Methods

This was an observational outcomes study. The institutional review boards of the 2 participating centers approved the study protocol. Pediatric cardiology databases were used to identify consecutive patients who had undergone TC of isolated secundum ASD from 1986 to 2005. Patients were included only if they had a relatively isolated secundum ASD closed because of evidence of significant left-to-right shunting associated with echocardiographic RV dilation. To provide a comparable contemporary surgical cohort treated by consistent surgical techniques, we identified all patients undergoing SC at the Cleveland Clinic from 1993 to 2005. All patients were offered TC if they met the criteria for SC and the implanting physician believed the anatomy was suitable. In the early years of the present study, devices were available only if the patient agreed to participate in the Food and Drug Administration trials of safety and efficacy.

Living patients were excluded if it was not possible to obtain ≥5 years of postprocedural follow-up, if other significant congenital heart defects were present, or if the patient had a documented pre-existing medical condition likely to significantly influence short-term mortality (e.g., neoplastic disease, moderate or severe pulmonary hypertension, cardiomyopathy), independent of the ASD. Patients who underwent transcatheter ASD device implantation for alternate indications such as possible paradoxical embolus or orthodeoxia were excluded.

Follow-up was obtained through a combination of chart review, primary care physician office records review, and telephone survey performed during the 2-year study window (October 15, 2008 to February 3, 2011). Outside physician office records were obtained when cardiac or neurologic events were possible. For patients who did not have a physician office visit within the preceding 2 years, follow-up was recommended, and reports were obtained. The records were reviewed in detail to evaluate the incidence of significant complications and to elicit the nature of any adverse events or significant ongoing medical issues possibly related to ASD closure. We focused on objective data obtained from the medical records, including echocardiographic reports and hospitalizations, and subjective complaints. All clinically significant adverse events were tabulated. Structured telephone interviews were attempted with patients who did not have documented follow-up visit in the previous 2 years. Social Security Death Index data were searched for patients for whom follow-up information was not recorded and who were unable to be contacted. Death certificates were obtained when possible for deceased patients for whom the cause of death could not be determined from the medical records or family report. All deaths, including those occurring <5 years after the procedure, were included in the analysis.

Data are expressed as numbers with percentages and median values with ranges, as appropriate. The incidence of any adverse events (i.e., arrhythmias, ventricular dysfunction, stroke, exercise limitation, disability) and the late hazard or risk of death was assessed during the follow-up period. The TC and SC patients were compared by the categorical and continuous variables using chi-square, Fisher’s exact, and Wilcoxon rank sum tests, as appropriate, for the entire cohort and stratified by age at procedure and pre-existing conditions. Univariate and multivariate logistic regression models were used to assess risk factors for adverse events and late outcomes. All tests were 2-tailed and at a significance level of 0.05. Statistical analyses were performed using SAS, version 9.2 (SAS Institute, Cary, North Carolina).

Results

Before excluding living subjects with <5 years of follow-up, the entire cohort consisted of 375 patients, 207 in the SC group and 168 in the TC group. Follow-up data at least 5 years postprocedure for living patients and mortality data from any time postprocedure was obtained in 300 patients (study cohort). This constituted a follow-up rate of 80%. Although the study cohort had equal parts of TC (148 [49%]) and SC (152 [51%]), those with <5 years of follow-up included proportionately more SC patients than TC patients (73% vs 27%, p <0.001). The patients treated at the primary site included 275 and those from the second institution 25 of the study cohort. The device types were Clamshell (USCI Bard, Bellerica, Massachusetts) or CardioSEAL/Starflex (NMT, Boston, Massachusetts) occluders (n = 57), Amplatzer septal occluder (AGA, Plymouth, Minnesota; n = 53), and Helex Septal Occluder (W.L. Gore, Flagstaff, Arizona; n = 38). The median age at procedure was 20 years (range 1 to 82) overall and was 15.7 years (range 1 to 74) in the SC group and 25 years (range 2 to 82) in the TC group. The SC group underwent closure at a younger age than the TC group (p = 0.03). The TC group had had a greater number of medications before closure (p <0.001) and had more multiple defects (p <0.001), and the SC group had larger defects (p <0.001). No significant difference was found between the groups with regard to RV dilation (p = 0.34), RV dysfunction (p = 0.35), co-morbidities, including previous stroke (p = 0.06), smoking (p = 0.16), arrhythmias (p = 0.15), or New York Heart Association class (p = 0.75). No patient with pre-existing arrhythmias had received ablation therapy before closure. The study cohort was stratified into 3 groups according to patient age at treatment; <20, 20 to 40, and >40 years. The patient characteristics at closure are listed in Table 1 .

The median follow-up duration was 10 years. The follow-up data are summarized in Table 2 . Nine patients died (3%)—5 from previously unknown malignancies, 1 from ruptured cerebral arteriovenous malformation, and 1 from arrhythmia/congestive heart failure-related causes. The cause of death in 2 patients was unknown. Most (90%) patients were minimally symptomatic at intervention, with reported activity levels consistent with New York Heart Association functional class 1 or 2. The functional class at long-term follow-up was unchanged in 227, improved in 25, worse in 15, and could not be determined in 33 patients. The characteristics of the study cohort at the most recent follow-up visit stratified into the 3 age groups at treatment are listed in Table 3 . There were no incidents suggestive of device-related erosions or embolizations during follow-up. Among the patients who underwent TC with Clamshell devices, there were 3 instances of device fracture identified at 5 and 10 years of follow-up. Two patients during follow-up after Clamshell device closure were identified to have residual shunt and mild right atrial dilation on transthoracic echocardiograms 15 years after TC; both underwent transcatheter reintervention for placement of Amplatzer septal occluders.

Table 3

Follow-up data of the study cohort stratified into 3 age groups

Variable Age (years)	Total	TC Group			SC Group
		<20	20–40	>40	<20	20–40	>40
Patients (n)	300	64 (43%)	29 (20%)	55 (37%)	85 (56%)	31 (20%)	36 (24%)
Gender
Male	76	16	2	14	31	7	6
Female	224	48	27	41	54	24	30
Pre-existing atrial arrhythmia	33	1 (2%)	5 (17%)	16 (29%)	2 (2%)	1 (3%)	8 (22%)
Duration of follow-up
Median	10	9.0	7.3	8.1	11	13	12.4
Range	2.2–20	5.7–20	5.6–17	2.2–19	5.4–17	6.4–17	4.7–16
Change in New York Heart Association class
Worse	15	0	1 (4%)	5 (10%)	1 (1%)	3 (10%)	5 (14%)
Same	227	41 (95%)	24 (92%)	38 (76%)	75 (90%)	22 (76%)	27 (75%)
Better	25	2 (5%)	1 (4%)	7 (14%)	7 (8%)	4 (14%)	4 (11%)
Clinically significant atrial arrhythmia on follow-up	28	1 (2%)	3 (10%)	10 (18%)	2 (2%)	3 (10%)	9 (25%)
Embolic neurologic events on follow-up	8	0	1 (3%)	4 (7%)	2 (2%)	0	1 (3%)
Last known status
Alive	291	64 (100%)	29 (100%)	51 (93%)	83 (98%)	31 (100%)	33 (92%)
Died	9	0	0	4 (7%)	2 (2%)	0	3 (8%)

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