Identification of potential influencing factors associated with elimination of migraine headache in patients with PFO after percutaneous closure / 中华心血管病杂志

Objective: To recognize the potential factors that contribute to the eradication of migraine headache in patients with patent foramen ovale (PFO) at one year after percutaneous closure. Methods: A prospective cohort study was conducted, which enrolled patients diagnosed with migraines and PFO at the Department of Structural Heart Disease, First Affiliated Hospital of Xi'an Jiaotong University between May 2016 and May 2018. The patients were segregated into two groups based on their response to treatment, and one group showed elimination of migraines while another did not. Elimination of migraines was defined as a Migraine Disability Assessment Score (MIDAS) score of 0 at one year postoperatively. Least Absolute Shrinkage and Selection Operator (LASSO) regression model was utilized to identify the predictive variables for migraine elimination post-PFO closure. Multiple logistic regression analysis was employed to determine the independent predictive factors. Results: The study enrolled a total of 247 patients, with an average age of (37.5±13.6) years, comprising 81 male individuals (32.8%). One year after closure, 148 patients (59.9%) reported eradication of their migraines. Multivariate logistic regression analysis revealed that migraine with or without aura (OR=0.003 9, 95%CI 0.000 2-0.058 7, P=0.000 18), a history of antiplatelet medication use (OR=0.088 2, 95%CI 0.013 7-0.319 3, P=0.001 48) and resting right-to-left shunt (RLS) (OR=6.883 6, 95%CI 3.769 2-13.548 0, P<0.001) were identified as independent predictive factors for elimination of migraine. Conclusion: Migraine with or without aura, a history of antiplatelet medication use, and resting RLS are the independent prognostic factors associated with elimination of migraine. These results provide important clues for clinicians to choose the optimal treatment plan for PFO patients. However, further studies are needed to confirm these findings.

Safety and efficacy of left atrial appendage closure combined with patent foramen ovale closure for atrial fibrillation patients with patent foramen ovale / 中华心血管病杂志

Objective: To analyze the safety and efficacy of combined left atrial appendage (LAA) and patent foramen ovale (PFO) closure in adult atrial fibrillation (AF) patients complicating with PFO. Methods: This study is a retrospective and cross-sectional study. Seven patients with AF complicated with PFO diagnosed by transesophageal echocardiography (TEE) in Zhoupu Hospital Affiliated to Shanghai University of Medicine & Health Sciences from June 2017 to October 2020 were selected. Basic data such as age, gender and medical history were collected. The atrial septal defect or PFO occluder and LAA occluder were selected according to the size of PFO, the ostia width and depth of LAA. Four patients underwent left atrial appendage closure(LAAC) and PFO closure at the same time. PFO closure was performed during a one-stop procedure of cryoablation combined with LAAC in 2 patients. One patient underwent PFO closure at 10 weeks after one-stop procedure because of recurrent transient ischemic attack (TIA). All patients continued to take oral anticoagulants. TEE was repeated 8-12 weeks after intervention. In case of device related thrombus(DRT), TEE shall be rechecked 6 months after adjusting anticoagulant and antiplatelet drug treatment. Patients were follow-up at 1, 3, 6, 12, 24 months by telephone call, and the occurrence of cardio-cerebrovascular events was recorded. Results: Among the 7 patients with AF, 2 were male, aged (68.0±9.4) years, and 3 had a history of recurrent cerebral infarction and TIA. Average PFO diameter was (3.5±0.8)mm. Three patients were implanted with Watchman LAA occluder (30, 30, 33 mm) and atrial septal defect occluder (8, 9, 16 mm). 2 patients were implanted with LAmbre LAA occluder (34/38, 18/32 mm) and PFO occluder (PF1825, PF2525). 2 patients were implanted with LACbes LAA occluder (24, 28 mm) and PFO occluder (PF2525, PF1825) respectively. The patients were followed up for 12 (11, 24) months after operation. TEE reexamination showed that the position of LAA occluder and atrial septal defect occluder or PFO occluder was normal in all patients. DRT was detected in 1 patient, and anticoagulant therapy was adjusted in this patient. 6 months later, TEE showed that DRT disappeared. No cardiovascular and cerebrovascular events occurred in all patients with AF during follow-up. Conclusions: In AF patients complicated with PFO, LAAC combined with PFO closure may have good safety and effectiveness.

