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Background: Limited data are available on transcatheter patent foramen ovale (PFO) closure outcomes in the elderly., Aims: Through this study, we aimed to determine the incidence and predictors of adverse events (recurrent cerebrovascular events [CVE] and atrial fibrillation [AF]) post-PFO closure in older patients with cryptogenic events., Methods: This multicentre international study included patients over 60 years undergoing PFO closure for cryptogenic thromboembolic events. A dedicated database compiled baseline, procedural, and follow-up data. Competing risk and adjusted outcome predictor analyses were conducted., Results: A total of 689 patients were included (median age 65 years, 41.2% female, mean Risk of Paradoxical Embolism [RoPE] score 4.5). The procedural success rate was 99.4%. After a median follow-up of 2 (interquartile range 1-5) years, 66 patients (9.6%) had died. CVE and stroke rates were 1.21 and 0.55 per 100 patient-years, respectively. Diabetes (hazard ratio [HR] 3.89, 95% confidence interval [CI]: 1.67-9.07; p=0.002) and atrial septal aneurysm (ASA; HR 5.25, 95% CI: 1.56-17.62; p=0.007) increased the CVE risk. New-onset AF occurred at a rate of 3.30 per 100 patient-years, with 51.3% within one month post-procedure. Older age (HR 1.05 per year, 95% CI: 1.00-1.09; p=0.023) and the absence of hypertension (HR 2.04, 95% CI: 1.19-3.57; p=0.010) were associated with an increased risk of AF., Conclusions: Older patients undergoing PFO closure had a relatively low rate of CVE and new-onset AF after a median follow-up of 2 years. The presence of diabetes, ASA, and a more advanced age determined an increased risk of adverse clinical events. These factors may be considered in the clinical decision-making process regarding PFO closure in this challenging population.

Background: Both transcatheter edge-to-edge repair (TEER) of mitral regurgitation or left atrial appendage closure (LAAC) require periprocedural anticoagulation with unfractionated heparin (UFH) that is administered either before or immediately after transseptal puncture (TSP). The optimal timing of UFH administration (before or after TSP) is unknown. The Strategy To Optimize PeriproCeduraL AnticOagulation in Structural Transseptal Interventions trial (STOP CLOT Trial) was designed to determine if early anticoagulation is effective in reducing ischemic complications without increasing the risk of periprocedural bleeding., Methods: The STOP CLOT trial is a multicenter, prospective, double-blind, placebo-controlled, randomized trial. A total of 410 patients scheduled for TEER or LAAC will be randomized 1:1 either early UFH administration (iv. bolus of 100 units/kg UFH or placebo, given after obtaining femoral vein access and at least 5 minutes prior to the start of the TSP) or late UFH administration (iv. bolus of 100 units/kg UFH or placebo given immediately after TSP). Prespecified preliminary statistical analysis will be performed after complete follow-up of the first 196 randomized subjects. To ensure blinding, a study nurse responsible for randomization and UFH/placebo preparation is not involved in the care of the patients enrolled into the study. The primary study endpoint is a composite of (1) major adverse cardiac and cerebrovascular events (death, stroke, TIA, myocardial infarction, or peripheral embolization) within 30 days post-procedure, (2) intraprocedural fresh thrombus formation in the right or left atrium as assessed with periprocedural transesophageal echocardiography, or (3) occurrence of new ischemic lesions (diameter ≥4 mm) on brain magnetic resonance imaging performed 2 to 5 days after the procedure. The safety endpoint is the occurrence of moderate or severe bleeding complications during the index hospitalization., Conclusions: Protocols of periprocedural anticoagulation administration during structural interventions have never been tested in a randomized clinical trial. The Stop Clot trial may help reach consensus on the optimal timing of initiation of periprocedural anticoagulation., Clinical Trials Registration Number: The study protocol is registered at ClinicalTrials.gov, identifier NCT05305612., Competing Interests: Declaration of competing interest Dr Pręgowski is a proctor for Abbott, Boston Scientific and Edwards LifeSciences; Dr Capodanno reports speaker's or consulting honoraria from Daiichi Sankyo, Sanofi Aventis, Terumo, Novo Nordisk (personal) and Medtronic (institutional); Dr Grygier is a proctor and reports speaker's or consulting honoraria from Abbott, Boston Scientific and Medtronic; Dr De Baker received institutional research grants and consulting fees from Abbott and Boston Scientific; Dr Wojakowski is a proctor for Abbott and reports speaker's fee from Edwards LifeSciences; Dr Witkowski is a proctor for Edwards LifeSciences; The other authors do not have relevant disclosures., (Copyright © 2024 Elsevier Inc. All rights reserved.)

