Outcomes and performance of the ACURATE neo2 transcatheter heart valve in clinical practice: one-yearresults of the ACURATE neo2 PMCF Study.

Background: Transcatheter aortic valve implantation is an effective treatment for patients with aortic stenosis; however, complications related to paravalvular leakage (PVL) persist, including increased risk of mortality, cardiovascular mortality, and rehospitalisation.

Aims: We sought to evaluate the clinical outcomes and valve performance at 1 year in patients with severe aortic stenosis treated with the ACURATE neo2 valve in a post-market clinical setting.

Methods: Valve Academic Research Consortium-2 safety events were assessed up to 1 year.

Anatomical predictors for suture-based closure of the patent foramen ovale: A multicenter experience.

Background: NobleStitch EL is a novel suture-based technique used for patent foramen ovale (PFO) closure and an alternative to traditional double-disc devices without the need for antithrombotic therapy. However, successful closure rates are still unknown, and certain anatomies may be unfavorable for successful closure.

Aims: We assessed the efficacy of the NobleStitch EL and sought to identify patient-related anatomical features associated with successful suture-based closure.

Impact of coronary artery disease on clinical outcomes after TAVR: Insights from the BRAVO-3 randomized trial.

Objective: To determine the prognostic impact of coronary artery disease (CAD) in patients randomized to bivalirudin or unfractionated heparin (UFH) during transcatheter aortic valve replacement (TAVR).

Background: CAD is a common comorbidity among patients undergoing TAVR and studies provide conflicting data on its prognostic impact.

Methods: The Bivalirudin on Aortic Valve Intervention Outcomes-3 (BRAVO-3) randomized trial compared the use of bivalirudin versus UFH in 802 high-surgical risk patients undergoing transfemoral TAVR for severe symptomatic aortic stenosis.

Clinical Outcome of Transcatheter Aortic Valve Replacement With TriGUARD 3™ Cerebral Embolic Protection Device.

Objective: Periprocedural stroke during transcatheter aortic valve replacement (TAVR) is a highly feared adverse event. The TriGUARD 3 cerebral embolic protection device (CEPD) may have the potential benefit of reduction of embolic events, but it still remains unclear whether it reduces the incidence of periprocedural stroke or transient ischemic attack (TIA). We aimed to investigate whether the latest TriGUARD 3 CEPD reduces the incidence of clinically overt stroke within 72 h or at discharge after TAVR.

Long-term follow-up of contemporary drug-eluting stent implantation in diabetic patients: Subanalysis of a randomized controlled trial.

Objective: The elevated risk of adverse events following percutaneous coronary intervention in diabetic patients persists with newer-generation DES. The polymer-free amphilimus-eluting stent (PF-AES) possesses characteristics with a potentially enhanced performance in patients with diabetes. Data from the 1-year follow-up period has been previously published.

Clinical outcomes of the ACURATE neo2 transcatheter heart valve: a prospective, multicenter, observational, post-market surveillance study.

Background: The next-generation ACURATE neo2 transcatheter aortic valve was designed for simplified implantation and to mitigate the risk of paravalvular leak (PVL) compared to the earlier device.

Aims: To collect clinical outcomes and device performance data, including echocardiography and 4-dimensional computed tomography (4D-CT) data, with the ACURATE neo2 transcatheter heart valve in patients with severe aortic stenosis (AS).

Methods: ACURATE neo2 PMCF is a single-arm, multicentre study of patients with severe AS treated in routine clinical practice.

High bleeding risk in patients undergoing percutaneous coronary intervention with drug-eluting stent implantation: ReCre8 subanalysis.

Objectives: In an all-comers cohort undergoing percutaneous coronary intervention (PCI), we aimed to assess prevalence of high bleeding risk (HBR) patients and impact of HBR and dual antiplatelet therapy (DAPT) on clinical events.

Background: HBR represents a complex subgroup of patients undergoing PCI.

Methods: In the ReCre8 trial, patients undergoing PCI were stratified for troponin status and diabetes and randomized to a permanent polymer zotarolimus-eluting- or polymer-free amphilimus-eluting stent.

The impact of frailty on adverse outcomes after transcatheter aortic valve replacement in older adults: A retrospective cohort study.

