Foramen Ovale Closure Research Articles

Transcatheter closure of the patent foramen ovale in children: intermediate-term follow-up results.

The patent foramen ovale is almost a normal anatomical hole between the atria with ~30% incidence in the general population. It has been suggested that the patent foramen ovale is the cause of some neurological events, which is explained by paradoxical embolism. Transcatheter closure of the patent foramen ovale is a common procedure in adult patients with cerebral ischaemic events, but there are limited data investigating the results in children. Between January, 2005 and February, 2014, 17 patients' patent foramen ovales were closed by the transcatheter approach in our department. The indications for closure were transient ischaemic attack in 10 patients, stroke in four patients, and migraine in three patients. The mean age and mean weight at the time of the procedure were 11.1±3.7 years and 42.1±15.4 kg, respectively. We asked our patients whether their previous ailments continued. All patients responded to the study survey. In 15 patients, ailments did not continue after patent foramen ovale closure and they significantly decreased in two of them. We suggest that under the right conditions device closure of the patent foramen ovale is a safe solution for these cryptogenic ischaemic events and migraine.

United Kingdom: coronary and structural heart interventions from 2010 to 2015.

In the United Kingdom, a clinical data set is completed for every patient undergoing coronary intervention and certain structural interventions, and sent to central servers in the National Institute for Cardiovascular Outcomes Research (NICOR) on behalf of the British Cardiovascular Intervention Society (BCIS). These data are linked to the national mortality register. In addition, data are obtained about the structure of healthcare provision using an annual survey. Analyses of these data are provided for different audiences in several formats. Public reports of individual consultant operator activity and risk-adjusted outcomes from percutaneous coronary intervention (PCI) have also been produced annually since 2012. Transcatheter aortic valve implantation (TAVI) has been performed since 2007. Over 2,000 cases were performed in 2015, giving a rate of 30 per million population. Complications to discharge have fallen as case mix has changed and technologies improved. While the mean age has remained about 81 years, the logistic EuroSCORE of patients treated by TAVI has fallen from about 22 in 2010 to 18 in 2015. Tracked 30-day mortality was 3.7% in 2014. Left atrial appendage occlusion and patent foramen ovale (PFO) closure for stroke, and the use of the MitraClip® system (Abbott Vascular, Santa Clara, CA, USA) for mitral regurgitation have been funded through a process called "commissioning through evaluation".

TCTAP A-076 Transcatheter Closure of Patent Foramen Ovale: Clinical Efficacy for Prevention of Recurrent Cryptogenic Stroke or Migraine Headache

Transcatheter closure of patent foramen ovale (PFO) for prevention of recurrent cryptogenic cerebrovascular events (CVE) has not been officially approved in Japan. However, previous studies suggested that >10000 patients/year are suffered from a cryptogenic stroke due to PFO in Japan. Additionally,

TCTAP C-167 Young Paradoxical Stroke Treated Successfully with Mechanical Thrombectomy Using Solitaire Device and Transcatheter Closure of Patent Foramen Ovale with Cardio-O-Fix Occluder

### Patient initials or identifier number 475813 ### Relevant clinical history and physical exam A 27-year-old woman was admitted to department of neurology with left-sided limb weakness of 8 hours duration. There was no history of atherosclerosis risk factors such as hypertension, diabetes,

Abstract WP419: Long-term Risk of Complications after Endovascular Closure of Patent Foramen Ovale

Background: The long-term safety of patent foramen ovale (PFO) closure following stroke or transient ischemic attack (TIA) is uncertain. We sought to evaluate the long-term risk of complications following endovascular PFO closure in a large, heterogeneous group of patients with cerebrovascular disease. Methods: We performed a retrospective cohort study using administrative claims data on all acute care hospitalizations from 2005-2011 in California, 2006-2013 in New York, and 2005-2013 in Florida. Using ICD-9-CM codes, we identified patients without other forms of congenital heart disease who underwent endovascular PFO closure within 1 year of a stroke or TIA. The primary outcome was a serious complication, defined as in prior studies as atrial fibrillation, cardiac tamponade, pneumothorax, hemothorax, a vascular access complication, or death. Kaplan-Meier survival analysis was used to calculate the cumulative rate of complications. In a secondary analysis, we included other serious complications described in previous randomized trials of PFO closure after stroke: venous thromboembolism, ventricular arrhythmia, infective endocarditis, and sepsis. Results: We identified 1,887 patients who underwent PFO closure after stroke or TIA, among whom the mean age at the time of closure was 54.2 (±14.3) years. By 7 years, the cumulative rate of any complication or death was 18.3% (95% confidence interval [CI], 15.9-21.0%). The mortality rate was 3.4% (95% CI, 2.5-4.6%). Atrial fibrillation was the most common complication, occurring in 8.3% (95% CI, 7.1-9.5%) of patients. The rate of any complication during the index hospitalization for PFO closure was 7% (95% CI, 5.8-8.1%). When venous thromboembolism, ventricular arrhythmia, infective endocarditis, and sepsis were included, the cumulative rate of any complication or death throughout follow-up was 21.4% (95% CI, 19.0-24.0%). Conclusions: Approximately 1 in 5 patients who undergo PFO closure after stroke or TIA experience a serious complication or death within 7 years.

