MedicalResearch.com Interview with:
H.A. (Hendrika) van den Ham PharmD
Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences
Utrecht University
The Netherlands.
Medical Research: What is the background for this study? What are the main findings?
Dr. van den Ham: Atrial fibrillation (AF) is associated with a substantial risk of ischemic stroke and thromboembolism. The CHADS2 and the CHA2DS2-VAScrisk scores are developed to guide the decision to prescribe anticoagulants. Recently a new clinically-based risk score, the ATRIA study risk score, was developed. We compared the predictive ability of the ATRIA risk score with the CHADS2 and CHA2DS2-VASc risk scores in a large, independent, community-based cohort of Atrial fibrillation patients in the United Kingdom. We found that the ATRIA score more accurately identified low risk patients that the CHA2DS2-VASc score assigned to higher risk categories. Such reclassification of stroke risk could prevent overuse of anticoagulants in very low stroke risk patients with Atrial fibrillation.
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MedicalResearch.com Interview with:
Jerry D. Estep, MD, FACC, FASE
Associate Professor of Clinical Cardiology
Houston Methodist Institute of Academic Medicine
Section Head of Heart Transplant & Mechanical Circulatory Support, Division of Heart Failure
Medical Director, Heart Transplant & LVAD Program
Methodist DeBakey Heart & Vascular Center
Houston Methodist
Medical Research: What is the background for this study? What are the main findings?
Dr. Estep: Data for left ventricular assist devices (LVADs) in non-inotrope-dependent advanced heart failure (HF) patients are limited. The risk-benefit tradeoff of LVADs versus optimal medical management (OMM) in this patient cohort is not well understood. ROADMAP is the first prospective, nonrandomized, observational study comparing LVAD support to OMM in advanced, ambulatory HF patients who are not dependent on intravenous inotropic support, and meet the FDA-approved indications for LVAD destination therapy. The main 5 findings from the ROADMAP Study include the following:
1) LVAD patients were more severely ill, with more INTERMACS profile 4 compared to OMM patients (65% LVAD vs. 34% OMM, p < 0.001);
2) more LVAD patients met the primary endpoint of survival on original therapy with improvement in 6 minute walk distance of at least 75 meters at 12 months (39% LVAD vs. 21% OMM; [OR: 2.4 [95% CI: 1.2 to 4.8]; p = 0.012) with differences in the primary endpoint primarily due to the use of delayed LVADs in the OMM group;
3) on the basis of as-treated (event free) analysis, 12-month survival (freedom from death, urgent transplant, or delayed LVAD) was greater for LVAD versus OMM (80 ± 4% vs. 63 ± 5%, p = 0.022);
4) adverse events (AEs) were higher in LVAD patients, at 1.89 events/patient-year (eppy), primarily driven by bleeding (1.22 eppy), than with OMM, at 0.83 eppy, primarily driven by worsening HF (0.68 eppy); and
5) health-related quality of life and depression improved from baseline more significantly with LVADs than with OMM (Δvisual analog score [VAS]: 29 ± 25 vs. 10 ± 22, p < 0.001 and ΔPHQ9: -5 ± 7 vs. -1 ± 5, p < 0.001).
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MedicalResearch.com Interview with:
Ashley Winning, ScD, MPH
Postdoctoral Research Fellow
Department of Social and Behavioral Sciences
Harvard T.H. Chan
School of Public Health
Medical Research: What is the background for this study? Dr.Winning: Several studies have found associations between psychological distress and heart disease and diabetes; however, much of the research has measured distress and disease risk in adulthood and we can’t tell how long people have been distressed or how far-reaching the effects of distress are. Some work has shown that childhood distress is associated with adult health, indicating that distress may start to affect health even earlier in life than we thought. However most of the research has measured distress at a single point in time so we have not been able to answer questions regarding effects of persistent distress or if effects on health are less bad if people become less distressed over time.
Medical Research: What are the main findings?Dr.Winning: Distress at any period in the life course was associated with increased cardiovascular and metabolic disease risk in adulthood (age 45). Not surprisingly, those with high levels of distress in both childhood and adulthood had the greatest cardiometabolic risk. The most striking finding is that high levels of childhood distress (measured in childhood) predicted heightened adult disease risk, even when there was no evidence that these high levels of distress persisted into adulthood.
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MedicalResearch.com Interview with:
Laura Mauri, MD, MSc
Division of Cardiovascular Medicine,
Department of Medicine
Brigham and Women’s Hospital
Boston, MA 02115
Medical Research: What is the background for this study? What are the main findings?
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 (either drug-eluting [DES] or bare metal [BMS]), 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. We analyzed these outcomes in a post hoc analysis of the subset of patients who received everolimus-eluting stents (EES) in the DAPT Study, because EES were the most frequently used stent in the study, and because data suggest that EES may have lower rates of stent thrombosis when compared with paclitaxel-eluting stents. We found that 30 months of dual antiplatelet therapy after coronary stenting (compared to 12 months) was associated with reduced rates of stent thrombosis and MI, no difference in a composite outcome of death, MI and stroke, and increased rates of moderate or severe bleeding.
