Day 1 :
Keynote Forum
Ehud Baron
X-Cardio Corp. KK, Japan
Keynote: Cardiovascular health maps for health positioning and optimize interventions
Time : 9:15-10:00
Biography:
Ehud Baron was the Professor and Researcher in Technion at Israel Institute of Technology, Aalborg University, UC Berkeley and Stanford University. He was also a serial entrepreneur who served as a Chairman, President/CTO in Medical device companies like X-Cardio Corp. KK, Tokyo, GoldTech Sino-HK, Concardio, Inc., Cleveland and Heart Beat Technologies, Ltd., Israel and JV with LifeQ, SA, US, NL. He was also the Interventional Cardiologist at SHLV, St. Louis and Inventor of bifurcation stent that has 30 patents to his name. He serves as an Assistant Professor of Clinical Medicine in the Department of Medicine at Washington University School of Medicine.
Abstract:
Statement of the Problem: Several studies attempted to predict patient’s deterioration or progress using a combined score. However, since the combined score is just numeric value that combines many parameters, it does not provide the multidimensional health status or where to go from here, how to evaluate alternative treatments, etc. Medicine in general including cardiology, does not have one acceptable and explicit framework that defines the position of a patient in the cardiovascular health space, her/his target zone and paths (interventions) from the current position to the target. This makes it difficult to decide about the costs/benefits of each alternative treatment and even more to quantify effectiveness and visualize it in a way that both the doctor and the patient can understand it. According to this approach we use the BP pulse shape as indication to the cardiovascular status of the patient and create a continuous space spanned by its N dimensional features.
Method: The theoretical framework we suggest is that of fuzzy sets, where each patient get different level of membership in different pathological and healthy conditions i.e. we view health and sickness in different diseases as a continuous space, where subjects do not fall into one category or another but are points in this continuous space. Their position defines their health condition in a certain moment in time and changes dynamically with the interventions. The methodology was to do a multicenter study, record the BP pulse wave continuously over long periods of time and in parallel use continuous or frequent BP measurements. In one clinical study in Fresenius Kidney Care, St. Louis the trial was done on 14 patients, each patient had 2-4 sessions and each session was about of 4 hours. PPG (Photoplethysmogram) has been recorded continuously by a watch with finger optical sensor probe and compared to CNAP continuous hemodynamic monitor. In another clinical study done in a Calcutta hospital for hypertensive and diabetic patients, we used the same watch for continuous recording of PPG and use ABPM (Ambulatory Blood Pressure Monitoring) every 15 minutes for 24 hours on hypertensive and diabetic patients. In a third center in Meir Hospital in Israel, recording with the same watch was done during stress tests, where each 2 minutes BP is measured and ECG is measured continuously. Also, cardiac output has been measured in the beginning and end using echocardiography. Using 2-4 light wavelengths allowed us also to interrogate the capillary bed at different penetration levels to estimate features related to the microcirculation.
Findings: In all the three studies which provided tens of thousands BP measurements with simultaneous BP pulse shapes, we did fuzzy clustering algorithm we developed to cluster the pulse shapes in the N dimensional feature space and minimize dimensionality by looking for the smallest dimensionality space and its 2D projections. By doing it we discovered that different health conditions fell into different clusters. For example diabetics tended to fall into a cluster of their own, where the severity of the diabetic condition indicated the position between diabetic centroid and healthy subjects.
Conclusion: The finding concluded that different health conditions can be defined by the BP pulse shape clustering generates a continuous health space, cluster centroids that represent various pulse.
Keynote Forum
David F Kong
Duke Clinical Research Institute, USA
Keynote: Harmonization By Doing: Looking to the next decade
Time : 10:00-10:45
Biography:
David F Kong is an Associate Professor of Medicine at Duke University Medical Center and Co-Director of the Cardiovascular Devices Unit at the Duke Clinical Research Institute. An Interventional Cardiologist at Duke Hospital and a Faculty Member in the Duke Center for Healthcare Informatics, he specializes in cardiovascular informatics research and integration of evidence from cardiovascular clinical trials. He has completed his graduation in magna cum laude from Harvard University, where he also received a Master’s degree in Organismic and Evolutionary Biology. He has received his Medical degree from the Johns Hopkins University School of Medicine and was a Resident on the Osler Medical Service at the Johns Hopkins Hospital. He has completed his Fellowships in Cardiovascular Disease and Interventional Cardiovascular Medicine at Duke University before joining the Duke Faculty. He is board certified in Internal Medicine, Cardiology and Interventional Cardiology. He is a Certified Diver Medic, Master Diver and Dive Medical Examiner and has been elected Fellow of the American College of Cardiology and the Society for Cardiovascular Angiography and Interventions.