Abstract 72: Procedural and Long Term Safety of PFO Closure in Cryptogenic Stroke: Insights from the RESPECT Trial

Background: Complications of percutaneous patent foramen ovale (PFO) closure using the Amplatzer TM PFO Occluder were reported in 2012 after a median follow-up of 2.1 years. The FDA requested an analysis of long-term device safety observed in the Randomized Evaluation of Recurrent Stroke Comparing PFO Closure to Established Current Standard of Care Treatment (RESPECT) trial. Methods: We randomized patients with cryptogenic stroke and PFO in a 1:1 ratio between PFO closure and medical management alone (MM). Post procedure medical management in the closure arm was 30 days of aspirin and clopidogrel followed by 5 months of aspirin alone and continued medical therapy as per the site neurologist. Medical treatment in the MM arm was a guideline-directed antiplatelet regimen or warfarin. An independent data and safety monitoring board adjudicated all adverse events as serious (SAE) or non-serious, and as procedure, device or protocol related. Results: We enrolled 980 patients (mean age, 45.9 years) at 69 sites who were followed for a median of 5.9 years (IQR 4.2-8.0). Follow-up was unequal – 3141 patient-years in the closure arm vs. 2669 in the MM arm, due to a higher dropout rate in the MM arm. There was less warfarin use in the closure arm vs. the MM arm (109 vs 578 patient-years). There were no study-related deaths. Two patients had procedure-related ischemic strokes (7 days and 3 months post-procedure). SAEs were equally distributed between the two arms: 13.7 in the closure arm vs. 12.4 per 100 patient-years in the MM arm, p=0.17. There was no device thrombus or erosion. The incidence of post procedure AF was not increased in the closure arm. Venous thromboembolic events (VTE) occurred at a higher rate in the closure arm, 0.87 per 100 patient-years vs. 0.22 in the MM arm, p=0.0008. In univariable logistic regression modeling, a remote history of DVT prior to randomization was a significant predictor of VTEs in the closure arm. No VTEs occurring beyond 6 months were attributed to the procedure or the device. Conclusions: These new long-term data reaffirm that the Amplatzer TM PFO Occluder has a low rate of procedure (2.4%) and device (2%) related SAE’s. A small subset of cryptogenic stroke patients have an underlying proclivity to VTE and may need long-term anticoagulation.

Abstract TP215: Clinical Utility of Hypercoagulability Screening in Young Adults With Ischemic Stroke

Introduction: We aimed to evaluate the ability of current genetic and serological testing to diagnose clinically relevant thrombophilic states in young adults with ischemic stroke. Methods: We performed a retrospective cohort study of patients aged 18 to 65 years who presented to Weill Cornell Medical Center between 2011 and 2014 with an ischemic stroke and had laboratory testing for a hypercoagulable state within six months of the index stroke. A hypercoagulable state was diagnosed by the criteria listed in Table 1. The primary outcome was any positive thrombophilia test. The secondary outcome was a change in clinical management based on the thrombophilia testing, defined as a change in antithrombotic selection or patent foramen ovale (PFO) closure. Using Fisher’s exact or Mann-Whitney U tests, we assessed whether the following prespecified risk factors were associated with our outcomes: age, sex, prior venous thromboembolism, family history of stroke, stroke subtype, and presence of PFO. Results: Of 146 ischemic stroke patients who met inclusion criteria, the mean age was 47 (±10) years and 47% were women. Of these patients, 61 (42.0%, 95% CI 33.7-49.9%) had at least one positive thrombophilia test and 8 (5.5%, 95% CI 1.7-9.2%) had a resultant change in management. A cryptogenic stroke subtype was documented in 87 patients, of whom 40 (46.0%, 95% CI 35.3-56.7%) had an abnormal hypercoagulability screen and 5 (5.7%, 95% CI 0.8-10.7%) had a change in management. There was no association between cryptogenic stroke subtype and a positive hypercoagulability test (p=0.2). No prespecified risk factors were associated with a positive hypercoagulability screen or a change in clinical management. Conclusions: Hypercoagulability screening among young patients with cryptogenic stroke changed clinical management in roughly one of every twenty patients tested. Cryptogenic stroke subtype and other clinical factors were not associated with a positive hypercoagulable screen.

