Transcatheter Aortic Valve Implantation with ACURATE : Results from the PROGRESS PVL Registry.

Objectives: The PROGRESS PVL registry evaluated transcatheter aortic valve implantation (TAVI) in patients treated with ACURATE , a supra-annular self-expanding bioprosthetic aortic valve.

Background: While clinical outcomes with TAVI are comparable with those achieved with surgery, residual aortic regurgitation (AR) and paravalvular leak (PVL) are common complications. The ACURATE valve has a pericardial sealing skirt designed to minimize PVL.

Reduced rate of admissions for acute coronary syndromes during the COVID-19 pandemic: an observational analysis from a tertiary hospital in Germany.

Background: Several observational studies have suggested a worrying reduction in hospitalisations for acute coronary syndromes in the emergency cardiology department in the last few months all over the world. The aim of the present study is to assess the impact of the current COVID-19 health crisis on admission for acute coronary syndrome (ACS) in the cardiology department of a tertiary general hospital in Germany with a COVID-19 ward.

Methods And Results: The authors retrieved clinical data evaluating consecutive patients with ACS admitted to their emergency cardiology department.

Balloon Filling Algorithm for Optimal Size of Balloon Expandable Prosthesis During Transcatheter Aortic Valve Replacement.

Aim is to report on the results of an optimized balloon filling algorithm and suggest a refinement of the implantation approach to maximize safety. Appropriate sizing of balloon expandable valves during transcatheter aortic valve implantation is crucial. Study comprised 370 consecutive patients receiving SAPIEN 3 valve between 2015 and 2018.

Comparison of Valve Durability and Outcomes of Transcatheter Aortic Valve Implantation Versus Surgical Aortic Valve Replacement in Patients With Severe Symptomatic Aortic Stenosis and Less-Than-High-Risk for Surgery.

This study aimed to investigate the rate of severe structural valve deterioration (SVD) and long-term outcomes of patients with severe symptomatic aortic stenosis undergoing transcatheter aortic valve implantation (TAVI) or surgical aortic valve replacement (SAVR). Propensity score matched analysis of patients who underwent TAVI (n = 216) and SAVR (n = 216) between 2008 and 2012. Long-term echocardiographic parameters and clinical outcomes were assessed after more than 6 years after TAVI/SAVR.

Outcomes of transfemoral balloon expandable transcatheter aortic valve implantation: Comparison of two subsequent valve generations.

Background: The SAPIEN 3 (S3) addresses several limitations of the SAPIEN XT (SXT) for the performance of transfemoral (TF-) balloon expandable transcatheter aortic valve implantation (TAVI).

Objectives: We aimed to determine whether their altered features translate into improved outcomes in a real-world TF-TAVI patient population.

Methods: Data for 3,314 patients were extracted from the European registries SOURCE-XT and SOURCE-3.

Balloon-expandable transfemoral transcatheter aortic valve implantation with or without predilation: findings from the prospective EASE-IT TF multicentre registry.

Background: Predilation of the native valve has long been deemed necessary in transfemoral transcatheter aortic valve implantation (TF-TAVI), despite little trial evidence to support its clinical use. As most evidence is derived from retrospective analyses of observational studies, we conducted a two-armed, prospective multicentre registry.

Methods: Patients undergoing TF-TAVI with the Edwards SAPIEN 3 valve, with or without balloon aortic valvuloplasty (BAV), were included and their procedural characteristics, short-term safety and short-term efficacy outcomes compared.

Safety and efficacy of a self-expanding versus a balloon-expandable bioprosthesis for transcatheter aortic valve replacement in patients with symptomatic severe aortic stenosis: a randomised non-inferiority trial.

Background: Transcatheter aortic valve replacement (TAVR) is the preferred treatment option for older patients with symptomatic severe aortic stenosis. Differences in the properties of available TAVR systems can affect clinical outcomes. Among patients undergoing TAVR, we compared the self-expanding ACURATE neo TAVR system with the balloon-expandable SAPIEN 3 TAVR system with regard to early safety and efficacy.

Interdisciplinary consensus on indications for transfemoral transcatheter aortic valve implantation (TF-TAVI) : Joint Consensus Document of the Arbeitsgemeinschaft Leitende Kardiologische Krankenhausärzte e.V. (ALKK) and cooperating Cardiac Surgery Departments.

