Quantitative aortography for assessing aortic regurgitation after transcatheter aortic valve implantation: results of the multicentre ASSESS-REGURGE Registry.

Aims: Quantitative aortography using videodensitometry is a valuable tool for quantifying paravalvular regurgitation after TAVI, especially in the minimalist approach - without general anaesthesia. However, retrospective assessment of aortograms showed moderate feasibility of assessment. We sought to determine the prospective feasibility of quantitative aortography after a protocol of acquisition.

Critical Appraisal of Contemporary Clinical Endpoint Definitions in Coronary Intervention Trials: A Guidance Document.

The Academic Research Consortium (ARC) and the Standardized Data Collection for Cardiovascular Trials Initiative have recently published updated clinical and angiographic endpoint definitions for percutaneous coronary intervention trials. The aim of this document is to provide practical guidance to facilitate and harmonize the implementation of those definitions in randomized trials or registries, as well as to foster consistency among independent adjudication committees. The authors compared the ARC-2 and Standardized Data Collection for Cardiovascular Trials Initiative definitions to identify areas of consistency, complex scenarios, and definitions in need of further standardization.

The Role of Quantitative Aortographic Assessment of Aortic Regurgitation by Videodensitometry in the Guidance of Transcatheter Aortic Valve Implantation.

Background: Balloon post-dilatation (BPD) is often needed for optimizing transcatheter heart valve (THV) implantation, since paravalvular leak (PVL) after transcatheter aortic valve implantation is associated with poor outcome and mortality. Quantitative assessment of PVL severity before and after BPD is mandatory to properly assess PVL, thus improving implantation results and outcomes.

Objective: To investigate a quantitative angiographic assessment of aortic regurgitation (AR) by videodensitometry before and after BPD.

A prospective multicentre randomised all-comers trial to assess the safety and effectiveness of the thin-strut sirolimus-eluting coronary stent SUPRAFLEX: rationale and design of the Thin Strut Sirolimus-eluting Stent in All Comers Population vs Everolimus-eluting Stent (TALENT) trial.

Aims: The aim of this study is to compare the SUPRAFLEX sirolimus-eluting stent (SES) with the XIENCE everolimus-eluting stent (EES) with respect to target lesion failure (TLF) at 12 months in a non-inferiority trial in a "real-world" patient population.

Methods And Results: This is a prospective, randomised, 1:1 balanced, controlled, single-blind, multicentre study comparing clinical outcomes at 12 months between SUPRAFLEX and XIENCE in an "all-comers" patient population, comprising a total of 1,430 enrolled subjects with symptomatic coronary artery disease who qualify for percutaneous coronary interventions at 23 centres in Europe. The primary endpoint is a non-inferiority comparison of the device-oriented composite endpoint target lesion failure (cardiac death, target vessel myocardial infarction and clinically indicated target lesion revascularisation) of the SUPRAFLEX group to the XIENCE group at 12 months post procedure.

Inter-Technique Consistency and Prognostic Value of Intra-Procedural Angiographic and Echocardiographic Assessment of Aortic Regurgitation After Transcatheter Aortic Valve Implantation.

Background: We investigated the relationship between intraprocedural angiographic and echocardiographic AR severity after TAVI, and the clinical robustness of angiographic assessment.

Methods and results: In 74 consecutive patients, the echocardiographic circumferential extent (CE) of the paravalvular regurgitant jet was retrospectively measured and graded based on the VARC-2 cut-points; and angiographic post-TAVI AR was retrospectively quantified using contrast videodensitometry (VD) software that calculates the ratio of the contrast time-density integral in the LV outflow tract to that in the ascending aorta (LVOT-AR). Seventy-four echocardiograms immediately after TAVI were analyzable, while 51 aortograms were analyzable for VD.

Role of Computed Tomography in Planning the Appropriate X-Ray Gantry for Quantitative Aortography of Post-transcatheter Aortic Valve Implantation Regurgitation.

Background: The clinical robustness of contrast-videodensitometric (VD) assessment of aortic regurgitation (AR) after transcatheter aortic valve implantation (TAVI) has been demonstrated. Correct acquisition of aortic root angiography for VD assessment, however, is hampered by the opacified descending aorta and by individual anatomic peculiarities. The aim of this study was to use preprocedural multi-slice computed tomography (MSCT) to optimize the angiographic projection in order to improve the feasibility of VD assessment.

Determinants of success and hemodynamic impact of balloon postdilatation of self-expanding transcatheter aortic valves.

Objectives: To explore the rate, the determinants of success, and the hemodynamic impact of balloon postdilatation (BPD) of self-expanding transcatheter heart valves (SE-THVs) BACKGROUND: BPD is commonly used to optimize valve expansion and reduce paravalvular leakage (PVL) after transcatheter aortic valve implantation (TAVI) without clearly knowing its hemodynamic benefits.

