Author Interviews, Heart Disease, JACC, Surgical Research, Technology / 20.11.2018
Comparison of the Evolut R™TAVR Valve with the Evolut PRO™
MedicalResearch.com Interview with:
Dr. Shazia Afzal MD
University Hospital Düsseldorf, Medical Faculty, Division of Cardiology, Pulmonology and Vascular Medicine, Düsseldorf, Germany
MedicalResearch.com: What is the background for this study?
Response: Since its introduction in 2002, transcatheter aortic valve replacement (TAVR) emerged to an increasingly important interventional procedure in the field of structural heart disease. Widespread use in Europe, the USA and Canada lead to continuous technological development and improved patient’s safety, procedural success and clinical outcome.
In 08/2017 one of the market leaders introduced its latest generation valve model -the CoreValve Evolut PROTM- which was especially designed to mitigate paravalvular leakage after valve deployment. We conducted the first prospective study which directly compares the Evolut PROTM with its direct predecessor the Evolut RTM as a head-to-head analysis especially focusing on hemodynamic performance and clinical outcome in a real-world setting. To ensure comparability between groups, we performed propensity score matching with special interest in CT-derived data to guarantee equitable anatomical conditions.
Since both valves are on the market but sold at different prices the pivotal question is whether the Evolut PROTM reaches its target. In a highly budget restricted health care system with limited refunding cost-effectiveness evolves to a substantial discussion point in daily clinical practice. Our results may not be marketing friendly but we think of relevance for the interventional community.
Dr. Shazia Afzal MD
University Hospital Düsseldorf, Medical Faculty, Division of Cardiology, Pulmonology and Vascular Medicine, Düsseldorf, Germany
MedicalResearch.com: What is the background for this study?
Response: Since its introduction in 2002, transcatheter aortic valve replacement (TAVR) emerged to an increasingly important interventional procedure in the field of structural heart disease. Widespread use in Europe, the USA and Canada lead to continuous technological development and improved patient’s safety, procedural success and clinical outcome.
In 08/2017 one of the market leaders introduced its latest generation valve model -the CoreValve Evolut PROTM- which was especially designed to mitigate paravalvular leakage after valve deployment. We conducted the first prospective study which directly compares the Evolut PROTM with its direct predecessor the Evolut RTM as a head-to-head analysis especially focusing on hemodynamic performance and clinical outcome in a real-world setting. To ensure comparability between groups, we performed propensity score matching with special interest in CT-derived data to guarantee equitable anatomical conditions.
Since both valves are on the market but sold at different prices the pivotal question is whether the Evolut PROTM reaches its target. In a highly budget restricted health care system with limited refunding cost-effectiveness evolves to a substantial discussion point in daily clinical practice. Our results may not be marketing friendly but we think of relevance for the interventional community.
Dr. Mangione[/caption]
Dr. Carol Mangione M.D., M.S.P.H., F.A.C.P
Ronald Reagan UCLA Medical Center
Division Chief of General Internal Medicine and Health Services Research
Professor of Medicine.
Barbara A. Levey, MD, and Gerald S. Levey, MD
Endowed chair in medicine David Geffen School of Medicine
University of California
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: Unhealthy alcohol use is relatively common and is increasing among U.S. adults. Alcohol use is the third leading cause of preventable death in the U.S. and contributes to more than 88,000 deaths per year. In pregnancy, it also leads to birth defects and developmental problems in children. The Task Force found that screening tests and brief counseling interventions can help detect and reduce unhealthy alcohol use among adults, and in turn help prevent negative consequences related to alcohol use. For adolescents ages 12 to 17, clinicians should use their best judgment when deciding whether or not to screen and refer their patients to counseling, until we have better studies available.
Dr. Pedersen[/caption]
Professor Oluf Pedersen
Novo Nordisk Foundation Center for Basic Metabolic Research
University of Copenhagen
MedicalResearch.com: What is the background for this study?
Response: We focused our study on healthy people due to the world-wide bottom-up movement among healthy adults to live gluten-free or on a low-gluten diet.
Therefore, we undertook a randomised, controlled, cross-over trial involving 60 middle-aged healthy Danish adults with two eight week interventions comparing a low-gluten diet (2 g gluten per day) and a high-gluten diet (18 g gluten per day), separated by a washout period of at least six weeks with habitual diet (12 g gluten per day).
The two diets were balanced in number of calories and nutrients including the same total amount of dietary fibres. However, the composition of fibres differed markedly between the two diets.
When the low-gluten trend started years back the trend was without any scientific evidence for health benefits. Now we bring pieces of evidence that a low-gluten diet in healthy people may be related to improved intestinal wellbeing due to changes in the intestinal microbiota which to our surprise is NOT induced by gluten itself but by the concomitant change in the type of dietary fibres linked to a low-gluten intake.
Eliane Abou-Jaoude, MD
Allergy and Immunology Fellow
Henry Ford Health System
Detroit, Michigan
MedicalResearch.com: What is the background for this study?
Response: Early life exposure to diverse types of microbes is necessary for healthy immune development and may impact the risk for developing allergic disorders.
Theoretically the transfer of parental microbes to their offspring during infancy can influence a child’s developing gut microbiome and subsequent immune response patterns.
We wished to investigate whether parental pacifier cleaning methods, reported at 6-months of age, were associated with altered serum IgE trajectory over the first 18 months of life.
Dr. Nidich[/caption]
Sanford Nidich, Ed.D.
Director, Center for Social-Emotional Health
Maharishi University of Management Research Institute
Fairfield, Iowa
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: Posttraumatic stress disorder (PTSD) is a complex and difficult-to-treat disorder, affecting 10-20% of veterans across eras. Previous research raised the question of whether a non-trauma focused treatment can be as effective as trauma exposure therapy in reducing PTSD symptoms. The overall objective of the study was to compare Transcendental Meditation (TM), a non-trauma focused practice, to prolonged exposure (PE) in a non-inferiority clinical trial, and to compare both to a PTSD health education control group.
Transcendental Meditation was found to be as effective as PE in reducing PTSD symptoms severity from baseline to three-month posttest. In standard superiority comparisons, significant reductions in PTSD symptoms were found for TM vs. HE, and PE vs. HE. Percentages of participants with clinically significant improvement, as measured by the Clinician-Administered PTSD Scale (CAPS) interview (≥10 point reduction), were TM=61%, PE=42%, and HE=32%