Healthcare analytics, AI solutions for biological big data, providing an AI platform for the biotech, life sciences, medical and pharmaceutical industries, as well as for related technological approaches, i.e., curation and text analysis with machine learning and other activities related to AI applications to these industries.
CV/metabolic disorders comprise aggregates of many niche diseases that may be targeted with therapies against specific molecular alterations, yet the final potential markets are much larger. This model creates challenges for both drug development and patient care with implications for initial indication selection and design and execution of clinical trials – from first-in-human through post marketing studies.
SVP, Global Head of Regenerative Medicine Unit, Head of Scientific Affairs, Japan, Takeda
Stem Cells Skin cells or blood cells and converted to other cells
development of Cell-based therapy for Cardiac myocytes: propiatory method to purify myocytes
In Japan, Cardiac transplant in very small cases – Alternative for Heart Transplant for HF – development of gene therapy and stem cell converted to myocytes
Govenrment initiative to develop regenerative medicine, procedure can be improved,
approval for EF improval – conditional Approval given by Government on 100 patients
Severe HF — cell therapy and procedure is consider
Osaka University, cell transplantatio – in Acadedmic Center
If efficacy and safety — continuous improvement – inject the cell be applied to more patient beyond CVD applications
Post approval registry, call patient back every few month, HF continuos Monitoring
Tools to make the Patient the center of the Trial and engaged
Information arrives in Real Time with Analytics – value derived from Dashboard design
Multidimensional Data
Definition of Disease – not as a point once a year but continual
Real Time monitoring, deep IT design, each Patient has own Portal, monitoring takes major resources, Large Informatics companies, screen ECG of huge populations
FDA interested in NEW tools, data that comes from individual
Biomarkers: Biosignals broader, connection Genomics and physiology – Neurlology
CVD – BP druds and QT prolongation
User-centric Design – Patient-center, data infrastructure for MDs
2016 – three drug studies CVD and DM – Insulin: (1) Post market on Safety, (2) Preapproval assessement (3) Insulin study assess data without compromising the continuation of the study (CVRT)
Engaging Patients and Investigators – Global Trials varies by Regions – Global Experts, Local Experts and RN as Coordinators — worked very well
CVD Outcome Trials – engaging patients
Intermediate Analysis: conduct and protect the Intermediate results no disclosure till Trial is completed
Identify the right site id a challenge
Multiple pathway related to CVD – Biomarkers difficult to find as insightful
In Israel data integrity is the highest
Innovative Medical Initiative – Novo, Lilly, Sanofi — DM data comparison
Cardiovascular trials have a proud history of providing some of the most robust data in evidence-based medicine. However the growing size and complexity of these trials imperils their future. This panel will discuss the design and implementation of clinical studies globally, considering strategies for patient access, leveraging electronic health records and mobile device data, personalized medicine, regulatory implications, cost containment and management of relationships with global service providers.
Large Cohort studies: Framingham Study, 1958 – CVD Risk for: Policy: Lowering BP and Cholesterol
CVD hot areas
Value-based Care
Gary Gibbons, MD – Public Service, appointed by NIH Director, not by the President
Director, NHLBI
Enabling other the pursuit of Science for Public Good
Ecosystem – the Government arm –
ROI – funds Projects
KI – New Program – funding PIs – investigators initiatives – Next generation of Scholars
50% of KI converts to ROI
Reduction in CVD is an ROI in research in CVD Biology and Drug development and Devices
2018 NIH Funding – last two years increase in budget, cuts may or may not occur
Opportunity to reinvent Longitudinal Cohort Studies with insertion of Genomics sequencing – 7,000 Whole Genome – target 100,000
Concepts of Data Commons – Sharing ONE resource for distributed Analytics: Reusability, interoperability, API
CVD – portfolio to include Minority Population disease prevalent
Translation of Science, concept mechanism
Epigenomics and Patho-biology DB and changes over time -a rare resource
Science is to be done for the Public Good, commonwealth of the entire nation – Accessibility of Genome Data after the National goal of sequencing the Genome
20% investigators take up 50% of the grants and squeeze out the younger generation
Pragmatic optimist in this position, scientists innovate for Patients
Explore the evolving role of adipose tissue as an active endocrine organ and discuss the possibilities to discover novel signaling pathways relevant to cardiovascular health and viable druggable targets.
Global VP, Cardiovascular, Renal and Metabolism AstraZeneca
Renal condition CKD
CVD
comorbidity
Drug perspective: White fat in not inert, signalling
combination of drug
compounds that have impact on CV system
Three Barriers: (1) Science, (2) access to medicines (3) holistic approach: Nephrology needs to use DM drugs, Cardiologist other drugs than cardiac drugs
Discussion on unique aspects of cardiometabolic market in Japan, its projected trend over the next 5 years and explore transformative models of open innovation to accelerate development of new therapeutic options.
Balancing acceptable answers to high and escalating drug prices in the United States while making strides in medical innovation. Leaders in innovation, policy, care delivery, academia, and insurance discuss potential collaborative solutions.
Pricing of Pharmaceutical in last 10 years, “List price” and the “Net Price” collected by Pharma has widen,
high deductable plans are prevalent 40%-50% – out of pocket cost increased
backlog of generic drugs – it takes 36 month to approve vs 12 month of non-generic
Value-based pay, drug is only one enabler in MDs tool kit
Out of pocket cost: Exposure is largest on the drug-side, that is preventive to avoid hospitalization
Unfair pricing leading to not be active in certain markets, Price control outside the US, take position on Importation, not disrable to import drugs into the US, we do not wish drug shortage around the world, Canada is a Small market US is a huge market
FDA on Oncology drug-device, potential exists for existing drugs
Continue to do Clinical Trials in the US, claims orientations exacerbation, describe the benefit
Evolution of mitral disease management, current practice and impact of new technologies on both repair and replacement, implications of a heterogeneous patient population, triage, timing of intervention.
State of the Art, Mitral regurgitation and degenerative Mitral valve: mechanism and elements responsible for regurgitation, repair of Annuals vs replacement of the valve.
Options at different stage of the disease
Functional Mitral Regurgitation: care pathways, compounding effects, two little too late
AF can cause Valve dilatation and regurgitation
Treatment, patient less symptomatic
HTN cause of LV systolic disfunction – treated first – improve the Mitral regurgitation
Mechanism under pinning in the decision process, CLinical Trials – Device may not work for all patients in the Study
leaflet condition dealt in repair strategy vs device selection
Having devices focus the clinical pathways for therapeutic options, TAILORING OF DEVICES TO SPECIFIC STRUCTURAL CONDITION OF THE HEART
60,000 procedures in the US vs. 2.4 million patients with the MR condition
Percutanious is an opportunity not to damage the heart, challenge, how to attach to the heart and how much regorgitation to get clinical benefit, optimal benefit to patient: Multiple products are in development
Aortic stenosis: we learned which patient will benefit, clinical studies, cost effective, two companies validated the approach
Mitral Valve is in early stage Trans catheter is the direction
CVD opportunities: Science and commercial – Heart disease, tools of Human genetics for drug development in CVD: REPATA a molecule targeting PCSK9 – variant on gene associated with LDL Pathways – genetic clue
Innovation in Human genetics new sequencing technologies allowed to see disease in Human populations, disease and pathways
Aging associated with risks of CVD, How we pay for innovative therapies?
