[Management of patent foramen ovale in non-cardiac surgery]. / Gestione della pervietà del forame ovale nella chirurgia non cardiaca.

Patent foramen ovale (PFO) is a remnant of normal fetal anatomy which may persist into adulthood, mostly asymptomatic. In some adults, PFO may result in a potential for shunting venous thromboembolism to the arterial circulation; less frequently it can cause interatrial, right-to-left shunting of deoxygenated blood. The pathogenesis of several medical conditions is related to the presence of PFO. Some randomized clinical trials have shown evidence of benefit for device closure as compared with medical therapy in patients with cryptogenic stroke. The literature reported several cases of carbon dioxide embolism during general laparoscopic surgery and sometimes stroke after laparoscopic or neurosurgery but there are neither prospective studies addressing these issues, nor randomized clinical trials assessing the effectiveness of pharmacotherapy or interventional procedures at decreasing risk. The European position paper suggests routine monitoring in non-cardiac surgery of patients with a PFO and no actual indications for closure. This article aims to further stratify the risk of periprocedural stroke and paradoxical embolism in this category of patients.

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.

Very long-term follow-up after percutaneous closure of patent foramen ovale.

AIMS: To evaluate the very long-term risk of recurrent thromboembolic events in patients treated by percutaneous PFO closure. METHODS AND RESULTS: Between 1998 and 2008, a total of 232 consecutive patients with PFO and a high suspicion of paradoxical embolism were treated by percutaneous closure. The following major events were observed during hospitalisation: implantation failure (one patient) and appearance of an acute left-sided device thrombus requiring surgery (one patient). The primary endpoint of the study was a recurrent embolic event beyond at least five years' follow-up. During a mean follow-up of 7.6±2.4 years, this event occurred in five patients, representing a 0.28% annual/patient risk. Other major complications during follow-up were the following: late thrombus formation on the device (two patients) and transient atrial fibrillation (15 patients). Three patients died during follow-up from cardiovascular causes considered not related to the index procedure. The PFO was judged closed on follow-up echocardiography in 92.3% of patients. CONCLUSIONS: Long-term follow-up following percutaneous PFO closure for presumed paradoxical embolism reveals very low recurrence rates. This observation should be put in perspective with recent published randomised trials comparing percutaneous closure and medical therapy.

The effectiveness of prophylactic inferior vena cava filters in trauma patients: a systematic review and meta-analysis.

IMPORTANCE: Trauma is known to be one of the strongest risk factors for pulmonary embolism (PE). Current guidelines recommend low-molecular-weight heparin therapy for prevention of PE, but trauma places some patients at risk of excess bleeding. Experts are divided on the role of prophylactic inferior vena cava (IVC) filters to prevent PE. OBJECTIVE: To perform a systematic review and meta-analysis examining the comparative effectiveness of prophylactic IVC filters in trauma patients, particularly in preventing PE, fatal PE, and mortality. DATA SOURCES: We searched the following databases for primary studies: MEDLINE, EMBASE, Scopus, CINAHL, International Pharmaceutical Abstracts, clinicaltrial.gov, and the Cochrane Library (all through July 31, 2012). We developed a search strategy using medical subject headings terms and text words of key articles that we identified a priori. We reviewed the references of all included articles, relevant review articles, and related systematic reviews to identify articles the database searches might have missed. STUDY SELECTION: We reviewed titles followed by abstracts to identify randomized clinical trials or observational studies with comparison groups reporting on the effectiveness and/or safety of IVC filters for prevention of venous thromboembolism in trauma patients. DATA EXTRACTION AND SYNTHESIS: Two investigators independently reviewed abstracts and abstracted data. For studies amenable to pooling with meta-analysis, we pooled using the random-effects model to analyze the relative risks. We graded the quantity, quality, and consistency of the evidence by adapting an evidence-grading scheme recommended by the Agency for Healthcare Research and Quality. RESULTS: Eight controlled studies compared the effectiveness of no IVC filter vs IVC filter on PE, fatal PE, deep vein thrombosis, and/or mortality in trauma patients. Evidence showed a consistent reduction of PE (relative risk, 0.20 [95% CI, 0.06-0.70]; I(2)=0%) and fatal PE (0.09 [0.01-0.81]; I(2)=0%) with IVC filter placement, without any statistical heterogeneity. We found no significant difference in the incidence of deep vein thrombosis (relative risk, 1.76 [95% CI, 0.50-6.19]; P=.38; I(2)=56.8%) or mortality (0.70 [0.40-1.23]; I(2)=6.7%). The number needed to treat to prevent 1 additional PE with IVC filters is estimated to range from 109 (95% CI, 93-190) to 962 (819-2565), depending on the baseline PE risk. CONCLUSIONS AND RELEVANCE: The strength of evidence is low but supports the association of IVC filter placement with a lower incidence of PE and fatal PE in trauma patients. Which patients experience benefit enough to outweigh the harms associated with IVC filter placement remains unclear. Additional well-designed observational or prospective cohort studies may be informative.

