European experience with the second-generation Edwards SAPIEN XT transcatheter heart valve in patients with severe aortic stenosis: 1-year outcomes from the SOURCE XT Registry.

Objectives: The SOURCE XT Registry (Edwards SAPIEN XT Aortic Bioprosthesis Multi-Region Outcome Registry) assessed the use and clinical outcomes with the SAPIEN XT (Edwards Lifesciences, Irvine, California) valve in the real-world setting.

Background: Transcatheter aortic valve replacement is an established treatment for high-risk/inoperable patients with severe aortic stenosis. The SAPIEN XT is a balloon-expandable valve with enhanced features allowing delivery via a lower profile sheath.

How to adapt the implantation technique for the new SAPIEN 3 transcatheter heart valve design.

The new balloon-expandable Edwards SAPIEN 3 THV has significant design improvements requiring adjustments in the implantation technique as compared to the previous generation SAPIEN XT. Basically, the new valve requires less oversizing due to the outer skirt, which, if positioned underneath the annulus, can reduce the occurrence and severity of paravalvular leak (PVL). As with any transcatheter vale, a thorough assessment of the device-landing-zone, the surrounding structures, and the distribution of calcifications is of vast importance.

Serial intravascular ultrasound analysis of stent strut distribution and fracture: an integrated analysis of the taxus IV, V, and VI trials.

Aims: Non-uniform distribution of drug-eluting stent struts may cause uneven drug deposition associated with an adverse neointimal response and clinical events. This study assesses circumferential stent strut distribution in bare-metal (BMS) and paclitaxel-eluting (Taxus) stents post implantation and at 9-month follow-up, as well as its impact on intimal hyperplasia (IH).

Methods And Results: In the current analysis, intravascular ultrasound (IVUS) substudies of the Taxus IV, V, and VI trials were combined.

Changes in speckle tracking echocardiography measures of ventricular function after percutaneous implantation of the Edwards SAPIEN transcatheter heart valve in the pulmonary position.

Background: Patients with free pulmonary regurgitation or mixed pulmonary stenosis and regurgitation and severely dilated right ventricles (RV) show little improvement in ventricular function after pulmonary valve replacement when assessed by traditional echocardiographic markers. We evaluated changes in right and left ventricular (LV) function using speckle tracking echocardiography in patients after SAPIEN transcatheter pulmonary valve (TPV) placement.

Methods: Echocardiograms were evaluated at baseline, discharge, 1 and 6 months after TPV placement in 24 patients from 4 centers.

Emergent cardiac surgery during transcatheter aortic valve implantation (TAVI): insights from the Edwards SAPIEN Aortic Bioprosthesis European Outcome (SOURCE) registry.

Aims: Transcatheter aortic valve implantation (TAVI) carries the risk of intraprocedural complications that may ultimately require emergent cardiac surgery (ECS). However, few data exist on the incidence, reasons and outcomes of patients needing ECS during TAVI. We analysed data from 2,307 TAVI patients, prospectively enrolled in the multicentre Edwards SAPIEN Aortic Bioprosthesis European Outcome (SOURCE) registry.

Improved strut coverage and less late incomplete apposition with thin-strut TAXUS Liberté vs. TAXUS Express: the importance of stent platform design for drug-eluting stents.

Background: The objective of this intravascular ultrasound (IVUS) analysis was to evaluate the vascular response of the thin-strut TAXUS Liberté stent compared with the otherwise identical TAXUS Express stent.

Methods And Materials: The TAXUS ATLAS and TAXUS ATLAS Long Lesion studies are nonrandomized trials comparing the thin-strut TAXUS Liberté stent to historical TAXUS Express controls from the TAXUS IV and TAXUS V trials. A total of 377 patients enrolled in the two TAXUS ATLAS studies were randomly selected for the IVUS subset and compared to 314 TAXUS Express IVUS controls.

Impact of post-intervention minimal stent area on 9-month follow-up patency of paclitaxel-eluting stents: an integrated intravascular ultrasound analysis from the TAXUS IV, V, and VI and TAXUS ATLAS Workhorse, Long Lesion, and Direct Stent Trials.

Objectives: We investigated the predictive value of the intravascular ultrasound (IVUS) measured post-intervention minimum stent area (MSA) on 9-month follow-up paclitaxel-eluting stent (PES) patency compared with bare-metal stents (BMS).

Background: Stent underexpansion is a strong predictor for restenosis after sirolimus-eluting stent implantation, but the implication of underexpansion in PES is still unknown.

Methods: From the combined TAXUS IV, V, and VI and TAXUS ATLAS Workhorse, Long Lesion, and Direct Stent trials, 1,580 patients (PES 1,098, BMS 482) in IVUS substudies were analyzed.

