Date: Monday, April 24, 2017 at 2:26 PM
To: Aviva Lev-Ari <AvivaLev-Ari@alum.berkeley.edu>
Subject: cardiovascular symposium in Boston, May 20
Posted in Aortic Valve: TAVR, TAVI vs Open Heart Surgery, Cancer Surgery of the Heart, Cardiac and Cardiovascular Surgical Procedures, Frontiers in Cardiology and Cardiovascular Disorders, PCI, Stents & Tools, Valves & Tools, tagged HF Program including Cardiomems on April 24, 2017| Leave a Comment »
Date: Monday, April 24, 2017 at 2:26 PM
To: Aviva Lev-Ari <AvivaLev-Ari@alum.berkeley.edu>
Subject: cardiovascular symposium in Boston, May 20
Posted in Bioresorbable Vascular Scaffold (BVS), Cardiac and Cardiovascular Surgical Procedures, Frontiers in Cardiology and Cardiovascular Disorders, Medical Devices R&D and Inventions, PCI, Stents & Tools on April 2, 2017| Leave a Comment »
Stephen Ellis, M.D., professor of medicine and director of interventional cardiology at Cleveland Clinic, discusses the two year outcomes of the ABSORB III trial of Absorb vs. Xience. The late-breaking trial was presented at ACC 2017. Read the article on the ABSORB III results. Watch a VIDEO with Gregg Stone, M.D., “Poor Outcomes for Bioresorbable Stents in Small Coronary Arteries.”
Posted in Cardiac and Cardiovascular Surgical Procedures, Cardiovascular Fluid Management: algorithms, Cardiovascular Research, Congestive Heart Failure, Frontiers in Cardiology and Cardiovascular Disorders, Heart Failure (HF), Innovations, Intellectual Property, Innovations, Commercialization, Investment in technological breakthrough, Medical Devices R&D and Inventions, tagged fluid shifts, Sepsis, starling curve, third-space, volume overload on February 16, 2017| Leave a Comment »
Reporter: Lawrence J Mulligan, PhD
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.
“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.
Posted in Cardiac and Cardiovascular Surgical Procedures, Mitral Valve: Repair and Replacement, PCI, tagged transcatheter structural heart disease technologies on January 25, 2017| Leave a Comment »
Reporter: Aviva Lev-Ari, PhD, RN
Valtech’s Cardioband device is designed to reshape the mitral valve using specially designed anchors, aka
transcatheter structural heart disease technologies.
Valtech won CE Mark approval in the European Union for Cardioband in September 2015 but the device is not approved for the U.S. market.
Israel-based Valtech was the target of a previous takeover attempt by HeartWare International that was spiked early this year after a proxy war. (HeartWare itself was acquired by Medtronic (NYSE:MDT) for $1.1 billion in August.)
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.
JANUARY 24, 2017 BY
Posted in Allergy and Infectious Diseases, Cancer Prevention: Research & Programs, Cardiac and Cardiovascular Surgical Procedures, Childhood cancer, Diabetes Mellitus, Gastroenterology, Hematology, Hospital reputation, Intellectual Property, Innovations, Commercialization, Investment in technological breakthrough, Interviews with Scientific Leaders, Lung and pulmonology, Patient Experience, Pulmonary diseases, Support Staff, Uncategorized, tagged research center; pediatric and youth medicine, zurich; university children's hospital; child and adolescent hospital on December 21, 2016| Leave a Comment »
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
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:
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:
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:
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:
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:
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.
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.
We would like to thank Manuela Frey, communications manager, University Children’s Hospital Zurich, for the help and support she provided during this interview.
University Children’s Hospital Zurich (Universitäts-Kinderspital Zürich — http://www.kispi.uzh.ch)
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Posted in Aortic Valve: TAVR, TAVI vs Open Heart Surgery, Cardiac and Cardiovascular Surgical Procedures, Electrophysiology, Frontiers in Cardiology and Cardiovascular Disorders, Medical Devices R&D and Inventions, Valves & Tools on December 21, 2016| Leave a Comment »
Reporter: Aviva Lev-Ari, PhD, RN
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.
For more information: www.biotracemedical.com
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.”
For more information: www.biotracemedical.com
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
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.