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Catheter Cardiovasc Interv. 2014 Sep 1;84(3):464-70. doi: 10.1002/ccd.25434. Epub 2014 Feb 27.

Immediate and short-term outcomes after percutaneous atrial septal defect closure using the new nit-occlud ASD-R device.

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1
Division of Cardiology, Hospital Privado de Córdoba, Av Naciones Unidas 346, (5016), Córdoba, Argentina; Interventional Cardiology Section, Hospital Privado de Córdoba, Av Naciones Unidas 346, (5016), Córdoba, Argentina.

Abstract

OBJECTIVES:

To evaluate the feasibility, safety, and efficacy of implantation of the new Nit Occlud ASD-R® (NOASD-R) device for percutaneous closure of ostium secundum atrial septal defects (ASD-OS).

BACKGROUND:

Device catheter implantation has become the method of choice for most patients with ASD-OS. No single device has proven to be ideal for this type of procedure. The NOASD-R has a distinct design that may help to overcome limitations of other devices.

METHODS:

A prospective, single arm, observational study including all consecutive patients receiving the NOASD-R device for ASD-OS closure between October 2011 and September 2013 was performed. Patient selection, device design, deployment technique, complications, and procedural outcomes were evaluated.

RESULTS:

Seventy-four patients underwent attempted transcatheter ASD-OS closure using the NOASD-R device. Implantation of the occluder was successful in 73 patients (98.6%). The majority of patients were female (79.5%) with a median age of 17.2 years (range: 2-74). A 2-D transthoracic color-Doppler echocardiogram (TTE) obtained at the 3 or 6 month follow-up visit showed complete occlusion of the ASD-OS in 72/73 patients (98.6%). At a mean follow-up interval of 11.4 ± 6.8 months there have been no episodes of late device embolization, cardiac perforation or erosion, endocarditis, thromboembolism, wire fracture, embolic neurologic events, or death.

CONCLUSIONS:

We report the first worldwide clinical experience using the NOASD-R device for ASD-OS closure. The procedure was feasible, with a high rate of successful implantations, and safe. High ASD-OS closure rates and no complications were encountered during short-term follow-up. © 2014 Wiley Periodicals, Inc.

KEYWORDS:

Nit-Occlud ASD-R; atrial septal defect; device closure; outcomes

Comment in

PMID:
24677704
DOI:
10.1002/ccd.25434
[Indexed for MEDLINE]
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