Friday, March 13, 2015

ResQCPR System Approved by FDA. First and only CPR adjunct ever approved.

Keith Lurie and his colleagues have spent over 25 years trying to improve outcomes in cardiac arrest.  I know him personally.  He is very smart and very hard working, and has impeccable integrity.   He is more committed to saving lives than anyone I know.

I asked Dr. Lurie to tell us about this device he has worked on for so long and which has finally been FDA approved.

I do not promote any commercial products on my site, nor have any advertisements.

I am promoting this because it saves lives, neuro intact.

We have been using the inspiratory threshold device for years in our ED and all over Minnesota, where we have the highest cardiac arrest survival rates in the country, according to the CARES Registry.

Keith developed the system and founded Advanced Circulatory Systems, the manufacturer and marketer.  Advanced Circulatory Systems was recently bought by Zoll.

He has no more personal interest in this, so there is no longer a conflict of interest.  He only wants to save lives.

Full text of ResQTrial, funded by NIH.  One of the great emergency medicine NIH studies.


ResQCPR System

The ResQCPR System was approved by the FDA on Friday March 7, 2015. The ResQCPR System is a combination of the ResQPUMP, a manual active compression decompression (ACD) CPR device, and the ResQPOD, an impedance threshold device  (ITD). It is the first and only CPR adjunct the FDA has ever approved to increase the likelihood of survival after non-traumatic cardiac arrest. ZOLL Medical is the manufacturer of this new device (http://www.advancedcirculatory.com/resqcpr-system/). 

The ResQCPR System was approved based upon clinical data from a clinical trial called the ResQTRIAL, published in Lancet showing this system increases 1-year neurologically intact survival after cardiac arrest by 49% relative to conventional CPR in patients in cardiac arrest of a primary cardiac etiology,1 (full text link) and by 34% for all patients in non-traumatic cardiac arrest, regardless of the etiology.2 This is an important milestone in the history of CPR. Widely used, the ResQCPR System will save many lives.

The combination of the ResQPUMP and ResQPOD works by lowering pressures inside the chest with each decompression. This negative intrathoracic pressure pulls more venous blood back to the heart from the brain and the rest of the body, which in turn increases the refilling of the heart. With the next compression, circulation to the heart and brain is nearly three times higher with the ResQCPR System compared with conventional CPR. In addition, the ResQPUMP has a gauge and metronome to help guide compression depth, active decompression height, and the correct compression rate. The ResQPOD has a timing light to help guide the correct ventilation rate. More details related to the ResQCPR System can be found on the ZOLL website (www.zoll.com). Research supporting the new ResQCPR System indication for use includes: Aufderheide  - Lancet 2011 (http://www.ncbi.nlm.nih.gov/pubmed/21251705) and Frascone – Resuscitation 2013 (http://www.ncbi.nlm.nih.gov/pubmed/23669489).


To reduce any misconceptions, the ResQCPR System is not just a manual version of the LUCAS device (with or without an ITD). The LUCAS device does not perform active decompression to any significant degree (it pulls up only 3 lbs), although it does help assure full chest wall recoil. The ResQCPR System is the only FDA-approved device that allows the user to perform full active chest wall decompression (~15 lbs of upward force on average), thereby helping to lower pressures inside the chest, and lower ICP, with each decompression. This generates increased circulation to the heart and brain. At present, no automated CPR devices have an approved indication for survival like the ResQCPR System. Now that the ResQCPR System has been approved, efforts are underway to develop a better automated system that provides similar benefits to the ResQCPR System.