Indications for TF-TAVI (transfemoral transcatheter aortic valve implantation) are rapidly changing according to increasing evidence from randomized controlled trials. Present trials document the non-inferiority or even superiority of TF-TAVI in intermediate-risk patients (STS-Score 4-8%) as well as in low-risk patients (STS-Score < 4%). However, risk scores exhibit limitations and, as a single criterion, are unable to establish an appropriate indication of TF-TAVI vs transapical TAVI vs SAVR (surgical aortic valve replacement).

Balloon-expandable transcatheter aortic valve implantation with or without pre-dilation - results of a meta-analysis of 3 multicenter registries.

Background: To evaluate the outcomes of transcatheter aortic valve implantation (TAVI) without balloon aortic valvuloplasty (BAV) in a real-world setting through a patient-level meta-analysis.

Methods: The meta-analysis included patients of three European multicenter, prospective, observational registry studies that compared outcomes after Edwards SAPIEN 3 or XT TAVI with (n = 339) or without (n = 355) BAV. Unadjusted and adjusted pooled odds ratios (with 95% confidence intervals) were calculated for procedural and 30-day outcomes.

The association of diabetes mellitus treated with oral antidiabetic drugs and insulin with mortality after transcatheter valve implantation: a 3-year follow-up of the TAVIK registry.

Background: Diabetes mellitus (DM) on insulin is a patient-related factor in the assessment of surgical risk based on the EuroSCORE II and, as such, it confers additional risk on outcomes after transcatheter aortic valve implantation (TAVI). The aim of this study was to investigate the effect of diabetes mellitus treated with insulin and oral antidiabetic drugs on clinical outcomes after TAVI.

Methods: This study is an analysis of 2000 patients who underwent TAVI between 2008 and 2015.

Transcatheter aortic valve implantation in severe calcified annulus using the Lotus valve system: Increased incidence of fatal major vascular complications.

Objectives: This study reports the outcome of a highly selected transcatheter aortic valve implantation (TAVI) population.

Background: In patients with aortic valve stenosis and severe calcification of the left ventricular outflow tract and/or the annulus, the Boston Scientific Lotus valve provided a low paravalvular leakage rate omitting the risk of annular rupture.

Methods: Until now more than 3,600 TAVI procedures were performed at our institution.

Degree of valve calcification in patients undergoing transfemoral transcatheter aortic valve implantation with and without balloon aortic valvuloplasty: Findings from the multicenter EASE-IT TF registry.

Aims: We aimed to assess whether the level of aortic root calcification is associated with BAV performance/omission during transcatheter aortic valve implantation (TAVI), and to explore related outcomes.

Methods And Results: EASE-IT TF was a prospective, observational, multicenter registry of patients undergoing TF-TAVI with the Edwards SAPIEN 3, with or without BAV predilation. Valvular calcification was quantified from pre-procedural multi-slice computed tomography images and compared between BAV and no BAV patients.

Impact of Dialysis on the Prognosis of Patients Undergoing Transcatheter Aortic Valve Implantation.

End-stage renal disease (ESRD) affects approximately 2% to 4% of patients with severe aortic stenosis. It is because these patients have been excluded from clinical trials, the impact of transcatheter aortic valve implantation (TAVI) in this patient group has not been thoroughly investigated. Between April 2008 and March 2015, 2,000 patients (dialysis group, n = 56 [2.

Evolution of transcatheter aortic valve implantation over 7 years: results of a prospective single-centre registry of 2000 patients in a large municipal hospital (TAVIK Registry).

Objectives: Use of transcatheter aortic valve implantation (TAVI) to treat severe aortic stenosis (AS) has gained popularity, accompanied by an evolution of patient and clinical factors. We aimed to characterise changes and evaluate their impact on outcomes.

Setting: In this single-centre, German TAVIK registry patients undergoing TAVI between 2008 and 2015 were documented prospectively.

Two-Year Outcomes of Transcatheter Compared With Surgical Aortic Valve Replacement in "Minimal-Risk" Patients Lacking EuroSCORE Co-morbidities (from the TAVIK Registry).

We aimed to compare the outcomes of transcatheter aortic valve implantation (TAVI) with surgical aortic valve replacement (SAVR) in an elderly but nonfrail, minimally co-morbid population. Although data comparing these 2 procedures in intermediate- and low-risk patients are mounting, no distinction has been made between co-morbidity and age/gender as driving forces for surgical risk. Patients undergoing isolated TAVI or SAVR between May 2008 and March 2015 were documented.

Computed tomography-based oversizing and incidence of paravalvular aortic regurgitation and permanent pacemaker implantation with a new-generation self-expanding transcatheter heart valve.

