Day 1 :
Heart and Vascular Institute- Germantown & International College of Angiology, USA
Keynote: The potential role of a unique, simple, quick, accurate, inexpensive, routine evaluation of autonomic nervous system sympathetic (S) and parasympathetic (P) activity in cardiovascular diseases
Time : 08:35-09:10
Gary L Murray received a Phi Beta Kappa Bachelor’s degree from Rhodes College, Memphis, USA. He received Belk Bible Award for the most outstanding Bible student. After graduating from Tulane University School of Medicine, New Orleans, USA, his Post-doctoral training was at University of Tennessee Center of Health Care Sciences, Memphis, USA. He became Co-director of Cardiac Catheterization as well as Nuclear Cardiology laboratories at Baptist Hospital, Memphis, USA. He then became Chief of Medicine, North Las Vegas, 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 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 is currently Director of Research at Heart and Vascular Institute, Germantown, USA.
Evaluation of the important role of autonomic nervous system (ANS) plays in the development, progression, treatment and prognosis of cardiovascular diseases (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.
Autonomous University of Barcelona & St. Pau Hospital, Spain
Time : 09:10-09:45
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 is member of more than 20 national societies of cardiology. He has published 306 papers, and just in the last 20 years, he has achieved H factor 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: AF is not the final cause of stroke; atrial fibrotic CM is the substrate of both AF and A-IAB; 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; there is a clear evidence that A-IAB and AF are risk factors of stroke, and even dementia, and global, CV, and sudden death; 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 anti-coagulate patients in SN without documented AF; 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; 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.).
1. Bacharova L and Wagner G S (2015) The time for naming the inter-atrial block syndrome: Bayes Syndrome. J Electrocardiol
2. Martínez-Sellés M, Massó-van Roessel A, Álvarez-Garcia J, Garcia de la Villa B, Cruz-Jentoft A, Vidán M T, López J, Felix-Redondo F J, Durán J M, Bayés-Genís A, Bayés de Luna A (2016) The investigators of the Cardiac and Clinical Characterization of Centenarians (4C) registry; inter-atrial block and atrial arrhythmias in centenarians: prevalence, associations, and clinical implications. Heart Rhythm 13:645-651.
3. Fabritz L (2016) The power of P in the elderly: small biphasic wave, big impact. Heart Rhythm 13(3):653.
4. Enriquez A, Sarrias A, Villuendas R, Ali F S, Conde D, Hopman W M, Redfearn D P, Michael K, Simpson C, De Luna A B, Bayes-Genis A and Baranchuk A (2015) New-onset atrial fibrillation after cavotricuspid isthmus ablation: identification of advanced inter-atrial block is key. Europace 17:1289-1293.
5. Bayés de Luna A, Martínez-Sellés M, Bayés-Genís A, Elosua R and Baranchuk A (2017) Surface ECG inter-atrial blockguided treatment for stroke prevention: rationale for an attractive hypothesis. BMC Cardiovascular Disorders 17:211.
Sechenov University, Russia
Keynote: Personalized and translational medicine as a model of the healthcare services and armamentarium to get the model armed: Myth or the reality?
Time : 09:45-10:20
Sergey Suchkov completed his Graduation from Astrakhan State Medical University; MD and PhD. He worked for Helmholtz Eye Research Institute and Moscow Regional Clinical Research Institute (MONIKI). He 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, he is Director at Center for Personalized Medi-cine, Sechenov University; Chair in the Department for Translational Medicine, Moscow En-gineering Physical University (MAPhI) and; Secretary General at United Cultural Convention (UCC), Cambridge, UK. He is 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 bio-indicators (bio-predictors and biomarkers) of hidden abnormalities long before the disease clinically mani-fests 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 ad-visor-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 new branch.
1. T A Bodrova, D S Kostyushev, E N Antonova, Sh Slavin, D A Gnatenko, M O Bo-charova, M Legg, P Pozzilli and S V Suchkov (2012) Introduction into PPPM as a new paradigm of public health service: an integrative view. EPMA Journal 3(16):3-16.
2. I A Sadkovsky, O Golubnitschaja, M A Mandrik, M A Studne-va, H Abe, H Schroeder, E N Antono-va, F Betsou, T A Bodrova, K Payne and S V Suchkov (2014) Predictive, Preventive and Personalized Medicine (PPPM) 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 5:855-870.
3. Zemskov V M, Alekseev A A, Gnatenko D A, Kozlova M N, Shishkina N S, Zemskov A M, Zhegalova I V, Bleykhman D A, Bahov N I and Suchkov S V (2016) 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 5:1-18.
4. Zemskov A, Zemskov V, Zemskova V, Buch T, Cherno-va L, Bleykhman D, Marshall T, Abe H, Zhegalova I, Barach P and Suchkov S (2017) A stepwise screening protocol to secure the module-based treatment for managing immunopathology. International Journal of Information Research and Review 4(1):3507-3510.
Pharmaceuticals and Medical Devices Agency, Japan
Time : 10:20-10:55
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 postmarketing
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