Is percutaneous coronary intervention safe during uninterrupted direct oral anticoagulant therapy in patients with atrial fibrillation and acute coronary syndromes?

OBJECTIVES: No data on optimal management of patients with acute coronary syndromes (ACS) on long-term direct oral anticoagulants (DOACs) undergoing percutaneous coronary intervention (PCI) are available. Using the data of the Management of Antithrombotic TherApy in Patients with Chronic or DevelOping AtRial Fibrillation During Hospitalization for PCI study, we sought to compare the outcome of patients with ACS and atrial fibrillation (AF) who underwent PCI during uninterrupted DOAC (UDOAC group) and those who interrupted DOAC before PCI (IDOAC group). METHODS: The primary outcomes of our analysis were the incidence of major adverse cardiovascular events (MACEs), a composite of death, cerebrovascular events, recurrent myocardial infarction or revascularisation and net adverse clinical events (NACEs), including major bleeding, at 6 months. RESULTS: Among the 132 patients on long-term DOAC, 72 (54.6%) underwent PCI during UDOAC and 60 (45.4%) after IDOAC. The mean CHA2DS2-VASc score was 3.8±1.7 and 3.9±1.3 (p=0.89), while the HAS-BLED score was 2.5±1.0 and 2.5±0.9 (p=0.96), in UDOAC and IDOAC groups, respectively. The median time from hospital admission to PCI was 9.5 (IQR: 2.0-31.5) hours in UDOAC and 45.5 (IQR: 22-5-92.0) hours in IDOAC group (p<0.0001). A radial approach was used in 92%, and a drug-eluting stent was implanted in 98% of patients. At 6 months, the rates of MACE (13.9% vs 16.7%) and NACE (20.8% vs 21.7%) did not differ between UDOAC and IDOAC groups. At multivariable analysis, increasing CHA2DS2-VASc score (HR: 1.39; 95% CIs 1.05 to 1.83; p=0.02) resulted as the only independent predictor of NACE. CONCLUSIONS: Our study shows that PCI is a safe procedure during UDOAC in patients with concomitant ACS and AF.

Insertable cardiac monitor detection of silent atrial fibrillation in candidates for percutaneous patent foramen ovale closure.

AIM: An underlying atrial vulnerability or a preexisting misdiagnosed atrial fibrillation in some patients who are candidates for patent foramen ovale (PFO) closure may lead to an unnecessary percutaneous intervention. The aim of this work was to define paroxysmal atrial fibrillation rate, through a 6-month insertable loop-recorder monitoring, in patients over 55 years old with cryptogenic stroke and PFO. METHODS: PFO closure criteria: significant right-to-left shunt and at least one high-risk feature (permanent right-to-left shunt, atrial septal aneurysm, prominent Eustachian valve, recurrent brain ischemia, previous deep vein thrombosis, thrombophilia). Insertable cardiac monitoring criteria: previous cryptogenic stroke, more than 55 years and at least one atrial fibrillation risk factor (heart failure, hypertension, age older than 65 years, diabetes, atrial runs, left atrium dilatation, left ventricle hypertrophy, pulmonary disease, thyroid disease, obesity). Atrial fibrillation detection threshold: arrhythmia duration longer than 5 min. RESULTS: From January 2008 to March 2017, 195 patients underwent to loop-recorder monitoring. A total of 70 (36%) patients were candidates for PFO closure. The 6-month silent atrial fibrillation rate was 11.4%. In the arrhythmia-free cohort, 28 patients (45.2%) underwent percutaneous foramen ovale closure (group A) and 34 (54.8%) were medically treated (group B). Atrial fibrillation detection rate was 14.3% in group A and 0% in group B. The 36-month atrial fibrillation-free survival was 76%. CONCLUSION: An occult preexisting atrial fibrillation may lead to unnecessary percutaneous foramen ovale closure in a significant proportion of patients. A 6-month loop-recorder monitoring may improve the patient oriented decision-making.

Short term outcome following acute phase switch among P2Y12 inhibitors in patients presenting with acute coronary syndrome treated with PCI: A systematic review and meta-analysis including 22,500 patients from 14 studies.

