European position paper on the management of patients with patent foramen ovale. Part II - Decompression sickness, migraine, arterial deoxygenation syndromes and select high-risk clinical conditions.

Patent foramen ovale (PFO) is implicated in the pathogenesis of a number of medical conditions but to date only one official position paper related to left circulation thromboembolism has been published. This interdisciplinary paper, prepared with the involvement of eight European scientific societies, reviews the available evidence and proposes a rationale for decision making for other PFO-related clinical conditions. In order to guarantee a strict evidence-based process, we used a modified grading of recommendations, assessment, development, and evaluation (GRADE) methodology. A critical qualitative and quantitative evaluation of diagnostic and therapeutic procedures was performed, including assessment of the risk/benefit ratio. The level of evidence and the strength of the position statements were weighed and graded according to predefined scales. Despite being based on limited and observational or low-certainty randomised data, a number of position statements were made to frame PFO management in different clinical settings, along with suggestions for new research avenues. This interdisciplinary position paper, recognising the low or very low certainty of existing evidence, provides the first approach to several PFO-related clinical scenarios beyond left circulation thromboembolism and strongly stresses the need for fresh high-quality evidence on these topics.

Outcomes following endovascular therapy for acute stroke by interventional cardiologists.

OBJECTIVES: To summarize the outcomes of acute ischemic stroke (AIS) intervention by interventional cardiologists (IC) working on a stroke team. BACKGROUND: There is a geographic maldistribution of dedicated neuro-interventionalists (NI) to treat large vessel occlusion (LVO) AIS. METHODS: Results of 166 consecutive patients who received endovascular therapy (EVT) for AIS due to LVO by IC at three centers between 2009 and 2019 are reported. A modified Rankin score (mRs) of ≤ 2 at 90 days after EVT was used as the primary measurement of a good neurological outcome. Univariate logistic regression was used to evaluate predictors of the mRS > 2 and mortality. Those variables with significance of p < .2 from the univariate analysis were included in a multivariate analysis. RESULTS: All-cause mortality at 30 days was 22%. A favorable clinical outcome, mRS ≤ 2 at 90 days, was 49%. After multivariate analysis and controlling for confounders, a higher baseline NIHSS was predictive of 30-day mortality (OR 1.20 [95% CI 1.09-1.32] p < .001) and unfavorable clinical outcome (mRS > 2) at 90 days (OR 1.16 [95% CI 1.07-1.25] p < .001). CONCLUSION: Outcomes for carotid stent capable IC performing EVT for AIS are comparable to those achieved by NI physicians in major randomized clinical trials. Our data supports conducting a clinical trial of carotid stent capable IC working on multidisciplinary stroke teams to perform EVT for AIS due to LVO in communities and hospitals without timely access (<60 min by ground transport) to dedicated NI.

European position paper on the management of patients with patent foramen ovale. General approach and left circulation thromboembolism.

The presence of a patent foramen ovale (PFO) is implicated in the pathogenesis of a number of medical conditions; however, the subject remains controversial and no official statements have been published. This interdisciplinary paper, prepared with involvement of eight European scientific societies, aims to review the available trial evidence and to define the principles needed to guide decision making in patients with PFO. In order to guarantee a strict process, position statements were developed with the use of a modified grading of recommendations assessment, development, and evaluation (GRADE) methodology. A critical qualitative and quantitative evaluation of diagnostic and therapeutic procedures was performed, including assessment of the risk/benefit ratio. The level of evidence and the strength of the position statements of particular management options were weighed and graded according to predefined scales. Despite being based often on limited and non-randomised data, while waiting for more conclusive evidence, it was possible to conclude on a number of position statements regarding a rational general approach to PFO management and to specific considerations regarding left circulation thromboembolism. For some therapeutic aspects, it was possible to express stricter position statements based on randomised trials. This position paper provides the first largely shared, interdisciplinary approach for a rational PFO management based on the best available evidence.

Catheter-based closure of residual leaks after percutaneous occlusion of the left atrial appendage.

