2018 ESC/EACTS Guidelines on myocardial revascularization.

Authors/Task Force Members: Franz-Josef Neumann* (ESC Chairperson) (Germany), Miguel Sousa-Uva* (EACTS Chairperson) (Portugal), Anders Ahlsson (Sweden), Fernando Alfonso (Spain), Adrian P. Banning (UK), Umberto Benedetto (UK), Robert A. Byrne (Germany), Jean-Philippe Collet (France), Volkmar Falk (Germany), Stuart J. Head (The Netherlands), Peter Jüni (Canada), Adnan Kastrati (Germany), Akos Koller (Hungary), Steen D. Kristensen (Denmark), Josef Niebauer (Austria), Dimitrios J. Richter (Greece), Petar M. Seferovi c (Serbia), Dirk Sibbing (Germany), Giulio G. Stefanini (Italy), Stephan Windecker (Switzerland), Rashmi Yadav (UK), Michael O. Zembala (Poland) Document Reviewers: William Wijns (ESC Review Co-ordinator) (Ireland), David Glineur (EACTS Review Co-ordinator) (Canada), Victor Aboyans (France), Stephan Achenbach (Germany), Stefan Agewall (Norway), Felicita Andreotti (Italy), Emanuele Barbato (Italy), Andreas Baumbach (UK), James Brophy (Canada), Héctor Bueno (Spain), Patrick A. Calvert (UK), Davide Capodanno (Italy), Piroze M. Davierwala

/pdf/2014-esc-eacts-guidelines-on-myocardial-revascularization-3fr5n9jz36.pdf

2014 ESC/EACTS Guidelines on myocardial revascularization: The Task Force on Myocardial Revascularization of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS)Developed with the special contribution of the European Association of Percutaneous Cardiovascular Interventions (EAPCI).

Guidelines and Expert Consensus Documents summarize and evaluate all available evidence with the aim of assisting physicians in selecting the best management strategy for an individual patient suffering from a given condition, taking into account the impact on outcome and the risk–benefit ratio of diagnostic or therapeutic means. Guidelines are no substitutes for textbooks and their legal implications have been discussed previously. Guidelines and recommendations should help physicians to make decisions in their daily practice. However, the ultimate judgement regarding the care of an individual patient must be made by his/her responsible physician(s).

The recommendations for formulating and issuing ESC Guidelines and Expert Consensus Documents can be found on the ESC website (http://www.escardio.org/knowledge/guidelines/rules).

Members of this Task Force were selected by the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS) to represent all physicians involved with the medical and surgical care of patients with coronary artery disease (CAD). A critical evaluation of diagnostic and therapeutic procedures is performed including assessment of the risk–benefit ratio. Estimates of expected health outcomes for society are included, where data exist. The level of evidence and the strength of recommendation of particular treatment options are weighed and graded according to predefined scales, as outlined in Tables 1 and 2 .

View this table:

Table 1 
Classes of recommendations



View this table:

Table 2 
Levels of evidence



The members of the Task Force have provided disclosure statements of all relationships that might be perceived as real or potential sources of conflicts of interest. These disclosure forms are kept on file at European Heart House, headquarters of the ESC. Any changes in conflict of interest that arose during the writing period were notified to the ESC. The Task Force report received its entire financial support from the ESC and EACTS, without any involvement of the pharmaceutical, device, or surgical industry.

ESC …

/pdf/guidelines-on-myocardial-revascularization-the-task-force-on-3qs3gmu7h5.pdf

Guidelines on myocardial revascularization: The Task Force on Myocardial Revascularization of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS)

2017 ESC Guidelines on the Diagnosis and Treatment of Peripheral Arterial Diseases, in collaboration with the European Society for Vascular Surgery (ESVS) : Document covering atherosclerotic disease of extracranial carotid and vertebral, mesenteric, renal, upper and lower extremity arteries

