Percutaneous Closure Research Articles

Incidence, determinants, and impact of in-hospital complications during percutaneous patent foramen ovale closure

Abstract Introduction The incidence, types, determinants, and clinical impact of in-hospital complications after contemporary patent foramen ovale (PFO) percutaneous closure is unclear. Purpose To describe the incidence, types, determinants, and clinical impact of in-hospital complications after percutaneous PFO closure. Methods This study included consecutive patients undergoing PFO percutaneous closure for any indication in 18 centers in France and Italy from the ongoing AIR-FORCE registry. Periprocedural complications were collected, including death, bleeding, myocardial infarction (MI), supraventricular arrhythmia, pericardial effusion or tamponade, cardiac perforation, device embolization, intracardiac thrombus, venous thrombosis, atrioventricular block, brachial paraesthesia, oesophageal hematoma, and veno-arterial fistula. Determinants of periprocedural complications were evaluated using a logistic multivariate model. The clinical impact of periprocedural complications on cardiovascular events after discharge measured by the composite endpoint of death, stroke, transient ischemic attack, MI atrial arrhythmia, pulmonary embolism, deep veinous thrombosis, BARC ≥2 bleeding, or percutaneous or surgical re-intervention on the PFO) at longest follow-up was evaluated using a Cox model adjusted on age, sex, body mass index, diabetes mellitus, hypertension, dyslipidemia, and shunt severity prior to closure. Results We analyzed a total of 2,799 patients undergoing PFO closure with median age 50.7 [41.7-58.6] years and 57.9% male. A total of 109 (3.9% 95%CI 3.2%-4.7%) patients presented at least one in-hospital complication, the most frequent being supraventricular arrhythmia in 39 (1.4% 95%CI 1.0-1.9%) patients and BARC bleeding type ≥2 in 26 (0.9% 95%CI 0.6-1.4%) patients. Determinants of in-hospital complications were older age (per on year aOR 1.02 95%CI 1.01-1.04), diabetes mellitus (aOR 2.58 95%CI 1.36-4.89) and PFO closure for secondary prevention of an arterial embolic event (aOR 2.12 95%CI 1.18-3.82). With a median follow-up of 1.1 [0.3-3.1] years, the occurrence of an in-hospital complication was associated with an increased risk of cardiovascular events after discharge (aHR 1.90 95%CI 1.26-2.89) (Figure 1). Conclusions Although relatively rare, the occurrence of in-hospital complication during PFO percutaneous closure is associated with an increased risk of cardiovascular events in the year following the procedure.

Prevalence, determinants, and impact of significant shunt after percutaneous patent foramen ovale closure

Abstract Introduction Percutaneous closure of patent foramen ovale closure is increasingly performed for secondary prevention of PFO-related arterial embolic event. The clinical significance of postclosure residual right-to-left significant shunt remains unclear. Purpose To describe the prevalence, determinants, and clinical impact of a significant post-closure. Methods The AIR-FORCE is an ongoing prospective international registry of patients undergoing PFO closure from 19 centers in France, Canada and Italy. Only patients undergoing PFO for secondary prevention of an arterial embolic event with at least one available post-closure contrast transthoracic echocardiography (TTE) with agitated saline injection and Valsalva maneuvers were analyzed. Residual shunt was categorized according to the number of bubbles in the left atrial within 3 cardiac cycles at the first available contrast TTE as small (<10), moderate (10-20) or severe (> 20). Determinants of the presence of moderate or severe shunt were evaluated with multivariate logistic regression and its impact on the primary outcome (stroke, transient ischemic attack or peripheral arterial emboly) was evaluated with Cox model adjusted on age and sex. Results A total of 2413 patients, with a median age of 49.3 [40.4-57.4] years, 56% male, undergoing PFO closure between 2001 and 2023 were included. The first contrast TTE, which was performed after a median delay of 3.4 [0.9-5.8] months, reported the presence of moderate or severe residual shunt in 214 (8.9% 95%CI 7.8-10.1) patients. Determinants of the presence of moderate or severe residual shunt at the first contrast TTE were decreased body mass index (per 1kg/m², aOR 0.96 95%CI 0.93-0.99), severe shunt prior to PFO closure (aOR 3.54 95%CI 2.25-5.55) and increased device left disc diameter (per 1mm, aOR 1.08 95%CI 1.05-1.12). With a median follow-up of 2.2 [0.9-4.9] years, a total of 60 events were reported and the presence of moderate or severe residual shunt was associated with an increased risk of the primary outcome (aHR 2.46 95%CI 1.15-5.24) (Figure 1). Conclusions A moderate to severe residual right-to-left intracardiac shunt is not uncommon after PFO percutaneous closure and seems to be associated with an increased risk of arterial emboly recurrence.

