Propensity-Score Matched Comparison of the Cera PFO Occluder With the Amplatzer PFO Occluder for Percutaneous Closure of Patent Foramen Ovale Without Echocardiographic Guidance.
PubMed ID
28570259
Abstract
BACKGROUND
Percutaneous patent foramen ovale (PFO) closure has become a routine procedure and was proven to be safe and feasible. In a recently published pooled analysis of randomized trials, percutaneous PFO closure was shown to more effectively reduce recurrent stroke when compared with medical therapy in patients with cryptogenic strokes. However, procedural safety and closure rate are device dependent.
METHODS
We performed a propensity-score matched comparison of 28 patients undergoing percutaneous PFO closure using the Cera PFO occluder (CPO) with 28 patients who received the Amplatzer PFO occluder (APO). The main endpoints were procedural complications and closure rate at 6 months verified by transesophageal echocardiography.
RESULTS
The implantation procedure using the CPO was successful and without complications in all cases. After propensity-score matching, there was no significant difference between groups for the primary endpoint of residual shunt at 6 months (7% in the CPO group vs 4% in the APO group; log-rank test P=.15).
CONCLUSIONS
With regard to procedural safety and closure rate at 6 months, the performance of the CPO is comparable with the APO in this small patient cohort.
Percutaneous patent foramen ovale (PFO) closure has become a routine procedure and was proven to be safe and feasible. In a recently published pooled analysis of randomized trials, percutaneous PFO closure was shown to more effectively reduce recurrent stroke when compared with medical therapy in patients with cryptogenic strokes. However, procedural safety and closure rate are device dependent.
METHODS
We performed a propensity-score matched comparison of 28 patients undergoing percutaneous PFO closure using the Cera PFO occluder (CPO) with 28 patients who received the Amplatzer PFO occluder (APO). The main endpoints were procedural complications and closure rate at 6 months verified by transesophageal echocardiography.
RESULTS
The implantation procedure using the CPO was successful and without complications in all cases. After propensity-score matching, there was no significant difference between groups for the primary endpoint of residual shunt at 6 months (7% in the CPO group vs 4% in the APO group; log-rank test P=.15).
CONCLUSIONS
With regard to procedural safety and closure rate at 6 months, the performance of the CPO is comparable with the APO in this small patient cohort.
Date Issued
2017-08
Publication Type
Article
Subject(s)
Language(s)
en
Author(s)
Ulmi, Mirjam | |
Praz, Fabien | |
Siontis, George C M | |
Wahl, Andreas | |
Windecker, Stephan | |
Meier, Bernhard |
Additional Credits
Journal
The journal of invasive cardiology
Publisher
HMP Communications
ISSN
1557-2501
Access(Rights)
metadata.only