Dr. Jacquelyn Kulinski[/caption]
Jacquelyn Kulinski, MD
Assistant Professor
Division of Cardiovascular Medicine
Medical College of Wisconsin
Milwaukee, WI 53226
MedicalResearch.com: What is the background for this study? What are the main findings?
Dr. Kulinski: Sedentary behavior, or “sitting disease”, is increasingly recognized as a risk factor for cardiovascular disease, diabetes, cancer and early death. Many of these associations appear to be independent of exercise activity. The mechanisms through which sedentary behavior influences cardiovascular risk are largely unknown. Therefore, we investigated the association between accelerometer measured sedentary behavior and coronary artery calcium (CAC), a marker of subclinical heart disease, in over 2,000 participants using data from the Dallas Heart Study (DHS) population.
We found a significant association between increasing sitting time and CAC in a population without prior history of cardiovascular disease. This association was independent of measured exercise activity, traditional risk factors, and even socioeconomic factors. Each hour of sedentary time was associated with a 16% increase in CAC burden. Interestingly, the association between exercise and CAC was not significant in the fully-adjusted model.
Dr. Luigi Di Biase[/caption]
Luigi Di Biase, MD, PhD, FACC, FHRS
Section Head Electrophysiology
Director of Arrhythmia Services
Associate Professor of Medicine, Department of Medicine (Cardiology)
Albert Einstein College of Medicine at Montefiore Hospital
Moses and Weiler Campuses
Montefiore-Einstein Center for Heart & Vascular Care
Bronx, NY 10467
MedicalResearch.com: What is the background for this study? What are the main findings?
Dr. Di Biase: The superiority of catheter ablation of atrial fibrillation (AF) over antiarrhythmic drugs (AADS) has been tested and demonstrated in several randomized clinical trial in patients with normal ejection fraction and paroxysmal AF. Only a few studies are available for patients with heart failure and persistent AF. In this multicenter randomized trial we compared the most utilized AAD for heart failure patients to achieve a rhythm control strategy (Amiodarone) vs ablation of atrial fibrillation in patients with heart failure, persistent AF and ICD. Catheter ablation was superior to Amiodarone to achieve long term freedom from AF. In addition patients undergoing ablation had a lower re-hospitalization rate and importantly a lower mortality.
Dr. Frank Peacock[/caption]
Dr. William Frank Peacock MD, FACEP
Baylor College of Medicine, Houston
MedicalResearch.com: What is the background for this study? What are the main findings?
Dr. Peacock: Patients with atrial fibrillation get strokes but can take anticoagulation which is very effective at preventing strokes.
Patients on anticoagulation bleed, to the point that a very few die.
The higher the CHADSVASC score, the more likely you are to have a stroke.
Also the more likely you are to bleed.
But the risk of stroke ALWAYS exceeds the risk of bleeding.
We studied diabetics with atrial fibrillation as a subset, because diabetes is significant predictor for both stroke and bleeding and we wanted to determine if our understanding of the risks and benefits were maintained in real world trial.
What we found was the risk of a fatal major bleed for a diabetic with atrial fibrillation who was taking rivaroxaban was 0.09/100 patient years of treatment.
We know that the risk of having a stroke in a patient with a CHADS score of 2 is about 3% per year (that is 3/100 patients will stroke).
Put in a similar denominator as our study, failing to treat an Afib diabetic will results 300 strokes for every 100 patient years, which compares to the effect of treatment, which will significantly prevent stroke, at the cost of 0.1 major bleed fatality per 100 patient years. Even if the effect of treatment was as low as 50% (which it is not), that is still preventing 150 strokes.
0.1 dead, to prevent 150 strokes seems like easy math to me.
Dr. Laura Mauri[/caption]
Laura Mauri, MD,MSc
Professor, Harvard Medical School
Brigham and Women Hospital
MedicalResearch.com: What is the background for this study?
Dr. Mauri: The Dual Antiplatelet Therapy (DAPT) Study, the largest randomized controlled trial to date comparing different durations of dual antiplatelet therapy (thienopyridine plus aspirin) after coronary stenting, found that patients who were free from major ischemic or bleeding events at 1 year after coronary stenting with either drug-eluting or bare metal stents, and who were compliant with their antiplatelet therapy, experienced significant reductions in stent thrombosis and myocardial infarction (MI) but increases in moderate or severe bleeding when treated with 30 months of thienopyridine plus aspirin, as compared with 12 months. In this analysis of the DAPT Study, we wanted to determine whether the subset of patients who had a MI before the study or at the time of the index stenting procedure had different risks or benefits with long-term dual antiplatelet therapy compared to patients with no history of MI prior to or at the time of the index stenting procedure. We also wanted to evaluate whether the use of a clinical decision tool to identify patients expected to derive benefit vs. harm from continuing thienopyridine beyond one year after coronary stenting (the DAPT Score), would aid in the individualized prescription of dual antiplatelet therapy duration among these populations.