Relationship of inflammatory factors with migraine in patients with patent foramen ovale undergoing percutaneous closure

Abstract Background Observational studies have reported the incidental reduction of the frequency and severity of migraine attacks following transcatheter patent foramn ovale (PFO) for established indications. Possible physiologic mechanisms for a relationship between PFO and migraine, if such a link does exist, have been the subject of much speculation, with some researchers suggesting the possible role of PFO as a conduit for the passage of various migraine-inducing inflammatory, vasoactive triggers in cerebral circulation. Purpose The aim of this study was to compare the levels of inflammatory mediators between migraineurs and non –migraineurs and to investigate the impact of PFO closure on the inflammatory state of individuals with migraine and alleviation of migraine symptoms. Methods Forty-five patients (mean age 48.2 ± 10.8 years, 48% male) undergoing percutaneous PFO closure were enrolled in the study. Among them, 15 patients reported recurrent migraine episodes (mean age 46.4 ± 8.90 years, 86% female) while 30 individuals (mean age 49 ± 12.32 years, 70% male) were non-migraineurs. White blood cell count, C-reactive protein (CRP), ferritin and d-dimers levels, as well as the erythrocyte sedimentation rate (ESR) were compared between migraineurs and non-migraineurs. We additionally analyzed the inflammatory levels before and after the percutaneous PFO closure in migraineurs, correlating these changes with migraine relief assessed using the Migraine Disability Assessment Questionnaire (MIDAS) over a 6-month follow-up period. Results White blood cell count, d-dimers levels and ESR were similar in migraineurs and non-migraineurs (6,583 ± 2,251 Χ1 0.e3/uL vs 6,115 ± 1,958 Χ10.e3/uL; p-value = 0.48; 0.54 ± 0.49 μg/L vs 0.45 ± 0.29 μg/L; p- value= 0.49; 23.08 ± 16.68 mm vs 18.51 ± 14.98 mm; p- value 0.402; respectively). However, CRP and ferritin levels were significantly greater in patients with migraine compared to non- migraineurs (3.82 ± 1.87 mg/L vs 1.34 ± 1.52 mg/L; p- value =0.037 and 111.21 ± 82.70 ng/ml vs 50.12 ± 47.9 ng/ml; p- value = 0.023, respectively). Moreover, there was no significant difference between pre- and post-procedural inflammatory levels in migraineurs undergoing percutaneous PFO closure. Of note, following the procedure a reduction in CRP levels was observed without, however, reaching statistical significance. Finally, all patients observed a cessation in the occurrence of migraine attacks after closure. Conclusions Our study revealed significantly higher baseline levels of CRP and ferritin in migraineurs compared to non-migrainers with PFO. Although no alteration in inflammatory factors was observed following the procedure in migraineurs with PFO, all individuals experienced relief from migraine symptoms. Given the limitation of our study due to the small sample size, future studies may provide more insights into the potential benefits of PFO closure in specific migraine patient phenotypes.

4-year follow-up results of percutaneous closure of atrial septal defect with the total biodegradable poly-L-lactic acid device: date from a prospective, single-center trial

Abstract Background The poly-L-lactic acid (PLLA) device is a novel, total biodegradable occluder dedicated to percutaneous closure of atrial septal defect (ASD) .Closure of ASD with the PLLA device has proven to be relatively safe and effective in our preclinical and first-in-human studies. Objective The aim of the study was to evaluate long-term safety and efficacy of the PLLA device in percutaneous closure of ASD in a large cohort of patients. Methods A prospective study enrolling patients who had a clinically significant ASD was conducted in our institution from May 2018 to August 2019. Percutaneous ASD closure was undertaken with the PLLA device. Evaluations were scheduled pre-hospital discharge and again at 1, 3, 6, 12, 24, 36 and 48 months post implantation. Primary endpoints were a composite of clinical success, including closure success and no major complications at the 48-month follow-up evaluation. Results A total of 52 patients (35 children, 55.8% females, median age 7.55 years, median weight 28.75Kg) underwent an attempt at percutaneous ASD closure with PLLA device. Successful device implantation was achieved in 50 (96.1%) of 52 patients with delivery attempts. All the 50 patients (100%) completed 4-year follow-up visit. Closure success at 4-year follow-up were 84% (42/50), with 8 patient (16%) reported to have clinically significant leaks, including 2 large residual leaks, 5 moderate residual leaks, and 1 small residual leak. 10 complications occurred, with 1 event of cardiac arrhythmia during procedure, and 9 follow-up events, consisting in cardiac arrhythmias (n=6), moderate or large mitral regurgitation (n=2), and headache (n=1). Conclusion Percutaneous ASD closure with PLLA device in human seems to be safe. However, increased occurrence of residual leaks overtime indicated that long-term efficacy of PLLA device in human was sub-optimal.TTE follow-up of a case with PLLA device

Features of recurrence and contralateral metachronous inguinal hernia (CMIH) in the patients underwent laparoscopic percutaneous extraperitoneal closure (LPEC) for pediatric inguinal hernia.

