Catheter-based Patent Foramen Ovale Closure Research Articles

Screening and Risk Stratification Strategy Reduced Decompression Sickness Occurrence in Divers With Patent Foramen Ovale

ObjectivesThis paper sought to evaluate the occurrence of decompression sickness (DCS) after the application of a patent foramen ovale (PFO) screening and risk stratification strategy. BackgroundPFO is associated with an increased risk of DCS. Recently, transcatheter closure was reported to reduce DCS occurrence in divers with a high-grade shunt. However, to date, there are no data regarding the effectiveness of any PFO screening and risk stratification strategy for divers. MethodsA total of 829 consecutive divers (age 35.4 ± 10.0 years, 81.5% men) were screened for PFO by means of transcranial color-coded sonography in the DIVE-PFO (Decompression Illness Prevention in Divers with a Patent Foramen Ovale) registry. Divers with a high-grade PFO were offered either catheter-based PFO closure (the closure group) or advised conservative diving (high grades). Divers with a low-grade shunt were advised conservative diving (low grades), whereas those with no PFO continued unrestricted diving (controls). A telephone follow-up was performed. To study the effect of the screening and risk stratification strategy, DCS occurrence before enrollment and during the follow-up was compared. ResultsFollow-up was available for 748 (90%) divers. Seven hundred and 2 divers continued diving and were included in the analysis (mean follow-up 6.5 ± 3.5 years). The DCS incidence decreased significantly in all groups, except the controls. During follow-up, there were no DCS events in the closure group; DCS incidence was similar to the controls in the low-grade group (HR: 3.965; 95% CI: 0.558-28.18; P = 0.169) but remained higher in the high-grade group (HR: 26.170; 95% CI: 5.797-118.160; P < 0.0001). ConclusionsThe screening and risk stratification strategy using transcranial color-coded sonography was associated with a decrease in DCS occurrence in divers with PFO. Catheter-based PFO closure was associated with a DCS occurrence similar to the controls; the conservative strategy had a similar effect in the low-grade group, but in the high-grade group the DCS incidence remained higher than in all other groups.

EFFECTIVENESS OF CATHETER-BASED PATENT FORAMEN CLOSURE IN DECOMPRESSION SICKNESS PREVENTION: LONG-TERM FOLLOW-UP

Patent foramen ovale (PFO) is associated with increased risk of decompression sickness (DCS). Catheter-based PFO closure might prevent paradoxical embolization of bubbles and prevent DCS. However, to date the evidence is limited. This study sought to evaluate the effectiveness of catheter-based PFO

New Data Support Patent Foramen Ovale Closure After Stroke.

Patent foramen ovale (PFO) can be found in ≈1 of 4 adults,1 and it has been implicated as a potential source of ischemic stroke, likely via paradoxical embolization.2 The association between stroke and PFO is particularly robust among younger patients with otherwise cryptogenic stroke.3 However, the merit of percutaneous PFO closure for secondary stroke prevention has been the focus of much debate. Although the first 3 randomized trials of PFO closure did not demonstrate benefit in their primary intention-to-treat analyses, newly available data will likely change practice for many clinicians. Percutaneous catheter-based PFO closure was introduced to clinical practice in 1992.4 Subsequently, randomized clinical trials were undertaken to demonstrate efficacy of closure for secondary stroke prevention, yet enrollment was slow because many clinicians and patients were pursuing PFO closure outside the trials. Eventually, in 2012, the CLOSURE I trial5 was published, comparing medical therapy with PFO closure with the NMT Medical STARFlex device in 909 patients with PFO and cryptogenic stroke or transient ischemic attack. Patients randomized to medical therapy were given aspirin, warfarin, or both at the discretion of the enrolling investigator. The 2-year recurrent stroke rate was 2.9% after closure and 3.1% with medical therapy (hazard ratio [HR], 0.90; 95% confidence interval [CI], 0.41–1.98; P =0.79). There was no heterogeneity in the results based on the presence of atrial septal aneurysm or large shunt. Major procedural complications, atrial fibrillation, and serious adverse event rates from this and other described trials are reported in the Table. View this table: Table. Safety of Patent Foramen Ovale Closure Across All Randomized Control Trials The PC trial6 (Randomized Clinical Trial Comparing the Efficacy …

Effect of conservative dive profiles on the occurrence of venous and arterial bubbles in divers with a patent foramen ovale: A pilot study

Patent foramen ovale (PFO) is a risk factor for decompression sickness (DCS) in divers due to paradoxical embolization of nitrogen bubbles formed in peripheral blood during decrease of ambient pressure [1]. In our previous study we have demonstrated that catheter-based PFO closure prevented right-to-left shunting of bubbles and might prevent DCS recurrence [2]. However, the question of PFO closure is still debatable [3]. Also, randomized clinical data are lacking in this field. Therefore, the majority of divers are currently not referred for PFO closure, and various conservative dive profiles (CDP) are recommended to prevent unprovoked DCS (i.e., without violation of decompression regimen) [4].