INTRODUCTION: The efficacy and safety of switching P2Y12 receptor antagonists in patients admitted for acute coronary syndrome (ACS) remain unclear. We assessed the short-term clinical outcomes (in-hospital and within 30 days) of switching P2Y12 inhibitor (P2Y12I) drugs versus maintaining the same regimen by performing a comprehensive review and meta-analysis of available data. METHODS: MEDLINE/PubMed/SCOPUS/Cochrane databases were screened for studies regarding switching of P2Y12I in patients with ACS that reported 30 days follow-up. Major cardiac events (MACE) and bleeding were compared between patients who were switched/not switched. RESULTS: 22,500 patients from 14 studies were included. Unstable angina/non-ST elevation myocardial infarction (62.0%, interquartile range, 52.8%-68.0%) was the most common clinical presentation. The total number switched was 4294 (19.1%); escalation in 3416 (79.5%) patients (from clopidogrel to prasugrel, 62.9%) and de-escalation in 18.5%. Pooled analysis revealed no significant differences in MACE for any comparison; risk of bleeding was significantly increased among switched patients overall (odds ratio [OR], 1.60; 95% confidence interval [CI] 1.22-2.10) and increased in the escalation group (OR, 1.51; 95% CI, 1.06-2.16). CONCLUSIONS: Among patients presenting with ACS, switching from one P2Y12I agent to another in the acute phase seems associated with a short-term increased risk of bleeding. Accurate upfront selection and prescription of a P2Y12I based on ischemic and bleeding risks is paramount to avoid adverse events switching-related during hospitalization and in the first 30 days.

Angiography vs transesophageal echocardiography-guided patent foramen ovale closure: A propensity score matched analysis of a two-center registry.

OBJECTIVES: The purpose of this study is to compare the long-term outcomes of patent foramen ovale (PFO) closure using angiography or transesophageal echocardiography as procedural guidance. BACKGROUND: The interventional treatment is emerging as a safe and efficient option for patients with high likelihood of PFO-related cryptogenic stroke and high risk of recurrence. The "gold-standard" guidance technique remains an issue. METHODS: Two cohorts of patients undergoing PFO closure for cryptogenic stroke in two catheterization laboratories of the same institution, using similar inclusion criteria but different guidance, were compared with propensity score matching. RESULTS: A total of 374 patients were enrolled, 161 in Angio-group and 213 in Echo-group. No difference was detected in the procedural complication rate. In Angio-group, radiological exposure (P = .001) and 6-month residual shunt (16.8% vs 8.0%, P = .015) were higher. After a mean follow-up of 41 ± 30 months, 28 patients (7.5%) presented any adverse event (death, recurrent cerebral ischemia, device-related complications, reintervention), with a higher rate in Angio-group (13.0% vs 3.3%, P = .001), mainly due to repeated percutaneous intervention (10.6% vs 1.4%, P = .001). The results were confirmed after propensity score matching (118 patients/group). The rate of recurrent cerebral ischemia was 1.9% and was not significantly different in the two groups. Intra-procedural guidance and atrial septum aneurysm were independent predictors of the composite primary endpoint (OR 1.2, P = .016). CONCLUSIONS: The use of intra-procedural transesophageal echocardiography (TEE) guidance for PFO closure allows lower residual shunt rate, radiological exposure, and adverse events, mainly driven by a significant reduction in percutaneous reintervention.

Impact of chronic kidney disease on mortality in patients with ST-segment elevation myocardial infarction treated with primary percutaneous coronary intervention. A long-term single-center mortality study.

BACKGROUND: Chronic kidney disease (CKD) is associated with increased risk of mortality. We examined the impact of moderate and severe CKD at presentation on short- and long-term mortality among unselected patients with ST-segment elevation myocardial infarction (STEMI) treated with primary percutaneous coronary intervention (PPCI). METHODS: The study cohort consists of 501 patients (pts), enrolled from October 2005 to December 2012. The median follow-up was 46.52±25.58 months (range 8-99). A severe CKD (estimated Glomerular Filtration Rate [eGFR] <30 mL/min/1.73 m2) was detected in 16 pts (3.19%), a moderate CKD (eGFR 30-59 mL/min/1.73 m2) in 110 (21.96%) and a normal kidney function (eGFR >60 mL/min/1.73 m2) in 375 (74.85%). RESULTS: The crude in-hospital mortality rate resulted significantly higher in pts with severe and moderate CKD compared to pts with normal renal function (50% and 19.08% versus 2.93%, P<0.0001), as well as the long-term mortality rate (57.14% and 46.34% versus 8.77%, P<0.0001). After adjustment for confounding variables, severe and moderate CKD resulted the main independent predictors of in-hospital (odds ratio [OR]=21.815, P<0.0001 for severe CKD and OR= 4.203, P=0.002 for moderate CKD) and long-term (hazard ratio [HR]= 5.272, P=0.001; HR= 1.978, P=0.006) mortality. CONCLUSIONS: CKD is a frequent condition in patients with STEMI treated with PPCI and it is associated to an excess of mortality, resulting the main independent negative prognostic predictor.

