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Scientific documents

Position papers and consensus documents on Interventional Cardiology - published and/or endorsed by the EAPCI

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Papers published by the EAPCI

Dual antiplatelet therapy duration after coronary stenting in clinical practice: results of an EAPCI survey - See more at: http://www.pcronline.com/eurointervention/84th_issue/volume-11/number-1/11/dual-antiplatelet-therapy-duration-after-coronary-stenting-in-clinical-practice-results-of-an-eapci-survey.html#sthash.ZrwirHKF.dpuf

Assessing the cardiology community position on transradial intervention and the use of bivalirudin in patients with acute coronary syndrome undergoing invasive management: results of an EAPCI survey

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Marianna Adamo; Robert A. Byrne; Andreas Baumbach; Michael Haude; Stephan Windecker; Marco Valgimigli
EuroIntervention 2016;12:1154-1163 published online ahead of print December 2015
Pii:EIJ-D-15-00044
Doi: 10.4244/EIJY15M12_01. [Epub ahead of print]
PubMed PMID:26674737

Aims: Our aim was to report on a survey initiated by the European Association of Percutaneous Cardiovascular Interventions (EAPCI) collecting the opinion of the cardiology community on the invasive management of acute coronary syndrome (ACS), before and after the MATRIX trial presentation at the American College of Cardiology (ACC) 2015 Scientific Sessions.
Methods and results: A web-based survey was distributed to all individuals registered on the EuroIntervention mailing list (n=15,200). A total of 572 and 763 physicians responded to the pre- and post-ACC survey, respectively. The radial approach emerged as the preferable access site for ACS patients undergoing invasive management with roughly every other responder interpreting the evidence for mortality benefit as definitive and calling for a guidelines upgrade to class I. The most frequently preferred anticoagulant in ACS patients remains unfractionated heparin (UFH), due to higher costs and greater perceived thrombotic risks associated with bivalirudin. However, more than a quarter of participants declared the use of bivalirudin would increase after MATRIX.
Conclusions: The MATRIX trial reinforced the evidence for a causal association between bleeding and mortality and triggered consensus on the superiority of the radial versus femoral approach. The belief that bivalirudin mitigates bleeding risk is common, but UFH still remains the preferred anticoagulant based on lower costs and thrombotic risks.

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Dual antiplatelet therapy duration after coronary stenting in clinical practice: results of an EAPCI survey

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Marco Valgimigli; Francesco Costa; Robert Byrne; Michael Haude; Andreas Baumbach; Stephan Windecker
EuroIntervention 2015 May;11(1):68-74
Doi:10.4244/EIJV11I1A11
PubMed PMID: 25982650

Aims: Our aim was to report on a survey initiated by the European Association of Percutaneous Cardiovascular Interventions (EAPCI) concerning opinion on the evidence relating to dual antiplatelet therapy (DAPT) duration after coronary stenting.
Methods and results: Results from three randomised clinical trials were scheduled to be presented at the American Heart Association Scientific Sessions 2014 (AHA 2014). A web-based survey was distributed to all individuals registered in the EuroIntervention mailing list (n=15,200) both before and after AHA 2014. A total of 1,134 physicians responded to the first (i.e., before AHA 2014) and 542 to the second (i.e., after AHA 2014) survey. The majority of respondents interpreted trial results consistent with a substantial equipoise regarding the benefits and risks of an extended versus a standard DAPT strategy. Two respondents out of ten believed extended DAPT should be implemented in selected patients. After AHA 2014, 46.1% of participants expressed uncertainty about the available evidence on DAPT duration, and 40.0% the need for clinical guidance.
Conclusions: This EAPCI survey highlights considerable uncertainty within the medical community with regard to the optimal duration of DAPT after coronary stenting in the light of recent reported trial results. Updated recommendations for practising physicians to guide treatment decisions in routine clinical practice should be provided by international societies.

Article posted on PCRonline website (requires log in)

Motivations for and barriers to choosing an interventional cardiology career path: results from the EAPCI Women Committee worldwide survey

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Piera Capranzano; Vijay Kunadian; Josepa Mauri; Anna Sonia Petronio; Neus Salvatella; Yolande Appelman; Martine Gilard; Ghada W. Mikhail; Stefanie Schüpke; Maria D. Radu; Beatriz Vaquerizo; Patrizia Presbitero; Marie-Claude Morice; Julinda Mehilli
EuroIntervention 2016;12:53-59 published online ahead of print July 2015