As found in the primary analysis of the DAPT Study, 30 months of dual antiplatelet therapy was associated with increased all-cause mortality, largely due to increased non-cardiovascular mortality. Bleeding-related deaths accounted for a minority of these deaths, where as cancer-related deaths in patients with pre-existing cancer diagnoses accounted for the majority of the mortality difference.
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MedicalResearch.com Interview with:
Salim S. Virani, M.D., Ph.D
Investigator, Health Policy, Quality & Informatics Program, Center for Innovations in Quality, Effectiveness and Safety, Staff Cardiologist, Michael E. DeBakey VA Medical Center
Associate Director for Research, Cardiology Fellowship Training Program
Associate Professor (tenured), Section of Cardiovascular Research
Baylor College of Medicine Houston
Medical Research: What is the background for this study? What are the main findings?
Dr. Virani: The increase in Americans securing health care coverage under the Affordable Care Act, in combination with a projected shortage of specialty and non-specialty physicians, has led to a growing pressure on the existing physician workforce in America. One proposed solution is to increase the scope of practice for advanced practice providers (APPs) (nurse practitioners [NPs] and physician assistants [PAs]. An important aspect of this discussion is whether the quality of care provided by APPs is comparable to that provided by physicians.
The study utilized data from the American College of Cardiology’s (ACC) National Cardiovascular Data Registry PINNACLE Registry® to examine whether there were clinically meaningful differences in the quality of coronary artery disease (CAD), heart failure (HF), and atrial fibrillation (AF) care delivered by advanced practice providers versus physicians in a national sample of cardiology practices.
The primary analyses included 883 providers (716 physicians and 167 APPs) in 41 practices who cared for 459,669 patients. The mean number of patients seen by APPs (260.7) was lower compared to that seen by physicians (581.2). Compliance with most CAD, HF, and AF measures was comparable, except for a higher rate of smoking cessation screening and intervention (adjusted rate ratio [RR] 1.14, 95% CI 1.03-1.26) and cardiac rehabilitation referral (RR 1.40, 95% CI 1.16-1.70) among CAD patients receiving care from APPs. Compliance with all eligible CAD measures was low for both (12.1% and 12.2% for APPs and physicians, respectively) with no significant difference. Results were consistent when comparing practices with both physicians and APPs (n = 41) and physician-only practices (n = 49).
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MedicalResearch.com Interview with:
W.H. Wilson Tang, MD, FACC
Assistant Professor in Medicine,
Cleveland Clinic Lerner College of Medicine
Staff, Section of Heart Failure & Cardiac Transplant Medicine
Assistant Program Director, General Clinical Research Center
The Cleveland Clinic Cleveland, OH
Medical Research: What is the background for this study? What are the main findings?
Dr. Tang: Cardiac function is a key determinant of outcomes after surgery, especially transplantation. End-stage renal disease (ESRD) poses a unique scenario, as the metabolic and uremic derangements that result from this condition lead to adverse cardiac remodeling, and kidney transplantation offers a potential for reverse remodeling. We studied patients who underwent kidney transplantation and found that echocardiogram following transplantation demonstrated consistent and significant improvement in cardiac structure and function. Post-transplant improvement in anemia was a vital factor that independently predicted such positive changes, whereas post-transplant changes in blood pressure, renal function at 12 months, and dialysis duration duration did not. Moreover, patients that demonstrated reverse remodeling had outcomes comparable to those with normal baseline cardiac function.
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MedicalResearch.com Interview with:
Dr. Wilson Tang MD
Professor of Medicine
Cleveland Clinic Lerner College of Medicine
Case Western Reserve University
Director of the Center for Clinical Genomics
Cleveland ClinicMedical Research: What is the background for this study? What are the main findings?
Dr. Tang: Renal impairment has long been associated with worse outcomes in acute heart failure. Administration of diuretic therapy often obscures accurate assessment of renal function by urine output. Despite extensive literature suggesting the poor outcomes in those with a rise in creatinine following treatment, recent data has suggested that in the presence of effective diuresis, this phenomenon likely represents hemoconcentration and azotemia rather than acute kidney injury. We observed that using a novel and sensitive biomarker that identified acute kidney injury, specific to tubular injury, we can identify those at higher risk of adverse outcomes in patents admitted for acute heart failure. However, after adjusting for standard risk factors, the prognostic value was clearly attenuated.
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MedicalResearch.com Interview with:
Ambarish Pandey, MD
Cardiology Fellow, PGY5
University of Texas Southwestern Medical Center,
Dallas, Texas 75390
Medical Research: What is the background for this study? What are the main findings?
Dr. Berry: Physical inactivity is considered a major modifiable risk factor for coronary artery disease and the current guidelines recommend atleast 150 min/week (~ 500 MET-min/week) of moderate intensity physical activity to reduce the burden of coronary artery disease. In contrast, the role of physical activity in reducing risk of heart failure is not emphasized in the current guidelines. This is particularly relevant considering the increasing burden of heart failure in the community. Against this background, we performed this study to the dose-response relationship between physical activity levels and risk of heart failure.