Relationship between ventricular pressure and coronary artery disease in asymptomatic adult heart transplant recipients.

INTRODUCTION: The association between data of right heart catheterization and cardiac allograft vasculopathy (CAV) in adult heart transplant (HTx) recipients remains to be determined. METHODS AND RESULTS: This is an observational, retrospective study, including all consecutive asymptomatic HTx patients undergoing routine right and left catheterization. The independent predictive power of pulmonary capillary wedge pressure (PCWP) to predict CAV (classified according to working formulation of a standardized nomenclature for CAV-2010) was the primary end point. Seventy-one patients were included, with a mean time from HTx to procedure of 19 ±â€Š25 months. At coronary angiography first degree of CAV was found in eight patients (11.2%), second degree of CAV in two patients (2.8%), and third in two (2.8%). PCWP values were significantly higher in patients with CAV compared with patients without CAV (17.5 ±â€Š7.5 vs. 10.4 ±â€Š5.6, P < 0.001) and values of 15 mmHg or greater had an AUC of 0.71 (0.48-0.92), with a sensitivity of 71% and a specificity of 73% in predicting CAV, with an independent relationship confirmed at logistic regression analysis (odds ratio 1.28, IC 1.06-1.53; P = 0.008). CONCLUSION: A significantly elevated PCWP at the time of the diagnosis of transplant coronary artery disease may be considered as an early marker of CAV, especially in asymptomatic HTx recipients.

Recurrent cerebral ischemia after patent foramen ovale percutaneous closure in older patients: A two-center registry study.

OBJECTIVES: The aim of this study is to describe the cerebral ischemia recurrence rate after percutaneous patent foramen ovale (PFO) closure in patients older than 55 years and their outcomes, compared with younger patients. BACKGROUND: The registries data and the recent randomized trials about PFO closure are focused on patients younger than 55 years. Little is known about older patients' long-term outcome. METHODS: In total, 458 patients underwent PFO closure for cryptogenic cerebral ischemia and were stratified into an "older" (≥ 55 years, 151 patients) and a "younger" (<55 years, 307 patients) group. RESULTS: Older patients had mean age of 63 ± 6 years and more atrial septum aneurysm (P = 0.05), hypertension, diabetes, and dyslipidemia (P = 0.001). Mean followup was 4.5 ± 2.8 years. Older patients had a higher rate of ischemic recurrence (0.3 vs. 4.0%, P = 0.002), after a mean time of 3.1 ± 2.6 years. The Kaplan-Meier curve confirmed higher event-free survival in the youngers (P = 0.008). None of the patients with ischemic recurrence had significant residual shunt. Age and hypertension were correlated to ischemic recurrence, but age was the only independent predictor at multivariate analysis. CONCLUSIONS: Recurrent cerebral ischemia after PFO closure is more frequent in older patients and could most likely be associated to conditions related to age (atherosclerosis, atrial fibrillation), than to paradoxical embolism. The procedure is as safe as in younger patients.

Starfix lead extraction: Clinical experience and technical issues.

Transvenous lead extraction (TLE) of the Starfix coronary sinus (CS) active-fixation lead may be challenging, due to undeployment of fixation lobes and venous occlusion. We report our experience in Starfix TLE, in comparison with previous data. A 78-year-old male, implanted in 2009 with Starfix lead, was referred to our institution for TLE, due to infective endocarditis with lead-associated vegetations. The tip of Starfix lead was located in distant, anterior position, in the great cardiac vein, close to patent left internal mammary artery-to-left anterior descending artery anastomosis, and first-choice surgical removal had a prohibitive operative risk. Conventional dilatation beyond CS ostium, as well as the use of a standard delivery catheter, was ineffective. An off-label modification of the delivery, by cutting the distal soft tip, was successful. However, the tip of the lead fragmented and was trapped in the innominate vein. Then a gooseneck snare grasped the fragment, allowing complete retrieval. TLE of Starfix leads may be particularly challenging, especially when its tip is located in a distant anterior location. In these cases, important help may be obtained by dilatation within the CS, by means of conventional or modified delivery catheters. Only experienced operators, sometimes with non-conventional techniques, should perform TLE of Starfix leads. .