Motivations for and barriers to choosing an interventional cardiology career path: results from the EAPCI Women Committee worldwide surve - See more at: http://www.pcronline.com/eurointervention/98th_issue/volume-12/number-1/09/motivations-for-and-barriers-to-choosing-an-interventional-cardiology-career-path-results-from-the-eapci-women-committee-worldwide-survey.html#sthash.21lebVIn.dpuf

Aims: Very few women become interventional cardiologists, although a substantial proportion of cardiologists and the majority of medical students are women. In accordance with the EAPCI Women Committee mission of attaining gender equality at the professional level, a worldwide survey was recently conducted aiming to understand better the motivations and the barriers for women in selecting interventional cardiology (IC) as a career path.
Methods and results: A total of 1,787 individuals (60.7% women) responded to the survey. Women compared to men were less frequently married (women vs. men, 57.0% vs. 79.8%, p<0.001) and more frequently childless (46.6% vs. 20.5%, p<0.002). The most prevalent reason for choosing IC was passion (83.3% vs. 76.1%, p=0.12), while those for not choosing were, sequentially, lack of opportunity (29.0% vs. 45.7%), radiation concerns (19.9% vs. 11.6%) and preference (16.2% vs. 29.5%), p<0.001. According to 652 men replying to why, in their opinion, women do not choose IC, on-calls and long working hours were the most frequent reasons (35.3%).
Conclusions: Several barriers preclude women from choosing IC, including lack of opportunity, concerns regarding radiation exposure and the prejudices of their male colleagues. This highlights the need to develop new strategies for future training, education, and support of women in order to choose IC.

Article posted on PCRonline website (requires log in)

Appraising the safety and efficacy profile of left atrial appendage closure in 2016 and the future clinical perspectives. Results of the EAPCI LAAC survey

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Andrea Santucci; Robert A. Byrne; Andreas Baumbach; Roisin Colleran; Michael Haude; Stephan Windecker; Marco Valgimigli
EuroIntervention 2016;12:112-118

Aims: The aim of this study was to determine the opinion of the scientific community regarding percutaneous left atrial appendage closure (LAAC). The main focus of the survey was on concerns and expectations regarding the safety and efficacy profile of LAAC in clinical practice and on current and future clinical perspectives.

Methods and results: A voluntary web-based survey was distributed by the European Association of Percutaneous Coronary Interventions (EAPCI) to all individuals registered on the EuroIntervention mailing list (n=21,800). A total of 724 physicians responded to the survey, of whom 31.8% had first operator experience with LAAC. Exclusive use of the Amulet (34.4%) or WATCHMAN (30.3%) was similar, but the former was the most frequently used device in Europe. The majority of respondents (59.3%) deemed LAAC to be as effective as, but safer than oral anticoagulants (OAC) in reducing stroke risk. Periprocedural complications (40.3%) and cost (28.8%) were the major concerns. Most practitioners did not consider novel oral anticoagulants (NOACs) to be a deterrent for performing LAAC procedures. Moreover, a history of serious haemorrhage was not deemed necessary to justify LAAC for 59.8% of physicians.

Conclusions: The results of this survey reveal a high level of confidence in percutaneous LAAC amongst surveyed interventional cardiologists, with the majority believing it to be as effective as OAC in terms of stroke prevention and safer in terms of bleeding risk.

- See more at: http://www.pcronline.com/eurointervention/98th_issue/volume-12/number-1/19/appraising-the-safety-and-efficacy-profile-of-left-atrial-appendage-closure-in-2016-and-the-future-clinical-perspectives-results-of-the-eapci-laac-survey.html#sthash.s1ud6m1i.dpuf

Aims: The aim of this study was to determine the opinion of the scientific community regarding percutaneous left atrial appendage closure (LAAC). The main focus of the survey was on concerns and expectations regarding the safety and efficacy profile of LAAC in clinical practice and on current and future clinical perspectives.
Methods and results: A voluntary web-based survey was distributed by the European Association of Percutaneous Coronary Interventions (EAPCI) to all individuals registered on the EuroIntervention mailing list (n=21,800). A total of 724 physicians responded to the survey, of whom 31.8% had first operator experience with LAAC. Exclusive use of the Amulet (34.4%) or WATCHMAN (30.3%) was similar, but the former was the most frequently used device in Europe. The majority of respondents (59.3%) deemed LAAC to be as effective as, but safer than oral anticoagulants (OAC) in reducing stroke risk. Periprocedural complications (40.3%) and cost (28.8%) were the major concerns. Most practitioners did not consider novel oral anticoagulants (NOACs) to be a deterrent for performing LAAC procedures. Moreover, a history of serious haemorrhage was not deemed necessary to justify LAAC for 59.8% of physicians.
Conclusions: The results of this survey reveal a high level of confidence in percutaneous LAAC amongst surveyed interventional cardiologists, with the majority believing it to be as effective as OAC in terms of stroke prevention and safer in terms of bleeding risk.