Historia natural del cierre percutáneo de foramen oval permeable / Natural history of patent foramen ovales closure

INTRODUCCIÓN: El cierre percutáneo del foramen oval permeable (FOP) se ha posicionado como el tratamiento de elección para la prevención secundaria de pacientes con infartos encefálicos (IE) criptogénicos asociados a FOP. OBJETIVO: Revisar los cierres de FOP realizados en nuestra institución, evaluando las características clínicas y del procedimiento, los resultados a mediano plazo luego del procedimiento y la tendencia en el número de intervenciones durante el período estudiado. MÉTODOS: Se incluyeron 101 pacientes consecutivos en que se realizó cierre de FOP, con una mediana de seguimiento de 4,6 años. Se analizaron las características basales de los pacientes, la indicación del cierre de FOP, el éxito del procedimiento y la presencia de shunt residual en ecocardiografía al año. Se realizó una encuesta telefónica estructurada a todos los pacientes, en la cual se preguntó por nuevo IE o crisis isquémica transitoria (CIT), otros eventos cardiovasculares y la presencia de sangrados. El seguimiento fue completado en el 95%. Se calculó el puntaje RoPE ("Risk of Paradoxical Embolism") el cual provee una estimación de la posibilidad de que ese IE se haya debido al FOP y del riesgo de repetir un nuevo IE en caso de no cerrar el FOP para cada paciente. RESULTADOS: La edad promedio fue de 49,1±13,7 años, con 53% mujeres. Sólo en 3 pacientes se diagnosticó una trombofilia. En 96 pacientes la indicación fue para prevención de embolía paradojal e IE (74% IE, 17% CIT y 4% embolía periférica), mientras que en 5% por síndrome de ortodeoxia/platipnea. El cierre de FOP fue exitoso en todos los pacientes. Shunt residual en ecocardiograma al año se observó en 5% - ninguno de estos pacientes presentó un nuevo evento encefálico durante el seguimiento. Se registraron 2 nuevos IE (4 IE por 1000 pacientes/año) y 1 nueva CIT (2 CIT por 1000 pacientes/año) en el seguimiento, con un promedio de presentación de 3,6 años post procedimiento. Esta tasa de eventos fue significativamente menor a lo predicho por el puntaje RoPE en nuestra cohorte. Se observó un marcado aumento en el número de procedimientos desde el año 2017 en adelante. CONCLUSIONES: En nuestra cohorte, el cierre de FOP fue un procedimiento exitoso y seguro. Se asoció a una baja tasa de nuevos eventos cerebrales, marcadamente menor a lo estimado por el puntaje de riesgo actualmente disponible (RoPE).

INTRODUCTION: The percutaneous closure of a patent foramen ovale (PFO) has been established as the preferred treatment for those with an ischemic stroke (IS) and associated PFO. AIMS: To review the PFO closure experience at our institution, characterizing the patients and procedures, mid-term results and the trend in the number of interventions during the study period. METHODS: One hundred and one consecutive patients undergoing PFO closure were included, with a median follow-up of 4.6 years. Baseline demographics, PFO closure indications, procedural success rates and residual shunt at 1-year were recorded. A telephonic survey was performed to complete follow-up, asking for new IS or transient ischemic attacks (TIA), other cardiovascular events and bleeding. Follow-up was completed by 95%. The RoPE score was calculated for each patient, providing an estimate of the chance a given IS being due to a PFO and the risk of a new event when the defect is not closed. RESULTS: Mean age was 49.1±13.7 years and 53% were females. Whereas the indication for PFO closure was paradoxical embolism in 96 patients (74% IS, 17% TIA and 4% peripheral embolism), in 5 it was for platypnea-orthodeoxia syndrome. All patients had a successful PFO closure procedure. Residual shunt at 1 year was found in 5% - yet, none of these patients experienced a new stroke during the study period. During follow-up there were 2 new IS (4 IS per 1,000 patients/year) and 1 new TIA (2 TIA per 1,000 patients/year), with a mean incidence time of 3.6 years after the procedure. This rate of new events was significantly lower than the one predicted by the RoPE score. From 2017 onwards, there was a marked increase in the number of procedures performed at our institution. CONCLUSION: In this cohort, PFO closure was a successful and safe procedure. It was associated to a low rate of new cerebral events during mid-term follow-up, markedly lower than the RoPE predicted rate.