INTRODUCTION: The purpose of this study was to evaluate safety and efficacy of catheter-based occlusion of residual leaks after percutaneous closure of the left atrial appendage (LAA). METHODS: All cases of LAA closure at our center were reviewed to identify secondary interventions for residual leaks. Leaks with a width of more than 3 mm by transesophageal echocardiography (TEE) were considered relevant. In a case-specific approach, depending on the respective morphology of the defect, either an LAA occlusion device or an Amplatzer Vascular Plug was implanted under TEE and fluoroscopic guidance. RESULTS: Between June 2003 and December 2013, 12 patients underwent residual leak closure. All procedures were technically successful and without complications. In 10 cases (83%), complete sealing was confirmed at TEE follow-up. In 2 patients, minimal gaps (2-3 mm) persisted and anticoagulation was continued. None of the patients had strokes during the follow-up period. CONCLUSION: Percutaneous residual leak closure after attempted LAA occlusion can be done safely and with high procedural success rates. © 2015 Wiley Periodicals, Inc.

Predictors of blood pressure response: Obesity is associated with a less pronounced treatment response after renal denervation.

OBJECTIVES: The purpose of this study was to identify predictors of BP response. BACKGROUND: Catheter-based renal denervation (RDN) causes significant blood pressure (BP) reductions in a large number of patients with resistant hypertension. METHODS: One hundred one consecutive patients with resistant hypertension who underwent RDN with the Symplicity™ catheter were included in this retrospective study. Primary endpoint was the change in office systolic BP after 6 months. Uni- and multivariate logistic regression analyses were performed to detect baseline predictors of a significant BP response 6 months after RDN (age, gender, office and ambulatory BP, renal function, body mass index [BMI], diabetes mellitus, antihypertensive medication, number of ablations). RESULTS: The procedure was technically uneventful in all patients. Mean BP at baseline was 166.6/90.2 ± 22.5/16.4 mmHg and decreased by -14.7 (P < 0.0001)/-5.3 (P < 0.001) ± 22.8/14.1 mm Hg at 6-month follow-up. Similarly, paired analysis of 24-hr-ambulatory BP measurement (n = 71) showed a significant reduction of mean systolic BP by 6.8 ± 14.4 mm Hg (P < 0.0002). Upon univariate analyses, a higher baseline office systolic BP (P < 0.0001) and lower BMI (P = 0.014) were identified as significant predictors of the magnitude of BP response after 6 months. Importantly, on multivariate analysis, baseline office systolic BP (standardized ß = -0.46; r = -0.47; P < 0.0001) and BMI (standardized ß = 0.21; r = 0.95; P = 0.019) remained significant. CONCLUSION: Blood pressure reductions after RDN were more pronounced in patients with higher baseline blood pressure and lower BMI. These findings may have implications regarding patient selection for renal denervation. © 2015 Wiley Periodicals, Inc.

Percutaneous closure of patent foramen ovale in patients with cryptogenic embolism: a network meta-analysis.

BACKGROUND: Up to 40% of ischaemic strokes are cryptogenic. A strong association between cryptogenic stroke and the prevalence of patent foramen ovale (PFO) suggests paradoxical embolism via PFO as a potential cause. Randomized trials failed to demonstrate superiority of PFO closure over medical therapy. METHODS AND RESULTS: Randomized trials comparing percutaneous PFO closure against medical therapy or devices head-to-head published or presented by March 2013 were identified through a systematic search. We performed a network meta-analysis to determine the effectiveness and safety of PFO closure with different devices when compared with medical therapy. We included four randomized trials (2963 patients with 9309 patient-years). Investigated devices were Amplatzer (AMP), STARFlex (STF), and HELEX (HLX). Patients allocated to PFO closure with AMP were less likely to experience a stroke than patients allocated to medical therapy [rate ratio (RR) 0.39; 95% CI: 0.17-0.84]. No significant differences were found for STF (RR 1.01; 95% CI: 0.44-2.41), and HLX (RR, 0.71; 95% CI: 0.17-2.78) when compared with medical therapy. The probability to be best in preventing strokes was 77.1% for AMP, 20.9% for HLX, 1.7% for STF, and 0.4% for medical therapy. No significant differences were found for transient ischaemic attack and death. The risk of new-onset atrial fibrillation was more pronounced for STF (RR 7.67; 95% CI: 3.25-19.63), than AMP (RR 2.14; 95% CI: 1.00-4.62) and HLX (RR 1.33; 95%-CI 0.33-4.50), when compared with medical therapy. CONCLUSIONS: The effectiveness of PFO closure depends on the device used. PFO closure with AMP appears superior to medical therapy in preventing strokes in patients with cryptogenic embolism.

Transcatheter patch closure of an atrial septal defect of sinus venosus type using the immediate release patch.

Following promising preclinical studies, we report our first clinical experience with transcatheter closure of an atrial septal defect of sinus venosus type in a 65-year-old patient using the Immediate Release Patch.

