Environments and Conditions that Facilitate Cardiac Arrest Research through Better Coordination, Oversight and Strategy.

Size: px

Start display at page:

Download "Environments and Conditions that Facilitate Cardiac Arrest Research through Better Coordination, Oversight and Strategy."

Lionel McBride
5 years ago
Views:

1 Environments and Conditions that Facilitate Cardiac Arrest Research through Better Coordination, Oversight and Strategy. Demetris Yannopoulos MD Professor of Medicine Robert K Eddy Endowed Chair for Cardiovascular Resuscitation Medical Director, Minnesota Resuscitation Consortium Division of Cardiovascular Medicine University of Minnesota

2 Disclosures Demetris Yannopoulos MD, is the Medical Director of the Minnesota Resuscitation Consortium, a state wide initiative to improve survival in the state of MN from cardiac arrest. This initiative is sponsored by the Medtronic Foundation and is part of the Heart Rescue Program. Dr. Yannopoulos is funded by the following NIH grants for CPR and resuscitation research. Transformative Research NIH Director s Award R01HL (PI) R01 HL (PI) R01HL (co-pi) 1R43HL A1 No industry related conflicts are present.

3 Cardiac Arrest as a Public Health Problem A national initiative should be considered. Cardiac Arrest claims >600,000 lives each year (in-hospital and out of hospital) Represents a multiorgan problem. The physiology of low flow and now flow followed by reperfusion are poorly understood especially in the setting of multi systemic involvement (heart, brain, liver, intestines, kidney pathophysiology in the setting of acute injury). The complexity of injury requires systematic investigation and transcends traditional scientific expertise that no single scientist can possess. We need to target those scientific relationships with funding opportunities.

4 Clinical trial funding National efforts similar to decoding the human genome, the brain initiative, may be needed to move forward scientifically. Although the NIH has dedicated significant funds towards the field over the last 10 years, a national fund dedicated to cardiac arrest science and resuscitation maybe needed to solve fundamental problems. Suggestion: Pull resources of large national funding agencies (NIH, DoD, NSF, PCORI, AHA ) and combine with large corporate foundations to allocate $ for a clear purpose. No resources, no success. Consider political efforts to have US Congress declare war on cardiac arrest. A strategic initiative is needed.

Clinical trial power and the P-VALUE Clinical trials

the study is based on the best guess and estimate.

5 Clinical trial power and the P-VALUE Clinical trials in resuscitation deal with neurologically intact survival. A rare event compared to the number of patients treated. The magnitude of an effect of an intervention to power the study is based on the best guess and estimate. Many times without any significant scientific support. When the trials show benefit but fail to rich the MAGIC p value we tend to disregard the therapies as futile.

Clinical trial power and the P-VALUE As Andrew Gelman, statistician from Columbia University said: People want something that they cant really get: They want certainty. A P value of 0.

6 Clinical trial power and the P-VALUE As Andrew Gelman, statistician from Columbia University said: People want something that they cant really get: They want certainty. A P value of 0.05 does not mean that there is a 95% chance that a given hypothesis is correct. Instead, it signifies that if the null hypothesis is true, and all other assumptions made are valid, there is a 5% chance of obtaining a result at least as extreme as the one observed.

7 Study design. Quality of CPR CPR quality is a significant effect modifier of reported outcomes and leads to many missed opportunities Challenge: manual CPR quality is difficult to control effectively.

8 Trial Design. Cause of cardiac arrest. Coronary artery stenosis is a critical determinant of the ability to achieve ROSC and is a very important target for therapy. Uneven distribution of disease between groups could drastically mask the effect of various prehopsital interventions. Given the small number of patients that survive in each trial, having one of the most important contributors to survival be unknown, is a potential problem in evaluating results. The assumption that randomization evens out the distribution of confounders is exactly that: an assumption. The presence of a new body of evidence dissociates the ability of large prehospital pragmatic studies to look at long term outcomes when the cardiac underlying coronary pathology is not studied and treated.

9 Coronary etiology of SCA

10 Conclusions Declare war on cardiac arrest as a nation and scientific community. Bundle funding sources to include national funding agencies and industry under a new entity to specifically review, evaluate and fund basic, translational and clinical trials in the field. Incorporate important determinants and confounders of outcomes in the future study designs (such as CPR quality, underline etiology of cardiac arrest) to target populations where the effect is more likely to be detected. Work with clinicians and statisticians to decide what is significant in our field. What is the level of chance or certainty we accept in order to offer potential beneficial treatments to our patients and decrease the nihilism from resuscitation practice.

All under the division of cardiovascular medicine University of Minnesota

The Team 1) Demetris Yannopoulos M.D. Medical Director, 2) Kim Harkins, Program Manager 3) Lucinda Klann, CARES Data Manager 4) Esther Almeida, Administrative Assistant All under the division of cardiovascular