MC Medicor Slovenia, Ljubljana, Slovenia.
Department of Cardiology, General Hospital Izola, Izola, Slovenia.
Catheter Cardiovasc Interv. 2020 Feb 15;95(3):349-354. doi: 10.1002/ccd.28360. Epub 2019 May 27.
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.
比较经胸超声心动图（TOE）在应用 BioSTAR（NMT Medical Inc，波士顿，马萨诸塞州）和 Amplatzer 卵圆孔未闭（PFO）封堵器（雅培血管，普利茅斯，明尼苏达州）关闭卵圆孔未闭（PFO）后的发现。
使用可生物降解装置进行 PFO 封堵代表了永久性装置的一种有吸引力的替代方法。但长期有效性和生物降解后的形态仍不清楚。
在 2008 年 2 月至 2014 年 6 月期间，49 例患者接受了 BioSTAR 治疗，48 例患者接受了 Amplatzer PFO 封堵器治疗。封堵后、6 个月和 2 年以上进行 TOE。
两组 PFO 特征相似。BioSTAR 组即刻有效封堵率（<5 个瓦尔萨尔瓦动作气泡）为 96%，Amplatzer PFO 封堵器组为 88%（p=.16）。除 BioSTAR 后出现一过性发热（10.8%比 0%；p=.08）外，两组均无不良事件。6 个月时的 TOE 显示出相似的有效封堵率（93%比 89%；p=.74），所有装置均位于正确位置，无血栓/心包积液。在 BioSTAR 组中，1 例（2.2%）患者出现器械周围左向右彩色多普勒分流，2 例（4.3%）患者出现 Nitinol 框架支柱突入心房腔，1 例（2.2%）患者同时出现这两种情况。2 年以上的 TOE 显示出相似的有效封堵率（92%比 96%；p= 1.00），同时还显示出与 BioSTAR 相关的器械周围左向右分流和金属框架支柱突入。两组均无卒中或外周栓塞，而 BioSTAR 患者的短暂性脑缺血发作（TIA）发生率更高（6.8%比 2.5%；p=.61）。
BioSTAR 提供了与 Amplatzer PFO 封堵器相似的 PFO 封堵率。尚未报道的 BioSTAR 相关器械周围左向右分流和金属框架支柱突入可能对可生物降解装置的进一步发展具有实际意义。
