Risk of early clinical deterioration and 30-day mortality in pulmonary embolism intermediate-high-risk patients with patent foramen ovale.

We assess the prognostic role of patent foramen ovale (PFO) for the estimation of 30-day mortality and risk of 48-h clinical deterioration since admission, in intermediate-high-risk pulmonary embolism (PE) patients. A post-hoc analysis of intermediate-high-risk PE patients enrolled in the Italian Pulmonary Embolism Registry (IPER) (Trial registry: ClinicalTrials.gov; No.: NCT01604538) was performed. The entire cohort was divided according to the presence or absence of PFO after transthoracic echocardiography (TTE) evaluation. Among 450 intermediate-high-risk PE patients (mean age 71.4 ± 13.8 years, 298 males), PFO was diagnosed in 68 (15.1%) cases. A higher mortality rate (29.4% vs. 3.1%, p < 0.001) as well as occurrence of clinical deterioration within 48 h from admission (38.2% vs. 3.6%, p < 0.001) were observed in intermediate-high-risk PE patients with PFO compared to those without multivariate Cox regression analysis showed that the presence of a PFO predicts 30-day mortality (HR: 3.21, 95% CI 3.16-3.27, p < 0.001) and was also associated with a significantly higher risk of 48-h clinical deterioration [HR: 2.24 (95% CI 2.20-2.29), p < 0.0001] in intermediate-high-risk PE patients. The presence of a PFO in intermediate-high-risk PE patients is associated with a higher risk of clinical deterioration within 48 h from admission and 30-day mortality.

Embolic Stroke of Undetermined Source and Patent Foramen Ovale: Risk of Paradoxical Embolism Score Validation and Atrial Fibrillation Prediction.

Background and Purpose: The Risk of Paradoxical Embolism (RoPE) score stratifies patients with stroke according to the probability of having a patent foramen ovale (PFO), which (through Bayes theorem and simple assumptions) can be used to estimate the probability that a PFO is pathogenic in a given subgroup of patients with specific features (ie, a given RoPE score value): a higher PFO prevalence corresponds to a higher probability that a PFO is pathogenic. Among alternative mechanisms in embolic stroke of undetermined source (ESUS), the actual stroke cause may be covert atrial fibrillation. We aimed to validate the RoPE score in a large ESUS population and investigate the rate of stroke recurrence and new incident atrial fibrillation during follow-up according to PFO status and RoPE score. Methods: We pooled data of consecutive patients with ESUS from 3 prospective stroke registries. We assessed RoPE score's calibration and discrimination for the presence of PFO (and consequently for the probability that it is pathogenic). Multivariate logistic regression analysis was performed to identify factors associated with PFO. Results: Among 455 patients with ESUS (median age 59 years), 184 (40%) had PFO. The RoPE score's area under the receiver operating characteristic curve was 0.75. In addition to RoPE score variables, absence of left ventricular hypertrophy, absence of atherosclerosis, and infratentorial lesions were independently associated with PFO. In patients with PFO and RoPE 7 to 10, PFO and RoPE 0 to 6, and without PFO, new incident atrial fibrillation rate was 3.1%, 20.5%, and 31.8%, respectively (log-rank test=6.28, P=0.04). Stroke recurrences in patients with likely pathogenic PFO were not statistically different from other patients. Conclusions: This multicenter study validates the RoPE score to predict the presence/absence of PFO in patients with ESUS, which strongly suggests that RoPE score is helpful in identifying patients with ESUS with pathogenic versus incidental PFOs. Left ventricular hypertrophy, atherosclerosis, and infratentorial stroke may further improve the score. Low RoPE scores were associated with more incidental atrial fibrillation during 10-year follow-up.