Benefit from innovation – 800,000 in US have a stroke every year $60 Billion treatment for patient of CVD
Value of innovation at a price that allows access and lowering cost of care
Cardiologist prescribed the medication for himself it took 6 month for insurance to approve
Utilization management – move to innovative technologies if current therapies do not work
Pay for benefit and for outcome, no pay if med does not do what it was supposed to do – refund patients
focus on right patient get access. if LDL is so high – the therapy is there – the payers, enable access
Access challenge: Discount, Rebates, Co-pay assistance to access therapy as REPATA at $5 a day value is high,
A single payer is the Government in other countries
Future at Amgen: Potential for Innovation to improve Medicine, paying for innovation needs to be strainten
Coming drug is Pharmcogenetics for atherosclerosis
Awarded to one BWH and one MGH First Look participant who embodies the innovative, entrepreneurial, and visionary spirit of cardiovascular legends W. Gerald Austen, MD and Eugene Braunwald, MD. Granted based on select criteria, including overall presentation quality, innovativeness, commercial potential, caliber of disruption, and market need.
A 125 year company, shade lighting business to focus of Healthcare, global challenge a goal in Humanity for solution, services, products
R&D diagnostics, Informatics to integrate data
Africa and India – emerging markets with infant mortality high — develop a clinic as franchise for every price point
shift from Products to Cloud-based solutions – Prevention, Diagnostics, @Home care: Neuro, Cancer, CVD
Academic Institutions: Karlinska in Sweden – Stroke solution in partnership with Philips
Affordability, maximum of the technology, partnership with Industry consultants, does not work everywhere, took in house the Services part and developed algorithms to assist MDs in interpretation of radiological data
Patient monitoring 24×7 in ICUs,
eICU – measure evolution to forcast 6 hours in advance a deterioration – highest performance, reduction 40% of death by insight from data
Complex diseases created enormous data,
Measuring progression of AM – AI algorithms for a digital platform
Data integration, oncology patients: Genomics, Pathology, Clinical Data Scientist,
R&D will be co-creation with clinical validation and publication for Market adoption
Head of Radiology across several Hospitals – Better Outcomes Operations improvement due to technology
Rural Africa market connected to a Hospital in a city — working on that teleconference
UAE – crowdsource for nearest AED – locate incidence like UBER for CVD
AI in Pathology – genomics and patient targeting – Lab in Cambridge, Big Data
Cardiovascular trials currently account for 10 percent of all clinical trial participants. Discussion on design and implementation of clinical studies globally, considering strategies for patient access, regulatory implications, cost containment and management of relationships with global service providers.
Explore how precision medicine is changing the face of cardiovascular medicine specifically. The session will examine the impact of combined phenotypic and genotypic characterization on optimizing response to therapeutics, trial design, improving outcomes, and redefining reimbursement.
Arrhythmia: Mutation if down played causes Arrhythmia if Overexpressed causes Arrhythmia – caution in terapeutics tatgets – gene indication not to develop therapy
Diastolic HF – make a drug, pick up one signaling cascade and show efficacy not in all pathways
View on investing landscape, opportunities in the CV/metabolic marketplace, the drugs, devices and diagnostics currently in pipelines and notable positive trends.
Address implications of gender as a key biological factor for personalized medicine. Stroke is likely to be the first cardiovascular event, tied to AF and secondarily to hypertension. Opportunities for medication utilization and optimization in context of, manifestation of disease and understanding the biology, complications, strategies to collect relevant clinical evidence, and treatment response.
Recent advances of biological drugs have broadened the scope of therapeutic targets for a variety of human diseases. This holds true for dozens of RNA-based therapeutics currently under clinical investigation for diseases including heart failure. These emerging drugs could be considered in context of genomic/germ line screening, family history and epigenetics.
PCSK9 – as a target genetically defined mutation, Hyper-cholesteronemia – subcutaneous delivery – Lowering LDL by bi-annual injection or quarterly – non-complaint with Statin
Harvard Medical School investigators describe their most promising work in rapid fire presentations highlighting commercial opportunities in cardiovascular and cardiometabolic care. Nineteen rising stars from Brigham and Women’s Hospital and Massachusetts General Hospital will present in 10-minute sessions.
Early career Harvard Medical School investigators kick-off the World Medical Innovation Forum with rapid fire presentations of their high potential new technologies. Nineteen rising stars from Brigham Health and Massachusetts General Hospital will highlight in ten-minute presentations their discoveries and insights that will be the disruptive cardiovascular care of the future. This session is designed for investors, leaders, donors, entrepreneurs and investigators and others who share a passion for identifying emerging high-impact technologies. The top presenter each from BWH and MGH will be awarded the Austen-Braunwald Innovation Prize on Day 2 of the Forum. The prize carries a $10,000 award.
Novel Target Discovery Pipeline for Calcific Aortic Valve Disease Elena Aikawa, MD, PhD Director, Heart Valve Translational Research Program, Brigham and Women’s Hospital; Associate Professor of Medicine, Harvard Medical School
Aortic stenosis is a progress of Calcific Aortic Valve Disease (CAVD) – 80,000 patients – sole solution is surgery
Serum Sortilin associated with aortic calcification and CVD risk
Discovery pipeline and CAVD Mapping
A zebrafish pipeline for cardiovascular precision medicine Manu Beerens, PhD
Postdoctoral Research Fellow, Brigham and Women’s Hospital; Harvard Medical School
Cardiomyopathy – group of cardiac disorders: CHF, Atherosclerosis, metabolic syndrome, AF
Zebrafish at the forefront of CVD Precision Medicine
Luciferase activity vs ttn
high throughput screening to identify naxos modifiers
Endpoints: BNP levels Cardiac contractility
Using zebrafish to understand and harness cardiac regeneration
Caroline Burns, PhD Associate Biologist, Massachusetts General Hospital; Associate Professor of Medicine, Harvard Medical School
Heart regeneration
Regenerative hearts vs Non-Regenerative hearts
How cardiomyocytes proliferation induced following injury
Uninjured, 1 day after, 7 days after,
Failure to regenerate is related to failure of myoocardial proliferation
Genetic factors required for myocardial proliferation
myocardial proliferation – by Chromatin – mononuclear >4c ploidy
Mononuclear in Human Heart – as research target
How to promote myocardial proliferation
Small molecule as enhanced to drive proliferation
