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ASD and PFO closure with the Solysafe septal occluder - results of a prospective multicenter pilot study.

https://arctichealth.org/en/permalink/ahliterature87344
Source
Catheter Cardiovasc Interv. 2008 Feb 15;71(3):398-402
Publication Type
Article
Date
Feb-15-2008
Author
Ewert Peter
Söderberg Bjoern
Dähnert Ingo
Hess Otto
Schuler Gerhard
Bussmann Christiane
Bernhard Jerome
Sick Peter
Author Affiliation
Abt. für angeborene Herzfehler, Deutsches Herzzentrum, Berlin, Germany. ewert@dhzb.de
Source
Catheter Cardiovasc Interv. 2008 Feb 15;71(3):398-402
Date
Feb-15-2008
Language
English
Publication Type
Article
Keywords
Adolescent
Adult
Aged
Balloon Occlusion - instrumentation - methods
Child
Electrocardiography, Ambulatory
Female
Follow-Up Studies
Foramen Ovale, Patent - diagnosis - therapy
Heart Catheterization
Heart Septal Defects, Atrial - diagnosis - therapy
Humans
Male
Middle Aged
Pilot Projects
Prospective Studies
Prosthesis Design
Prosthesis Implantation - methods
Risk assessment
Treatment Outcome
Abstract
OBJECTIVE: We report the results of a prospective multicenter pilot study performed in Germany, Sweden, and Switzerland with a new self-centering device for transcatheter closure of an atrial septal defect (ASD) or a patent foramen ovale (PFO) called the Solysafe Septal Occluder. INTERVENTIONS: The device was successfully implanted in 44 patients. In 15 patients with a median age of 40 years (range 6-76 years), a Solysafe device was successfully implanted in an ASD. The median size of the stretched defects was 17 mm (range 10-21 mm). Three 15-mm devices, eight 20-mm devices, and four 25-mm devices were used. Procedure time ranged from 40 to 107 min (median 66 min) and fluoroscopic time from 5.3 to 17.5 min (median 12 min). In 29 patients with a median age of 47 years (range 15-78 years), a Solysafe device was implanted in a PFO. The procedure time ranged from 21 to 155 min (median 51 min) and fluoroscopic time from 3.1 to 31.3 min (median 7.6 min). RESULTS: At discharge, 1 of the 29 patients (3%) had a small shunt. No patient in either the ASD or the PFO group had any major complication. Six months after implantation, the overall closure rate with the Solysafe septal occluder in both groups was 100% (44/44). CONCLUSION: With the self-centering Solysafe Septal Occluder, PFOs, and ASDs with a stretched diameter of up to 21 mm can be effectively closed with very high occlusion rates.
Notes
Comment In: Catheter Cardiovasc Interv. 2008 Feb 15;71(3):403-418288746
Comment In: Catheter Cardiovasc Interv. 2008 Feb 15;71(3):41718288749
PubMed ID
18288739 View in PubMed
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