TCTAP A-119 Catheter-based Patent Foramen Ovale Closure Eliminated Post-dive Arterial Bubbles in Scuba Divers

TCTAP A-119 Catheter-based Patent Foramen Ovale Closure Eliminated Post-dive Arterial Bubbles in Scuba Divers

Effect of Catheter-Based Patent Foramen Ovale Closure on the Occurrence of Arterial Bubbles in Scuba Divers

This study sought to evaluate the effect of catheter-based patent foramen ovale (PFO) closure on the occurrence of arterial bubbles after simulated dives. PFO is a risk factor of decompression sickness in divers due to paradoxical embolization of bubbles. To date, the effectiveness of catheter-based PFO closure in the reduction of arterial bubbles has not been demonstrated. A total of 47 divers (age 35.4 ± 8.6 years, 81% men) with a PFO (PFO group) or treated with a catheter-based PFO closure (closure group) were enrolled in this case-controlled observational trial. All divers were examined after a simulated dive in a hyperbaric chamber: 34 divers (19 in the PFO group, 15 in the closure group) performed a dive to 18 m for 80 min, and 13 divers (8 in the PFO group, 5 in the closure group) performed a dive to 50 m for 20 min. Within 60 min after surfacing, the presence of venous and arterial bubbles was assessed by transthoracic echocardiography and transcranial color-coded sonography, respectively. After the 18-m dive, venous bubbles were detected in 74% of divers in the PFO group versus 80% in the closure group (p = 1.0), and arterial bubbles were detected in 32% versus 0%, respectively (p = 0.02). After the 50-m dive, venous bubbles were detected in 88% versus 100%, respectively (p = 1.0), and arterial bubbles were detected in 88% versus 0%, respectively (p < 0.01). No difference was observed in the occurrence of venous bubbles between the PFO and closure groups, but the catheter-based PFO closure led to complete elimination of arterial bubbles after simulated dives. (Nitrogen Bubble Detection After Simulated Dives in Divers With PFO and After PFO Closure; NCT01854281).

Impact of social characteristics on the treatment of patients with ischaemic events and patent foramen ovale

Objective Percutaneous closure of a patent foramen ovale (PFO) is a technically simple and safe procedure. PFO is a common finding present in up to one third of the population. Although several conditions such as stroke, migraine, and sleep apnoea have been associated with a PFO, as underlined by observational studies, no causal relationship has been documented so far. As this setting may potentially leave more space for the involved physicians for the choice of treatment, we hypothesized that social characteristics of the patient with a PFO might play a role.Methods We retrospectively analysed the data of 153 patients with a cerebrovascular and/or peripheral ischaemic event with the diagnosis of a PFO as documented in echocardiography from 2000 until 2005 at the University Hospital in Zurich, Switzerland.Results Forty-four patients (= 23%) underwent catheter-based PFO closure. There was no significant difference with respect to age (< 40 years: P=0.094, ns; 40-59 years: P=0.923, ns; > 60 years: P=0.234, ns), gender (P=0.356, ns) and insurance status (< 40 years: P = 0.15, ns; 40-59 years: P=0.37, ns; > 60 years: P=0.26, ns) between those who underwent percutaneous PFO closure and those who did not.Conclusion We conclude from this single-centre experience that social characteristics of patients only have a marginal impact on the indication of percutaneous closure of a PFO, if at all.

Incomplete Aneurysm Coverage after Patent Foramen Ovale Closure in Patients with Huge Atrial Septal Aneurysm: Effects on Left Atrial Functional Remodeling

Large devices are often implanted to treat patent foramen ovale (PFO) and atrial septal aneurysm (ASA) with increase risk of erosion and thrombosis. Our study is aimed to assess the impact on left atrium functional remodeling and clinical outcomes of partial coverage of the approach using moderately small Amplatzer ASD Cribriform Occluder in patients with large PFO and ASA. We prospectively enrolled 30 consecutive patients with previous stroke (mean age 36 +/- 9.5 years, 19 females), significant PFO, and large ASA referred to our center for catheter-based PFO closure. Left atrium (LA) passive and active emptying, LA conduit function, and LA ejection fraction were computed before and after 6 months from the procedure by echocardiography. The preclosure values were compared to values of a normal healthy population of sex and heart rate matched 30 patients. Preclosure values demonstrated significantly greater reservoir function as well as passive and active emptying, with significantly reduced conduit function and LA ejection fraction, when compared normal healthy subjects. All patients underwent successful transcatheter closure (25 mm device in 15 patients, 30 mm device in 6 patients, mean ratio device/diameter of the interatrial septum = 0.74). Incomplete ASA coverage in both orthogonal views was observed in 21 patients. Compared to patients with complete coverage, there were no differences in LA functional parameters and occlusion rates. This study confirmed that large ASAs are associated with LA dysfunction. The use of relatively small Amplatzer ASD Cribriform Occluder devices is probably effective enough to promote functional remodeling of the left atrium.

Late Complications of Transcatheter Closure of Patent Foramen Ovale: New Technology and New Outcomes

As a method to prevent recurrent paradoxical embolism and therefore cryptogenic stroke, catheter-based patent foramen ovale closure was first reported in 1992. Since then numerous different devices have been designed to prevent paradoxical embolism. The development of new devices has risen pretty rapidly. Currently, no device can be regarded as the gold standard. Prospective randomized trials comparing interventionalpatent foramen ovale closure with medical treatment are still lacking. The primary aim is to create a device which is easy to implant and able to prevent paradoxical embolism. Additional goals are to minimize early and late complications, such as thrombembolism, erosion of adjacent structures, thrombus formation or atrial arrhythmia. This review gives an overview of the data and the current literature regarding long-term complications (follow-up > or = 1 month) after patent foramen ovale closure with current devices and presents the initial, midterm and late results after patent foramen ovale closure with newer devices.

Suture‐mediated closure of a patent foramen ovale during surgery without cardiopulmonary bypass

A patent foramen ovale (PFO) is associated with an increased risk of recurrent ischemic strokes and transient ischemic attacks due to paradoxical emboli in patients with prior neurological events. We report a case of a surgical suture-mediated of a PFO closure without cardiopulmonary bypass in a patient with recurrent cerebral ischemic events, who was intolerant of medical therapy, was a poor candidate for catheter-based PFO closure, and presented as a potentially high risk for poor wound healing from traditional surgical closure.

Devices for PFO Closure

Paradoxical embolism via patent foramen ovale (PFO) is now a recognized cause of cryptogenic stroke. Catheter-based PFO closure is becoming more common