Patent Foramen Ovale Closure Using a Bioabsorbable Closure Device

Branden, Ben J Van den; Post, Martijn C.; Plokker, H. W. M.; Berg, Jurriën Ten; Suttorp, Maarten J.

doi:10.1016/j.jcin.2010.06.012

Cited by 27 publications

(17 citation statements)

References 25 publications

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“…Their reported residual shunting is significantly higher than what is reported in the literature and may be secondary to the utilization of the BioSTAR (NMT Medical Inc.) PFO closure device which has been associated with increased residual shunting after PFO closure and is no longer manufactured. 33,34 More cases of PFO closure in OSA patients would need to be studied to better evaluate this intriguing association.…”

Section: Discussionmentioning

confidence: 99%

Sleep Apnea in Patients with and without a Right-to-Left Shunt

Mojadidi

Bokhoor

Gevorgyan

et al. 2015

Journal of Clinical Sleep Medicine

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BRIEF SUMMARYCurrent Knowledge/Study Rationale: Right-to-left shunt (RLS) occurs more frequently in patients with sleep apnea, and may be involved in the pathophysiology of sleep apnea. In this observational study, we determined the prevalence of RLS among patients with sleep apnea and compared clinical characteristics and the results of sleep studies of patients with and without RLS. Study Impact: Patients with OSA and RLS have hypoxemia out of proportion to the observed respiratory disturbance, highlighting the likely role of RLS in the resultant nocturnal desaturation. Such observational studies support the hypothesis that the presence of a RLS from a PFO may exacerbate sleep apnea symptoms Objectives: To assess the presence of right-to-left shunting (RLS) in patients with obstructive sleep apnea (OSA), and compare clinical characteristics and parameters of the sleep studies of patients with and without RLS. Background: The most common cause of RLS is due to intermittent fl ow through a patent foramen ovale (PFO). PFO occurs more frequently in patients with OSA and may be involved in the exacerbation of OSA. Methods: Patients with an abnormal polysomnogram seen at UCLA-Santa Monica Sleep Medicine Clinic were enrolled. A diagnosis of RLS was made using a transcranial Doppler (TCD) bubble study. Gender and age-matched controls were drawn from patients referred for cardiac catheterization who underwent a TCD. The frequency of RLS in OSA patients and the controls was evaluated. Clinical characteristics and polysomnogram parameters were compared between OSA patients with and without a RLS. Results: A total of 100 OSA patients and 200 controls participated in the study. The prevalence of RLS was higher in patients with OSA compared to the control group (42% versus 19%; p < 0.0001). Patients with OSA and a RLS had a lower apnea-hypopnea index (AHI), less obstructive apnea, and fewer hypopnea episodes than patients with OSA without a RLS. The baseline and nadir SpO 2 were similar in both groups and did not correlate with the level of RLS assessed by TCD. The degree of desaturation for a given respiratory disturbance, as measured by oxygen desaturation index (ODI)/AHI ratio, was higher in OSA patients with RLS versus OSA patients without RLS (0.85 ± 0.07 versus 0.68 ± 0.04; p < 0.0001). Conclusion: RLS, most commonly due to a PFO, occurs 2.2 times more frequently in OSA patients compared to a control population that was matched for age and gender. The severity of sleep apnea is not greater in OSA patients who have a PFO. However, patients with OSA and a PFO are more likely to become symptomatic at a younger age with an equivalent decrease in nocturnal SpO 2 , and have greater arterial desaturation in proportion to the frequency of respiratory disturbances. Keywords: sleep apnea, patent foramen ovale, right-to-left shunt Citation: Mojadidi MK, Bokhoor PI, Gevorgyan R, Noureddin N, MacLellan WC, Wen E, Aysola R, Tobis JM. Sleep apnea in patients with and without a right-to-left shunt. J Clin Sleep Med 2015;11(11):1299 -...

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Section: Discussionmentioning

confidence: 99%

Sleep Apnea in Patients with and without a Right-to-Left Shunt

Mojadidi

Bokhoor

Gevorgyan

et al. 2015

Journal of Clinical Sleep Medicine

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“…The BioSTAR septal repair implant (NMT Medical, Boston) is a bioabsorbable device, instead of the polyester fiber membrane of occluder; the device is made of a cellular porcine intestinal type I collagen layer. As compared with nondegradable polyester fiber membrane occluder device, BioSTAR can be absorbed and replaced by host tissue in vivo and has the advantage of reducing thrombogenicity and improving biocompatibility [9–12]. But the device cannot be completely degraded because the BioSTAR possesses the traditional stainless steel framework.…”

Section: Discussionmentioning

confidence: 99%

Animal Experimental Study of the Fully Biodegradable Atrial Septal Defect (ASD) Occluder

Zhu

Huang

Cao

et al. 2012

Journal of Biomedicine and Biotechnology

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This study was conducted to evaluate the feasibility, safety, biocompatibility, and degradation features of a fully biodegradable occluder for closure of atrial septal defect (ASD) in an acute canine model. The ASD was created in 20 healthy mongrel dogs by the brockenbrough needle, and the fully biodegradable occluders were implanted by self-made delivery system. The success rate and complications were observed. Acute ASD models were successfully created in 18 dogs, and 16 occluders were successfully implanted in the ASD models. Animals were sacrificed at different times after procedure. The cardiac gross anatomy showed that all occluders were stable in the interatrial septum, no vegetation or thrombus formation was observed on the surface of all occluders. They were embedded into endogenous host tissue gradually at 12-week follow-up. Different periods of pathological observations suggested that the occluders degraded gradually over about 24 weeks and essentially became an integral part of the septum. Transcatheter closure of ASD in acute canine model using the fully biodegradable ASD occluder has the potential of a high successful rate of technique, excellent biocompatibility, and fewer complications with adequate, immediate, and short-term results.

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“…It was noted that 90% to 95% of the device was absorbed in healthy native tissue 91. Although the device is associated with a low complication and embolic event rate, there was a high percentage of residual mild to moderate shunting after 6 months (23.7%) 92. In 2015, Sievert et al published a study on the effectiveness and safety of the Carag Bioresorbable Septal Occluder.…”

Section: Future Directionsmentioning

confidence: 99%