Cierre percutáneo del foramen oval permeable en pacientes mayores de 60 años con ictus criptogénico / Transcatheter closure of patent foramen ovale in patients older than 60 years of age with cryptogenic embolism

INTRODUCCIÓN Y OBJETIVOS: Estudios aleatorizados han mostrado la eficacia del cierre percutáneo del foramen oval permeable (FOP) en pacientes de edad ≤ 60 años con ictus criptogénico. El objetivo de este estudio es determinar la seguridad y la eficacia a largo plazo del cierre percutáneo del FOP en pacientes mayores de 60 años con ictus criptogénico. MÉTODOS: De 475 pacientes consecutivos con ictus criptogénico que se sometieron al cierre del FOP, 90 eran mayores de 60 años (media, 66+/-5 años) y se los comparó con los 385 del grupo de edad ≤ 60 años (media, 44+/-10 años). RESULTADOS: Los pacientes mayores de 60 años tuvieron mayor prevalencia de factores de riesgo cardiovascular (FRCV) (hipertensión, dislipemia y diabetes; p <0,01). No hubo diferencias en cuanto a complicaciones periprocedimiento. El seguimiento medio fue de 8 (4-12) años y hubo 17 muertes, todas de causa no cardiovascular (el 7,8% de los mayores de 60 años y el 2,6% de los de edad ≤ 60 años; HR=4,12; IC95%, 1,56-10,89). Tuvieron un ictus recurrente 4 pacientes (el 2,2% de los mayores de 60 años frente al 0,5% de los de edad ≤ 60 años; HR=5,08; IC95%, 0,71-36,2), y un accidente isquémico transitorio (AIT) 12 pacientes (el 3,3 frente al 2,3%; HR=1,71; IC95%, 0,46-6,39). Hubo tendencia a una mayor incidencia de ictus/AIT en los mayores de 60 años (el 5,5 frente al 2,6%; HR=2,62; IC95%, 0,89-7,75; p = 0,081), que no persistió tras ajustar por FRCV (HR=1,97; IC95%, 0,59-6,56; p = 0,269). CONCLUSIONES: El cierre percutáneo del FOP en pacientes mayores de 60 años con ictus criptogénico resultó seguro y se asoció con una baja incidencia de eventos isquémicos a largo plazo. Sin embargo, en los pacientes mayores de 60 años se observó una tendencia a mayor incidencia de ictus/AIT probablemente relacionada con mayor prevalencia de FRCV

INTRODUCTION AND OBJECTIVES: Randomized trials have shown the efficacy of transcatheter closure of patent foramen ovale (PFO) in patients aged ≤ 60 years with cryptogenic embolism. We aimed to assess the long-term safety and efficacy of PFO closure in patients aged> 60 years. METHODS: Of 475 consecutive patients with cryptogenic embolism who underwent PFO closure, 90 older patients aged> 60 years (mean, 66+/-5 years) were compared with 385 younger patients aged ≤ 60 years (mean, 44+/-10 years). RESULTS: Older patients had a higher prevalence of cardiovascular risk factors (CVRF) (hypertension, dyslipidemia, diabetes; P <.01 for all vs younger patients). There were no differences in periprocedural complications between the 2 groups. During a median follow-up of 8 (4-12) years, there were a total of 17 deaths, all from noncardiovascular causes (7.8% and 2.6% in the older and younger patient groups, respectively; HR, 4.12; 95%CI, 1.56-10.89). Four patients had a recurrent stroke (2.2% and 0.5% in the older and younger patient groups, respectively; HR, 5.08; 95%CI, 0.71-36.2), and 12 patients had a transient ischemic attack (TIA) (3.3% and 2.3% in the older and younger patient groups, respectively; HR, 1.71; 95%CI, 0.46-6.39). There was a trend toward a higher rate of the composite of stroke/TIA in older patients (5.5% vs 2.6%; HR, 2.62; 95%CI, 0.89-7.75; P=.081), which did not persist after adjustment for CVRF (HR, 1.97; 95%CI, 0.59-6.56; P=.269). CONCLUSIONS: In older patients with cryptogenic embolism, PFO closure was safe and associated with a low rate of ischemic events at long-term. However, older patients exhibited a tendency toward a higher incidence of recurrent stroke/TIA compared with younger patients, likely related to a higher burden of CVRF

Transcatheter closure of patent foramen ovale in patients older than 60 years of age with cryptogenic embolism.