We observed a dose dependent inverse association between physical activity levels and heart failure risk. Furthermore, we observed that the current guideline recommended physical activity levels (500 MET-min/week) are associated with only modest reduction in HF risk (< 10%). In contrast, a substantial reduction in heart failure risk was observed at twice and four times the recommended physical activity levels (19% and 35% risk reduction respectively)
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MedicalResearch.com Interview with:
Mark DeBoer, MD
Children's Hospital's Department of Pediatrics
University of VirginiaMedical Research: What is the background for this study? What are the main findings?
Dr. DeBoer: We have been interested in how the severity of the metabolic syndrome relates to long term risks, both for children and adults. We formulated a score that takes the different components of the metabolic syndrome (body mass index, blood pressure, fasting blood sugar, triglycerides and high density cholesterol) for an individual and forms a score estimating how severe the metabolic syndrome is in that individual. When we looked at long-term data from individuals followed for 40 years, we found that children and adults with higher scores were more much likely to develop cardiovascular disease.
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MedicalResearch.com Interview with:
Adela Hruby PhD
Adjunct Instructor, Friedman School of Nutrition Science and Policy
Research Fellow, Harvard School of Public Health
Fellow, Oak...
MedicalResearch.com Interview with:
Gbenga Ogedegbe, MD, MS, MPH FACP
Professor of Population Health and Medicine
Director, Division of Health and Behavior
Director, Center for Healthful Behavior Change
Vice Dean, NYU College of Global Public Health
NYU Langone School of Medicine
Department of Population Health
New York, NY 10016
Medical Research: What is the background for this study?
Dr. Ogedebge: Evidence from clinical trials have previously indicated that a common blood pressure medication, angiotensin-converting-enzyme (ACE) inhibitors, (when prescribed as first line treatment) may not provide the same benefits in blacks compared to whites. However blacks are grossly underrepresented in these studies, despite the fact they have disproportionately higher rates of hypertension-related morbidity and mortality than whites. Thus, we chose to study this particular question because it allows us to evaluate this evidence in a large population of hypertensive black patients who receive care in a real-world practice setting. This study evaluates racial differences in cardiovascular outcomes and mortality between hypertensive black and white patients whose treatment was initiated with angiotensin-converting-enzyme (ACE) inhibitors, outside of a clinical trial. ACE inhibitors are one of several classes of drugs commonly prescribed to individuals with hypertension to prevent deaths, heart attack, kidney failure, heart failure and stroke.
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MedicalResearch.com Interview with:
Renato Valenti, MD
David Antoniucci, MD
Cardiology Department; Careggi Hospital
Florence; Italy
Medical Research: What is the background for this study?
Response: Previous data have shown that high residual platelet reactivity in patients receiving clopidogrel is associated with high risk of ischemic events and cardiac death after PCI at short- and long-term follow-up. Clopidogrel nonresponders patients of the REsponsiveness to CLOpidogrel and StEnt thrombosis (RECLOSE-2) ACS study received an increased dose of clopidogrel or switched to ticlopidine under light transmittance aggregometry (LTA) adenosine diphosphate (ADP) test guidance. Despite some decrease of ADP test after treatment adjustment, there was no improvement on clinical outcome. Currently no evidence exists that the achievement of an optimal platelet aggregation inhibition in clopidogrel nonresponders modifies the risk profile of these patients. The RECLOSE-3 study invesigated if a new antiplatet therapy with prasugrel in clopidogrel nonresponders can modify the risk profile of these patients and improve the outcome in term of cardiac mortality.
From the RECLOSE-3 registry we identified 302 consecutive patients who were clopidogrel nonresponders. Nonresponders switched to prasugrel therapy. Due to the nonrandomized study design the clinical outcome of clopidogrel nonresponders switched to prasugrel (from RECLOSE-3 study) was compared with the historical cohort of clopidogrel nonresponders of the RECLOSE-2 ACS (248 patients) study. The primary endpoint of the study was cardiac mortality. The 2-year cardiac mortality rate was 4.0% in the RECLOSE-3 group and 9.7% in the RECLOSE-2 group (p=0.007). The difference in 2-year cardiac mortality remained also considering exclusively patients with ACS on admission: 3.2% and 9.7%, respectively, p=0.023.At the final model of multivariable analysis, prasugrel treatment was inversely related to the risk of 2-year cardiac death (HR 0.32; p=0.036) after adjusting for ACS and other well known covariates related to the outcome.
Medical Research: What are the main findings?
Response: The main finding of the RECLOSE-3 study is that nonresponsiveness to clopidogrel may be a “modifiable risk factor” for cardiac death after PCI. Prasugrel treatment overcomes nonresponsiveness to clopidogrel and results in thrombotic risk similar to the one of clopidogrel responders.
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MedicalResearch.com Interview with:
Dr.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,
Principal Investigator ISCHEMIA-CKD trial
Medical Research: What is the background for this study? What are the main findings?
Dr. Bangalore: Patients with chronic kidney disease are at high risk of coronary artery disease. However, they are also at risk for worsening kidney function from revascularization procedures and have been routinely excluded from clinical trials of stenting vs bypass surgery. In this registry study of over 5900 patients with multivessel coronary artery disease who underwent bypass surgery or stenting using the latest generation drug eluting stent (everolimus eluting stent), we showed that there are trade off between both procedures. With bypass surgery there was increase in the risk of death, myocardial infarction and stroke in the short term (in-hospital/30-days). For PCI, there was long term risk of repeat revascularization and also increase in myocardial infarction in those who achieved incomplete revascularization.