The Role of Patent Foramen Ovale Closure in the Secondary Prevention of Cryptogenic Stroke: a Meta-Analysis Report

Abstract Background: Patent foramen ovale (PFO) closure has been compared to medical therapy for secondary prevention of recurrent cryptogenic stroke. Objectives: To produce an updated meta-analysis including only data from the primary analyses of clinical trials and to evaluate the role of PFO closure in the secondary prevention of recurrent stroke. Methods: Search in Medline (PubMed) and in ISI Web of Knowledge. Parameters under analysis and meta-analyses were: stroke, transient ischemic attack (TIA) and atrial fibrillation (AF). Comprehensive Meta-analysis Software V.2.0 (Biostat) was used. Random-effects analyses were carried out. A level of significance of 5% was used. Results: In this study six, randomized trials enrolling 3,750 patients were included. Unlike other published meta-analyses on the same topic, in this case, only clinical trial data, and not follow-up data, were used. PFO closure, as compared with medical therapy alone, demonstrated superiority in reducing the rate of recurrent stroke (risk ratio with PFO closure vs. medical therapy, 0.37; 95% confidence interval [CI], 0.17 to 0.78; p = 0.01). PFO closure did not offer a significant benefit in prevention of TIA (risk ratio with PFO closure vs. medical therapy, 0.96; 95% CI, 0.64 to 1.44; p = 0.85). Among patients assigned to closure group, an increased risk of atrial fibrillation was seen (risk ratio with PFO closure vs. medical therapy, 4.64; 95% CI, 2.38 to 9.01; p < 0.01). Conclusions: In patients with cryptogenic stroke who had a patent foramen ovale, a protective effect of closure was seen concerning the risk of recurrent stroke, but not regarding the prevention of TIA.

Endovascular closure of patent foramen ovale: a critical appraisal of published trials / Fechamento endovascular do forame oval patente: análise crítica dos estudos publicados

ABSTRACT The treatment of cryptogenic stroke patients with a patent foramen ovale (PFO) is controversial. A critical review of these studies is presented. Methods A description of all trials comparing medical and endovascular treatment with closing devices is given. Additional pertinent studies are discussed to help construct a rational basis for treatment decisions. Results Initial negative trials evaluating PFO closure were followed by positive studies published in 2017 and 2018. All trials evaluated young patients (up to 60 years). Methodological problems are present in all trials including their open label construction. Most positive trials developed strategies to increase the percentage of patients with interatrial septal aneurysms or hypermobility and large right-to-left shunts. Even in these positive trials, large numbers of patients need to be treated to avoid one stroke. Atrial fibrillation occurred in 2-6% and other adverse effects related to the procedure and to the devices occurred in a substantial number of patients. Incomplete occlusion of the PFO is also frequent. Anticoagulant treatment has not been adequately studied as a therapeutic option. Conclusion Young patients with cryptogenic strokes seem to benefit from endovascular closure of a PFO in the presence of a large right-to-left shunt or an associated atrial septum aneurysm. For most other patients, a highly-individualized decision must be made, taking into account the low risk of recurrence in patients with a cryptogenic stroke attributable to a PFO, the high numbers needed to treat and the risks related to the procedure.