Article posted on PCRonline website (requires log in)

European expert consensus on rotational atherectomy

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Emanuele Barbato; Didier Carrié; Petros Dardas; Jean Fajadet; Georg Gaul; Michael Haude; Ahmed Khashaba; Karel Koch; Markus Meyer-Gessner; Jorge Palazuelos; Krzysztof Reczuch; Flavio L. Ribichini; Samin Sharma; Johann Sipötz; Iwar Sjögren; Gabor Suetsch; György Szabó; Mariano Valdés-Chávarri; Beatriz Vaquerizo; William Wijns; Stephan Windecker; Adam de Belder
This document is endorsed by the EAPCI.
EAPCI Scientific Documents Committee: Marco Valgimigli; Robert A. Byrne
EAPCI Review co-ordinator: Antonio Colombo
Document reviewers: Carlo Di Mario; Azeem Latib; Christian Hamm

Summary: The interest in rotational atherectomy (RA) has increased over the past decade as a consequence of more complex and calcified coronary stenoses being attempted with percutaneous coronary interventions. Yet adoption of RA is hampered by several factors: amongst others, by the lack of a standardised protocol. This European expert consensus document stems from the awareness of the large heterogeneity in the protocols adopted to perform rotational atherectomy. The objective of the present document is to provide some points of consensus among highly experienced operators on the most controversial steps of RA in an attempt to build the basis of a standardised and universally accepted protocol.

Article posted on PCRonline website (requires log in)

Report of a European Society of Cardiology-European Association of Percutaneous Cardiovascular Interventions task force on the evaluation of coronary stents in Europe

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Robert A. Byrne, Patrick W. Serruys, Andreas Baumbach, Javier Escaned, Jean Fajadet, Stefan James, Michael Joner, Semih Oktay, Peter Ju, Adnan Kastrati, George Sianos, Giulio G. Stefanini, William Wijns and Stephan Windecker

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Summary:  The evaluation for European Union market approval of coronary stents falls under the Medical Device Directive that was adopted in 1993. Specific requirements for the assessment of coronary stents are laid out in supplementary advisory documents. In response to a call by the European Commission to make recommendations for a revision of the advisory document on the evaluation of coronary stents (Appendix1 of MEDDEV 2.7.1), the European Society of Cardiology (ESC) and the European Association of Percutaneous Cardiovascular Interventions (EAPCI) established a Task Force to develop an expert advisory report. As basis for its report, the ESC-EAPCI Task Force reviewed existing processes, established a comprehensive list of all coronary drug-eluting stents that have received a CE mark to date, and undertook a systematic review of the literature of all published randomized clinical trials evaluating clinical and angiographic outcomes of coronary artery stents between 2002 and 2013. Based on these data, the TF provided recommendations to inform a new regulatory process for coronary stents. The main recommendations of the task force include implementation of a standardized non-clinical assessment of stents and a novel clinical evaluation pathway for market approval. The two-stage clinical evaluation plan includes recommendation for an initial pre-market trial with objective performance criteria (OPC) benchmarking using invasive imaging follow-up leading to conditional CE-mark approval and a subsequent mandatory, large-scale randomized trial with clinical endpoint evaluation leading to unconditional CE-mark. The data analysis from the systematic review of the Task Force may provide a basis for determination of OPC for use in future studies. This paper represents an executive summary of the Task Force’s report.

Cardiac arrhythmias in acute coronary syndromes: position paper from the joint EHRA, ACCA, and EAPCI task force

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Bulent Gorenek, Carina Blomström Lundqvist, Josep Brugada Terradellas, A. John Camm, Gerhard Hindricks, Kurt Huber, Paulus Kirchhof,
Karl-Heinz Kuck, Gulmira Kudaiberdieva, Tina Lin, Antonio Raviele, Massimo Santini, Roland Richard Tilz, Marco Valgimigli, Marc A. Vos, Christian Vrints, Uwe Zeymer.
Document Reviewers: Gregory Y.H. Lip, Tatjania Potpara, Laurent Fauchier, Christian Sticherling, Marco Roffi, Petr Widimsky, Julinda Mehilli, Maddalena Lettino, Francois Schiele, Peter Sinnaeve, Giueseppe Boriani, Deirdre Lane, Irene Savelieva.
EuroIntervention 2014;10-online publish-ahead-of-print August 2014

EHRA/EAPCI expert consensus statement on catheter-based left atrial appendage occlusion

