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1.
The aim of our study is to compare patent foramen ovale (PFO) closure versus medical treatment and antiplatelet versus anticoagulant therapy in patients with cryptogenic stroke (CS) and PFO. We conducted a systematic review and meta-analysis with trial sequential analysis (TSA) of randomized trials. Primary outcomes are stroke or transient ischemic attack (TIA) and all-cause mortality. Secondary outcomes are peripheral embolism, bleeding, serious adverse events, myocardial infarction and atrial dysrhythmias. We performed an intention to treat meta-analysis with a random-effects model. We include six trials (3677 patients, mean age 47.3 years, 55.8% men). PFO closure is associated with a lower recurrence of stroke or TIA at a mean follow-up of 3.88 years compared to medical therapy [risk ratio (RR) 0.55, 95% CI 0.38–0.81; I2?=?40%]. The TSA confirms this result. No difference is found in mortality (RR 0.74, 95% CI 0.35–1.60; I2?=?0%), while PFO closure is associated with a higher incidence of atrial dysrhythmias (RR 4.55, 95% CI 2.16–9.60; I2?=?25%). The rate of the other outcomes is not different among the two groups. The comparison between anticoagulant and antiplatelet therapy shows no difference in terms of stroke recurrence, mortality and bleeding. There is conclusive evidence that PFO closure reduces the recurrence of stroke or TIA in patients younger than 60 years of age with CS. More data are warranted to assess the consequences of the increase in atrial dysrhythmias and the advantage of PFO closure over anticoagulants.  相似文献   

2.

Background

Recent reports showing the favorable role of patent foramen ovale (PFO) closure in patients with cryptogenic stroke have raised the issue of selecting optimal candidates.

Objectives

This study, DEFENSE-PFO (Device Closure Versus Medical Therapy for Cryptogenic Stroke Patients With High-Risk Patent Foramen Ovale), evaluated whether the benefits of PFO closure can be determined on the basis of the morphologic characteristics of the PFO, as evaluated by transesophageal echocardiography.

Methods

Patients with cryptogenic stroke and high-risk PFO were divided between a transcatheter PFO closure and a medication-only group. High-risk PFO included PFO with atrial septal aneurysm, hypermobility (phasic septal excursion into either atrium ≥10 mm), or PFO size (maximum separation of the septum primum from the secundum) ≥2 mm. The primary endpoint was a composite of stroke, vascular death, or Thrombolysis In Myocardial Infarction–defined major bleeding during 2 years of follow-up.

Results

From September 2011 until October 2017, 120 patients (mean age: 51.8 years) underwent randomization. PFO size, frequency of septal aneurysm (13.3% vs. 8.3%; p = 0.56), and hypermobility (45.0% vs. 46.7%; p > 0.99) were similar between the groups. All PFO closures were successful. The primary endpoint occurred exclusively in the medication-only group (6 of 60 patients; 2-year event rate: 12.9% [log-rank p = 0.013]; 2-year rate of ischemic stroke: 10.5% [p = 0.023]). The events in the medication-only group included ischemic stroke (n = 5), cerebral hemorrhage (n = 1), Thrombolysis In Myocardial Infarction–defined major bleeding (n = 2), and transient ischemic attack (n = 1). Nonfatal procedural complications included development of atrial fibrillation (n = 2), pericardial effusion (n = 1), and pseudoaneurysm (n = 1).

Conclusions

PFO closure in patients with high-risk PFO characteristics resulted in a lower rate of the primary endpoint as well as stroke recurrence. (Device Closure Versus Medical Therapy for Cryptogenic Stroke Patients With High-Risk Patent Foramen Ovale [DEFENSE-PFO]; NCT01550588)  相似文献   

3.

Background

Migraine headache and the presence of a patent foramen ovale have been associated with each other, although the precise pathophysiological mechanism(s) are uncertain. The purpose of this systematic review was to identify the extent of patent foramen ovale prevalence in migraineurs and to determine whether closure of a patent foramen ovale would improve migraine headache.

Methods

An electronic literature search was performed to select studies between January 1980 and February 2013 that were relevant to the prevalence of patent foramen ovale and migraine, and the effects of intervention(s) on migraine attacks. Of the initial 368 articles presented by the initial search, 20 satisfied the inclusion criteria assessing patent foramen ovale prevalence in migraineurs and 21 presented data on patent foramen ovale closure.

