cardiovascular-agents and Foramen-Ovale--Patent

Cryptogenic strokes account for about 25% to 40% of total ischemic strokes, and 1 of the 3 of these have a patent foramen ovale (PFO). A meta-analysis concerning the effectiveness and safety of PFO closure in cryptogenic strokes or transient ischemic attacks (TIAs) was performed. We systematically searched Medline, Embase, and the Cochrane Library through April 2018. Eligible studies were randomized clinical trials. Primary and secondary end points were, respectively, stroke or TIA and stroke recurrences. We calculated risk ratios (RRs) and 95% confidence intervals (CIs) for all end points using fixed- and random-effects meta-analyses. Data were included from 6 trials involving 3560 patients. In the pooled analysis, PFO closure was superior to medical treatment for both primary (RR: 0.39; 95% CI: 0.18-0.82; P < .02) and secondary end points (RR: 0.58; 95% CI: 0.44-0.76; P < .001). Transcatheter closure significantly increased the risk of new-onset atrial fibrillation (AF; RR: 5.74; P < .001). Percutaneous closure is superior to medical treatment in reducing stroke and TIA recurrence, even if with a significant risk increasing for new-onset AF. These findings suggest that transcatheter closure is indicated in patients with cryptogenic strokes and large PFO.

Topics: Adult; Age Factors; Atrial Fibrillation; Cardiac Catheterization; Cardiovascular Agents; Female; Foramen Ovale, Patent; Humans; Ischemic Attack, Transient; Male; Middle Aged; Randomized Controlled Trials as Topic; Recurrence; Risk Factors; Secondary Prevention; Sex Factors; Stroke; Time Factors; Treatment Outcome

The ideal treatment strategy for patients with cryptogenic stroke and patent foramen ovale (PFO) is not yet clear. Previous randomized controlled trials (RCTs) comparing transcatheter PFO closure with medical therapy in patients with cryptogenic stroke to prevent recurrent ischemic stroke showed mixed results. This meta-analysis aims to compare rates of recurrent stroke, transient ischemic attack (TIA) and all-cause mortality with PFO closure and medical therapy vs. medical therapy alone.. PubMed and the Cochrane Center Register of Controlled Trials were searched for studies published through June 2018, comparing PFO closure plus medical therapy versus medical therapy alone. Six RCTs (n = 3750) comparing PFO closure with medical therapy were included in the analysis. End points were recurrent stroke, TIA and all-cause mortality. The odds ratios (OR) with 95% confidence interval (CI) were computed and p < 0.05 was considered as a level of significance.. A total of 1889 patients were assigned to PFO closure plus medical therapy and 1861 patients were assigned to medical therapy only. Risk of recurrent stroke was significantly lower in the PFO closure plus medical therapy group compared to medical therapy alone. (OR 0.47, 95% CI 0.33-0.67, p < 0.0001). Rate of TIA was similar between the two groups (OR 0.76, 95% CI 0.52-1.14), p = 0.18). There was no difference in all-cause mortality between two groups (OR 0.73, CI 0.33-1.58, p = 0.42). Patients undergoing PFO closure were more likely to develop transient atrial fibrillation than medical therapy alone (OR: 5.85; CI: 3.06-11.18, p ≤0.0001) whereas the risk of bleeding was similar between the groups (OR: 0.93; CI: 0.55-1.57, p = 0.78).. The results of this meta-analysis suggest that transcatheter closure of PFO plus medical therapy is superior to medical therapy alone for the prevention of recurrent cryptogenic stroke. However, PFO closure in these patients has not been shown to reduce the risk of recurrent TIA or all-cause mortality. There is a higher rate of transient atrial fibrillation post PFO closure device placement, the long-term effects of which have yet to be studied.

