Five-Year Multiple Comparison of Transcatheter Aortic Valves: Insights From the OBSERVANT II study.

Background: Head-to-head comparisons of second and third generations of transcatheter heart valves (THVs) are mostly limited to 2-arm studies and to mid-term follow-up. The aim of this study was to simultaneously compare clinical outcomes of transcatheter aortic valve replacement (TAVR) with 4 different THVs at 5 years.

Methods: Patients undergoing transfemoral TAVR with 4 second-generation THV platforms and enrolled in the multicentre prospective OBSERVANT II study from December 2016 to September 2018 were compared according to the THV received.

Impact of Chronic Coronary Artery Disease and Revascularization Strategy in Patients with Severe Aortic Stenosis Who Underwent Transcatheter Aortic Valve Implantation.

The prognostic impact of coronary artery disease (CAD) after transcatheter aortic valve implantation (TAVI) is controversial. The aim of this study is to investigate the impact of CAD and different revascularization strategies on clinical outcomes in patients who underwent TAVI with third generation devices. Patients enrolled in the national observational Observational Study of Effectiveness of SAVR-TAVI Procedures for Severe Aortic Stenosis Treatment II study were stratified according to the presence of CAD (CAD+, n = 1,130) versus no CAD (CAD-, n = 1,505), and compared using a propensity matched analysis.

Impact of vascular complications after transcatheter aortic valve implantation. VASC-OBSERVANT II sub-study.

Background: Trans-femoral (TF) access is the commonest approach for transcatheter aortic valve implantation (TAVI). However this vascular approach is associated with vascular complications (VC) which in turn have prognostic implications. The aim of this study is to evaluate the clinical impact of access site VC in patients undergoing TAVI with newer generation transcatheter prostheses enrolled in the national observational prospective multicenter study OBSERVANT II.

Real-World Multiple Comparison of Transcatheter Aortic Valves: Insights From the Multicenter OBSERVANT II Study.

Background: Head-to-head comparisons of devices for transcatheter aortic valve implantation (TAVI) are mostly limited to 2-arm studies so far. The aim of this study was to compare simultaneously outcomes of the most used, second- and third-generation transcatheter aortic valves in a real-world population.

Methods: A total of 2728 patients undergoing TAVI with different second- and third-generation devices, and enrolled in the multicenter, prospective OBSERVANT II study (Observational Study of Effectiveness of TAVI With New Generation Devices for Severe Aortic Stenosis Treatment) from December 2016 to September 2018 were compared according to the transcatheter aortic valve received.

[Italian Society of Interventional Cardiology (SICI-GISE) Position paper: Transcatheter left atrial appendage occlusion in patients with non-valvular atrial fibrillation].

Atrial fibrillation (AF) is the most common arrhythmia worldwide. Thromboembolism from the left atrial appendage (LAA) is the most feared complication in patients with AF. The cornerstone for the management of AF is oral anticoagulation to reduce the incidence of cardioembolic stroke.

One-Year Outcomes and Trends over Two Eras of Transcatheter Aortic Valve Implantation in Real-World Practice.

Background: Data reflecting the benefit of procedural improvements in real-world transcatheter aortic valve implantation (TAVI) practice are sparse.

Aims: To compare outcomes and trends of two TAVI eras from real Italian practice.

Methods: A total of 1811 and 2939 TAVI patients enrolled in the national, prospective OBSERVANT and OBSERVANT II studies in 2010-2012 and 2016-2018, respectively, were compared in a cohort study.

Intracardiac echocardiography for guidance of transcatheter left atrial appendage occlusion: An expert consensus document.

Transcatheter left atrial appendage occlusion (LAAO) is an increasingly used alternative to oral anticoagulation in selected patients with atrial fibrillation. Intraprocedural imaging is a crucial for a successful intervention, with transesophageal echocardiography (TEE) as the current gold standard. Since some important limitations may affect TEE use, intracardiac echocardiography (ICE) is increasingly used as an alternative to TEE for guiding LAAO.

[Transcatheter closure of ventricular septal defect: how and when?].

Ventricular septal defect (VSD) is a rare but clinically severe complication of acute myocardial infarction. Although cardiac surgery is the gold standard to correct post-infarction VSD, transcatheter closure represents an effective therapeutic alternative in selected cases. However, the correct timing for VSD correction is a matter of debate.