Abstract 168: Differences in Description of Patent Foramen Ovale Influence Choice of Treatment

Background: Clinical trials of patent foramen ovale (PFO) closure for stroke prevention have produced controversial results. We investigated differences in presenting the net benefits of PFO closure or description of the PFO in a randomized vignette-based internet survey. Methods: Adults aged 18 to 60 inclusive were recruited via Amazon’s Mechanical Turk. Participants read a vignette asking them to imagine that they had a minor stroke. The vignettes included three randomized factors in a 2 x 2 x 3 factorial design: a) benefit of PFO closure (no proven benefit versus ~3% absolute risk reduction, analogous to difference in individual trials versus subsequent meta-analysis); b) normalization intervention (PFO described as very common and benign for most individuals versus no such description); and c) labeling of the PFO (?PFO? versus ?hole in the heart? versus ?difference in heart structure?). Participants were then asked their choice of treatment (PFO closure or aspirin). Secondary outcomes included self-perceived stroke risk and level of anxiety about the PFO diagnosis. Regression analysis was used to assess predictors of treatment choice (logistic) and secondary outcomes (linear). Results: 2157 participants completed the survey (54.6% female, 76.2% non-Hispanic white, median age 32 with IQR 27 – 41). Participants shown data suggesting 3% absolute risk reduction for PFO closure were more likely to choose PFO closure (30.9% vs. 7.5%, p < 0.001). The normalization intervention decreased anxiety about the PFO. The labeling intervention increased self-perceived stroke risk and had differential effects on patient anxiety (see Table for details). Conclusion: Differences in how information is presented can influence choice of treatment, perceived stroke risk, and level of anxiety surrounding PFO-associated stroke. Future work should address the impact of information presentation on potential variability in use of PFO closure and patient psychological outcomes.

Closure of patent foramen ovale: do meta-analyses do justice?

Closure of patent foramen ovale: do meta-analyses do justice?

Percutaneous Closure of Patent Foramen Ovale–Single Centre Experience, Waikato Hospital

Percutaneous Closure of Patent Foramen Ovale–Single Centre Experience, Waikato Hospital

Role of closure of patent foramen ovale in cryptogenic stroke: Current status.

Ischaemic stroke is among the leading causes of disability and death. Despite extensive vascular, cardiac and serological evaluations, the cause remains unknown in 20%-40% of patients. These are classified as cryptogenic stroke. Paradoxical embolism is one of the many causes of cryptogenic stroke. The term paradoxical embolism is used to describe an embolus of venous origin entering the systemic circulation through a patent foramen ovale (PFO), atrial septal defect (ASD), ventricular septal defect or extracardiac communication such as pulmonary arteriovenous malformation. PFO is present in about 25% of the population. PFO is seen more commonly in patients with cryptogenic stroke. Secondary prevention of stroke in such patients includes the prevention of formation of a thrombus with antiplatelets, vitamin K antagonists or closure of the PFO by either surgery or the percutaneous route. Percutaneous closure using devices has been shown to be safe and beneficial in preventing secondary stroke. Data from randomized trials have shown device closure to be superior to medical management in the secondary prevention of cryptogenic stroke due to PFO.

Long-Term Outcome Following Patent Foramen Ovale (PFO) Closure

Long-Term Outcome Following Patent Foramen Ovale (PFO) Closure

TCT-28 Occlutech Percutaneous PFO Closure: Safety and Efficacy Registry (OPPOSE)

Safety and efficacy data on patent foramen ovale (PFO) closure with the Occlutech Figulla Flex II device are lacking. We undertook a fully monitored prospective Registry on PFO closure using this device. 100 patients undergoing PFO closure were prospectively enrolled into the OPPOSE Registry at 6

Hypertension Editors' Picks: Hypertension and Sleep.

Hypertension Editors' Picks: Hypertension and Sleep.

Patent foramen ovale: indications for closure and techniques.

Non-surgical closure of the patent foramen ovale (PFO) has been possible for 40 years and proved safe in probably a million cases performed worldwide. Nonetheless, indications are still restricted as only a few are supported by randomised data. Paradoxical embolism through a PFO causes stroke, myocardial infarction, and visceral or peripheral ischaemia. The PFO is a likely mediator of migraine, diving or high altitude sickness, dyspnoea, and sleep apnoea problems. As untoward effects of a PFO are rare and spaced widely timewise, large cohorts and long follow-ups are required to prove unequivocally that PFO closure is bene-ficial and appropriate in comparison to no treatment or medical therapy. The most compelling respective randomised data have been gathered so far in the realm of secondary prevention of cerebral attacks and migraine. Invariably they showed a numerical advantage of PFO closure with significant difference in sub-analyses. Evidence-based medicine carries a danger of underutilising valuable therapies while accumulating further data. PFO closure is an example. Its documented innocuousness invites a more proactive reflection in upcoming guidelines. At worst, PFO closure may not convey the projected amount of benefit. This even opens the door for primary prevention in some PFOs with high-risk characteristics.