Two-year results of paclitaxel-eluting stents in patients with medically treated diabetes mellitus from the TAXUS ARRIVE program.

Drug-eluting stents decrease revascularization compared with bare metal stents in diabetic patients, but few studies have compared drug-eluting stent use in diabetic versus nondiabetic patients. The objective of this study was to assess whether paclitaxel provides equivalent revascularization decrease in diabetic and nondiabetic patients. The ARRIVE registries enrolled 7,492 patients receiving TAXUS Express stents, including 2,112 with medically treated diabetes; results were compared with those in the remaining 5,380 nondiabetic patients.

TAXUS Liberté attenuates the risk of restenosis in patients with medically treated diabetes mellitus: results from the TAXUS ATLAS program.

Objectives: The aim of this study was to assess the relative efficacy and safety of the second-generation TAXUS Liberté paclitaxel-eluting stent (PES) in patients with and without diabetes mellitus.

Background: Diabetic patients suffer from accelerated atherosclerosis and increased risk of restenosis after coronary interventions; however, prior data suggest that PES might blunt this effect, providing equal benefit in diabetic and nondiabetic patients.

Methods: A pooled analysis of all 4 TAXUS ATLAS studies was conducted that included 413 diabetic and 1,116 nondiabetic subjects treated with the TAXUS Liberté stent for de novo coronary lesions.

Reduced risk of restenosis in small vessels and reduced risk of myocardial infarction in long lesions with the new thin-strut TAXUS Liberté stent: 1-year results from the TAXUS ATLAS program.

Objectives: The TAXUS ATLAS Small Vessel (SV) and Long Lesion (LL) multicenter studies compared the performance of the thin-strut (0.0038 inch) TAXUS Liberté 2.25-mm stent (Boston Scientific; Natick, Massachusetts) and the TAXUS Liberté 38-mm long stent (Boston Scientific; Natick, Massachusetts) with the earlier paclitaxel-eluting TAXUS Express (Boston Scientific) stent that has identical polymer, drug dosage, and release kinetics but different stent geometry and thicker struts (0.

Chronic arterial responses to overlapping paclitaxel-eluting stents: insights from serial intravascular ultrasound analyses in the TAXUS-V and -VI trials.

Objectives: The purpose of this study was to use intravascular ultrasound (IVUS) to investigate chronic arterial responses at the site of and adjacent to overlapping paclitaxel-eluting TAXUS stents (PES) compared with overlapping bare-metal stents (BMS).

Background: Increased paclitaxel dose in the PES-overlap region might be associated with arterial toxicity expressed as excessive expansive remodeling, incomplete stent apposition, or aneurysm formation.

Methods: In the TAXUS-V and -VI trials, 51 patients with overlapping stents (27 PES and 24 BMS) were imaged with serial IVUS immediately after procedure and at 9 months.

Direct stenting with the TAXUS Liberté drug-eluting stent: results from the Taxus Atlas Direct Stent Study.

Objectives: This study was conducted to determine whether direct stenting with TAXUS Liberté is noninferior to stenting after pre-dilation.

Background: Direct stenting is performed in approximately 30% of patients, but data on clinical and angiographic outcomes with drug-eluting stents are limited.

Methods: The TAXUS ATLAS DIRECT STENT is a single-arm, multicenter study that enrolled patients with de novo coronary lesions visually estimated to be 10 to 28 mm in length in vessels 2.

An integrated TAXUS IV, V, and VI intravascular ultrasound analysis of the predictors of edge restenosis after bare metal or paclitaxel-eluting stents.

We used intravascular ultrasound data after stent implantation from the TAXUS IV, V, and VI trials to determine predictors of angiographic stent edge restenosis. In the combined TAXUS IV, V, and VI trials, intravascular ultrasound was performed at implantation in 255 patients with bare metals stents (BMSs) and 276 patients with paclitaxel-eluting stents who underwent quantitative coronary angiography at 9 months. At follow-up, 6 BMSs (2.

Impact of mild or moderate renal insufficiency on the intravascular ultrasonic analysis of chronic vascular response to paclitaxel-eluting and bare-metal stents (from the TAXUS IV, V, and VI trials).

The presence of even mild renal insufficiency is usually associated with an increased rate of cardiovascular events after coronary stenting. The aim of this study was to evaluate the impact of mild to moderate renal insufficiency on the chronic vascular responses to the implantation of paclitaxel-eluting stents (PES; Taxus) and bare-metal stents (BMS). In the TAXUS IV, TAXUS V, and TAXUS VI trials, patients with serum creatinine levels >2.

Impact of in-stent minimal lumen area at 9 months poststent implantation on 3-year target lesion revascularization-free survival: a serial intravascular ultrasound analysis from the TAXUS IV, V, and VI trials.