Comprehensive assessment of prophylactic preoperative inferior vena cava filters for major spinal reconstruction in adults.

STUDY DESIGN: A retrospective data analysis. OBJECTIVE: To report a comprehensive assessment of preoperative prophylactic inferior vena cava (IVC) filter placement in spine surgery. SUMMARY OF BACKGROUND DATA: Venous thromboembolism (VTE) is a serious complication after major spinal reconstructive surgery in adults. Specifically, pulmonary embolism (PE) can result in significant morbidity and mortality, and it has been reported in up to 13% of patients. Prophylactic IVC filter placement was initiated for all "high-risk" spinal surgery patients after a pilot study demonstrated decreased VTE-related morbidity and mortality. METHODS: After institutional review board approval, the medical records of all patients receiving an IVC filter at a single institution from 2000 to 2007 were reviewed. Age, sex, surgical approach, postoperative deep vein thrombosis (DVT), postoperative superficial thrombus, presence of pulmonary or paradoxical embolus, mortality, and IVC filter complications were all evaluated. Indications for IVC filter placement included history of DVT or PE, malignancy, hypercoagulability, prolonged immobilization, staged procedures of longer than 5 segment levels, combined anterior-posterior approaches, iliocaval manipulation during exposure, and anesthetic time of more than 8 hours. Descriptive statistics were used for the analysis of patient characteristics. Nonparametric frequency statistics (odds ratios [OR], χ) were used for analysis of main outcomes. RESULTS: A total of 219 patients (150 women, 69 men) with a mean age of 58.8 (range, 17-86) years, were analyzed. There were 2 complications from IVC filter placement (66 Greenfield filters; 157 retrievable filters). The incidence of lower extremity DVT was 18.7% (41/219) in 36 patients. PE incidence was 3.7% (8/219 patients), and the paradoxical embolus rate was 0.5% (1 patient). Prophylactic IVC filter use reduced the odds of developing a pulmonary embolus (OR = 3.7, P < 0.05) compared with population controls. Patients receiving Greenfield filters had significantly higher VTE incidence than those receiving retrievable filters (OR = 2.8, P = 0.008). Anesthesia duration of more than 8 hours significantly increases VTE incidence (P = 0.029). No statistical significance (P < 0.05) was noted with combined anterior-posterior approach (118 patients) versus posterior-only approach (101 patients) and the incidence of DVT (24/118, 20.3% for former; 17/101, 16.8% for latter). There were a total of 14 deaths; none related to PE or paradoxical embolism during an 8-year period. Mean and median follow-up was 2.8 and 2.4 years, respectively, with 126 achieving 2 or more years of follow-up. CONCLUSION: VTE-related morbidity and mortality have heightened the awareness within the spine community to the perioperative management of patients undergoing major spinal reconstruction. Prophylactic IVC filter placement significantly lowers VTE-related events, including PE development, than population controls.

Persistent iatrogenic atrial septal defect after pulmonary vein isolation by cryoballoon: an under-recognized complication.