Results

In case series and cohort studies, patent foramen ovale prevalence in migraineurs ranged from 14.6% to 66.5%. Case-control studies reported a prevalence ranging from 16.0% to 25.7% in controls, compared with 26.8% to 96.0% for migraine with aura. The extent of improvement or resolution of migraine headache attack symptoms was variable. In case series, intervention ameliorated migraine headache attack in 13.6% to 92.3% of cases. One single randomized trial did not show any benefit from patent foramen ovale closure. The data overall do not exclude the possibility of a placebo effect for resolving migraine following patent foramen ovale closure.

Conclusion

This systematic review demonstrates firstly that migraine headache attack is associated with a higher prevalence of patent foramen ovale than among the general population. Observational data suggest that some improvement of migraine would be observed if the patent foramen ovale were to be closed. A proper assessment of any interventions for patent foramen ovale closure would require further large randomized trials to be conducted given uncertainties from existing trial data.  相似文献   

4.

Background

Surgical timing in infective endocarditis (IE) with preoperative neurological events remains controversial. The relevant society guidelines are each on the basis of a small number of observational studies. This meta-analysis was designed to search the available literature broadly and assess the weight of available evidence as comprehensively as possible.

Methods

We searched MEDLINE and EMBASE to April 2018 for studies that compared mortality or neurological exacerbation in early vs late surgery for IE complicated by neurological events. Random effects meta-analysis was performed.

Results

Twenty-seven observational studies (25 unadjusted, n = 879; 2 adjusted, n = 451) met inclusion criteria. Using early and late thresholds defined in each study (7 or 14 days), early surgery in ischemic or hemorrhagic stroke was associated with elevated perioperative mortality vs late surgery (pooled relative risk [RR], 1.74; 95% confidence interval, 1.34-2.25; P < 0.0001; I2 = 0%) and greater neurological exacerbation (RR, 2.09; 95% confidence interval, 1.32-3.32; P = 0.002; I2 = 33%). In subgroup analysis, for ischemic stroke, early surgery before 7 vs before 14 days exhibited similar perioperative mortality and neurological exacerbation. For hemorrhagic stroke, performing surgery before 21 vs before 28 days showed trends toward perioperative mortality (RR, 1.77 vs 0.63, interaction P = 0.14) and neurological (RR, 2.02 vs RR, 0.44; interaction P = 0.11) exacerbation. There was no difference in long-term mortality but reporting was sparse. Early surgery was often performed for clinical deterioration, negatively biasing outcomes.

Conclusions

Available observational data support delaying surgery by 7-14 days if possible in IE complicated by ischemic stroke and > 21 days in hemorrhagic stroke to decrease perioperative mortality and neurological exacerbation rates. Randomized trials are needed for definitive guidance.  相似文献   

5.

Background/objectives

This study aims to assess whether patent foramen ovale (PFO) closure is superior to medical therapy in preventing recurrence of cryptogenic ischemic stroke or transient ischemic attack (TIA).

Methods

We searched PubMed for randomized trials which compared PFO closure with medical therapy in cryptogenic stroke/TIA using the items: “stroke or cerebrovascular accident or TIA” and “patent foramen ovale or paradoxical embolism” and “trial or study”.

Results

Among 650 potentially eligible articles, 3 were included including 2303 patients. There was no statistically significant difference between PFO-closure and medical therapy in ischemic stroke recurrence (1.91% vs. 2.94% respectively, OR: 0.64, 95%CI: 0.37–1.10), TIA (2.08% vs. 2.42% respectively, OR: 0.87, 95%CI: 0.50–1.51) and death (0.60% vs. 0.86% respectively, OR: 0.71, 95%CI: 0.28–1.82). In subgroup analysis, there was significant reduction of ischemic strokes in the AMPLATZER PFO Occluder arm vs. medical therapy (1.4% vs. 3.04% respectively, OR: 0.46, 95%CI: 0.21–0.98, relative-risk-reduction: 53.2%, absolute-risk-reduction: 1.6%, number-needed-to-treat: 61.8) but not in the STARFlex device (2.7% vs. 2.8% with medical therapy, OR: 0.93, 95%CI: 0.45–2.11). Compared to medical therapy, the number of patients with new-onset atrial fibrillation (AF) was similar in the AMPLATZER PFO Occluder arm (0.72% vs. 1.28% respectively, OR: 1.81, 95%CI: 0.60–5.42) but higher in the STARFlex device (0.64% vs. 5.14% respectively, OR: 8.30, 95%CI: 2.47–27.84).

