A novel drug-coated scoring balloon for the treatment of coronary in-stent restenosis: Results from the multi-center randomized controlled PATENT-C first in human trial

ACKGROUND:Scoring balloons produce excellent acute results in the treatment of in-stent restenosis (ISR), fibro-calcific and bifurcation lesions but have not been shown to affect the restenosis rate. A novel paclitaxel-coated scoring balloon (SB) was developed and tested to overcome this limitation.METHODS AND RESULTS:SB were coated with paclitaxel admixed with a specific excipient. Patients at four clinical sites in Germany and one in Brazil with ISR of coronary bare metal stent (BMS) were randomized 1:1 to treatment with either a drug-coated or uncoated SB. Baseline and 6-month follow-up quantitative coronary angiography was performed by an independent blinded core lab and all patients will be evaluated clinically for up to one year. The primary endpoint was angiographic in-segment late lumen loss (LLL). Secondary endpoints included the rate of clinically driven target lesion revascularization (TLR), composite of major adverse cardiovascular events (MACE), stent thrombosis and other variables. Sixty-one patients were randomized (28 uncoated and 33 drug-coated SB); mean age 65 years, males 72%, and presence of diabetes 39%. At 6-month angiography, in-segment LLL was 0.48 ± 0.51 mm in the uncoated SB group versus 0.17 ± 0.40 mm in the drug-coated SB group (P = 0.01; ITT analysis). The rate of binary restenosis was 41% in the uncoated SB group versus 7% in the drug-coated SB group (P = 0.004). The MACE rate was 32% with the uncoated SB vs. 6% in the drug-coated SB group (P = 0.016). This difference was primarily due to the reduced need for clinically driven TLR in the coated SB group (3% vs. 32% P = 0.004)...

[ESC guidelines on the management of valvular heart disease. What has changed and what is new?]. / ESC-Leitlinien zu Herzklappenerkrankungen. Was ist neu und anders?

In 2012 the new and collaborative "Guidelines on the management of valvular heart disease (version 2012)" were published by the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS). These guidelines emphasize that decision-making in patients with valvular heart disease should ideally be carried out by a"heart team" with particular expertise in valvular heart disease. In aortic regurgitation pathologies of the aortic root are frequent and in patients with Marfan syndrome, surgery is indicated when the maximal ascending aortic diameter is ≥50 mm, while the threshold for intervention should be lower in patients with risk factors for progression. Regarding aortic stenosis, transcatheter aortic valve implantation (TAVI) should be performed only in hospitals with on-site cardiac surgery and with a"heart team" available to assess patient risks. The TAVI procedure is indicated in patients with severe symptomatic aortic stenosis who are judged by the"heart team" to be unsuitable for surgery but have sufficient life expectancy. It should be considered for high-risk patients with severe symptomatic aortic stenosis based on the individual risk profile assessed by the"heart team". Furthermore, low flow - low gradient aortic stenosis with normal ejection fraction and the difficult topic of asymptomatic severe aortic stenosis and the indications for aortic valve replacement are discussed. With respect to mitral regurgitation, valve repair should be the preferred technique when it is expected to be durable. The topics of asymptomatic mitral regurgitation as well as percutaneous mitral valve repair using the edge to edge technique as an alternative for high risk patients are discussed. Tricuspid disease should not be forgotten and during left-sided valve surgery, tricuspid valve surgery should be considered in the presence of mild to moderate secondary regurgitation if there is significant annular dilatation. Last but not least, in patients with aortic bioprostheses the use of low-dose aspirin is now favored for a 3-month postoperative period.

Echocardiography in transcatheter aortic valve implantation.

Transcatheter aortic valve implantation (TAVI) has become a feasible and effective therapeutic option for patients with severe aortic stenosis and high operative risk or relative contraindications for surgical aortic valve replacement (SAVR). Patient selection plays a crucial role in the success of TAVI. Echocardiography is a mainstay during the whole process starting with the very important morphological evaluation and accurate measurement of the aortic root, followed by guiding the procedure and detecting possible complications, and ending with serial assessment of the patient's heart and the implanted prosthesis. This present article reviews the role of echocardiography before, during, and after transcatheter aortic valve implantation.

Left atrial appendage closure devices. Their role in 2013.

Stroke prevention is the major goal in treating patients with atrial fibrillation. Warfarin therapy, if used appropriately, is highly effective in preventing thromboembolic events, but is simultaneously burdened by a narrow therapeutic window, multiple food and drug interactions, and a substantial bleeding risk. New pharmacological agents show only a modest reduction of bleeding complications compared to warfarin. Percutaneous device left atrial appendage (LAA) closure has now been technologically advanced as an additional and potential alternative to pharmacotherapy in patients with AF. Promising randomized data are obtainable with the WATCHMAN® device, while several other devices are in various stages of clinical and preclinical development. In this article we review the current knowledge and status of this technique.