[Interventional closure of atrial septal defects, patent oval foramen and ventricular septal defects]. / Interventioneller Verschluss von Vorhofseptumdefekt, persistierendem Foramen ovale und Ventrikelseptumdefekt.

Percutaneous transcatheter closure techniques and devices for congenital intracardiac shunts have considerably improved; therefore, catheter closure is now the treatment of choice for atrial septal defects (ASD). This is technically feasible in more than 80% of patients with a secundum ASD and the success rate is higher than 99%. General anesthesia is as a rule unnecessary and the hospital stay is very short. A patent oval foramen (POF) is a potential cause of cryptogenic stroke and peripheral embolisms. The catheter occlusion has many advantages in comparison to lifelong anticoagulation therapy and for some patients it is the only therapeutic option. Randomized trials have shown that interventional closure leads to results which are comparable to drug therapy and for some occlusion systems even evidence of significant advantages compared to drug therapy was found. Even ventricular septal defects (VSD), including perimembraneous and post-myocardial infarction VSDs can be closed by catheter techniques with a high success rate.

Long-term results of a randomized trial comparing three different devices for percutaneous closure of a patent foramen ovale.

AIMS: Percutaneous patent foramen ovale (PFO) closure for secondary stroke prevention is discussed controversially. Long-term data comparing different closure devices are limited. The objective is the prospective comparison of procedural complications and long-term results after PFO closure in patients with cryptogenic stroke randomized to three different closure devices. METHODS AND RESULTS: Between January 2001 and December 2004, 660 patients with cryptogenic stroke were randomized to three different closure devices (Amplatzer, CardioSEAL-STARflex, and Helex occluder, 220 patients per group). The primary endpoint was defined as recurrent cerebral ischaemia [stroke, transient ischaemic attacks (TIA), or Amaurosis fugax], death from neurological cause, or any other paradoxical embolism within 5 years after the index procedure. Device implantation was technically successful in all interventions (n = 660; 100%). The procedure was complicated by pericardial tamponade requiring surgery in one patient (Amplatzer group) and device embolization in three patients (all Helex group). Thrombus formation on the device was detected in 12 cases (11 CardioSEALSTARflex, 1 Helex, 0 Amplatzer; P < 0.0001), of which 2 required surgery. Complete closure after single device implantation was more common with the Amplatzer and with the CardioSEAL-STARflex than with the Helex occluder: Amplatzer vs. Helex vs. CardioSEAL-STARflex: n = 217 (98.6%) vs. n = 202 (91.8%) vs. n = 213 (96.8%; P = 0.0012). Within 5 years of follow-up, the primary endpoint occurred in 25 patients (3.8%; 10 TIAs, 12 strokes and 3 cases of cerebral death). Compared with the CardioSEAL-STARflex (6%; 6 TIAs, 6 strokes, 1 cerebral death) and Helex groups (4%; 4 TIAs, 4 stroke, 1 cerebral death), significantly fewer events (P = 0.04) occurred in the Amplatzer group (1.4%; 2 strokes, 1 cerebral death). CONCLUSION: Although procedural complications and long-term neurological event rates are low regardless of the device used, the recurrent neurological event rate was significantly lower after Amplatzer than after CardioSEAL-STARflex or Helex implantation. This has important implications regarding the interpretation of trials comparing PFO closure with medical management.

Long-term results after carotid stent implantation.

BACKGROUND: Though carotid artery stenting (CS) has gained popularity as an alternative to carotid endarterectomy, studies examining long-term results are limited. METHODS: All consecutive patients who underwent unilateral CS between 7/1993 and 8/2005 with no or non-significant contralateral stenosis were included. Follow-up with duplex sonography and/or angiography and neurological assessment was performed at 6 and/or 12 months. Thereafter, annually, a questionnaire was sent to the patients and their referring physicians. RESULTS: Two-hundred and seventy-nine patients underwent CS. In 99% of procedures stent delivery was successful. The periprocedural major and minor stroke rates were 2.2%, respectively. The periprocedural major stroke or death rate was 2.9%. Median clinical follow-up was 49 ± 32 months (range: 30 days-12.1 years). Excluding perioperative (<30 days) events, the annual major and minor stroke rate was 1.3% and the annual ipsilateral major and minor stroke rate was 0.6%. In symptomatic and asymptomatic patients, the annual major and minor stroke rates were 2.2% and 0.8%, respectively, and the ipsilateral major and minor stroke rates were 1.1% and 0.3%, respectively. There was no significant difference between ipsilateral and contralateral major or minor strokes at long-term follow-up. At last sonographic follow-up (median 36 ± 32 months), restenosis rates for symptomatic and asymptomatic stenoses were 5% and 3%, respectively. CONCLUSION: The results of our study demonstrate very low long-term cerebral event rates after CS supporting the long-term safety of CS. Importantly, there was no significant difference in long-term ipsilateral versus contralateral cerebral events lending support to the hypothesis of plaque stabilization.