Methods: Patients (n = 307) who received a SE-THV were stratified according to whether a BPD was performed or not. Patients who received BPD were stratified according to the severity of PVL remaining after BPD into two groups: Successful BPD (≤mild PVL + BPD) and Failed BPD (moderate-severe PVL + BPD).

Acute performance of a novel restorative transcatheter aortic valve: preclinical results.

Aims: The Xeltis aortic valve leaflets are made from a bioabsorbable supramolecular polymer that guides the tissue to restoring itself. It is mounted on a self-expanding nitinol frame that includes three feelers and a native leaflet clipping mechanism. We sought to investigate the acute valve performance in a preclinical setting.

Safety and feasibility of contrast echocardiography for the evaluation of patients with HeartMate 3 left ventricular assist devices.

Aims: Patients with a left ventricular assist device (LVAD) are challenging to evaluate using conventional imaging techniques, such as standard echocardiography (SE). The aim of this pilot study was to evaluate the potential of contrast echocardiography (CE) for the evaluation of the left ventricle (LV).

Methods And Results: This prospective study included 14 ambulatory patients (mean age 58 ± 9 years, 79% male) with a LVAD (all HeartMate 3, Abbott Laboratories, Chicago, IL, USA).

Restorative valve therapy by endogenous tissue restoration: tomorrow's world? Reflection on the EuroPCR 2017 session on endogenous tissue restoration.

The current standard of treatment of valvular diseases with severe functional and/or clinical consequences is the repair or replacement of the valve, which is usually surgical or, in specific scenarios, percutaneous. The available prosthetic valves, however, are not a magic bullet in the physicians' arsenal for the management of valvular diseases, since the age-dependent structural valve deterioration (SVD) and the need for prolonged systemic anticoagulation in the case of metallic prosthetic valves are not inconsequential during the lifespan of a patient with an implanted prosthetic valve. Based on decades of research combining the scientific disciplines of supramolecular chemistry, electrospinning and regenerative medicine, endogenous tissue restoration has emerged as a very promising domain to provide this magic bullet, in the form of valves, which enables functional restoration by the body itself.

Derivation and Validation of a Novel Right-Sided Heart Failure Model After Implantation of Continuous Flow Left Ventricular Assist Devices: The EUROMACS (European Registry for Patients with Mechanical Circulatory Support) Right-Sided Heart Failure Risk Score.

Background: The aim of the study was to derive and validate a novel risk score for early right-sided heart failure (RHF) after left ventricular assist device implantation.

Methods: The EUROMACS (European Registry for Patients with Mechanical Circulatory Support) was used to identify adult patients undergoing continuous-flow left ventricular assist device implantation with mainstream devices. Eligible patients (n=2988) were randomly divided into derivation (n=2000) and validation (n=988) cohorts.

A novel synchronised diastolic injection method to reduce contrast volume during aortography for aortic regurgitation assessment: in vitro experiment of a transcatheter heart valve model.

Aims: In the minimalist transcatheter aortic valve implantation (TAVI) era, the usage of transoesophageal echocardiography has become restricted. Conversely, aortography has gained clinical ground in quantifying prosthetic valve regurgitation (PVR) during the procedure. In a mock circulation system, we sought to compare the contrast volume required and the accuracy of aortographic videodensitometric PVR assessment using a synchronised diastolic and standard (non-synchronised) injection aortography.

Relation between calcium burden, echocardiographic stent frame eccentricity and paravalvular leakage after corevalve transcatheter aortic valve implantation.

Aims: Paravalvular aortic leakage (PVL) after transcatheter aortic valve implantation (TAVI) is a complication with potentially severe consequences. The relation between native aortic root calcium burden, stent frame eccentricity and PVL was not studied before.

Methods And Results: Two-hundred-and-twenty-three consecutive patients with severe aortic stenosis who underwent TAVI with a Medtronic CoreValve System© and who had available pre-discharge transthoracic echocardiography were studied.

Accuracy of an automated transthoracic echocardiographic tool for 3D assessment of left heart chamber volumes.

Aims: The feasibility and accuracy of an automated adaptive algorithm (Heart Model) for the quantification of left heart chamber volumes and left ventricular ejection fraction has been reported earlier. An improved version of the algorithm is available, and we aimed to test its accuracy compared with manual 3D echocardiography.

Methods And Results: Apical 3D transthoracic datasets were obtained in 67 patients.

Angiographic assessment of aortic regurgitation by video-densitometry in the setting of TAVI: Echocardiographic and clinical correlates.

Objectives: We sought to investigate a new angiographic method for aortic regurgitation (AR) severity assessment in the setting of transcatheter aortic valve implantation (TAVI).

Background: AR after TAVI is common but challenging to quantitate, especially in the cath-lab.

Methods: In 228 patients, AR was quantitated before and after TAVI by echocardiography and by video-densitometric analysis of aortograms.