RESUMO O tratamento de pacientes com infarto cerebral criptogênico e forame oval patente (FOP) é controverso. Uma revisão crítica destes estudos é apresentada. Métodos São descritos em detalhes os estudos comparando tratamento médico com o uso de próteses de oclusão do FOP após infarto cerebral. Discutem-se outros estudos pertinentes para ajudar na tomada racional de decisões terapêuticas individualizadas. Resultados Estudos iniciais avaliando fechamento endovascular com próteses foram negativos, porém seguidos de outros estudos com resultados positivos em 2017 e 2018. Somente pacientes até 60 anos foram estudados. Os estudos apresentam vários problemas metodológicos, incluindo sua natureza aberta. A maioria dos estudos positivos desenvolveu estratégias para aumentar o percentual de pacientes com risco aumentado de recorrência, especificamente grandes shunts direita-esquerda e aneurismas/hipermobilidade do septo interatrial. Mesmo estes estudos positivos revelaram um alto NNT (número de pacientes tratados para evitar um evento de desfecho). Fibrilação atrial ocorreu em 2-6 % dos pacientes tratados. Outras complicações relacionadas ao procedimento e às endopróteses e ainda fechamento incompleto do FOP foram também frequentes. Anticoagulantes poderiam constituir estratégia alternativa de tratamento clínico, mas não foram adequadamente estudados. Conclusão Pacientes jovens com infartos criptogênicos parecem beneficiar-se de oclusão endovascular do FOP na presença de grandes shunts e principalmente aneurismas ou hipermobilidade de septo interatrial. Para a maioria dos outros pacientes, uma decisão altamente individualizada deve ser tomada, considerando o baixo risco de recorrência dos infartos atribuíveis ao FOP, o ato NNT e os riscos inerentes ao procedimento.

Ruptura traumática de músculo papilar da valva tricúspide com forame oval patente adquirido e ruptura atrial direita oculta / Traumatic tricuspid valve papillary muscle case with concomitant acquired patent foramen ovale and covert right atrial rupture

RESUMO O traumatismo cardíaco é comum em acidentes com veículos automotores. Uma mulher com 50 anos de idade foi transportada para nosso hospital após sofrer múltiplos traumatismos em um acidente de automóvel quando dirigia em alta velocidade. Após admissão à unidade de terapia intensiva, uma ultrassonografia cardíaca revelou ruptura traumática de músculo papilar da valva tricúspide e forame oval patente, enquanto se observou, no exame físico, o sinal de Lancisi. Foi realizado tratamento cirúrgico com anuloplastia da valva e fechamento do forame oval patente; durante o ato cirúrgico, diagnosticou-se ruptura oculta do átrio direito.

ABSTRACT Cardiac trauma often occurs in motor vehicle accidents. A 50-year-old female driver was transported to our hospital with multiple trauma after a high-speed car accident. After admission to the intensive care unit, cardiac ultrasound examination revealed traumatic tricuspid valve papillary muscle rupture and patent foramen ovale, while Lancisi's sign was noted on physical examination. Surgical treatment was performed with valve annuloplasty and closure of the patent foramen ovale and a covert right atrial defect that was detected intraoperatively.

Updated meta-analysis on the closure of patent foramen ovale in reduction of stroke rates: the defense-pfo trial does not change the scenario

Abstract Objective: We aimed to analyze whether patent foramen ovale (PFO) closure reduces the risk of stroke, assessing also some safety outcomes after the publication of a new trial. Introduction: The clinical benefit of closing a PFO has been an open question, so it is necessary to review the current state of published medical data in regards to this subject. Methods: MEDLINE, EMBASE, CENTRAL/CCTR, SciELO, LILACS, Google Scholar and reference lists of relevant articles were used to search for randomized controlled trials (RCTs) that reported any of the following outcomes: stroke, death, major bleeding or atrial fibrillation. Six studies fulfilled our eligibility criteria and included 3560 patients (1889 for PFO closure and 1671 for medical therapy. Results: The risk ration (RR) for stroke in the "closure" group compared with the "medical therapy" showed a statistically significant difference between the groups, favouring the "closure" group (RR 0.366; 95%CI 0.171-0.782, P=0.010). There was no statistically significant difference between the groups regarding the safety outcomes, death and major bleeding, but we observed an increase in the risk of atrial fibrillation in the "closure" group (RR 4.131; 95%CI 2.293-7.443, P<0.001). We also observed that the larger the proportion of effective closure, the lower the risk of stroke. Conclusion: This meta-analysis found that stroke rates are lower with percutaneously implanted device closure than with medical therapy alone, being these rates modulated by the rates of hypertension, atrial septal aneurysm and effective closure. The publication of a new trial did not change the scenario in the medical literature.