INTRODUCTION AND OBJECTIVES: Randomized trials have shown the efficacy of transcatheter closure of patent foramen ovale (PFO) in patients aged ≤ 60 years with cryptogenic embolism. We aimed to assess the long-term safety and efficacy of PFO closure in patients aged> 60 years. METHODS: Of 475 consecutive patients with cryptogenic embolism who underwent PFO closure, 90 older patients aged> 60 years (mean, 66±5 years) were compared with 385 younger patients aged ≤ 60 years (mean, 44±10 years). RESULTS: Older patients had a higher prevalence of cardiovascular risk factors (CVRF) (hypertension, dyslipidemia, diabetes; P <.01 for all vs younger patients). There were no differences in periprocedural complications between the 2 groups. During a median follow-up of 8 (4-12) years, there were a total of 17 deaths, all from noncardiovascular causes (7.8% and 2.6% in the older and younger patient groups, respectively; HR, 4.12; 95%CI, 1.56-10.89). Four patients had a recurrent stroke (2.2% and 0.5% in the older and younger patient groups, respectively; HR, 5.08; 95%CI, 0.71-36.2), and 12 patients had a transient ischemic attack (TIA) (3.3% and 2.3% in the older and younger patient groups, respectively; HR, 1.71; 95%CI, 0.46-6.39). There was a trend toward a higher rate of the composite of stroke/TIA in older patients (5.5% vs 2.6%; HR, 2.62; 95%CI, 0.89-7.75; P=.081), which did not persist after adjustment for CVRF (HR, 1.97; 95%CI, 0.59-6.56; P=.269). CONCLUSIONS: In older patients with cryptogenic embolism, PFO closure was safe and associated with a low rate of ischemic events at long-term. However, older patients exhibited a tendency toward a higher incidence of recurrent stroke/TIA compared with younger patients, likely related to a higher burden of CVRF.

Recurrent Stroke Reduction with Patent Foramen Ovale Closure versus Medical Therapy Based on Patent Foramen Ovale Characteristics: A Meta-Analysis of Randomized Controlled Trials.

Efficacy of patent foramen ovale (PFO) closure in patients with cryptogenic stroke remains a matter of debate. We performed a comprehensive meta-analysis of available randomized controlled trials (RCTs) to evaluate the efficacy and safety of PFO closure versus medical therapy (MT) based on PFO characteristics. Random-effects meta-analysis was conducted to estimate risk ratio (RR) with 95% confidence intervals (CI) for the primary end points of stroke. After systematic search, six RCTs (3,747 patients) with 1,889 patients randomized to PFO closure and 1,858 patients randomized to the MT group were included in the meta-analysis. Overall, PFO closure was associated with a significant reduction in recurrent stroke compared to MT [RR 0.41; 95% CI 0.20-0.83]. While there were no differences in mortality or major bleeding between the two groups, risk of newly diagnosed atrial fibrillation was higher in the PFO closure group compared to MT [RR 5.29; 95% CI 2.32-12.06]. Further, risk reduction in stroke with PFO closure was significant in patients with high-risk PFO characteristics [RR 0.37; 95% CI 0.16-0.87] but not in low-risk patients [RR 0.73; 95% CI 0.29-1.84]. In conclusion, among patients with cryptogenic stroke, PFO closure is associated with a significantly reduced risk of recurrent stroke compared to MT. Additionally, the benefit of PFO closure might be dependent on certain PFO characteristics.

Updated meta-analysis of closure of patent foramen ovale versus medical therapy after cryptogenic stroke.