Bioactive Lipid Profiling Can Identify Potential Targets for Altering Life Course Trajectories Toward Cardiometabolic Disease Susan Cheng, MD Associate Physician, Brigham and Women’s Hospital, Partners HealthCare; Assistant Professor, Harvard Medical School
Bioactive Lipids
Endogenous and exhaugenous factors
Biochemical intermediates
mechanisms
health and disease outcomes
Small lipid Mediators of Upstream: Eicosanoids and Incidence of Diabetes as Targets for Present and Future
cardiometabolic risk in future early vs late prediabetes, and DM
shared pathways
Statins favoral response
Stree or Injury
Linoleic Acid
Disease and Phynotyping specific investigations
dosing
Small Molecule Predictors of Outcome After Cardiac Interventions Sammy Elmariah, MD Assistant in Medicine, Massachusetts General Hospital; Assistant Professor of Medicine, Harvard Medical School
Valvular heart disease – elderly, Aortic valve stenosis leads to failure of compensatory ventricular activity of dysfunction
small molecule
fiadnostics biomarkers
Acute kidney injury due to metabolite, adenohomosestine
validate the model – after METABOLITE data is added to the risk classification
Personalizing the timing of Valve Intervention
Biomarkers in blood predicts systolic function, EF,
Metabolite-Driven clinical trial of Aortic stenosis
TAVR
Translational trials in microRNAs Mark Feinberg, MD Physician, Brigham and Women’s Hospital; Associate Professor of Medicine, Harvard Medical School
New approaches to controlling stem cell fate Yick Fong, PhD Research Scientist, Brigham and Women’s Hospital; Assistant Professor of Medicine, Harvard Medical School
controlling Stem cell fate by Transcription Factors
Pluripotent, fibroblasts – transformed into Bone, nerve, heart, pancreatic cells
This process is randon and inefficient
GOAL: Transplantation, drug/therapeutic screens
Cellular identity and function
In Vitro Reconstruction of cell-type specific Transcription
Identify Disease mechanism of Heart disease by mutation that cause disruptionCo-regulators disruption
Exercise Prescription to Improve Cardiovascular and Cancer Outcomes in Cancer Survivors John Groarke, MD Cardiologist, Brigham and Women’s Hospital; Instructor of Medicine, Harvard Medical
cancer survivers have risk for CVD
Metabolic Equivalent ((METS)
METS is the highest to lower CVD in Cancer survivors
Onco-cardiac rehabilitation
Increase excercise performance vs physical de-conditioned state
Cardioprotection to mitigate CV Toxicities of cancer therapy
Personalizing Diabetic Management with Hemoglobin A1c John Higgins, MD Associate Pathologist, Massachusetts General Hospital; Associate Professor, Harvard Medical School
Non glucose factors that affect A1C
RBC Age span – if circulate live longer accumulates more glucose
AstraZeneca, Eli Lilly, Novo Nordics – ALL conduct clinical trials to lower A1C
Personalize DM Management
Using existing assays with the RBC Age adjustment — for achieving better future Outcomes
Device Manufacturers to adjust the device
Characterizing an Early HeartFailure pulmonary EF (HFpEF) Phenotype: Cardiometabolic Disease and Pulmonary Hypertension Jennifer Ho, MD Assistant Physician, Massachusetts General Hospital; Member of the Faculty of Medicine, Harvard Medical School
Genetic Risk, Adherence to a Healthy Lifestyle, and Coronary Disease Amit Khera, MD Cardiologist, Massachusetts General Hospital; Instructor, Harvard Medical School
Integration of Genetic data and CVD data
GWAS –>> 60 variants associated with coronary risk
Polygenic genetic risk score
Risk for MI: Genetic risk Interpretation: Monogenic vs Polygenic
High risk comes from polygenic risk: Smoking, Obesity, Excercise, Health diet
Healthy lifestyle “corrects” genetic factor
Monogenic:
Hypercholesterolemia
Trycleceride
increased lipoproteins _ ASA Lp(a) inhibitors
Polygenic
life style, diet excercise
medicationS: Statins
A Novel Epigenetic Complex Implicated in Thoracic Aortic Aneurysm (TAA)
Mark Lindsay, MD, PhD Physician, Massachusetts General Hospital; Assistant Professor, Harvard Medical School
Thoracic Aortic Aneurysm
Aortic dissection
VSCULAR SMOOOTH MUSCLE CELLS in the aorta’s leaves – neo-intima damage vs knockout MALAT1 – nepangiogenesis
Atrial Fibrillation: Genetic Basis and Clinical Implications Steven Lubitz, MD Cardiac Electrophysiologist, Massachusetts General Hospital
6 million in US 34 Million WOrldwide
Leading cause of stroke
AF is hard to diagnose
preventable with anticoagulation
AF is Familial and inheritable
Genetic Variation associated with AF – genetics stratified risk
AF Screening: as Stroke prevention – AliveCor
electronic health records are powerful repositories
AF genetic risk – as a Biomarker
Technologies for screening
Targeting Vascular Calcification to Prevent Cardiovascular Disease Rajeev Malhotra, MD Staff Cardiologist, Associate Medical Director of the Cardiac Intensive Care Unit, Associate Director of the Cardiopulmonary Exercise Laboratory, Massachusetts General Hospital; Instructor in Medicine, Harvard Medical School
Vascular Classification: Atherocalcification Vascula r disease
plaque destabilization
coronary and aortic
HUMAN GENETICS Studies: GWAS
Genotype
Aortic CT
Identify Potential Genes, increase expression associated with classification
Functional-Mechanical Studies: smooth muscle cell – more proliferative vs more contractile
control vs inhibition
Human model of Vascular classification vs Mouse Model
Disease of Vascular classification: Calxiphylaxis – HEMODialysis patients – >50% mortality within 1 year of diagnosis
Drug development and Clinical Trials
Stratifying Exercise Dysfunction Bradley Maron, MD Association Physician, Brigham and Women’s Hospital; Assistant Professor, Harvard Medical School
NEW SYSTEM DESIGNED: Network-Based Clinical Risk Calculator by Four Clusters – Network determine cluster assignment
Point of care tool – integrate into iCPET
Provides insights into HTN, Valvular, Myocaritis, cardiomyopathy
Pulmonary
exercise capacity
ventilation perf
o2 transport
Invasive cardiac
Novel Mouse Models of Remote Cardioprotection Benjamin Olenchock, MD, PhD Cardiovascular Medicine Specialist, Brigham and Women’s Hospital; Instructor in Medicine, Harvard Medical School
Ischemic Preconditing
Remote limb BP Cuff in pig prevented Ischemia in heart
Aging and the activin type II receptor pathway: a new target for heart failure therapy? Jason Roh, MD Assistant in Medicine, Massachusetts General Hospital; Instructor, Harvard Medical School
AGING and CVD – it is part of pathophysiology – CATABOLIC PROCESSES
Organ level
muscle waist, atropy –>> impaired function: Hand grip strength, walk speed —->> HF, systolic and diastolic Strain rate
Cell level: Isotype Abvs ActRII Ab
contractility, Seen in HF models and HFpEF
Activin-A decreases with AGE
Signaling and pulmonary vascular disease – PAH Paul Yu, MD, PhD
Physician, Brigham and Women’s Hospital; Associate Professor of Medicine, Harvard Medical School
FIBROSIS: TGF
OSTEOGENESIS ANTI-APOPTOSIS
Activin/TGFBeta —>>> BMP9 (ALK1c)
Loss od signaling
Inflammation
high shear stress
PAH
Idiopathic: Sporadic or heritable
Associated PAH: Scleroderma or lupus
Dysregulated angiogenesis– Anti VEGF165 – Zr-bevacizumab – Using PET-CT
Seven intensive workshops led by our top faculty will address cutting-edge cardiovascular topics. Seating is reserved at the point of registration. Lunch included.