Outcomes of Patients Undergoing Balloon Aortic Valvuloplasty in the TAVI Era: A Multicenter Registry.

BACKGROUND: Few clinical data about indications and prognoses of patients undergoing balloon aortic valvuloplasty (BAV) in the transcatheter aortic valve implantation (TAVI) era have been reported. METHODS: Data from all consecutive patients undergoing BAV in seven European centers from 2006 to 2013 were collected. Acute results and long-term outcomes were assessed. RESULTS: A total of 811 patients aged 82 ± 9 years were included; 416 patients (51%) underwent BAV as palliative destination therapy, 320 patients (40%) as bridge to TAVI, and 75 patients (9%) as bridge to surgical aortic valve replacement (SAVR). Patients undergoing BAV as destination therapy had a higher risk profile (logistic EuroSCORE, 20 ± 17 vs 22 ± 14 vs 11 ± 8, respectively; P<.001). Post procedure, peak gradient decreased from 87 ± 22 mm Hg to 66 ± 22 mm Hg (P<.001) and aortic valve area increased from 0.61 ± 0.2 cm2 to 0.8 ± 0.2 cm2 (P<.001). At 30 days, the all-cause death rate (6.5% vs 6.2% vs 7.4%, respectively; P=.56) and the rate of life-threatening and major bleedings (8.0% vs 5.7% vs 6.0%, respectively) did not differ between groups. After a mean follow-up of 318 days (range, 116-500 days), rates of all-cause death were similar (30% vs 34% vs 31%, respectively; P>.99), although patients undergoing BAV as bridge to SAVR showed a lower cardiovascular death rate (11% vs 11% vs 3%, respectively; P=.04). CONCLUSION: In the TAVI era, BAV may represent a reasonable option for patients with severe aortic stenosis and temporary contraindications to definite therapy. Given the mortality rates at 30 days, patients should be carefully selected, while events at follow-up are deeply influenced by the decision of whether or not subsequent interventions are performed.

Meta-analysis of randomized controlled trials and adjusted observational results of use of clopidogrel, aspirin, and oral anticoagulants in patients undergoing percutaneous coronary intervention.

The optimal antiaggregant therapy after coronary stenting in patients receiving oral anticoagulants (OACs) is currently debated. MEDLINE and Cochrane Library were searched for studies reporting outcomes of patients who underwent PCI and who were on triple therapy (TT) or dual-antiplatelet therapy (DAPT) with aspirin and clopidogrel or dual therapy (DT) with OAC and clopidogrel. Major bleeding was the primary end point, whereas all-cause death, myocardial infarction (MI), stent thrombosis, and stroke were secondary ones. Results were reported for all studies and separately for those deriving from randomized controlled trials or multivariate analysis. In 9 studies, 1,317 patients were treated with DAPT and 1,547 with TT. DAPT offered a significant reduction of major bleeding at 1 year for overall studies and for the subset of observational works providing adjusted data (odds ratio [OR] 0.51, 95% confidence interval [CI] 0.39 to 0.68, I2 60% and OR 0.36, 95% CI 0.28 to 0.46) compared to TT. No increased risk of major adverse cardiac events (MACE: death, MI, stroke, and stent thrombosis) was reported (OR 0.71, 95% CI 0.46 to 1.08), although not deriving from randomized controlled trials or multivariate analysis. Six studies tested OAC and clopidogrel (1,263 patients) versus OAC, aspirin, and clopidogrel (3,055 patients) with a significant reduction of bleeding (OR 0.79, 95% CI 0.64 to 0.98), without affecting rates of death, MI, stroke, and stent thrombosis (OR 0.90, 95% CI 0.69 to 1.23) also when including clinical data from randomized controlled trials or multivariate analysis. In conclusion, compared to TT, both aspirin and clopidogrel and clopidogrel and OAC reduce bleeding. No difference in major adverse cardiac events is present for clopidogrel and OAC, whereas only low-grade evidence is present for aspirin and clopidogrel.

Sex-related differences in patients with ST-elevation myocardial infarction undergoing primary PCI: A long-term mortality study.

