Day 1 :
Director of Research, Heart and Vascular Institute, USA
Keynote: The potential role of a unique, simple, quick, accurate, inexpensive, routine evaluation of Autonomic Nervous System (ANS) Sympathetic (S) and Parasympathetic (P) activity in cardiovascular diseases (CVD)
Time : 08:35-09:10
Gary L. Murray, M.D. received a Phi Beta Kappa Bachelor’s degree from Rhodes College, Memphis, TN, USA, receiving the Belk Bible Award for the most outstanding Bible student. After graduating from the Tulane University School of Medicine, New Orleans, LA, USA, his postdoctoral training was at the University of Tennessee Center of Health Care Sciences, Memphis, TN, USA. He became Co-Director of the Cardiac Catheterization as well as Nuclear Cardiology laboratories at Baptist Hospital, Memphis, TN, USA. He then became Chief of Medicine, Nellis AFB, North Las Vegas, NV, USA. Since, he has been in private practice in Memphis, yet he has managed to publish several articles and co-created the Shad-Murray first pass RNA exercise test for coronary disease that was employed at many centers in the USA and Europe. He participated in clinical trials of the first elective coronary stent, as well as the first coronary atherectomy and laser devices. His ANS studies have been cited in the new textbook on clinical autonomic disorders by Colombo. He has spoken in several countries worldwide He currently is Director of Research at the Heart and Vascular Institute, Germantown, TN, USA.
Evaluation of the important role the ANS plays in the development, progression, treatment, and prognosis of CVD has not been routine in clinical practice. However, new studies using a unique, easily applied technology have demonstrated the importance of ANS measures in the management of patients with risk factors for CVD, hypertension, orthostatic hypotension, congestive heart failure, and coronary disease. This new, unique technique and results of many studies will be discussed in detail. It is suggested that ANS measurement should be routinely used in CVD clinics, improving outcomes and lowering costs.
Chairman of Cardiac Department, St. Pau Hospital, Spain
Time : 09:10-09:45
Prof. Antonio Bayés de Luna has been full Professor of Cardiology of Autonomous University of Barcelona, and Chairman of Cardiac Department of St. Pau Hospital of Barcelona. He has been president of Catalan, Spanish, and World Heart Federation, and also president of International Society of Cardiovascular Pharmacotherapy (ISCP). He has received many awards, including “Metge de l’any” from Catalonia, “Médico del año” of Spain (two times), “Creu de Sant Jordi” award of Generalitat of Catalonia, and “Premio Jaime I” of Generalitat of Valencia. He has received 4 Honorius Cause, and is member of more than 20 National Societies of Cardiology. He has been very active scientifically having published some than 306 papers, and just in the last 20 years, he has achieved an in factor H of 32. The number of references is more of 5.000. He has published more than 20 books, 10 as unique author. His book Clinical Electrocardiography has been translated to 10 languages.
The patients with advanced interatrial block (A-IAB) (P≥120ms plus ± pattern in II, III and aVF) present more frequently atrial fibrillation (Bayes syndrome) and even stroke and dementia. The following considerations have to be considered: 1) AF is not the final cause of stroke; 2) Atrial fibrotic CM is the substrate of both AF and A-IAB; 3) There are many similarities between these two processes. Very often A-IAB is a precursor of AF and both may be considered mediators of stroke; 4) There is a clear evidence that A-IAB and AF are risk factors of stroke, and even dementia, and global, CV, and sudden death; 5) In a group of patients in SR (A-IAB) that are risk factors of AF and stroke, we have to perform a randomized to demonstrate the benefits to anticoagulate patients in SN without documented AF; 6) If this trial is positive, we have to establish a score of risk of stroke for patients in sinus rhythm to be used at a global level; 7) Until then, we can take decisions at individual level according to the careful observations of ECG (P-wave) and other parameters (CHA2DS2-V, ambiental arrhythmias, detection of fibrosis, etc).
- Bayés de Luna A, Cladellas M, Oter R, et al. Interatrial conduction block and retrograde activation of the Left Atrium and paroxysmal supraventricular tachyarrhythmia. Eur Heart J 1988; 9: 1112-1118.
- Bacharova L, Wagner GS. The time for naming the interatrial block Syndrome: Bayes Syndrome. J Electrocardiol 2015; 48:133-134.