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MedicalResearch.com Interview with:James M. Shikany, DrPH
Professor of Medicine
Division of Preventive Medicine
University of Alabama at Birmingham
Birmingham, AL
Medical Research: What is the background for this study? What are the main findings?
Dr. Shikany: There is a growing interest in the field of nutritional epidemiology in relating overall dietary practices to various disease endpoints. For example, the assessment of dietary patterns in a population may be more meaningful than concentrating on isolated nutrients or foods because they more closely reflect how people eat in the real world. Previously, we looked at how the degree to which one adhered to 5 dietary patterns identified in the Reasons for Geographic and Racial Differences in Stroke (REGARDS) study was associated with the risk of stroke. In the current study, we investigated how the degree to which one adhered to these dietary patterns was related to the risk of incident acute coronary heart disease.
The main finding was that a Southern dietary pattern (characterized by added fats, fried foods, eggs and egg dishes, organ meats, processed meats, and sugar-sweetened beverages) was associated with a significantly greater hazard of incident acute coronary heart disease in REGARDS participants. The association persisted following adjustment for sociodemographics, lifestyle factors, and energy intake. Specifically, following multivariable adjustment, participants in the highest quartile of consumption of the Southern pattern experienced a 56% greater hazard of incident coronary heart disease compared with those in the lowest quartile of consumption of this pattern. Another pattern we observed – the Plant-based pattern – characterized by vegetables, fruits, beans, yogurt, poultry, and fish was not associated with an increased risk of coronary heart disease.
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MedicalResearch.com Interview with:
Connie N. Hess, MD, MHS
Duke Clinical Research Institute
Duke University
Durham, North Carolina
Medical Research: What is the background for this study? What are the main findings?
Dr. Hess: Guidelines recommend the use of anticoagulation for thromboembolic prophylaxis in atrial fibrillation and also recommend use of dual antiplatelet therapy to reduce cardiovascular events after myocardial infarction and percutaneous coronary intervention. The use of triple therapy in patients with indications for DAPT and anticoagulation is challenging due to the increased bleeding risk associated with this regimen. The optimal antithrombotic regimen in this population has not yet been defined.
This study specifically focused on older patients, a population that is at greater risk for Atrial Fibrillation-related stroke and recurrent events after MI but also higher risk for bleeding. Despite a growing population of older patients with indications for triple therapy, these patients have been underrepresented in clinical trials and are therefore understudied.
We found that relative to DAPT, patients on triple therapy had a similar risk of 2-year major adverse cardiac events but a significantly increased risk of bleeding requiring hospitalization, including greater risk of intracranial hemorrhage.
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MedicalResearch.com Interview with:
Alan Cheng, MD, FACC, FAHA, FHRS
Associate Professor of Medicine and Pediatrics
Director, Arrhythmia Device Service
Johns Hopkins University School of Medicine
Baltimore, MD
Medical Research: What is the background for this study? What are the main findings?Dr. Cheng: Sudden cardiac death (SCD) has been the most common way in which people in the United States die. While it's hard to accurately identify who is a higher risk for SCD, we have learned from a number of studies over the past 30-40 years that people with significant reductions in their heart function (measured as the ejection fraction (EF)) is one group of individuals at high risk for Sudden cardiac death. In fact, the current American College of Cardiology and American Heart Association guidelines state that people with an EF below 35% are at high enough risk for Sudden cardiac death that these patients should undergo implantation of an implantable cardioverter defibrillator (or ICD for short), a device capable of monitoring the heart 24/7 and shocking the heart out of any arrhythmias that could lead to Sudden cardiac death. The data they cite for this recommendation are so compelling that they currently recommend implanting ICDs in patients not only among those who already experienced an Sudden cardiac death event, but also those who have not. Implanting an ICD to prevent Sudden cardiac death before they have had Sudden cardiac death is known as primary prevention and this accounts for about 70-80% of all ICD implants in the United States.
While the EF is the best metric out there to determine if a patient should get an ICD, it has its limitations. Because of these limitations, we have been interested for a long time in better understanding how the EF and other metrics affect a patient's risk for Sudden cardiac death.
In this study, we followed 538 patients who were recipients of a primary prevention ICD who underwent repeat assessment of their EF during followup in order to determine if changes in their EF over time altered their risk for ICD shocks for ventricular arrhythmias or death. Over a median of almost 5 years of followup, we found that 40% of the cohort had improvements in their EF. And when the EF does improve, the risk goes down for ICD shocks for ventricular arrhythmias as well as for death.
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MedicalResearch.com Interview with:
Patricia Kim Phuong Nguyen MD and
Joseph C. Wu, MD, PhD
Stanford Cardiovascular Institute
Stanford University School of Medicine, Stanford, California
Medical Research: What is the background for this study? What are the main findings?Response: The application of CT imaging has greatly increased in the last two decades, raising concern over the effects of low dose radiation exposure from medical imaging.
