MedicalResearch.com Interview with: Matthew E. Dupre, PhD
Associate Professor of Medicine
Department of Community and Family Medicine
Department of Sociology
Duke Clinical Research Institute
MedicalResearch: What is the background for this study? What are the main findings?Dr. Dupre: The negative health consequences of divorce have been known for some time. However, we showed that lifetime exposure to divorce can have a lasting impact on ones’ cardiovascular health, particularly in women. This is a good example of why people going through a divorce need a good divorce lawyer chicago in order to keep their stress levels down and help their cardiovascular health. Results from our study showed that risks for acute myocardial infarction (AMI) were significantly higher in women who had one divorce, two or more divorces, and among the remarried compared with continuously married women after adjusting for multiple risk factors. Risks for AMI were elevated only in men with a history of two or more divorces relative to continuously married men. We were especially surprised to find that women who remarried had risks for AMI that were nearly equivalent to that of divorced women. Men who remarried had no significant risk for acute myocardial infarction.
The results of this study provide strong evidence that cumulative exposure to divorce increases the risk of acute myocardial infarction in older adults. Also somewhat unexpected was that the associations remained largely unchanged after accounting for a variety socioeconomic, psychosocial, behavioral, and physiological factors. However, we lacked information on several factors that we suspect may have contributed to the risks related to divorce – such as elevated stress, anxiety, and the loss of social support; as well as possible changes is medication adherence or other prophylactic behaviors.
MedicalResearch: What should clinicians and patients take away from your report?(more…)
MedicalResearch.com Interview with: Salah Altarabsheh, MD,MRCSI
Cardiac Surgery Senior Specialist
Queen Alia Heart Institute Amman, Jordan
Coronary artery bypass grafting is the most common surgical procedure performed by cardiac surgeons worldwide. With the increased life expectancy for the general population, and the added comorbidities among elderly population, we are seeing a good number of elderly populations who are referred for coronary artery bypass surgery. There are few reports which compare off-pump versus on-pump methods of revascularization among this subset of elderly people. We choose octogenarians in our meta-analysis to see whether off-pump revascularization method could be of benefit since there is increased chance to have ascending aortic calcifications among these patients, and off-pump coronary artery bypass in which there is lesser chance for aortic manipulations, can be beneficial.
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MedicalResearch.com Interview with:
Pamela S. Douglas, M.D.
Duke University School of Medicine
Duke University Medical Center
Durham, NC 27715
Medical Research: What is the background for this study?
Dr. Douglas: The primary objective of the PROMISE study was to compare the health outcomes of people who went to the doctor with new symptoms such as shortness of breath and/or chest pain that were suggestive of coronary artery disease and that required additional evaluation. This was an important investigation because no large research trial has ever been conducted to help guide the care of such patients. Instead, the selection of tests for such patients—which constitutes at least 4 million patients in the United States each year—has been largely left up to physician and patient preference rather than proven results.
Medical Research: What are the main findings?
Dr. Douglas: 10,003 patients from 193 different medical facilities across the US and Canada agreed to be part of the PROMISE study and were randomized to a functional stress test or an anatomic test Using CT angiography. The study found that the clinical outcomes of participants with suspected coronary artery disease were excellent overall, and were similar in terms of death and major cardiac conditions regardless of whether patients had a functional stress test or a computed tomographic scan. However, the CT scan may be better at ruling out the need for subsequent tests and procedures in patients who are free of heart disease, and involved a lower radiation exposure relative to a stress nuclear study. We also found, in a separately reported study, that the costs of the two diagnostic strategies were similar.
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MedicalResearch.com Interview with:
Anne Vorlat MD
Department of Cardiology
Antwerp University Hospital
Department of Cardiology, Edegem, Belgium
MedicalResearch: What is the background for this study? What are the main findings?Dr. Vorlat: Early diagnosis of myocardial infarction is critical for optimal treatment and prognosis of the patient. The third universal definition of myocardial infarction states that a rise and/or fall of cardiac biomarkers (preferably troponin) with at least one value above the 99th percentile of the upper reference limit is mandatory with symptoms and or ST segment changes on the ECG. Since the development of more sensitive assays for cardiac troponins, myocardial injury can be detected earlier. This has permitted to shorten the timing of the second sampling of cardiac biomarkers from 6h to 3h after the first sampling. Recent studies have tested biomarker protocols with a very short delay (e.g., 1 hour) or with a single measurement of troponin and copeptin (a marker of endogenous stress, not cardiac specific) to rule in or to rule out myocardial injury in a population with chest pain. Although these newer protocols appear to be promising, early presenters (chest pain for less than 2 hours) are underreported. The present study evaluated the usefulness of early rule-in and rule-out biomarker protocols to estimate ischemia-induced myocardial injury in an early presenter model. The “early presenter” model was tested in 107 stable patients after a short period of myocardial ischemia, induced by stenting of a significant coronary artery stenosis. High-sensitivity troponin T (hsTnT), hsTnI and copeptin were measured at the start, and 90, 180 and 360 minutes after stent implantation. We confirmed our hypothesis that short biomarkers protocols underestimate myonecrosis in early presenters.