Background: Transcatheter aortic valve replacement (TAVR) is an effective alternative to surgical aortic valve replacement for patients who are at increased surgical risk. Consequently, frailty is common in patients undergoing TAVR.

Objectives: This study aims to investigate the impact of frailty on outcomes following TAVR.

Rationale and Design of the Project to Look for Early Discharge in Patients Undergoing TAVR With ACURATE (POLESTAR Trial).

Background: Transcatheter aortic valve replacement (TAVR) is now an established treatment strategy for elderly patients with symptomatic aortic stenosis (AS) across the entire operative risk spectrum. Streamlined TAVR protocols along with reduced procedure time and expedited ambulation promote early hospital discharge. Selection of patients suitable for safe early discharge after TAVR might improve healthcare efficiency.

Clinically Significant Incidental Findings on CT Imaging During TAVI Work-up: A Systematic Review and Meta-Analysis.

Background: The transcatheter aortic valve implantation (TAVI) population is mostly elderly and frail. Clinically significant incidental findings (SIFs) are commonly encountered in the work-up of TAVI patients. This is a systematic review of current literature on the occurrence of SIFs on computed tomography (CT) imaging preceding TAVI and their association with mortality, delayed planning, and procedure cancellation.

3-Year Clinical Outcomes After Implantation of Permanent-Polymer Versus Polymer-Free Stent: ReCre8 Landmark Analysis.

Objectives: The aim of this analysis was to assess long-term clinical outcomes of the polymer-free Amphilimus-eluting stent (PF-AES) compared with a latest generation permanent-polymer drug-eluting stent (DES) in an all-comers population.

Background: PF-AES possess multiple properties improving targeted drug elution without the presence of polymers. Evaluation of long-term clinical performance of PF-AES versus latest generation permanent-polymer DES has not yet been performed in a large randomized trial introducing shortened dual-antiplatelet therapy.

Intraoperative hypotension and delirium among older adults undergoing transcatheter aortic valve replacement.

Background: Postoperative delirium (POD) is a frequently observed complication after transcatheter aortic valve replacement (TAVR). The effects of intraoperative hypotension (IOH) on POD occurrence are currently unclear.

Methods: A retrospective observational cohort study of patients who underwent TAVR was conducted.

Optical coherence tomography, intravascular ultrasound or angiography guidance for distal left main coronary stenting. The ROCK cohort II study.

Objectives: to test the safety and efficacy of intravascular imaging and specifically optical coherence tomography (OCT) as a diagnostic tool for left main angioplasty and analyze the mid-term outcome accordingly.

Background: Clinical data and international guidelines recommend the use of intravascular imaging ultrasound (IVUS) to guide left main (LM) angioplasty. Despite early experience using OCT in this setting is encouraging, the evidence supporting its use is still limited.

Predictors of clinical outcome following transcatheter aortic valve implantation: a prospective cohort study.

Objective: In recent years, transcatheter aortic valve implantation (TAVI) has become the treatment of choice for patients with symptomatic aortic valve stenosis considered to be at increased or high surgical risk. The aim of this study was to identify predictors of postoperative adverse events in older adults undergoing TAVI.

Methods: A prospective observational cohort study of patients who were referred to a geriatric outpatient clinic for a geriatric assessment prior to TAVI was conducted.

Paclitaxel Drug-Coated Balloon for the Treatment of De Novo Small-Vessel and Restenotic Coronary Artery Lesions: 12-Month Results of the Prospective, Multicenter, Single-Arm PREVAIL Study.

Objectives: The PREVAIL study evaluated the safety and effectiveness of a paclitaxel-coated percutaneous transluminal coronary angioplasty balloon catheter for the treatment of coronary de novo and in-stent restenosis (ISR) lesions in patients with symptomatic ischemic heart disease.

Methods: PREVAIL was a prospective, multicenter, single-arm study that enrolled patients with clinical evidence of ischemia who had coronary lesions (de novo or first ISR) amenable to treatment with a drug-coated balloon (DCB). The study included 50 subjects (53 target lesions) who were treated with a Prevail DCB (Medtronic) during the index procedure and followed for 12 months.

