Early safety after TAVR according to VARC-3 criteria: incidence, predictors, and clinical impact.

Introduction And Objectives: The Valve Academic Research Consortium (VARC)-3 definition of the early safety (ES) composite endpoint after transcatheter aortic valve replacement (TAVR) lacks clinical validation. The aim of this study was to determine the incidence, predictors, and clinical impact of ES after TAVR as defined by VARC-3 criteria.

Methods: We performed a multicenter study including 10 078 patients with severe aortic stenosis undergoing transarterial TAVR.

Balloon- vs Self-Expanding Transcatheter Valves for Failed Small Surgical Aortic Bioprostheses: 1-Year Results of the LYTEN Trial.

Background: Data comparing valve systems in the valve-in-valve transcatheter aortic valve replacement (ViV-TAVR) field have been obtained from retrospective studies.

Objectives: The authors sought to compare the 1-year hemodynamic performance and clinical outcomes between balloon-expandable valves (BEV) SAPIEN 3/ULTRA (Edwards Lifesciences) and self-expanding valves (SEV) Evolut R/PRO/PRO+ (Medtronic) in ViV-TAVR.

Methods: Patients with a failed small (≤23 mm) surgical valve undergoing ViV-TAVR were randomized to receive a SEV or a BEV.

Safety and Efficacy of TAVR With a Pressure Sensor and Pacing Guidewire: SAFE-TAVI Trial.

Background: The SavvyWire (OpSens Inc) is a 0.035-inch preshaped guidewire with dedicated pacing properties and a distal pressure sensor allowing for continuous hemodynamic pressure monitoring.

Objectives: This study sought to determine the efficacy and safety of the guidewire during transcatheter aortic valve replacement (TAVR) procedures.

Transcatheter or Surgical Aortic Valve Replacement in Patients With Severe Aortic Stenosis and Small Aortic Annulus: A Randomized Clinical Trial.

Background: The optimal treatment in patients with severe aortic stenosis and small aortic annulus (SAA) remains to be determined. This study aimed to compare the hemodynamic and clinical outcomes between transcatheter aortic valve replacement (TAVR) and surgical aortic valve replacement (SAVR) in patients with a SAA.

Methods: This prospective multicenter international randomized trial was performed in 15 university hospitals.

Balloon- vs Self-Expanding Valve Systems for Failed Small Surgical Aortic Valve Bioprostheses.

Background: Data comparing valve systems in the valve-in-valve transcatheter aortic valve replacement (ViV-TAVR) field have been obtained from retrospective studies.

Objectives: The purpose of this study was to compare the hemodynamic results between the balloon-expandable valve (BEV) SAPIEN (3/ULTRA, Edwards Lifesciences) and self-expanding valve (SEV) Evolut (R/PRO/PRO+, Medtronic) in ViV-TAVR.

Methods: Patients with a failed small (≤23 mm) surgical valve were randomized to receive a BEV or an SEV.

Late arrhythmias in patients with new-onset persistent left bundle branch block after transcatheter aortic valve replacement using a balloon-expandable valve.

Background: The arrhythmic burden after discharge in patients with new-onset left bundle branch block (LBBB) undergoing transcatheter aortic valve replacement (TAVR) with the balloon-expandable SAPIEN 3 (S3) valve remains largely unknown.

Objective: The purpose of this study was to determine the incidence of late arrhythmias in patients with new-onset LBBB undergoing TAVR with the balloon-expandable S3 valve.

Methods: This was a multicenter, prospective study that included 104 consecutive TAVR patients with new-onset persistent LBBB following TAVR with the S3 valve.

Arrhythmic burden in patients with new-onset persistent left bundle branch block after transcatheter aortic valve replacement: 2-year results of the MARE study.

Aims: We determined the incidence and type of arrhythmias at 2-year follow-up in patients with new-onset persistent left bundle branch block (LBBB) following transcatheter aortic valve replacement (TAVR).

Methods And Results: Multicentre prospective study including 103 consecutive patients with new-onset persistent LBBB post-TAVR (SAPIEN XT/3: 53; CoreValve/Evolut R: 50). An implantable cardiac monitor (Reveal XT, Reveal Linq) was implanted before hospital discharge and patients had continuous monitoring for up to 2 years.

Cerebral Embolism After Transcarotid Transcatheter Aortic Valve Replacement: Factors Associated With Ipsilateral Ischemic Burden.

Background: Transcarotid transcatheter aortic valve replacement (TAVR) recipients may be exposed to a higher ipsilateral subclinical cerebral ischemic burden compared with the contralateral hemisphere. We sought (1) to compare the cerebral ischemic burden of the 2 hemispheres after transcarotid TAVR, as evaluated by diffusion weighted-magnetic resonance imaging (DW-MRI), and (2) to identify the factors associated with ipsilateral ischemic burden.