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MedicalResearch.com Interview with:
Sayan Sen, PhDInternational Centre for Circulatory Health, National Heart and Lung Institute
Imperial College London
London, United Kingdom
Medical Research: What is the background for this study? What are the main findings?
Dr. Sayan Sen: Intra-aortic balloon pumps (IABP) are often used in Acute Myocardial Infarction, particularly in patients with cardiogenic shock. We analysed the available Randomized Controlled Trials (RCT) and observational studies, spanning 30 years, to establish the evidence for this use.
There is no identifiable group of patients with Acute Myocardial Infarction that have been demonstrated to derive a mortality benefit from insertion of an IABP. The studies, including over 17000 patients, have studied mortality in patients receiving IABP in comparison to mortality of patients that received no IABP in the era of no reperfusion, fibrinolysis and primary percutaneous intervention. This lack of mortality reduction with IABP in AMI is consistent in patients with and without cardiogenic shock across both RCTs and observational studies; questioning the continued use of this technology in Acute Myocardial Infarction.(more…)
MedicalResearch.com Interview with:
Tanush Gupta, MD
Department of Medicine, Division of Cardiology
New York Medical College, NY
Medical Research: What is the background for this study? What are the main findings?
Dr. Gupta: There are approximately 600,000 prevalent cases of end stage renal disease (ESRD) in the United States. Cardiovascular disease is the leading cause of death in ESRD patients. Moreover, approximately 20% of these deaths due to cardiovascular disease are attributable to acute myocardial infarction (AMI). Multiple studies have shown that ESRD patients have poor short- and long-term survival after AMI relative to the general population. We analyzed the publicly available Nationwide Inpatient Sample (NIS) databases from 2003 to 2011 to examine the temporal trends in ST-elevation myocardial infarction (STEMI), use of mechanical revascularization for STEMI, and in-hospital outcomes in adult ESRD patients in the United States.
We found that from 2003 to 2011, whereas the number of acute myocardial infarction hospitalizations in ESRD patients increased from 13,322 to 20,552, there was a decline in the number of STEMI hospitalizations from 3,169 to 2,558. The use of percutaneous coronary intervention (PCI) for STEMI increased from 18.6% to 37.8%, whereas there was no significant change in the use of coronary artery bypass grafting. During the study period, in-hospital mortality in ESRD patients with STEMI increased from 22.3% to 25.3%. We also observed an increase in average hospital charges and a decrease in mean length of stay during the study period.
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MedicalResearch.com Interview with:
Abhishek Sharma MD (on behalf of all co-authors)
Division of Cardiovascular Medicine
State University of New York Downstate Medical Center
Brooklyn, New York
MedicalResearch: What is the background for this study? Authors: Heart failure (HF) is the second most common cause of hospitalization after child delivery in the US. In general, increasing degrees of obesity have been associated with progressively worse outcomes among individuals without known cardiovascular (CV) diseases. Therefore intentional weight loss, via structured dietary and exercise training programs or bariatric surgery, has been suggested to reverse hemodynamic and cardiac structural changes associated with obesity. However, several recent studies have reported lower mortality and morbidity among heart failure patients who were overweight or obese compared with those whose weight was normal or subnormal. This phenomenon has been commonly labeled the “obesity paradox” or “reverse epidemiology.” These findings question the prognostic significance of BMI and the practice of extrapolating findings derived from the general population to HF patients.