In this study, we recruited 67 patients who underwent CT imaging for various cardiovascular indications including:
1) Pre atrial fibrillation ablation
2) Pre Trans-catheter valve replacement
3) Aortic dissection, and
4) coronary artery disease.
A wide range of doses were sampled. We detected damage to DNA and a small percentage of death of T lymphocytes isolated from patients who were exposed to greater than 7.5 mSv of radiation.
No damage was detected in patients exposed to very low doses (less than or equal 7.5 mSv).
This study did not look at the relationship between radiation and cancer.
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MedicalResearch.com Interview with:
Dr. Jagat NarulaMD, PhD
Associate Dean For Global Affairs
Professor Medicine, Cardiology and Radiology
Mt. Sinai Hospital, NY
Medical Research: What is the background for this study? What are the main findings?
Dr. Narula: The cardiovascular diseases remain number one cause of mortality in men and women and in high as well as middle and low income countries. It is important that we identify those who are likely to die of preventable causes. Identification of the vulnerable plaques that are likely to result in acute events has been an interesting focus of investigators, and numerous intravascular imaging and noninvasive imaging strategies have been employed. CT angiography has offered fairly attractive accuracy. We were the first to establish the features of high-risk plaques (Motoyama, Narula JACC 2007) and their short-term prognostic implications (Motoyama, Narula JACC 2009). In this new paper in a large population we present intermediate- to long-term follow-up that critically analyzes the role of plaque characterization and puts it in perspective. Should we keep chasing plaques or should we treat the patient? Does the answer lie in high risk plaque busting or prevention be the mainstay?
From the previous studies from us and others we have known that computed tomography angiography (CTA)-based plaque characteristics identify high-risk plaque (HRP) that predict short-term risk of acute coronary syndrome (ACS). We in this study wanted to evaluate whether plaque characteristics by CTA would predict intermediate- to long-term likelihood of acute events. The presence of high-risk plaque characteristics were evaluated in more than 3000 patients undergoing CTA and plaque progression (PP) in additional 450 patients who had two CTA one year apart. We recorded fatal and nonfatal acute events and outcomes during follow-up: mean about 4 years and maximum up to 10 years. Acute Coronary Syndrome occurred in about 40 of ~300 (16%) with high risk plaque and 40 (less than 1.5%) of the remaining patients with non high risk plaques. In patients with serial CTA, plaque progression also was an independent predictor of ACS, with HRP (27%) and without HRP (10%) compared with patients without plaque progression (0.3%).
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MedicalResearch.com Interview with:
Dr Scot GargFRCP PhD (Hons) FESC
Cardiology Department, Royal Blackburn Hospital
United Kingdom
Medical Research: What is the background for this study?
Dr. Garg: In contrast to other countries, in particular the United States, the UK has seen a vast expansion in the number of PCI centres operating without on-site surgical support. Part of the reason for this is that outcome data from these centres are from modest populations at short-term follow-up; consequently the ACC/AHA have failed to give delivery of PCI in centres without surgical back-up a strong endorsement. The study was ultimately driven therefore to show whether any differences existed in mortality between patients having PCI in centres with- and without surgical support at long-term follow-up in large unselected population cohort.
Medical Research: What are the main findings?
Dr. Garg: The study included the largest population of patients treated in centres without off-site surgical support (n=119,036) and main findings were that following multi-variate adjustment there were no differences in mortality for patients treated at centres with- or without surgical support at 30-days, 1-year or 5-year follow-up irrespective of whether patients were treated for stable angina, NSTEMI or STEMI. Furthermore, similar results were seen in a sensitivity analysis of a propensity matched cohort of 74,001 patients. (more…)
Medical Research Interview with:
Prof. Johan Bosmans
Interventional cardiologist
University Hospital Antwerp, Wilrijkstraat 10, 2650,
Edegem, Belgium
MedicalResearch: What is the background for this study? What are the main findings?Prof. Bosmans : Transcatheter aortic valve replacement (TAVR) has become standard of care for patients who cannot undergo surgery. With this, it is important to ensure that the risks associated with TAVR be fully understood, and if possible prevented. Even at this stage of the adoption of TAVR, large trials continue to provide information to the clinician about how to select the right patients to ensure the best possible outcomes. The ADVANCE Study is a prospective, multicenter study that evaluated the use of TAVR in 1015 patients at 44 experienced TAVR centers, which was designed to reflect routine clinical practice.
We know that the risk of serious adverse events, such as stroke or transient ischemic attack (TIA), in post-TAVR patients can vary based on the timing before and after the procedure. A patient’s baseline demographics and medical history can affect their risk of procedure-related events as well as long-term outcomes. The manipulations required crossing the aortic valve and appropriately positioning any type of TAV has been thought to be related to procedural stroke events. Therefore, we performed a multivariable analysis looking for predictors of stroke – or stroke and TIA at 3 unique time periods (periprocedural, early and late) following TAVR.