Conclusions

This meta-analysis does not support PFO closure for secondary prevention with unselected devices in cryptogenic stroke/TIA. In subgroup analysis, selected closure devices may be superior to medical therapy without increasing the risk of new-onset AF, however. This observation should be confirmed in further trials using inclusion criteria for patients with high likelihood of PFO-related stroke recurrence.  相似文献   

6.

Background

Patent foramen ovale (PFO) might be a risk factor for unexplained (“cryptogenic”) stroke or transient ischemic attack (TIA). We sought to determine the efficacy and safety of transcatheter PFO closure compared with antithrombotic therapy for secondary prevention of cerebrovascular events among patients with cryptogenic stroke.

Methods

We performed a systematic review and meta-analysis of MedLine and Embase (from inception to March 2013) for randomized controlled trials (RCTs) that compared transcatheter PFO closure with medical therapy in subjects with cryptogenic stroke. Data were independently extracted on trial conduct quality, baseline characteristics, efficacy, and safety events from published articles and appendices. Risk ratios (RRs) and 95% confidence intervals (CIs) for the composite of stroke or TIA, and adverse cardiovascular events including atrial fibrillation/flutter were constructed.

Results

Three RCTs of 2303 subjects with previous stroke, TIA, or systemic arterial embolism (mean age, 45.7 years; 47.3% women; mean follow-up, 2.6 years) were included. PFO closure did not significantly reduce the risk of recurrent stroke/TIA (3.7% vs 5.2%; RR, 0.73; 95% CI, 0.50-1.07; P = 0.10); however, an increased risk of incident atrial fibrillation/flutter was detected (3.8% vs 1.0%; RR, 3.67; 95% CI, 1.95-6.89; P < 0.0001). No significant heterogeneity was detected for any end point among subgroups of patients stratified according to age, sex, index cardiovascular event, device type, interatrial shunt size, and presence of an atrial septal aneurysm (all P interactions ≥ 0.09).

Conclusions

Meta-analysis of RCTs that assessed transcatheter PFO closure for secondary prevention of cerebrovascular events in subjects with cryptogenic stroke does not demonstrate benefit compared with antithrombotic therapy, and suggests potential risks.  相似文献   

7.

Objectives

This study was sought to evaluate the effectiveness of patent foramen ovale (PFO) closure in selected patients (PFO shunt grade more than moderate) with cryptogenic stroke (CS).

Background

Whether closure of PFO is an effective treatment for prevention of CS is still unclear.

Methods

Consecutive 158 patients (mean age: 49.9 years old, closure group: 67 patients, medication group: 91 patients) were enrolled. The primary end point was a composite of recurrent stroke and transient ischemic attack.

Results

Baseline characteristics were similar between the two groups, except age which was younger in the closure group (47.7 ± 10.8 vs 51.9 ± 9.9, P = 0.013), and the presence of shunt at rest was more common in the closure group (35.8% vs 10.4%, P = 0.000). Procedural success was 94.0%. Over a mean follow‐up of 27.8 months, a total of six primary end point, all of which were strokes, occurred only in the medication group (6.6% vs 0%, P = 0.039). Stroke‐free survival rate was significantly higher in the closure group (P = 0.026)

Conclusions

Our study showed that PFO closure may be an effective treatment strategy to prevent recurrent stroke or TIA for patients with CS if it is conducted in selective patients who have PFO shunt more than moderate grade.
  相似文献   

8.

Background

Transcatheter left atrial appendage (LAA) occlusion is an alternative strategy for stroke prevention in patients with atrial fibrillation (AF).

Objectives

This study sought to determine the incidence, predictors, and prognosis of thrombus formation on devices in patients with AF who were treated with LAA closure.

Methods

The study retrospectively analyzed data from patients treated with 2 LAA closure devices seen in 8 centers in France from February 2012 to January 2017.

Results

A total of 469 consecutive patients with AF underwent LAA closure (272 Watchman devices [Atritech, Boston Scientific, Natick, Massachusetts] and 197 Amplatzer devices [St. Jude Medical, Minneapolis, Minnesota]). Mean follow-up was 13 ± 13 months, during which 339 (72.3%) patients underwent LAA imaging at least once. There were 98 major adverse events (26 thrombi on devices, 19 ischemic strokes, 2 transient ischemic attacks, 18 major hemorrhages, 33 deaths) recorded in 89 patients. The incidence of device-related thrombus in patients with LAA imaging was 7.2% per year. Older age (hazard ratio [HR]: 1.07 per 1-year increase; 95% confidence interval [CI]: 1.01 to 1.14; p = 0.02) and history of stroke (HR: 3.68; 95% CI: 1.17 to 11.62; p = 0.03) were predictors of thrombus formation on the devices, whereas dual antiplatelet therapy (HR: 0.10; 95% CI: 0.01 to 0.76; p = 0.03) and oral anticoagulation at discharge (HR: 0.26; 95% CI: 0.09 to 0.77; p = 0.02) were protective factors. Thrombus on the device (HR: 4.39; 95% CI: 1.05 to 18.43; p = 0.04) and vascular disease (HR: 5.03; 95% CI: 1.39 to 18.23; p = 0.01) were independent predictors of ischemic strokes and transient ischemic attacks during follow-up.

