Data on plug-based large-bore arteriotomy vascular closure device related access complications.

This article provides supplementary tables and figures to the research article: Frequency, Impact and Predictors of Access Complications with Plug-Based Large-Bore Arteriotomy Closure - A patient level meta-analysis [1]. The data provide insight in the type and management of access complications related to the plug-based MANTA vascular closure device (VCD) for large-bore catheter-based cardiovascular interventions. Since MANTA is mostly used in transcatheter aortic valve replacement (TAVR) procedures, this article also contains a sub-group analysis on TAVR procedures using contemporary valve-platforms.

Frequency, Impact, and Predictors of Access Complications With Plug-Based Large-Bore Arteriotomy Closure - A Patient-Level Meta-Analysis.

Background/purpose: The MANTA is a dedicated plug-based large-bore vascular closure device (VCD) providing safe hemostasis in most patients, but data on the clinical impact and mechanisms of MANTA related complications are limited. This study sought to determine the frequency, impact and predictors of MANTA-related access complications.

Methods/materials: This patient-level meta-analysis included data from 2 medical device approval studies and 1 post-approval registry.

Impact of Baseline and Newly Acquired Conduction Disorders on Need for Permanent Pacemakers With 3 Consecutive Generations of Self-Expanding Transcatheter Aortic Heart Valves.

Introduction: We aimed to compare conduction dynamics and need for permanent pacemaker implantation (PPI) after CoreValve, Evolut R and PRO (transcatheter aortic valve replacement (TAVR)).

Methods: Patients were stratified based on conduction at baseline; Cohort A had normal conduction, Cohort B had conduction abnormalities including atrioventricular (AV)-block, fascicular block or complete bundle branch block. Three different dynamic QRS-patterns were defined: stable QRS-duration, transient QRS-prolongation and persistent QRS-prolongation.

Vascular complications with a plug-based vascular closure device after transcatheter aortic valve replacement: Predictors and bail-outs.

Background: The MANTA vascular closure device (VCD) is dedicated to large bore access closure and associated with favorable results in selected study populations. Anatomical predictors for access site complications are lacking.

Aim: To evaluate MANTA in a real-world population and identify predictors for vascular complications.

Suture- or Plug-Based Large-Bore Arteriotomy Closure: A Pilot Randomized Controlled Trial.

Objectives: This study sought to test the superiority in terms of efficacy and safety of a dedicated plug-based vascular closure device (VCD) during transcatheter aortic valve replacement (TAVR) over a suture-based VCD.

Background: Vascular complications after TAVR are relevant and often associated with VCD failure.

Methods: The MASH (MANTA vs.

Dedicated plug based closure for large bore access -The MARVEL prospective registry.

Objectives: To study safety and performance of the MANTA Vascular closure device (VCD) under real world conditions in 10 centers.

Background: The MANTA is a novel plug-based device for large bore arteriotomy closure.

Methods: We included all eligible patients who underwent transfemoral large bore percutaneous procedures.

Heterogeneity of debris captured by cerebral embolic protection filters during TAVI.

Aims: The aim of this study was to investigate the total amount, size and heterogeneity of debris captured among different transcatheter valve types and while repositioning.

Methods And Results: A total of 328 patients who underwent transcatheter aortic valve implantation (TAVI) with the SENTINEL cerebral embolic protection (CEP) at our centre were eligible. Histopathological and semiquantitative analysis of captured debris was performed and data were entered into our prospective database.

Patient-Specific Computer Simulation in TAVR With the Self-Expanding Evolut R Valve.

Objectives: The aim of this study was to assess the added value and predictive power of the TAVIguide (Added Value of Patient-Specific Computer Simulation in Transcatheter Aortic Valve Implantation) software in clinical practice.

Background: Optimal outcome after transcatheter aortic valve replacement (TAVR) may become more important as TAVR shifts toward low-risk patients. Patient-specific computer simulation is able to provide prediction of outcome after TAVR.