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Bernhard Meier, Yuri Blaauw, Ahmed A. Khattab, Torsten Lewalter, Horst Sievert, Claudio Tondo, Michael Glikson.
Document Reviewers: Gregory Y. H. Lip, Jose Lopez-Minguez, Marco Roffi, Carsten Israel, Dariusz Dudek, Irene Savelieva
EuroIntervention 2014;10-online publish-ahead-of-print August 2014

Invasive coronary treatment strategies for out-of-hospital cardiac arrest: A consensus statement from the European Association for Percutaneous Cardiovascular Interventions (EAPCI)/Stent for Life (SFL) groups

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Marko Noc, MD; Jean Fajadet, MD; Jens F. Lassen, MD; Petr Kala, MD; Philip MacCarthy, MD; Goran K. Olivecrona, MD; Stephan Windecker, MD; Christian Spaulding, MD
EuroIntervention 2014;10:31-37

Summary: Due to significant improvement in the pre-hospital treatment of patients with out-of-hospital cardiac arrest (OHCA), an increasing number of initially resuscitated patients are being admitted to hospitals. Because of the limited data available and lack of clear guideline recommendations, experts from the EAPCI and “Stent for Life” (SFL) groups reviewed existing literature and provided practical guidelines on selection of patients for immediate coronary angiography (CAG), PCI strategy, concomitant antiplatelet/anticoagulation treatment, haemodynamic support and use of therapeutic hypothermia. Conscious survivors of OHCA with suspected acute coronary syndrome (ACS) should be treated according to recommendations for ST-segment elevation myocardial infarction (STEMI) and high-risk non-ST-segment elevation -ACS (NSTE-ACS) without OHCA and should undergo immediate (if STEMI) or rapid (less than two hours if NSTE-ACS) coronary invasive strategy. Comatose survivors of OHCA with ECG criteria for STEMI on the post-resuscitation ECG should be admitted directly to the catheterisation laboratory. For patients without STEMI ECG criteria, a short “emergency department or intensive care unit stop” is advised to exclude non-coronary causes. In the absence of an obvious non-coronary cause, CAG should be performed as soon as possible (less than two hours), in particular in haemodynamically unstable patients. Immediate PCI should be mainly directed towards the culprit lesion if identified. Interventional cardiologists should become an essential part of the “survival chain” for patients with OHCA. There is a need to centralise the care of patients with OHCA to experienced centres.

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Consensus document on the radial approach in percutaneous cardiovascular interventions: A position paper by the European Association of Percutaneous Cardiovascular Interventions and Working Groups on Acute Cardiac Care and Thrombosis of the European Society of Cardiology

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Martial Hamon; Christian Pristipino; Carlo Di Mario; James Nolan; Josef Ludwig; Marco Tubaro; Manel Sabate; Josepa Mauri Ferre; Kurt Huber; Kari Niemela; Michael Haude; William Wijns; Dariusz Dudek; Jean Fajadet; Ferdinand Kiemeneij
International experts: Gerald Barbeau, Shigeru Saïto, Sanjit Jolly, Yves Louvard, Tejas Patel, Sunil V. Rao, Nicolaus Reifart, Philippe Gabriel Steg, OrazioValsecchi, Yuejin Yang
EuroIntervention 2013;8-online publish-ahead-of-print January 2013

Summary: Radial access use has been growing steadily but, despite these encouraging results, still varies greatly between operators, hospitals, countries and continents. Twenty years from its introduction, it was felt that time had come to develop a common evidence-based view on the technical, clinical and organisational complications of using the radial approach for coronary angiography and interventions. The European Association of Percutaneous Cardiovascular Interventions (EAPCI) has, therefore, appointed a core group of European and non-European experts, including pioneers of radial angioplasty and operators with different practices in vascular access supported by experts nominated by the Working Groups on Acute Cardiac Care and Thrombosis of the European Society of Cardiology (ESC). Their goal was to define the role of the radial approach in modern interventional practice and give advice on technique, training needs, and optimal clinical indications.

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Papers endorsed by the EAPCI

Percutaneous left atrial appendage occlusion: the Munich consensus document on definitions, endpoints and data collection requirements for clinical studies

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Apostolos Tzikas; David R. Holmes Jr; Sameer Gafoor; Carlos E. Ruiz; Carina Blomström-Lundqvist; Hans-Christoph Diener; Riccardo Cappato; Saibal Kar; Randal J. Lee; Robert A. Byrne; Reda Ibrahim; Dhanunjaya Lakkireddy; Osama I. Soliman; Michael Näbauer; Steffen Schneider; Johannes Brachman; Jeffrey L. Saver; Klaus Tiemann; Horst Sievert; A. John Camm; Thorsten Lewalter