AIMS: Iatrogenic atrial septal defect (IASD) has been reported as a complication of transseptal puncture. This study aims to investigate the incidence, echocardiographic characteristics, and clinical outcome of persistent IASD after pulmonary vein isolation (PVI) by cryoballoon catheter delivered by a large transseptal sheath. METHODS AND RESULTS: Thirteen patients (9 males, mean age 54.9 ± 13.0) with paroxysmal (10) or persistent (3) atrial fibrillation underwent PVI with cryoballoon catheter. Single transseptal puncture was performed with a BRK-1 shaped Brockenbrough needle and an 8 F sheath which was exchanged for a steerable transseptal sheath (15 F outer diameter and 12 F inner diameter) with the support of a stiff guidewire. Pulmonary vein isolation was performed with a 28 mm cryoballoon catheter. The incidence of persistent IASD was evaluated by transoesophageal echocardiography performed at 6 and 9 months after the procedure. At 6 months, five (38%) patients had persistent IASD with left-to-right shunt. The mean size of the IASD was 5.5 ± 2.4 mm. At 9 months, one patient had closure of the IASD and four (31%) patients had persistent IASD with mean size of 4.6 ± 1.4 mm. No patient died or suffered clinically from paradoxical embolism. CONCLUSIONS: Persistent IASD is a common complication after PVI by cryoballoon catheter. Only left-to-right, but not right-to-left, interatrial shunting occurred as a result of the IASD. There was no clinical occurrence of paradoxical embolism. Patients should be screened for this complication after cryoballoon procedures and regular reassessment with echocardiographic or other techniques should be performed for monitoring.

Ictus isquémico en puérpera secundario a embolismo paradójico / Stroke following paradoxical embolism in the postpartum period

El infarto cerebral durante el embarazo o puerperio es una complicación grave que causa alta morbimortalidad materna. Presentamos el caso de una mujer previamente sana, de 32 años de edad, que sufrió embolismo cerebral posparto. La ecocardiografía confirma la presencia de foramen oval permeable, que puede ser causa de embolismo paradójico, causando un accidente vascular cerebral transitorio o infarto. Para prevenir episodios recurrentes de embolismo cerebral durante el embarazo, parto o puerperio, se realizó el cierre intervencional del foramen oval sin complicaciones.

Stroke during pregnancy and puerperium is a severe complication that causes high morbidity and mortality. We report a case of previously healthy, 32 year old woman, who suffered cerebral embolism after delivery. Echocardiography confirmed the patent foramen ovale. Patent foramen ovale may be a mechanism of paradoxical embolism causing a transient ischemic attack or stroke. To prevent recurrent cerebral embolism during pregnancy, delivery and puerpuerium, interventional closure of the patent foramen ovale was performed. The postinterventional course was uneventeful.

Appendectomy for an adult with cyanotic congenital heart disease.

Few patients with cyanotic congenital heart disease reach adulthood without a cardiac operation. The prognosis for ''unrepaired'' pulmonary atresia with ventricular septal defect is approximately 8% in the 1st decade of age. Consequently, the number of adults with this particular heart disease (unrepaired) who are expected to need a non-cardiac surgery is extremely low. General anesthesia may aggravate the preexisting right to left shunt and lead to persistent severe hypoxemia. The goal of anesthetic management should be to maintain intravascular volume. Systemic and pulmonary vascular resistance changes, such as might occur due to acidosis, hypothermia, hypercarbia or excessive airway pressures, should be avoided. Maintenance of preload, contractility and sinus rhythm is of major importance. The complex pathophysiology of such heart disease, in addition to the circumstances of emergency operation, exacerbate the total anesthetic risk. We present here a rare case of an acute appendectomy with successful outcome in an adult with pulmonary atresia and ventricular septal defect.

Use of Amplatzer occlusion devices to occlude Fontan baffle leaks during fenestration closure procedures.

The authors describe the use of Amplatzer occlusion devices to successfully occlude Fontan baffle leaks in three patients. These additional right to left shunts were recognized at the time of elective transcatheter closure of surgically created fenestrations. A common site of baffle leak is described at the base of the right atrial appendage. This suture line serves to exclude the right atrial appendage from Fontan baffle flow and lies within the corrugated surface of the pectinate muscles, making it particularly vunerable to baffle leaks over time.

[Brief report: stroke in multiple myeloma patient treated with thalidomide].

We presented a patient suffered from stroke related to thalidomide therapy. The patient was a 74-year-old man who had about two-year history of multiple myeloma and treated with 100 mg of oral thalidomide daily. He was diagnosed as having cryptogenic stroke attributable to patent foramen ovale, when he admitted to our hospital with sudden onset left-side hemiparesis. Antiplatelet and neuroprotective therapies were commenced along with the use of elastic stocking to prevent further embolic event. Then, warfarin was selected as secondary prevention to reduce the risk of paradoxical embolism during thalidomide therapy. Although the risk of deep vein thrombosis on thalidomide therapy has been well documented, only a few cases have been noted documenting the risk of stroke during thalidomide therapy. We need to be careful about the risk of deep vein thrombosis on thalidomide therapy, even as monotherapy, and consider using anticoagulant therapy while prescribing thalidomide.