Reasons for the association between BMI and all- cause and CV mortality and hospitalizations in HF are not fully understood. Due to contradictory results in various studies and lack of definitive data on prognostic value of BMI and its purposeful alteration in HF, the American College of Cardiology Foundation/American Heart Association do not provide any firm recommendations for purposeful weight loss in heart failure. To further explore the relationship between obesity and outcome in heart failure patients, we systematically examined the association between BMI and all- cause mortality, CV mortality and hospitalizations among patients with chronic heart failure.(more…)
MedicalResearch.com Interview with:
Sripal Bangalore, MD, MHA, FACC, FAHA, FSCAI
Director of Research, Cardiac Catheterization Laboratory,
Director, Cardiovascular Outcomes Group,
Associate Professor of Medicine,
New York University School of Medicine,
New York, NY 10016
Medical Research: What is the background for this study? What are the main findings?
Dr. Bangalore: Prior studies have shown a mortality benefit of bypass surgery over stenting. But these studies compared bypass surgery with older generation stents which are no longer used. We used data from the New York state registry of patients who underwent stenting or bypass surgery for 2 or more blockages of coronary arteries. With data from over 18,000 patients we found that there was no difference between stenting and bypass surgery for long term mortality. In addition we found that both procedures have trade offs. Bypass surgery has upfront risk of death and stroke whereas PCI has long term risk of needing a repeat procedure. In addition, in patients who underwent incomplete revascularization, there was increase in myocardial infarction with PCI.
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MedicalResearch.com Interview with:
Jonathan L. Halperin, M.D.
The Robert and Harriet Heilbrunn Professor of Medicine
Mount Sinai School of Medicine
Dr. Halperin is a member of the Steering Committee for the GLORIA-AF program and a consultant to Boehringer Ingelheim, which sponsored this research.Medical Research: What is the background for this study? What are the main findings?
Dr. Halperin: The two analyses come from the GLORIA-AF Registry Program, a global, prospective, observational study supported by Boehringer Ingelheim, which is designed to characterize the population of newly diagnosed patients with non-valvular atrial fibrillation (NVAF) at risk for stroke, and to study patterns, predictors and outcomes of different treatment regimens for stroke risk reduction in non-valvular atrial fibrillation patients. The data is based on treatment trends in 3,415 patients who entered the registry from November 2011 to February 2014 in North America. All patients had a recent diagnosis of NVAF, and 86.2 percent had a CHA2DS2-VASc score of 2 or higher.
Results from the first analysis demonstrated that patients with the paroxysmal (occasional) form of non-valvular atrial fibrillation and at a high risk for stroke (CHA2DS2-VASc score of 2 or higher) were given an anticoagulant medication less often than those with persistent or permanent forms of NVAF, and a CHA2DS2-VASc score of 2 or higher. This pattern runs counter to NVAF guidelines calling for patients to receive oral anticoagulant therapy based on their risk of stroke, rather than the type of atrial fibrillation.
In the second analysis, researchers found that despite high stroke risk, a considerable number of patients receive only aspirin or no medication.
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MedicalResearch.com Interview with:Donald M Lloyd-Jones, MD/ScM
Senior Associate Dean for Clinical and Translational Research, Chair, Department of Preventive Medicine
Director, Northwestern University Clinical and Translational Sciences Institute (NUCATS) Eileen M. Foell Professor
Professor in Preventive Medicine-Epidemiology and Medicine-Cardiology
Northwestern University Feinberg School of MedicineMedicalResearch: What is the background for this study? What are the main findings?Dr. Lloyd-Jones: Previous studies have examined the associations of cardiovascular health, as defined by the American Heart Association, with outcomes in younger and middle-aged adults. Prior studies have also examined the status (i.e., prevalence) of cardiovascular health in adults across the age spectrum, and in adolescents ages 12-19 years. However, no study to date has examined the status of cardiovascular health in children under 12 years of age, so we sought to define it in detail using nationally-representative data.
Overall, although we have inadequate surveillance systems to monitor cardiovascular health optimally in our youngest children, this study shows that there are concerning signals that they are losing the intrinsic cardiovascular health they are born with, even well before age 12 years. The implications for loss of cardiovascular health before adulthood have been well established, with earlier onset of cardiovascular diseases, cancer and other diseases, earlier mortality, lower quality of life and many other adverse consequences.
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MedicalResearch.com Interview with:
Prof. Ran Kornowski, M.D, FACC, FESC
Chairman - Division of Cardiology,
Rabin Medical Center
Petah-Tikva, Israel
MedicalResearch: What is the background for this study? Prof. Kornowski: Over the years, the PCI procedure went-through many progresses. Among those are some angioplasty techniques, generalize use of stents and drug eluting stents, and adjuvant novel antithrombotic therapy. Unmistakably, these were associated with an overall improved PCI outcome. As many of the data on PCIs’ adverse outcomes predictors come from predates studies, we sought to update this matter.