Conclusions

Thrombus formation on the device is not uncommon in patients with AF who are treated by LAA closure. Such events are strongly associated with a higher risk of ischemic stroke during follow-up. (REgistry on Real-Life EXperience With Left Atrial Appendage Occlusion [RELEXAO]; NCT03279406)  相似文献   

9.
Patent foramen ovale and atrial septal defect are risk factors for paradoxical embolism and subsequent cerebral ischemic events. The transseptal passage of emboli from the right to the left cardiac chambers appears to play an important role. The therapeutic options are medical therapy (anti-aggregation or anticoagulation), surgical closure, or transcatheter closure. Transcatheter closure of atrial septal defects affords the advantage of closing an atrial defect without the associated morbidity of open-heart surgery and the bleeding sequelae of oral anticoagulation. After closure, however, the presence of a residual shunt is independently associated with an increased risk of recurrent ischemic events. Newer devices, such as the AMPLATZER Septal Occluder, have decreased the risk of residual shunting and thromboembolic events. In addition, they have a very low risk of device dislodgement, migration, and embolization.We describe the case of a 60-year-old woman with Ebstein anomaly and recurrent ischemic strokes who presented with acute ischemic infarcts and paradoxical embolism 3 years after undergoing transcatheter closure of an atrial septal defect. A right-to-left shunt through a displaced AMPLATZER Septal Occluder was detected. Pulmonary hypertension and resultant right ventricular failure and right atrial dilation could have contributed to the persistent shunting and paradoxical embolism.To our knowledge, the delayed dysfunction of an AMPLATZER Septal Occluder has not been reported. In addition to describing the patient''s case, we review the relevant medical literature.Key words: Ebstein anomaly/pathology, echocardiography, embolism, paradoxical/complications/epidemiology/etiology/physiopathology, foramen ovale, patent/therapy, heart septal defects, atrial/therapy, ischemic attack, transient/etiology/prevention & control, risk factors, septal occluder device, stroke/etiology/prevention & control, thrombosis/etiologyA right-to-left intracardiac shunt due to patent foramen ovale (PFO) or atrial septal defect (ASD) increases the risk of cerebrovascular events (stroke, transient ischemic attack [TIA], or peripheral emboli) due to paradoxical embolism. The transseptal passage of emboli from the right to the left cardiac chambers due to transient increases in right-side pressures (from the Valsalva maneuver or coughing) or persistent elevation (as in pulmonary hypertension or Eisenmenger syndrome) appears to play an important role. The therapeutic options are medical therapy (anti-aggregation or anticoagulation), which yields an annual recurrence rate of 3% to 4% for stroke or TIA; surgical closure; or percutaneous transcatheter closure. Whereas long-term medical therapy increases the risk of bleeding sequelae, percutaneous closure of ASDs has been equally efficacious and offers the advantage of closing a defect without the associated morbidity of open-heart surgery or the bleeding sequelae of oral anticoagulation. Several single-center, nonrandomized studies have shown the safety of transcatheter PFO closure and its protective effects against recurrent neurologic events.1–4 The totality of evidence suggests that device closure is a safe and effective alternative to surgical closure for preventing recurrent episodes of paradoxical embolism.5,6 Along with fewer complications, percutaneous treatment offers other advantages over open surgery, such as shorter hospital stays, earlier return to normal activities, and better cosmesis.7 Although rare, device displacement leading to failure and cardiac erosion is a known and severe sequela of device closure.Ebstein anomaly is a congenital cardiac malformation characterized by apical displacement of the septal and posterior tricuspid valve leaflets, leading to various degrees of hypertrophy and thinning of the atrialized portion of the right ventricle. An associated atrial septal communication, whether an ASD or a PFO, can enable right-to-left shunting with right atrial pressure elevation, particularly upon exertion (when cardiac output is increased and the right ventricle is required to accept more volume).8 We report the case of a woman with Ebstein anomaly in whom device displacement occurred, and we review other cases of device-related sequelae.  相似文献   

10.