The most striking result from our analyses was that we were not able to identify any predictors of periprocedural (either during the procedure or on the day after) stroke, illustrating this very multifactorial etiology. We were able to show that being female, experiencing acute kidney injury or a major vascular complication positively predicted stroke during the early (2-30 days post procedure) time period. When we combined the outcome of stroke or TIA, we found that a history of prior atrial fibrillation (AF) was also a predictor. The only late predictor (day 31-730 post-procedure) of stroke was a history of coronary artery bypass grafting, which could reflect the patients’ risk of vascular disease.
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MedicalResearch.com Interview with:
Liana C. Del Gobbo, PhD
Postdoctoral Research Fellow
Friedman School of Nutrition Science & Policy
Tufts University Boston MA
Medical Research: What is the background for this study? What are the main findings?
Dr. Del Gobbo: Heart failure most commonly develops in adults over 65 years old- the most rapidly growing portion of the US population. The condition greatly reduces the quality of life of older adults. Heart failure is the leading cause of hospitalizations in the US among those on Medicare, and is associated with large health care costs. Prevention is key for reducing the burden of this disease.
A detailed analysis of factors that might help prevent heart failure, such as a person's pattern of eating (as well as individual foods), in addition to other lifestyle factors (eg. smoking, physical activity, etc), had not been previously examined all together, in the same study.
To get a fuller picture of how to prevent this condition, this study examined the relative importance of dietary habits and other lifestyle factors for development of heart failure.
Our paper shows that older adults can cut their risk in half by adhering to a few healthy lifestyle factors, including moderate physical activity, modest alcohol consumption (eg. more than one drink/week, but not more than 1-2 drinks/day), not smoking, and maintaining a healthy weight.
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MedicalResearch.com Interview with:Jennifer A. Sumner, Ph.D.
Columbia University Mailman School of Public Health
New York, NY 10032
Medical Research: What is the background for this study? What are the main findings?
Dr. Sumner: Cardiovascular disease, which includes conditions like heart attack and stroke, is the leading cause of death worldwide. Stress has long been thought to increase risk of cardiovascular disease, and posttraumatic stress disorder (PTSD) is the quintessential stress-related mental disorder. Some individuals who are exposed to traumatic events, such as unwanted sexual contact, the sudden unexpected death of a loved one, and physical assault, develop PTSD, which is characterized by symptoms of re-experiencing the trauma (e.g., nightmares), avoidance of trauma reminders (e.g., avoiding thinking about the trauma), changes in how one thinks and feels (e.g., feeling emotionally numb), and increased physiological arousal and reactivity (e.g., being easily startled). PTSD is twice as common in women as in men; approximately 1 in 10 women will develop PTSD in their lifetime. Research has begun to suggest that rates of cardiovascular disease are higher in people with PTSD. However, almost all research has been done in men.
My colleagues and I wanted to see whether PTSD was associated with the development of cardiovascular disease in a large sample of women from the general public. We looked at associations between PTSD symptoms and new onsets of heart attack and stroke among nearly 50,000 women in the Nurses’ Health Study II over 20 years, beginning in 1989. Women with the highest number of PTSD symptoms (those reporting 4+ symptoms on a 7-item screening questionnaire) had 60% higher rates of developing cardiovascular disease (both heart attack and stroke) compared to women who were not exposed to traumatic events. Unhealthy behaviors, including lack of exercise and obesity, and medical risk factors, including hypertension and hormone replacement use, accounted for almost 50% of the association between elevated PTSD symptoms and cardiovascular disease. We also found that trauma exposure alone (reporting no PTSD symptoms on the screening questionnaire) was associated with elevated cardiovascular disease risk compared to no trauma exposure.
Our study is the first to look at trauma exposure and PTSD symptoms and new cases of cardiovascular disease in a general population sample of women. These results add to a growing body of evidence suggesting that trauma and PTSD have profound effects on physical health as well as mental health.
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MedicalResearch.com Interview with:
Jessica Parsh MD
Hitinder Gurm MBBS
Department of Internal Medicineb
University of Michigan Health System
Medical Research: What is the background for this study? What are the main findings?
Response: Chronic kidney disease (CKD) is associated with adverse events after percutaneous coronary interventions (PCI). Estimated glomerular filtration rate (eGFR) is used for CKD stage classification and there are several widely used eGFR equations, including the Cockcroft-Gault, CKD-EPI, and MDRD. Others have shown that the CKD-EPI equation is more accurate, more precise and less bias. The current Kidney Disease Improving Global Outcomes (KDIGO) guidelines recommend the use of CKD-EPI. Even so, there remains wide variability among equation choice between different institutions as well as between different health care providers (physicians, pharmacists, etc). In addition, in a recent survey, up to 12% of providers were "unsure" of which equation they used. Furthermore, the FDA has no clear guidelines regarding equation selection for pharmacokinetic studies of novel medications and the equation used for development of a particular drug is not always clearly labeled on package inserts.