World Federation for Interventional Stroke Treatment (WIST) multispecialty training guidelines for endovascular stroke intervention.

Introduction: Today, endovascular treatment (EVT) is the therapy of choice for strokes due to acute large vessel occlusion, irrespective of prior thrombolysis. This necessitates fast, coordinated multi-specialty collaboration. Currently, in most countries, the number of physicians and centres with expertise in EVT is limited. Thus, only a small proportion of eligible patients receive this potentially life-saving therapy, often after significant delays. Hence, there is an unmet need to train a sufficient number of physicians and centres in acute stroke intervention in order to allow widespread and timely access to EVT. Aim: To provide multi-specialty training guidelines for competency, accreditation and certification of centres and physicians in EVT for acute large vessel occlusion strokes. Material and methods: The World Federation for Interventional Stroke Treatment (WIST) consists of experts in the field of endovascular stroke treatment. This interdisciplinary working group developed competency - rather than time-based - guidelines for operator training, taking into consideration trainees' previous skillsets and experience. Existing training concepts from mostly single specialty organizations were analysed and incorporated. Results: The WIST establishes an individualized approach to acquiring clinical knowledge and procedural skills to meet the competency requirements for certification of interventionalists of various disciplines and stroke centres in EVT. WIST guidelines encourage acquisition of skills using innovative training methods such as structured supervised high-fidelity simulation and procedural performance on human perfused cadaveric models. Conclusions: WIST multispecialty guidelines outline competency and quality standards for physicians and centres to perform safe and effective EVT. The role of quality control and quality assurance is highlighted.

World Federation for Interventional Stroke Treatment (WIST) Multispecialty Training Guidelines for Endovascular Stroke Intervention.

INTRODUCTION: Today, endovascular treatment (EVT) is the therapy of choice for strokes due to acute large vessel occlusion, irrespective of prior thrombolysis. This necessitates fast, coordinated multi-specialty collaboration. Currently, in most countries, the number of physicians and centres with expertise in EVT is limited. Thus, only a small proportion of eligible patients receive this potentially life-saving therapy, often after significant delays. Hence, there is an unmet need to train a sufficient number of physicians and centres in acute stroke intervention in order to allow widespread and timely access to EVT. AIM: To provide multi-specialty training guidelines for competency, accreditation and certification of centres and physicians in EVT for acute large vessel occlusion strokes. MATERIAL AND METHODS: The World Federation for Interventional Stroke Treatment (WIST) consists of experts in the field of endovascular stroke treatment. This interdisciplinary working group developed competency - rather than time-based - guidelines for operator training, taking into consideration trainees' previous skillsets and experience. Existing training concepts from mostly single specialty organizations were analysed and incorporated. RESULTS: The WIST establishes an individualized approach to acquiring clinical knowledge and procedural skills to meet the competency requirements for certification of interventionalists of various disciplines and stroke centres in EVT. WIST guidelines encourage acquisition of skills using innovative training methods such as structured supervised high-fidelity simulation and procedural performance on human perfused cadaveric models. CONCLUSIONS: WIST multispecialty guidelines outline competency and quality standards for physicians and centres to perform safe and effective EVT. The role of quality control and quality assurance is highlighted. SUMMARY: The World Federation for Interventional Stroke Treatment (WIST) establishes an individualized approach to acquiring clinical knowledge and procedural skills to meet the competency requirements for certification of interventionalists of various disciplines and stroke centres in endovascular treatment (EVT). WIST guidelines encourage acquisition of skills using innovative training methods such as structured supervised high-fidelity simulation and procedural performance on human perfused cadaveric models. WIST multispecialty guidelines outline competency and quality standards for physicians and centers to perform safe and effective EVT. The role of quality control and quality assurance is highlighted. SIMULTANEOUS PUBLICATION: The WIST 2023 Guidelines are published simultaneously in Europe (Adv Interv Cardiol 2023).

Prospective, multicenter European study of the GORE flow reversal system for providing neuroprotection during carotid artery stenting.