OBJECTIVES: To assess sex differences in clinical presentation, in-hospital and long-term outcome in ST-elevated myocardial infarction (STEMI) patients undergoing primary PCI (PPCI). BACKGROUND: Several studies have shown higher rates of mortality in women. These differences are not always confirmed after adjusting for confounding variables. METHODS: From January 2007 to December 2011, 325 consecutive patients (23.1% females and 76.9% males) were prospectively treated and retrospectively analyzed. Primary outcome was in-hospital and long-term mortality. RESULTS: Women were older (71.8±11.7 vs. 62.5±12.6years; p<0.0001), presented more renal failure (45.3% vs. 20.8%; p<0.0001) and severe haemodynamic impairment (9.3% vs. 3.6%; p=0.04). In-hospital overall mortality (14.7% vs. 4.8%; p=0.003) and cardiac death (12% vs. 2%; p=0.002) were significantly higher in women. The multivariate analysis identified age (OR 1.07; 95% CI: 1.01-1.13), resuscitated cardiac arrest (CCA) and cardiogenic shock (CS) (OR 15.31; 95% CI: 4.30-61.75), renal failure (OR 0.20; 95% CI: 0.06-0.68), but not sex (OR 1.49; 95% CI: 0.53-4.22) as independent prognostic factors of in-hospital mortality. During a median follow-up of 46.5months (IQR range 32.7-63.1months), long-term overall mortality (24.2% vs. 11.0%; p=0.007) and cardiac death (4.8% vs. 1.7%; p=0.02) were significantly higher in women. The multivariate analysis identified age (HR 1.06; 95% CI: 1.02-1.11), previous AMI (HR 3.9; 95% CI: 1.63-9.35), renal failure (HR 5.21; 95% CI: 2.12-12.85), technical success (HR 0.35; 95% CI: 0.14-0.84) but not sex (HR 0.90; 95% CI: 0.42-1.94) as independent prognostic factors of long-term mortality. CONCLUSIONS: Worse clinical presentation rather than sex may explain the excess of mortality in women with STEMI undergoing PPCI.

The beneficial effect of extracorporeal shockwave myocardial revascularization in patients with refractory angina.

OBJECTIVES: The incidence of patients with refractory angina (RA) is increasing. Medical therapy for RA is limited and prognosis is poor. Experimental data suggest that the use of Extracorporeal shockwave myocardial revascularization (ESMR) may contribute to angiogenesis and improve symptoms of angina in patients with RA. Purpose of our study is to determine the efficacy of cardiac shock wave therapy (ESMR) in the management of patients with nonrevascolarized coronary artery disease (CAD). METHODS: We performed a prospective cohort study to examine the efficacy of ESMR applcation in patients with RA despite optimal medical therapy, not suitable for further PCI or CABG. Characteristics such as angina class scores (CCS class score), nitroglycerin consumption and hospitalization rate among cases (patients with RA who received ESMR) and controls (patients with RA who did not receive ESMR) were compared at baseline and 6 months after ESMR therapy. In patients receiveing d ESMR the effect of on cardiac perfusion was assessed. RESULTS: There were 43 patients in the case group and 29 patients in the control group. The mean age of the patients was 70 ± 9.5 years in the case group and 71 ± 5.3 years in the control group. Other characteristics (diabetes, coronary artery bypass graft, percutaneus coronary intervention, baseline CCS class score) were similar in both groups. There was a significant improvement in CCS class score (1.33 ± 0.57 in cases and 1.92 ± 0.69 in controls; p = 0.0002), nitroglycerin consumption (20% in case cases, and 44.8% in controls; P < 0.03) and hospitalization rate significantly reduced (13.9% in case cases, and 37.9% in controls; P < 0.03). The patients who received ESMR, there was a significantly improvement in myocardial perfusion after 6 months with a 33% relative reduction of summed stress score (SSS) (p = 0.002). CONCLUSION: This case control study demonstrates the beneficial effect of ESMR therapy on cardiac symptoms, myocardial perfusion and reduced hospitalization in patients with refractory angina. Ther current study supports a role for ESMR as a non-invasive therapuetic option for patients with RA.

Sixty-day readmission rate after percutaneous coronary intervention: predictors and impact on long-term outcomes.