Multimodality Imaging for Left Ventricular Hypertrophy Severity Grading: A Methodological Review.

Left ventricular hypertrophy (LVH), defined by an increase in left ventricular mass (LVM), is a common cardiac finding generally caused by an increase in pressure or volume load. Assessing severity of LVH is of great clinical value in terms of prognosis and treatment choices, as LVH severity grades correlate with the risk for presenting cardiovascular events. The three main cardiac parameters for the assessment of LVH are wall thickness, LVM, and LV geometry.

Comparison of valve performance of the mechanically expanding Lotus and the balloon-expanded SAPIEN3 transcatheter heart valves: an observational study with independent core laboratory analysis.

Aims: The Lotus and SAPIEN3 are second-generation transcatheter heart valves, which are designed to minimize paravalvular aortic regurgitation (PAR) after transcatheter aortic valve replacement (TAVR). We sought to compare both devices for valve performance and with emphasis on PAR by independent core laboratory analysis.

Methods And Results: A total of 162 (79 Lotus and 83 SAPIEN3) consecutive patients (51% female, 80 ± 8 years, Logistic EuroSCORE 14.

Delayed and decreased LV untwist and unstrain rate in mutation carriers for hypertrophic cardiomyopathy.

Background: The echocardiographic focus to detect abnormalities in genetically hypertrophic cardiomyopathy (HCM) affected subjects without left ventricular (LV) hypertrophy (G+/LVH-) has been on diastolic abnormalities in transmitral flow and longitudinal myocardial function with tissue Doppler imaging. The aim of this study was to assess diastolic LV unstrain and untwist.

Methods And Results: Forty-one consecutive genotyped family members of HCM patients (mean age 37 ± 11 years, 16 men) and 41 age- and gender-matched healthy volunteers underwent speckle-tracking echocardiography to measure untwist and unstrain.

The interaction of de novo and pre-existing aortic regurgitation after TAVI: insights from a new quantitative aortographic technique.

Aims: The aim of this study was to evaluate the intermediate-term clinical impact of aortic regurgitation (AR) after transcatheter aortic valve implantation (TAVI) using a novel quantitative angiographic method taking into account the influence of pre-existing AR.

Methods And Results: AR after TAVI was quantified in 338 patients (age 82 [78-86] years; 55% male) and the influence on intermediate-term all-cause mortality was evaluated. In 228 aortograms, AR was quantitated using a dedicated videodensitometric method focused in the left ventricular outflow tract (LVOT-AR).

Quantitative Doppler for Estimation of Paravalvular Leakage after Transcatheter Aortic Valve Implantation.

Background: The echocardiographic grading of paravalvular aortic leakage (PVL) after transcatheter aortic valve implantation (TAVI) severity is challenging. The study aim was to assess the value of quantitative Doppler echocardiography to monitor PVL severity.

Methods: A total of 100 subjects was enrolled in the study, including 65 consecutive patients who had undergone TAVI with a CoreValve prosthesis and without valvular aortic regurgitation, and 35 normal controls.

Limitations and difficulties of echocardiographic short-axis assessment of paravalvular leakage after corevalve transcatheter aortic valve implantation.

To make assessment of paravalvular aortic leakage (PVL) after transcatheter aortic valve implantation (TAVI) more uniform the second Valve Academic Research Consortium (VARC) recently updated the echocardiographic criteria for mild, moderate and severe PVL. In the VARC recommendation the assessment of the circumferential extent of PVL in the short-axis view is considered critical. In this paper we will discuss our observational data on the limitations and difficulties of this particular view, that may potentially result in overestimation or underestimation of PVL severity.

Quantitative assessment of the entire right ventricle from one acoustic window: an attractive approach.

Aims: The aim of this prospective study was to evaluate the feasibility and establish normal values of functional right ventricle (RV) parameters as assessed in our four, long-axis view RV model using iRotate echocardiography. Furthermore, we evaluated the potential use of this model in patients with abnormally loaded RVs.

Method And Results: One hundred and fifty-five healthy subjects aged 20-72 years (≥28 subjects per decile) were prospectively recruited.

A granular approach to improve reproducibility of the echocardiographic assessment of paravalvular regurgitation after TAVI.

Paravalvular leak (PVL) after transcatheter aortic valve implantation (TAVI) is challenging to quantitate. Transthoracic echocardiography (TTE) is the main tool used for the assessment of PVL but is modestly reproducible. We sought to develop a reproducible echocardiographic approach to assess PVL in the post-TAVI setting.

A simplified and reproducible method to size the mitral annulus: implications for transcatheter mitral valve replacement.

Aims: Transcatheter mitral valve replacement (TMVR) provides definitive valve replacement through a minimally invasive procedure. In the setting of TMVR, it remains unclear how relevant the differences between different mitral annular (MA) diameters are. We sought to define a simplified and reproducible method to describe the MA size.