HAS-BLED score and actual bleeding in elderly patients undergoing transcatheter aortic valve implantation.

Background: The optimal antithrombotic therapy after transcatheter aortic valve implantation (TAVI) is unsettled. Short and longer-term thromboembolic and bleeding risk post TAVI remain high. Non-vitamin K oral anticoagulant drugs (NOAC) may be attractive after TAVI but the implications of prolonged NOAC in this setting require further research.

Impact of Valvulo-Arterial Impedance on Long-Term Quality of Life and Exercise Performance After Transcatheter Aortic Valve Replacement.

Background: In aortic stenosis, valvulo-arterial impedance (Zva) estimates the overall left ventricular afterload (valve and arterial component). We investigated the association of Zva (≥5 versus <5 mm Hg mL m) on quality of life (QOL) and exercise performance (EP) ≥1 year after transcatheter aortic valve replacement (TAVR).

Methods: The study population consists of 250 TAVR patients in whom baseline Zva and follow-up QOL was prospectively assessed using EuroQOL-5-dimensions instruments; EP was assessed in 192 patients who survived ≥1 year after TAVR using questionnaires related to daily activities.

Early Clinical Impact of Cerebral Embolic Protection in Patients Undergoing Transcatheter Aortic Valve Replacement.

Background We aimed to compare the rate of neurological events in patients with or without cerebral embolic protection (CEP) during transcatheter aortic valve replacement (TAVR). Methods and Results Data on clinical end points including neurological events ≤30 days post-TAVR were collected for all patients who underwent transfemoral TAVR in 2 academic tertiary care institutions. Patients were matched through propensity scoring, which resulted in 333 pairs of patients with versus without CEP out of a total of 831 consecutive patients.

Moderate Aortic Stenosis and Reduced Left Ventricular Ejection Fraction: Current Evidence and Challenges Ahead.

Moderate aortic stenosis (AS) and reduced left ventricular ejection fraction (LVEF) constitute a clinical entity that has been proposed as a therapeutic target for transcatheter aortic valve replacement (TAVR). It is defined by a mean trans-aortic gradient between 20 and 40 mmHg and an aortic valve area between 1.0 and 1.

Conduction dynamics after transcatheter aortic valve implantation and implications for permanent pacemaker implantation and early discharge: the CONDUCT-study.

Aims: To correlate dynamics in electrical conduction after transcatheter aortic valve implantation (TAVI) with need for permanent pacemaker implantation (PPM) and assess implications for early discharge.

Methods And Results: Daily electrocardiograms after TAVI were analysed for rhythm and conduction times and were correlated with PPM. Transcatheter aortic valve implantation was performed in 291 consecutive patients with three contemporary transcatheter heart valve designs: Medtronic CoreValve (n = 111), Edwards Sapien XT (n = 29) and Sapien 3 (n = 72), and Boston Lotus (n = 79).

Need for Embolic Protection During Transcatheter Aortic Valve Implantation: An Interventionalist's Perspective on Histopathology Findings.

Transcatheter aortic valve implantation (TAVI) is a less invasive aortic valve replacement technique and is indicated for patients with symptomatic severe aortic stenosis and a high operative risk. Cerebral embolisation seems inherent to TAVI, as illustrated by the consistent appearance of new brain lesions on post-procedural MRI studies. Embolic protection devices may capture or deflect embolised material en route to the brain and thus reduce TAVI-related brain injury.

Complete filter-based cerebral embolic protection with transcatheter aortic valve replacement.

Objectives: To evaluate the value of left vertebral artery filter protection in addition to the current filter-based embolic protection technology to achieve complete cerebral protection during TAVR.

Background: The occurrence of cerebrovascular events after transcatheter aortic valve replacement (TAVR) has fueled concern for its potential application in younger patients with longer life expectancy. Transcatheter cerebral embolic protection (TCEP) devices may limit periprocedural cerebrovascular events by preventing macro and micro-embolization to the brain.