Comparative evaluation of intracardiac, transesophageal, and transthoracic echocardiography in the assessment of patent foramen ovale: A retrospective single-center study.

INTRODUCTION: Certain patent foramen ovale (PFO) characteristics, such as a large right-to-left shunt (RLS) or atrial septal aneurysm, identify patients who may receive the highest clinical benefit from percutaneous PFO closure. This study aimed to compare intracardiac echocardiography (ICE) with standard echocardiographic imaging in the evaluation of high-risk PFO characteristics and RLS severity in patients with PFO-associated stroke. METHODS: We conducted a retrospective review of all patients aged ≥18 years who underwent percutaneous PFO closure for PFO-associated stroke and received all three ultrasound-based cardiac imaging modalities and had interpretable results (N = 51). We then compared RLS severity, high-risk PFO characteristics, and the proportion of patients with a higher likelihood of PFO-associated stroke by ICE versus transthoracic echocardiogram (TTE) and transesophageal echocardiogram (TEE). RESULTS: The final cohort had a mean (±SE) age of 48.4 (±1.8) years and was predominantly female (58.8%). ICE was more likely to identify a large RLS versus TTE/TEE combined (66.7% vs. 45.1%; p = 0.03). The use of ICE resulted in significantly more patients being reclassified as having a higher likelihood of PFO-associated stroke (TTE vs. TEE vs. ICE: 10.4% vs. 14.6% vs. 25%; p = 0.03). A high-quality bubble study was found to be the single most important factor associated with identifying a larger RLS across all modalities (ρ [p]; TTE: 0.49 [<0.001], TEE: 0.60 [<0.001], ICE: 0.32 [0.02]). The presence of a hypermobile septum was associated with significantly greater RLS on ICE (ρ [p]: 0.3 [0.03]), especially with poor quality bubble studies (ρ [p]: 0.49 [0.02]). CONCLUSION: In this observational study of patients with PFO-associated stroke, ICE detected a large RLS more frequently than TTE and TEE; and reclassified some patients as having a higher likelihood of PFO-associated stroke.

Right-to-Left Shunt in Divers with Neurological Decompression Sickness: A Systematic Review and Meta-Analysis.

OBJECTIVE: The aim of this study was to assess the association between the presence of a right-to-left shunt (RLS) and neurological decompression sickness (NDCS) and asymptomatic brain lesions among otherwise healthy divers. BACKGROUND: Next to drowning, NDCS is the most severe phenotype of diving-related disease and may cause permanent damage to the brain and spinal cord. Several observational reports have described the presence of an RLS as a significant risk factor for neurological complications in divers, ranging from asymptomatic brain lesions to NDCS. METHODS: We systematically reviewed the MEDLINE, Embase, and CENTRAL databases from inception until November 2021. A random-effects model was used to compute odds ratios. RESULTS: Nine observational studies consisting of 1830 divers (neurological DCS: 954; healthy divers: 876) were included. RLS was significantly more prevalent in divers with NDCS compared to those without (62.6% vs. 27.3%; odds ratio (OR): 3.83; 95% CI: 2.79-5.27). Regarding RLS size, high-grade RLS was more prevalent in the NDCS group than the no NDCS group (57.8% versus 18.4%; OR: 4.98; 95% CI: 2.86-8.67). Further subgroup analysis revealed a stronger association with the inner ear (OR: 12.13; 95% CI: 8.10-18.17) compared to cerebral (OR: 4.96; 95% CI: 2.43-10.12) and spinal cord (OR: 2.47; 95% CI: 2.74-7.42) DCS. RLS was more prevalent in divers with asymptomatic ischemic brain lesions than those without any lesions (46.0% vs. 38.0%); however, this was not statistically significant (OR: 1.53; 95% CI: 0.80-2.91). CONCLUSIONS: RLS, particularly high-grade RLS, is associated with greater risk of NDCS. No statistically significant association between RLS and asymptomatic brain lesions was found.

Patent foramen Ovale-related paradoxical embolism after noncardiac surgery.

Patent foramen ovale (PFO) is a remnant of the fetal circulation that remains in a significant portion of the adult population, predisposing to a higher risk of stroke. This risk is further elevated in the postoperative hypercoagulative period. Here we present a case where a patient underwent a total knee arthroplasty and presented with right-sided hemiparesis on post-operative day 2. Subsequently, the patient underwent percutaneous PFO closure with a 25-mm Amplatzer PFO Occluder (Abbott; Chicago, IL, USA). The patient has not had a stroke since the PFO closure. Recent randomized trials have demonstrated superiority of percutaneous PFO closure over standard-of-care medical therapy for secondary prevention of PFO-associated stroke. Since post-operative PFO-associated stroke is under-recognized in clinical practice, further large-cohort studies are needed to evaluate whether PFO screening and device closure would decrease post-operative stroke risk for noncardiac surgeries. Learning Objective: Patent foramen ovale (PFO) is a remnant of the fetal circulation commonly found in the adult population, which can increase the risk of stroke. Stroke is a complication of PFO, yet closure of this remnant only occurs on a specific case-by-case basis. Further research in this area is required to determine whether a larger population would benefit from PFO closure.

