Predictors of unfavorable outcome after atrial septal defect closure in adults

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after atrial septal defect closure in adults H. M. Gabriel 1, M. Humenberger 1, R. Rosenhek 1, GP. Diller 2, G. Kaleschke 2, TH. Binder 1, P. Probst 1, G. Maurer 1, H. Baumgartner 2 (1) Medical University of Vienna, Dept. of Internal Medicine II, Division of Cardiology, Vienna, Austria (2) Adult Congenital and Valvular Heart Disease Center, University Hospital of Muenster, Muenster, Germany No relationships to disclose

Background Previous studies demonstrated that transcatheter atrial septal defect (ASD) closure can successfully be performed at all ages and that even adults of advanced age can benefit with regard to - symptomatic improvement - right ventricular (RV) size and - pulmonary artery pressure (PAP) decrease. Nevertheless, some adults remain symptomatic after intervention. However, predictors of such unfavorable outcome have poorly been defined.

Purpose of the Study To identify predictors of unfavorable outcome of ASD closure defined by persistent NYHA FC > II - in a large group of consecutive patients presenting to an adult congenital heart disease program

Methods: Study Population All consecutive patients undergoing transcatheter ASD closure Indication for closure: significant left-to-right shunt (signs of right ventricular volume overload) irrespective of the presence of symptoms no severe pulmonary vascular disease (defined by PVR > 5 Wood units even after vasoreactivity testing or after targeted treatment) balloon stretched defect diameter <36mm sufficient rim, no significant additional lesions

Methods: Patient Assessement Clinical evaluation (NYHA FC) Physical examination ECG Echocardiography (TTE + TEE) including RV size (4-chamber view), PAP (TR), Qp:Qs, defect morphology Catheterization: estimation of PVR when PAP > 50% systemic pressure Intervention (Amplatzer Occluder) General anesthesia, TEE, balloon sizing

Patient Characteristics at Study Entry N 317 Gender 218 female (69%) Age 51±18 yrs (range:16 to 83) Defect size 18±6 mm Qp:Qs 2.2±0.8 RV size 43±7 mm PAPsyst. 41±15 mmhg PAP > 35mmHg 59 %

Patients (%) Symptoms Before and After ASD-Closure Most of the 317 pts. improved with ASD closure but - 62 (19.5%) continued to be symptomatic - 2 of 128 asympt. pts. developed symptoms Pts < 40yrs Pts 40 60yrs Pts > 60yrs

Systolic Pulmonary Artery Pressure (mmhg) Predictors of unfavorable outcome PAP Before and After ASD-Closure 60 50 40 30 20 < 40y 40-60y > 60y 10 0 spap pre spap day 1 spap week 1 spap month 3

RV-Size Before and After ASD-Closure Right Ventricular size (mm) 48 46 44 42 40 38 36 < 40y 40-60y > 60y 34 32 30 RV size pre RV size day 1 RV size week 1 RV size month 3

(NYHA FC II) Univariate Analysis P-Value OR 95% CI Age <.0001 2.12/10yrs 1.68-2.67 Symptoms <.0001 33.0 7.9-138.5 Syst. PAP <.0001 1.75/10mmHg 1.38-2.21 RV size <.001 1.13/10mm 1.07-1.19 Defect size Qp:Qs NS NS

(NYHA FC II) Multiple logistic regression analysis Univariate P-Value Multivariate P-Value Age <.0001.0004 Symptoms <.0001.002 Syst. PAP <.0001 NS RV size <.001 NS Defect size NS - Qp:Qs NS -

RVP.0 PAPsyst. (mmhg) Predictors of unfavorable outcome Results: Relationship Between PAP at Presentation and Age 120 110 100 90 80 70 60 50 40 30 20 R = 0.63 p < 0.0001 Patients: Age Group PAPsyst. Mean±S D 4 th Decade 33 ± 9 43 5 th Decade 35 ± 6 52 6 th Decade 39 ± 11 50 7 th Decade 40 ± 9 57 8 th Decade 60 ± 17 100 PAPsyst. >35 (%) 10 10 20 30 40 50 60 70 80 90 age Age (yrs)

ROC analysis Age > 60yrs: sensitivity 70% specificity 80%

ROC analysis Syst. PAP > 38mmHg: sensitivity 80% specificity 65%

ROC analysis RV > 42mm: sensitivity 84% specificity 51%

Conclusion Although the vast majority of adults benefits from ASD device closure, the likelihood of an unfavorable outcome with persistent symptoms increases with - pre-existing symptoms - age (more than doubled per decade) - PAP (almost doubled per 10mmHg). Patients younger than 60yrs with a systolic PAP <40 mmhg have a very high chance to become or remain symptom-free.