Topics: Adolescent; Adult; Cardiac Catheterization; Cardiovascular Agents; Combined Modality Therapy; Female; Foramen Ovale, Patent; Humans; Ischemic Attack, Transient; Male; Middle Aged; Randomized Controlled Trials as Topic; Recurrence; Risk Assessment; Risk Factors; Stroke; Time Factors; Treatment Outcome; Young Adult

Patent foramen ovale (PFO) closure has emerged as a secondary prevention option in patients with PFO and cryptogenic stroke. However, the comparative efficacy and safety of percutaneous closure and medical therapy in patients with cryptogenic stroke and PFO remain unclear.. Randomized controlled trials (RCTs) and comparative observational studies that compared PFO closure against medical therapy, each with a minimal of 20 patients in the closure arm and 1-year follow-up were included.. We analyzed 6961 patients from 20 studies (5 RCTs and 15 observational studies) with a median follow-up of 3.1 years. Moderate-quality evidence showed that PFO closure was associated with a significantly lower incidence of the composite outcome of ischemic stroke, transient ischemic attack (TIA), or all-cause death (odds ratio [OR]: 0.57; 95% confidence interval [CI]: 0.38 to 0.85; P = 0.006), mainly driven by lower incidence of stroke (OR: 0.39; 95% CI: 0.24 to 0.63; P < 0.001). The numbers needed to treat were 43 and 39 for the composite outcome and recurrent ischemic stroke respectively. PFO closure increased the risks for atrial fibrillation or atrial flutter (OR: 5.74; 95% CI: 3.08 to 10.70; P < 0.001; high-quality evidence) and pulmonary embolism (OR: 3.03; 95% CI: 1.06 to 8.63; P = 0.038; moderate-quality evidence), with the numbers needed to harm being 30 and 143 respectively. The risks for TIA, all-cause death, and major bleeding were not statistically different. Analyses limited to RCTs showed similar findings, as did a series of other subgroup analyses.. In conclusion, PFO closure reduced the incidences of stroke and the composite outcome of ischemic stroke, TIA, or all-cause death, but increased risks for atrial fibrillation or atrial flutter and pulmonary embolism compared with medical therapy.

Topics: Adult; Atrial Fibrillation; Atrial Flutter; Cardiac Catheterization; Cardiovascular Agents; Female; Foramen Ovale, Patent; Humans; Incidence; Ischemic Attack, Transient; Male; Middle Aged; Observational Studies as Topic; Pulmonary Embolism; Randomized Controlled Trials as Topic; Risk Factors; Stroke; Time Factors; Treatment Outcome

Patent foramen ovale (PFO) with atrial septal aneurysm is suggested as an important potential source for cryptogenic strokes. Percutaneous PFO closure to reduce the recurrence of stroke compared to medical therapy has been intensely debated. The aim of this study is to assess whether PFO closure in patients with cryptogenic stroke is safe and effective compared with medical therapy.. A search of PubMed, Medline, and Cochrane Central Register from January 2000 through September 2017 for randomized controlled trails (RCT), which compared PFO closure to medical therapy in patients with cryptogenic stroke was conducted. We used the items "PFO or patent foramen ovale", "paradoxical embolism", "PFO closure" and "stroke". Data were pooled for the primary outcome measure using the random-effects model as pooled rate ratio (RR). The primary outcome was reduction in recurrent strokes.. Among 282 studies, 5 were selected. Our analysis included 3,440 patients (mean age 45 years, 55% men, mean follow-up 2.9 years), 1,829 in the PFO closure group and 1,611 in the medical therapy group. The I2 heterogeneity test was found to be 48%. A random effects model combining the results of the included studies demonstrated a statistically significant risk reduction in risk of recurrent stroke in the PFO closure group when compared with medical therapy (RR 0.42; 95% CI 0.20-0.91, p = 0.03).. Pooled data from 5 large RCTs showed that PFO closure in patients with cryptogenic stroke is safe and effective intervention for prevention of stroke recurrence compared with medical therapy.

Topics: Adult; Cardiac Catheterization; Cardiovascular Agents; Embolism, Paradoxical; Female; Foramen Ovale, Patent; Humans; Male; Middle Aged; Randomized Controlled Trials as Topic; Recurrence; Risk Factors; Secondary Prevention; Stroke; Treatment Outcome

We performed a systematic review and meta-analysis of randomized controlled trials to assess the effect of closure of a patent foramen ovale (PFO) compared with medical therapy for the prevention of stroke in patients with prior cryptogenic stroke.. The role of PFO closure in reducing risk of stroke in patients with prior cryptogenic stroke has been controversial.. We searched PubMed, Embase, CINAHL, and CENTRAL for randomized trials investigating PFO closure versus medical therapy. We assessed trial bias and the quality of evidence for main outcomes was rated using GRADE. The primary outcome of interest was the occurrence of stroke. Estimates of effect were pooled with a random-effects model. This study is registered with PROSPERO (CRD42017081579).. PFO closure reduced risk of stroke compared with medical therapy. PFO closure is a therapeutic option that should be offered to adults with cryptogenic stroke.