Exclusion of patients with arteriosclerosis reduces long-term recurrence rate of presumed arterial embolism after PFO closure.

BACKGROUND: Percutaneous transcatheter closure of patent interatrial communications after presumed paradoxical embolism is used as an alternative to surgery or long-term anticoagulation for the treatment of patients who are at risk for recurrent thromboembolism. To avoid atherosclerotic events to be judged as recurrent paradoxical embolism, we prospectively excluded all patients with detectable arteriosclerosis from our series and investigated long-term results. METHODS AND RESULTS: We report the outcome of 180 patients who underwent percutaneous transcatheter closure of patent foramen ovale (PFO), PFO like atrial septal defect (ASD), or an ASD because of paradoxical embolism. One hundred four patients had cerebral embolism, 57 had transient ischemic attacks, 16 coronary embolism, and 3 had peripheral embolism. Twenty-three patients experienced multilocal arterial embolism. One hundred twenty-five patients had a PFO, 63 of them with an atrial septal aneurysm (ASA), 24 a PFO-like ASD (7 of them with an ASA), and 31 had an ASD. After 18 months, only 5 patients (2.8%) showed a trivial residual shunt. At a mean follow-up of 40 months (range 4 to 88), resulting in 602 observed patient-years, only 1 patient experienced a presumed paradoxical (coronary) embolism (calculated annual risk to suffer a recurrent thromboembolic event: 0.16%). CONCLUSIONS: Percutaneous transcatheter closure of PFO/ASD is a safe and effective therapeutic option for the secondary prevention of presumed paradoxical embolism. It is associated with a high success rate, low incidence of hospital complications, and very low frequency of recurrent systemic embolic events.

Interatrial septal defect closure for prevention of cerebrovascular accidents: impact on recurrence and frequency of migraine headaches.

BACKGROUND: Recent data suggest that percutaneous closure of interatrial septal defect (IASD) is associated with a reduction in the intensity, frequency and duration of migraine headaches. In this study we review our own data to determine if we can reproduce the relationship between IASD closure in patients with a history of a central nervous system event (stroke or a transient ischemic attack [TIA]) and migraine headaches (HA). METHODS: Fifty-eight consecutive patients with a history of unexplainable stroke or TIA with the exception of the presence of an IASD were included in this retrospective study. Multiple variables were collected including age, gender, history of smoking, hypertension, diabetes, hypercholesterolemia, ejection fraction, anticoagulant use pre- and postprocedure, shunt grade across the IASD pre- and postprocedure, defect size and right-sided filling pressures. All patients with a history of migraine HA answered the Migraine Disability Assessment Test (MIDAS), a standardized migraine questionnaire. Descriptive analysis was performed on all variables and compared among migraine and nonmigraine HA patients. Pre and post closure intensity and frequency of migraine HA were compared. RESULTS: Of 58 patients, 14 (24.14%) had migraine HAs prior to percutaneous closure. There were no significant differences among the migraine and nonmigraine HA groups except that the migraine HA sufferers were younger (p = 0.016). One patient with migraine HA died on follow up from complications of cardiomyopathy. Only 5 (38.5%) of 13 patients reported still having migraine HA post closure of IASD. The frequency (41.6 +/- 36.4 vs. 9.3 +/- 24.8; p = 0.005) and intensity (8.0 +/- 1.9 vs. 2.1 +/- 3.2; p = 0.001) of the migraine HAs were markedly reduced post closure at 759 +/- 545.6 days (range 89 to 1,433 days). There was no relationship between the shunt grade and the frequency or intensity of migraine HA. CONCLUSION: We conclude that IASD closure in patients with history of migraine HA and stroke or TIA have a marked improvement in the frequency and intensity of their HA. Migraine HA resolved in 61.54% patients post closure. Larger randomized studies are needed to confirm these findings, which could have significant implications for sufferers of migraine HA.

Neurosurgical operations with the patient in sitting position: analysis of risk factors using transcranial Doppler sonography.