Objectives: To describe the occurrence of postprocedural atrial fibrillation (AF) among patients with cryptogenic stroke undergoing patent foramen ovale (PFO) closure in the REDUCE clinical study and analyze for potential risk factors for the development of postprocedural AF., Background: AF is an adverse event that might potentially counterbalance the stroke prevention benefit from PFO closure. Data on AF after transcatheter PFO closure are sparse., Methods: We evaluated data from patients having PFO closure (Gore HELEX or Gore Cardioform Septal Occluder) in the REDUCE clinical trial (n = 408) in at post hoc explorative analysis. Median follow-up was 5.0 years., Results: AF occurred in 30 patients (7.4%) after PFO closure with a total of 34 AF events. Most were reported as non-serious (68%), detected within 45 days post-procedure (79%), and resolved within 2 weeks of onset (63%). One subject with AF had recurrent stroke. Postprocedural AF occurred more frequently among subjects with higher age and large device sizes. Male sex was the only independent predictor of postprocedural AF. We found no association between the type of occluder (HELEX or Gore Cardioform Septal Occluder) or PFO anatomical characteristics and post-procedural AF., Conclusion: In the REDUCE clinical study, postprocedural atrial fibrillation was mostly early onset, transient and with no later recurrence. Postprocedural AF occurred more frequently among patients with higher age and larger devices. Male sex was the only independent predictor of postprocedural AF., (© 2021 Wiley Periodicals LLC.)