BACKGROUND: Among patients with cryptogenic stroke, PFO closure has remained controversial. We hypothesized that with the cumulative number of subjects in randomized controlled trials (RCTs), there is now sufficient power to ascertain whether PFO closure in patients with cryptogenic stroke improves the risk of stroke. METHODS: We performed an updated meta-analysis by including newer RCTs that examined the benefit of PFO closure compared with medical therapy for improvement in risk of stroke. We utilized random effects models to compute the association and performed subgroup analyses by medical therapy, shunt size and presence/absence of atrial septal aneurysm. RESULTS: Overall, 6 RCTS were included with 1839 patients that underwent PFO closure and 1671 patients that received medical therapy and were followed for a period of 2-6 years. The incidence of recurrent stroke was 1.52% among PFO closure group and 3.94% among medical therapy group. There was decreased risk of stroke in PFO closure group (OR 0.34, 95% CI 0.15-0.79, p = 0.012). Patients with larger shunt size derived more benefit from PFO closure than smaller or moderate sized shunts. There was no difference in outcomes by presence or absence of atrial septal aneurysm or type of medical therapy used i.e. antiplatelet therapy only vs. antiplatelet + anticoagulant therapy. CONCLUSION: This meta-analysis of 6 RCTs demonstrated benefits of PFO closure for secondary prevention of stroke among patients with cryptogenic stroke and small increase in risk of new onset atrial fibrillation.

Patent foramen ovale and neurologic events in patients undergoing liver transplantation.

BACKGROUND: Patent foramen ovale (PFO) is present in approximately 20% of individuals. During liver transplantation (LT), intra-operative transesophageal echocardiography can observe transient intra-cardiac shunting of atheromatous debris via a PFO. Closure of PFOs prior to LT has thus been suggested as a potential treatment to reduce peri-operative cerebral vascular accident (CVA). The objective of this study was to assess if the presence of PFO is associated with CVA in patients undergoing LT. METHODS: Three hundred fifty-eight patients undergoing LT at a single academic institution were included. All patients underwent standardized cardiac evaluation including a detailed cardiovascular history and physical examination, electrocardiogram and transthoracic echocardiogram. Five patients were excluded because of poor transthoracic echocardiographic image quality, and three patients were excluded because of PFO closure prior to LT, yielding a study population of 350 patients. Medical records were reviewed to determine demographics, echocardiographic findings and outcome following LT. Major adverse cardiovascular events, myocardial infarction, CVA and death were collected. RESULTS: Mean age was 53.4 ±â€¯10.2 years; 61% male and 5% of patients had a prior history of CVA. Alcohol and hepatitis C were the most common etiologies for liver disease. Forty-six patients (13.1%) were diagnosed with PFO prior to LT. In-hospital CVA occurred in 6 patients (1.7%). The prevalence of a CVA was not significantly higher in patients with PFO compared to patients without PFO, 2.2% vs 1.6%, p = 0.57. In-hospital mortality was similar in patients with PFO compared to patients without PFO, 4.4% and 5.3%, p = 1.0. CONCLUSIONS: The presence of a PFO in patients undergoing LT is not associated with postoperative CVA. Prophylactic closure of PFOs, in the absence of other indications, does not appear to be warranted in patients undergoing LT.

Closure, Anticoagulation, or Antiplatelet Therapy for Cryptogenic Stroke With Patent Foramen Ovale: Systematic Review of Randomized Trials, Sequential Meta-Analysis, and New Insights From the CLOSE Study.