[caption id="attachment_20452" align="alignleft" width="117"] Dr. Joseph Yeboah[/caption] MedicalResearch.com Interview with: Joseph Yeboah MD, MS M.B.Ch.B. Maya Angelou Center for Health Equity Epidemiology & Prevention Heart and Vascular Center of Excellence Wake Forest University School of Medicine Medical Research: What is the background for this study? What are the main findings? Dr. Yeboah: In 2013 the American College of Cardiology/American...
Dr. Joseph Ladapo[/caption]
Joseph A. Ladapo, MD, PhD
Assistant Professor of Medicine and Population Health
Section on Value and Effectiveness
Department of Population Health
NYU Langone School of Medicine
New York NY 10016
MedicalResearch.com: What are the main findings?
Dr. Ladapo: While cardiac implantable electronic devices (CIEDs) are increasingly used to treat patients with arrhythmias, heart failure, and other risk factors for sudden cardiac death, these implantable devices require life-long follow-up to assess their performance and functionality. This need for continuous monitoring has galvanized the development of remote monitoring technologies for patients with CIEDs. Although randomized studies have shown that remote monitoring may reduce healthcare utilization and expenditures when compared to in-office monitoring, little is known about whether these findings generalize to day-to-day clinical practice. We aimed to address this uncertainty by evaluating healthcare utilization and expenditures in a cohort of patients with newly-implanted CIEDs who were followed remotely or with in-office monitoring.
MedicalResearch.com: What is the background for this study?
Dr. Ladapo: Remote monitoring is associated with a reduction in patients’ utilization of ambulatory and acute care and a reduction in expenditures associated with this utilization—at least over 24 months. This reduction was most pronounced among remotely monitored patients with implantable cardioverter defibrillators (ICDs). Although many of our comparisons between remote and office monitoring were not statistically significant, they trended toward favoring remote monitoring.
Dr. Kazuomi Kario[/caption]
Kazuomi Kario, MD, PhD, FACP, FACC, FAHA, FESC
Professor, Chairman
Division of Cardiovascular Medicine, Department of Medicine
Jichi Medical University School of Medicine (JMU)
JMU Center of Excellence, Cardiovascular Research and Development (JCARD)
Hypertension Cardiovascular Outcome Prevention and Evidence in Asia (HOPE Asia) Network
Staff Visiting Professor of Medicine,
UCL Institute of Cardiovascular Science
University College London, London UK
MedicalResearch.com: What is the background for this study? What are the main findings?
Dr. Kario: The relationship between out-of-office blood pressure (BP), such as ambulatory BP and home BP, and cardiovascular events has been investigated in several studies. However, there is insufficient evidence as yet regarding which BP measurement predicts coronary artery disease (CAD) events most strongly.
The HONEST Study is the largest prospective observational study in the world, which enrolled >20,000 hypertensive patients. The study observed cardiovascular events, monitoring both clinic BP and home BP on treatment of antihypertensive agent.
The present analysis shows that home BP measured in morning (morning home BP) is a strong predictor of both CAD and stroke events in future, and may be superior to clinic BP in this regard. Furthermore, there does not appear to be a J-curve in the relationship between morning home BP and CAD or stroke events.
Dr. Klaus Witte[/caption]
Dr Klaus Witte MD, FRCP, FESC, FACC
Associate Professor and Consultant Cardiologist
Lead Clinician for Cardiology
University of Leeds and Leeds Teaching Hospitals NHS Trust
MedicalResearch.com: What is the background for this study? What are the main findings?
Dr. Witte: Chronic heart failure (CHF) is a condition of heart muscle weakness that despite optimal treatment often leaves patients with ongoing symptoms of breathlessness and fatigue.
Vitamin D has a large number of effects in the body beyond its known effects on the skeleton.
Patients with Chronic heart failure are frequently deficient in vitamin D, but until now there were no data demonstrating a benefit from supplements.
We conducted a randomised, placebo-controlled study of a non-calcium-based vitamin D supplement providing 4000IU or 100mcg per day of vitamin D3 (VINDICATE).
