heart 2002) Prospective Surg: 16Kt: 27

5.5 (2.7-15.2)9.7 (2.1-44.6)

Vida (JACC 2006) Retrospective Surg: 28Kt: 83

7.145.518.315.5

Results: Primary Results: Primary outcomesoutcomes

DeathDeath

No death was reported with any of the two methods




Total complication rateTotal complication rate

0 10 20 30 40 50 60 70

surgery

kt

31 % (95 % CI: 21-41%)

6.6% (95% CI: 3.9-9.2)

(p<0.0001)




Total complication rateTotal complication rate




Major complication rateMajor complication rate

0 10 20

surgery

kt

6,8 % (95 % CI: 4-9,5%)

1,9% (95% CI:0,9-2,9)

(p<0.0001)




Major complication rateMajor complication rate




Major complicationsMajor complications

SurgeryRedo 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 closureEmbolization/malposition needing surgery, Pericardial tamponade, Vascular injury of femoral veins/artery needing surgical repair, Thrombus formation, Device erosion, Major arrhythmias



Results: Secondary Results: Secondary outcomesoutcomes

Major complication rate excluding device embolizationMajor complication rate excluding device embolization



Results: Secondary Results: Secondary outcomesoutcomes

Length of hospital stayLength of hospital stay



Additional analysesAdditional analyses

Testing for publication bias yielded Testing for publication bias yielded non-significant results (P=0.107 at non-significant results (P=0.107 at Egger test) Egger test)

Excluding one study at a time, did Excluding one study at a time, did not determine major changes in not determine major changes in direction or magnitude of statistical direction or magnitude of statistical findingsfindings



LimitationsLimitationsInherent limitations of individual Inherent limitations of individual

studies withinstudies within

meta-analysis impact on overall resultmeta-analysis impact on overall result

Retrospective, unblinded, non-randomizedRetrospective, unblinded, non-randomized

Single center studiesSingle center studies

Quite wide range of publication dates Quite wide range of publication dates (1999---2006)(1999---2006)Departement Of Pediatric Cardiology And GUCH Unit


ConclusionsConclusionsThe largest cohort to date of The largest cohort to date of patients with secundum ASD shows patients with secundum ASD shows that:that:

- - percutaneous closure has apercutaneous closure has a

significantly lower rate of eithersignificantly lower rate of either

total or major complicationstotal or major complications

- - shorter hospital stayshorter hospital stay



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Documents

A meta-analysis of percutaneous versus surgical closure of ostium secundum atrial septal defects Butera G, Biondi-Zoccai G, Abella R, Piazza L, Chessa