HEMODYNAMIC CONSEQUENCES OF A RESTRICTIVE DUCTUS ARTERIOSUS AND FORAMEN OVALE IN FETAL TRANSPOSITION OF THE GREAT ARTERIES

Newborns with D-transposition of the great arteries (D-TGA) are at risk of compromise at delivery due to foramen ovale (FO) closure and pulmonary vascular abnormalities. We describe the in-utero hemodynamic changes that led to FO closure and aortopulmonary (AP) collateral formation. A fetus with D-

Abstract WP422: Mechanisms of Recurrent Ischemic Stroke Under Medical versus Device Therapy: Long Term Follow-up in the RESPECT PFO Trial

Introduction: The RESPECT trial evaluated the superiority of patent foramen ovale (PFO) closure over standard-of-care medical management (MM) in patients with PFO and cryptogenic stroke (CS). Hypothesis: Analysis of stroke mechanisms and topography of recurrent events will provide insight into the clinical efficacy of PFO closure. Methods: RESPECT is a prospective, multicenter, randomized event-driven trial of PFO closure vs. MM in patients with CS and PFO. Patients were randomized to treatment in a 1:1 ratio. The primary results were analyzed and reported when the target of 25 events were adjudicated (NEJM 2013; 368:1092-100). At that time, mean follow-up was 2.6 years, range 0-8.1 years. Prospective follow-up has continued. Recurrent strokes were assigned phenotypes using the ASCOD system by investigators blinded to treatment assignment. Results: 980 subjects were randomized to PFO closure (n=499) or MM (n=481). The primary analysis in the intention-to-treat population after a mean follow-up of 2.6 years exhibited a hazard ratio of 0.49 favoring closure that did not reach statistical significance (p=0.08). The per-protocol cohort demonstrated a significant reduction in the primary endpoint in favor of closure (HR 0.37, p=0.03). Among the initial 25 recurrent ischemic strokes, MM patients more often had superficial or multiple-penetrator territory infarcts (12 vs 4) and infarcts of larger size (69% vs 14%, p=0.06). Since the primary results report, follow-up has continued for an additional 3.5 years and additional recurrent infarcts have been observed. Long-term stroke rates, phenotyping, and topography will be presented. Conclusions: Our prior reports suggest that PFO closure was associated with prevention of stroke subtypes particularly associated with PFO, including superficial and larger infarcts. Long-term safety, efficacy, and stroke mechanisms, with >4000 patient-years of follow-up will be presented.

Percutaneous closure of patent foramen ovale: long-term follow-up shows benefit

Long-term follow-up solidifies the biological impact of PFO closure so that it may become the first line therapy for the prevention of paradoxical embolism in patients with cryptogenic stroke.

Randomized trials of closure of persistent foramen ovale (PFO) vs medical therapy for patients with cryptogenic stroke — Effect of lost-to-follow-up and withdrawal of consent

Randomized trials of closure of persistent foramen ovale (PFO) vs medical therapy for patients with cryptogenic stroke — Effect of lost-to-follow-up and withdrawal of consent

Influence of hospital volume and outcomes of adult structural heart procedures.

Hospital volume is regarded amongst many in the medical community as an important quality metric. This is especially true in more complicated and less commonly performed procedures such as structural heart disease interventions. Seminal work on hospital volume relationships was done by Luft et al more than 4 decades ago, when they demonstrated that hospitals performing > 200 surgical procedures a year had 25%-41% lower mortality than those performing fewer procedures. Numerous volume-outcome studies have since been done for varied surgical procedures. An old adage "practice makes perfect" indicating superior operator and institutional experience at higher volume hospitals is believed to primarily contribute to the volume outcome relationship. Compelling evidence from a slew of recent publications has also highlighted the role of hospital volume in predicting superior post-procedural outcomes following structural heart disease interventions. These included transcatheter aortic valve repair, transcatheter mitral valve repair, septal ablation and septal myectomy for hypertrophic obstructive cardiomyopathy, left atrial appendage closure and atrial septal defect/patent foramen ovale closure. This is especially important since these structural heart interventions are relatively complex with evolving technology and a steep learning curve. The benefit was demonstrated both in lower mortality and complications as well as better economics in terms of lower length of stay and hospitalization costs seen at high volume centers. We present an overview of the available literature that underscores the importance of hospital volume in complex structural heart disease interventions.