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Five-year clinical and echocardiographic evaluation of the Das AngelWings atrial septal occluder.

Publication ,  Journal Article
Kay, JD; O'Laughlin, MP; Ito, K; Wang, A; Bashore, TM; Harrison, JK
Published in: Am Heart J
February 2004

BACKGROUND: The late outcome of patients treated with atrial septal occluder devices remains incompletely defined. The purpose of this study was to assess the late outcome (range 4-7 years postprocedure) of patients in whom the Das AngelWings septal occluder device was implanted in the atrial septum. We report the clinical and echocardiographic outcome, at an average of 5 years following the procedure, of patients treated with the Das AngelWings device used to close either a secundum atrial septal defect (ASD) or a patent foramen ovale (PFO). METHODS: Thirty-two patients underwent successful percutaneous closure of an atrial septal closure, patent foramen ovale, or fenestration in the lateral tunnel of their Fontan with the Das AngelWings device between June 1995 and March 1998 at Duke University Medical Center. Two of the 32 patients were lost to follow-up. The remaining 30 patients were divided into 3 groups based on indication for device implantation. Group 1 consisted of 14 patients with a secundum ASD and predominantly left-to-right atrial shunting. Group 2 consisted of 8 patients who had a PFO and who suffered a thromboembolic event. Group 3 (compassionate use) consisted of 10 patients with multiple comorbid medical problems with predominantly right-to-left shunting at the atrial level causing hypoxemia. Eight of the patients in group 3 were severely ill at the time of device implantation. The 2 remaining patients in group 3 underwent AngelWings implantation for closure of right-to-left shunting through a Fontan fenestration. Mean follow-up was 59 months. RESULTS: There was no device embolization. No patient in the ASD or PFO/stroke group had a clinical complication. By radiographic examination, 2 of 27 patients had evidence of fracture of the nitinol framework at 2-year follow-up. Residual shunting was present in 44% at 24 hours, 20% at 1 year, and 18.8% at 2 years by use of Doppler color flow imaging and/or microcavitation echocardiographic studies. Mild mitral regurgitation caused by the AngelWings device occurred in 1 patient. One patient in the compassionate use group had a subsequent neurologic event. Five of the 10 patients in the compassionate use group died of comorbid illnesses in follow-up, none directly related to device complications. CONCLUSION: The late clinical outcome of secundum ASD and PFO/stroke patients in this study demonstrates that Das AngelWings closure of the atrial septum is effective and safe. These data are encouraging with respect to the expanding use of other percutaneously implanted ASD occlusion devices, although late clinical safety and efficacy data are needed for the specific devices being implanted.

Duke Scholars

Published In

Am Heart J

DOI

EISSN

1097-6744

Publication Date

February 2004

Volume

147

Issue

2

Start / End Page

361 / 368

Location

United States

Related Subject Headings

  • Treatment Outcome
  • Prosthesis Design
  • Prostheses and Implants
  • Male
  • Humans
  • Heart Septal Defects, Atrial
  • Follow-Up Studies
  • Female
  • Echocardiography, Transesophageal
  • Child, Preschool
 

Citation

APA
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ICMJE
MLA
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Kay, J. D., O’Laughlin, M. P., Ito, K., Wang, A., Bashore, T. M., & Harrison, J. K. (2004). Five-year clinical and echocardiographic evaluation of the Das AngelWings atrial septal occluder. Am Heart J, 147(2), 361–368. https://doi.org/10.1016/j.ahj.2003.07.018
Kay, Joseph D., Martin P. O’Laughlin, Kristin Ito, Andrew Wang, Thomas M. Bashore, and J Kevin Harrison. “Five-year clinical and echocardiographic evaluation of the Das AngelWings atrial septal occluder.Am Heart J 147, no. 2 (February 2004): 361–68. https://doi.org/10.1016/j.ahj.2003.07.018.
Kay JD, O’Laughlin MP, Ito K, Wang A, Bashore TM, Harrison JK. Five-year clinical and echocardiographic evaluation of the Das AngelWings atrial septal occluder. Am Heart J. 2004 Feb;147(2):361–8.
Kay, Joseph D., et al. “Five-year clinical and echocardiographic evaluation of the Das AngelWings atrial septal occluder.Am Heart J, vol. 147, no. 2, Feb. 2004, pp. 361–68. Pubmed, doi:10.1016/j.ahj.2003.07.018.
Kay JD, O’Laughlin MP, Ito K, Wang A, Bashore TM, Harrison JK. Five-year clinical and echocardiographic evaluation of the Das AngelWings atrial septal occluder. Am Heart J. 2004 Feb;147(2):361–368.
Journal cover image

Published In

Am Heart J

DOI

EISSN

1097-6744

Publication Date

February 2004

Volume

147

Issue

2

Start / End Page

361 / 368

Location

United States

Related Subject Headings

  • Treatment Outcome
  • Prosthesis Design
  • Prostheses and Implants
  • Male
  • Humans
  • Heart Septal Defects, Atrial
  • Follow-Up Studies
  • Female
  • Echocardiography, Transesophageal
  • Child, Preschool