Recurrence and contralateral metachronous inguinal hernia (CMIH) are important postoperative complications in patients with inguinal hernia (IH) who undergo laparoscopic percutaneous extraperitoneal closure (LPEC). This study aimed to evaluate the incidence and causes of recurrence and CMIH after LPEC. Among the included patients, 2484 hernias were included in the analysis of recurrence. CMIH was analyzed in 2094 cases with unilateral IH without a history of contralateral IH. Overall, 21 hernias (0.85%) recurred and seven patients (0.34%) experienced CMIH. Based on the video inspection, injury and skipping of the peritoneum were suspected as the cause of recurrence in eight cases, while loose ligation was suspected in five cases. The cause of recurrence could not be predicted in the remaining eight patients. Of the seven patients with CMIH, three had a mild depression around the internal inguinal ring at the first surgery. In the remaining four CMIH cases, no noteworthy findings were noted around the internal ring. More than half of the recurrences, in which skipping of the peritoneum and loose ligation were suspected, could have been prevented by secure ligation during the first surgery. Extending the indications of prophylactic surgery for shallow depressions may reduce CMIH.

Sex differences in outcomes of percutaneous left atrial appendage closure

Abstract Background Atrial fibrillation (AF) is the most common arrhythmia in adults and is associated with an increased risk of embolic stroke. In a previous survey, 91% of nonrheumatic AF-related left atrial thrombi was originated in the left atrial appendage (LAA). Percutaneous left atrial appendage closure (LAAC) with the Watchman device has been shown to be noninferior to anticoagulation therapy in clinical trials for stroke prevention in nonrheumatic AF. It has been used in Japan since September 2019 only for patients who are at the high risk of bleeding events. The WATCHMAN family is the only left atrial appendage closure (LAAC) device in Japan. Since long time ago, sex differences have been attracting attention in the cardiology. Due to the cardiovascular protective effects of endogenous estrogens, premenopausal women are thought to be less likely to develop cardiovascular disease. Whereas, in area of AF, Female with AF have higher stroke risk and female with AF have severe after effect. However, there are few studies on sex differences in LAAC implantation outcomes. Purpose We aimed to identify the sex differences of outcomes of LAAC in Japanese patients. Methods A total of 118 consecutive patients who underwent LAAC at our hospital from January 2020 to August 2023 were prospectively analyzed. Various patient characteristics, comorbidities, and outcomes were identified and compared between male and female. Results Results are shown in Table. Female were older (79 vs. 73 years, p = 0.0009), thinner (Body mass index 22 vs. 24 kg/m2, p = 0.0326), and less likely to have had diabetes (19 vs. 40%, p = 0.0340). Pulmonary embolism was significantly more common in female after LAAC. If anticoagulants are discontinued after LAAC, women’s susceptibility to coagulation may become apparent. Conclusions LAAC was feasible and safe for Japanese patients of both genders. However, these results could have a relevant impact on the antithrombotic management of patients who are at the high risk of embolic considering sex difference. Especially, we should pay great attention when discontinuing anticoagulants after LAAC in female.

Association between preprocedural thromboembolic or bleeding events under oral anticoagulation therapy and mid-term outcomes after percutaneous left atrial appendage closure

Abstract Background Currently, no consensus has been established on the most effective antithrombotic therapy to prevent thromboembolic and bleeding events in patients undergoing percutaneous left atrial appendage closure (LAAC). Methods We retrospectively investigated the incidence of device-related thrombosis (DRT), thromboembolic events, and bleeding events in patients who underwent LAAC from September 2019 to October 2022. After categorizing patients into groups based on preprocedural thromboembolic or bleeding events under oral anticoagulation (OAC) therapy, we compared the incidence of DRT and prognosis according to the postprocedural antithrombotic therapy. Results In patients who received the conventional antithrombotic therapy (OAC with and without single antiplatelet therapy for 45 days after LAAC and dual-antiplatelet therapy from 45 days to 6 months followed by single antiplatelet therapy), preprocedural thromboembolic events despite OAC were independently associated with DRT or postprocedural thromboembolic events at the 3-year follow-up (hazard ratio [HR] 4.55; 95% confidence interval [CI] 1.32–15.6; P = 0.016), whereas preprocedural bleeding events were independently associated with postprocedural bleeding events (HR 8.01, 95% CI 1.45–58.3; P = 0.036). Continuation of OAC for 12 months among patients who developed preprocedural thromboembolic events during OAC significantly decreased the incidence of DRT or postoperative thromboembolic events (P = 0.002) with no increase in the bleeding events (P = 0.522). Conclusions Preprocedural thromboembolic and bleeding events can predict adverse events after LAAC with conventional antiplatelet-based antithrombotic therapy. Patients who develop thromboembolic events under continuous OAC may benefit from continuous OAC for 1 year after LAAC.

