Natasa Cernic Suligoj1,2, Maja Rojko1, Brina Suligoj1,2, Metka Zorc1, Saibal Kar1,3, Marko Noc1,4. 1. MC Medicor Slovenia, Ljubljana, Slovenia. 2. Department of Cardiology, General Hospital Izola, Izola, Slovenia. 3. Cardiovascular Intervention Center, Cedars-Sinai Heart Institute, Los Angeles, California. 4. Center for Intensive Internal Medicine, University Medical Center, Ljubljana, Slovenia.
Abstract
OBJECTIVES: 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). BACKGROUND: PFO closure with a biodegradable device represents an attractive alternative to permanent devices. Long-term effectiveness and morphology after biodegradation remain unknown. METHODS: 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. RESULTS: 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). CONCLUSION: 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.
OBJECTIVES: 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). BACKGROUND: PFO closure with a biodegradable device represents an attractive alternative to permanent devices. Long-term effectiveness and morphology after biodegradation remain unknown. METHODS: 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. RESULTS: 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). CONCLUSION: 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.
Authors: Yajuan Du; Hang Xie; Hui Shao; Gesheng Cheng; Xingye Wang; Xumei He; Beidi Lan; Lu He; Yushun Zhang Journal: Front Cardiovasc Med Date: 2022-05-03