Pooled Analysis of PFO Occluder Device Trials in Patients With PFO and Migraine.

BACKGROUND: Although observational studies have shown percutaneous patent foramen ovale (PFO) closure to be a safe means of reducing the frequency and duration of migraine, randomized clinical trials have not met their primary efficacy endpoints. OBJECTIVES: The authors report the results of a pooled analysis of individual participant data from the 2 randomized trials using the Amplatzer PFO Occluder to assess the efficacy and safety of percutaneous device closure as a therapy for episodic migraine with or without aura. METHODS: The authors analyzed individual patient-level data from 2 randomized migraine trials (the PRIMA [Percutaneous Closure of Patent Foramen Ovale in Migraine With Aura] and PREMIUM [Prospective Randomized Investigation to Evaluate Incidence of Headache Reduction in Subjects with Migraine and PFO Using the Amplatzer PFO Occluder Compared to Medical Management] studies). Efficacy endpoints were mean reduction in monthly migraine days, responder rate (defined as ≥50% reduction in monthly migraine attacks), mean reduction in monthly migraine attacks, and percentage of patients who experienced complete cessation of migraine. The safety endpoint was major procedure- and device-related adverse events. RESULTS: Among 337 subjects, 176 were randomized by blocks to device closure and 161 to medical treatment only. At 12-month follow-up, the analysis met 3 of the 4 efficacy endpoints: mean reduction of monthly migraine days (-3.1 days vs. -1.9 days; p = 0.02), mean reduction of monthly migraine attacks (-2.0 vs. -1.4; p = 0.01), and number of subjects who experienced complete cessation of migraine (14 [9%] vs. 1 [0.7%]; p < 0.001). For the safety analysis, 9 procedure-related and 4 device-related adverse events occurred in 245 subjects who eventually received devices. All events were transient and resolved. CONCLUSIONS: This pooled analysis of patient-level data demonstrates that PFO closure was safe and significantly reduced the mean number of monthly migraine days and monthly migraine attacks, and resulted in a greater number of subjects who experienced complete migraine cessation.

Safety of transradial access compared to transfemoral access with hemostatic devices (vessel plugs and suture devices) after percutaneous coronary interventions: A systematic review and meta-analysis.

OBJECTIVES: Comparing the safety of transradial access (TRA) and conventional hemostasis with transfemoral access (TFA) and vascular closure devices (vessel plugs and suture devices) in patients undergoing percutaneous coronary interventions. BACKGROUND: TRA for PCIs is associated with fewer bleeding and vascular complications compared with TFA. Vascular closure devices (VCD) are often used post TFA to establish early hemostasis and mitigate bleeding risk. However, the comparative efficacy of TRA and TFA with VCDs remains controversial. METHOD: Electronic database were systematically searched for all pertinent studies from inception through January 2020. Randomized studies, registry data, and abstracts published in peer-reviewed indexed journals were included. The short-term outcomes: major bleeding, vascular complications, and closure device failure were evaluated. Random-effects model was used to pool individual study results. RESULTS: Twelve studies (8 observational, 4 randomized) including 7,961 patients (TRA: 3,121 patients, TFA and vessel plugs: 3,157 patients, TFA & suture devices: 1,683 patients) were included in the analysis. Major bleeding was significantly lower with TRA compared with TFA and vessel plugs (odds ratio [OR] 0.22, 95%CI 0.11-0.44, p < .00001) and TFA & suture devices (OR 0.12, 95%CI 0.05-0.28, p < .00001). Vascular complications were significantly lower with TRA compared to TFA and vessel plugs (OR 0.25, 95%CI 0.13-0.49, p < .0001) and TFA & suture devices (OR 0.13, 95%CI 0.04-0.41, p = 0.0005). Rates of closure device failure were lower for TRA compared to TFA & suture devices (OR 0.13, 95%CI 0.04-0.41, p = .0005), but similar to TFA & vessel plugs (OR 0.23, 95%CI 0.01-4.28, p = .33), although confidence intervals were wide. All analysis revealed a low to moderate level of heterogeneity. CONCLUSION: TRA with conventional hemostasis is safer than TFA with hemostasis via vessel plugs or suture devices and should be considered best practice.

Proposal for Updated Nomenclature and Classification of Potential Causative Mechanism in Patent Foramen Ovale-Associated Stroke.

Importance: Recent epidemiologic and therapeutic advances have transformed understanding of the role of and therapeutic approach to patent foramen ovale (PFO) in ischemic stroke. Patent foramen ovale is likely responsible for approximately 5% of all ischemic strokes and 10% of those occurring in young and middle-aged adults. Observations: Randomized clinical trials have demonstrated that, to prevent recurrent ischemic stroke in patients with PFO and an otherwise-cryptogenic index ischemic stroke, PFO closure is superior to antiplatelet medical therapy alone; these trials have provided some evidence that, among medical therapy options, anticoagulants may be more effective than antiplatelet agents. Conclusions and Relevance: These new data indicate a need to update classification schemes of causative mechanisms in stroke, developed in an era in which an association between PFO and stroke was viewed as uncertain. We propose a revised general nomenclature and classification framework for PFO-associated stroke and detailed revisions for the 3 major stroke subtyping algorithms in wide use.

