Trans-catheter closure of atrial septal defect: Balloon sizing or no Balloon sizing – single centre experience

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Abstract

Background:

Selecting the device size using a sizing balloon could oversize the ostium secundum atrial septal defect (OSASD) with floppy margins and at times may lead to complications. Identifying the firm margins using trans-esophageal echocardiography (TEE) and selecting appropriate-sized device optimizes ASD device closure. This retrospective study was undertaken to document the safety and feasibility of device closure without balloon sizing the defect.

Methods:

Sixty-one consecutive patients who underwent trans-catheter closure of OSASD guided by balloon sizing of the defect and intra procedural fluoroscopy (group I) and 67 consecutive patients in whom TEE was used for defect sizing and as intraprocedural imaging during device deployment (group II) were compared. The procedural success rate, device characteristics, and complications were compared between the two groups.

Results:

The procedure was successful in 79.7 % patients. The success rate in group II (60 of 67, 89.6%) was significantly higher than in group I (41 of 61, 67.2 %) (P = 0.002). Mean upsizing of ASD device was significantly lower in group II ( P < 0.001). TEE also provided better success rate with smaller device in subjects with large ASD (>25 mm) and in those who were younger than 14 years of age. There were four cases of device embolization (two in each group); of which one died in group II despite successful surgical retrieval.

Conclusion:

Balloon sizing may not be essential for successful ASD device closure. TEE-guided sizing of ASD and device deployment provides better success rate with relatively smaller sized device.

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Most cited references 25

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Early and late complications associated with transcatheter occlusion of secundum atrial septal defect.

Massimo Chessa, Mario Carminati, Gianfranco Butera … (2002)

The goal of this study was to report the early and late complications experienced in atrial septal defect (ASD) transcatheter closure. Atrial septal defect transcatheter occlusion techniques have become an alternative to surgical procedures. A number of different devices are available for transcatheter ASD closure. The type and rate of complications are different for different devices. Between December 1996 and January 2001, 417 patients (mean age: 26.6 +/- 19 years) underwent transcatheter occlusion of secundum type ASD. Complications were categorized into major and minor. Two different devices were used: the CardioSEAL/STARFlex in 159 patients and the Amplatzer septal occluder in 258 patients. Thirty-four patients experienced 36 complications during the hospitalization (8.6%, 95% confidence interval: 6.1% to 11.1%). Ten patients underwent elective surgical repair because of device malposition (three patients) or device embolization (seven patients). Twenty-four patients experienced 25 minor complications: unsatisfactory device position or embolization. Devices were retrieved using a gooseneck snare and/or a basket; 11 patients experienced arrhythmic problems. Other complications were: pericardial effusion, thrombus formation on the left atrial disc, right iliac vein dissection, groin hematoma, hemorrhage in the retropharynx and sizing balloon rupture. Two patients had late complications: peripheral embolization in the left leg one year after implantation of an Amplatzer device and sudden death 1.5 year later. Our series of patients with ASD by transcatheter occlusion shows that the procedure is safe and effective in the vast majority of cases. To further reduce the complications rate, the criteria of device selection according to ASD morphology and some technical tips during implantation are discussed.

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Erosion of Amplatzer septal occluder device after closure of secundum atrial septal defects: review of registry of complications and recommendations to minimize future risk.

S Kleinman, J. Bass, Ziyad M Hijazi … (2004)