Abstract:
The US-Japan Medical Device Harmonization By Doing (HBD) program has enabled the US FDA, Japan PMDA, international regulators, academia, and industry to develop practical standards for global clinical trials. This has facilitated development of novel cardiovascular devices and helped overcome regulatory barriers that have historically delayed timely medical device approvals in both countries. The collaborative activity is expanding its scope to create additional synergies in global medical device development, particularly for early feasibility studies, non-cardiovascular therapeutic areas and pediatric medical device applications. Encouraging single global clinical trial protocols will facilitate device evaluation in both the US and Asia by improving the timeliness and cost-effective generation of more informative clinical datasets for pre-market, and potentially post market evaluation. This will reduce the data requirements for device development programs by reducing redundant data collection. For example, the Japanese Registry for Mechanically Assisted Circulatory Support (J-MACS) registry and the US Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) registry, both collect and analyze clinical and laboratory data from patients receiving mechanical circulatory support devices for end-stage heart failure. The complementary datasets in these registries provide valuable information for improving the treatment of advanced heart failure patients in both countries. Clinical trial programs, such as the HARMONEE (NCT02073565) and COAST (NCT02132611) trials, represent a new approach to evaluating efficacy and safety in a global environment. Future directions will extend these initiatives and their benefits to additional countries and facilitate patient access to new medical device technology worldwide.
Keynote Forum
Deepak Puri
Ivy Healthcare, India
Keynote: Cardiomersion: Balancing advancing technology with comprehensive cost effective cardiovascular management
Time : 11:15-12:00
Biography:
Deepak Puri is the former Director, Cardiovascular and Thoracic Surgery Max Super specialty Hospital Mohali and Additional Director Fortis Healthcare Mohali, Assistant Professor at PGIMER Chandigarh. He also has 65 publications in reputed international and national journals. He is the former Vice President, Chandigarh Surgical Society and IGMC alumni society, Convener Cardiovascular Sciences National Stem Cell Regenerative Medicine and Anti-aging Society, India. Editor in Chief CTVS and Reviewer for several reputed international journals. He is currently the Visiting Surgeon for Leipzig Heart Centrum Germany, Swedish Medical Center Seattle Washington, USA and University of Maryland Medical Center, Baltimore, USA. He is having experience of OPCAB surgeries in high risk patients like acute MI, ischemic heart failure and cardiogenic shock. He is interested in minimally invasive and cosmetic incisions for closure of septal defects, thymectomies, cardiac re-synchronization therapy, pericardectomies, PDA closure, valve, vascular, endovascular, thoracic surgeries and several own innovative techniques published in international journals. He has successfully repaired several penetrating cardiac injuries and he has also been a part of liver and renal transplant team.
