Five-year clinical outcome of multicenter randomized trial comparing amphilimus - with paclitaxel-eluting stents in de novo native coronary artery lesions.

Objectives: Long-term data from randomized studies on polymer-free stents are scarce. Long-term data of Cre8 amphilimus eluting stent are still not available. We sought to investigate contribution of a polymer-free design versus a permanent-polymer one on the long-term.

Facilitated Data Relay and Effects on Treatment of Severe Aortic Stenosis in Europe.

Background Many patients with severe aortic stenosis are referred late with advanced symptoms or inappropriately denied intervention. The objective was to investigate whether a structured communication to referring physicians (facilitated data relay) might improve the rate and timeliness of intervention. Methods and Results A prospective registry of consecutive patients with severe aortic stenosis at 23 centers in 9 European countries with transcatheter as well as surgical aortic valve replacement being available was performed.

Symptoms, disease severity and treatment of adults with a new diagnosis of severe aortic stenosis.

Objective: Contemporary data on patients with previously undiagnosed severe aortic stenosis (AS) are scarce. We aimed to address this gap by gathering data from consecutive patients diagnosed with severe AS on echocardiography.

Methods: This was a prospective, multicentre, multinational, registry in 23 tertiary care hospitals across 9 European countries.

A multicenter post-marketing evaluation of the Elixir DESolve Novolimus-eluting bioresorbable coronary scaffold system: First results from the DESolve PMCF study.

Objectives: To date, experience with bioresorbable scaffolds (BRS) that elute agents other than everolimus is limited. Thus, a post-marketing clinical follow-up study was conducted to evaluate the continued safety and effectiveness of the DESolve® NOVOLIMUS™ Eluting BRS as treatment for patients with stable coronary artery disease.

Background: The DESolve BRS combines a poly-l-lactide-based backbone with a biodegradable polylactide-based polymer and Novolimus, a macrocyclic lactone mTOR inhibitor.

The role of echocardiography and CT angiography in transcatheter aortic valve implantation patients.

The transcatheter aortic valve implantation (TAVI) consist an alternative treatment in patients with severe aortic stenosis. Multimodality imaging using transthoracic echocardiography (TTE) or transesophageal echocardiography (TOE) and multislice CT (MSCT) constitute cornerstone techniques for the pre-operative management, peri-procedural guidance, follow up and recognition of possible transcatheter valve related complications. CT angiography is much more accurate regarding the total definition of aortic annulus diameter and circumferential area.

Prospective Multicenter Evaluation of the Direct Flow Medical Transcatheter Aortic Valve System: 12-Month Outcomes of the Evaluation of the Direct Flow Medical Percutaneous Aortic Valve 18F System for the Treatment of Patients With Severe Aortic Stenosis (DISCOVER) Study.

Objectives: The aim of this study was to assess the 1-year outcome after transcatheter aortic valve replacement (TAVR) of the Direct Flow Medical (DFM) valve in patients with severe symptomatic aortic stenosis who were contraindicated or high risk for surgery.

Background: The DFM transcatheter heart valve is a new-generation, nonmetallic aortic valve with a pressurized support structure and conformable double-ring annular sealing delivered through an 18-F sheath. The device allows repositioning, retrieval, and assessment of valve performance before permanent implantation.

Reducing Patient Radiation Dose With Image Noise Reduction Technology in Transcatheter Aortic Valve Procedures.

X-ray radiation exposure is of great concern for patients undergoing structural heart interventions. In addition, a larger group of medical staff is required and exposed to radiation compared with percutaneous coronary interventions. This study aimed at quantifying radiation dose reduction with implementation of specific image noise reduction technology (NRT) in transcatheter aortic valve implantation (TAVI) procedures.

Transcatheter valve-in-ring implantation of a repositionable valve system for treatment of severe mitral regurgitation.