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MedicalResearch.com Interview with: Dr Rajeev Kumar Pathak MBBS, FRACP
Cardiologist and Electrophysiology Fellow
Centre for Heart Rhythm Disorders | University of Adelaide
Cardiovascular Investigation Unit | Royal Adelaide Hospital Adelaide Australia
Medical Research: What is the background for this study? What are the main findings?Response: Obesity and atrial fibrillation (AF) are dual epidemics that frequently coexist. Weight-loss reduces atrial fibrillation burden; however, whether this is sustained, has a dose effect or is influenced by weight-fluctuation is not known. In this study we evaluated the long-term impact of weight-loss and weight-fluctuation on rhythm control in obese individuals with atrial fibrillation.
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MedicalResearch.com Interview with:
Stephen W. Waldo, MD
Research Fellow in MedicineMassachusetts General Hospital
MedicalResearch: What is the background for this study? What are the main findings?Dr. Waldo: Public reporting is intended to improve outcomes for our patients. Proponents of public reporting applaud the increased transparency that it offers, allowing both patients and physicians to objectively evaluate health care outcomes for a given institution or individual provider. Previous research has demonstrated, however, that public reporting of procedural outcomes may create disincentives to provide percutaneous coronary intervention for critically ill patients. The present study sought to evaluate the association between public reporting of outcomes with procedural management and clinical outcomes among patients with acute myocardial infarction. As the data demonstrate, public reporting of outcomes is associated with a lower rate of percutaneous revascularization and increased overall in-hospital mortality among patients with an acute myocardial infarction, particularly among those that do not receive percutaneous intervention. This may reflect risk aversion among physicians in states that participate in public reporting, an unintended consequence of this policy.
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MedicalResearch.com Interview with:
Raffaele Bugiardini, M.D.
Professor of Cardiology
University of Bologna
Medical Research: What is the background for this study? What are the main findings?
Dr. Bugiardini: Our analysis differs from previous reports of outcomes following STEMI because prior studies have not looked at sex differences in outcomes adjusted for time from symptom onset to hospital presentation and subsequent utilization of cardiac revascularization procedures, and rates of revascularization are typically significantly lower in women compared with men
Our study is the first to look at the relationship between delays and outcomes. (more…)
MedicalResearch.com Interview with:Marco Valgimigli, MD, PhD
Erasmus MC, Thoraxcenter,
Rotterdam The Netherlands
MedicalResearch: What is the background for this study? What are the main findings?Dr. Valgimigli: Interventional cardiologists can choose between two entry sites in order to perform a diagnostic coronary angiography and or a percutaneous coronary intervention, namely an artery which is in the groin called femoral artery or an artery which is located in the wrist which is called radial artery. The latter is more superficial and has small calibre as compared to the former. Femoral artery is the entry site which is most frequently used in the world especially in US where the use of radial artery is relatively limited.
Our study randomly allocated 8,404 patients to undergo diagnostic coronary angiography and PCI, if clinically indicated, either vie the femoral or the radial artery.
The main results of our study are that radial access reduced the composite of net adverse clinical events driven by a reduction of mortality and of major bleeding, including transfusions and need for surgical repair or the entry site.
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MedicalResearch.com Interview with: Pam R. Taub, MD, FACC
Assistant Professor of Medicine
UC San Diego Health System
Division of Cardiology Encinitas, CA 92024
Medical Research: What is the background for this study?Dr. Taub: Epidemiological studies indicate that the consumption of modest amounts of dark chocolate (DC), which contains the natural cacao flavanol (-)-epicatechin (Epi,) is associated with reductions in the incidence of cardiovascular diseases (CVD). The health benefits of dark chocolate have been attributed to Epi. Clinical studies using cocoa and/or DC in normal volunteers or subjects with CVD have reported improvements in peripheral and coronary vascular endothelial function, blood pressure, lipids, insulin resistance, and inflammatory markers. The mechanism underlying these improvements is thought to be due to increased nitric oxide levels and improved endothelial function. We have also shown that capacity of Epi to favorable impact mitochondria under normal and disease states.
We previously conducted pilot study in five patients with heart failure and type II diabetes, and showed that in skeletal muscle (SkM) biopsies there is a severe reduction in mitochondrial volume and cristae, as well as, in structural/functional proteins. After treatment with Epi rich dark chocolate , there was a significant recovery of SkM mitochondrial cristae, structural/functional proteins (e.g. mitofilin), as well as in regulators of mitochondrial biogenesis. However, no studies have examined the capacity of Epi rich dark chocolate to enhance exercise capacity in normal subjects and assess its impact on mitochondrial and oxidative control systems.