/pdf/2017-esc-guidelines-on-the-diagnosis-and-treatment-of-2vt5ciu2yn.pdf

Guidelines and Expert Consensus Documents summarize and
evaluate all available evidence with the aim of assisting
physicians in selecting the best management strategy for an
individual patient suffering from a given condition, taking
into account the impact on outcome and the risk benefit
ratio of diagnostic or therapeutic means. Guidelines are no
substitutes for textbooks and their legal implications have
been discussed previously. Guidelines and recommendations should help physicians to make decisions in their daily
practice. However, the ultimate judgement regarding the
care of an individual patient must be made by his/her
responsible physician(s).
The recommendations for formulating and issuing ESC
Guidelines and Expert Consensus Documents can be found
on the ESC website (http://www.escardio.org/knowledge/
guidelines/rules).
Members of this Task Force were selected by the European
Society of Cardiology (ESC) and the European Association for
Cardio-Thoracic Surgery (EACTS) to represent all physicians
involved with the medical and surgical care of patients
with coronary artery disease (CAD). A critical evaluation
of diagnostic and therapeutic procedures is performed
including assessment of the risk benefit ratio. Estimates
of expected health outcomes for society are included,
where data exist. The level of evidence and the strength
of recommendation of particular treatment options are
weighed and graded according to predefined scales, as
outlined in Tables 1 and 2.
The members of the Task Force have provided disclosure
statements of all relationships that might be perceived as
real or potential sources of conflicts of interest. These
disclosure forms are kept on file at European Heart House,
headquarters of the ESC. Any changes in conflict of interest
that arose during the writing period were notified to the ESC.
The Task Force report received its entire financial support
from the ESC and EACTS, without any involvement of the
pharmaceutical, device, or surgical industry.
ESC and EACTS Committees for Practice Guidelines are
responsible for the endorsement process of these joint
Guidelines. The finalized document has been approved by all
the experts involved in the Task Force, and was submitted to
outside specialists selected by both societies for review. The
document is revised, and finally approved by ESC and EACTS and subsequently published simultaneously in the European
Heart Journal and the European Journal of Cardio-Thoracic
Surgery.
After publication, dissemination of the Guidelines is of
paramount importance. Pocket-sized versions and personal
digital assistant-downloadable versions are useful at the
point of care.
Some surveys have shown that the intended users are
sometimes unaware of the existence of guidelines, or simply
do not translate them into practice. Thus, implementation
programmes are needed because it has been shown that
the outcome of disease may be favourably influenced by the
thorough application of clinical recommendations.

Guidelines on myocardial revascularization.

Die Erfindung betrifft ein festes Rontgenkontrastmittel umfassend Microspharen fur die Darstellung des Gastrointestinaltraktes mit einem Hohlraumvolumen von mindestens 25% des Gesamtvolumens, wobei im Hohlraum mindestens ein Gas enthalten ist, und welches dadurch gekennzeichnet ist, dass die Microspharen in ein trockenes Bindemittel, eingebettet sind. Weiterhin betrifft die Erfindung die Herstellung dieses Rontgenkontrastmittels sowie dessen Verwendung.

Festes, negatives röntgenkontrastmittel zur darstellung des gastrointestinaltraktes

BACKGROUND
Although controversially discussed, paclitaxel is the only clinically proven drug that inhibits restenosis when released from drug-coated balloons (DCBs). Limus drugs are currently being explored as alternatives. The aim of the preclinical studies was to investigate drug candidates beyond paclitaxel considered for balloon coating.


METHODS
Drugs were tested with respect to dissolution in organic solvents, coating on balloons, and drug transfer to the vessel wall. Inhibition of neointimal proliferation was tested in the porcine model of coronary in-stent stenosis. Intravascular drug treatment was achieved by DCBs at the time of stent implantation.


RESULTS
Coating had to be adjusted for each drug. Doses on the balloons ranged from 1.0 to 8.6 μg/mm2 balloon surface. Satisfactory amounts of drug ranging from 5% to 29% of initial doses were transferred into the vessel wall. Angiographic parameters such as late lumen loss (LLL) at 4 weeks did not show reduction of in-stent neointimal proliferation by treatment with arsenic trioxide (0.87 ± 0.44 mm), betamethasone dipropionate (1.00 ± 0.54 mm), bortezomib (1.74 ± 0.46 mm), green tea extract (1.24 ± 0.51 mm), fantolon, an epothilone (0.86 ± 0.61 mm), methotrexate (1.09 ± 0.72 mm), and thalidomide (1.59 ± 0.55 mm) compared to treatment with uncoated balloons (1.07 ± 0.60 mm), while coatings with paclitaxel reliably reduced in-stent stenosis (LLL = 0.36 ± 0.25 mm).