Methods: This prospective study included 52 patients undergoing transcarotid TAVR, followed by a DW-MRI examination.

Hemodynamic performance of the balloon-expandable SAPIEN 3 valve as assessed by cardiac magnetic resonance.

Background: Scarce data exist on transcatheter heart valve (THV) performance evaluated by cardiac magnetic resonance (CMR) in newer generation THV patients. Furthermore, it has been suggested that echocardiographic evaluation after TAVR may inaccurately assess residual AR in some patients. This study aimed to determine the incidence and severity of aortic regurgitation (AR) assessed by CMR in patients undergoing TAVR with the SAPIEN 3 valve, and evaluate the agreement between CMR and transthoracic echocardiography (TTE) on the assessment of AR severity in such patients.

Prolonged Continuous Electrocardiographic Monitoring Prior to Transcatheter Aortic Valve Replacement: The PARE Study.

Objectives: This study sought to determine, using continuous electrocardiographic monitoring (CEM) pre-transcatheter aortic valve replacement (TAVR), the incidence and type of unknown pre-existing arrhythmic events (AEs) in TAVR candidates, and to evaluate the occurrence and impact of therapeutic changes secondary to the detection of AEs pre-TAVR.

Background: Scarce data exist on the arrhythmic burden of TAVR candidates (pre-procedure).

Methods: This was a prospective study including 106 patients with severe aortic stenosis and no prior permanent pacemaker screened for TAVR.

Mitral Regurgitation in Low-Flow, Low-Gradient Aortic Stenosis Patients Undergoing TAVR: Insights From the TOPAS-TAVI Registry.

Objectives: This study sought to determine the incidence, clinical impact, and changes over time of mitral regurgitation (MR) in patients with low-flow, low-gradient aortic stenosis (LFLG-AS) undergoing transcatheter aortic valve replacement (TAVR).

Background: Few data exist on the clinical impact and changes in severity over time of MR in patients with LFLG-AS undergoing TAVR.

Methods: A total of 308 TAVR candidates with LFLG-AS were included.

Late Electrocardiographic Changes in Patients With New-Onset Left Bundle Branch Block Following Transcatheter Aortic Valve Implantation.

This study sought to determine, in patients with new-onset persistent left bundle branch block (NOP-LBBB) after transcatheter aortic valve implantation (TAVI), the incidence and factors associated with (i) LBBB recovery and (ii) permanent pacemaker implantation (PPI) at 1-year follow-up. This was a multicenter study including 153 patients (mean age: 81 ± 5 years, 56% of women) with NOP-LBBB post-TAVI (balloon-expandable valve in 112 patients). Delta PR (ΔPR) and delta QRS (ΔQRS) were defined as the difference in PR and QRS length between baseline and hospital discharge ECG, and the relative ΔPR and ΔQRS as absolute ΔPR and ΔQRS divided by baseline PR and QRS length, respectively.

Effect of Aortic Regurgitation by Cardiovascular Magnetic Resonance After Transcatheter Aortic Valve Implantation.

Cardiovascular magnetic resonance (CMR) has demonstrated a high accuracy for evaluating the severity of aortic regurgitation (AR). However, scarce data exist on the impact of AR as evaluated by CMR on clinical outcomes following transcatheter aortic valve implantation (TAVI). The objective of this study was to evaluate the impact of AR as determined by CMR on clinical outcomes (mortality, heart failure [HF] hospitalization) post-TAVI.

Outcomes From Transcatheter Aortic Valve Replacement in Patients With Low-Flow, Low-Gradient Aortic Stenosis and Left Ventricular Ejection Fraction Less Than 30%: A Substudy From the TOPAS-TAVI Registry.

Importance: In low-flow, low-gradient aortic stenosis (LFLG AS), the severity of left ventricular dysfunction remains a key factor in the evaluation of aortic valve replacement.

Objective: To evaluate the clinical outcomes and changes in left ventricular ejection fraction (LVEF) after transcatheter aortic valve replacement (TAVR) in patients with LFLG AS and severe left ventricular dysfunction.

Design, Setting, And Participants: This multicenter registry is a substudy of the True or Pseudo-Severe Aortic Stenosis-TAVI registry that included patients with classic LFLG AS, defined as a mean transvalvular gradient less than 35 mm Hg, an effective orifice area less than 1.

Arrhythmic Burden as Determined by Ambulatory Continuous Cardiac Monitoring in Patients With New-Onset Persistent Left Bundle Branch Block Following Transcatheter Aortic Valve Replacement: The MARE Study.