BACKGROUND: We conducted a systematic review and meta-analysis of randomized controlled trials (RCTs) comparing patent foramen ovale (PFO) closure, anticoagulation, and antiplatelet therapy to prevent stroke recurrence in patients with PFO-associated cryptogenic stroke. METHODS AND RESULTS: We searched Medline, Cochrane Library, and EMBASE through March 2018. The primary outcome was stroke recurrence. Pooled incidences, hazard ratios, and risk ratios (RRs) were calculated in random-effects meta-analyses. PFO closure was associated with a lower risk of recurrent stroke compared with antithrombotic therapy (antiplatelet therapy or anticoagulation: 3560 patients from 6 RCTs; RR=0.36, 95% CI: 0.17-0.79; I2=59%). The effect of PFO closure on stroke recurrence was larger in patients with atrial septal aneurysm or large shunt (RR=0.27, 95% CI, 0.11-0.70; I2=42%) compared with patients without these anatomical features (RR=0.80, 95% CI, 0.43-1.47; I2=12%). Major complications occurred in 2.40% (95% CI, 1.03-4.25; I2=77%) of procedures. New-onset atrial fibrillation was more frequent in patients randomized to PFO closure versus antithrombotic therapy (RR=4.33, 95% CI, 2.37-7.89; I2=14%). One RCT compared PFO closure versus anticoagulation (353 patients; hazard ratio=0.14, 95% CI, 0.00-1.45) and 2 RCTs compared PFO closure versus antiplatelet therapy (1137 patients; hazard ratio=0.18, 95% CI, 0.05-0.63; I2=12%). Three RCTs compared anticoagulation versus antiplatelet therapy, with none showing a significant difference. CONCLUSIONS: PFO closure is superior to antithrombotic therapy to prevent stroke recurrence after cryptogenic stroke. The annual absolute risk reduction of stroke was low, but it has to be tempered by a substantial time at risk (at least 5 years) in young and middle-aged patients. PFO closure was associated with an increased risk of atrial fibrillation.

Percutaneous closure versus medical therapy for stroke with patent foramen Ovale: a systematic review and meta-analysis.

BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSION: 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.

Transcatheter closure of patent foramen ovale for secondary prevention of ischemic stroke: Quantitative synthesis of pooled randomized trial data.

OBJECTIVES: To evaluate the safety and efficacy of percutaneous device closure of patent foramen ovale (PFO) for secondary prevention of ischemic stroke BACKGROUND: Stroke remains the leading cause of serious long-term disability in the United States. The effectiveness of a percutaneous PFO closure in the prevention of recurrent cryptogenic strokes has not been established. METHODS: We performed a literature search using PubMed, EMBASE, Cochrane Central Register of Controlled Trials, Google Scholar, and Internet-based sources from January 2003 to September 2017. Randomized controlled trails (RCTs) comparing percutaneous PFO closure to medical therapy alone. RESULTS: Five RCTs (CLOSURE I, PC Trial, REDUCE, RESPECT, and CLOSE) with 1,829 patients in the device group and 1,611 patients in the medical group met inclusion criteria. The cumulative incidence of recurrent stroke was 2.02% in the PFO closure arm and 4.4% in the medical therapy group (RR 0.42, 95%CI 0.20, 0.91; P = 0.03). There was no difference in the incidence of death [0.7% vs. 0.9%; RR 0.76 (95% CI 0.35, 1.64), P = 0.49] or adverse events during the follow-up period [24.6% vs. 23.7% (RR 1.03; 95% CI 0.91, 1.16), P = 0.65] between the closure and medical therapy groups. Incidence of atrial fibrillation was significantly higher in closure group compared to medical therapy [4% vs. 0.6% (RR 4.73; 95% CI 2.09, 10.70), P = 0.0002]. The comparative effectiveness of PFO closure (compared to medical therapy) was significantly more pronounced in those younger than 45 years, males, larger shunts and disc design platforms (P < 0.05). CONCLUSIONS: Based on the results of this analysis of randomized trial data, percutaneous PFO closure appears to be a safe and effective therapeutic option for the secondary prevention of ischemic stroke in patients with PFO and cryptogenic stroke.

Patent foramen ovale in patients with pulmonary embolism: A prognostic factor on CT pulmonary angiography?