Surgical treatment for thrombus straddling a patent foramen ovale

Abstract We present a case of a 41-year-old female with deep vein thrombosis after abdominal surgery. The patient quickly developed severe pulmonary embolism and stroke representative of paradoxical embolism. Echocardiography showed a thrombus straddling a patent foramen ovale, which was confirmed intraoperatively. An accurate diagnosis and rapid treatment decisions are crucial for preventing patient deterioration in the form of new pulmonary embolisms or stroke.

Postoperative rescue closure of patent foramen ovale in the clinical setting of acute hypoxemic respiratory failure and stroke following coronary artery bypass surgery.

We describe a case of intraoperative diagnosis and successful deferred percutaneous closure of a patent foramen ovale (PFO) in the clinical setting of acute refractory hypoxemic respiratory failure and new‑onset ischemic stroke in an elderly patient after coronary artery bypass graft. Perioperative morbidity (i.e. severe hypoxemia, worsening right ventricular dysfunction, and embolic stroke) that is potentially related to intraoperatively diagnosed PFO during cardiac surgery can complicate management in the Intensive Care Unit and perhaps affect the patient’s outcome. Although the PFO closure can be challenging in the clinical setting of hypoxemic respiratory failure and stroke following cardiac surgery, it can be a reasonable perioperative option.

Is the patent foramen ovale closure the best option? / O fechamento do foramen oval patente é a melhor opção?

Patent foramen ovale (PFO) closure is indicated in some cases to protect patients against embolic events. The aim of this study was to certify that the method of PFO closure to prevent microemboli (MES) is reliable, using contrast enhanced transcranial Doppler (cTCD) as a diagnostic and follow-up tool. METHODS: cTCD was performed before and after PFO closure in 20 patients. Results obtained a minimum of 12 months after the procedure were analyzed in this study. RESULTS: After the procedure, 14 patients (82%) showed no microemboli in cTCD at rest, but after provocative Valsalva maneuver (VM) microembolic phenomenon were still detected in 14 (70%): 7 (35%) <10 MES, 3 (15%) 10-20 MES and 4 (20%) had more than 20 MES ("curtain"). Only six of the total patients presented no MES in both resting and VM. CONCLUSION: These results showed a large percentage of patients with MES detection in a bubble study with transcranial Doppler more than one year after the procedure of PFO closure, showing right-to-left residual shunting. Despite the small number of patients, this study provides important data about this therapeutic decision.

O fechamento do forame oval patente (FOP) é indicado em alguns casos para prevenir eventos embólicos. O objetivo deste estudo foi certificar que o fechamento do FOP previne contra microembolia usando o Doppler transcraniano contrastado (cTCD) como método diagnóstico e de controle. MÉTODOS: O cTCD foi realizado antes e depois do fechamento do FOP em 20 pacientes. Foram analisados somente os resultados obtidos após 12 meses do procedimento. RESULTADOS: Após o procedimento, 14 pacientes (82%) não apresentaram microembolia (MES) ao exame de repouso. Entretanto, após sensibilização com manobra de Valsalva (MV), detectou-se ainda passagem de MES em 14 (70%) dos pacientes: 7 (35%) <10 MES; 3 (15%) 10-20 MES e 4 (20%) com mais de 20 MES (padrão "cortina"). Somente seis pacientes não apresentaram sinais de MES em ambas as etapas do teste (repouso e MV). CONCLUSÃO: Grande porcentagem de pacientes apresentou MES após o procedimento para fechamento do FOP, o que é consistente com presença de shunt direito-esquerdo residual. Apesar do pequeno número de pacientes, este estudo apresenta dados que contribuem com esta importante decisão terapêutica.

Tromboembolismo pulmonar masivo de alto riesgo asociado a foramen oval permeable / High-risk massive pulmonary thromboembolism associated with patent foramen ovale

La alta mortalidad de los pacientes con tromboembolismo pulmonar masivo de alto riesgo amerita un enfoque terapéutico enérgico e invasivo que incluya la embolectomía pulmonar quirúrgica en aquellos pacientes con contraindicación para trombolisis o trombolisis fallida. Describimos un caso de tromboembolismo pulmonar masivo de alto riesgo que recibió tratamiento quirúrgico en vez de trombolisis debido a que al momento del diagnóstico presentaba un trombo móvil a través de un foramen oval permeable con altísima posibilidad de embolismo paradójico arterial.