Topics to be covered include:
Cardiac Replacement Therapy: The Next Ten Years
Heart Failure: Back in The Game through New Pathways
Payment Models: Provider’s Perspective
Molecular Imaging: New Biological Endpoints – Function Over Structure
Open Innovation in Medical Devices: What is it? What Are the Barriers?
Wearables for Cardiovascular Health: How to Validate and Integrate in Care Paths?
Image Based Artificial Intelligence: Which Cardiac Disease Segments and Why?
Seven intensive workshops led by our top faculty will address cutting-edge cardiovascular topics. Seating is reserved at the point of registration. Lunch included.
Panels
Cardiac Replacement Therapy: The Next Ten Years- Great Republic | 7th Floor
Garrick Stewart, MD, Associate Physician, Medical Director, Mechanical Circulatory Support Unit, Brigham and Women’s Hospital; Instructor in Medicine, Harvard Medical School
Erin Coglianese, MD, Medical Director, Mechanical Cardiac Support Program, Massachusetts General Hospital
Heart Failure: Back in The Game through New Pathways- Essex North | 3rd Floor
Introducer: Dan Castro, Managing Director, Licensing, Partners HealthCare
Anju Nohria, MD, Director, Cardio-Oncology Program, Cardiovascular Medicine Specialist, Brigham and Women’s Hospital
Christopher Newton-Cheh, MD, Cardiologist, Heart Failure and Transplantation, Massachusetts General Hospital
Payment Models: Provider’s Perspective- North Star | 7th Floor
Marcelo Di Carli, MD, Chief, Division of Nuclear Medicine and Molecular Imaging, Brigham and Women’s Hospital; Professor of Radiology and Medicine, Harvard Medical School
Farouc Jaffer, MD, PhD, Director, Coronary Intervention, Cardiac Catheterization Laboratory, Cardiology Division, Massachusetts General Hospital, Associate Professor of Medicine, Harvard Medical School
Sharmila Dorbala, MD, Director, Nuclear Cardiology, Brigham and Women’s Hospital; Associate Professor of Radiology, Harvard Medical School
Open Innovation in Medical Devices: What is it? What Are the Barriers?- Essex South | 3rd Floor
Introducer: Pat Fortune, PhD, Vice President for Market Sectors, Partners HealthCare
Elazer Edelman, MD, PhD, Senior Attending Physician, Brigham and Women’s Hospital; Professor of Medicine, Harvard Medical School; Thomas D. and Virginia W. Cabot Professor of Health Sciences and Technology, MIT
Mortality of cardiovascular disease declines as a result of Medical Innovations as Devices
Are innovations tappering off or New ones are coming??
Bruce Rosengard, MD, Chief Medical Science and Technology Officer, Johnson & Johnson Medical Devices Companies
Ronald Tompkins, MD, Director, Surgery, Innovation & Bioengineering, Massachusetts General Hospital; Sumner M. Redstone Professor of Surgery, Harvard Medical School
ALL
Solution for Heart Failure – low hanging fruit was picked already – a workabke artificial heart more important than another Stent
Large scale Programs better than multiple PI small grant applications, many are not innovating, conflict of interests, Academia and Industry relations
99% get better with a device but 1% is been harmed
FDA – overworked Underfunded 52 applications reviewed per employee
Wearables for Cardiovascular Health: How to Validate and Integrate in Care Paths?- Parliament/Adams | 7th Floor
Introducer: Thomas Aretz, MD, Vice President, Global Programs, Partners HealthCare
David Levine, MD, Home Hospital Director, Brigham and Women’s Hospital; Fellow in General Internal Medicine, Harvard Medical School
Kamal Jethwani, MD, Senior Director, Connected Health Innovation, Partners HealthCare; Assistant Professor, Dermatology, Harvard Medical School
Paolo Bonato, PhD, Director, Motion Analysis Laboratory, Spaulding Hospital; Associate Professor, Harvard Medical School
Image Based Artificial Intelligence: Which Cardiac Disease Segments and Why? Empire | 7th Floor
Introducer: Trung Do, Vice President, Business Development, Partners HealthCare
George Washko, MD, Associate Physician, Brigham and Women’s Hospital; Associate Professor of Medicine, Harvard Medical School
Mark Michalski, MD, Director, CCDS, Brigham and Women’s Hospital, Massachusetts General Hospital
Two renowned clinical leaders provide an overview of the medical and economic challenges that cardiovascular and cardiometabolic disorders present.
They will highlight strategic direction in cardiac research and clinical care at Partners, and address how recent trends in investment, regulation, and policy may be dovetailed with efforts at Partners.
The experts also spotlight for attendees the various therapies, diagnostics, devices, and critical issues that will be discussed throughout the upcoming 2.5 days of the World Medical Innovation Forum.
Discussion on contribution of technology innovation to the treatment of cardiovascular disease reflecting on lessons and how they shape investment decisions.
Executive in Residence, Partners HealthCare Innovation
Electrical physiology: implantable paceamker – first 1958, lead to RV, last 10years th enetire pacemaker implanted in the heart no leads. Surgical TAVR, Implantabke to Mitral valve
Evolving trends in diagnosis, prevention, and treatment of atrial fibrillation. Factors that will influence patient care over the next 5 years are considered, including risk stratification, procedure and technology options, and potential implications of CMS policies, such as bundling.
Innovations are the essence of Medical Devices development as mission in technology
Training Challenge in Surgical Robotic – patient comfort of minimal invasive therapy, cost lower
Antibacterial sleeve saves cost of hospitalization, id infection occur Medtronic reimburses Hospital
Respect of NOT INVENTED HERE – internal and external
M&A 0 TAVR internal development THEN acquisition, HTN – acquisition did not work
DIABETIC PUMP – investment in R&D over 15 years
Care management as Services – therapy and care management
Technology company paid when it is delivered: understand cohorts,
Strategy: Chronic Disease: AF, ablation is needed –
Strategy: episodic care – success of intervention and the recovery from acuity, HF compensation in early stageCRT – hospitalization one year after the intervention is not acceptable
9 and 10 are measuring outcome differently
Mitral Valve – platform for new generation of diagnostics
One million patients are hospitalized annually for HF—80% of total US cost of HF management. After discharge from HF hospitalization, 24% are rehospitalized within 30 days, greater than 50% within 6 months. Perspective on disease management, addressing the issues of hospital readmission and optimizing therapies.
PAD is the most challenging atherosclerotic syndrome, largely due to the technological challenges of managing peripheral artery disease through minimally invasive strategies. Top physician, governmental, and industry leaders in the field discuss the potential for new breakthroughs including novel implantable devices, pharmacologic approaches, and reductions in associated cardiovascular morbidity and mortality.
The panel will also discuss, Below The Knee: The Persisting Unmet Need
Cheetah Medical Introduces New Algorithm for Fluid Management
Reporter: Lawrence J Mulligan, PhD
Cheetah Medical Advances the Science of Fluid Management
Cheetah Medical is the pioneer and leading global provider of 100% noninvasive hemodynamic monitoring technologies that are designed for use in critical care, OR and emergency department settings. The CHEETAH NICOM™ and STARLING™ SV technologies use a proprietary algorithm to calculate parameters related to the volume of blood and the functioning of patients’ circulatory systems. Medical professionals use this information to assess patients’ unique volume requirements, guide volume management decisions and maintain adequate organ perfusion. Cheetah Medical technologies are designed to enable more confident, informed therapy decisions that support clinical goals of improving patient outcomes and driving economic efficiencies.