Early and late outcomes after transcatheter versus surgical aortic valve replacement in obese patients.

Introduction: Data on the early and late outcome following transcatheter aortic valve implantation (TAVI) and surgical aortic valve replacement (SAVR) in obese patients are limited. We investigated whether TAVI may be superior to SAVR in obese patients.

Material And Methods: Obese patients (body mass index ≥ 30 kg/m) who underwent either SAVR or TAVI were identified from the nationwide OBSERVANT registry, and their in-hospital and long-term outcomes were analysed.

[First results from the OBSERVANT II study: clinical characteristics of patients with aortic stenosis undergoing transcatheter treatment with new generation devices].

Background: The OBSERVANT study evaluated the medium and long-term outcomes in patients undergoing transcatheter aortic valve implantation (TAVI) versus surgical aortic valve replacement obtaining comparative effectiveness results at least for the first-generation devices. The OBSERVANT II study enrolled a new series of TAVI procedures to evaluate whether the use of new-generation devices has modified outcome differences recorded in the OBSERVANT study. The aim of this paper is to describe the clinical characteristics of the OBSERVANT II population and compare them with those of the OBSERVANT population.

Factors influencing the choice between transcatheter and surgical treatment of severe aortic stenosis in patients younger than 80 years: Results from the OBSERVANT study.

Objectives: We aimed to analyze the baseline features and clinical outcomes of patients younger than 80 years undergoing transfemoral transcatheter aortic valve implantation (TAVI) or surgical aortic valve replacement (SAVR) enrolled in the OBservational Study of Effectiveness of SAVR-TAVR procedures for severe Aortic steNosis Treatment (OBSERVANT) real-world study, focusing on variables guiding Heart Team decision toward TAVI.

Background: Patients treated with TAVI, independently of surgical risk score, are mostly older than 80 years.

Methods: OBSERVANT is a multicenter, observational, prospective cohort study that enrolled patients with symptomatic severe aortic stenosis (AS) who underwent SAVR or TAVI from December 2010 to June 2012 in 93 Italian participating hospitals.

Value of a comprehensive geriatric assessment for predicting one-year outcomes in patients undergoing transcatheter aortic valve implantation: results from the CGA-TAVI multicentre registry.

Background: In a three-month report from the CGA-TAVI registry, we found the Multidimensional Prognostic Index (MPI) and Short Physical Performance Battery (SPPB) to be of value for predicting short-term outcomes in elderly patients undergoing transcatheter aortic valve implantation (TAVI). In the present analysis, we examined the association of these tools with outcomes up to one year post-TAVI.

Methods: CGA-TAVI is an international, observational registry of geriatric patients undergoing TAVI.

Five-Year Outcomes of Transfemoral Transcatheter Aortic Valve Replacement or Surgical Aortic Valve Replacement in a Real World Population.

Background: The OBSERVANT study (Observational Study of Effectiveness of SAVR-TAVI Procedures for Severe Aortic Stenosis Treatment) showed that mortality at 1 year is similar after transfemoral transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR) for real-world propensity-matched patients with aortic stenosis at low and intermediate risk. We report the 5-year outcomes of the Italian OBSERVANT study.

Methods And Results: The unadjusted enrolled population (N=7618) between December 2010 and June 2012 included 5707 patients on SAVR and 1911 patients on TAVR.

Left atrial appendage occlusion for stroke despite oral anticoagulation (resistant stroke). Results from the Amplatzer Cardiac Plug registry.

Introduction And Objectives: Despite the efficacy of oral anticoagulant (OAC) therapy, some patients continue to have a high residual risk and develop a stroke on OAC therapy (resistant stroke [RS]), and there is a lack of evidence on the management of these patients. The aim of this study was to analyze the safety and efficacy of left atrial appendage occlusion (LAAO) as secondary prevention in patients with nonvalvular atrial fibrillation who have experienced a stroke/transient ischemic attack despite OAC treatment.

Methods: We analyzed data from the Amplatzer Cardiac Plug multicenter registry on 1047 consecutive patients with nonvalvular atrial fibrillation undergoing LAAO.