Background

Non-vitamin K oral anticoagulants are now proven alternatives to vitamin K antagonists for stroke prevention in atrial fibrillation. However, there are few data on the efficacy and safety of their use for cardioversion, in which the risk of thromboembolic events is heightened.

Methods

We performed a random-effects meta-analysis of patients undergoing both electrical and pharmacologic cardioversion for atrial fibrillation in the RE-LY, ROCKET-AF, ARISTOTLE, ENGAGE AF-TIMI 48, X-VeRT, and ENSURE-AF trials. We assessed Mantel-Haenszel pooled estimates of risk ratios (RRs) and 95% confidence intervals (CIs) for stroke/systemic embolism and major bleeding at ≤42 days of follow-up.

Results

The analysis pooled 6148 patients in whom 6854 cardioversions for atrial fibrillation were performed. Compared with vitamin K antagonists, non-vitamin K antagonist oral anticoagulant therapy was associated with a similar risk of stroke/systemic embolism (RR, 0.82; 95% CI, 0.38-1.75) and major bleeding (RR, 0.98; 95% CI, 0.51-1.87). We found no significant statistical heterogeneity among studies (Cochrane Q P = .75, I2 = 0% for stroke/systemic embolism; P = .54; I2 = 0% for major bleeding).

Conclusions

The short-term incidence of thromboembolism and major bleeding after cardioversion on non-vitamin K antagonist oral anticoagulants was comparable to the incidence observed on dose-adjusted vitamin K antagonist therapy. Non-vitamin K antagonist oral anticoagulants are a reasonable alternative to vitamin K antagonists in patients undergoing cardioversion.  相似文献   

11.

Objectives

The purpose of this study was to compare the effectiveness of device closure with the transseptal puncture and standard technique in patients with patent foramen ovale (PFO) and ischemic events.

Methods

Eighty‐two consecutive patients (men: 60 patients, mean age: 45.2 years) who underwent PFO closure with the Amplatzer PFO Occluder were enrolled. PFO closure with the transseptal puncture was performed in 22 patients (transseptal puncture technique, group I). In the remaining patients (n = 60), PFO closure was performed with the standard technique (group II). The co‐primary end points were the incidence of significant residual shunt on follow‐up transesophageal echocardiography (TEE) and a composite of death, stroke, transient ischemic attack (TIA), and peripheral embolism.

Results

Baseline characteristics were similar between the two groups. On TEE, despite similar grade of interatrial right‐to‐left shunt, shunt at rest/septal hypermobility was less common in group I than in group II (40.9% vs. 72.9%, P < 0.010). The device was successfully implanted in all patients. On follow‐up TEE, significant residual shunt was more common in group I than in group II (28.6% vs. 4.3%, P = 0.021). In addition, composite of death, stroke, TIA, or peripheral embolism was more common in group I than in group II (13.6% vs. 0%, P = 0.017) during the follow‐up period (mean 25.4 months).

Conclusion

Compared to the standard technique, PFO closure with the transseptal puncture technique showed higher incidence of residual shunt and ischemic events. Therefore, this technique might be considered in only highly selected patients as the last option.
  相似文献   

12.

Background

Although diabetes mellitus is an established risk factor for myocardial infarction and stroke, data on the association with sudden cardiac death are less extensive and the findings have not been entirely consistent. We therefore conducted a systematic review and meta-analysis of prospective studies on diabetes mellitus and risk of sudden cardiac death.

Methods and results

PubMed and Embase databases were searched up to July 18th 2017. Prospective studies that reported adjusted relative risk (RR) estimates and 95% confidence intervals (CIs) for the association between a diabetes diagnosis or pre-diabetes and risk of sudden cardiac death were included. Summary RRs were estimated by use of a random effects model. Nineteen population-based prospective studies (11 publications) (3610 cases, 249,225 participants) and 10 patient-based prospective studies (2713 cases, 55,098 participants) were included. The summary RR for diabetes patients vs. persons without diabetes was 2.02 (95% CI: 1.81–2.25, I2 = 0%, pheterogeneity = 0.91) in the population-based studies. The summary RR was 1.23 (95% CI: 1.05–1.44, I2 = 6%, pheterogeneity = 0.34) for the association between pre-diabetes and sudden cardiac death (n = 3 studies, 1000 sudden cardiac deaths, 18,360 participants). In the patient-based studies, the summary RR of sudden cardiac death for diabetes patients vs. patients without diabetes was 1.75 (95% CI: 1.51–2.03, I2 = 39%, pheterogeneity = 0.10) for all patients combined, 1.63 (95% CI: 1.36–1.97, I2 = 39%, n = 5) for coronary heart disease patients, and 1.85 (95% CI: 1.48–2.33, I2 = 0%, n = 3) for heart failure patients.