EuroIntervention 2016;12:103-111

The increasing interest in left atrial appendage occlusion (LAAO) for ischaemic stroke prevention in atrial fibrillation (AF) fuels the need for more clinical data on the safety and effectiveness of this therapy. Besides an assessment of the effectiveness of the therapy in specific patient groups, comparisons with pharmacological stroke prophylaxis, surgical approaches and other device-based therapies are warranted. This paper documents the consensus reached among clinical experts in relevant disciplines from Europe and North America, European cardiology professional societies and representatives from the medical device industry regarding definitions for parameters and endpoints to be assessed in clinical studies. Adherence to these definitions is proposed in order to achieve a consistent approach across clinical studies on LAAO among the involved stakeholders and various clinical disciplines and thereby facilitate continued evaluation of therapeutic strategies available. - See more at: http://www.pcronline.com/eurointervention/98th_issue/volume-12/number-1/18/percutaneous-left-atrial-appendage-occlusion-the-munich-consensus-document-on-definitions-endpoints-and-data-collection-requirements-for-clinical-studies.html#sthash.460t1DHA.dpuf

Summary: The increasing interest in left atrial appendage occlusion (LAAO) for ischaemic stroke prevention in atrial fibrillation (AF) fuels the need for more clinical data on the safety and effectiveness of this therapy. Besides an assessment of the effectiveness of the therapy in specific patient groups, comparisons with pharmacological stroke prophylaxis, surgical approaches and other device-based therapies are warranted. This paper documents the consensus reached among clinical experts in relevant disciplines from Europe and North America, European cardiology professional societies and representatives from the medical device industry regarding definitions for parameters and endpoints to be assessed in clinical studies. Adherence to these definitions is proposed in order to achieve a consistent approach across clinical studies on LAAO among the involved stakeholders and various clinical disciplines and thereby facilitate continued evaluation of therapeutic strategies available.

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The appropriate and justified use of medical radiation in cardiovascular imaging

A position document of the ESC Associations of Cardiovascular Imaging, Percutaneous Cardiovascular Interventions and Electrophysiology

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Author: Picano, E., Vano, E., Rehani, M. M., Cuocolo, A., Mont, L., Bodi, V., Bar, O., Maccia, C., Pierard, L., Sicari, R., Plein, S., Mahrholdt, H., Lancellotti, P., Knuuti, J., Heidbuchel, H., Di Mario, C., Badano, L. P.
Eur Heart J
DOI: doi/10.1093/eurheartj/eht394

Summary: The benefits of cardiac imaging are immense, and modern medicine requires the extensive and versatile use of a variety of cardiac imaging techniques. Cardiologists are responsible for a large part of the radiation exposures every person gets per year from all medical sources. Therefore, they have a particular responsibility to avoid unjustified and non-optimized use of radiation, but sometimes are imperfectly aware of the radiological dose of the examination they prescribe or practice. This position paper aims to summarize the current knowledge on radiation effective doses (and risks) related to cardiac imaging procedures. We have reviewed the literature on radiation doses, which can range from the equivalent of 1–60 milliSievert (mSv) around a reference dose average of 15 mSv (corresponding to 750 chest X-rays) for a percutaneous coronary intervention, a cardiac radiofrequency ablation, a multidetector coronary angiography, or a myocardial perfusion imaging scintigraphy. We provide a European perspective on the best way to play an active role in implementing into clinical practice the key principle of radiation protection that: ‘each patient should get the right imaging exam, at the right time, with the right radiation dose’.

Management of Antithrombotic Therapy in Atrial Fibrillation Patients Presenting With Acute Coronary Syndrome and/or Undergoing Percutaneous Coronary Intervention / Stenting

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A Consensus Document of the European Society of Cardiology Working Group on Thrombosis, endorsed by the European Heart Rythym Association [EHRA] and the European Association of Percutaneous Cardiovascular Interventions [EAPCI]
Gregory Y.H.Lip, Kurt Huber, Felicita Andreotti, Harald Arnesen, K. Juhani Airaksinen, Thomas Cuisset, Paulus Kirchhof, Francisco Marin
Thromb Haemost 2009; 102
Summary: there remains uncertainty over optimal antithrombotic management strategy for patients with atrial fibrillation (AF) presenting with an acute coronary syndrome and/or undergoing percutaneous coronary intervention/stenting. Clinicians need to balance the risk of stroke and thromboembolism against the risk of recurrent cardiac ischaemia and/or stent thrombosis, and the risk of bleeding. This consensus document comprehensively reviews the published evidence and presents a consensus statement on a "best practice" antithrombotic therapy guideline for the management of antithrombotic therapy such as AF patients.