NEWTON, Mass. –(BUSINESS WIRE)– Cheetah Medical announced today that its eighth abstract on fluid management will be presented at Society of Critical Care Medicine meeting in January. Building on previous work, this abstract demonstrates a strong association between large volume fluid administration in septic shock and increased risk of death in more than 23,000 patients.
Each year, millions of patients require hemodynamic monitoring to ensure optimal volume and perfusion management. While intravenous fluid is typical first-line therapy for many critical care situations, volume management has been a challenge for the healthcare community. It is often difficult for a clinician to know the right amount of fluid to administer to patients, and there are serious complications associated with both under and over resuscitation.
“Ever since we’ve been using intravenous fluid, clinicians have been asking, ‘What is the right amount?’” said Doug Hansell, MD and Cheetah’s Chief Physician Executive. “Today, with non-invasive Cheetah technology, we have new tools to answer this question, and we are learning that getting this question right is more important than ever.”
Cheetah Medical has been working with leading researchers using a large U.S. dataset to better understand the risks and benefits of fluid administration. During the past two years, researchers have now released eight clinical abstracts on the importance of fluid management.
FLUID ADMINISTRATION IN SEPSIS AND SEPTIC SHOCK – PATTERNS AND OUTCOMES: Sepsis and septic shock is a huge national priority, as it is the most expensive condition to treat, at $24 billion per year (AHRQ). This study identified a strong association between large fluid administration (more than five liters) and excess mortality in septic shock patients. As expected, sicker patients received more fluid. However, even after accounting for the severity of illness, these patients had an increased risk of dying. (Society of Critical Care Medicine Annual Conference, January 2017)
FLUID ADMINISTRATION IN OPEN AND LAPAROSCOPIC ABDOMINAL SURGERY: The study looked at the relationship between intraoperative fluid therapy and complications following abdominal surgery.Based on data from 18,633 patients, an increase in complications was found with day-of-surgery fluid use above five liters for open abdominal procedures. The study recommended individualized fluid therapy to reduce potentially negative effects from over/under resuscitation with intravenous fluids. (American Society of Anesthesiologists [ASA] 2016 Annual Meeting)
FLUID PRESCRIPTIONS IN HOSPITALIZED PATIENTS WITH RENAL FAILURE: The implication of volume resuscitation and potential complications among patients with acute kidney injuries (AKIs) has been widely debated. This study examined the relationship between fluid administration and outcomesamong 62,695 AKI patients. It found the potential for both under and over resuscitation in those who received treatments with vasopressors. A better understanding of individual fluid needs was seen for patients requiring pressor and mechanical ventilation support. (European Society of Intensive Care Medicine [ESICM] Annual Congress, 2016)
EFFECTS OF FLUIDS ADMINISTRATION IN PATIENTS WITH SEPTIC SHOCK WITH OR WITHOUT HEART FAILURE (HF): The study examined the relationship between indications of fluid overload in sepsis patients (with or without diastolic HF) and outcomes. For 29,098 patients, mortality was the highest among those who received the highest volumes of fluid. It also noted that patients with diagnosed diastolic HF received less fluids and exhibited a significantly lower mortality than predicted. These lower mortality rates could be a result of a more conservative fluid treatment strategy applied in patients known to be at risk for fluid overload. (American Thoracic Society [ATS] 2016 International Conference)
WIDE PRACTICE VARIABILITY IN FLUID RESUSCITATION OF CRITICALLY ILL PATIENTS WITH ARDS: The study looked at how variable fluid resuscitation testing and treatments impacted the outcomes of patients with acute respiratory distress syndrome (ARDS). An analysis of 1,052 patients highlighted a highly variable fluid resuscitation. The findings suggest a widespread variability in provider decision-making regarding fluid resuscitation, which may be detrimental to quality and costs, lowering the overall value of care. (American Thoracic Society [ATS] 2016 International Conference)
POTENTIAL HARM ASSOCIATED WITH SEVERITY-ADJUSTED TREATMENT VARIABILITY IN FLUID RESUSCITATION OF CRITICALLY ILL SEPTIC PATIENTS: The study set out to determine treatment variability for patients with severe sepsis and how it may impact mortality. Retrospectively analyzing 77,032 patients, a high degree of treatment variability was found for fluid resuscitation, with a range of 250 ml to more than 7L of fluid administered. For patients who received less fluid, there was no increased risk of mortality. In those who received the most fluid, there was a strong association with worse hospital mortality. (American Thoracic Society [ATS] 2016 International Conference)
ASSOCIATION OF FLUIDS AND OUTCOMES IN EMERGENCY DEPARTMENT PATIENTS HOSPITALIZED WITH COMMUNITY-ACQUIRED PNEUMONIA (CAP): Analyzing 192,806 CAP patients, the study looked at the correlation between fluid-volume overload, hospital mortality and ventilator-free days (VFDs). A significant association was found between the amount of fluid administered on day one, increased mortality and decreased VFDs. The study may have also identified a subset of CAP patients who could benefit from a more restrictive fluid strategy. (36thInternational Symposium on Intensive Care and Emergency Medicine)
FLUID ADMINISTRATION IN COMMUNITY-ACQUIRED SEPSISEXAMINATION OF A LARGE ADMINISTRATIVE DATABASE: The study looked at variation in fluid administration practices and compliance with “Surviving Sepsis” guidelines, which recommend a minimum initial fluid administration of 30cc/kg in sepsis-induced tissue hypoperfusion patients. It found that a substantial proportion of patients (47.4 %) with community-acquired sepsis received less than the recommended guidelines within the first 24 hours. (Society of Critical Care Medicine Annual Conference, 2016)
“We are very proud to have supported this work – we are advancing the science of fluid management and helping to improve our understanding of how better fluid management may improve patient outcomes,” said Chris Hutchison, CEO of Cheetah Medical.
The deal, announced in November 2016, calls for $340 million in up-front cash and another $350 million in milestones over 10 years. It does not include Valtech Cardio’s trans-septal mitral valve replacement program; that business is slated to be spun out on its own before the buyout’s closing, expected in early 2017, but Edwards said last year that it’s due to keep an option to buy.
EDWARDS LIFESCIENCES COMPLETES ACQUISITION OF VALTECH CARDIO
IRVINE, Calif., Jan. 23, 2017 – Edwards Lifesciences Corporation (NYSE: EW), the global leader in patient-focused innovations for structural heart disease and critical care monitoring, today announced that it has closed its acquisition of Valtech Cardio Ltd., a privately held company based in Israel and developer of the Cardioband System for transcatheter repair of the mitral and tricuspid valves. Edwards announced in November that it had signed an agreement to acquire Valtech.