Endpoints included 6-minute walk distance and cardiac function. We saw no improvement in 6 minute walk distance but a large and significant improvement in heart function (left ventricular ejection fraction) and heart size (left ventricular dimensions and volumes) after on year. We saw no significant adverse effects and the tablets were well tolerated.
Dr. Jordan B. King[/caption]
Dr. Jordan B. King
Post Doctoral Fellow
Pharmacotherapy Outcome Resctr,
University of Utah
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: The cornerstone of treatment in heart failure with reduced ejection fraction (HFrEF) revolves around low-cost generic medications such as angiotensin converting enzyme inhibitors (ACEIs) and beta-blockers (BBs). However, recently the dual-acting angiotensin receptor neprilysin inhibitor (ARNI) sacubitril-valsartan, demonstrated improved survival and reduction in heart failure hospitalizations relative to enalapril, an ACEI, and optimal background therapy. This creates a situation in which we have a new medication which improves outcomes, but carries a high price tag ($4,560 per year) compared with ACEIs, the standard of care over the last 20 years, and are available as generic medications for <$50 per year. We set out to determine the incremental cost-effectiveness ratio (ICER) per quality adjusted life year gained (QALY) from the perspective of a health care payer in the U.S. The ICER is a measure of how much we have to pay for sacubitril-valsartan to gain 1 unit of health relative to enalapril. In this case the unit of health is a year of life adjusted for quality.
We used a Markov model to estimate the costs and effectiveness of the two treatment options over a lifetime. In the base case, the ICER for sacubitril-valsartan was $50,959 per QALY gained. Health care interventions which cost <$50,000 per QALY are generally considered cost-effective, but some argue that <$100,000 per QALY is a more appropriate threshold in the U.S. In a probabilistic sensitivity analysis, 57% and 80% of all simulations fell below the $50,000 and $100,000 per QALY thresholds, respectively. Sacubitril-valsartan was the less costly treatment arm in 5% of simulations, and enalapril dominated (less costly and more effective) in 17% of simulations.
Dr. Ross Tsuyuki[/caption]
Ross T. Tsuyuki, BSc(Pharm), PharmD, MSc, FCSHP, FACC
Professor of Medicine (Cardiology) and Director, EPICORE Centre
Faculty of Medicine and Dentistry
University of Alberta
EPICORE CENTRE
Research Transition Facility
University of Alberta Edmonton, AB
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: As you know, most cardiovascular disease is caused by modifiable risk factors. However, the identification and control of these risk factors continues to elude us.
Pharmacists in the community are the most accessible primary healthcare providers. That is being increasingly recognized and the scope of practice for pharmacists has been changing to meet these needs. In Alberta, Canada, pharmacists have one of the broadest scopes of practice - many can independently prescribe and order laboratory tests.
We sought to test the effect of a pharmacist-based prescribing and care program in patients at high risk for cardiovascular events.
We enrolled 723 patients at high risk for cardiovascular events (defined as those with diabetes, vascular disease (coronary, cerebrovascular, or peripheral arterial disease), chronic kidney disease, or high Framingham risk (>20%) primary prevention. All patients were recruited by their pharmacist and had to have at least one modifiable risk factor not well controlled.
Patients were randomized to receive pharmacist intervention or usual care.
Intervention patients received a Medication Therapy Management review, consisting of assessment of cardiovascular risk, patient education, and management of the patients' risk factors, according to the latest Canadian guidelines. Pharmacists conducted follow-up visits monthly.
Usual care patients were the control (comparison) group and received usual pharmacist and physician care. Both groups were followed for 3 months.
The primary outcome measure was the difference in estimated cardiovascular risk at 3 months, as calculated using validated risk engines such as Framingham, the International Risk Score, and the UKPDS risk.
We found a 21% reduction in the risk for cardiovascular events in the pharmacist care group compared to control.
There was also significant reductions in blood pressure, LDL cholesterol, glycated hemoglobin in those with diabetes, and 21% fewer smokers in the pharmacist care group compared to control.
Dr. Jacob Joseph[/caption]
Jacob Joseph, MD, FACC, FAHA
Associate Professor of Medicine, Harvard Medical School
Cardiology Consortium Lead, VA Clinical Trial Network,
Associate Physician, Brigham & Women's Hospital
MedicalResearch.com: What is the background for this study? What are the main findings?
Dr. Joseph: The background for this study is the fact that heart failure with preserved ejection fraction (HFPEF) continues to be a challenge for cardiology. Clinical trials have thus far failed to give us a treatment. One of the major issues in clinical care and research is the marked heterogeneity of this condition. Is an 80 year old woman with HFPEF, chronic kidney disease, and atrial fibrillation the same as a 50 year old hypertensive with left ventricular hypertrophy and HFPEF? In fact the recently reported TOPCAT study showed that the outcomes in patients enrolled in North and South America were significantly different from patients enrolled from Russia and Georgia, an effect that may have partly affected the results of the entire trial.