Peripheral Arterial Disease in Women: The Gender Effect.

Peripheral arterial disease (PAD) is a common atherosclerotic disease approximately affecting 8.5 million Americans above age 40 and is associated with significant functional impairment, morbidity and mortality from both cardiovascular and non-cardiovascular causes. PAD has increasing prevalence in females contrary to previous findings. Compared to men, women with PAD are more asymptomatic or have atypical symptoms. Women with PAD have increased quality of life impairment, increased risk of depression and increased cardiovascular mortality. The intent of this review is to provide an update on gender differences in PAD that can help in timely diagnosis and appropriate management through intensive cardiovascular risk factor modification, exercise program and guideline directed therapy to improve cardiovascular outcomes.

Revascularization strategies for patients with myocardial infarction and multi-vessel disease: A critical appraisal of the current evidence.

Approximately half of patients presenting with myocardial infarction are found to have non-infarct related multi-vessel severe coronary artery disease. Various observational studies and randomized controlled trials have been conducted to assess if revascularization of non-infarct related artery is associated with better clinical outcomes. In this review, the authors discuss the various revascularization strategies in patients with multi-vessel disease who present with myocardial infarction.

Transcatheter Closure of Patent Foramen Ovale: Randomized Trial Update.

A patent foramen ovale (PFO) is found in about one-quarter of all adults, but the prevalence increases to approximately half of those with a history of a so-called cryptogenic stroke. The true efficacy of PFO closure for prevention of recurrent paradoxical embolism has been debated for years, as the early 3 randomized trials did not show a statistically significant benefit of PFO closure over standard-of-care medical therapy. However, 3 recent randomized trials along with the long-term follow-up data from the largest early trial demonstrated superiority of device closure for secondary stroke prevention.

Patent Foramen Ovale and Hypoxemia.

Patent foramen ovale (PFO), an embryonic remnant of the fetal circulation, is present in 20-25% of adults. Although recent observational studies and clinical trials have established the link between PFO-mediated right-to-left shunting with cryptogenic stroke and migraine with aura, the role of a PFO in exacerbating hypoxemic medical conditions (ie, sleep apnea, chronic obstructive pulmonary disease, pulmonary hypertension, platypnea-orthodeoxia, pulmonary arteriovenous malformation, high-altitude pulmonary edema, and exercise desaturation) remains less understood. PFO-mediated hypoxemia occurs when deoxygenated venous blood from the right atrium enters and mixes with oxygenated arterial blood in the left atrium. Patients with an intracardiac right-to-left shunt may have profound hypoxemia out of proportion to underlying primary lung disease, even in the presence of normal right-sided pressures. The presence of right-to-left cardiac shunting can exacerbate the degree of hypoxemia in patients with underlying pulmonary disorders. In a subset of these patients, percutaneous PFO closure may result in marked improvement in dyspnea and hypoxemia. This review discusses the association between PFO-mediated right-to-left shunting with medical conditions associated with hypoxemia and explores the role of percutaneous PFO closure in alleviating the hypoxemia.

Drug-Eluting Balloons Versus Everolimus-Eluting Stents for In-Stent Restenosis: A Meta-Analysis of Randomized Trials.

OBJECTIVES: Individual randomized trials comparing drug-eluting balloons (DEB) versus everolimus-eluting stents (EES) for in-stent restenosis (ISR) were underpowered for clinical end-points. The objective of this study was to compare the clinical outcomes of DEB versus EES for any ISR. MATERIALS & METHODS: Electronic databases were searched for randomized trials which compared DEB versus EES for any ISR (i.e., drug eluting or bare metal stents). Summary estimate risk ratios (RRs) were constructed using a DerSimonian and Laird random effects model. RESULTS: Five trials with 962 patients were included. In-segment minimum lumen diameter (MLD) was lower with DEB (standardized mean difference -0.24, 95% confidence interval [CI] -0.46 - -0.01) on angiographic follow-up at a mean of 8.6 months. There was no statistically significant difference in the risk of target vessel revascularization (TVR) at 1 year (RR 1.15, 95% CI 0.60-2.19), but TVR was increased with DEB at 3 years (RR 1.87, 95% CI 1.15-3.03). The risk of target lesion revascularization (TLR) was statistically increased with DEB (RR 2.17, 95% CI 1.13-4.19) at a mean of 24.4 months. There was no difference in the risk of MI, stent thrombosis, cardiac mortality and all-cause mortality between both groups. CONCLUSION: In patients with any type of ISR, DEB was associated a similar risk of TVR at 1-year, but increased risk of TVR and TLR at longer follow-up, as compared with EES. The quality of evidence was moderate, suggesting the need for further randomized trials with longer follow-up to confirm the role of DEB in the management of ISR.