Conclusions

These results suggest that diabetes patients are at an increased risk of sudden cardiac death both in the general population and among different patient groups.  相似文献   

13.
Patent foramen ovale is a common clinical finding that generally becomes a concern in the presence of transient ischemic attack or stroke. Rarely, patent foramen ovale is associated with hypoxemia in the presence of substantial right-to-left atrial shunting.We present the case of an 86-year-old woman with a pacemaker, who was initially asymptomatic notwithstanding a patent foramen ovale. Over 1.5 years, her symptoms progressed in a stepwise fashion, in the setting of progressive pacemaker-associated tricuspid regurgitation. Ultimately, the patient''s symptoms and her hypoxemia resolved after percutaneous closure of her patent foramen ovale with use of a 25-mm “Cribriform” occluder device.This case highlights the fact that clinically significant right-to-left shunting requires an anatomic lesion, such as patent foramen ovale, together with elevated right atrial pressure, which in this case was contributed by severe tricuspid regurgitation.  相似文献   

14.

Background

Effective closure performance for patent foramen ovale (PFO) has been suggested to be one of the factors that plays a relevant role in future clinical outcomes after stroke or transient ischemic attack.

Methods

Between January 2009 and June 2012, all consecutive patients undergoing transcatheter PFO closure in our institution using the Amplatzer PFO Occluder (APO) (St Jude Medical, St Paul, MN), BioSTAR (NMT Medical Inc, Boston, MA), GORE HELEX (HELEX) (W.L. Gore & Associates, Newark, DE), and GORE Septal Occluder (GSO) (W.L. Gore & Associates) were included. Closure performance was assessed using transesophageal echocardiography 4 months after the index procedure.

Results

One hundred ninety-three patients were included in the study. Patient distribution was as follows: (1) 48 GSO (24.8%); (2) 34 HELEX (17.6%); (3) 74 APO (38.3%); and (4) 37 BioSTAR (19.1%). No complications occurred during device implantation. During clinical follow-up (20.8 ± 13.2 months), 2 (1.1%) patients had a stroke, 3 (1.7%) patients had a peripheral embolism, and 8 (4.7%) patients presented with a documented atrial arrhythmia. There were no significant differences in clinical outcomes among the devices. Transesophageal echocardiography follow-up revealed higher closure rates with GSO (92.6%) and BioSTAR (93.7%) compared with HELEX (74.2%; P = 0.031 and P = 0.034, respectively) and APO (76.4%; P = 0.036 and P = 0.041, respectively).

Conclusions

The GSO and BioSTAR showed better closure rates than HELEX and APO at 4 months. PFO closure is a safe procedure with a low rate of clinical events at follow-up.  相似文献   

15.

Objectives

We assessed efficacy and safety of the Gore® Septal Occluder (GSO) for patent foramen ovale (PFO) closure focusing on patients with challenging septal anatomies.

Background

In times of controversial discussion whether percutaneous PFO closure is superior to medical therapy for the prevention of recurrent embolic events after cryptogenic stroke, patient selection should mainly focus on individuals with an increased likelihood that the ischaemic event is related to the PFO. In this context, specific septal anatomies—such as the presence of an atrial septal aneurysm as well as long PFO tunnel anatomy—have been associated with a higher rate of cerebrovascular accidents.

Methods

The GSO was used for PFO closure in 41 patients presenting with either atrial septal aneurysm (ASA; 27/41; 65.9%) or long PFO tunnel (> 10 mm; 32/41; 78%). Seven of these patients even presented with a tunnel length ≥ 20 mm (7/41; 17.1%). Eighteen patients had both, long‐tunnel anatomy and ASA (18/41; 43.9%).

Results

The GSO was successfully implanted in all cases. No procedural complications occurred and all patients were discharged the day after the procedure. Short‐term follow‐up, including TEE examination, in all patients was performed 37.6 ± 9.0 days after the procedure. Mid‐term follow‐up was performed after 192.7 ± 45.3 days. Later complications occurred in 7.3% (2 new onset atrial fibrillation, 1 device thrombus). Only 3 patients (7.3%) had more than trace residual shunts at 6‐weeks follow‐up. At 6‐months follow‐up, the complete closure rate was 95.1% (39/41).