Medical Research: What are the main findings?Dr. Taub: Seventeen subjects were randomized to placebo (n=8) or DC groups (n=9) and consumed 2 squares of chocolate (20 g, provided by Hershey) for 3 months.
We showed in the chocolate group subjects had improved levels of HDL cholesterol and enhanced exercise capacity that is linked to the stimulation of SkM metabolic control endpoints which enhance mitochondrial function.
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MedicalResearch.com Interview with:
Sameer Bansilal, MD, MS
Asst. Prof.- Medicine and Cardiology
Clinical Trials & Global Health Studies
Icahn School of Medicine at Mount Sinai
Medical Research: What is the background for this study? What are the main findings?
Dr. Bansilal: Our group has previously published data from FREEDOM, COURAGE and BARI showing that adherence to recommended therapies are low in diabetic (DM) patients. We have spent the last decade developing a potential solution to this- the Fuster-Ferrer polypill. This study was done to better inform the association between levels of medication adherence and long term major adverse cardiovascular events (MACE) in high risk diabetic patients.
We analyzed a U.S. health insurers’ claims data for 19,962 high risk diabetic subjects. Using proportion of days covered (PDC) for 1 year after first refill, we stratified patients as fully adherent (FA≥80%), partially adherent (PA ≥40- ≤79%) or non-adherent (NA <40%) and examined the associations with a primary cardiovascualr outcome measure of death, myocardial infarction, stroke and coronary revascularization. We found that only 34% participants were fully adherent to therapy. When compared to being non-adherent at 2 yrs follow up,, being fully adherent was associated with a 28% lower rate of MACE; being partially adherent was associated with a 21% lower rate of MACE. Efforts towards improving adherence in diabetic subjects may lead to substantial reductions in MACE.
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MedicalResearch.com Interview with:
Colleen K. McIlvennan, DNP, ANP
Assistant Professor of Medicine
University of Colorado, Division of Cardiology
Section of Advanced Heart Failure and Transplantation
Medical Research: What is the background for this study?Response: Destination therapy left ventricular assist device (DT LVAD) patients are often older with significant comorbidities that preclude heart transplantation. As such, the decision to get a DT LVAD is arguably more complicated than the decision to receive a temporary LVAD in anticipation of a transplant. Centers offering LVADs often require the identification of a caregiver prior to proceeding with the implant. Caregivers are commonly female spouses of DT LVAD patients, who are also older with co-morbidities. Understanding their perspective in DT LVAD decision making is extremely important as they are at particular risk for experiencing stress and caregiver burden due to the increased demands on caregiving with DT LVAD.
Medical Research: What are the main findings?Response: We performed semi-structured qualitative interviews with 17 caregivers: 10 caregivers of patients living with DT LVAD, 6 caregivers of patients who had died with DT LVAD, and 1 caregiver of a patient who had declined DT LVAD. Throughout the interviews, the overarching theme was that considering a DT LVAD is a complex decision-making process.
Additionally, three dialectical tensions emerged:
1) the stark decision context, with tension between hope and reality;
2) the challenging decision process, with tension between wanting loved ones to live and wanting to respect loved ones’ wishes; and
3) the downstream decision outcome, with tension between gratitude and burden.
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MedicalResearch.com Interview with:
Prof. David Newby
British Heart Foundation Professor of Cardiology
University of Edinburgh
Director of the Wellcome Trust Clinical Research Facility
MedicalResearch: What is the background for this study? What are the main findings?Dr. Newby: The diagnosis of angina (chest pain) due to coronary heart disease can be very challenging and we often get it wrong. We have a wide range of tests that can try and identify patients with angina due to coronary heart disease. However, even with these tests, we fail to identify 1 in 3 patients who go on to have heart attacks. So we need better tests.
The study shows that if you add CTCA to a clinic consultation, you clarify the diagnosis in 1 in 4 patients, alter the investigations in 1 in 6 and change the subsequent treatments in 1 in 4. This did appear not only to increase the use of coronary revascularisation but also reduce the risk of subsequent heart attacks by 38-50%. (more…)
Prof Samir R Kapadia MD Director, Sones Cardiac Catheterization Laboratories
Cleveland Clinic Cleveland, OH
For patients with severe symptomatic aortic stenosis (AS) who are not candidates for surgical valve replacement, transcatheter aortic valve replacement (TAVR) offers superior benefit to standard therapy, as measured by all-cause mortality, cardiovascular mortality, repeat hospital admission and functional status. PARTNER 1B 5 year data were published simultaneously with PARTNER 1A 5 year data in 2 separate manuscripts in the Lancet (March 15 2105).