Aims: We aimed to evaluate the relationship between CT-based annular perimeter oversizing and the incidence of paravalvular aortic regurgitation (PAR) and permanent pacemaker (PPM) implantation in patients treated with the new self-expanding CENTERA transcatheter heart valve (THV) for severe aortic stenosis.

Methods And Results: One hundred and ninety-eight patients in the CENTERA-EU trial were stratified a priori into four groups based on the perimeter oversizing (2.5-10%, 10-15%, 15-20% and >20%).

Periprocedural anticoagulation during left atrial ablation: interrupted and uninterrupted vitamin K-antagonists or uninterrupted novel anticoagulants.

Background: There is a lack of data on anticoagulation requirements during ablation of atrial fibrillation (AF). This study compares different oral anticoagulation (OAC) strategies to evaluate risk of bleeding and thromboembolic complications.

Methods: We conducted a single-centre study in patients undergoing left atrial ablation of AF.

Feasibility of transcatheter aortic valve implantation in patients with coronary heights ≤7 mm: insights from the transcatheter aortic valve implantation Karlsruhe (TAVIK) registry.

Objectives: Transcatheter aortic valve implantation (TAVI) in patients with low coronary heights is generally denied but is not impossible. Information about these high-risk procedures is sparse.

Methods: Since May 2008, data of more than 3000 patients who had TAVI were prospectively collected in the institutional TAVI Karlsruhe registry.

Treatment of Aortic Stenosis With a Self-Expanding, Resheathable Transcatheter Valve: One-Year Results of the International Multicenter Portico Transcatheter Aortic Valve Implantation System Study.

Background: The aim of the Portico TAVI (transcatheter aortic valve implantation) system study was to evaluate outcomes ≤1 year after implantation of a novel resheathable, self-expanding TAVI system in a multicenter patient population with severe aortic stenosis (AS).

Methods And Results: High-risk patients (n=222) with symptomatic severe AS (mean age, 83.0±4.

Self-Expanding Transcatheter Aortic Valve System for Symptomatic High-Risk Patients With Severe Aortic Stenosis.

Background: The CENTERA transcatheter heart valve (THV) is a low-profile, self-expanding nitinol valve made from bovine pericardial tissue that is 14-F compatible with a motorized delivery system allowing for repositionability.

Objectives: The pivotal study evaluated safety and efficacy of this THV in high-surgical-risk study patients with severe symptomatic aortic stenosis.

Methods: Implantations were completed in 23 centers.

Transcatheter aortic valve implantation in patients with a reduced left ventricular ejection fraction: a single-centre experience in 2000 patients (TAVIK Registry).

Background: Previous studies into the effect of a reduced left ventricular ejection fraction (EF) on the short- and long-term prognosis of patients undergoing transcatheter aortic valve implantation (TAVI) have reported conflicting findings. We analysed data from the Karlsruhe TAVI registry with the aim of addressing this question.

Methods And Results: Patients with aortic stenosis undergoing TAVI were divided into sub-groups according to EF: severely reduced (<30%; n = 109), reduced (≥30 and ≤40%; n = 201), and mid-range/preserved (>40%; n = 1690).

Implantation and 30-Day Follow-Up on All 4 Valve Sizes Within the Portico Transcatheter Aortic Bioprosthetic Family.

Objectives: The aim of this study was to evaluate the short-term safety and performance of the full range of valve sizes offered within the Portico transcatheter aortic valve replacement system.

Background: The Portico transcatheter aortic heart valve is a fully resheathable, repositionable, and self-expanding bioprosthesis designed to achieve optimal valve position and hemodynamic performance and limit conduction disturbances.

Methods: Patients (n = 222) with symptomatic (New York Heart Association functional class ≥II) severe aortic stenosis considered by a multidisciplinary heart team to be at high surgical risk were recruited between December 2011 and September 2015 in this prospective, nonrandomized, multicenter study.

SOURCE 3: 1-year outcomes post-transcatheter aortic valve implantation using the latest generation of the balloon-expandable transcatheter heart valve.

Aims: Transcatheter aortic valve implantation (TAVI) has developed from a procedure for patients with aortic stenosis inoperable or high risk for surgery, into a treatment option even for intermediate risk elderly patients. This development has been facilitated by the clinical learning curve and constant improvements of transcatheter heart valves used. We present total 1-year results of SOURCE 3, the European post-approval multicentre registry of the latest generation balloon expandable SAPIEN 3TM (Edwards Lifesciences, Irvine, CA, USA).