Evaluation of efficacy and safety of simplified procedure for the percutaneous closure of patent foramen ovale: the Ile De France Foramen Ovale Permeable(IDFFOP) prospective, multicenter cohort study

Abstract The superiority of device closure over medical therapy for the prevention of recurrent stroke in patients with cryptogenic stroke and patent foramen ovale (PFO) was reported in several meta –analyses of randomized controlled trials. The growing number of PFO procedures requires to find alternatives to conventional guidance by transoesophageal echocardiography (TOE) needing general anesthesia. The aim of our study was to assess prospectively the efficacy and safety of a simplified procedure based on trans thoracic echocardiography (TTE) and local anesthesia rather than TOE during PFO closure. Methods Design and study oversight. The IDFFOP study was a French prospective, multicenter cohort study performed in four centers expert in TTE-guided device deployment. All patients had a stroke history, a PFO and a large or moderate right to left shunt defined by the number of microbubbles in the left atrium ( large shunt > 30, moderate : 10 to 30 microbubbles). A(Risk of Paradoxical Embolism) score>5 was required to confirm PFO imputability in stroke history. The primary end point was efficacy of TTE during the transcatheter PFO closure defined as the successful implantation of the device without malposition, without need of TOE, and absence of significant residual shunt at 3-month TTE control. Safety was defined as the absence of any periprocedural complications. Results 280 patients were enrolled from January 2018 to October 2020 ( male sex : 59.5%; Average age 57 years old ). Average ROPE score was 7; Cumulative immediate procedural success with the TTE-guided method was 99%, without any device embolization. However, in 2 patients, TOE was needed to guide device deployment. There was no severe vascular complication, or any ischaemic event during or after the procedure. 6 post-procedure groin hematomas occurred but none needed anyblood transfusion .One patient experienced a transient periprocedural atrial fibrillation. At 3 months there were only 8 (2,8%) residual right to left shunts (3 large, 5 moderate). Conclusion A simplified procedure for percutaneous PFO closure based on TTE and local anesthesia is safe and effective. Randomized controlled trials should be performed to confirm these results.

Anatomical classification of patent foramen ovale before percutaneous closure

Abstract Introduction Anatomical characteristics of patent foramen ovale (PFO) vary a lot, potentially impacting the embolic risk, selection of the device and the final sealing results of the closure procedure. Objective To categorize the different PFO anatomies and evaluate the consequence on the type of device used and the incidence of residual shunt. Methods 624 consecutive patients who underwent PFO percutaneous closure with transoesophageal echocardiography (TEE) guidance were retrospectively reviewed. Four types of PFO were identified once a rigid wire was in place using per-procedural TEE. This new classification was based on the PFO sheathed tunnel’s length and width, presence of concomitant atrial septal aneurysm (ASA) or additional defect (ASD), width of the septum secundum (SS) and aortic enlargement (Figure 1). Type I, or "single PFO" was defined by the absence of ASA or ASD, a tunnel width ≤ 4mm, SS’s width ≤ 10mm and no aortic enlargement (i.e., aortic root diameter <21mm/m², distorted anatomy or scoliosis). Type II or "dominant septal aneurysm" was defined by the presence of an ASA, with a distinction between subtype IIa (long PFO tunnel with length ≥10mm) and subtype IIb (short PFO tunnel with length <10mm). Type III or "modified PFO" was defined by SS’s width > 10 mm, aortic enlargement, or severe scoliosis, and type IV or "multi perforated" was defined by the presence of a concomitant ASD or a multifenestrated septal wall. In case of concomitant criteria, the predominant order was IV, then IIb, then III. For each category, the presence of residual shunt was evaluated after Valsalva manoeuvres with contrast echocardiogram 6 months after the procedure. Results Our population had a median age of 51 [41-59] years and included 43.8% women. The type II PFO was the most frequently encountered, with 42% of the patients (Table 1). A total of 44 (7.1%) patients presented multiple types concomitantly (mostly type II and III). PFO occluders were the most implanted devices overall, particularly with type I and IIb, while ASD occluder were more frequently used with types IV and IIb. Cribriform/Uni™ devices were more frequently used with type IV. Large devices (i.e., left disc’s diameter >25 mm) were predominantly used with type III and IV, but scarcely employed with type I and II. Within type II anatomies, large devices were significantly more frequently used with type IIb. Fluoroscopy duration was significantly higher with type IV. At 6 months ultrasound evaluation, large right-to-left residual shunt was significantly more frequent with type IV anatomy and with patients presenting multiple types concomitantly (18/34 - 40.9%). No significant differences were observed regarding clinical outcomes during follow-up. Conclusion Based on specific anatomical characteristics, four types of PFO may be identified, presenting with increasing procedural complexity, and requesting specific closure devices.