In this landmark trial, TAVR produced a 22 percent survival benefit and a 28 percent reduced risk of cardiovascular mortality, compared with standard treatment.
According to Cleveland Clinic interventional cardiologist Samir Kapadia, MD, lead author of PARTNER 1B, these findings have changed the treatment paradigm for severe Aortic Stenosis patients who can’t undergo surgical Aortic Valve Replacement.
“This trial is the first—and will probably be the only—randomized AS trial that includes a standard treatment group, since these results will make it unethical to treat severe AS patients with medical therapy alone without aortic valve replacement. ” he says.
Superior survival benefit with TAVR
PARTNER 1B is the only rigorous randomized trial of extreme-risk aortic stenosis patients that has prospectively reported the outcomes of TAVR versus standard treatment in patients for whom the estimated probability of death or serious irreversible morbidity after surgical aortic valve replacement was 50 percent or greater.
The trial enrolled 358 patients between May 11, 2007 and March 16, 2009; 179 patients were assigned to TAVR with the first-generation Sapien valve and 179 to standard therapy which includes medical therapy and balloon aortic valvuloplasty. TAVR was performed under general anesthesia with common femoral artery access. Guidance was provided by transesophagel echocardiography and fluoroscopy. The mean age of participants was 83.
The primary endpoint was all-cause survival. Secondary endpoints included cardiovascular mortality, stroke, vascular complications, major bleeding and functional status.
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MedicalResearch.com Interview with:
Ricardo Stein, MD, ScD
Exercise Cardiology Research Group, Cardiology Division
Federal University of Rio Grande do Sul, Hospital de Clinicas de Porto Alegre,
Porto Alegre, RS, Brazil
MedicalResearch:What is the background for this study? Dr. Stein: Patients with a recent myocardial infarction (MI) present a reduction in functional capacity expressed as a decrease in peak oxygen consumption (VO2 peak). The impact of a Tai Chi Chuan (TCC) cardiac rehabilitation program for patients recovering from recent MI has yet to be assessed. Our goal was to evaluate functional capacity after a TCC-based cardiac rehabilitation program in patients with recent non complicated MI.
MedicalResearch:What are the main findings?
Dr. Stein: After the 12-week study period, participants in the Tai Chi Chuan group experienced a significant 14% increase in VO2 peak from baseline (21.6 ± 5.2 to 24.6 ± 5.2 mL.Kg-1.min-1), whereas control participants had a non-significant 5% decline in VO2 peak (20.4 ± 5.1 to 19.4 ± 4.4 mL.Kg-1.min-1). There was a significant difference between the two groups (P<0.0001).
As a primary outcome, CPET results for the TCC and control groups at baseline and after the 12-week intervention period leading to a significant difference in peak VO2 (5.2 mL.Kg-1.min-1; 95% CI, 2.8 to 7.7, in favor to TCC group). This difference remained significant after adjustment to baseline measurements, age, gender, diabetes, and smoking (4.1 mL.Kg-1.min-1; 95% CI, 2.6 to 5.6, in favor to TCC group).
Summarizing:
- We observed a significant increase in VO2 peak in TCC group participants.
- Our results provide important information data from a randomized clinical trial of Tai Chi Chuan in patients with a history of recent MI.
- Tai Chi Chuan can be an attractive alternative to cardiac rehabilitation for patients who don't have access to conventional cardiac rehabilitation programs.
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MedicalResearch.com Interview with:
Barnaby C. Reeves, D.Phil.
Professor of Health Services Research, Clinical Trials & Evaluation Unit
School of Clinical Sciences, University of Bristol
Bristol Royal Infirmary Bristol
Medical Research: What is the background for this study?
Response: Variable decisions are made about when to transfuse patients after cardiac surgery. The circumstances of particular patients influence decisions about whether to give a transfusion.