Topics: Adolescent; Adult; Cardiac Catheterization; Cardiovascular Agents; Female; Foramen Ovale, Patent; Humans; Male; Middle Aged; Prosthesis Design; Randomized Controlled Trials as Topic; Recurrence; Risk Factors; Secondary Prevention; Septal Occluder Device; Stroke; Time Factors; Treatment Outcome; Young Adult

The optimal strategy of secondary stroke prevention in patients with patent foramen ovale (PFO) is controversial. This study was performed to evaluate the efficacy and safety of the device closure (DC) versus the medical therapy (MT) in patients with cryptogenic stroke or transient ischemic attack (TIA) and PFO.. Randomized controlled trials with active and control groups receiving the DC plus MT and MT alone in patients with history of cryptogenic stroke/TIA and diagnosis of PFO were systematically searched. The main efficacy outcome was stroke recurrence. Subgroup-analyses were performed according to age, shunt size, and presence of atrial septal aneurysm (ASA). Safety endpoints included any serious adverse event (SAE), atrial fibrillation (AF), and major bleeding complications. Risk ratios (RRs) and hazard ratios (HRs) with 95% CIs were estimated. Five trials were included, involving 3,440 participants (DC = 1,829, MT = 1,611). There was a protective effect of closure in the risk of recurrent stroke (RR 0.43 [0.21-0.90]; p = 0.024; HR = 0.39 [0.19-0.83]; p = 0.014). The benefit of PFO closure was significant in patients with PFO associated with substantial right-to-left shunt or ASA. There were no differences in the risks of SAEs and major bleedings between the groups. The rate of new-onset AF was higher in the DC than in the MT arm (RR 4.46 [2.35-8.41]; p < 0.001). Successful device implantation and effective PFO closure were achieved in 96 and 91% of the patients respectively. Key Messages: In selected adult patients with PFO and history of cryptogenic stroke, the DC plus MT is more effective to prevent stroke recurrence and is associated with an increased risk of new-onset AF compared to the MT alone.

Topics: Adult; Cardiac Catheterization; Cardiovascular Agents; Female; Foramen Ovale, Patent; Humans; Ischemic Attack, Transient; Male; Middle Aged; Protective Factors; Randomized Controlled Trials as Topic; Recurrence; Risk Factors; Secondary Prevention; Stroke; Time Factors; Treatment Outcome

To examine long-term clinical outcomes with transcatheter patent foramen ovale (PFO) closure versus medical therapy alone in patients with cryptogenic stroke.. A long-standing debate regarding the optimal approach for the management of patients with PFO after a cryptogenic stroke exists.. An electronic search was performed for randomized clinical trials (RCTs) reporting clinical outcomes with PFO closure vs. medical therapy alone after stroke. Random effects DerSimonian-Laird risk ratios (RR) were calculated. The main outcome was recurrence of stroke. Other outcomes included transient ischemic attack (TIA), new-onset atrial fibrillation/flutter (AF/AFL), major bleeding, serious adverse events, and device-related complications. All-cause mortality was also examined.. Transcatheter PFO closure reduces the recurrence of stroke compared with medical therapy alone, with no significant safety concerns. Close follow-up of patients after PFO closure is recommended to detect new-onset atrial arrhythmias.