Another misconception is that the ResQCPR System was evaluated in the Resuscitation Outcomes Consortium (ROC) PRIMED Study. That was not the case. In the ROC RPIMED study, patients were only treated with conventional manual CPR. They were then randomized to either a sham (or placebo) ITD or an active (functional) ITD, and either 30 seconds or 3 minutes of CPR before analysis and shock. The first ROC PRIMED paper reported no difference between the active and sham device,3 or 30 seconds and 3 minutes of CPR.4 As we know it was a complicated study. More recently the ROC investigators published three more papers showing there was a wide range in compression rate and compression depth in the ROC PRIMED study.5,6 When the rate and depth were outside the AHA-recommended range, survival rates decreased. When the compression rate and depth were within the AHA-recommended range, use of the active ITD increased the number of patients who lived with good brain function by more than 25% compared with the sham ITD.7 The ROC PRIMED study and its reanalysis demonstrated how critical it is to perform high quality CPR, at the correct rate and depth, and to guide rescuers so they can perform high quality CPR. (Yannopoulos Circulation 2014: http://circ.ahajournals.org/content/130/Suppl_2/A9.abstract?sid=aefe5b91-bc4b-4ac4-9415-b0bbc86a2284). It is reasonable to conclude that the ITD should be recommended for use if caregivers are able to monitor their CPR quality and use feedback tools to assure that compressions are delivered at the right rate and depth. We do that here in Minnesota, and often use the LUCAS device to provide CPR after ALS arrives. Based upon the Cardiac Arrest Registry to Enhance Survival (CARES)(www.mycares.net), Minnesota leads the nation in the highest survival rates with good neurological function (13%) of any state in the CARES database. The average survival rate with good neurological function nationwide for those who participate in CARES is 8%.


1Aufderheide TP, Frascone RJ, Wayne MA, et al. Standard cardiopulmonary resuscitation versus active compression-decompression cardiopulmonary resuscitation with augmentation of negative intrathoracic pressure for out-of-hospital cardiac arrest: a randomized trial. Lancet 2011;377(9762):301-311.
2Frascone RJ, Wayne MA, Swor RA, et al. Treatment of non-traumatic out-of-hospital cardiac arrest with active compression decompression cardiopulmonary resuscitation plus an impedance threshold device. Resuscitation 2013;84:1214-1222.
3Aufderheide TP, Nichol G, Rea TD, et al. A trial of an impedance threshold device in out-of-hospital cardiac arrest. N Engl J Med 2011;365(9):798-806.
4Stiell IG, Nichol G, Leroux BG, et al. Early versus later rhythm analysis in patients with out-of-hospital cardiac arrest. N Engl J Med 2011;365(9):787-797.
5Idris AH, Guffey D, Aufderheide TP, et al. Relationship between chest compression rates and outcomes from cardiac arrest. Circulation 2012;125:3004-3012.
6Stiell IG, Brown SP, Nichol G, et al. What is the optimal chest compression depth during out-of-hospital cardiac arrest resuscitation of adult patients? Circulation 2014;130(22):1962-1970.
7Yannopoulos D, Abella B, Duval S, Aufderheide T. The effect of CPR quality: a potential confounder of CPR clinical trials. Circulation 2014;130:A9.



Kaplan Meier curve of neurologically intact survival:






ResQCPR System Information Sheet


ResQCPR System: A System for Survival

The Problem
Every day, sudden cardiac arrest, the number one killer in the US, takes the lives of 1500 Americans. Current survival rates are generally poor, with fewer than 10% of patients surviving out-of-hospital cardiac arrest. There is now new hope for the people who experience cardiac arrest.

The Solution
The newly-approved ResQCPR™ System delivers Intrathoracic Pressure Regulation (IPR) Therapy during cardiac arrest resuscitation. IPR Therapy regulates pressure in the chest to enhance perfusion in states of low blood flow, such as cardiac arrest and shock. In a pivotal clinical trial, use of the ResQCPR System increased one-year survival by 49% compared to patients receiving conventional CPR.1,2 The ResQCPR System is the only CPR device with an approved indication to increase the likelihood of survival.3 If implemented widely, this could mean that thousands more people would survive cardiac arrest every year.

Product Description
The ResQCPR System is a device combination that includes both the ResQPUMPâ
ACD-CPR Device
and the ResQPODâ ITD 16.

The ResQPUMP ACD-CPR Device is a re-usable, hand-held device comprised of a suction cup that is placed on the chest, and a handle that contains a force gauge and metronome. It is the only device approved in the US that allows the caregiver to perform active compression decompression CPR (ACD-CPR), which compresses the chest like manual CPR, but allows the user to actively re-expand the chest to generate the negative pressure (or vacuum) that helps to refill the heart (i.e. create preload).