Impact of left atrial appendage closure on left atrial function: insights from the OCEAN-LAAC registry

Abstract Background Percutaneous left atrium appendage closure (LAAC) is an effective therapy to prevent thromboembolic events among patients with atrial fibrillation (AF) (Ref 1). However, since the left atrium appendage (LAA) potentially serves as a part of the left atrium (LA) volume and a buffer for increasing LA pressure, this procedure may impair LA compliance (Ref 2). Purpose In this study, we sought to investigate the effect of LAAC on LA function. Methods/Results The OCEAN-LAAC registry is an ongoing, multicentre Japanese registry including patients who underwent LAAC in Japan (Ref 3). Among 225 patients from the registry, LA volume index (LAVI) and tricuspid regurgitation pressure gradient (TRPG) at baseline and 6 months after the procedure were analysed. In the overall population, no significant increase in LAVI (Abstract Picture 1A) and TRPG (Abstract Picture 1B) was observed (LAVI baseline vs 6 months, 55.0 [44.0, 70.0] ml/m2 vs 55.0 [42.0, 75.6] ml/m2; P = 0.31; TRPG, 25.0 [20.3, 32.0] mmHg vs 25.0 [20.0, 32.0] mmHg; P = 0.85). However, particular patients underwent an increase in LAVI (Abstract Picture 1C), and multivariable analysis showed smaller LAVI and elevated TRPG at baseline, rather than any procedural factors, were significantly associated with an increase in LAVI (Odds ratio (OR) for baseline LAVI: 0.98 [95% confidential interval (CI): 0.97 - 0.996]; OR for baseline TRPG: 1.04 [95% CI: 1.00 - 1.08]). A 5 ml/m2 increase in LAVI at a 6-month follow-up was significantly associated with subsequent heart failure hospitalization (HFH) (Hazard ratio: 3.37 [95% CI: 1.18 - 9.65]) (Abstract Picture 2A). However, this predictive value was not observed in patients with lower LAVI (≤ 55 ml/m2) at baseline; instead, it was observed in those with a baseline LAVI over 55 ml/m² (Abstract Picture 2B). Conclusions In summary, our study did not elucidate the negative impact of LAAC on LA function, yet demonstrated an increase in LAVI at 6 month follow-up was frequently observed in patients with lower LAVI and higher TRPG at baseline. Additionally, increase in LAVI was significantly associated with subsequent HFH, which was more evident in patients with higher LAVI at baseline.

Feasibility, accuracy, and reproducibility of device sizing in virtual reality for percutaneous left atrial appendage closure - a single center study

Abstract Background Left atrial appendage closure (LAAC) is a safe and effective procedure for stroke prevention in patient with non-valvular atrial fibrillation. Procedural planning and device sizing remains challenging due to the highly complex and variable three-dimensional (3D) anatomy of the left atrial appendage (LAA). Virtual reality (VR) is a innovative, recent technology allowing a superior spatial orientation visualization of 3D imaging datasets. Purpose Therefore, we aimed to evaluate feasibility and accuracy of LAA measurements in VR for device sizing in patients planned for LAAC. Methods Twenty-one patients (79±7 years, 62% male) with non-valvular atrial fibrillation scheduled for LAAC were randomly included in our study. Preprocedural a multi-slice computed tomography (MSCT) was performed for device sizing in all patients. MSCT-based 3D models were established and visualized in VR using a dedicated software (VMersive, Warsaw, Poland). LAA dimensions (Ostium, landing zone (LZ), and depth) were assessed directly in the virtual environment. Conventional measurements of LAA ostium, landing zone (LZ) and depth using commercially available software were compared to measurements in VR. Results 3D reconstruction of MSCT datasets and visualization in VR were successfully performed automatically in all patients within a few seconds. MSCT and VR demonstrated good correlations for ostium minimum (r = 0.93), maximum (r = 0.8) and mean (r = 0.88, all p<0.001) diameters. Additionally, LZ minimum (r=0.84), maximum (r=0.86) and mean (r=0.9) diameters showed good correlation (all p<0.001). Moderate correlation was observed for depth measurements (r=0.76, p<0.001). Furthermore, intraclass correlation coefficients ranging from 0.88 to 0.98 denoted high inter- and intraobserver agreement. Conclusion Immersive VR allows highly feasible, accurate and reproducible measurements of the LAA dimensions directly in the virtual environment, hence enabling accurate device sizing for LAAC.

