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Author Interview: Dr Mamas A Mamas
Clinical Lecturer in Cardiology, Manchester Heart Centre
Manchester Royal Infirmary, Manchester M13 9PT, UK
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Publication:
Influence of access site selection on PCI-related adverse events in patients with STEMI: meta-analysis of randomised controlled trials.
Mamas MA, Ratib K, Routledge H, Fath-Ordoubadi F, Neyses L,
Louvard Y, Fraser DG, Nolan J.
Heart. 2011 Dec 6. [Epub ahead of print]
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What are the main findings of the study?
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We undertook a meta-analysis of 9 randomized controlled trials that consisted of 2977 patients with ST-Elevation Myocardial Infarction (STEMI) undergoing PCI and compared outcomes associated with the transradial and transfemoral approach.
The main finding of the study was that the transradial approach was associated with a 48% reduction in mortality and 38% reduction in major adverse cardiovascular events (MACE) in this setting.
Peri-procedural bleeding complications following PCI may occur in up to 5% of cases performed in patients presenting with acute coronary syndromes (ACS) and this procedure-related bleeding is independently associated with adverse events including 30-day mortality and MACE.
Furthermore, previous studies with treatments that reduce the
risk of bleeding but retain efficacy similar to that of standard treatment have shown reductions in mortality thereby suggesting a causative link between major bleeding and death.
Patients with STEMI undergoing PCI are at the highest risk for the development of such bleeding complications and a significant proportion of major bleeding is related to the access site which has led many interventionists to recommend that radial access is employed as the primary access site in patients with STEMI undergoing PCI.
Our meta-analysis has shown that the transradial approach is associated with a reduction of major bleeding complications of 45% and access site complications of 70%, which may explain the mortality / MACE benefit that we have found associated with the transradial approach in this STEMI cohort.
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Were any of the findings unexpected?
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Observational studies such as the MORTAL study (Mortality benefit Of Reduced Transfusion after PCI via the Arm or Leg) in which over 32 000 PCI procedures were analysed have similarly demonstrated that PCI performed through the transradial route is independently associated with a reduction in mortality in comparison with procedures performed through the femoral route. Similarly, a large UK based retrospective observational study involving 1051 patients admitted with STEMI, in-hospital mortality in the femoral group was approximately double that recorded in the radial group (Hetherington et al Heart 2009;95:1612-18). Many other retrospective studies have similarly demonstrated both a decrease in mortality and a reduction in major bleeding complications in patients with STEMI undergoing PCI through the transradial route in comparison with the femoral access site.
A major criticism of such data is that of selection bias, in that complex patients who are at highest risk of bleeding complications and hence mortality are more likley to have their PCI procedures undertaken through the transfemoral approach which would bias outcomes towards an increase in mortality in the transfemoral arm. Using data derived from randomized controlled studies as per our current analysis in which patients are randomized to either a transradial or transfemoral approach eliminates such potential selection bias and so represents best available evidence for optimal access site use in STEMI patients undergoing PCI.
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What should clinicians and patients take away from this study?
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Our analysis shows that the transradial route is associated with a halving of mortality in STEMI patients undergoing PCI and so provides a compelling case that PCI procedures undertaken in patients presenting with STEMI are performed through the transradial route .
Whilst the transradial access site is the primary access site through which PCI procedures are performed in STEMI, NSTEMI and elective patient cases in the UK and the rest of the world, the transradial access site still only accounts for approximately 10% of PCI procedures performed within the United States.
This is a clear opportunity to improve outcomes in patients at highest risk of bleeding complications through facilitation of training / optimal utilization of the transradial access site in PCI particularly in the US.
Many interventional fellowship programs across the US have introduced transradial PCI training as part of their training program and there has been an increase in discussion of transradial techniques in major interventional meetings such as TCT in North America.
A major challenge remains in understanding why operators still choose to undertake PCI procedures through an access site associated with an increase in mortality in such high risk patient cohorts.
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What recommendations do you have for nephrology health care providers as a result of your study?