Conclusions

The Gore® Septal Occluder is an efficient device for patent foramen ovale closure in challenging anatomies, including long‐tunnel PFOs and atrial septal aneurysms.
  相似文献   

16.

Background

Patent foramen ovale (PFO) closure is the gold standard for treating patients with cryptogenic stroke and PFO. However, scarce data exist on the long-term outcomes following PFO closure.

Objectives

The purpose of this study was to determine the long-term (>10 years) clinical outcomes (death, ischemic, hemorrhagic events) following transcatheter PFO closure.

Methods

We included 201 consecutive patients (mean age: 47 ± 12 years, 51% women) who underwent PFO closure due to a cryptogenic embolism (stroke: 76%, transient ischemic attack [TIA]: 32%, systemic embolism: 1%). Echocardiographic examinations were performed at 1- to 6-month follow-up. Ischemic and bleeding events and antithrombotic medication were collected at a median follow-up of 12 years (range 10 to 17 years), and follow-up was complete in 96% of the patients.

Results

The PFO closure device was successfully implanted in all cases, and residual shunt was observed in 3.3% of patients at follow-up echocardiography. A total of 13 patients died at follow-up (all from noncardiovascular causes), and nondisabling stroke and TIA occurred in 2 and 6 patients, respectively (0.08 strokes per 100 patient-years; 0.26 TIAs per 100 patient-years). A history of thrombophilia (present in 15% of patients) tended to associate with a higher rate of ischemic events at follow-up (p = 0.067). Bleeding events occurred in 13 patients and were major (intracranial bleeding) in 4 patients (all of them under aspirin therapy at the time of the event). A total of 42 patients stopped the antithrombotic treatment at a median of 6 months (interquartile range 6 to 14 months) post-PFO closure, and none of them had any ischemic or bleeding episode after a mean of 10 ± 4 years following treatment cessation.

Conclusions

PFO closure was associated with a low rate of ischemic events (stroke, 1%) at >10 years of follow-up. Major bleeding events occurred in 2% of the patients (all of them in patients on antiplatelet therapy). One-fifth of patients stopped the antithrombotic therapy during the follow-up period (the majority within the first-year post-PFO closure), and this was not associated with any increase in ischemic events at long-term follow-up.  相似文献   

17.

BACKGROUND:

Liver transplantation (LT) using organs donated after cardiac death (DCD) is increasing due, in large part, to a shortage of organs. The outcome of using DCD organs in recipients with hepatits C virus (HCV) infection remains unclear due to the limited experience and number of publications addressing this issue.

OBJECTIVE:

To evaluate the clinical outcomes of DCD versus donation after brain death (DBD) in HCV-positive patients undergoing LT.

METHODS:

Studies comparing DCD versus DBD LT in HCV-positive patients were identified based on systematic searches of seven electronic databases and multiple sources of gray literature.

RESULTS:

The search identified 58 citations, including three studies, with 324 patients meeting eligibility criteria. The use of DCD livers was associated with a significantly higher risk of primary nonfunction (RR 5.49 [95% CI 1.53 to 19.64]; P=0.009; I2=0%), while not associated with a significantly different patient survival (RR 0.89 [95% CI 0.37 to 2.11]; P=0.79; I2=51%), graft survival (RR 0.40 [95% CI 0.14 to 1.11]; P=0.08; I2=34%), rate of recurrence of severe HCV infection (RR 2.74 [95% CI 0.36 to 20.92]; P=0.33; I2=84%), retransplantation or liver disease-related death (RR 1.79 [95% CI 0.66 to 4.84]; P=0.25; I2=44%), and biliary complications.

CONCLUSIONS:

While the literature and quality of studies assessing DCD versus DBD grafts are limited, there was significantly more primary nonfunction and a trend toward decreased graft survival, but no significant difference in biliary complications or recipient mortality rates between DCD and DBD LT in patients with HCV infection. There is insufficient literature on the topic to draw any definitive conclusions.  相似文献   

18.

Objectives

The aim of this study was to assess the incidence of persistently positive results on agitated saline contrast injection after patent foramen ovale (PFO) closure, the underlying mechanism, and management.

