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- Ali, Ziad A., et al.
(författare)
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Optical Coherence Tomography Characterization of Coronary Lithoplasty for Treatment of Calcified Lesions : First Description
- 2017
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Ingår i: JACC: Cardiovascular Imaging. - : Elsevier BV. - 1936-878X. ; 10:8, s. 897-906
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Tidskriftsartikel (refereegranskat)abstract
- Objectives This study sought to determine the mechanistic effects of a novel balloon-based lithoplasty system on heavily calcified coronary lesions and subsequent stent placement using optical coherence tomography (OCT). Background The Shockwave Coronary Rx Lithoplasty System (Shockwave Medical, Fremont, California) delivers localized, lithotripsy-enhanced disruption of calcium within the target lesion (i.e., lithoplasty) for vessel preparation before stent implantation. Methods We analyzed OCT findings in 31 patients in whom lithoplasty was used to treat severely calcified stenotic coronary lesions. Results After lithoplasty, intraplaque calcium fracture was identified in 43% of lesions, with circumferential multiple fractures noted in >25%. The frequency of calcium fractures per lesion increased in the most severely calcified plaques (highest tertile vs. lowest tertile; p = 0.009), with a trend toward greater incidence of calcium fracture (77.8% vs. 22.2%; p = 0.057). Post-lithoplasty, mean acute area gain was 2.1 mm2, which further increased with stent implantation, achieving a minimal stent area of 5.94 ± 1.98 mm2 and mean stent expansion of 112.0 ± 37.2%. Deep dissections, as part of the angioplasty effect, occurred in 13% of cases and were successfully treated with stent implantation without incidence of acute closure, slow flow/no reflow, or perforation. Conclusions High-resolution imaging by OCT delineated calcium modification with fracture as a major mechanism of action of lithoplasty in vivo and demonstrated efficacy in the achievement of significant acute area gain and favorable stent expansion.
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- Byrne, Robert A., et al.
(författare)
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Report of a European Society of Cardiology-European Association of Percutaneous Cardiovascular Interventions task force on the evaluation of coronary stents in Europe : executive summary
- 2015
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Ingår i: European Heart Journal. - : Oxford University Press (OUP). - 0195-668X .- 1522-9645. ; 36:38, s. 2608-2620
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Tidskriftsartikel (refereegranskat)abstract
- 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 (Appendix 1 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.
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- Komajda, Michel, et al.
(författare)
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Relations between professional medical associations and the health-care industry, concerning scientific communication and continuing medical education: a Policy Statement from the European Society of Cardiology.
- 2012
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Ingår i: European Heart Journal. - : Oxford University Press. - 0195-668X .- 1522-9645. ; 33:5, s. 666-674
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Tidskriftsartikel (refereegranskat)abstract
- Physicians have an ethical duty to keep up-to-date with current knowledge. Professional medical associations such as the European Society of Cardiology (ESC) support these obligations. In Europe, the costs of continuing medical education (CME) are insufficiently supported from governments and employers; however, medical associations have been criticized for accepting alternative financial support from industry. Medical education and training in research include learning how to assess the quality and reliability of any information. There is some risk of bias in any form of scientific communication including intellectual, professional, and financial and it is essential that in particular, the latter must be acknowledged by full disclosure. It is essential that there is strong collaboration between basic and clinical researchers from academic institutions on the one hand, with engineers and scientists from the research divisions of device and pharmaceutical companies on the other. This is vital so that new diagnostic methods and treatments are developed. Promotion of advances by industry may accelerate their implementation into clinical practice. Universities now frequently exhort their academic staff to protect their intellectual property or commercialize their research. Thus, it is not commercial activity or links per se that have become the target for criticism but the perceived influence of commercial enterprises on clinical decision-making or on messages conveyed by professional medical organizations. This document offers the perspective of the ESC on the current debate, and it recommends how to minimize bias in scientific communications and CME and how to ensure proper ethical standards and transparency in relations between the medical profession and industry.
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- Kristensen, Steen D., et al.
(författare)
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Reperfusion therapy for ST elevation acute myocardial infarction 2010/2011 : current status in 37 ESC countries
- 2014
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Ingår i: European Heart Journal. - : Oxford University Press (OUP). - 0195-668X .- 1522-9645. ; 35:29, s. 1957-1970
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Tidskriftsartikel (refereegranskat)abstract
- Aims Primary percutaneous coronary intervention (PPCI) is the preferred reperfusion therapy in ST-elevation myocardial infarction (STEMI). We conducted this study to evaluate the contemporary status on the use and type of reperfusion therapy in patients admitted with STEMI in the European Society of Cardiology (ESC) member countries. Methods and results A cross-sectional descriptive study based on aggregated country-level data on the use of reperfusion therapy in patients admitted with STEMI during 2010 or 2011. Thirty-seven ESC countries were able to provide data from existing national or regional registries. In countries where no such registries exist, data were based on best expert estimates. Data were collected on the use of STEMI reperfusion treatment and mortality, the numbers of cardiologists, and the availability of PPCI facilities in each country. Our survey provides a brief data summary of the degree of variation in reperfusion therapy across Europe. The number of PPCI procedures varied between countries, ranging from 23 to 884 per million inhabitants. Primary percutaneous coronary intervention and thrombolysis were the dominant reperfusion strategy in 33 and 4 countries, respectively. The mean population served by a single PPCI centre with a 24-h service 7 days a week ranged from 31 300 inhabitants per centre to 6 533 000 inhabitants per centre. Twenty-seven of the total 37 countries participated in a former survey from 2007, and major increases in PPCI utilization were observed in 13 of these countries. Conclusion Large variations in reperfusion treatment are still present across Europe. Countries in Eastern and Southern Europe reported that a substantial number of STEMI patients are not receiving any reperfusion therapy. Implementation of the best reperfusion therapy as recommended in the guidelines should be encouraged.
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- Noc, Marko, et al.
(författare)
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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
- 2014
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Ingår i: EuroIntervention. - 1969-6213. ; 10:1, s. 31-37
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Tidskriftsartikel (refereegranskat)abstract
- 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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