Transfusion is a life-saving intervention when a patient is experiencing life-threatening bleeding but most patients have only one or two units of red cells transfused. These transfusions are given at varying levels of anaemia. Some doctors prefer to give a transfusion after cardiac surgery when a patient is only mildly anaemic, believing that the transfusion will promote recovery, while other doctors prefer to wait to transfuse until a patient is substantially anaemic, believing that a transfusion may do more good than harm and is wasteful if it is not needed. Therefore, we carried out a randomized controlled trial comparing restrictive (transfuse when haemoglobin <7.5 g/dL) and liberal transfusion thresholds (transfuse when haemoglobin <9.0 g/dL).*
Medical Research: What are the main findings?
Response: We obtained written informed consent before surgery but only randomized participants after surgery, in intensive care, if their Hb dropped below 9 g/dL. (Hence, we recruited over 3,500 patients but randomized only 2007.) This design avoids ‘diluting’ any difference between groups by including participants who would not usually be ‘considered’ for transfusion.
The primary outcome was the occurrence of one or more serious complications: heart attack, stroke, acute kidney injury, bowel infarction, infection; this included/involved 35.1% of the patients in the restrictive-threshold group and 33.0% of the patients in the liberal-threshold group. This slight difference – more in the restrictive group – was not statistically significant.
We then compared the percentages of patients who died; these were 4.2% in the restrictive group and 2.6% in the liberal group. The difference in this secondary outcome was of borderline statistical significance. Frequencies of other secondary outcomes (infections, ischaemic events, days in critical care and hospital, pulmonary complications) were not different in the two groups.
We also carried out some pre-specified sensitivity analyses for the primary outcome and all-cause mortality. The two most important ones aimed to avoid dilution of the difference between groups as a result of patients having transfusions or outcome events before randomization. Excluding patients who were transfused before randomization shifted the treatment effect to favour the liberal threshold more strongly, for both the primary outcome and mortality. Excluding patients who experienced an outcome event in the first 24 hours after randomization did not change the treatment effect for either outcome. (more…)
MedicalResearch.com Interview with:
Joost Besseling PhD-student
Academic Medical Center
Dept. of Vascular Medicine
Amsterdam
Medical Research: What is the background for this study? What are the main findings?
Response: Statins are associated with an increased risk for type 2 diabetes mellitus (DM). The exact mechanism for this adverse event is largely unknown, although the upregulation of the low-density lipoprotein receptor (LDLR) has been suggested to play a role. In familial hypercholesterolemia (FH) the uptake of LDL-cholesterol via the LDLR is decreased due to a genetic defect. We found that the prevalence of type 2 DM is 50% lower in relative terms in patients with familial hypercholesterolemia. Moreover, there was a dose-response relationship: the more severe the genetic defect that causes familial hypercholesterolemia, the lower the prevalence of type 2 DM.
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MedicalResearch.com Interview with:
Dr. Borja Quiroga MD Ph.D.
Nephrology Unit, Hospital General Universitario Gregorio Marañón
Madrid, Spain
Medical Research: What is the background for this study? What are the main findings?
Dr. Quiroga: Chronic kidney disease patients are at high-risk for the development of cardiovascular events. Although several strategies have been tried for identifying those patients with poorer prognosis, no one has demonstrated by itself being the best one. This could be explained by the fact that several factors are implied in the cardiovascular profile of chronic kidney disease patients.
With this background, in our study we hypothesized if differences in the interarm systolic blood pressure could detect patients with enhanced cardiovascular risk early, and, consequently therapies could be initiated.
Our results provide interesting data on this regard, as we have concluded that an interarm systolic blood pressure difference higher that 10 mmHg is an independent prognosis factor for cardiovascular events. (more…)
MedicalResearch.com Interview with: Leslie Curry PhD, MPH
Senior Research Scientist in and Lecturer in Public Health (Health Policy)
Co-Director, Robert Wood Johnson Clinical Scholars Program
Yale School of Public Health
Medical Research: What is the background for this study? What are the main findings?
Dr. Curry: Quality of care for patients with acute myocardial infarction (AMI) has improved substantially in recent years due to important investments by clinicians and policymakers; however, survival rates across U.S. Hospitals still differ greatly. Evidence suggests links between hospital organizational culture and hospital performance in care of patients with AMI. Yet few studies have attempted to shift organizational culture in order to improve performance, fewer have focused on patient outcomes, and none have addressed mortality for patients with acute myocardial infarction. We sought to address this gap through a novel longitudinal intervention study, Leadership Saves Lives (LSL). We have a large team of people with backgrounds in nursing, medicine, health care administration and research working in 10 very diverse hospitals across the country in 10 states. All hospitals are members of the Mayo Clinic Care Network and are fully committed to saving lives of patients with heart attacks. Teams of 10-12 clinicians and administrators are devoting substantial energy, expertise and good will to this project.