Under the terms of the merger agreement, Edwards paid $340 million in stock and cash for Valtech at closing, subject to typical adjustments. In addition, there is the potential for up to $350 million in pre-specified milestone-driven payments over the next 10 years. Edwards’ financial guidance provided at its Investor Conference in December incorporated the expected financial impact of the transaction in 2017.
“We look forward to the Valtech team joining Edwards. We believe their knowledge, experience and the Cardioband technology are valuable additions to Edwards,” said Michael A. Mussallem, Edwards’ chairman and CEO. “This therapy has the potential to be a breakthrough structural heart therapy to help many patients in desperate need, and we look forward to gaining valuable insights from its commercial use in Europe.”
The Cardioband System is not approved for sale in the United States. The mitral application of the Cardioband System has received CE Mark in Europe.
About Edwards Lifesciences
Edwards Lifesciences, based in Irvine, Calif., is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the world’s leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. For more information, visit http://www.edwards.com and follow us on Twitter @EdwardsLifesci.
University Children’s Hospital Zurich (Universitäts-Kinderspital Zürich), Switzerland – A Prominent Center of Pediatric Research and Medicine
Author: Gail S. Thornton, M.A.
Co-Editor: The VOICES of Patients, Hospital CEOs, HealthCare Providers, Caregivers and Families: Personal Experience with Critical Care and Invasive Medical Procedures
Article ID #227: University Children’s Hospital Zurich (Universitäts-Kinderspital Zürich), Switzerland – A Prominent Center of Pediatric Research and Medicine. Published on 12/21/2016
WordCloud Image Produced by Adam Tubman
University Children’s Hospital Zurich (Universitäts-Kinderspital Zürich — http://www.kispi.uzh.ch), in Switzerland, is the largest specialized, child and adolescent hospital in the country and one of the leading research centers for pediatric and youth medicine in Europe. The hospital, which has about 220 beds, numerous outpatient clinics, a day clinic, an interdisciplinary emergency room, and a specialized rehabilitation center, is a non-profit private institution that offers a comprehensive range of more than 40 medical sub-specializations, including heart conditions, bone marrow transplantation and burns. There are approximately 2,200 physicians, nurses, and other allied health care and administrative personnel employed at the hospital.
Just as important, the hospital houses the Children’s Research Center (CRC), the first research center in Switzerland that is solely dedicated to pediatric research, and is on par with the largest children’s clinics in the world. The research center provides a strong link between research and clinical experience to ensure that the latest scientific findings are made available to patients and implemented in life-saving therapies. By developing highly precise early diagnoses, innovative therapeutic approaches and effective new drugs, the researchers aim to provide a breakthrough in prevention, treatment and cure of common and, especially, rare diseases in children.
Several significant milestones have been reached over the past year. One important project under way is approval by the hospital management board and Zurich city council to construct a new building, projected to be completed in 2021. The new Children’s Hospital will constitute two main buildings; one building will house the hospital with around 200 beds, and the other building will house university research and teaching facilities.
In the ongoing quest for growing demands for quality, safety and efficiency that better serve patients and their families, the hospital management established a new role of Chief Operating Officer. This new position is responsible for the daily operation of the hospital, focusing on safety and clinical results, building a service culture and producing strong financial results. Greater emphasis on clinical outcomes, patient satisfaction and partnering with physicians, nurses, and other medical and administrative staff is all part of developing a thriving and lasting hospital culture.
Recently, the hospital’s Neurodermatitis Unit in cooperation with Christine Kuehne – Center for Allergy Research and Education (CK-Care), one of Europe’s largest private initiatives in the field of allergology, has won the “Interprofessionality Award” from the Swiss Academy of Medical Sciences. This award highlights best practices among doctors, nurses and medical staff in organizations who work together to diagnose and treat the health and well-being of patients, especially children with atopic dermatitis and their families.
At the northern end of Lake Zurich and between the mountain summit of the Uetliberg and Zurichberg, Children’s Hospital is located in the center of the residential district of Hottingen.
Image SOURCE: Photograph courtesy of Children’s Hospital Zurich (Universitäts-Kinderspital Zürich), Switzerland. Interior and exterior photographs of the hospital.
Below is my interview with Hospital Director and Chief Executive Officer Markus Malagoli, Ph.D., which occurred in December, 2016.
How do you keep the spirit of innovation alive?
Dr. Malagoli: Innovation in an organization, such as the University Children’s Hospital, correlates to a large extent on the power to attract the best and most innovative medical team and administrative people. It is our hope that by providing our employees with the time and financial resources to undertake needed research projects, they will be opened to further academic perspectives. At first sight, this may seem to be an expensive opportunity. However, in the long run, we have significant research under way in key areas which benefits children ultimately. It also gives our hospital the competitive edge in providing quality care and helps us recruit the best physicians, nurses, therapists, social workers and administrative staff.
The Children’s Hospital Zurich is nationally and internationally positioned as highly specialized in the following areas:
Neonatal and malformation surgery as well as fetal surgery,
Neurology and neurosurgery as well as neurorehabilitation,
Oncology, hematology and immunology as well as oncology and stem cell transplants,
Metabolic disorders and endocrinology as well as newborn screening, and
Combustion surgery and plastic reconstructive surgery.
We provide patients with our special medical expertise, as well as an expanded knowledge and new insights into the causes, diagnosis, treatment and prophylaxis of diseases, accidents or deformities. We have more than 40 medical disciplines that cover the entire spectrum of pediatrics as well as child and youth surgery.
As an example, for many years, we have treated all congenital and acquired heart disease in children. Since 2004, specialized heart surgery and post-operative care in our cardiac intensive care unit have been carried out exclusively in our child-friendly hospital. A separate heart operation area was set up for this purpose. The children’s heart center also has a modern cardiac catheter laboratory for children and adolescents with all diagnostic and catheter-interventional therapeutic options. Heart-specific non-invasive diagnostic possibilities using MRI are available as well as a large cardiology clinic with approximately 4,500 outpatient consultations per year. In April 2013, a special ward only for cardiac patients was opened and our nursing staff is highly specialized in the care of children with heart problems.
In addition to the advanced medical diagnostics and treatment of children, we also believe in the importance of caring and supporting families of sick children with a focus on their psychosocial well-being. For this purpose, a team of specialized nurses, psychiatrists, psychologists, and social workers are available. Occasionally, the children and their families need rehabilitation and we work with a team of specialists to plan and organize the best in-house or out-patient rehabilitation for the children and their families.
We also provide therapeutic, rehabilitation and social services that encompass nutritional advice, art and expression therapy, speech therapy, physical therapy, psychomotor therapy, a helpline for rare diseases, pastoral care, social counseling, and even hospital clowns. Our hospital teams work together to provide our patients with the best care so they are on the road to recovery in the fastest possible way.
What draws patients to Children’s Hospital?
Dr. Malagoli: Our hospital depends heavily on complex, interdisciplinary cases. For many diagnosis and treatments, our hospital is the last resort for children and adolescents in Switzerland and even across other countries. Our team is fully committed to the welfare of the patients they treat in order to deal with complex medical cases, such as diseases and disorders of the musculo-skeletal system and connective tissue, nervous system, respiratory system, digestive system, and ear, nose and throat, for example.