Transcatheter or surgical treatment of severe aortic stenosis and coronary artery disease: A comparative analysis from the Italian OBSERVANT study.

Background: To assess clinical outcomes of patients with concomitant severe aortic stenosis (AS) and coronary artery disease (CAD) who underwent transcatheter aortic valve implantation (TAVI) and percutaneous coronary intervention (PCI) or surgical aortic valve replacement (SAVR) and coronary artery bypass grafting (CABG).

Methods: Data were extracted from the multicenter OBSERVANT study. For the purposes of the present analysis, we included only patients with established stable CAD meeting any of the following inclusion criteria: 1) TAVI patients with CAD undergoing staged PCI or TAVI and PCI in the same session; 2) SAVR patients undergoing combined SAVR and CABG in the same session.

Comprehensive geriatric assessment in patients undergoing transcatheter aortic valve implantation - results from the CGA-TAVI multicentre registry.

Background: In older patients with aortic stenosis (AS) undergoing TAVI, the potential role of prior CGA is not well established. To explore the value of comprehensive geriatric assessment (CGA) for predicting mortality and/or hospitalisation within the first 3 months after transcatheter aortic valve implantation (TAVI).

Methods: An international, multi-centre, prospective registry (CGA-TAVI) was established to gather data on CGA results and medium-term outcomes in geriatric patients undergoing TAVI.

Transcatheter aortic valve implantation compared with surgical aortic valve replacement in patients with anaemia.

Objectives: We compared the outcome of anaemic patients undergoing transcatheter (TAVI) and surgical aortic valve replacement (SAVR) for severe aortic valve stenosis.

Methods: Anaemic patients (haemoglobin <13.0 g/dL in men and <12.

Left atrial appendage closure using AMPLATZER™ devices: A large, multicenter, Italian registry.

Background: Left atrial appendage occlusion (LAAO) has been proven to be effective for stroke prophylaxis in patients with non-valvular atrial fibrillation (NVAF). We aim to assess the safety and efficacy of LAAO by AMPLATZER™ devices in a large, multicenter, single-nation cohort of NVAF patients at high-risk of stroke and bleeding.

Methods: From December 2008 to April 2015 613 NVAF patients (75.

[OBSERVANT II: OBservational Study of Effectiveness of transcatheter aortic valve implantation with new geneRation deVices for severe Aortic steNosis Treatment. Study protocol].

Background: The rapid spread of transcatheter aortic valve implantation (TAVI) for the treatment of severe symptomatic aortic stenosis in the last decade in Italy has led to a gradually increasing use of TAVI procedures also in patients potentially eligible for aortic valve replacement (AVR). For this subset of patients, the OBSERVANT study (2011-2012) evaluated the short- and medium term outcome of TAVI vs AVR, at least for the first generations of TAVI devices, but failed to gather information on all the technological innovations occurred in recent years. The launch of a phase II of the study will allow to recruit a new series of TAVI, with different risk profiles compared with the historical OBSERVANT TAVI cohort, in order to assess whether and how much the use of new-generation devices mitigate the differences in outcomes recorded in the OBSERVANT study.

Left Atrial Appendage Occlusion in Patients With Atrial Fibrillation and Previous Major Gastrointestinal Bleeding (from the Amplatzer Cardiac Plug Multicenter Registry).

History of major gastrointestinal (GI) bleeding may represent a frequent clinical indication for left atrial appendage occlusion (LAAO) in patients with non-valvular atrial fibrillation (AF). This study aims to investigate the procedural safety and long-term outcome of patients with previous major GI bleeding (MGIB) who underwent LAAO. Data from the Amplatzer Cardiac Plug multicenter registry on 1,047 patients were analyzed.

Incidence and Clinical Impact of Device-Associated Thrombus and Peri-Device Leak Following Left Atrial Appendage Closure With the Amplatzer Cardiac Plug.

Objectives: Routine device surveillance after successful left atrial appendage closure is recommended to evaluate for intermediate to late complications. The aim of this study was to assess the incidence and clinical impact of these complications on cardiovascular events.

Methods: Centers participating in the Amplatzer Cardiac Plug multicenter study were requested to submit their post-procedural transesophageal echocardiograms for independent adjudication.