AIMS: Thirty-day readmission rate after percutaneous coronary intervention (PCI) is used as an index of quality of care, but the complete recovery from any myocardial damage needs 8 weeks. We evaluated the readmission rate 60 days after PCI, defined its predictors, and investigated its relationship with long-term prognosis. METHODS AND RESULTS: All consecutive patients undergoing PCI in a large volume hospital were enrolled, and their outcomes were explored using an institutional database. The primary outcome was unplanned 60-day readmission. A composite of major adverse cardiovascular events (MACEs) including all-cause death, myocardial infarction, and repeated revascularization were the secondary endpoints. Among the 1193 enrolled patients, 71 (6.0%) underwent unplanned 60-day readmission for unstable angina (35.3%), chest pain (21.1%), heart failure (14.1%), and acute myocardial infarction (11.3%); 40.8% patients underwent repeated PCI. Readmitted patients carried more frequently left main disease (16.9 vs. 8.3%, P = 0.001), proximal left descending artery disease (31.0 vs. 27.4%, P = 0.03), and bifurcation disease (26.8 vs. 20.5%, P = 0.03). The only predictor of readmission was left main disease. After a mean follow-up of 743 ± 334 days, patients with 60-day readmission experienced higher rates of all-cause death (8.5 vs. 3.8%, P = 0.05). General baseline conditions and multivessel disease, but not 60-day readmissions, were predictors of MACE and death at follow-up. CONCLUSION: Unplanned 60-day readmissions after PCI are mainly related to the extent of coronary artery disease, being associated with left main, proximal left descending artery, and bifurcation disease. Readmissions are associated with higher long-term all-cause mortality.

Real time triplane echocardiography in the assessment of the functional area of prosthetic aortic valves: reliability and feasibility.

PURPOSE: Our study is aimed at evaluating the feasibility and reliability of a simple method for the measurement of the functional area of prosthetic aortic valves (EOA). Three-dimensional echocardiography has proven accurate for left ventricular volume, stroke volume, and aortic valve area measurement. We studied the feasibility and reliability of real time simultaneous triplane echocardiography (RT3P) for assessing the EOA with a fast formula based on the principle of continuity equation, in which we replaced Doppler-derived stroke volume (SV) with SV directly measured with RT3P. METHODS AND RESULTS: EOA of prosthetic aortic valves were measured in 23 consecutive patients requiring periodical follow up. EOA was calculated using Doppler continuity equation (DCE) and the RT3P method by replacing Doppler-derived SV with SV measured with real time triplane echocardiography. We compared functional areas obtained with the two methods with the prosthetic area indicated in the manufacturer's specifications and with the mean transprosthetic gradient. Both methods had a good correlation with the area indicated by the manufacturer. RT3P revealed an inverse correlation between functional area and mean gradient that was better than DCE (P = 0.0359). Inter- and intraobserver variability was not different between the two methods. Execution time was significantly shorter for RT3P. CONCLUSIONS: RT3P is a simple method that can be performed quite rapidly, and can complement the overall assessment of prosthetic valve function. Further studies can confirm our technique.

Percutaneous closure of patent foramen ovale in patients with anatomical and clinical high-risk characteristics: long-term efficacy and safety.

BACKGROUND: Transcatheter closure of patent foramen ovale (PFO) is a widespread procedure, but no randomized study on its outcome in high-risk patients is available. Our aims were to determine the efficacy and safety of this procedure in a cohort of high-risk patients through the observation of clinical adverse events and residual shunt, to evaluate the impact of transesophageal echocardiography (TEE) guidance during the procedure, and investigate the relationship between the anatomical and clinical characteristics and the outcome. METHODS AND RESULTS: Ninety-five patients underwent PFO closure for cryptogenic cerebral ischemia; each of them presented one or more of the following risk factors: recurrent cerebral ischemia (9.5%), atrial septum aneurysm (ASA, 74.5%), prominent Eustachian valve (EV, 23.2%), severe basal shunt (9.5%), thrombophilic factors (20%), deep vein thrombosis (4.2%). The procedure was performed successfully in all patients. On median follow-up of 18 months, the neurologic recurrent events rate was 1.1% and the major adverse cardiac event (MACE) rate was 1.1%. At 6-month TEE follow-up, the residual shunt rate was 12.6% (3.1% moderate to severe). A significant correlation was found between residual shunt and prominent EV alone (P = 0.036) or in association with ASA (P = 0.021). All adverse events occurred in the first 8 months, and the event-free survival rate was 86.2%. CONCLUSIONS: Our study suggests that transcatheter PFO closure is a safe procedure even in a selected population of high-risk patients, presenting satisfactory efficacy and safety. The presence of a prominent EV alone or with ASA correlates positively with the occurrence of residual shunt.