Three-Year Outcomes With a Supra-Annular, Self-Expanding Bioprosthesis and a Pericardial Wrap-The FORWARD PRO Study.

Background: The self-expanding, supra-annular Evolut valve is an established platform for Transcatheter Aortic Valve Implantation (TAVI). Evolut PRO introduced an outer sealing wrap to mitigate paravalvular leakage. We evaluated the 3-year clinical outcomes and valve performance of the Evolut PRO in standard clinical practice for severe aortic stenosis (AS) patients at intermediate or higher risk for surgery.

Impact of Access Site on Periprocedural Bleeding and Cerebral and Coronary Events in High-Bleeding-Risk Percutaneous Coronary Intervention: Findings from the RIVA-PCI Trial.

Introduction: The preference for using transradial access (TRA) over transfemoral access (TFA) in patients requiring percutaneous coronary intervention (PCI) is based on evidence suggesting that TRA is associated with less bleeding and fewer vascular complications, shorter hospital stays, improved quality of life, and a potential beneficial effect on mortality. We have limited study data comparing the two access routes in a patient population with atrial fibrillation (AF) undergoing PCI, who have a particular increased risk of bleeding, while AF itself is associated with an increased risk of thromboembolism.

Methods: Using data from the RIVA-PCI registry, which includes patients with AF undergoing PCI, we analyzed a high-bleeding-risk (HBR) cohort.

Rivaroxaban in Patients With Atrial Fibrillation Who Underwent Percutaneous Coronary Intervention in Clinical Practice.

Little is known about the efficacy and safety of rivaroxaban in patients with atrial fibrillation (AF) who underwent percutaneous coronary intervention (PCI) in clinical practice. We therefore conducted a prospective observational study to determine the rate of ischemic, embolic, and bleeding events in patients with AF and PCI treated with rivaroxaban in a real-world experience. The RIVA-PCI ("rivaroxaban in patients with AF who underwent PCI") (clinicaltrials.

Hemodynamic Performance of Two Current-Generation Transcatheter Heart Valve Prostheses in Severely Calcified Aortic Valve Stenosis.

Background: Treatment of severely calcified aortic valve stenosis is associated with a higher rate of paravalvular leakage (PVL) and permanent pacemaker implantation (PPI). We hypothesized that the self-expanding transcatheter heart valve (THV) prostheses Evolut Pro (EPro) is comparable to the balloon-expandable Sapien 3 (S3) regarding hemodynamics, PPI, and clinical outcome in these patients.

Methods: From 2014 to 2019, all patients with very severe calcification of the aortic valve who received an EPro or an S3 THV were included.

Current status of antithrombotic therapy and in-hospital outcomes in patients with atrial fibrillation undergoing percutaneous coronary intervention in Germany.

Background: Little is known about current patterns of antithrombotic therapy in patients with atrial fibrillation (AF) undergoing percutaneous coronary intervention (PCI) in clinical practice in Germany.

Methods: The RIVA-PCI is a prospective, non-interventional, multicenter study with follow-up until hospital discharge including consecutive patients with AF undergoing PCI.

Results: Between January 2018 and March 2020, 1636 patients (elective in 52.

High-sensitivity cardiac troponin I after coronary artery bypass grafting for post-operative decision-making.

Aims: Current troponin cut-offs suggested for the post-operative workup of patients following coronary artery bypass graft (CABG) surgery are based on studies using non-high-sensitive troponin assays or are arbitrarily chosen. We aimed to identify an optimal cut-off and timing for a proprietary high-sensitivity cardiac troponin I (hs-cTnI) assay to facilitate post-operative clinical decision-making.

Methods And Results: We performed a retrospective analysis of all patients undergoing elective isolated CABG at our centre between January 2013 and May 2019.

Final 3-year clinical outcomes following transcatheter aortic valve implantation with a supra-annular self-expanding repositionable valve in a real-world setting: Results from the multicenter FORWARD study.

Objectives: The Evolut R FORWARD study confirmed safety and effectivenesss of the Evolut R THV in routine clinical practice out to 1 year. Herein, we report the final 3-year clinical follow up of the FORWARD study.

Background: Transcatheter aortic valve replacement (TAVR) is a proven alternative to surgery in elderly patients with symptomatic severe aortic stenosis.

Idiopathic pulmonary arterial hypertension phenotypes determined by cluster analysis from the COMPERA registry.