- Martínez-Sellés M, Massó-van Roessel A, Álvarez-Garcia J, Garcia de la Villa B, Cruz-Jentoft A, Vidán MT, López J, Felix-Redondo FJ, Durán JM, Bayés-Genís A, Bayés de Luna A, (The Investigators of the Cardiac and Clinical Characterization of Centenarians (4C) registry). Interatrial block and atrial arrhythmias in centenarians: prevalence, associations, and clinical implications. Heart Rhythm 2016; 13: 645-651.
- Fabritz L. The power of P in the elderly: small biphasic wave, big impact. Heart Rhythm 2016; 13 (3): 653.
- Enriquez A, Sarrias A, Villuendas R, Ali FS, Conde D, Hopman WM, Redfearn DP, Michael K, Simpson C, De Luna AB, Bayes-Genis A, Baranchuk A. New-onset atrial fibrillation after cavotricuspid isthmus ablation: identification of advanced interatrial block is key. Europace 2015;17:1289-1293.
- Bayés de Luna A, Martínez-Sellés M, Bayés-Genís A, Elosua R, Baranchuk A. Surface ECG interatrial block-guided treatment for stroke prevention: rationale for an attractive hypothesis. BMC Cardiovascular Disorders 2017; 17: 211.
Director, Center for Personalized Medicine, Sechenov University, Russian Federation
Keynote: Personalized and translational medicine as a model of the healthcare services and armamentarium to get the model armed: Myth or the reality?
Time : 10:00-10:35
Sergey Suchkov was born in the City of Astrakhan, Russia, in a dynasty of medical doctors, graduated from Astrakhan State Medical University and was awarded with MD. Then he maintained his PhD and Doctor’s Degree and later was working for Helmholtz Eye Research Institute and Moscow Regional Clinical Research Institute (MONIKI). Dr. Suchkov was a Secretary-in-Chief of the Editorial Board, Biomedical Science, an international journal published jointly by the USSR Academy of Sciences and the Royal Society of Chemistry, UK. At present, Dr. Sergey Suchkov is: (i) a Director, Center for Personalized Medicine, Sechenov University, (ii) Chair, Dept for Translational Medicine, Moscow Engineering Physical University (MAPhI), and (iii) Secretary General, United Cultural Convention (UCC), Cambridge, UK. A Member of the: New York Academy of Sciences, American Chemical Society (ACS), American Heart Association (AHA), AMEE, Dundee, UK; EPMA, Brussels, EU; PMC, Washington, DC, USA and ISPM, Tokyo, Japan.
A new systems approach to diseased states and wellness result in a new branch in the healthcare services, namely, personalized medicine (PM). To achieve the implementation of PM concept into the daily practice including clinical cardiology, it is necessary to create a fundamentally new strategy based upon the subclinical recognition of bioindicators (biopredictors and biomarkers) of hidden abnormalities long before the disease clinically manifests itself.
Each decision-maker values the impact of their decision to use PM on their own budget and well-being, which may not necessarily be optimal for society as a whole. It would be extremely useful to integrate data harvesting from different databanks for applications such as prediction and personalization of further treatment to thus provide more tailored measures for the patients and persons-at-risk resulting in improved outcomes whilst securing the healthy state and wellness, reduced adverse events, and more cost effective use of health care resources. One of the most advanced areas in cardiology is atherosclerosis, cardiovascular and coronary disorders as well as in myocarditis. A lack of medical guidelines has been identified by the majority of responders as the predominant barrier for adoption, indicating a need for the development of best practices and guidelines to support the implementation of PM into the daily practice of cardiologists!
Implementation of PM requires a lot before the current model “physician-patient” could be gradually displaced by a new model “medical advisor-healthy person-at-risk”. This is the reason for developing global scientific, clinical, social, and educational projects in the area of PM to elicit the content of the new branch.
- T.A. Bodrova, D.S. Kostyushev, E.N. Antonova, Sh. Slavin, D.A. Gnatenko, M.O. Bocharova, M. Legg, P. Pozzilli, S.V..Suchkov. Introduction into PPPM as a new paradigm of public health service: an integrative view EPMA Journal, 2012, 3, 16, P. 3-16.