BACKGROUND: Embolic protection devices (EPDs) are used to provide protection against brain embolization during carotid artery stenting (CAS) to treat carotid artery stenosis, but the optimal type of EPD has not been determined. Distally positioned filters are commonly used but do not provide protection during crossing of the lesion. This prospective, multicenter study investigated a proximally placed device (GORE Flow Reversal System) that reverses blood flow in the internal carotid artery during CAS, thereby directing emboli away from the brain. METHODS: Outcomes in 122 patients (28% symptomatic), who underwent CAS using the flow reversal system were assessed (intention-to-treat analysis). The primary endpoint was a major adverse event (MAE; defined as death or stroke) within 30 days of CAS. The secondary endpoint was a myocardial infarction (MI) or nonstroke-related neurologic event within 30 days. RESULTS: The flow reversal system could not be used in one patient because of severe vessel tortuosity and in two patients (1.6%) because of intolerance. The 30-day MAE rate and the secondary endpoint rate were each 1.6%. No patient in the series died or had an MI within 30 days. No patient who was symptomatic before CAS had an MAE. One symptomatic and one asymptomatic patient had a transient ischemic attack. CONCLUSIONS: Use of the GORE Flow Reversal System during CAS had a high rate of technical success and low 30-day rates of adverse neurologic and cardiac events.

European Registry of Carotid Artery Stenting: results from a prospective registry of eight high volume EUROPEAN institutions.

BACKGROUND: Carotid endarterectomy (CEA) is the standard revascularization therapy to prevent stroke in patients with carotid artery disease. Carotid artery stenting (CAS) could be considered a potential alternative in patients at high surgical risk. Recent clinical trials have challenged this concept due a relatively high incidence of post-CAS adverse events, which occurred in low volume centers. The aim of this study was to evaluate the outcomes associated with neuroprotected CAS in selected high volume centers. METHODS: From January 2007 to December 2007, 1,611 patients underwent neuroprotected CAS in eight European Centers. For each patients, clinical, procedural, and one month follow-up data from all patients have been collected. An independent clinical events committee adjudicated the events. RESULTS: Overall in hospital death was 0.06% (one patient), whereas in-hospital stroke was 0.49% (eight patients). Between hospital discharge and 30 days three additional patients died (0.18%) and 10 patients experienced a stroke (0.67%). Overall 30 days mortality was 0.24% (four patients) and stroke incidence 1.12% (18 patients). The 30 day stroke/death rate was 1.36%. CONCLUSIONS: CAS is a reasonable alternative to CEA to treat carotid artery atherosclerosis in well-experienced high volume centers. These data suggest that future prospective trials comparing CAS and CEA outcomes should include only centers highly experienced in both treatment modalities.

Post-Market Clinical Follow-Up With the Patent Foramen Ovale Closure Device IrisFIT (Lifetech) in Patients With Stroke, Transient Ischemic Attack, or Other Thromboembolic Events.

BACKGROUND: A patent foramen ovale (PFO) has been associated with embolic strokes and transient ischemic attacks (TIAs). Catheter closure of PFO is effective in preventing recurrent events. Residual shunts and procedure or device related complications can occur, including atrial fibrillation and thrombus formation. This study examines the initial experience with a new PFO closure device, the IrisFIT PFO-Occluder (Lifetech Scientific, Shenzhen, China). METHODS: 95 patients with indications for PFO closure underwent percutaneous closure with the IrisFIT PFO-Occluder. The primary endpoint was the rate of accurate device placement with no/small residual shunt at 3 or 6 months follow-up. All patients underwent transoesophageal echocardiography (TEE) after 1 to 6 months. In case of a residual shunt, an additional TEE was performed after 12 months. Clinical follow-up was performed up to a mean of 33.1 ± 3.6 months. RESULTS: The device was successfully implanted in 95 (100%) patients with no relevant procedural complications. At final TEE follow-up (7.6 ± 3.9 months) the effective closure rate was 96.8% with 1 moderate and 2 large residual shunts. There were 8 cases of new onset atrial fibrillation and 2 TIAs. There were no cases of device embolization or erosion. CONCLUSION: The IrisFIT occluder is a new PFO closure device with several advantages compared to other devices. In this small study cohort, technical success rate, closure rate and adverse event rate were comparable to other devices. The rate of new onset atrial fibrillation was higher in comparison to other studies and warrants further investigation.