The term idiopathic pulmonary arterial hypertension (IPAH) is used to categorize patients with pre-capillary pulmonary hypertension of unknown origin. There is considerable variability in the clinical presentation of these patients. Using data from the Comparative, Prospective Registry of Newly Initiated Therapies for Pulmonary Hypertension, we performed a cluster analysis of 841 patients with IPAH based on age, sex, diffusion capacity of the lung for carbon monoxide (DLCO; <45% vs ≥45% predicted), smoking status, and presence of comorbidities (obesity, hypertension, coronary heart disease, and diabetes mellitus).

Pulmonary Hypertension in Adults with Congenital Heart Disease: Real-World Data from the International COMPERA-CHD Registry.

Introduction: Pulmonary hypertension (PH) is a common complication in patients with congenital heart disease (CHD), aggravating the natural, post-operative, or post-interventional course of the underlying anomaly. The various CHDs differ substantially in characteristics, functionality, and clinical outcomes among each other and compared with other diseases with pulmonary hypertension.

Objective: To describe current management strategies and outcomes for adults with PH in relation to different types of CHD based on real-world data.

Transcatheter Aortic Valve Implantation in Patients With Pre-Existing Mechanical Mitral Valve Prostheses.

Objectives: Transcatheter aortic valve implantation (TAVI) has become standard therapy for aortic stenosis patients with intermediate or high operative risk. Treatment of patients with pre-existing mechanical mitral valve replacement (MVR) is challenging due to possible interference between the TAVI prosthesis and MVR. We present our single-center experience with this special patient cohort.

Feasibility of Transfemoral Aortic Valve Implantation in Patients With Aortic Disease and Simultaneous or Sequential Endovascular Aortic Repair.

Objectives: The transfemoral approach for transcatheter aortic valve implantation (TF-TAVI) is associated with a significant survival benefit for intermediate and high-risk patients. Due to the increased procedural risk, many operators avoid TF-TAVI in patients with aortic disease. Moreover, significant peri-interventional device interaction may occur in patients with previous endovascular aortic repair (EVAR).

Outcomes of left main revascularization in patients with acute coronary syndromes and stable ischemic heart disease: Analysis from the EXCEL trial.

Background: Prompt revascularization is often required in acute coronary syndromes (ACS), whereas stable ischemic heart disease (SIHD) may allow for more measured procedural planning. Whether the acuity of presentation preferentially affects outcomes after coronary artery bypass grafting (CABG) versus percutaneous coronary intervention (PCI) in patients with left main coronary artery disease (LMCAD) is unknown. We investigated whether the acuity of presentation discriminated patients who derived a differential benefit from PCI versus CABG in the randomized Evaluation of XIENCE versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization (EXCEL) trial.

1-Year Outcomes With the Evolut R Self-Expanding Transcatheter Aortic Valve: From the International FORWARD Study.

Objectives: This study sought to report the 1-year safety and efficacy outcomes in the FORWARD (CoreValve Evolut R FORWARD) study following transcatheter aortic valve replacement (TAVR) with the next-generation Evolut R device (Medtronic, Minneapolis, Minnesota) in routine clinical practice.

Background: The FORWARD study reported low incidences of mortality, disabling stroke, and significant paravalvular leak following TAVR in routine clinical practice at 30 days. Longer-term results in large patient populations with the Evolut R self-expanding, repositionable transcatheter heart valve (THV) are lacking.

Minimally invasive versus transapical versus transfemoral aortic valve implantation: A one-to-one-to-one propensity score-matched analysis.

Objectives: Although transcatheter aortic valve implantation was the treatment of choice in inoperable and high-risk patients, the effect of transcatheter aortic valve implantation relative to conventional aortic valve replacement via ministernotomy in patients with moderate surgical risk remains unclear.

Methods: We consecutively enrolled patients who underwent minimally invasive aortic valve replacements via ministernotomy (n = 1929), transapical (n = 607), and transfemoral (n = 1273) aortic valve implantations from a single center during the period from July 2009 to July 2017. Of those, we conducted a 1:1:1 propensity score matching according to 23 preoperative risk factors.

Delayed Coronary Obstruction After Transcatheter Aortic Valve Replacement.

Background: Delayed coronary obstruction (DCO) is an uncommon and barely reported complication following transcatheter aortic valve replacement (TAVR).

Objectives: The aim of this study was to describe the incidence and pathophysiological features of DCO after TAVR, obtained from a large international multicenter registry.

Methods: Data were retrospectively collected from an international multicenter registry consisting of 18 centers between November 2005 and December 2016.