Background

Transcatheter intervention to close a PFO is reasonable in highly selected patients younger than 60 years, after a thorough cardioneurological investigation following a cryptogenic stroke, particularly in the presence of thromboembolic disease or in patients at high risk for venous thrombosis. The U.S. Food and Drug Administration approved the Amplatzer PFO Occluder in October 2016 for such an indication. Confirmation of PFO closure is usually verified by an agitated saline contrast injection during an echocardiographic examination. The appearance of bubbles in the left atrium raises the concern of incomplete closure or other sources of shunting.

Methods

The medical records and echocardiograms of patients who were treated with transcatheter closure of a PFO for cryptogenic stroke were reviewed.

Results

From January 1998 through December 2015, 880 patients were taken to the catheter laboratory for PFO closure, of whom 568 patients, 320 men (56.3%), underwent transcatheter closure of a PFO using an Amplatzer PFO Occluder, at a mean age of 48.1 ± 12.9 years. The incidence of right-to-left shunting (RLS) was 19.5% at a mean of 4 months’ follow-up, which reduced to 8.4% at 11 ± 2 months. Sources of RLS were identified in 10 (1.8%); pulmonary arteriovenous malformation (n = 4) was the most common etiology, followed by leak through the device (n = 3). All patients with additional sources of RLS were treated percutaneously. At 2-year follow-up, 16 patients (2.8%) persisted with only mildly positive results on agitated saline contrast injection, without an apparent additional source of shunting.

Conclusions

Coexistence of a PFO and an additional lesion responsible for RLS is uncommon, but not rare; the majority are amenable to transcatheter or surgical intervention.  相似文献   

19.

Purpose

Continuous positive airway pressure (CPAP) therapy may decrease the risk of mortality and cardiovascular events in patients with obstructive sleep apnea. However, these benefits are not completely clear.

Methods

We undertook a meta-analysis of randomized clinical trials identified in systematic searches of MEDLINE, EMBASE, and the Cochrane Database.

Results

Eighteen studies (4146 patients) were included. Overall, CPAP therapy did not significantly decrease the risk of cardiovascular events compared with the control group (odds ratio (OR), 0.84; 95 % confidence intervals (CI), 0.62–1.13; p = 0.25; I 2 = 0 %). CPAP was associated with a nonsignificant trend of lower rate of death and stroke (for death: OR, 0.85; 95 % CI, 0.35–2.06; p = 0.72; I 2 = 0.0 %; for stroke: OR, 0.56; 95 % CI, 0.18–1.73; p = 0.32; I 2 = 12.0 %), a significantly lower Epworth sleepiness score (ESS) (mean difference (MD), ?1.78; 95 % CI, ?2.31 to ?1.24; p < 0.00001; I 2 = 76 %), and a significantly lower 24 h systolic and diastolic blood pressure (BP) (for 24 h systolic BP: MD, ?2.03 mmHg; 95 % CI, ?3.64 to ?0.42; p = 0.01; I 2 = 0 %; for diastolic BP: MD, ?1.79 mmHg; 95 % CI, ?2.89 to ?0.68; p = 0.001; I 2 = 0 %). Daytime systolic BP and body mass index were comparable between the CPAP and control groups. Subgroup analysis did not show any significant difference between short- and mediate-to-long-term follow-up groups with regard to cardiovascular events, death, and stroke.

Conclusions

CPAP therapy was associated with a trend of decreased risk of cardiovascular events. Furthermore, ESS and BP were significantly lower in the CPAP group. Larger randomized studies are needed to confirm these findings.
  相似文献   

20.

Background

Atrial tachyarrhythmias are associated with patent foramen ovale. The objective was to determine the anti-arrhythmic effect of patent foramen ovale closure on pre-existing atrial tachyarrhythmias.

Methods

Medline, EMBASE, Cochrane Library, and Google Scholar databases were searched between 1967 and 2010. The search was expanded using the ‘related articles’ function and reference lists of key studies. All studies reporting pre- and post-closure incidence (or prevalence) of atrial tachyarrhythmia in the same patient population were included. Random and fixed effect meta-analyses were used to aggregate the data.

Results

Six studies were identified including 2570 patients who underwent percutaneous closure. Atrial fibrillation was in fact the only AT reported in all studies. Meta-analysis using a fixed effects model demonstrated a significant reduction in the prevalence of atrial fibrillation with an OR of 0.43 (95% CI 0.26-0.71). When using the random-effects model, OR was 0.44 (95% CI 0.18-1.04) with a statistically significant trend demonstrated (test for overall effect: Z = 1.87, p = 0.06).

Conclusion

Closure of a patent foramen ovale may be associated with reduction in the prevalence of atrial fibrillation.  相似文献   

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