Background: Optimal preprocedural planning is essential to ensure successful device closure of the left atrial appendage (LAA)., Design: The PREDICT-LAA study is a prospective, international, multicentre, randomised controlled trial (ClinicalTrials.gov NCT04180605). Two hundred patients eligible for LAA closure with an Amplatzer Amulet device (Abbott, USA) will be enrolled in the study. Patients will be allocated to a computational simulation arm (experimental) or standard treatment arm (control) using a 1:1 randomisation. For patients randomised to the computational simulation arm, preprocedural planning will be based on the analysis of cardiac computed tomography (CCT)-based patient-specific computational simulations (FEops HEARTguide, Ghent, Belgium) in order to predict optimal device size and position. For patients in the control arm, preprocedural planning will be based on local practice including CCT analysis. The LAA closure procedure and postprocedural antithrombotic therapy will follow local practice in both arms. The primary endpoint of the study is incomplete LAA closure and device-related thrombus as assessed at 3 months postprocedural CCT. Secondary endpoints encompass procedural efficiency (number of devices used, number of repositioning, procedural time, radiation exposure, contrast dye), procedure-related complications within 7 days postprocedure and a composite of all-cause death and thromboembolic events at 12 months., Conclusion: The objective of the PREDICT-LAA study is to test the hypothesis that a preprocedural planning for LAA closure with the Amplatzer Amulet device based on patient-specific computational simulations can result in a more efficient procedure, optimised procedural outcomes and better clinical outcomes as compared with a standard preprocedural planning., Trial Registration Number: ClinicalTrials.gov Registry (NCT04180605)., Competing Interests: Competing interests: ODB and LS have received institutional research grants from Abbott and FEops NV., (© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: The extent to which pressure generated by the valve on the aortic root plays a role in the genesis of conduction abnormalities after transcatheter aortic valve replacement (TAVR) is unknown. This study elucidates the role of contact pressure and contact pressure area in the development of conduction abnormalities after TAVR using patient-specific computer simulations., Methods and Results: Finite-element computer simulations were performed to simulate TAVR of 112 patients who had undergone TAVR with the self-expanding CoreValve/Evolut R valve. On the basis of preoperative multi-slice computed tomography, a patient-specific region of the aortic root containing the atrioventricular conduction system was determined by identifying the membranous septum. Contact pressure and contact pressure index (percentage of area subjected to pressure) were quantified and compared in patients with and without new conduction abnormalities. Sixty-two patients (55%) developed a new left bundle branch block or a high-degree atrioventricular block after TAVR. Maximum contact pressure and contact pressure index (median [interquartile range]) were significantly higher in patients with compared with those without new conduction abnormalities (0.51 MPa [0.43-0.70 MPa] and 33% [22%-44%], respectively, versus 0.29 MPa [0.06-0.50 MPa] and 12% [1%-28%]). By multivariable regression analysis, only maximum contact pressure (odds ratio, 1.35; confidence interval, 1.1-1.7; P =0.01) and contact pressure index (odds ratio, 1.52; confidence interval, 1.1-2.1; P =0.01) were identified as independent predictors for conduction abnormalities, but not implantation depth., Conclusions: Patient-specific computer simulations revealed that maximum contact pressure and contact pressure index are both associated with new conduction abnormalities after CoreValve/Evolut R implantation and can predict which patient will have conduction abnormalities., (© 2018 American Heart Association, Inc.)

The Portico system (St. Jude Medical, Minneapolis, MN, USA) consists of a self-expanding valve prosthesis and a delivery system designed for transcatheter aortic valve replacement (TAVR). We describe this system, its 10-steps implantation procedure, and provide tips and tricks based on our personal experience with this system., (© 2016, Wiley Periodicals, Inc.)

Aims: This document aims to describe a standardised methodology for performing left atrial appendage occlusion (LAAO) using the AMPLATZER Amulet device, and to provide useful tips and tricks for operators with different levels of experience., Methods and Results: Physicians who are experts in LAAO and had personal clinical experience with the AMPLATZER Amulet device were asked to contribute in the preparation of this consensus document. Twenty-seven physicians (20 interventional cardiologists and 7 electrophysiologists) from 14 different countries reviewed the manuscript. A step-by-step approach, simulating a real case, was followed. Starting with patient selection and planning, related cardiac imaging is discussed, followed by vascular access - transseptal puncture optimisation. Then, angiographic calibration/sizing and the required fluoroscopy views are explained and a device sizing strategy is proposed. Device preparation and de-airing is briefly described, followed by sheath exchange, device deployment steps, evaluation of device stability and decision for final release. The way to recapture and change a device is then shown, together with some additional tips on how to deal with challenging anatomies like "chicken wing" left atrial appendage. Finally, for operators who are switching from AMPLATZER Cardiac Plug to Amulet, the main differences between the two devices with respect to implantation technique are presented., Conclusions: In conclusion, this document reflects a consensus approach by expert implanters on the steps of LAAO technique and best practices for implantation of the AMPLATZER Amulet device, along with some practical tips to minimise the complication rate.