CONCLUSIONS
Despite the proven antiproliferative and/or anti-inflammatory effect of the drugs, none of the coatings significantly reduced LLL compared to uncoated balloons and thus, based on the results presented here, none of the tested coatings may be considered a substitute for the paclitaxel-based coatings currently in clinical use.

Drug-Coated Balloons: Drugs Beyond Paclitaxel?

Die Erfindung betrifft nekrose-affine Verbindungen und ihre Verwendung zur Herstellung von Praparaten zur Pharmakotherapie.

Nekrose-affine Verbindungen und ihre Verwendung zur Herstellung von Präparaten zur Pharmakotherapie

Formulations de revêtement améliorées pour strier ou découper des cathéters à ballonnet

The starting point of percutaneous transluminal coronary angioplasty was defined by Andreas Gruntzig in 1977 [1]. He developed the novel technique of revascularization and established a new speciality – interventional cardiology. Since that time, interventionalists have been confronted with the problems of vessel recoil during the procedure and restenosis within the first 6 months of balloon angioplasty. In spite of progress in some indications, in others these challenges have lost nothing of their significance, motivating investigators to pursue their research efforts with a view to finding new strategies for overcoming these difficulties. Stents proved to be a significant advance in reducing the frequency of restenosis by eliminating elastic recoil and negative remodeling at the treatment site [2]. However, neointimal proliferation is not prevented by stenting, and thus in-stent restenosis became a ‘new’ disease, especially in some patient populations such as diabetics or in certain lesions such as bifurcation, long lesions, lesions in small vessels, total occlusions and diffuse disease [3]. The systemic administration of anti-inflammatory, antiproliferative, anticlotting or other agents before or after balloon dilatation was shown to effectively reduce neointimal hyperplasia in animal models. Clinical use in humans, however, failed to result in adequate restenosis prevention [4]. The advent of drug-eluting stents (DESs) marked a decisive advance, enabling direct transfer of drugs to the target site and prolonged exposure of the vessel wall. Sirolimus and paclitaxel were shown to be effective pharmacological inhibitors of neointimal hyperplasia in vitro and in vivo [5,6]. Stents coated with these agents were successfully used in both the coronary arteries [7] and below the knee [8]. By contrast, use of these stents were not found to be superior to bare-metal stents in femoral and popliteal arteries or in patients with severe diffuse disease and long, complicated lesions [9]. The occurrence of late stent thrombosis, caused by incomplete endothelization of the stent struts and an inflammatory response to the polymer matrix, considerably limited the use of DES [10,11]. Coating paclitaxel onto the surface of conventional percutaneous transluminal coronary angioplasty balloon catheters with a new coating technique that provides immediate drug release upon inflation was a new approach to preventing restenosis without having to implant a stent. The drug is transferred to the dilated segment when the balloon is inflated. An effective local drug concentration is achieved with very low systemic exposure. Paclitaxel admixed to a small amount of the hydrophilic x-ray contrast medium iopromide (Ultravist) emerged as a very effective coating matrix from numerous in vitro and in vivo experiments investigating different coating techniques, the adhesion of paclitaxel to the balloon surface while the catheter is advanced to the lesion, and the release of the active agent into the vessel wall during balloon expansion [12,13]. Balloon catheters coated in this way have a paclitaxel dose of 3 μg/mm of balloon surface and are marketed as Paccocath (Bayer Schering Pharma AG, Germany). 1Department of Radiology, Charite – Universitatsmedizin Berlin, Chariteplatz 1, 10117 Berlin, Germany 2Clinic for Internal Medicine III, Cardiology, Angiology and Intensive Care, University Hospital of Saarland, Homburg/Saar, Germany †Author for correspondence: Tel.: +49 304 5053 9076 Fax: +49 304 5052 7993 E-mail: beatrix.schnorr@charite.de

Ulrich Speck

Papers

Festes, negatives röntgenkontrastmittel zur darstellung des gastrointestinaltraktes

Drug-Coated Balloons: Drugs Beyond Paclitaxel?

Nekrose-affine Verbindungen und ihre Verwendung zur Herstellung von Präparaten zur Pharmakotherapie

Formulations de revêtement améliorées pour strier ou découper des cathéters à ballonnet

Drug-eluting balloons: where are we and what are the problems?