High mortality rate associated with massive pulmonary embolism requires an aggressive invasive approach including surgical pulmonary embolectomy when thrombolytic therapy has failed or is contraindicated. We describe a case of high-risk massive pulmonary embolism who underwent surgical treatment due to the presence of a mobile intracardiac clot in a patent foramen ovale, and the possible risk of paradoxical arterial embolism.

Oclusão percutânea do forame oval patente com prótese PREMEREtm: resultados preliminares da primeira experiência no Brasil / Percutaneous occlusion of patent foramen ovale with the PREMERE TM device: preliminary results of the first experience in Brazil

INTRODUÇÃO: O forame oval parente ocorre em 27 por cento a 30 por cento da população e pode estar associado a eventos embólicos, dentre eles o acidente vascular cerebral criptogênico. A prótese PREMEREtm. especialmente desenvolvida para a correção do forame oval patente, apresenta baixo perfil, reduzida quantidade de metal e âncora no lado esquerdo, com reduzida superfície para minimizar o risco de formação de trombos. Avaliamos os resultados clínicos e ecocardiográficos imediatos e aos três e seis meses pós-implante do dispositivo. Métodos: Entre maio de 2008 e junho de 2009, a prótese foi implantada em 14 pacientes com forame oval patente e que apresentaram eventos embólicos cerebrais prévios, comprovados por tomografia computadorizada e/ou ressonância nuclear magnética de crânio. O diagnóstico ecocardiográfico de forame oval patente foi realizado quando microbolhas...

BACKGROUND: Patent foramen ovale is observed in 27% to 30% of the population and may be associated to embolic events, among them the cryptogenic stroke. The PREMERE TM device, specially developed to correct patent foramen ovale, has a low profile, reduced amount of metal and a left anchor with a small total surface to minimize the risk of thrombus formation. Clinical and echocardiographic results were evaluated immediately after the procedure and 3 and 6 months after device implantation. METHOD: From May 2008 to June 2009, the device was implanted in 14 patients with patent foramen ovale with prior cerebral embolic events, confirmed by computerized tomography and/or cranial magnetic resonance imaging. Echocardiographic patent foramen ovale was diagnosed when microbubbles were detected in the left atrium within three heartbeats after opacification of the right atrium. Patients with patent foramen ovale with interatrial septal aneurysm > 2 cm, those with atrial fibrilation/flutter or with other diseases that might explain the cryptogenic stroke were excluded. RESULTS: Nine (64.3%) patients were male and mean age was 47.2 ± 17.5 years. Successful implantation was achieved in 100% of the cases. Transesophageal echocardiogram immediately after the procedure showed the presence of microbubbles in the left atrium with Valsalva maneuver in 50% of the cases. All of the patients were discharged the following day, receiving acetyl salicylic acid 200 mg/day and clopidogrel 75 mg/day and returned after 3 months for clinical and echocardiographic follow-up. The transesophageal echocardiogram at three months showed a mild residual flow in only 3 (21.4%) patients. These patients had a totally occluded patent foramen ovale at the 6-month follow-up transesophageal echocardiogram. None of the patients had cardiovascular events during the follow-up period. CONCLUSION: The PREMERE TM device proved to be safe and effective in the occlusion of patent foramen ovale. The occlusion rate in this initial experience was high for a follow-up period of 6 months.

Trombo auricular atrapado en el foramen oval: Complicación infrecuente en el tromboembolismo pulmonar / Atrial thrombus entrapped in a patent foramen oval: Report of one case

We report a 63 year-old female with a pulmonary embolism in whom echocardiography revealed the presence ofríght heart thrombus. A section ofthis thrombus was entrapped in a patent foramen oval and floating in both atria. This rare situation, named impending paradoxical embolism, prompted us to perform a surgical intervention, removing the thrombus andrepairing the foramen ovale.