- Sergey Suchkov. Predictive, Preventive and Personalized Medicine (PPPM) as an integrative part of national healthcare services to move ahead In: Proceedings (Programme Book) of the ESBB Annual Meeting, Verona, Italy, October 8th-11th, 2013, P. 30-31, S-13.
- I.A. Sadkovsky, O. Golubnitschaja, M.A. Mandrik, M.A. Studne-va1, H. Abe, H. Schroeder, E.N. Antono-va, F.Betsou, T.A. Bodrova, K. Payne, S.V. Suchkov. PPPM (Predictive, Preventive and Personalized Medicine) as a New Model of the National and International Healthcare Services and Thus a Promising Strategy to Prevent a Disease: From Basics to Practice. International Journal of Clinical Medicine, 2014, 5, 855-870.
- Zemskov VM, Alekseev AA, Gnatenko DA, Kozlova MN, Shishkina NS, Zemskov AM, Zhegalova IV, Bleykhman DA, Bahov NI, Suchkov SV. Overexpression of Nitric Oxide Synthase Re-stores Circulating Angiogenic Cell Function in Patients With Coronary Artery Disease: Implications for Autologous Cell Therapy for Myocardial Infarction. The Journal of the American Heart Association, 2016, 5, 1-18.
- Zemskov, A., Zemskov, V., Zemskova, V., Buch, T., Cherno-va, L. Bleykhman, D., Marshall, T., Abe, H., Zhegalova, I., Barach, P. and Suchkov, S. A STEPWISE SCREENING PROTOCOL TO SECURE THE MODULE-BASED TREATMENT FOR MANAGING IMMUNOPATHOLOGY. International Journal of Information Research and Review, 2017, Vol. 04, Issue, 01, pp. 3507-3510.
Principal Reviewer, Office of Medical device, Pharmaceuticals and Medical Device Agency, Japan
Time : 10:35-11:10
Nobuhiro Handa, M.D. is presently the Principal Reviewer, Office of Medical device, Pharmaceuticals and Medical Device Agency, Japan. He completed his education from Nada, Junior and Senior High School in1979, then joined The University of Tokyo, College of Art and Science up to 1981. After that he completed his medical doctor degree from The University of Tokyo, Faculty of Medicine in March 1985. He did his hospital training from various institutes . He received Special Certificate as a certified physician for using Zenith AAA Endoprosthesis in Japan. He has society membership to The Japanese Surgical Society, The Japanese Association for Thoracic Surgery, The Japanese Society of Artificial Organs, The Japanese Society of Ultrasound in Medicine and The Japanese society for Heart and Lung Transplant.
The accumulation of real world data associated with medical devices, or a “Medical Device Registry”, plays an important role in promoting the development of medical devices. It is desirable to utilize registry data for pre-approval review as well as post-marketing safety measures. However, data has often been collected without compliance with a Good Clinical Practice. Furthermore, the registry may not include all data elements required for demonstrating the effectiveness and safety of medical devices. As such, it may not meet the regulatory requirements for pre-market review. Despite these limitations, there are many national registries, such as orthopedic total hip joint registries in multiple countries that have successfully detected the increased revision rate of metal on metal hip implant. In addition, there are several national registries in the European Union, US and Japan that include registries for artificial heart placement, trans-catheter aortic valve replacement and devices for peripheral arterial diseases. If registry is nationwide, it is an unbiased real world data for the country. The outputs of the analyses can be compared with registries in other countries if the findings are consistent between countries or not.
The current issues of registry management include ensuring a wide patient coverage, involvement of regulatory authority, implementing rules of data utilization by the manufacturer, regulators and the academic sector, and obtaining sustainable funding for registry management. In the presentation, we focus on the eight existing Nationwide Registries Associated with Cardiovascular Medical Devices in Japan and discuss their characteristics including data quality, data utilization and financial sustainability. Some of them were utilized for regulatory purposes. Early participation of regulators for developing a national registry and a system that assures accuracy of data seems to be a key element for their regulatory applications based on Japanese PMD-ACT. The cooperation between the academic sector, industry and regulatory bodies is essential for utilizing registry data efficiently.
Figure 1: Registry framework of Japan mechanically assisted circulatory support