European position paper on the management of patients with patent foramen ovale. Part II - Decompression sickness, migraine, arterial deoxygenation syndromes and select high-risk clinical conditions.

Patent foramen ovale (PFO) is implicated in the pathogenesis of a number of medical conditions but to date only one official position paper related to left circulation thromboembolism has been published. This interdisciplinary paper, prepared with the involvement of eight European scientific societies, reviews the available evidence and proposes a rationale for decision making for other PFO-related clinical conditions. In order to guarantee a strict evidence-based process, we used a modified grading of recommendations, assessment, development, and evaluation (GRADE) methodology. A critical qualitative and quantitative evaluation of diagnostic and therapeutic procedures was performed, including assessment of the risk/benefit ratio. The level of evidence and the strength of the position statements were weighed and graded according to predefined scales. Despite being based on limited and observational or low-certainty randomised data, a number of position statements were made to frame PFO management in different clinical settings, along with suggestions for new research avenues. This interdisciplinary position paper, recognising the low or very low certainty of existing evidence, provides the first approach to several PFO-related clinical scenarios beyond left circulation thromboembolism and strongly stresses the need for fresh high-quality evidence on these topics.

Acute Stroke Interventions Performed by Cardiologists: Initial Experience in a Single Center.

OBJECTIVES: The aim of this study was to evaluate the technical and clinical success of acute stroke interventions performed in our interventional cardiology center. BACKGROUND: Dedicated interventional stroke centers remain limited. Interventional cardiologists have established networks of catheterization laboratories and the necessary infrastructure to provide around the clock interventional therapy. These networks may also provide the currently lacking universal rapid access to prompt stroke intervention. METHODS: Between July 2012 and July 2018, 70 consecutive patients underwent acute stroke intervention for large-vessel occlusions. Seventeen patients (24%) had tandem or multiple vessel occlusions. The majority (n = 63, 90%) were admitted via our local stroke unit, and 7 (10%) patients were transferred from other regional referral centers. RESULTS: In 43 (61%) patients, systemic fibrinolytic therapy was started after baseline imaging. Mean time between symptom onset and arrival to the cath lab was 138 min; mean door-to-vascular access time was 64 min; mean time between cath lab activation and its operational readiness was 13 min. In all cases, access to supra-aortic vessels was achieved. Mean time between femoral arterial puncture and lesion crossing was 26 min. Stent implantation for extracranial stenosis or dissection was performed in 14 (20%) cases. Thrombectomy of intracranial occlusions was done with a stent retriever (n = 64, 91%) or an aspiration system (n = 14, 20%). In 20 (28%) cases, a combination of techniques was used. Recanalization was technically successful (Thrombolysis In Cerebral Infarction flow grade 2b or 3) in 65 (93%) patients. The 30-day mortality was 18% (n = 13). Favorable clinical outcome, defined as a modified Rankin Scale score of 0 to 2, was achieved in 61% at 3-month follow-up. CONCLUSIONS: Acute stroke interventions can be performed safely and with high technical and clinical success by experienced interventional cardiologists.

The IrisFIT Patent Foramen Ovale Closure Device in Patients With History of Cryptogenic Embolization.

BACKGROUND: The aim of this study was to assess safety, efficacy, and clinical outcome of the IrisFIT PFO Closure System (Lifetech Scientific) for transcatheter closure of patent foramen ovale (PFO) in patients with a history of cryptogenic stroke, transient ischemic attack (TIA), or peripheral embolization. PATIENTS AND METHODS: We report the results of 60 consecutive patients undergoing PFO closure with the IrisFIT occluder for secondary prevention of paradoxical embolization. All cases were analyzed for periprocedural and device-related adverse events up to 12 months after implantation. In addition, the patients were evaluated for complete defect closure with transesophageal echocardiography (TEE) after 1 month, 6 months, and (if indicated) 12 months. Mean patient age was 53 ± 14 years and 37 patients (62%) were males. All patients had a history of at least 1 cryptogenic stroke, TIA, or peripheral embolization. RESULTS: Technical success was achieved in all 60 procedures. The mean procedure time was 28 ± 11 minutes. There were no periprocedural or device-related complications up to 12 months after the implant. Successful defect closure at 6 months post device implantation was achieved in 56 cases (93.3%). Within 12 months of follow-up, 2 patients had recurrent TIAs, both with complete PFO sealing at the last TEE prior to the event. CONCLUSION: The IrisFIT PFO Closure System can be used safely and with high technical success for secondary prevention of cryptogenic stroke or peripheral embolization.