Objectives: The authors sought to determine: 1) the global arrhythmic burden; 2) the rate of arrhythmias leading to a treatment change; and 3) the incidence of high-degree atrioventricular block (HAVB) at 12-month follow-up in patients with new-onset persistent left bundle branch block (LBBB) following transcatheter aortic valve replacement (TAVR).

Background: Controversial data exist on the occurrence of significant arrhythmias in patients with LBBB post-TAVR.

Methods: This was a multicenter prospective study including 103 consecutive patients with new-onset persistent LBBB post-TAVR with the balloon-expandable SAPIEN XT/3 valve (n = 53), or the self-expanding CoreValve/Evolut R system (n = 50).

Percutaneous coronary intervention for treating de-novo lesions in small coronary vessels: initial experience with the Essential paclitaxel-coated balloon.

Background: Paclitaxel-coated balloon (PCB) coronary angioplasty is an alternative treatment for de-novo coronary lesions in small vessels. This study with the new Essential PCB aimed to evaluate early and mid-term clinical outcomes following angioplasty with the Essential PCB in the treatment of de-novo lesions in small vessels.

Patients And Methods: We included all patients who underwent PCB angioplasty for treating de-novo coronary lesions in small vessels (reference diameter <2.

Transcatheter Aortic Valve Replacement in Patients With Low-Flow, Low-Gradient Aortic Stenosis: The TOPAS-TAVI Registry.

Background: Few data exist on patients with low-flow, low-gradient aortic stenosis (LFLG-AS) undergoing transcatheter aortic valve replacement (TAVR). Also, very scarce data exist on the usefulness of dobutamine stress echocardiography (DSE) before TAVR in these patients.

Objectives: The authors sought to evaluate clinical outcomes and changes in left ventricular ejection fraction (LVEF) following TAVR in patients with classical LFLG-AS.

Three- and 6-month optical coherence tomographic surveillance following percutaneous coronary intervention with the Angiolite® drug-eluting stent: The ANCHOR study.

Background: Pre-clinical results of a novel open-cell, thin strut, durable polymer, laser cut cobalt chromium sirolimus-eluting stent (Angiolite) were promising. Using quantitative optical coherence tomographic (OCT) analyses, we explored the healing characteristics of the Angiolite DES system at 3- and 6-months post implantation.

Methods: A total of 103 patients with de novo coronary lesions underwent percutaneous coronary intervention with the Angiolite DES and were randomized 1:3 into two cohorts for angiographic and OCT follow-up, with 28 and 70 patients returning for 3- or 6-month post-PCI surveillance, respectively.

Transcatheter aortic valve implantation in patients with small aortic annuli using a 20 mm balloon-expanding valve.

Background: While transcatheter aortic valve implantation (TAVI) is established for treating high-operative risk surgical aortic valve replacement candidates, until recently the smallest transcatheter heart valve (THV) measured 23 mm, posing greater risk for annular rupture and THV failure in patients with aortic stenosis (AS) with small aortic annuli (≤20 mm).

Objectives: In the setting of a multicentre registry, we report on the safety, efficacy and early clinical outcomes of the SAPIEN XT 20 mm balloon-expanding THV.

Results: Among TAVI 55 recipients (n=30 for native AS, n=25 for a valve-in-valve procedure (V-in-V)), median age and Society of Thoracic Surgeons score were 85 (81 to 87) years and 7.

PCSK9 levels in abdominally obese men: association with cardiometabolic risk profile and effects of a one-year lifestyle modification program.

Objectives: Studies performed in rodents have suggested a role for proprotein convertase subtilisin/kexin type 9 (PCSK9) in insulin resistance and impaired body fat distribution. Our objective was to examine the relationships between markers of adiposity and insulin resistance and plasma PCSK9 levels in humans. In addition, we explored the effect of a one-year lifestyle modification program on plasma PCSK9 levels in abdominally obese, dyslipidemic men.

Interrelationships between changes in anthropometric variables and computed tomography indices of abdominal fat distribution in response to a 1-year physical activity-healthy eating lifestyle modification program in abdominally obese men.

The objectives were to (i) measure the effects of a 1-year lifestyle modification program on body fat distribution/anthropometric variables; (ii) determine the interrelationships between changes in all these variables; and (iii) investigate whether there is a selective reduction in deep (DSAT) vs. superficial subcutaneous adipose tissue (SSAT) at the abdominal level following a 1-year lifestyle modification program. Anthropometric variables, body composition and abdominal and midthigh fat distribution were assessed at baseline and after 1 year in 109 sedentary, dyslipidemic and abdominally obese men.