Using data from the Blue Cross Blue Shield of Michigan Cardiovascular Consortium for almost 130,000 patients who underwent PCI, we investigated whether use of different eGFR equations would lead to discrepant eGFR output, how this would lead to CKD stage reclassification and whether CKD stage reclassification by a certain equation led to improved risk prognostication for adverse events. We also studied how calculation of eGFR by various equations would affect drug dosing recommendations for common renally-dosed antiplatelet and antithrombotic medications. We found that there was wide discrepancy among the eGFR output of the various equations and this led to significant CKD stage reclassification (with agreement on stage classification as low as 56% for CKD-EPI and Cockcroft-Gault). Further, our data from receiver operating characteristic analysis and net reclassification index analysis support CKD-EPI as superior for risk prognostication for renal adverse outcomes of acute kidney injury and new requirement for dialysis. In regards to drug dosing, agreement between all three equations on dosing adjustment was as low as 34% (bivalirudin with eGFR cutoff < 30 ml/min/1.732).
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MedicalResearch.com Interview with:Satoru Kishi, MD
Division of Cardiology
Johns Hopkins University
Baltimore, Maryland
MedicalResearch: What is the background for this study? What are the main findings?Dr. Kishi: Blood pressure (BP) at the higher end of the population distribution may represent a chronic exposure that produces chronic injury to the cardiovascular system. Cumulative BP exposure from young adulthood to middle age may adversely influence myocardial function and predispose individuals to heart failure (HF) and other cardiovascular disease (CVD) later in life. The 2005 guidelines for the diagnosis and treatment of HF from the American College of Cardiology and American Heart Association highlight the importance of early recognition of subclinical cardiac disease and the importance of non-invasive tests in the clinical evaluation of heart failure.
Our main objective was to investigate how cumulative exposure to high blood pressure from young to middle adulthood influence LV function. In the Coronary Artery Risk Development in Young Adults (CARDIA) study, multiple repeated measures of BP and other cardiovascular risk factors was recorded over a 25 year time span, starting during early adulthood (ages 18-30). (more…)
MedicalResearch.com Interview with:
José C. Nicolau, MD, PhD, FACC
Professor -University of São Paulo Medical School
Director - Acute Coronary Disease Unit, Heart Institute
MedicalResearch: What is the background for this study?
Dr. Nicolau: Previous studies, mainly performed in patients undergoing percutaneous coronary intervention (PCI), have shown that concomitant use of proton-pump inhibitors (PPIs) diminishes the antiplatelet effect of the drug clopidogrel. This diminished response to clopidogrel has in turn been associated with an increased risk of stent thrombosis and ischemic events. Our paper presented results from a secondary analysis performed in patients enrolled in the TRILOGY ACS randomized clinical trial. Our study is the first to examine the influence of interactions between PPIs and clopidogrel or the newer, more potent antiplatelet drug prasugrel, as well as correlations with platelet reactivity and clinical outcomes in high-risk patients who were receiving medical management without revascularization following acute coronary syndrome (ACS).
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MedicalResearch.com Interview with:
James V. Freeman MD, MPH, MS
Yale University School of Medicine
New Haven, CT
Medical Research: What is the background for this study? What are the main findings?
Dr. Freeman: Atrial fibrillation (AF) substantially increases the risk of major adverse clinical outcomes such as stroke and death, but it can also cause frequent symptoms, affect patient’s functional status, and impair their quality of life. While prior studies have reported the range of AF-related symptoms in patient populations, these studies were generally from highly selected patients and referral based practices, and may not reflect results in community practice or results with contemporary AF management. Using the Outcomes Registry for Better Informed Treatment of Atrial Fibrillation (ORBIT-AF), a large, contemporary, prospective, community-based outpatient cohort, we evaluated the type and frequency of symptoms in patients with Atrial fibrillation. In addition, we measured the degree to which physician assessed symptom severity (using the European Heart Rhythm Association [EHRA] classification system) was correlated with patient reported quality of life (assessed by the Atrial Fibrillation Effect on QualiTy-of-life [AFEQT] questionnaire). Finally, we association between symptoms or quality of life with clinical outcomes, including death, hospitalization, stroke and major bleeding.
In our community-based study, the majority of AF patients (61.8%) were symptomatic (EHRA >2) and 16.5% had severe or disabling symptoms (EHRA 3-4). EHRA symptom class was well correlated with the AFEQT quality of life score (Spearman correlation coefficient -0.39). Over 1.8 years of follow-up, Atrial fibrillation symptoms were associated with a higher risk of hospitalization (adjusted HR for EHRA ≥2 vs EHRA 1 1.23, 95% CI 1.15-1.31) and a borderline higher risk of major bleeding. Lower quality of life was associated with a higher risk of hospitalization (adjusted HR for lowest quartile of AFEQT vs highest 1.49, 95% CI 1.2-1.84), but not other major adverse events including death. (more…)
MedicalResearch.com Interview with:
Christopher X WongMBBS MSc PhD
Clinical Research Fellow | Clinical Trial Service Unit, Oxford
Clinical Senior Lecturer | Centre for Heart Rhythm Disorders, Adelaide
Clinical Trial Service Unit, University of Oxford
Roosevelt Drive, Oxford
Medical Research: What is the background for this study? What are the main findings?Dr. Wong: Atrial fibrillation is an increasingly common heart rhythm disorder. This study demonstrates that even small increments in obesity are associated with a significantly increased risk of atrial fibrillation. Our data suggest that for every 1 unit reduction in body mass index there may be a 3-5% reduction in atrial fibrillation; for every 5 unit reduction, there may be 10-29% reductions. It should also be noted that this is likely to be a significant underestimate of the effect of weight reduction on atrial fibrillation rates as weight control has favourable effects on other risk factors for atrial fibrillation, such as hypertension and diabetes. Given the more than 45 million people with atrial fibrillation worldwide, even small but widespread reductions in obesity would thus help contain this ‘epidemic’ of atrial fibrillation.