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Our meta-analysis was performed on data derived from STEMI patients undergoing PCI including primary PCI, rescue PCI and those thrombolysed who then undergo PCI.
At TCT 2011, data derived from the Radial versus Femoral Randomized Investigation in ST-Elevation Acute Coronary Syndrome study (RIFLE STEACS study) was presented in which 1001 patients with ST-Elevation Myocardial Infarction undergoing primary PCI were entered into a multcentre randomized study involving 4 interventional centres in Italy and compared clinical outcomes associated with the transradial or transfemoral access site.
The main findings of the study were that the transradial access site was associated with a significant reduction in cardiac death (5.2% vs 9.2%; P=0.02), MACE (7.2% vs 11.4%; P=0.029) and Major Bleeding (7.8%vs 12.2%; P=0.026).
Further similar studies will be required in the future to validate these findings.
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Featured Angina| Acute Coronary Syndrome and Heart Disease Interviews
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Highlights of Article by Dr. Erik Hess et of Mayo Clinic ;CIRCOUTCOMES 2012
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Chest pain is the 2nd most common reason patients come to EDs across the United States
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Initial testing – including information obtained from the history, physical exam, electrocardiogram, and cardiac troponin – identifies > 98% of heart attacks
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To avoid missing a diagnosis of heart attack or pre-heart attack symptoms, emergency physicians often admit patients to observation units or to the hospital for extensive diagnostic testing, including stress testing
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This results in false positive test results, unnecessary exposure to radiation, and unnecessary downstream procedures such as stent placement in arteries of the heart
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Decision aids are evidence-based tools designed to educate and engage patients in decisions regarding their care
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We hypothesized that patients who were educated regarding their future risk for a heart attack and engaged in the decision of whether to be admitted to the observation unit for stress testing or to follow-up with a Mayo Clinic heart doctor in the next 72 hours would have greater knowledge about their short-term risk for heart attack, be more aware of the management options, and choose less intensive approaches to evaluation
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We randomly assigned 204 patients who came to the ED with chest pain and were being considered for observation unit admission to the decision aid or to usual care
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Decision aid patients:
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Had greater knowledge regarding their short-term risk for a heart attack
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Less frequently decided to be admitted to the observation unit for stress testing
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Had 4 times greater engagement in the decision making process
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Had no adverse events within 30 days of the ED visit
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Take home points
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Patients want to be educated and engaged in decisions regarding their care
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Once properly informed and engaged in treatment decisions, patients often choose less intensive treatment options
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Integrated health systems like the Mayo Clinic in which physicians collaboratively work together to provide ER patients ready access to outpatient follow-up have potential to improve the value of Emergency care
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Glucose, Insulin and Potassium (“GIK”) TO MINIMIZE IMPACT OF HEART ATTACKS BEFORE PATIENTS GET TO THE HOSPITAL
Study puts life-saving drugs in the hands of paramedics, decreasing rate of cardiac arrest and death from heart attacks
CHICAGO (March 27, 2012) — Paramedics can potentially reduce someone’s chances of having a cardiac arrest or dying by 50 percent by immediately administering a mixture of glucose, insulin and potassium (“GIK”) to people having a heart attack, according to research presented today at the American College of Cardiology’s 61st Annual Scientific Session. The Scientific Session, the premier cardiovascular medical meeting, brings cardiovascular professionals together to further advances in the field.
The study showed that patients who received GIK immediately after being diagnosed with acute coronary syndrome — which indicates a possible heart attack is either in progress or on the way — were 50 percent less likely to have cardiac arrest (a condition in which the heart suddenly stops beating) or die than those who received a placebo, although the treatment did not prevent the heart attack from occurring. The reduction in in-hospital cardiac arrest or death was a “secondary endpoint”, so statistically was not definitive, but was consistent with how GIK seems to work in experimental models of heart attack.
The effect was also present for patients with ST-elevation heart attacks, which require immediate treatment. For those patients, immediate GIK was associated with a 60 percent reduction in in-hospital cardiac arrest or death.