Aims: Transcatheter mitral valve implantation for mitral valve regurgitation is in the very early phase of development because of challenging anatomy and device dimensions. We describe the procedure of a transfemoral-transseptal implantation of the second-generation CardiAQ mitral valve bioprosthesis and 30-day follow-up., Methods and Results: The procedure was performed percutaneously, without any left extracorporeal circulatory support. The patient had severe mitral regurgitation with severely depressed ventricular function and other comorbidities. The patient was deemed extreme high risk for conventional cardiac surgery by a multidisciplinary team. The main procedural steps were the creation of an arteriovenous loop with an exchange nitinol wire, and the use of a customised "steerable snare system" to facilitate the catheter delivery system into the mitral annulus. Transoesophageal echocardiography and fluoroscopy were utilised for device positioning and deployment. The mitral valve prosthesis was implanted with mild mitral regurgitation. The postoperative course was uneventful and at 30-day follow-up the patient is in NYHA Class I, with good function of the mitral valve bioprosthesis., Conclusions: This procedure shows that percutaneous transfemoral transcatheter mitral valve implantation is feasible, safe and successful. Further experience is needed to render this procedure clinically available.

Background: Free pulmonary regurgitation (PR) after surgical correction of Tetralogy of Fallot (ToF) with transannular patching can lead to irreversible right ventricular (RV) failure. However, the optimal timing of valve replacement is still debated., Methods and Results: Thirty six pigs were included in the study. Twenty one pigs had a bare metal stent placed in the pulmonary annulus inducing free PR and 9 animals served as control. Six animals died prematurely due to procedural complications. The 21 animals were divided into 3 groups with differential duration of PR (1, 2, 3 months, respectively) after which PPVR was performed. After 1 month with competent valve the animals were euthanized. Cardiac magnetic resonance (CMR) and right heart catheterization were performed serially. Free PR led to severe dilation of the RV in all three groups compared to matched controls (p<0.001). Final RV volume after one month with competent pulmonary valve was modeled. Increase in RV volume from baseline to valve replacement (ΔRV) was the only predictor of RV recovery (p<0.001) and increases in ΔRV beyond 120 mL/m2 were predictive of very low probability of recovery. A total of 5 animals did not recover., Conclusions: Recovery of right ventricular function after free PR by treatment with PPVR was successful in the majority of animals. Increases in RV volume during PR were the only predictor of non-recovery after PPVR and duration of PR did not in itself predict treatment success., (Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.)

Objectives: To evaluate the effectiveness and safety of percutaneous pulmonary valve implantation (PPVI) with routine prestenting with a bare metal stent (BMS)., Background: PPVI is a relatively new method of treating patients with repaired congenital heart disease (CHD). Results of PPVI performed with routine prestenting have never been reported., Methods: Consecutive patients who underwent PPVI for homograft dysfunction with prestenting with BMS were studied. The schedule of follow-up assessment comprised clinical evaluation, cardiovascular magnetic resonance, transthoracic echocardiography, and chest X-ray to screen for device integrity., Results: PPVI was performed with no serious complications in all patients (n=10, mean age 26.8±4.0 years, 60% males). In nine patients with significant pulmonary stenosis, peak right ventricular outflow tract (RVOT) gradient was reduced from a mean of 80.6±22.7 to 38.8±10.4 mm Hg on the day following implantation (P=0.001). At 1-month and 6-month follow-ups, mean RVOT gradient was 34.0±9.8 and 32.0±12.2 mm Hg, respectively. In patients with significant pulmonary regurgitation, mean pulmonary regurgitation fraction decreased from 19%±6% to 2%±1% (P=0.0008). Relief of RVOT obstruction and restoration of pulmonary valve competence were associated with significant decrease in right ventricular (RV) end-diastolic and end-systolic volumes (125.5±48.6 to 109.2±42.9 mL/m2 ; P=0.002 and 68.4±41.5 vs. 50.9±40.6 mL/m2; P=0.001) as well as improvement in RV ejection fraction (48.8%±13.1% to 57.6%±14.4%; P=0.003) and New York Heart Association class (P=0.003). All patients completed 6-month follow-up. No stent fractures were observed., Conclusions: PPVI with routine prestenting with BMS is a safe and effective method of treatment in patients with repaired CHD., (Copyright © 2010 Wiley-Liss, Inc.)