Valve-in-valve transcatheter aortic valve implantation with CoreValve/Evolut R for degenerated small versus bigger bioprostheses.

Objectives: We present our single center experience with Medtronic CoreValve and Evolut R regarding procedural outcome and 3 years follow-up in patients with degenerated bioprostheses.

Methods: From 1645 patients who underwent transfemoral TAVI at our institution between February 2009 and December 2016, 37 patients with degenerated bioprosthesis were treated with Medtronic CoreValve/Evolut R. All data concerning baseline characteristic, procedural outcomes and follow-up were entered into a dedicated database.

Impact of sheath diameter of different sheath types on vascular complications and mortality in transfemoral TAVI approaches using the Proglide closure device.

Objective: Evaluation of the impact of the sheath diameter on vascular complications and mortality in transfemoral aortic valve implantation.

Method: Between 2012 and 2014, 183 patients underwent the procedure using a sheath diameter of 18-24 F. This collective was divided into two groups: group 1, with a sheath diameter of 18F (G1, n = 94), consisted of patients with 18F Medtronic Sentrant and 18 F Direct Flow sheaths, and group 2 with a sheath diameter of 19-24 F (G2, n = 89) consisted of patients with Edwards expandable e-sheath and Solopath sheaths.

Clinical Outcomes With a Repositionable Self-Expanding Transcatheter Aortic Valve Prosthesis: The International FORWARD Study.

Background: Clinical outcomes in large patient populations from real-world clinical practice with a next-generation self-expanding transcatheter aortic valve are lacking.

Objectives: This study sought to document the clinical and device performance outcomes of transcatheter aortic valve replacement (TAVR) with a next-generation, self-expanding transcatheter heart valve (THV) system in patients with severe symptomatic aortic stenosis (AS) in routine clinical practice.

Methods: The FORWARD (CoreValve Evolut R FORWARD) study is a prospective, single-arm, multinational, multicenter, observational study.

Transcatheter Aortic Valve Implantation in Nonagenarians: Procedural Outcome and Mid-Term Results.

Background: For nonagenarians with symptomatic severe aortic stenosis transcatheter aortic valve implantation (TAVI) has become a feasible therapeutic option. Therefore, the aim of this study was to evaluate the procedural outcomes and mid-term follow-up in this patient group and compare this to octogenarians.

Methods: From 1359 patients who underwent TAVI at our institution between March 2009 and February 2016, 82 patients were nonagenarians and 912 were octogenarians.

Impact of closure devices on vascular complication and mortality rates in TAVI procedures.

Background: Currently two closure devices are available for the vascular access in TAVI procedures. Their impact on vascular complications and mid-term mortality is yet unknown.

Methods: Between 2009 and 2014, 398 patients underwent TAVI TF procedures in which two different closure devices were used, Prostar® XL (n=215) and Perclose-Proglide® (n=183).

Left ventricular adaptation after TAVI evaluated by conventional and speckle-tracking echocardiography.

Objective: Our study aimed to evaluate myocardial adaption and outcome after transfemoral aortic valve implantation (TAVI TF) for severe aortic stenosis by LV ejection fraction (LVEF) and speckle tracking analysis.

Methods And Results: From 168 patients who underwent TAVI TF between 2010 and 2013 in our institution, n=95 with a follow-up period ≥3months were included and grouped (G) according to baseline left ventricular ejection fraction (LVEF; G1: LVEF<40%, G2: 40%-55%, G3: >55%). LV function was evaluated using conventional and speckle-tracking based parameters.

Pre-Capillary, Combined, and Post-Capillary Pulmonary Hypertension: A Pathophysiological Continuum.

Background: Pulmonary hypertension (PH) is hemodynamically classified as pre-capillary (as seen in idiopathic pulmonary arterial hypertension [IPAH]) or post-capillary (as seen in heart failure with preserved ejection fraction [HFpEF]). Overlaps between these conditions exist. Some patients present with risk factors for left heart disease but pre-capillary PH, whereas patients with HFpEF may have combined pre- and post-capillary PH.

First Explantation of Direct Flow Medical Transcatheter Valve.

Next-generation transcatheter heart valves are designed to overcome procedure-related adverse events such as vascular complications and annulus rupture, and to minimize paravalvular regurgitation. The Direct Flow Medical valve is fully repositionable and shows promising results. The case is presented of Direct Flow Medical valve implantation in a patient with a functional bicuspid aortic valve.