In this study we examined whether a simple clinical tool like QRS duration measured on ECG could help to identify a subgroup of HFPEF patients who are at risk of adverse outcomes. When we analyzed the patients enrolled in the TOPCAT trial, we did in fact find that prolonged QRS duration is associated with worse outcomes in HFPEF. This association was independent of the region of enrollment and traditional cardiac risk factors. We also found that the association was seen in different types of conduction blocks. Furthermore the risk of adverse events started at QRS duration of approximately 100ms.
Dr. H. Kirk Hammond[/caption]
H Kirk Hammond, MD
Professor of Medicine (Cardiology)
University of California San Diego
Veterans Affairs San Diego Healthcare System
San Diego, CA 92161
MedicalResearch.com: What is the background for this study?
Dr. Hammond: Heart failure affects >28 million patients worldwide and is the only cardiovascular disease that is increasing in prevalence. Despite steady improvement in drug therapy for heart failure, recent hospitalization rates and mortality have changed little. New therapies are needed. Adenylyl cyclase type 6 (AC6), is a protein that catalyzes the conversion of ATP to cAMP and is an important determinant of heart function. The amount and function of AC6 are reduced in failing hearts, and preclinical studies have shown benefits of increased cardiac AC6 content on the heart. The aim of the trial was to determine safety and heart function gene transfer of AC6, achieved by intracoronary delivery of an inactivated virus carrying the gene for AC6 (Ad5hAC6) in patients with symptomatic heart failure and reduced ejection fraction. Our hypothesis was that AC6 gene transfer would safely increase function of the failing hearts of patients with heart failure.
Dr. Nicola Gaibazzi[/caption]
Dr. Nicola Gaibazzi
Department of Cardiology
Parma University Hospital
Parma Italy
MedicalResearch.com: What is the background for this study? What are the main findings?
Dr. Gaibazzi: As clinical and research cardiologists we have never accepted that cardiac arrests are so frequently deadly throughout the world (sudden cardiac arrest is the world’s leading cause of death) because many of such events could be easily reversed by early defibrillation if only witnessed by a bystander who could quickly call emergency in place of the incapacitated subject.
This would be lifesaving for most of them, gaining quick access to defibrillation within the golden 8-10 minutes (in the Oregon state study 6.5 minutes is the average time from call to defibrillation). While this issue of early defibrillation access is not easy to be solved for cardiac arrest in the general population, it was surprising to us that there was no available tool to date to automatically alert emergency contacts for people who regularly practice outdoor sports alone, such as running or cycling, and may undergo sudden and unexpected sports-associated cardiac arrest. It is a rare event, but it may happen during exercise, when cardiac arrest is actually several times more frequent than during resting condition, both in sedentary and active subjects. It was surprising to us seeing all people practicing with their earbuds, listening to music from their last-generation smartphone, often used only as if it were an old music cassette “walkman”, while it is a powerful and wireless-connected portable computer with an incredible potential for emergency rescue.
Consequently, in 2015 we founded a startup company (www.parachute-app.com or temporary new site http://nicolagaibazzi.wix.com/mysite) and started building an app that could take advantage of the capabilities of modern smartphones to automatically detect sports-associated cardiac arrest, specifically aiming at recognizing ventricular tachycardia or ventricular fibrillation. This was not an easy task, since we wanted to use simple, cheap and commercially-available hardware, possibly already at hand for sportspeople; otherwise too few subjects would use it and you would not impact such infrequent disease with only few sportsmen using it, since sports-associated cardiac arrest is rare (2/100000 athletes/year) but not negligible, with 2450 deaths in US only each year.
We finally chose to use as the only additional required hardware a BT+ heart rate monitor chest strap (a chest strap can be bought if not already owned at 40$), which is cheap, reliable, able to transmit heart rate with trivial battery drainage detected through cardiac electrical signal with trivial battery drainage, and much more reliable than pulse-plethysmographic methods which fully depend on the device contact with the arm or wrist skin to collect a correct signal. We could not afford in our lifesaving app that a wrong wrist or arm device contact would cause absence of pulse signal detection erroneouslytriggering a cardiac arrest alert or not doing so when a cardiac arrest is truly present. Chest straps on the contrary send heart rate sensed from electrical heart activity and are almost impossible to displace even in case of an unconscious subject falling down.