BACKGROUND: Patent foramen ovale (PFO) in patients with acute pulmonary embolism (PE) represents a risk factor for mortality, but this has not been evaluated for CT pulmonary angiography (CTPA). The purpose of the present study was to assess the relationship between PFO and mortality in patients with acute PE diagnosed on CTPA. MATERIALS AND METHODS: This retrospective study included 268 adults [173 women, mean age 61 (range 22-98) years] diagnosed with acute PE on non-ECG-gated 64-slice CTPA in 2012 at our medical center. The images were reviewed for PFO by a panel of cardiothoracic radiologists with an average of 11 years of experience (range 1-25 years). CT signs of right heart strain and PE level were noted. Transthoracic echocardiograms (TTE), when available (n = 207), were reviewed for PFO by a cardiologist with subspecialty training in advanced imaging and with 3 years of experience. The main outcome was 30-day mortality. Fischer's exact test was utilized to compare mortality. RESULTS: PFO prevalence on CTPA was 22% (58/268) and 4% (9/207) on TTE. Overall 30-day mortality was 6% (16/268), 9% (5/58) for patients with PFO and 5% (11/210) for those without (p = 0.35). CT signs of right heart strain trended with higher mortality, but statistically significant only for hepatic vein contrast reflux [14% (6/44) vs 4% (10/224), p = 0.03]; right ventricular (RV) to left ventricular (LV) diameter ratio >1 [8% (13/156) vs RV:LV ≤ 1 3% (3/112), p = 0.07], septal bowing [10% (4/42) vs without 5% (12/226), p = 0.30]. CONCLUSION: PFO was demonstrated on CTPA in a proportion similar to the known population prevalence, while routine TTE was less sensitive. Mortality was non-significantly higher in patients with acute PE and PFO in this moderate-sized study. A larger study to answer this clinically important question is worthwhile.

Long-Term Outcomes of Patent Foramen Ovale Closure or Medical Therapy after Stroke.

BACKGROUND: Whether closure of a patent foramen ovale reduces the risk of recurrence of ischemic stroke in patients who have had a cryptogenic ischemic stroke is unknown. METHODS: In a multicenter, randomized, open-label trial, with blinded adjudication of end-point events, we randomly assigned patients 18 to 60 years of age who had a patent foramen ovale (PFO) and had had a cryptogenic ischemic stroke to undergo closure of the PFO (PFO closure group) or to receive medical therapy alone (aspirin, warfarin, clopidogrel, or aspirin combined with extended-release dipyridamole; medical-therapy group). The primary efficacy end point was a composite of recurrent nonfatal ischemic stroke, fatal ischemic stroke, or early death after randomization. The results of the analysis of the primary outcome from the original trial period have been reported previously; the current analysis of data from the extended follow-up period was considered to be exploratory. RESULTS: We enrolled 980 patients (mean age, 45.9 years) at 69 sites. Patients were followed for a median of 5.9 years. Treatment exposure in the two groups was unequal (3141 patient-years in the PFO closure group vs. 2669 patient-years in the medical-therapy group), owing to a higher dropout rate in the medical-therapy group. In the intention-to-treat population, recurrent ischemic stroke occurred in 18 patients in the PFO closure group and in 28 patients in the medical-therapy group, resulting in rates of 0.58 events per 100 patient-years and 1.07 events per 100 patient-years, respectively (hazard ratio with PFO closure vs. medical therapy, 0.55; 95% confidence interval [CI], 0.31 to 0.999; P=0.046 by the log-rank test). Recurrent ischemic stroke of undetermined cause occurred in 10 patients in the PFO closure group and in 23 patients in the medical-therapy group (hazard ratio, 0.38; 95% CI, 0.18 to 0.79; P=0.007). Venous thromboembolism (which comprised events of pulmonary embolism and deep-vein thrombosis) was more common in the PFO closure group than in the medical-therapy group. CONCLUSIONS: Among adults who had had a cryptogenic ischemic stroke, closure of a PFO was associated with a lower rate of recurrent ischemic strokes than medical therapy alone during extended follow-up. (Funded by St. Jude Medical; RESPECT ClinicalTrials.gov number, NCT00465270 .).

Safety Outcomes After Percutaneous Transcatheter Closure of Patent Foramen Ovale.

