Premere occlusion system for transcatheter patent foramen ovale closure: Mid‐term results of a single‐center registry

Rigatelli, Gianluca; Cardaioli, Paolo; Dell’Avvocata, Fabio; Giordan, Massimo; Chinaglia, Mauro

doi:10.1002/ccd.22713

Cited by 8 publications

(9 citation statements)

References 20 publications

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“…In the present study we demonstrate that PFO closure using the novel Premere PFO Closure System is safe and effective. Our findings are in line with other large series of percutaneous PFO closure using the Premere device [15][16][17][18].…”

Section: Discussionsupporting

confidence: 92%

“…Consistently, other studies also report a very low immediate interventional event rate. While Buscheck [15] and Rigatelli [18] did not experience any procedural complications likewise, the larger series of Stanczak [17] found an intraprocedural adverse event rate of 1.1% (consisting of two acute coronary syndromes and one device dislocation). Earlier studies involving various occlusion devices reported a major complication rate of 1.5% [19] and 2.5% [20], including death, major hemorrhage, need for surgical intervention, cardiac tamponade and device or air embolization.…”

Section: Discussionmentioning

confidence: 90%

“…Knowing these facts it is very important to know the anatomy of the PFO in each patient, to be able to decide which occluder is the optimal one. In patients with tubular PFO without ASA seems Premere to be the right one [18]. Selecting occlusion devices according to the different anatomical characteristics of a PFO and the interatrial septum appears favorable to further enhance closure rate; however, further specific studies are needed to elucidate the strengths and weaknesses of different PFO occluders with respect to individual anatomical features.…”

Section: Discussionmentioning

confidence: 99%

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Outcome of Percutaneous Patent Foramen Ovale Closure with the Premere Occluder — A Single Center Experience

2013

J Cardiobiol

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Introduction: Percutaneous closure of patent foramen ovale (PFO) has become a widely used procedure in patients with suspected paradoxical embolism. Despite being generally safe and effective, the minimally invasive intervention has been associated with several serious complications such as air embolism, cardiac perforation, device embolization, device thrombus formation and puncture site problems. Unlike the conventionally used devices originally designed for closure of atrial septum defects, the novel Premere PFO Closure System (St. Jude Medical, St. Paul, MN, USA) was exclusively designed for PFO occlusion. We therefore aimed to evaluate the safety and efficacy of the novel Premere PFO Closure System in patients with PFO and a previous transient ischemic attack (TIA) or stroke.Methods: 67 patients (mean age 47 ± 29 years) who underwent PFO closure with the novel Premere device were analyzed retrospectively. Indications for PFO closure were prior stroke (n=42), transient ischemic attack (n=20), or other related clinical events such as peripheral embolism (n=5). PFO was documented in all patients by transthoracic and transesophageal echocardiography. Procedural success was confirmed by fluoroscopy with contrast injection through the guiding catheter. Mid-term safety and efficacy was evaluated by clinical follow-up, including echocardiography (TTE/TEE) scheduled at 6 months after PFO closure.Results: Follow-up data was available in 64 patients (95.5%). Device implantation was successful in all patients without any periprocedural complications. At clinical follow-up after a median of 189 ± 135 days, one patient (1.6%) presented with device thrombus, which resolved under oral anticoagulation without further complications. Another was diagnosed with new onset of atrial fibrillation. One patient each had experienced a recurrent stroke and a transient ischemic attack. While in the former case no residual shunt could be detected, the later was likely related to device malposition. At echocardiographic follow-up, significant residual shunt was noted in 6 patients (9.4%) Conclusion:In our series we demonstrate that percutaneous PFO closure using the dedicated Premere occluder is safe and effective. Type and rate of complications are in line with other studies assessing this closure device.Our study aimed to evaluate the safety and efficacy of the novel Premere PFO Closure System in patients with a previous cryptogenic stroke or transient ischemic attack (TIA), and echocardiographic diagnosis of PFO. Methods Patient populationWe retrospectively analyzed 67 patients (41 male, mean age 49.2

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Section: Discussionsupporting

confidence: 92%

Section: Discussionmentioning

confidence: 90%

Section: Discussionmentioning

confidence: 99%

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Outcome of Percutaneous Patent Foramen Ovale Closure with the Premere Occluder — A Single Center Experience

2013

J Cardiobiol

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“…3 Large atrial septal aneurysms have been associated with an increased risk of paradoxical embolism compared with mild or no aneurysm. 4 The authors underscored that underidentification of PFO in the non-PFO group would have biased the study toward the null. In addition, without a clear grading of right-to-left shunt and knowledge of the presence or absence of atrial septal aneurysm, the association between PFO and risk of perioperative ischemic stroke may be inaccurate.…”

Section: Patent Foramen Ovale and Risk Of Perioperative Strokementioning

confidence: 99%

“…Because PFO may be a modifiable risk factor for postoperative stroke, new studies in selected groups of patients with PFO should be conducted to examine the value of prophylactic interventions such as antithrombotic therapy in the postoperative period. Apart from young patients with migraine who have a high risk of postoperative stroke, 3,4 other potential risk factors of PFO-associated stroke, such as malignancy or prolonged immobilization, should be studied so that adequately powered intervention studies may be designed.…”

Section: Gianlucamentioning

confidence: 99%

Patent Foramen Ovale and Risk of Perioperative Stroke

Rigatelli

Zuin

2018

JAMA

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Funding/Support: Financial support for NHBS was provided by the US Centers for Disease Control and Prevention (CDC) through a cooperative agreement with state and local health departments. Role of the Funder/Sponsor:The CDC was involved in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication. Disclaimer:The findings and conclusions in this letter are those of the authors and do not necessarily represent the views of the CDC.

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Patent Foramen Ovale and Risk of Perioperative Stroke—Reply

Houle

Eikermann

2018

JAMA

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Premere occlusion system for transcatheter patent foramen ovale closure: Mid‐term results of a single‐center registry

Abstract: The mid-term outcomes of our registry suggests that the Premere Occlusion System may be an excellent device for patients with long-channel PFO and absence of moderate/severe ASA, offering a physiological and anatomically respective closure of PFO also in patients with hypertrophic rims.

Cited by 8 publications

References 20 publications

Outcome of Percutaneous Patent Foramen Ovale Closure with the Premere Occluder — A Single Center Experience

Outcome of Percutaneous Patent Foramen Ovale Closure with the Premere Occluder — A Single Center Experience

Patent Foramen Ovale and Risk of Perioperative Stroke

Patent Foramen Ovale and Risk of Perioperative Stroke—Reply

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