Most of our patients come from Switzerland and other cantons within the country, yet other patients come from as far away as Russia and the Middle East. Our hospital sees about 80,000 patients each year in the outpatient clinic for conditions, such as allergic pulmonary diseases, endocrinology and diabetology, hepatology, and gastroenterology; about 7,000 patients a year are seen for surgery; and about 37,000 patients a year are treated in the emergency ward.
We believe that parents are not visitors; they belong to the sick child’s healing, growth, and development. This guiding principle is a challenge for us, because we care not only for sick children, but also for their families, who may need personal or financial resources. Many of our services for parents, for example, are not paid by the Swiss health insurance and we depend strongly on funds from private institutions. We want to convey the feeling of security to children and adolescents of all ages and we involve the family in the recovery process.
What are the hospital’s strengths?
Dr. Malagoli: A special strength of our hospital is the interdisciplinary thinking of our teams. In addition to the interdisciplinary emergency and intensive care units, there are several internal institutionalized meetings, such as the uro-nephro-radiological conference on Mondays, the oncological conference and the gastroenterological meeting on Tuesdays, and the pneumological case discussion on Wednesdays, where complex cases are discussed among our doctors. Foreign doctors are welcome to these meetings, and cases are also discussed at the appropriate external medical conferences.
Can you discuss some of the research projects under way at the Children’s Research Center (CRC)?
Dr. Malagoli: Our Children’s Research Center, the first research center in Switzerland focused on pediatric research, works closely with our hospital team. From basic research to clinical application, the hospital’s tasks in research and teaching is at the core of the Children’s Research Center for many young and established researchers and, ultimately, also for patients.
Our research projects focus on:
Behavior of the nervous, metabolic, cardiovascular and immune system in all stages of growth and development of the child’s condition,
Etiology (causes of disease) and treatment of genetic diseases,
Tissue engineering of the skin and skin care research: from a few cells of a child, complex two-layered skin is produced in the laboratory for life-saving measures after severe burns and treatment of congenital anomalies of the skin,
Potential treatment approaches of the most severe infectious diseases, and
Cancer diseases of children and adolescents.
You are making great strides in diagnostic work in the areas of Hematology, Immumology, Infectiology and Oncology. Would you elaborate on this particular work that is taking place at the hospital?
Dr. Malagoli: The Department of Image Diagnostics handles radiological and ultrasonographic examinations, and the numerous specialist labs offer a complete range of laboratory diagnostics.
The laboratory center makes an important contribution to the clarification and treatment of disorders of immune defense, blood and cancer, as well as infections of all kinds and severity. Our highly specialized laboratories offer a large number of analyzes which are necessary in the assessment of normal and pathological cell functions and take into account the specifics and requirements of growth and development in children and infants.
The lab center also participates in various clinical trials and research projects. This allows on-going validation and finally introducing the latest test methods.
The laboratory has been certified as ISO 9001 by the Swiss Government since 2002 and has met the quality management system requirements on meeting patient expectations and delivering customer satisfaction. The interdisciplinary cooperation and careful communication of the laboratory results are at the center of our activities. Within the scope of our quality assurance measures, we conduct internal quality controls on a regular basis and participate in external tests. Among other things, the work of the laboratory center is supervised by the cantonal medicine committee and Swissmedic organization.
Additionally, the Metabolism Laboratory offers a wide variety of biochemical and molecular diagnostic analysis, including those for the following areas:
Disorders in glycogen and fructose metabolism,
Lysosomal disorders,
Disorders of biotin and vitamin B12 metabolism,
Urea cycle disorders and Maple Syrup Urine Disease (MSUD),
Congenital disorders of protein glycosylation, and
Hereditary disorders of connective tissue, such as Ehlers-Danlos Syndrome and Marfan Syndrome.
Screening for newborn conditions is equally important. The Newborn Screening Laboratory examines all newborn children in Switzerland for congenital metabolic and hormonal diseases. Untreated, the diseases detected in the screening lead in most cases to serious damage to different organs, but especially to the development of the brain. Thanks to the newborn screening, the metabolic and hormonal diseases that are being sought can be investigated by means of modern methods shortly after birth. For this, only a few drops of blood are necessary, which are taken from the heel on the third or fourth day after birth. On a filter paper strip, these blood drops are sent to the laboratory of the Children’s Hospital Zurich, where they are examined for the following diseases:
Phenylketonuria (PKU),
Hypothyroidism,
MCAD deficiency,
Adrenogenital Syndrome (AGS),
Galactosemia,
Biotinide deficiency,
Cystic Fibrosis (CF),
Glutaraziduria Type 1 (GA-1), and
Maple Syrup Urine Disease (MSUD).
Ongoing physician medical education and executive training is important for the overall well-being of the hospital. Would you describe the program and the courses?
Dr. Malagoli: We place a high priority on medical education and training with a focus on children, youth, and their families. The various departments of the hospital offer regular specialist training courses for interested physicians at regular intervals. Training is available in the following areas:
Anesthesiology,
Surgery,
Developmental Pediatrics,
Cardiology,
Clinical Chemistry and Biochemistry,
Neuropediatrics,
Oncology,
Pediatrics, and
Rehabilitation.
As a training hospital, we have built an extensive network or relationships with physicians in Switzerland as well as other parts of the world, who take part in our ongoing medical education opportunities that focus on specialized pediatrics and pediatric surgery. Also, newly trained, young physicians who are in private practice or affiliated with other children’s hospitals often take part in our courses.
We also offer our hospital management and leaders from other organizations professional development in the areas of leadership or specialized competence training. We believe that all executives in leadership or management roles contribute significantly to our success and to a positive working climate. That is why we have developed crucial training in specific, work-related courses, including planning and communications skills, professional competence, and entrepreneurial development.
How is Children’s Hospital transforming health care?
Dr. Malagoli: The close cooperation between doctors, nurses, therapists and social workers is a key success factor in transforming health care. We strive for comprehensive child care that does not only focus on somatic issues but also on psychological support for patients and their families and social re-integration. However, it becomes more and more difficult to finance all the necessary support services.
Many supportive services, for example, for parents and families of sick children are not paid by health insurance in Switzerland and we do not receive financial support from the Swiss Government. Since 2012, we have the Swiss Diagnosis Related Groups (DRG) guidelines, a new tariff system for inpatient hospital services, that regulates costs for treatment in hospitals all over the country and those costs do not consider the amount of extra services we provide for parents and families as a children’s hospital. Those DRG principles mostly are for hospitals who treat adult patients.
Since you stepped into your role as CEO, how have you changed the way that you deliver health care?
Dr. Malagoli: I have definitely not reinvented health care! Giving my staff the space for individual development and the chance to realize their ideas is probably my main contribution to our success. Working with children is for many people motivating and enriching. We benefit from that, too. Moreover, we have managed to build up a culture of confidence and mutual respect – we call it the “Kispi-spirit”. “Kispi” as abbreviation of “Kinderspital.” Please visit our special recruiting site, which is www.kispi-spirit.ch.
I can think of a few examples where our doctors and medical teams have made a difference in the lives of our patients. Two of our physicians – PD (Privatdozent, a private university teacher) Dr. med. Alexander Moller and Dr. med. Florian Singer, Ph.D. – are involved in the development of new pulmonary functions tests which allow us to diagnose chronic lung diseases at an early stage in young children.