Novel predictor of thrombosis after left atrial appendage closure -Neutrophil to Lymphocyte Ratio (NLR), platelet to LymPhocyte Ratio (PLR), and Lymphocyte to Monocyte Ratio (LMR)-

Abstract Background Cardiogenic embolism by left atrial thrombi is one of the most important atrial fibrillation (AF)-related clinical problems. In a previous survey, 91% of nonrheumatic AF-related left atrial thrombi was originated in the left atrial appendage (LAA). The WATCHMAN device was developed as a permanent implantable device to seal off the LAA to prevent cardiogenic embolism. It has been used in Japan since September 2019. The WATCHMAN family is the only left atrial appendage closure (LAAC) device in Japan. After percutaneous left atrial appendage closure (LAAC), DRT is an important issue in some cases. Neutrophil to lymphocyte ratio (NLR), platelet to lymphocyte ratio (PLR), and lymphocyte to monocyte ratio (LMR) are known as cancer prognostic factors and indicators of immune status. There are few reports on the predictor for device related thrombosis (DRT), transient ischemic attack (TIA), and ischemic stroke. Finding novel biomarkers could help clinical decision in antithrombotic therapy post LAAC and follow-up intervals. Purpose To investigate the association of NLR, PLR, and LMR with device related thrombosis, transient ischemic attack, and ischemic stroke in patients with LAAC. Methods Our database of LAAC was respectively analyzed. All LAAC cases were performed between January 2020 and September 2023. Blood cell counts were sampled in three days before LAAC. Postoperative antithrombotic therapy was individualized based on the patient’s background. We examined their background and clinical events. Results A total of 116 consecutive patients underwent LAAC in our institution excepting for one case that could not be performed due to a huge LAA (follow-up period, 610±37 days; age, 75±1 years; male sex, 73%; left ventricular ejection fraction, 58±1%; CHAD2S2-VASc, 4.6±0.1; HAS-BLED, 3.4±0.1). The results are shown in the Figure. Receiver-operating characteristic curve analysis confirmed the best cut-off value of NLR, PLR, and LMR for composite of DRT, TIA, and ischemic stroke (AUC = 0.69; 0.70; 0.67). In the univariate analysis, NLR<1.88, PLR<144, and LMR>3.40 are the independent predictor for the combination of DRT, TIA, and ischemic stroke (p-value = 0.02; 0.04; 0.05, respectively). Conclusion Low NLR, low PLR, and high LMR are the independent predictor for the combination of DRT, TIA, and ischemic stroke. These parameters can be useful in routine use because they can be easily calculated without additional costs.

Neurologic recurrence after transcatheter PFO closure in patients with cryptogenic stroke

Abstract Background Patent foramen ovale (PFO) is associated with an increased risk of cryptogenic stroke, and interventional closure is recommended for secondary prevention. However, there is limited real-world data on long-term results. Our objective was to evaluate outcomes following successful transcatheter PFO occlusion. Methods Data from patients undergoing PFO closure for cryptogenic stroke between 2010 and 2015 were analysed to determine short- and long-term outcomes and to identify potential predictors of neurological recurrence. Results 330 patients underwent successful PFO closure. The mean age of patients was 49 (standard deviation (SD) ±12) years, and 55.5% were male. Any in-hospital adverse event was observed in eight patients (2.4%). During a median follow-up of 9.85 (SD ±2.5) years, the combined outcome of transient ischemic attack (TIA), stroke, or death from stroke was observed in 3.6% of patients (0.38 events per 100 person-years). After 5, 10, and 12 years the percentage of patients free of the composite outcome was 97.5%, 96.2%, and 96.2% respectively (Figure 1). New onset atrial fibrillation was detected in 10 patients (3.0%). A thorough analysis of the neurologic recurrences revealed a total number of six cryptogenic strokes (1.8%). Our results revealed that the Risk of Paradoxical Embolism (RoPE) score (adjHR: 0.70, 95% confidence interval [CI]: 0.52 to 0.95; p=0.022) and the number of prior neurologic events (adjHR: 9.78, 95% CI: 2.66 to 35.99; p<0.001) were strong independent predictors of future recurrent neurologic events. Kaplan Meier survival analysis stratified by number of previous neurologic events proved to be statistically significant (p<0.001; Figure 2). Conclusion In this real-world cohort of patients with cryptogenic stroke we observed excellent safety and good efficacy of percutaneous PFO closure, similar to randomized controlled trials or other long-term cohort studies. The rate of recurrent neurological events was low, especially cryptogenic strokes. The RoPE score confirmed good predictive power; in particular, the number of previous neurological events should be taken more into account when determining the indication for closure.

