Long-term transesophageal echocardiography after patent foramen ovale closure by BioSTAR and Amplatzer patent foramen ovale occluders. 2020

Natasa Cernic Suligoj, and Maja Rojko, and Brina Suligoj, and Metka Zorc, and Saibal Kar, and Marko Noc
MC Medicor Slovenia, Ljubljana, Slovenia.

To compare transesophageal echocardiography (TOE) findings after patent foramen ovale (PFO) closure by BioSTAR (NMT Medical Inc, Boston, MA) and Amplatzer PFO occluders (Abbott Vascular, Plymouth, MN). PFO closure with a biodegradable device represents an attractive alternative to permanent devices. Long-term effectiveness and morphology after biodegradation remain unknown. Between February 2008 and June 2014, 49 patients received BioSTAR and 48 Amplatzer PFO occluder. TOE was performed after closure, at 6 months and beyond 2 years. PFO features were comparable between the groups. Immediate effective closure (<5 bubbles on Valsalva) was obtained in 96% by BioSTAR and 88% by Amplatzer PFO occluder (p = .16). Except for transient fever after BioSTAR (10.8 vs. 0%; p = .08), there was no adverse events. TOE at 6 months revealed comparable effective closure (93 vs. 89%; p = .74), all devices in correct position and no thrombus/pericardial effusion. In the BioSTAR group, a peri-device left-to-right color Doppler shunt was documented in one patient (2.2%), protrusion of the nitinol framework strut(s) into the atrial cavity in two patients (4.3%), and both events in one patient (2.2%). TOE beyond 2 years showed comparable effective closure (92 vs. 96%; p = 1.00) and again BioSTAR-associated peri-device left-to-right shunt and metal framework strut(s) protrusion. There was no stroke or peripheral embolization in either group while TIA was numerically greater in BioSTAR patients (6.8 vs. 2.5%; p = .61). BioSTAR provided similar PFO closure rate as Amplatzer PFO occluder. As yet unreported BioSTAR-associated peri-device left-to-right shunt and metal framework strut(s) protrusion may have practical implications for further development of biodegradable devices.

UI MeSH Term Description Entries
D008297 Male Males
D008875 Middle Aged An adult aged 45 - 64 years. Middle Age
D011237 Predictive Value of Tests In screening and diagnostic tests, the probability that a person with a positive test is a true positive (i.e., has the disease), is referred to as the predictive value of a positive test; whereas, the predictive value of a negative test is the probability that the person with a negative test does not have the disease. Predictive value is related to the sensitivity and specificity of the test. Negative Predictive Value,Positive Predictive Value,Predictive Value Of Test,Predictive Values Of Tests,Negative Predictive Values,Positive Predictive Values,Predictive Value, Negative,Predictive Value, Positive
D011474 Prosthesis Design The plan and delineation of prostheses in general or a specific prosthesis. Design, Prosthesis,Designs, Prosthesis,Prosthesis Designs
D005260 Female Females
D006328 Cardiac Catheterization Procedures in which placement of CARDIAC CATHETERS is performed for therapeutic or diagnostic procedures. Catheterization, Cardiac,Catheterization, Heart,Heart Catheterization,Cardiac Catheterizations,Catheterizations, Cardiac,Catheterizations, Heart,Heart Catheterizations
D006801 Humans Members of the species Homo sapiens. Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D000328 Adult A person having attained full growth or maturity. Adults are of 19 through 44 years of age. For a person between 19 and 24 years of age, YOUNG ADULT is available. Adults
D013997 Time Factors Elements of limited time intervals, contributing to particular results or situations. Time Series,Factor, Time,Time Factor
D016896 Treatment Outcome Evaluation undertaken to assess the results or consequences of management and procedures used in combating disease in order to determine the efficacy, effectiveness, safety, and practicability of these interventions in individual cases or series. Rehabilitation Outcome,Treatment Effectiveness,Clinical Effectiveness,Clinical Efficacy,Patient-Relevant Outcome,Treatment Efficacy,Effectiveness, Clinical,Effectiveness, Treatment,Efficacy, Clinical,Efficacy, Treatment,Outcome, Patient-Relevant,Outcome, Rehabilitation,Outcome, Treatment,Outcomes, Patient-Relevant,Patient Relevant Outcome,Patient-Relevant Outcomes

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