Topics: Adult; Cardiac Catheterization; Cardiovascular Agents; Female; Foramen Ovale, Patent; Humans; Male; Middle Aged; Prosthesis Design; Randomized Controlled Trials as Topic; Recurrence; Risk Factors; Secondary Prevention; Septal Occluder Device; Stroke; Time Factors; Treatment Outcome

Up to 40% of ischaemic strokes are cryptogenic. A strong association between cryptogenic stroke and the prevalence of patent foramen ovale (PFO) suggests paradoxical embolism via PFO as a potential cause. Randomized trials failed to demonstrate superiority of PFO closure over medical therapy.. Randomized trials comparing percutaneous PFO closure against medical therapy or devices head-to-head published or presented by March 2013 were identified through a systematic search. We performed a network meta-analysis to determine the effectiveness and safety of PFO closure with different devices when compared with medical therapy. We included four randomized trials (2963 patients with 9309 patient-years). Investigated devices were Amplatzer (AMP), STARFlex (STF), and HELEX (HLX). Patients allocated to PFO closure with AMP were less likely to experience a stroke than patients allocated to medical therapy [rate ratio (RR) 0.39; 95% CI: 0.17-0.84]. No significant differences were found for STF (RR 1.01; 95% CI: 0.44-2.41), and HLX (RR, 0.71; 95% CI: 0.17-2.78) when compared with medical therapy. The probability to be best in preventing strokes was 77.1% for AMP, 20.9% for HLX, 1.7% for STF, and 0.4% for medical therapy. No significant differences were found for transient ischaemic attack and death. The risk of new-onset atrial fibrillation was more pronounced for STF (RR 7.67; 95% CI: 3.25-19.63), than AMP (RR 2.14; 95% CI: 1.00-4.62) and HLX (RR 1.33; 95%-CI 0.33-4.50), when compared with medical therapy.. The effectiveness of PFO closure depends on the device used. PFO closure with AMP appears superior to medical therapy in preventing strokes in patients with cryptogenic embolism.

Topics: Adult; Atrial Fibrillation; Balloon Occlusion; Cardiovascular Agents; Embolism, Paradoxical; Female; Foramen Ovale, Patent; Humans; Male; Randomized Controlled Trials as Topic; Septal Occluder Device; Stroke; Treatment Outcome

Stroke is the most debilitating cardiovascular event. It has a variety of causes that may be present simultaneously. In young or otherwise healthy people, the search for a patent foramen ovale (PFO) has become standard. In stroke of the elderly, atherosclerosis and atrial fibrillation are in the foreground but the PFO should not be ignored. The risk of a PFO-related stroke over time is controversial and so is its prevention by device closure. The association of proximal aortic plaques in arteries subtending the brain and stroke is considered strong, ignoring that it is as putative as that of the PFO. Statins can prevent progression of such plaques. Antiplatelet agents in asymptomatic and surgical endarterectomy in symptomatic patients or highly ulcerated lesions are the treatment of choice. Stenting with protection devices was shown competitive in selected patients.

Topics: Anticoagulants; Aortic Diseases; Balloon Occlusion; Cardiovascular Agents; Carotid Stenosis; Foramen Ovale, Patent; Humans; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Plaque, Atherosclerotic; Platelet Aggregation Inhibitors; Prosthesis Design; Randomized Controlled Trials as Topic; Recurrence; Risk Factors; Secondary Prevention; Septal Occluder Device; Stents; Stroke

'Translation' in medicine immediately suggests 'translational research', but there are many other varieties of 'translation'. I have selected 4 translations in the field of vascular neurology in which I have been involved in different respects: (1) the translation of results from men to women, taking the example of aspirin which, in primary prevention, decreases the risk of myocardial infarction in men and the risk of cerebral infarction in women, the reason for this sex difference being so far unknown; (2) the 'inverse translational research', from bedside to bench, taking the example of the disease we have identified--CADASIL--and showing how the study of one patient and his family led to the identification of a gene, Notch3, so far unknown in humans and to the discovery of its key role in the physiology of vascular smooth muscle cells; (3) the translation from individual case reports to multidisciplinary trials taking the example of hemicraniectomy in malignant cerebral infarction and emphasizing the interest in such rare and severe conditions of pooling and reporting the results of randomized clinical trials before the results of individual trials, and (4) the translation from research to practice, emphasizing not the well-known 'evidence to practice gap' but the slippery slope of 'lack of evidence to overpractice', taking the example of patent foramen ovale closure in migraine.