We built and tested our Parachute app for the iPhone during 2015, through long testing in the outdoor field and with arrhythmia simulators and at the ACC congress we present just part of the data collected from such tests in athletes running and cycling and with advanced arrhythmia simulators. Parachute was incredibly accurate both to avoid false positives and false negatives, thanks to continuously combined chest strap heart rate data and motion or, better, detection of “no motion”, corresponding to a possible incapacitated subject. These two mechanisms act together and complete each other, they are synergic, since while our patent-pending algorithm using heart rate data is very sensitive for serious arrhythmias, motion detection can easily exclude false positives during outdoor sports, where motion is by definition almost continuous.
MedicalResearch.com Interview with: [caption id="attachment_22924" align="alignleft" width="133"] Dr. Kristian Filion[/caption] Kristian B. Filion, Ph.D., FAHA Assistant Professor of Medicine, Division of Clinical Epidemiology, McGill University Principal Investigator, Center for Clinical Epidemiology, Lady Davis Institute, Jewish General Hospital Associate Member, Department of Epidemiology, Biostatistics, and Occupational Health, McGill University MedicalResearch.com: What is the background for this study? What...
MedicalResearch.com Interview with: [caption id="attachment_22792" align="alignleft" width="186"] Dr. Paul Gurbel[/caption] Paul A. Gurbel, M.D. Director, Inova Center for Thrombosis Research and Drug Development Director, Cardiovascular Medicine Research Director, Interventional Cardiology Inova Heart and Vascular Institute Falls Church, VA Professor of Medicine, Johns Hopkins University School of Medicine Adjunct Professor of Medicine, Duke University School of Medicine MedicalResearch.com: What is the background for...
Dr Marlene Grenon[/caption]
S. Marlene Grenon, MDCM, MMSc, FRCSC
Associate Professor of Surgery
Division of Vascular and Endovascular Surgery
University of California, San Francisco
Veterans Affairs Medical Center- Surgical Services
San Francisco, CA
MedicalResearch.com: What is the background for this study? What are the main findings?
Dr. Grenon: In this study, we investigated the impact of PTSD on endothelial function using flow-mediated brachial artery vasodilation.
After adjustments for different risk factors and comorbidities, we found that patients with PTSD had worse endothelial function.
Dr. Eric Secemsky[/caption]
Eric Alexander Secemsky, MD, MSc
Fellow in Cardiovascular Medicine
Massachusetts General Hospital
Harvard Medical School
Smith Center for Outcomes Research in Cardiology, Beth Israel Deaconess Medical Center
MedicalResearch.com: What is the background for this study?
Dr. Secemsky: Strategies to reduce bleeding, such as the selective use of procedural anticoagulants, have become an integral component of current percutaneous coronary intervention (PCI) practice to decrease adverse outcomes. For instance, previous randomized clinical trials had demonstrated that use of bivalirudin, a direct thrombin inhibitor, reduces major bleeding events following PCI among patients presenting with acute myocardial infarction (AMI) compared with unfractionated heparin (UFH). These findings resulted in a major increase in bivalirudin use during PCI.
However, more recent trials have contradicted these results and created uncertainty as to the relative safety and effectiveness of bivalirudin therapy. In addition, current United States guidelines do not endorse a primary antithrombotic strategy during PCI, leaving the choice of procedural anticoagulant to the discretion of the physician operator. As such, we wanted to determine how bivalirudin was currently being used among United States PCI operators and how usage may have changed in light of these trial findings.
Dr. Colleen McIlvennan[/caption]
Colleen K. McIlvennan, DNP, ANP-BC
Assistant Professor of Medicine
Division of Cardiology
Section of Advanced Heart Failure and Transplantation
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: As technology continues to advance, more people are becoming eligible for advanced therapies for end-stage illness. One such therapy, the left ventricular assist device (LVAD) is an option for carefully selected individuals suffering from end-stage heart failure. Use of this innovative technology has expanded from its original indication as a bridge to transplantation to also include destination therapy, in which patients live with the device for the remainder of their lives. Significant focus has been placed on developing and expanding LVAD programs, with less thought about the eventual end-of-life process awaiting patients whose LVAD is indicated for destination therapy.
We performed semi-structured interviews about experiences surrounding end of life with 8 caregivers of patients who died with an LVAD. There was a wide range of case histories represented by these patients; however, three main themes emerged that coalesced around feelings of confusion:
1) the process of death with an LVAD,
2) the legal and ethically permissible care of patients approaching death with an LVAD, and
3) the fragmented integration of palliative and hospice care.