Abstract:
Technological advances and improved surgical skills combined with better intensive care have improved outcome of
cardiovascular interventions in the last decade. Th is has necessitated for integrated approach involving team of cardiologists, cardiac surgeons, cardiac anesthesiologists, endocrinologists, nephrologists as well as community physicians for delivery of comprehensive care. Despite tremendous progress in management of cardiovascular diseases every year 17 million people die because of heart disease across the globe. Coronary artery disease has emerged as biggest threat and WHO has predicted India will be the coronary capital of the world by 2020. Although most interventions are safe, long term result are limited by the progression of disease and delayed treatment especially in acute coronary syndromes which can be responsible for high mortality and the increasing volumes of heart failure patients especially in regions located at far off distance from tertiary cardiovascular facilities. Although 80% of heart diseases are preventable this aspect is usually ignored by the patients as well as healthcare professionals. Prevention is the simplest and most cost-eff ective modality that plays major role in slowing progression of disease throughout life and includes primordial prevention, primary prevention and secondary prevention. Early diagnosis and prompt appropriate intervention improves immediate outcome as well as long term survival. We have a wide range of options in our armamentarium from percutaneous interventions to minimally invasive beating heart bypass, hybrid procedures, endovascular and robotic interventions and need to work in close coordination to deliver best possible prompt management judiciously using the advanced technology cost eff ectively and avoid complications. Wasteful and nonessential interventions can be avoided by making best use of prevention and medical management. Th e cost can be further minimized by having a highly skilled team willing to do multitasking and delivering their services at various centers as per need instead of having disproportionately large teams at each center where their services will remain underutilized. Cardiomersion promotes comprehensive cardiovascular care made cost eff ective by adopting integrated approach and utilizes the resources in a best possible way. Since 2011 we have delivered comprehensive cardiovascular services at more than 10 hospitals and the concept is expanding.
Keynote Forum
Ezzeldin A Mostafa
Ain Shams University Hospital, Egypt
Keynote: Comparative study between two devices of radio-frequency energy for bi-atrial maze operation for the treatment of long-standing atrial fibrillation: Prospective randomized trial
Time : 9:00AM to 6:00 PM
Biography:
Ezzeldin A Mostafa is an Emeritus Professor and Past HOD of Cardiovascular and Thoracic Surgery, Ain-Shams University Hospital, Faculty of Medicine, Cairo, Egypt. He is the Ex-Managing Director of Cardiac Surgery Academy, Ain-Shams University, Cairo, Egypt. He has Bachelor’s degree from Faculty of Medicine, Ain- Shams University (1976), MSc in General Surgery and then in Cardiology and Vascular Diseases (MCVD), and then his PhD (MD) in Thoracic and cardiovascular surgery (1984) and lastly MBA from ESLSCA (2010). He is a Member of the Society of Thoracic Surgery; the European Association of Cardio-Thoracic Surgery; the World Society of Pediatric Cardiology and Cardiac Surgery and the Egyptian Society of Cardio-Thoracic Surgery (ESCTS), etc. His major interests are neonatal and
pediatric cardiac surgery, mitral and aortic valve repair, Ebstein’s repair, dysrhythmia and maze surgery and health management by information system.
Abstract:
Background & Aim: The Electro Surgical Unit (ESU or Bovie) is a Radio Frequency (RF) generator and can be used to create surgical lesions, which cause interruption of the basic flutter cycle that initiates/maintains chronic permanent Atrial Fibrillation (AFib). The aim of the study is to evaluate the efficacy and efficiency of the bi-atrial electro-maze plus amiodarone in the management of chronic permanent AFib in mitral valve surgery and to compare between two sources of RF energy;
namely, ESU or bovie and RF devices.
Method: After approval of Local Ethics Committee and obtaining written informed consent, a prospective, comparative randomized study was conducted on 90 patients who were referred for mitral valve surgery with chronic AFib. They were divided into three groups. Group-1: 30 patients were submitted to bi-atrial RF maze and amiodarone protocol. Group-2: 30 patients were submitted to bi-atrial ESU or bovie maze and amiodarone protocol. Group-3: 30 patients were treated with amiodarone only. Patients were followed-up in the post-operative period at the following time intervals, 2 weeks, 3 months and 6 months.
Results: There was no mortality in any group. The aortic-cross clamp time, bypass time were slightly longer in the electro-maze groups, but without any statistical signifi cance. There was no statistical significance amongst the 3 groups as regard morbidity. There was an immediate intraoperative conversion to sinus rhythm in the 3 groups respectively (83.3%, 80% and 20%). Sinus rhythm has remained stable over 3-month duration in the 3 groups respectively (70%, 66.6% and 16.6%) and over a follow-up of 6-month duration (66.6%, 63.3% and 13.3%). In the electro-maze groups, there has been a signifi cant reduction in left atrial size.
Conclusion: The bi-atrial electro-maze protocol appears to be a simple, effective, and quick method to cure chronic permanent AFib. The ESU or bovie is as effective as radiofrequency device as a source of energy for ablation.