Topics: Aspirin; Awards and Prizes; Biomedical Research; CADASIL; Cardiovascular Agents; Cardiovascular Diseases; Cerebral Infarction; Craniotomy; Evidence-Based Medicine; Female; Foramen Ovale, Patent; Humans; Male; Medical Records; Migraine Disorders; Myocardial Infarction; Neurology; Randomized Controlled Trials as Topic; Receptor, Notch3; Receptors, Notch; Sex Factors; Treatment Outcome

We sought to compare the benefit of percutaneous closure to that of medical therapy alone for the secondary prevention of embolism in patients with patent foramen ovale (PFO) and otherwise unexplained ischemic stroke, in a propensity scored study.. Between 2000 and 2012, we selected consecutive first-ever ischemic stroke patients aged 18 to 45 years with PFO and no other cause of brain ischemia, as part of the IPSYS registry (Italian Project on Stroke in Young Adults), who underwent either percutaneous PFO closure or medical therapy for comparative analysis. Primary end point was a composite of ischemic stroke, transient ischemic attack, or peripheral embolism. Secondary end point was brain ischemia. Five hundred and twenty-one patients qualified for the analysis. The primary end point occurred in 15 patients treated with percutaneous PFO closure (7.3%) versus 33 patients medically treated (10.5%; hazard ratio, 0.72; 95% confidence interval, 0.39-1.32; P=0.285). The rates of the secondary end point brain ischemia were also similar in the 2 treatment groups (6.3% in the PFO closure group versus 10.2% in the medically treated group; hazard ratio, 0.64; 95% confidence interval, 0.33-1.21; P=0.168). Closure provided a benefit in patients aged 18 to 36 years (hazard ratio, 0.19; 95% confidence interval, 0.04-0.81; P=0.026) and in those with a substantial right-to-left shunt size (hazard ratio, 0.19; 95% confidence interval, 0.05-0.68; P=0.011).. PFO closure seems as effective as medical therapy for secondary prevention of cryptogenic ischemic stroke. Whether device treatment might be more effective in selected cases, such as in patients younger than 37 years and in those with a substantial right-to-left shunt size, deserves further investigation.

Topics: Adolescent; Adult; Age Factors; Brain Ischemia; Cardiac Catheterization; Cardiovascular Agents; Chi-Square Distribution; Embolism, Paradoxical; Female; Foramen Ovale, Patent; Humans; Intracranial Embolism; Italy; Male; Middle Aged; Propensity Score; Proportional Hazards Models; Registries; Risk Factors; Secondary Prevention; Stroke; Time Factors; Treatment Outcome; Young Adult

Since 2009, the United Kingdom diving incident data show an increasing number of fatalities in the over-50s age group. Previous studies also suggest some divers take cardiac medications. Since 2001, diving medicals have not been mandatory for UK sport divers. Instead, an annual medical self-certification form, submitted to their club/school or training establishment, is required. We documented in a survey of UK sport divers the prevalence of cardiac events and medications and the frequency of medical certifications.. An anonymous on-line questionnaire was publicised. Measures included diver and diving demographics, prescribed medications, diagnosed hypertension, cardiac issues, events and procedures, other health issues, year of last diving medical, diagnosed persistent foramen ovale (PFO), smoking and alcohol habits, exercise and body mass index.. Of 672 completed surveys, hypertension was reported by 119 (18%) with 25 of these (21%) having not had a diving medical. Myocardial infarction 6 (1%), coronary artery bypass grafting 3 (< 1%), atrial fibrillation 19 (3%) and angina 12 (2%) were also reported. PFOs were reported by 28 (4%), with 20 of these opting for a closure procedure. From 83 treated incidences of decompression illness (DCI), 19 divers reported that a PFO was diagnosed.. Divers inevitably develop health problems. Some continue to dive with cardiac issues, failing to seek specialised diving advice or fully understand the role of the diving medical. Physicians without appropriate training in diving medicine may inform a diver they are safe to continue diving with their condition without appreciating the potential risks. The current procedure for medical screening for fitness to dive may not be adequate for all divers.

Topics: Adolescent; Adult; Age Distribution; Aged; Alcohol Drinking; Angina Pectoris; Atrial Fibrillation; Body Mass Index; Cardiovascular Agents; Cardiovascular Diseases; Certification; Coronary Artery Bypass; Decompression Sickness; Diving; Exercise; Female; Foramen Ovale, Patent; Health Status; Humans; Hypertension; Male; Middle Aged; Myocardial Infarction; Recreation; Smoking; Surveys and Questionnaires; Time Factors; United Kingdom