The objectives of this study were to identify possible risk factors that may lead to erosion of the Amplatzer septal occluder (ASO) and recommend ways to minimize future risk. There have been rare occurrences of adverse events with development of pericardial effusion after ASO placement. Identification of high-risk cases, early recognition, and prompt intervention may minimize the future risks of adverse events. In all patients who developed hemodynamic compromise after ASO placement, echocardiograms (pre-, intra-, and postprocedure), atrial septal defect (ASD) size (nonstretched, stretched), size of the device used, cineangiograms, and operative records were reviewed by a panel selected by AGA Medical Corporation. The findings were compared to the premarket approval data obtained from FDA-approved clinical trials that were conducted in the United States, before the device was approved. A total of 28 cases (14 in United States) of adverse events were reported to AGA Medical. All erosions occurred at the dome of the atria, near the aortic root. Deficient aortic rim was seen in 89% and the defect described as high ASD, suggesting deficient superior rim. The device to unstretched ASD ratio was significantly larger in the adverse event group when compared to the FDA trial group. The incidence of device erosion in the United States was 0.1%. The risk of device erosion with ASO is low and complications can be decreased by identifying high-risk patients and following them closely. Patients with deficient aortic rim and/or superior rim may be at higher risk for device erosion. Oversized ASO may increase the risk of erosion. The defect should not be overstretched during balloon sizing. Patients with small pericardial effusion at 24 hr should have closer follow-up. (c) 2004 Wiley-Liss, Inc.

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Embolization and retrieval of the Amplatzer septal occluder.

R. Moore, Daniel Levi (2004)

Embolization and percutaneous retrieval of the Amplatzer septal occluder (ASO) after release have been reported. However, the incidence, the causes of embolization, and the methods for effective retrieval have not been systematically described. In a survey of the ASO company-designated proctors, the incidence of ASO embolization in this group's experience was 0.55% (21 embolizations in 3824 device placements) with a wide range of patient demographics, atrial septal defect (ASD) sizes, and device sizes. Most embolizations occurred because of inadequate rim or undersized devices. Of the 21 embolizations, 15 of the devices were retrieved percutaneously with a gooseneck snare without morbidity or mortality. Six were retrieved at surgery. Of the 21 patients, 12 had ASO closure of their ASDs, and 9 had surgical ASD closure. In vitro, all devices could be retrieved with sheathes 2 Fr sizes larger than their recommended delivery sheath. Any device larger than 26 mm could be retrieved with its delivery sheath. The ability to pull the snared button into a sheath was variable and was assisted by pulling the device from above with a bioptome and by using a rigid notched sheath. Because the incidence of ASO embolization is about 1 in 200 in the most experienced hands, all operators should be prepared with the techniques and equipment required for percutaneous ASO retrieval. Copyright 2004 Wiley-Liss, Inc.

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Author and article information

Journal

Journal ID (nlm-ta): Ann Pediatr Cardiol

Journal ID (publisher-id): APC

Title: Annals of Pediatric Cardiology

Publisher: Medknow Publications (India )

ISSN (Print): 0974-2069

ISSN (Electronic): 0974-5149

Publication date (Print): Jan-Jun 2011

Volume: 4

Issue: 1

Pages: 28-33

Affiliations

[1]Department of Cardiology, SCTIMST, Trivandrum, India

Author notes

Address for correspondence: Dr. Saurabh Kumar Gupta, Department of Cardiology, Sree Chitra Institute for Medical Sciences and Technology, Trivandrum, Kerala 695 011, India. E-mail: drsaurabhmd@ 123456gmail.com

Article

Publisher ID: APC-4-28

DOI: 10.4103/0974-2069.79619

PMC ID: 3104527

PubMed ID: 21677801

SO-VID: c1744a4f-8ea4-407b-b106-4f35dcd7dd95

License:

This is an open-access article distributed under the terms of the Creative Commons Attribution-Noncommercial-Share Alike 3.0 Unported, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Trans-catheter closure of atrial septal defect: Balloon sizing or no Balloon sizing – single centre experience

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Abstract

Background:

Methods:

Results:

Conclusion:

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Cardiovascular Innovations and Applications

Most cited references 25

Early and late complications associated with transcatheter occlusion of secundum atrial septal defect.

Erosion of Amplatzer septal occluder device after closure of secundum atrial septal defects: review of registry of complications and recommendations to minimize future risk.

Embolization and retrieval of the Amplatzer septal occluder.

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