Background: Intravascular ultrasound (IVUS) is used to assess intermediate lesions in native coronary arteries; minimum lumen area (MLA) <4.0 mm(2) is accepted as a cutoff for a significant stenosis. We evaluated the IVUS in-stent MLA at 9-month follow-up that best predicted subsequent target lesion revascularization (TLR)-free survival in patients from the TAXUS IV, V, and VI studies.

Meta-analysis of the effects of paclitaxel-eluting stents versus bare metal stents on volumetric intravascular ultrasound in patients with versus without diabetes mellitus.

Diabetes mellitus is a strong predictor of in-stent restenosis after bare-metal stent placement because of exaggerated intimal hyperplasia (IH). In this study, serial intravascular ultrasound was used to evaluate the effects of polymer-based, paclitaxel-eluting stents (PES) on in-stent neointima formation in patients with and without diabetes. A volumetric IVUS meta-analysis of 956 patients randomized to PES or bare-metal stents in the TAXUS IV (n=268), TAXUS V (n=509), and TAXUS VI (n=179) trials was performed.

Meta-analysis of angiographic versus intravascular ultrasound parameters of drug-eluting stent efficacy (from TAXUS IV, V, and VI).

Both quantitative coronary angiography (QCA) and intravascular ultrasound (IVUS) are currently used to assess in-stent restenosis. This study aimed to use standardized imaging and clinical follow-up to compare QCA parameters with several IVUS parameters to evaluate their strengths and weaknesses for detecting in-stent restenosis in a drug-eluting stent population. A subset of patients from the TAXUS IV, V, and VI studies was evaluated.

Effect of the polymer-based, paclitaxel-eluting TAXUS Express stent on vascular tissue responses: a volumetric intravascular ultrasound integrated analysis from the TAXUS IV, V, and VI trials.

Aims: The TAXUS Express stent has been shown to reduce angiographic restenosis, repeat revascularizations, and neointimal hyperplasia when compared with bare metal stent (BMS) control (TAXUS IV, V, and VI) in individual TAXUS trials. Since intravascular ultrasound (IVUS) methodology and core laboratory were consistent among all three TAXUS trials, an integrated analysis of 956 patients across all IVUS cohorts can be performed providing superior power.

Methods And Results: In the TAXUS randomized trials, patients received an Express BMS or paclitaxel-eluting TAXUS Express stent.

Polymer-based, paclitaxel-eluting TAXUS Liberté stent in de novo lesions: the pivotal TAXUS ATLAS trial.

Objectives: The goal of this research was to assess non-inferiority of the next-generation TAXUS Liberté stent (Boston Scientific Corp., Natick, Massachusetts) versus the TAXUS Express stent (Boston Scientific Corp.).

Inhibition of in-stent restenosis by oral copper chelation in porcine coronary arteries.

Stress-induced release of IL-1alpha and fibroblast growth factor-1 is dependent on intracellular copper and is a major driver of neointimal hyperplasia. Therefore, we assessed the effect of tetrathiomolybdate (TTM), a clinically proven copper chelator, on in-stent restenosis. Nine pigs were treated with TTM (5 mg/kg po) twice daily for 2 wk before stent implantation and for 4 wk thereafter, and nine pigs served as controls.

Copper chelation represses the vascular response to injury.

The induction of an acute inflammatory response followed by the release of polypeptide cytokines and growth factors from peripheral blood monocytes has been implicated in mediating the response to vascular injury. Because the Cu2+-binding proteins IL-1alpha and fibroblast growth factor 1 are exported into the extracellular compartment in a stress-dependent manner by using intracellular Cu2+ to facilitate the formation of S100A13 heterotetrameric complexes and these signal peptideless polypeptides have been implicated as regulators of vascular injury in vivo, we examined the ability of Cu2+ chelation to repress neointimal thickening in response to injury. We observed that the oral administration of the Cu2+ chelator tetrathiomolybdate was able to reduce neointimal thickening after balloon injury in the rat.

In vitro validation of volumetric blood flow measurement using Doppler flow wire.

Determination of any volumetric blood flow requires assessment of mean blood flow velocity and vessel cross-sectional area. For evaluation of coronary blood flow and flow reserve, however, assessment of average peak velocity alone is widely used, but changes in velocity profile and vessel area are not taken into account. We studied the feasibility of a new method for calculation of volumetric blood flow by Doppler power using a Doppler flow wire.

[Long-term results after successful mitral valvuloplasty: comparison of Inoue and double balloon technique].

Unlabelled: Mitral balloon valvuloplasty is the treatment of choice for severe mitral stenosis in young patients with a minimally calcified and pliable mitral valve. The present study reports the results of the first 65 patients undergoing mitral valvuloplasty in Zurich with the double-balloon or Inoue-balloon technique. Early outcome and late follow-up over 4.