Often times, newly born babies have a lung disease but do not show any specific symptoms, such as coughing. One of these new tests measures lung function based on inhaling and exhaling pure oxygen, rather than using the standard spirometry test used in children and adults to assess how well an infant’s lungs work by measuring how much air they inhale, how much they exhale and how quickly they exhale. The new test is currently part of a clinical routine in children with cystic fibrosis as well as in clinical trials in Europe. The test is so successful that the European Respiratory Society presented Dr. med. Singer, Ph.D., with the ‘Pediatric Research Award’ in 2015.
Another significant research question among the pediatric pulmonary disease community is how asthma can be diagnosed reliably and at an earlier stage. PD Dr. med. Moller, chief physician of Pneumology at the hospital, has high hopes in a new way to measure exhaled air via mass spectrometry. If it succeeds, it will be able to evaluate changes in the lungs of asthmatics or help with more specific diagnoses of pneumonia.
In what ways have you built greater transparency, accountability and quality improvement for the benefit of patients?
Dr. Malagoli: Apart from the quality measures which are prescribed by Swiss law, we have decided not to strive for quality certifications and accreditations. We focus on outcome quality, record our results in quality registers and compare our outcome internationally with the best in class.
Our team of approximately 2,200 specialized physicians largely comes from Switzerland, although we have attracted a number of doctors from countries such as Germany, Portugal, Italy, Austria, and even Serbia, Turkey, Macedonia, Slovakia, and Croatia.
We recently conducted an employee satisfaction survey, which showed about 88 percent of employees were very satisfied or satisfied with their working conditions at the hospital and the job we are doing with patients and their families. This ranking is particularly gratifying for us as a service provider for the children and families we serve.
How does your volunteer program help families better deal with hospitalized children?
Dr. Malagoli: We have an enormous commitment from volunteers to care for hospitalized children and we are grateful to them. We offer our patients and their families child care, dog therapy, and even parenting by the Aladdin Foundation, a volunteer visiting service for hospitalized children to relieve parents and relatives and help young patients stay in hospital to recover quickly. The volunteers visit the child in the absence of the parents and are fully briefed on the child’s condition and care plan. The handling of care request usually takes no more than 24 hours and is free of charge. The assignments range from one-off visits to daily care for several weeks.
Image SOURCE: Photograph of Hospital Director and Chief Executive Officer Markus Malagoli, Ph.D., courtesy of Children’s Hospital Zurich (Universitäts-Kinderspital Zürich), Switzerland.
Markus Malagoli, Ph.D. Director and Chief Executive Officer
Markus Malagoli, Ph.D., has been Hospital Director and Chief Executive Officer of the University Children’s Hospital Zurich (Universitäts-Kinderspital Zürich), since 2007.
Prior to his current role, Dr. Malagoli served as Chairman of Hospital Management and Head of Geriatrics of the Schaffhausen-Akutspital, the only public hospital in the Canton of Schaffhausen, from 2003 through 2007, where he was responsible for 10 departments, including surgery, internal medicine, obstetrics/gynecology, rheumatology/rehabilitation, throat and nose, eyes, radiology, anesthesia, hospital pharmacy and administration. The hospital employs approximately 1,000 physicians, nursing staff, other medical personal, as well as administration and operational services employees. On average, around 9,000 individuals are treated in the hospital yearly. Previously, he was Administrative Director at the Hospital from 1996 through 2003.
Dr. Malagoli began his career at Ciba-Geigy in 1985, spending 11 years in the company. He worked in Business Accounting in Basel, and a few years later, became Head of the Production Information System department in Basel. He then was transferred to Ciba-Geigy in South Africa as Controller/Treasurer and returned to Basel as Project Manager for the SAP Migration Project in Accounting.
Dr. Malagoli received his B.A. degree in Finance and Accounting and a Ph.D. in Business Administration at the University of St. Gallen.
He is a member of the Supervisory Board of Schaffhausen-Akutspital and President of the Ungarbühl in Schaffhausen, a dormitory for individuals with developmental impairments.
Editor’s note:
We would like to thank Manuela Frey, communications manager, University Children’s Hospital Zurich, for the help and support she provided during this interview.
REFERENCE/SOURCE
University Children’s Hospital Zurich (Universitäts-Kinderspital Zürich — http://www.kispi.uzh.ch)
Nation’s Biobanks: Academic institutions, Research institutes and Hospitals – vary by Collections Size, Types of Specimens and Applications: Regulations are Needed
BioTrace Medical, Inc., a venture backed company based in San Carlos, Calif., is dedicated to reinventing temporary pacing to improve patient outcomes and reduce hospital costs.
FDA Clears Temporary Pacing Technology for Transcatheter Aortic Valve and EP Procedures
The BioTrace Medical Tempo temporary pacing lead is designed to reduce complications and hospital length of stay
The Tempo Lead represents the first major advance in temporary pacing since the technology was introduced decades ago,” said Susheel Kodali, M.D., director of the Heart Valve Program at the Center for Interventional Vascular Therapy at Columbia University Medical Center in New York. “As a critical component of every TAVR procedure, temporary leads are integral to successful clinical outcomes for patients. I am excited about the potential of this technology and look forward to using it in my practice.”
Results of the first-in-human study of the technology will be presented at the annual Transcatheter Cardiac Therapeutics (TCT) conference in Washington, D.C. on Sunday, Oct. 30, at 10:59 a.m. eastern time in Room 209, Level 2.
“FDA clearance is an exciting milestone for BioTrace,” said Laura Dietch, CEO of BioTrace Medical. “We are pleased to bring this important innovation to the significant and growing number of patients needing better temporary pacing options to minimize risks and life-threatening complications. We look forward to launching in select U.S. centers in the coming weeks.”
December 19, 2016 — BioTrace Medical Inc. announced the first commercial use of the company’s Tempo Temporary Pacing Lead since U.S. Food and Drug Administration (FDA) 510(k) clearance in October.
The first cases involved patients undergoing transcatheter aortic valve replacement (TAVR) procedures and were performed by James Harkness, M.D., interventional cardiologist, and Brian K. Whisenant, M.D., medical director of the Structural Heart Disease Program at Intermountain Medical Center in Salt Lake City, Utah, and Susheel Kodali, M.D., director of the Heart Valve Program at Columbia University Medical Center/New York Presbyterian Hospital.
BioTrace Medical’s Tempo Lead is for use in procedures in which
Temporary pacing is indicated, including
TAVR and
Electrophysiology (EP) procedures.
The lead is designed for secure and stable cardiac pacing with the goal of reducing complications and allowing patients to ambulate sooner after procedures.
“The Tempo Lead is designed to alleviate the risks associated with lead dislodgement and inconsistent pacing, providing a safer option for patients.”
Temporary leads are used in more than 350,000 procedures each year, a number that is growing rapidly as the population ages and TAVR becomes increasingly common. The temporary pacing lead, a small catheter with two electrodes, is placed in the right ventricle of the heart through a vein in the groin or neck. The lead is then connected to an external pacemaker allowing a physician to monitor and control a patient’s heart rate for several days.
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