Key result
Transcatheter ASD closure without balloon sizing achieves similar success and closure rates versus balloon sizing.
Why the study?
The necessity of balloon sizing in transcatheter closure of atrial septal defect (ASD) was uncertain.
Does transcatheter closure of ASD without balloon sizing provide similar success and safety compared to closure with balloon sizing?
Cohort (n=514)
Does transcatheter closure of ASD without balloon sizing provide similar success and safety compared to closure with balloon sizing?
Absolute Event Rate: 97.9% vs 97%
Transcatheter closure of ASD without balloon sizing is feasible and safe, yielding success and complication rates comparable to the traditional balloon sizing method.
May allow TEE-guided ASD closure without balloon sizing; hypothesis-generating and requires randomized trials before practice change.
OBJECTIVE: To evaluate the safety and feasibility of transcatheter closure of atrial septal defect (ASD) without balloon sizing. METHODS: A total of 243 patients (group I), aged 2.1-76 years (median 22 years), underwent transcatheter closure of ASD without balloon sizing. The maximal diameter of the defect was measured on transesophageal echocardiographic (TEE) images. The size of device selected was generally 4-6 mm and 5-8 mm larger than the maximal diameter, if the defect was <14 mm and > or =14 mm, respectively. The results of ASD closure in group I were compared with those of 271 patients (group II, median age 11 years) who underwent ASD closure with balloon sizing prior to the study period. RESULTS: Of the 243 patients in group I, the maximal defect diameter ranged from 5.2 to 37 mm (mean 17.5 +/- 6.6 mm, median 17 mm). A total of 247 Amplatzer septal occluders were deployed in 240 patients. Two patients were found to develop distal embolization of a device the next day. Therefore, failure occurred in five patients. Comparing the results between group I and group II, there was no significant difference in success rate (238/243 vs. 263/271), incidence of embolization (2/243 vs. 2/271) and complete closure rate at 3-month follow-up (94.1% vs. 95.8%). There is significant difference in mean age (26.6 +/- 20.2 vs. 19.1 +/- 17.6), maximal defect diameter (17.5 +/- 6.6 vs. 14.1 +/- 5.9 mm) and Q(p)/Q(s) ratio (2.77 +/- 1.11 vs. 2.48 +/- 0.97) between group I and II. The mean diameter of device used was significantly larger in group I than in group II (23.1 +/- 8.1 vs. 19.6 +/- 7 mm, P < 0.001). CONCLUSIONS: Balloon sizing may not be necessary in transcatheter closure of ASD.
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Wang et al. (2007) conducted a cohort in Atrial septal defect (n=514). Transcatheter closure without balloon sizing vs. Transcatheter closure with balloon sizing was evaluated on Success rate of ASD closure. Transcatheter closure of atrial septal defect without balloon sizing achieved similar success rates (97.9% vs 97.0%) and 3-month complete closure rates (94.1% vs 95.8%) compared to balloon sizing.
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