Introduction: Years after mitral valve surgery, progressive degeneration of reconstructed mitral valves or bioprostheses might lead to severe mitral valve regurgitation. Patients with significant comorbidity, or impaired left ventricular function are poor candidates for redo surgery at an acceptable risk at that later time point.

Methods And Results: This study reports the first-in-man transapical valve-in-ring implantations in the mitral position of the fully repositionable Lotus valve system approved for transcatheter aortic valve replacement in Europe.

Use of a balloon-expandable transfemoral sheath in a TAVI cohort with complex access site - a propensity score matched analysis.

Aims: In patients undergoing transcatheter aortic valve implantation (TAVI), the high prevalence of peripheral artery disease (PAD) limits femoral access and increases vascular complications that are associated with mortality and morbidity. Our study assessed the ability of a balloon-expandable large-bore vascular sheath to increase access-site availability and to reduce vascular complications.

Methods And Results: Among 257 patients from two centres, 43 patients underwent transfemoral TAVI with the use of the SoloPath balloon-expandable sheath due to complex iliofemoral access anatomy.

Fifteen-year experience with carotid artery stenting (from the carotid artery stenting-registry of the Arbeitsgemeinschaft Leitende Kardiologische Krankenhausärzte).

To date only sparse data are available on trends and changes in indications, patient's characteristics, and clinical outcome of patients undergoing carotid artery stenting (CAS) in clinical practice. From February 1996 to December 2010, 6,116 CAS procedures were performed in 5,976 patients at 36 hospitals within the prospective, multicenter CAS registry of the Arbeitsgemeinschaft Leitende Kardiologische Krankenhausärzte. Median age of patients was 71 years, 71.

Use of drug-eluting stents in acute myocardial infarction with persistent ST-segment elevation: results of the ALKK PCI-registry.

Background: Drug-eluting stents (DES) reduce the rate of in-stent restenosis (ISR) and target vessel revascularization significantly when compared with bare metal stents (BMS). Their beneficial effects have been demonstrated in patients with acute myocardial infarction also, but the use of DES in the latter population seems to be still limited in clinical practice.

Methods And Results: From January 2006 to December 2011, 25,424 patients with ST-elevation myocardial infarction were enrolled in the German ALKK PCI-registry.

Comparison of the effectiveness of transcatheter aortic valve implantation in patients with stenotic bicuspid versus tricuspid aortic valves (from the German TAVI Registry).

Patients with bicuspid aortic valves (BAVs) are considered a relative contraindication to transcatheter aortic valve implantation (TAVI). One of the main reasons is the presumed risk for residual aortic regurgitation (AR). However, case reports and small case series have suggested that TAVI can be successfully performed with acceptable clinical outcomes in high-risk patients with BAV.

Prospective multicenter evaluation of the direct flow medical transcatheter aortic valve.

Objectives: The study sought a prospective multicenter nonrandomized evaluation of the Direct Flow Medical (DFM) system for the treatment of severe aortic stenosis.

Background: The DFM transcatheter aortic valve system is a nonmetallic design with a pressurized support structure that allows precise positioning, retrieval, and assessment of valve performance prior to permanent implantation.

Methods: One hundred high surgical risk patients with severe aortic stenosis were evaluated for the primary endpoint.

Intra-aortic balloon pump in patients with acute myocardial infarction complicated by cardiogenic shock: results of the ALKK-PCI registry.

Aims: The recommendation for the use of the intra-aortic balloon pump (IABP) as adjunct in patients with cardiogenic shock undergoing primary PCI in current guidelines is controversial. We sought to investigate the use and impact of the outcome of IABP in current practice of percutaneous coronary interventions in Germany.

Methods And Results: Between January 2006 and December 2011, a total of 55,008 consecutive patients with acute coronary syndromes undergoing PCI in 41 hospitals were enrolled into the prospective Arbeitsgemeinschaft Leitende Kardiologische Krankenhausärzte registry.