BACKGROUND AND PURPOSE: We sought to evaluate the real-world rate of safety outcomes after patent foramen ovale (PFO) closure in patients with ischemic stroke or transient ischemic attack (TIA). METHODS: We performed a retrospective cohort study using administrative claims data on all hospitalizations from 2005 to 2013 in New York, California, and Florida. Using International Classification of Diseases, Ninth Revision, Clinical Modification codes, we identified patients who underwent percutaneous transcatheter PFO closure within 1 year of ischemic stroke or TIA. Our outcome was an adverse event occurring during the hospitalization for PFO closure, defined as in prior studies as atrial fibrillation or flutter, cardiac tamponade, pneumothorax, hemothorax, a vascular access complication, or death. Crude rates were reported with exact confidence intervals. RESULTS: We identified 1887 patients who underwent PFO closure after ischemic stroke or TIA. The rate of any adverse outcome during the hospitalization for PFO closure was 7.0% (95% confidence interval [CI], 5.9%-8.2%). Rates of adverse outcomes varied by age and type of preceding cerebrovascular event. In patients >60 years of age, the rate of adverse outcomes was 10.9% (95% CI, 8.6%-13.6%) versus 4.9% (95% CI, 3.8%-6.3%) in patients ≤60 years of age. The rate of adverse outcomes was 9.9% (95% CI, 7.3%-12.5%) in patients with preceding ischemic stroke versus 5.9% (95% CI, 4.7%-7.1%) after TIA. CONCLUSIONS: Approximately 1 in 14 patients who underwent percutaneous transcatheter PFO closure after ischemic stroke or TIA experienced a serious periprocedural adverse outcome or death. The risk of adverse outcomes was highest in older patients and in those with preceding ischemic stroke.

Treatment options for the closure of secundum atrial septal defects: A systematic review and meta-analysis.

BACKGROUND: Secundum atrial septal defects (ASDs) are treated by surgical closure (SC) or transcatheter device closure (TCC). Due to a scarcity of data directly comparing these approaches, it remains unclear which is superior. This meta-analysis compares the clinical outcomes of the two treatment options. METHODS: A literature search was performed in MEDLINE, Embase, PubMed, Google Search, and Cochrane databases for studies directly comparing SC and TCC of ASDs. Outcomes studied were major and minor acute complications, all-cause mortality, residual shunt, reinterventions, and length of stay (LOS). Relative risk (RR), difference in mean (DM) and 95% confidence intervals (CI) were calculated using the Mantel-Haenszel method with a fixed effect model. In cases of heterogeneity (defined as I2>25%), random effect models were used. Sensitivity and meta-regression analyses were performed for each outcome. RESULTS: Of the 1742 manuscripts screened, 26 observational studies fulfilled the inclusion criteria (total n=14,559 patients). TCC was superior to SC for the following outcomes: all-cause mortality (RR, 0.66; 95% CI 0.64-0.99), total complications (RR, 0.48; 95% CI 0.35-0.65), major complications (RR, 0.57; 95% CI 0.40-0.81), minor complications (RR, 0.35; 95% CI 0.23-0.53), and LOS (DM, -2.92; 95% CI -3.25 to (-2.58)). Residual shunts were more common with TCC (RR, 3.35; 95% CI 1.72-6.51). No difference was observed regarding the need of reintervention (RR, 1.45; 95% CI 0.60-3.51). Meta-regression analysis showed that older age increases the risk of death and complications in patients undergoing TCC. CONCLUSIONS: Though both approaches are effective, TCC is associated with lower mortality, complications, and LOS while SC has a lower rate of residual shunting.

Transcatheter closure of PFO as secondary prevention of cryptogenic stroke.