BACKGROUND: One major risk factor of the sitting position for neurosurgery is air embolism, especially in patients with persistent foramen ovale (PFO). The first aim of this prospective study was to evaluate a bedside method for detecting PFO using transcranial Doppler sonography (TCD) with contrast medium. A second aim was to address intraoperative monitoring, patient positioning and the occurrence and clinical relevance of air embolism. METHODS: Ninety patients with a mean age of 56.5 yr (range 14-81 yr) undergoing surgery in sitting position were investigated by TCD with contrast agent to detect functional PFO, that is PFO that can be provoked with a Valsalva manoeuvre. In patients in whom TCD was not possible, transcranial duplex sonography, duplex sonography of the carotid artery at the neck or transoesophageal ECG was performed. RESULTS: In 26 patients PFO was detected. Thirteen of them presented a persistent PFO with high-intensity transient signal in both middle cerebral arteries without Valsalva manoeuvre. The intraoperative positioning in these patients was adapted to the risk for a paradoxical air embolism, although, after surgical recommendations, three patients with a persistent PFO underwent surgery in sitting position. Intraoperative air embolisms were seen in 8 of 80 patients in sitting or semi-sitting position with air aspirable through the central venous catheter. CONCLUSION: To address the risk of a paradoxical air embolism, especially in patients undergoing surgery in sitting position, preoperative detection of PFO is advisable. If surgery is performed in seated PFO patients, additional monitoring and special care are warranted.

Surgical closure of patent foramen ovale in patients with suspected paradoxical embolism: long-term results.

OBJECTIVE: It is thought that a patent foramen ovale (PFO) is the crucial mechanism in patients with suspected paradoxical embolism and cryptogenic stroke. It has been hypothesized that closure of the PFO would prevent further cerebrovascular incidents. We describe our early and late experience with surgical closure of the PFO in patients with paradoxical embolism. PATIENTS AND METHODS: Between May 1994 and December 2001, 33 patients (26 men, 7 women; mean age, 55.2 +/- 8.7 years; range, 37-74) underwent surgical closure of a PFO at our institution. All patients had preoperatively suffered from a stroke and/or a transient ischemic attack, after which echocardiography showed a PFO. Mean follow-up at 99 +/- 30 months (range, 10-111 months) was 100% complete. RESULTS: All patients survived the operative procedure. Early complications occurred in four patients (12%). Actuarial survival at 1, 5 and 8 years was 97 +/- 3%, 97 +/- 5% and 94 +/- 8%, respectively. At long-term follow-up all but two patients were alive. The deaths of these two patients were related to malignancy and ischemic heart disease, respectively. Two patients (6%) had suffered a residual cerebrovascular event after successful surgery. CONCLUSION: Surgical closure of PFO in patients with paradoxical embolism can safely be performed with a low risk of early mortality. Residual thromboembolic events were rare and in those few it occurred it did so with the interatrial septum being closed, indicating that in those patients the PFO was not the mechanism of the thromboembolic event in the first place.

Transcatheter closure versus medical therapy of patent foramen ovale and presumed paradoxical thromboemboli: a systematic review.

BACKGROUND: The optimal strategy to prevent recurrent presumed paradoxical emboli in patients with patent foramen ovale is unknown. PURPOSE: To synthesize the current knowledge about and qualitatively assess the relative benefits of transcatheter closure versus medical therapy for patent foramen ovale. DATA SOURCES: English-language and foreign-language journals listed in the MEDLINE database from January 1985 to July 2003 were systematically searched. Secondary sources were also used. STUDY SELECTION: Secondary prevention studies of transcatheter closure or medical therapy for patent foramen ovale were required to include at least 10 patients followed for more than 1 year and to report recurrent neurologic events. DATA EXTRACTION: Data from published studies were manually extracted and summarized. DATA SYNTHESIS: Ten studies of transcatheter closure (1355 patients) and 6 studies of medical therapy (895 patients) for patent foramen ovale were included. Overall, the 1-year rate of recurrent neurologic thromboembolism with transcatheter intervention was 0% to 4.9%, and the incidence of major and minor complications was 1.5% and 7.9%, respectively. Medical management was associated with a 1-year recurrence rate of 3.8% to 12.0%. However, limitations resulting from uncontrolled data, nonstandardized definitions, vigilance of follow-up, and baseline imbalances preclude definitive conclusions about the superiority of a particular approach. General differences in study samples included older age, greater proportion of men, and higher prevalence of diabetes and smoking among medically treated patients. Patients undergoing treatment with a transcatheter device were more likely to have had multiple thromboembolic events at baseline. CONCLUSION: Transcatheter closure of patent foramen ovale may prevent a substantial proportion of cryptogenic strokes. Randomized clinical trials are needed.