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MedicalResearch.com Interview with:
Dr. Renjie Chen PhD and Dr. Haidong Kan, PhDSchool of Public Health, Key Lab of Public Health Safety of the Ministry of Education, Fudan University, Shanghai, ChinaMedicalResearch: What is the background for this study? What are the main findings?
Response: Although several previous studies in developed countries with cleaner air have reported health benefits due to air filtration, no such interventional studies were conducted in a developing country with much severer air pollution problems. Our main findings suggested that even a short-term intervention (2 days) could significantly reduce indoor air pollution and improve cardiopulmonary health among healthy young adults. (more…)
MedicalResearch.com Interview with:
Dr. Samson Y. Gebreab, Ph.D., M.Sc.
Lead Study Author and Research Scientist
National Human Genome Research Institute
Bethesda, Maryland
Medical Research: What is the background for this study?
Dr. Gebreab: It is well known that African Americans hold a commanding lead in cardiovascular disease (CVD) mortality and morbidity compared to whites and other ethnic groups. Furthermore, the risk for developing CVD begins early in life and extends over a lifecourse. Previous studies have indicated the influence of both childhood and adult socioeconomic status (SES) on CVD risk. However, the impact of lifecourse socioeconomic status (both childhood and adulthood) on CVD risk in African American population is not fully understood. The purpose of our study was to investigate the associations of different measures of lifecourse socioeconomic status with cardiovascular disease risk in African Americans and whether the associations were modified by sex and/ or age after controlling for known cardiovascular disease risk factors. We analyzed 10-year follow-up data of African American adults who were participating in Jackson Heart Study, Jackson, MS.
Medical Research: What are the main findings?Dr. Gebreab: Our findings highlights that among those of lower socioeconomic status, women and younger (<=50 years old) African Americans are at increased risk of CVD, including heart disease and stroke compared to their counterparts of higher socioeconomic status groups.
African American women in the lowest socioeconomic status, had more than twice the risk of developing cardiovascular disease than those in the highest socioeconomic status group.
African Americans of 50 years and younger in the lowest socioeconomic status group had more than three times higher risk of experiencing a cardiovascular disease event than those in the highest socioeconomic status group.(more…)
MedicalResearch.com Interview with:
J L Mehta, MD, PhD
Professor of Medicine and Physiology and Biophysics
Stebbins Chair in Cardiology
University of Arkansas for Medical Sciences
Little Rock, AR 72205
Medical Research: What is the background for this study? What are the main findings?
Dr. Mehta: In 2007, ACC/AHA published new guidelines regarding infective endocarditis (IE) prevention. This guideline drastically differed from the way we practiced and prescribed antibiotics to our patients when they undergo surgery or any other procedure like dental procedure, endoscopy, etc. to prevent infective endocarditis. As a result of these guideline, antibiotic use is now being restricted to only a small number of patients who have cardiac conditions that puts them at very high risk for adverse outcomes from IE. However, there is paucity of data on IE trends in the community following such a major change in practice. Therefore evaluated the trend in incidence of infective endocarditis and their outcomes before and after the advent of new guideline.
Our study has several important findings.
First, there has been a steady increase in the incidence of infective endocarditis hospitalizations over the last decade in the US. However, the incidence of IE pre- and post-inception of new antibiotic prophylaxis guidelines is not significantly different. In parallel to these findings, the rate of valve replacement for infective endocarditis did not change after the release of new guidelines in 2007.
Secondly, the increase in IE incidence was seen across all types of pathogens- Staphylococcus, Streptococcus, gram negative bacteria and fungi. The major offender involved in IE in the United States is Staphylococcus.
Finally, the rate of Streptococcus infective endocarditis related hospitalization increased significantly following the release of new guideline in the US, while Staphylococcus IE hospitalizations although on rise, did not increase significantly following the 2007 ACC/AHA guideline update.
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MedicalResearch.com Interview with:
H.A. (Hendrika) van den Ham PharmD
Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences
Utrecht University
The Netherlands.
Medical Research: What is the background for this study? What are the main findings?
Dr. van den Ham: Atrial fibrillation (AF) is associated with a substantial risk of ischemic stroke and thromboembolism. The CHADS2 and the CHA2DS2-VASc risk scores are developed to guide the decision to prescribe anticoagulants. Recently a new clinically-based risk score, the ATRIA study risk score, was developed. We compared the predictive ability of the ATRIA risk score with the CHADS2 and CHA2DS2-VASc risk scores in a large, independent, community-based cohort of Atrial fibrillation patients in the United Kingdom. We found that the ATRIA score more accurately identified low risk patients that the CHA2DS2-VASc score assigned to higher risk categories. Such reclassification of stroke risk could prevent overuse of anticoagulants in very low stroke risk patients with Atrial fibrillation.
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