This article covers the main unsolved issues regarding the potential role that the patent foramen ovale (PFO) plays in the genesis of so-called cryptogenic stroke. Some brief notions of the anatomy and epidemiology of the PFO are outlined. Subsequently, the results of the three trials on secondary prevention (medical therapy vs. transcatheter closure) in patients with PFO and a history of cryptogenic stroke are presented. The conflicting results of numerous meta-analyses derived from the three randomized controlled trials are discussed. Official scientific guidelines dispute an alleged superior efficacy of transcatheter PFO occlusion in comparison with antithrombotic therapy alone (anticoagulants or antiplatelet agents), except for selected cases of patients with documented PFO and a concomitant clinical-instrumental picture of deep venous thrombosis. Nevertheless, considering recent doubts about the presumptive thrombogenic and arrhythmogenic potential of PFO occlusion, which concerns only one of the septal occluders previously used, further in-depth investigations are warranted, centered on the use of newer dedicated devices to be tested in comparison with antithrombotic regimens alone.

Endocardial Device Leads in Patients with Patent Foramen Ovale: Echocardiographic Correlates of Stroke/TIA and Mortality.

BACKGROUND: Echocardiographically detected patent foramen ovale (PFO) has been associated with stroke/transient ischemic attack (TIA) in patients with cardiac implantable electronic devices (CIEDs). We sought to evaluate the relationship between echocardiographic characteristics and risk of stroke/TIA and mortality in CIED patients with PFO. METHODS: In 6,086 device patients, PFO was detected in 319 patients. A baseline echocardiogram was present in 250 patients, with 186 having a follow-up echocardiogram. RESULTS: Of 250 patients with a baseline echocardiogram, 9.6% (n = 24) had a stroke/TIA during mean follow-up of 5.3 ± 3.1 years; and 42% (n = 105) died over 7.1 ± 3.7 years. Atrial septal aneurysm, prominent Eustachian valve, visible shunting across PFO, baseline or change in estimated right ventricular systolic pressure (RVSP)/tricuspid regurgitation (TR), or maximum RVSP were not associated with postimplant stroke/TIA (P > 0.05). An exploratory multivariate analysis using time-dependent Cox models showed increased hazard of death in patients with increase in TR ≥2 grades (hazard ratio [HR] 1.780, 95% confidence interval [CI] 1.447-2.189, P < 0.0001), or increase in RVSP by >10 mm Hg (HR 2.018, 95% CI 1.593-2.556, P < 0.0001), or maximum RVSP in follow-up (HR 1.432, 95% CI 1.351-1.516, P < 0.0001). A significant increase (P < 0.001) in TR was also noted during follow-up. CONCLUSIONS: In patients with CIED and PFO, structural and hemodynamic echocardiographic markers did not predict future stroke/TIA. However, a significantly higher TR or RVSP was associated with higher mortality.

Comparison of Outcomes after Device Closure and Medication Alone in Patients with Patent Foramen Ovale and Cryptogenic Stroke in Korean Population.

PURPOSE: To compare the effectiveness of device closure and medical therapy in prevention of recurrent embolic event in the Korean population with cryptogenic stroke and patent foramen ovale (PFO). MATERIALS AND METHODS: Consecutive 164 patients (men: 126 patients, mean age: 48.1 years, closure group: 72 patients, medical group: 92 patients) were enrolled. The primary end point was a composite of death, stroke, transient ischemic attack (TIA), or peripheral embolism. RESULTS: Baseline characteristics were similar in the two groups, except age, which was higher in the medical group (45.3±9.8 vs. 50.2±6.1, p<0.0001), and risk of paradoxical embolism score, which was higher in the closure group (6.2±1.6 vs. 5.7±1.3, p=0.026). On echocardiography, large right-to-left shunt (81.9% vs. 63.0%, p=0.009) and shunt at rest/septal hypermobility (61.1% vs. 23.9%, p<0.0001) were more common in the closure group. The device was successfully implanted in 71 (98.6%) patients. The primary end point occurred in 2 patients (2 TIA, 2.8%) in the closure group and in 2 (1 death, 1 stroke, 2.2%) in the medical group. Event-free survival rate did not differ between the two groups. CONCLUSION: Compared to medical therapy, device closure of PFO in patients with cryptogenic stroke did not show difference in reduction of recurrent embolic events in the real world's setting. However, considering high risk of echocardiographic findings in the closure group, further investigation of the role of PFO closure in the Asian population is needed.