Age-stratified baseline and outcome characteristics of patients undergoing transcatheter aortic valve implantation: results from the German multicenter registry.

Objectives: To analyze age dependencies in patients currently undergoing transcatheter aortic valve implantation (TAVI) based on the German TAVI registry.

Background: TAVI is a promising, less invasive treatment option for surgical high-risk patients with symptomatic aortic valve stenosis, with the majority being octogenarians treated so far. Younger patients with significant co-morbidities are now increasingly considered for this procedure, but little is known about this population.

The impact of peripheral arterial disease on early outcome after transcatheter aortic valve implantation: results from the German Transcatheter Aortic Valve Interventions Registry.

Background: A significant proportion of patients undergoing transcatheter aortic valve implantation (TAVI) have concomitant peripheral arterial disease (PAD), which plays a crucial role in the preinterventional selection process of determining an optimal vascular access site. The aim of our study was to determine the impact of PAD on clinical outcome after TAVI in a real-world setting.

Methods: A total of 1,315 patients (mean logistic European System for Cardiac Operative Risk Evaluation 20.

Age-related differences in diagnosis, treatment and outcome of acute coronary syndromes: results from the German ALKK registry.

Aims: The elderly constitute an increasing proportion of all patients with acute coronary syndromes (ACS). However, increased age has been identified as an important risk factor for adverse events and complications of ACS and treatment. The purpose of this study was to investigate age-related differences in presentation and diagnostics, as well as contemporary treatment and outcome in a large series of elderly patients receiving an invasive strategy for ACS.

A multicenter randomized trial comparing amphilimus- with paclitaxel-eluting stents in de novo native coronary artery lesions.

Objectives: This study sought to demonstrate the noninferiority of polymer-free amphilimus-eluting stents (Cre8, CID, Saluggia, Italy) versus permanent-polymer paclitaxel-eluting stents (Taxus Liberté, Boston Scientific, Natick, Massachusetts) in de novo percutaneous coronary intervention.

Background: Although the efficacy of the drug-eluting stent has been well established, the risk-benefit balance is still suboptimal, and the safety of polymers remains uncertain.

Methods: Patients undergoing percutaneous coronary intervention for de novo lesions were randomly assigned 1:1 to Cre8 or Taxus Liberté stents.

Carotid artery stenting in clinical practice: does sex matter? Results from the carotid artery stenting registry of the Arbeitsgemeinschaft Leitende Kardiologische Krankenhausärzte (ALKK).

Background: Carotid artery stenting (CAS) is increasingly used for treatment of severe carotid artery stenosis, but only few procedural risk factors for complications of CAS are clearly defined yet. A possible impact of the patient's gender on the outcome of patients undergoing CAS has not been investigated properly and only little information about this topic is available so far.

Methods: We analysed data of the German prospective, multicenter CAS Registry of the Arbeitsgemeinschaft leitende kardiologische Krankenhausärzte.

Coronary stenting with MGuard: extended follow-up of first human trial.

Objectives: To evaluate feasibility and safety of MGuard based percutaneous coronary interventions (PCI) in vein grafts (VG) and native coronaries (NC).

Background: Distal embolization is a frequent complication of PCI of VG and NC during acute coronary syndromes (ACS). MGuard was a stent designed to reduce embolization.

Contemporary success and complication rates of percutaneous coronary intervention for chronic total coronary occlusions: results from the ALKK quality control registry of 2006.

Aims: Despite successful prevention of lesion recurrence by drug-eluting stents (DES), and the advancement in procedural techniques in the treatment of chronic total coronary occlusions (CTO), the number of CTOs treated by percutaneous coronary intervention (PCI) is still low as compared to their prevalence. This study aims to assess the outcome of PCI for CTOs in a contemporary survey of PCI in interventional centres in Germany.

Methods And Results: The basis of this analysis is the 2006 quality assessment database of PCI conducted by the ALKK (working group of cardiology centres).