Browsing by Author "Tuzcu, E Murat"
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Item Open Access Embolization of patent foramen ovale closure devices: incidence, role of imaging in identification, potential causes, and management.(Tex Heart Inst J, 2013) Goel, Sachin S; Aksoy, Olcay; Tuzcu, E Murat; Krasuski, Richard A; Kapadia, Samir RTranscatheter patent foramen ovale (PFO) closure is an alternative to antiplatelet or anticoagulative therapy in patients with cryptogenic stroke, and it is associated with a small incidence of periprocedural sequelae. Because embolization of PFO closure devices is a very rare procedural complication, data on its frequency, causes, and management are sparse. We sought to review the medical literature and the cases of PFO closure-device embolization at our institution with the aim of identifying likely problems and reporting potential solutions. Out of 310 adult patients who underwent transcatheter PFO closure from June 2002 through April 2011, there were 2 cases (0.6%) of PFO closure-device embolization. In both patients, hypermobile septum primum and thick septum secundum were present. In one patient, failure to use a sizing balloon might have resulted in an underestimation of the PFO's size. In both patients, device embolization was identified in a timely fashion, the embolized device was safely retrieved, and the PFO was percutaneously closed with success. The incidence of PFO closure-device embolization is very low. The cases described here underscore the importance of imaging in the identification of morphologic predispositions to closure-device malpositioning, in the recognition of impending embolization, and in the timely management of embolization.Item Open Access Off-label closure during CLOSURE study.(J Invasive Cardiol, 2012-11) Stackhouse, Kathryn A; Goel, Sachin S; Qureshi, Athar M; Prieto, Lourdes; Kapadia, Samir; Tuzcu, E Murat; Krasuski, Richard ABACKGROUND: The role of percutaneous closure of patent foramen ovale (PFO) in patients with cryptogenic stroke or transient ischemic attack remains controversial. Registry data have suggested considerable benefit of closure over medical therapy, but the prospective, randomized CLOSURE I trial found no benefit for device closure. METHODS: We compared patients enrolled into CLOSURE I to off-label closures performed during the study recruitment period at a single large institution and prospectively enrolled into an institutional registry of PFO closure. We also compared CLOSURE I patients at our institution to the reported characteristics of the entire study to ensure generalizability. RESULTS: Between 11/3/2003 and 4/16/2007, there were 100 off-label closures and 33 patients randomized into CLOSURE I. Compared with off-label closure, patients in CLOSURE I were younger (41.6 ± 10.1 years vs 50.0 ± 14.0 years; P<.001) and had fewer cardiovascular risks including hypertension (12% vs 36%; P=.009), hyperlipidemia (24% vs 53%; P=.008), and coronary disease (3% vs 44%; P<.001). Degree of right-to-left shunting was considerably higher in off-label closures (28%, 14%, and 58% vs 45%, 30%, and 25% for mild, moderate, and severe, respectively; P=.026). CONCLUSION: Off-label closures outnumbered patient recruitment into CLOSURE 3:1 at our institution during study recruitment. Certain demographic differences were expected (age over 60 was an exclusion for CLOSURE I), but vascular risks were considerably greater in the off-label group and may be important mechanistically. Large shunts were considerably more common in off-label patients, suggesting that higher-risk patients may have been preferentially closed off-label. These results suggest that the results of CLOSURE I may not apply to all patients with initial cryptogenic stroke.