Feasibility and early outcomes of atrial septal defect prostheses use for percutaneous closure of widely open patent foramen ovale

Abstract Background The efficient closure of patent foramen ovale (PFO) with short canal length and large width, usually associated with atrial septal aneurysm (ASA), remains challenging. These cases frequently require the use of larger PFO devices to avoid the risk of device embolism at the cost of a higher rate of residual shunting, mostly due to interdisk spacing. The use of atrial septal defect (ASD) prosthesis could be useful in these patients. Purpose To describe feasibility and early outcomes of the use of ASD device for percutaneous closure of widely open PFO representing an "ASD-like anatomy". Methods Since January 2022 in a high volume French university center, we started to use ASD device for percutaneous closure of selected cases of PFO with complex anatomy as mainly defined by a sheathed width of PFO ≥ 5 mm and sheathed canal length ≤ 10 mm (Figure 1) facing major per-operative residual shunt with PFO prostheses in some patients. In addition to the descriptive results, we compared this ASD device subgroup with a cohort of patients with similar anatomy but previously treated in our center with PFO device. All available transesophageal echocardiography (TEE) examinations were reviewed. The main objective was to describe the feasibility of the procedure (success and safety), the secondary endpoint was immediate post-procedural moderate to severe residual right-to-left shunt (RLS), defined as ≥ 10 bubbles in the left atrium within 3 cardiac cycles after transfemoral agitated saline injection. Results A total of 65 patients was treated with ASD devices, procedural success was achieved in all patients with a low rate (4,2%) of intrahospital complications (two supraventricular arrythmia, one anaphylactic shock and one minor laryngeal injury) and without device embolism. As compared with a cohort of 127 patients of similar anatomy treated with PFO device, patients in the ASD device group had more complex characteristics especially higher mean sheathed PFO width and shorter mean sheathed PFO canal length. Immediate post-procedural residual moderate to severe RLS did not differ significatively between groups (Table 1). No or minimal shunting was observed in 91% and 92% of cases (p=NS) but the three patients with severe RLS were all in the PFO device group. Conclusion Percutaneous closure of "ASD-like" PFO with ASD prostheses is feasible and safe. Larger studies and longer follow-ups are now required to confirm the expected improved sealing effect with this strategy.

Optimizing elective high-risk PCI with ECMO support: the value of completely percutaneous use of VA-ECMO

Abstract Background Veno-arterial extracorporeal membrane oxygenation (VA-ECMO) is a suitable manner to prevent hemodynamic deterioration during high-risk percutaneous coronary intervention (PCI). VA-ECMO is mainly surgically deployed under general anaesthesia. New developments now facilitate completely percutaneous insertion of VA-ECMO with only local anaesthesia, reducing operating team size and hospital costs. Purpose The aim of this study is to provide data on the outcomes of completely percutaneous use of VA-ECMO during high-risk PCI with local anaesthesia. Methods A retrospective single-centre registry was performed including all patients undergoing ECMO-assisted high-risk PCI, who were rejected for coronary artery bypass graft (CABG) as primary treatment option. Primary endpoint was the incidence of major adverse cardiac events (MACE), assessed during hospital admission and after discharge up to 90 days. Results Between January 2020 and February 2024, 34 patients undergoing ECMO-assisted high-risk PCI were included. The mean age of the population is 71.9 (± 8.4) and 27 (79.4%) patients are male. The mean left ventricular ejection fraction is 28.5 (± 11.1) percent and complexity indices were high, including STS mortality score: 4.1 (± 2.8), SYNTAX score I: 31.7 (± 9.4), SYNTAX score II: (PCI) 54.8 (± 10.8). Femoral artery was used for cannulation in 30 (88.2%) patients, of which one patient required an additional femoral backflow cannula due to prolonged ECMO support. Local anaesthesia in combination with preprocedural oral benzodiazepine was the preferred choice of anaesthesia (85.3%). Closure was predominantly performed with a percutaneous closure device (97.1%). Successful revascularization and procedural success were achieved in all patients. In-hospital MACE occurred in 2 (6.1%) patients. MACE occurred within 90 days in 5 (20.8%) patients after discharge. Conclusion High-risk PCI with completely percutaneous use of VA-ECMO with local anaesthesia is a novel concept, providing a suitable alternative to the standard surgical use of VA-ECMO with general anaesthesia.

Transcatheter closure of the Gerbode type ventricular septal defect after redo mitral valve replacement

Gerbode defect is an uncommon ventricular septal defect (VSD) resulting in a left ventricle to right atrium shunt. Although typically congenital, acquired defects have been reported following infective endocarditis, cardiac surgery, trauma, or acute myocardial infarction. This condition causes left-to-right intracardiac shunt and potential hemodynamic instability. This complex anatomy poses therapeutic challenges, and optimal management is often unclear. We present a case of acquired Gerbode defect following a redo mitral valve replacement surgery in a 71-year-old man who developed severe dyspnea and pulmonary hypertension. Treatment was successfully performed with percutaneous transcatheter VSD closure using an Amplatzer device. This case highlights the importance of considering Gerbode defects in postoperative patients and demonstrates the efficacy of transcatheter closure in reducing symptoms and avoiding high-risk redo cardiac surgery. Transcatheter repair offers shorter recovery times, reduces pain, and avoids repeat sternotomy, making it a valuable and minimally invasive alternative for patients with acquired Gerbode defects. Keywords: Gerbode defect, left ventricle to right atrium shunt, redo mitral valve replacement, transcatheter closure

