Transcatheter closure of patent foramen ovale in older adults

Kiblawi, Fuad; Sommer, Robert J.; Levchuck, S.

doi:10.1002/ccd.20722

Cited by 65 publications

(44 citation statements)

References 99 publications

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“…Some patients may benefit from closure, but a potential for short-term deterioration exists in a minority of patients. 25 Larger randomized controlled studies that are ongoing will help further define the risk-to-benefit ratio.…”

Section: Discussionmentioning

confidence: 99%

Migraine Intervention With STARFlex Technology (MIST) Trial

Dowson¹,

Mullen²,

Peatfield³

et al. 2008

Circulation

511

145

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Background-Patent foramen ovale (PFO) is prevalent in patients with migraine with aura. Observational studies show that PFO closure resulted in migraine cessation or improvement in Ϸ80% of such patients. We investigated the effects of PFO closure for migraine in a randomized, double-blind, sham-controlled trial. Methods and Results-Patients who suffered from migraine with aura, experienced frequent migraine attacks, had previously failed Ն2 classes of prophylactic treatments, and had moderate or large right-to-left shunts consistent with the presence of a PFO were randomized to transcatheter PFO closure with the STARFlex implant or to a sham procedure. Patients were followed up for 6 months. The primary efficacy end point was cessation of migraine headache 91 to 180 days after the procedure. In total, 163 of 432 patients (38%) had right-to-left shunts consistent with a moderate or large PFO. One hundred forty-seven patients were randomized. No significant difference was observed in the primary end point of migraine headache cessation between implant and sham groups (3 of 74 versus 3 of 73, respectively; Pϭ0.51). Secondary end points also were not achieved. On exploratory analysis, excluding 2 outliers, the implant group demonstrated a greater reduction in total migraine headache days (Pϭ0.027). As expected, the implant arm experienced more procedural serious adverse events. All events were transient. Conclusions-This trial confirmed the high prevalence of right-to-left shunts in patients with migraine with aura. Although no significant effect was found for primary or secondary end points, the exploratory analysis supports further investigation. The robust design of this study has served as the model for larger trials that are currently underway in the

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Section: Discussionmentioning

confidence: 99%

Migraine Intervention With STARFlex Technology (MIST) Trial

Dowson¹,

Mullen²,

Peatfield³

et al. 2008

Circulation

511

145

View full text Add to dashboard Cite

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“…These patients tended to be older, with an average age of 50 years, and 3 had an atrial septal aneurysm, both of which are factors known to predispose to arrhythmia. 10,24 The 30-day postimplant TEE was performed in 54 (96%) of 56 patients. In all patients, the device was noted to be well positioned, with a low profile on the atrial septum.…”

Section: Resultsmentioning

confidence: 99%

“…This rate is consistent with previous studies. 8,10,11 On completion of the study, all symptoms had resolved in these patients, and only 1 was still taking antiarrhythmic medication. The patients who developed arrhythmia in the present study were on average 50 years old, and 3 had atrial septal aneurysms, which are more common in older patients and when an aneurysmal septum is present.…”

Section: Discussionmentioning

confidence: 96%

“…The patients who developed arrhythmia in the present study were on average 50 years old, and 3 had atrial septal aneurysms, which are more common in older patients and when an aneurysmal septum is present. 10,24 Thromboembolic events are a recognized complication of all currently used devices. 15 The BioSTAR implants used in the present study had a heparin coating.…”

Section: Discussionmentioning

confidence: 99%

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BioSTAR Evaluation STudy (BEST)

Mullen

Hildick‐Smith²,

Giovanni³

et al. 2006

Circulation

131

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Background-The use of permanent synthetic implants to close atrial septal defects (ASD) and patent foramen ovale (PFO) has a number of limitations, including late complications and the limiting of transeptal access to the left heart should it be required for the later treatment of acquired heart disease. BioSTAR is a novel, bioabsorbable, atrial septal repair implant. This phase I pilot study evaluates the feasibility, safety, and effectiveness of BioSTAR for the first time in humans. Methods and Results-We conducted a prospective, open-label, multicenter clinical study in 58 patients aged 28 to 68 years who had a clinically significant ASD or PFO. Percutaneous shunt closure was undertaken with the BioSTAR septal repair implant. Successful device implantation was achieved in 57 (98%) of 58 patients. Closure at 30 days and 6 months, assessed by contrast transthoracic echocardiography, was 48 (92%) of 52 and 54 (96%) of 56, respectively. There was no evidence of a clinically significant response to the device. Transient atrial arrhythmia occurred in 5 patients after implantation. No major safety issues were observed. Conclusions-This study demonstrates the feasibility, safety, and effectiveness of BioSTAR for the closure of ASD and PFO in humans with a high rate of early and complete shunt closure. BioSTAR is a novel septal repair implant designed to provide biological closure of atrial-level defects using the patient's natural healing response. Because 90% to 95% of the implant is absorbed and replaced with healthy native tissue, future access to the left atrium may be achieved.

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“…From a series of 456 patients who received PFO closure, the rate of episodes of new-onset, clinically detected atrial arrhythmia requiring therapy was 19% overall. 43 Atrial fibrillation has been reported in up to 8% of patients in the immediate postprocedure period. 36 Unfortunately, atrial tachycardias may not be restricted to the immediate periprocedural period.…”

Section: Percutaneous Pfo Closurementioning

confidence: 99%