“When started immediately in the home or on the way to the hospital — even before the diagnosis is completely established — GIK appears not completely prevent any heart attack from occurring, but appeared in this trial to reduce the size of heart attacks and to reduce by half the risk of having a cardiac arrest or dying,” said Harry P. Selker, MD, MSPH, executive director of the Institute for Clinical Research and Health Policy Studies at Tufts Medical Center, who led the study with Joni Beshansky, RN, MPH, co-principal investigator and project director. “Acute coronary syndromes represent the largest cause of death in this country. GIK is a very inexpensive treatment that appears to have promise in reducing those deaths and morbidity.”
The cost of the treatment is about $50.
“Because the trial is the first to show GIK could be effective when used by paramedics in real-world community settings, it could have important implications for the treatment of heart attacks,” Dr. Selker said. Previous clinical trials have shown no consistent effect, likely because the GIK was given too late to help. This study, the “IMMEDIATE Trial,” was the first to test the effectiveness of administering GIK at the very first signs of a threatening heart attack, in the community, rather than waiting hours until the diagnosis was well-established at a hospital, as done in previous clinical trials.
“We wanted to do something that is effective and can be used anywhere,” said Dr. Selker. “We’ve done a lot of studies of acute cardiac care in emergency departments and hospitals, but more people die of heart attacks outside the hospital than inside the hospital. Hundreds of thousands of people per year are dying out in the community; we wanted to direct our attention to those patients.”
The researchers trained paramedics in 36 Emergency Medical Services systems in 13 cities across the country to administer GIK after determining that a patient was likely having a threatened or already established heart attack using electrocardiograph-based ACI-TIPI (acute cardiac ischemia time-insensitive predictive instrument) and thrombolytic predictive instrument decision support that prints patient-specific predictions on the top of an electrocardiogram. The paramedics used these predictions to decide if a patient would likely benefit from treatment. There were 911 patients randomized to receive either the GIK treatment or a placebo.
Administering GIK immediately also reduced the severity of the damage to the heart tissue from the heart attack. On average, 2 percent of the heart tissue was destroyed by the heart attack in people receiving GIK, compared with 10 percent in those who received the placebo. Although a significant proportion of suspected heart attacks are later determined to be false alarms (23 percent in this study), administering GIK does not appear to cause any harmful effects in such patients.
The research team will follow up with study participants at six and 12 months to evaluate the longer-term benefit of the GIK treatment.
This study was funded by the NIH’s National Heart, Lung and Blood Institute.
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Keywords and tags:
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Angina | Heart Disease Resourses
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Amazon.com 's Editorial Reviews
Angina: New Ways to Treat
Chronic Chest Pain
Part of the award winning public television series Healthy head
/Healthy Mind. It's one of the scariest medical symptoms for people who are generally healthy: a tightening, painful feeling in the chest known as Angina. In some cases this chest pain can be a serious warning that requires immediate treatment. But for the millions of people with chronic, stable angina the discomfort is something that can be readily managed with a variety of treatments. In this program we take a look at what generally causes angina, what can be done to prevent it and how it can be effectively treated with lifestyle changes, innovative drug therapies and medical procedures.
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Amazon.com Editorial Review:
Philips HeartStart Home Defibrillator (AED)
Be prepared for the unexpected.
When sudden cardiac arrest (SCA) strikes, the electrical system of the heart short circuits, causing the heart to quiver rather than pump in a normal rhythm. It typically results in the abnormal heart rhythm know as ventricular fibrillation (VF). It usually happens without warning and the majority of people have no previously recognized symptoms of heart disease. And it most often happens at home. For the best chance of survival from SCA caused by VF, a defibrillator should be used within 5 minutes. Yet, less than 1 in 20 people survive largely because a defibrillator does not arrive in time.
Just as seat belts or airbags do not save every life in a traffic accident, a defibrillator will not save every person who suffers a sudden cardiac arrest. Yet many lives could be saved if more people could be reached more quickly.
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