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MedicalResearch.com Interview with:
Harindra C. Wijeysundera MD PhD FRCPC
Interventional Cardiology, Schulich Heart Centre, Sunnybrook Health Sciences Centre
Scientist, Sunnybrook Research Institute (SRI)
Assistant Professor, Dept. of Medicine & Institute of Health Policy, Management and Evaluation
University of Toronto Adjunct Scientist, Institute for Clinical Evaluative Sciences (ICES)
Toronto, ON, Canada
Medical Research: What is the background for this study? What are the main findings?
Dr. Wijeysundera: Given the rapid increase in health care costs, there has been growing emphasis on the more rational use of resources. One such effort is the development of appropriate use criteria. Such criteria have been developed in many areas of medicine, including in cardiology for diagnostic angiography. The underlying rationale for a test to be appropriate is that its anticipated benefit outweighs its anticipated harms. However, there is a paucity of empirical evidence validating this conceptual framework. Our goal was to validate the 2012 appropriate use criteria for diagnostic coronary angiography, by examining the relationship between the appropriateness of a coronary angiography in patients with suspected stable ischemic heart disease and the proportion of patients who were found to have obstructive coronary artery disease. We used data obtained from the Cardiac Care Network registry of Ontario, Canada. This is a population based registry of all cardiac procedures in the province of Ontario. We examined 48,336 patients and found that 58.2% of angiographic studies were classified as appropriate, 10.8% were classified as inappropriate, and 31.0% were classified as uncertain. Overall, 45.5% of patients had obstructive CAD. In patients with appropriate indications for angiography, 52.9% had obstructive CAD, with 40.0% undergoing revascularization. In those with inappropriate indications, 30.9% had obstructive CAD and 18.9% underwent revascularization; in those with uncertain indications, 36.7% had obstructive CAD and 25.9% had revascularization. Although more patients with appropriate indications had obstructive CAD and underwent revascularization (P < 0.001), a substantial proportion of those with inappropriate or uncertain indications had important coronary disease. Our conclusion was that despite the association between appropriateness category and obstructive CAD, this study raises concerns about the ability of the appropriate use criteria to guide clinical decision making.
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MedicalResearch.com Interview with:
Elaine W. Yu, MD, MMSc
Assistant Professor of Medicine
Harvard Medical School
Massachusetts General Hospital
MGH Endocrine Unit
Medical Research: What is the background for this study? What are the main findings?
Dr. Yu: It is well known that cardiovascular disease is more common in men than in women. The exact reasons for this are unknown, but may be related to gender differences in levels of sex hormones such as testosterone and estrogen. As compared to premenopausal women, men have higher testosterone and lower estrogen levels. It is currently unclear whether the actions of testosterone and/or estrogen affect cardiovascular risk factors.
In this study, we explored the regulation of cardiovascular risk factors by testosterone and estrogen in men. We found that higher levels of testosterone led to lower HDL levels (“good” cholesterol), whereas estrogen did not regulate HDL. In contrast, low levels of estrogen led to worsening insulin resistance and increased muscle fat, markers for developing diabetes. Importantly, LDL cholesterol (“bad” cholesterol”) was not affected by either testosterone or estrogen in men. (more…)
MedicalResearch.com Interview with:
Heidi May, Ph.D., M.S.P.H.
Cardiovascular Epidemiologist
Intermountain Medical Center Heart Institute
Salt Lake City
Medical Research: What is the background for this study? What are the main findings?
Dr. Heidi May: Cardiovascular disease remains the leading cause of morbidity and mortality worldwide. Statin therapy is known to reduce the risk of cardiovascular disease incidence through the reduction of blood cholesterol levels and through its pleiotropic cardioprotective properties. Depression is a risk factor for cardiovascular disease. It has been recommended that antidepressant medications should be considered first-line treatment for depression of any severity. We hypothesized that taking both statins and antidepressants would reduce cardiovascular risk more than either medication alone. However, we did not find this. Instead we found that the effectiveness of antidepressants and statin therapy to reduce death and incident cardiovascular disease at 3 years varied by the severity of depressive symptoms. Among those with none to mild depressive symptoms, statin use, with or without antidepressant therapy, was associated with a decrease in risk, but among those with moderate to severe depression, antidepressant use was associated with a decrease in risk. The combination of antidepressant and statin use did not result in a greater risk reduction in either depressive symptom category.
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