Percutaneous transcatheter closure of patent foramen ovale in patients with paradoxical embolism.

BACKGROUND: Percutaneous transcatheter closure of patent foramen ovale (PFO) is used as an alternative to surgery or long-term anticoagulation for the treatment of patients with paradoxical embolism and PFO. METHODS AND RESULTS: We report the immediate and long-term clinical and echocardiographic outcome of 110 consecutive patients (58 males, mean age 47+/-14 years) who underwent transcatheter closure of PFO because of paradoxical embolism between 1995 and 2001. Procedural success, defined as successful deployment of the device and effective occlusion (no, or trivial, shunt after device placement), was achieved in all (100%) patients. There was no in-hospital mortality, 1 device migration requiring surgical intervention (0.9%), and 1 episode of cardiac tamponade (0.9%) requiring pericardiocentesis. A progressive increment in full occlusion was observed (44%, 51%, 66%, and 71% at 1 day, 6 months, and 1 and 2 years, respectively, after device placement). At a mean follow-up of 2.3 years, 2 patients experienced recurrent neurological events (1 fatal stroke and 1 transient ischemic attack), representing an annual risk of recurrence of 0.9%. In addition, 4 (3.6%) of the patients required reintervention for device malalignment or significant shunt. Kaplan-Meier analysis showed a freedom from recurrent embolic events and reintervention of 96% and 90% at 1 and 5 years, respectively. CONCLUSIONS: Transcatheter closure of PFO is a safe and effective therapy for patients with paradoxical embolism and PFO. It is associated with a high success rate, low incidence of hospital complications, and low frequency of recurrent systemic embolic events.

Systematic surgical closure of patent foramen ovale in selected patients with cerebrovascular events due to paradoxical embolism. Early results of a preliminary study.

OBJECTIVE: To define therapeutic strategy for management of patients with ischemic stroke due to a high probability of paradoxical embolism through a Patent Foramen Ovale (PFO). METHODS: Since 1988 all consecutive patients with cerebrovascular events and PFO from the Stroke Registry of our population-based primary-care center are prospectively studied and followed. Since 1992, among 118 patients with cryptogenic embolic brain infarct or transient ischemic attack (TIA) and PFO, 32 consecutive patients younger than 60 years who presented at least two of the following criteria were admitted for surgery: history of Valsalva strain before stroke (11); multiple clinical events (13); multiple infarcts on brain Magnetic Resonance Imaging (MRI) (15); atrial septal aneurysm (ASA) (16); large right-to-left shunt (> 50 microbubbles) (12). RESULTS: Operative time 135' +/- 33'. CPB time 34' +/- 14'. Aortic crossclamping time 16' +/- 6'. Post-operative bleeding 485 +/- 170 ml. No homologous blood transfusion required. No neurological, cardiac or renal complications. All patients were followed-up corresponding to a cumulative time of 601 patient-months. This revealed no recurrent vascular events nor silent new brain lesions on brain MRI. Systematic simultaneous contrast Trans Esophageal Echocardiography (TEE)-Trans Cranial Doppler showed a small residual interatrial shunt in two patients. CONCLUSION: Surgical closure of a patent foramen ovale can be accomplished with very low morbidity and reduce efficiently the risk of stroke recurrence. It seems to be the option of choice in selected patients with a higher (> 1.5%/year) risk of stroke recurrence.

Screening for patent foramen ovale and prevention of paradoxical embolus.

Paradoxic embolus is uncommon. Definite diagnosis requires demonstration of thrombus astride a patent foramen ovale (PFO) in a patient presenting cerebral or peripheral arterial embolism. With current echocardiography techniques, it is now possible to identify subjects with a PFO at risk for paradoxal embolism, however, the possibility of screening rekindles debate on prophylaxis and treatment. In the present report, we describe a case involving a woman who presented acute ischemia of the lower extremities with all the pathophysiologic features of paradoxical arterial embolism.