Percutaneous transcatheter closure of a large saphenous vein graft aneurysm with Amplatzer vascular plug

A saphenous vein graft (SVG) aneurysm is a rare complication seen in coronary artery bypass grafts (CABG). While the sternotomy for surgical correction is used in most of these patients, depending on the patient’s condition, an alternative method may be required. This case is a 64-year-old man who developed SVG aneurysm more than 10 years after CABG and underwent a successful percutaneous transcatheter exclusion of SVG aneurysm using 10 mm Amplatzer Vascular Plug 2, resulting in prevention of blood flow into the aneurysm and future rupturing. This case illustrates the potential of noninvasive treatment with flexible procedures based on the patient’s anatomy and risk for complicated surgery. Keywords: Amplatzer vascular plug, saphenous vein graft, saphenous vein graft aneurysm, coronary artery bypass graft

When hypoxemia does not respond to oxygen therapy: a case of platypnea-orthodeoxia syndrome.

Platypnea-orthodeoxia syndrome (POS) is a rare clinical entity characterized by the onset of dyspnea and hypoxemia that normally manifests in the upright position, improving with recumbency. POS is generally caused by both anatomical and functional defects that lead to a right-to-left shunt. Herein, we present an illustrative case of POS in an elderly patient admitted for severe hypoxemia, in which a massive right-to-left shunt through a patent foramen ovale facilitated by an anatomic disturbance was found. Percutaneous closure of the defect was performed, thus correcting the POS.

Comparative Effectiveness of Devices for Interventional Patent Foramen Ovale Closure: Insights from a 23-Year Monocentric Analysis

Background/Objectives: Patent foramen ovale (PFO) is a congenital heart defect affecting up to 25% of the population, associated with an increased risk of cryptogenic stroke. Percutaneous PFO closure is a minimally invasive procedure aimed at reducing stroke risk by eliminating the right-to-left shunt. Methods: This monocentric, retrospective study analyzed 716 patients who underwent PFO closure between January 2000 and February 2023. Data collected included demographics, indications for closure, procedural details, and outcomes. Key endpoints were complications at the puncture site, pericardial effusion, recurrent stroke or transient ischemic attack (TIA), thrombi on the device, new-onset atrial fibrillation, and death. Results: The cohort had a mean age of 50.6 ± 12.6 years, with 60.8% female. Four devices were used: Occlutech PFO occluder (n = 106), Amplatzer PFO occluder (n = 227), Gore septal occluder (n = 296), and Cardia PFO-Star (n = 87). The initial procedural success rate was 98.9%, with no significant differences between devices. Complication rates were low across all devices. Residual shunt incidence decreased from 17.9% in 1 month to 3.4% in 12 months. Device-specific complications included late-onset pericardial effusion (p = 0.01), erosions (Cardia PFO-Star), and device thrombus formation (Gore septal occluder). Conclusions: PFO closure is a safe and effective method for preventing recurrent strokes, with high success rates and varying specific complication profiles, depending on the device. Further long-term studies are needed to evaluate newer devices and optimize patient outcomes.

Correlations Between Plasma BNP Level and Risk of Thrombotic-Hemorrhagic Events After Left Atrial Appendage Closure.

Background: Percutaneous left atrial appendage closure (LAAC) reduces the incidence of stroke/bleeding events in patients with non-valvular atrial fibrillation, high risk of stroke, and contraindication in continuing anticoagulation therapy. Of them, patients with heart failure may remain at high risk of these events after LAAC. Method: Patients who underwent LAAC and were listed for the multi-center, prospectively collected OCEAN-LAAC registry, were eligible. Of them, individuals without baseline plasma B-type natriuretic peptide (BNP) levels and those dependent on hemodialysis were excluded. The prognostic impact of baseline plasma BNP levels on the incidence of death or stroke/bleeding events after LAAC was evaluated. Results: A total of 937 patients (median 78 years, 596 men) were included. The LAAC device was successfully implanted in 934 (98%) patients. Over the 366 (251, 436) days after the LAAC, 148 patients encountered a primary outcome. The common logarithm of baseline plasma BNP was independently associated with the primary outcome with an adjusted hazard ratio of 1.46 (95% confidence interval 1.06-2.18, p = 0.043). A calculated cutoff of 2.12 (equivalent to 133 pg/mL of plasma BNP level) significantly stratified the cumulative incidence of the primary outcome (29% vs. 21% for 2 years, p = 0.004). Conclusions: Using prospectively collected large-scale multi-center Japanese registry data, we demonstrated that a baseline higher plasma BNP level was independently associated with a higher incidence of stroke/bleeding events and mortality after LAAC. Further studies are warranted to understand the optimal therapeutic strategy for LAAC candidates with elevated baseline plasma BNP levels.