Efficacy of coronary sinus Reducer in patients with refractory angina and diabetes mellitus.

Coronary sinus Reducer (CSR) implantation is currently recommended to relieve angina in patients with refractory symptoms despite optimal medical therapy and maximally achievable revascularization. The impact of diabetes mellitus on outcome after CSR implantation is at present unknown. We aimed to explore the impact of CSR in refractory angina patients with diabetes mellitus.

Safety and Effectiveness of the SVELTE Fixed-Wire and Rapid Exchange Bioresorbable-Polymer Sirolimus-Eluting Coronary Stent Systems for the Treatment of Atherosclerotic Lesions: Results of the OPTIMIZE Randomized Study.

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Safety and efficacy of coronary sinus narrowing in chronic refractory angina: Insights from the RESOURCE study.

Introduction: Refractory angina (RA) is considered the end-stage of coronary artery disease, and often has no interventional treatment options. Coronary sinus Reducer (CSR) is a recent addition to the therapeutic arsenal, but its efficacy has only been evaluated on small populations. The RESOURCE registry provides further insights into this therapy.

A randomized evaluation of the TriGuard™ HDH cerebral embolic protection device to Reduce the Impact of Cerebral Embolic LEsions after TransCatheter Aortic Valve ImplanTation: the REFLECT I trial.

Aims: The REFLECT I trial investigated the safety and effectiveness of the TriGuard™ HDH (TG) cerebral embolic deflection device in patients undergoing transcatheter aortic valve replacement (TAVR).

Methods And Results: This prospective, multicentre, single-blind, 2:1 randomized (TG vs. no TG) study aimed to enrol up to 375 patients, including up to 90 roll-in patients.

Clinical outcomes after permanent polymer or polymer-free stent implantation in patients with diabetes mellitus: The ReCre8 diabetes substudy.

Objectives: The purpose of this analysis was to compare target-lesion failure (TLF) of a permanent polymer zotarolimus-eluting stent (PP-ZES) versus a polymer-free amphilimus-eluting stent (PF-AES) in diabetics.

Background: The improvement of outcomes with new-generation drug-eluting stent as seen in the general population is less pronounced among diabetics. The PF-AES introduces an elution-technology with potential enhanced performance in diabetics.

The effect of transcatheter aortic valve implantation approaches on mortality.

Objectives: We aimed to evaluate the effect of transcatheter aortic valve implantation (TAVI) approaches on mortality and identify effect modifiers and predictors for mortality.

Background: Alternative access routes to transfemoral (TF) TAVI include the surgical intra-thoracic direct-aortic (DA) and transapical (TA) approach. TA TAVI has been associated with a higher mortality rate.

Coronary sinus narrowing for the treatment of refractory angina: a multicentre prospective open-label clinical study (the REDUCER-I study).

Background: The REDUCER-I study is a prospective (with a retrospective component), open-label, multi-centre, international, post-market study, which collects long-term data of patients with refractory angina treated with the Reducer. Here we present the overall clinical outcomes of the first 228 patients enrolled.

Aims: The aim of this study is to examine the safety and efficacy of the coronary sinus (CS) Reducer in improving angina severity and quality of life in patients suffering from angina pectoris, refractory to medical and interventional therapies.

Coronary sinus anatomical features: Description and procedural implications during coronary sinus Reducer implantation.

Objectives: We hypothesized that some coronary sinus (CS) anatomies allow a more straightforward CS Reducer (CSR) implantation.

Background: Recent decades have seen a rise in patients with chronic angina. When complete revascularization and maximal medical therapy fail to reduce symptoms, CSR has become a new therapeutic option.

Comparison of the Sapien 3 versus the ACURATE neo valve system: A propensity score analysis.

Objectives: To compare the outcomes of transfemoral ACURATE neo (NEO) and Sapien 3 (S3) patients in terms of device success and clinical safety outcomes using a propensity score analysis.

Background: Differences in clinical outcomes between the latest-generation balloon-expandable S3 and self-expanding NEO in a "real-world transfemoral TAVI population" are still unclear.

Methods: We compared up to 6 months clinical outcomes using a propensity score analysis (inverse probability of treatment weighting [IPTW]) to account for differences in baseline characteristics.