The ResQPOD ITD 16 is an impedance threshold device (ITD) that helps to further enhance negative intrathoracic pressure by preventing the influx of unnecessary air through the open airway during active chest wall recoil. It is disposable and fits into the airway circuit between the airway adjunct (e.g. facemask, endotracheal tube) and the ventilation source (e.g. ventilation bag).  




ResQCPR System Impact
When used together, the ResQPUMP and ResQPOD work synergistically to enhance the vacuum in the chest during CPR more effectively than either device individually:

   Airway Pressures During Conventional CPR:




  and  CPR with the ResQCPR System:



                         


Research Summary
The ResQCPR System has been extensively researched. Pre-clinical studies4 have been conducted and have shown that use of an ITD during ACD-CPR:
·       Lowered intracranial pressure (ICP), resulting in improved cerebral perfusion pressure5
·       Increased blood flow during resuscitation to near-normal levels6
·       Improved neurologically-intact survival5

Clinical studies have shown that use of an ITD during ACD-CPR:
·       Increased survival at one year by 34% in patients who arrested from non-traumatic etiologies2
·       Increased survival at one year by 49% in patients who arrested from cardiac etiologies2
·       Provided near-normal systolic and diastolic blood pressures7
·       Significantly enhanced the intrathoracic vacuum with both a facemask and ET tube8

Features and Benefits
·       Only device with an approved indication to increase the likelihood of survival3
·       Only device that enables rescuers to provide ACD-CPR
·       Cost-effective
·       Lightweight, portable and compact
·       Latex free
·       Can be applied rapidly by basic or advanced life support caregivers
·       Designed to promote high quality resuscitation:
o  ResQPOD contains timing lights, intended to promote proper ventilation rate
o  ResQPUMP contains metronome, intended to promote proper compression rate
o  ResQPUMP contains force gauge, intended to guide compression and lifting forces



Performing ResQCPR: Abbreviated Instructions9
1. Assess for signs of life.
2. Send for AED.
3. Begin ACD-CPR compressions ASAP:
            A. Place ResQPUMP between nipples and above xiphoid process.
            B. Perform ACD-CPR:
    Compression: to 2” (5 cm) depth and note force required to achieve that depth.
                Decompression: Lift to -10 kgs.
                Rate: 80 per minute
4. Apply ResQPOD ITD           
            A. Attach early to facemask. Maintain tight facemask seal.
            B. Begin ventilations at appropriate compression to ventilation ratio.
            C. Move to advanced airway once tube placement is confirmed and secured.
            D. Use lights to guide ventilations. Do not hyperventilate.
5. Remove BOTH devices when pulse returns.
           






Product Numbers
Part #
Description
Description
12-0825-000
ResQCPR System
Includes one ResQPUMP ACD-CPR Device and two ResQPOD ITD 16s
12-0823-000
ResQPUMP ACD-CPR Device
Replacement component
12-0822-000
ResQPOD ITD 16
Replacement component
12-0586-000
Suction cup for ACD-CPR Device
Replacement component
12-0935-000
ResQCPR Carrying Case
Designed to carry one ResQPUMP, two ResQPODs and other accessories needed to rapidly initiate ResQCPR
12-2116-000
ManiKIT
Allows many CPR manikins to be adapted for ResQCPR training
12-2117-000
ResQTRAINER
Training tool that helps learn psychomotor skills of ACD-CPR
12-0869-000
ResQCPR Demo Kit
ResQMAN Demonstrator with ResQPOD ITD

Availability and Customer Service
The ResQCPR System is available solely through ZOLL Medical Corporation. Customer Service is available to answer questions regarding product features and benefits, individual purchases, pricing, refunds, rebates, shipping status, or other service related information. Contact our Customer Service representatives by phone or e-mail:
ZOLL - Chelmsford (Resuscitation Products)
Monday – Friday; 8:30 am to 7:00 pm Eastern Standard Time
Direct:              978-421-9440
Toll-free:          800-348-9011
Fax:                 978-421-0015
E-mail:
info@zoll.com
Email:               esales@zoll.com
Website:          www.zoll.com

References
1Patients in cardiac arrest from cardiac etiologies
2ResQCPR System Summary of Safety and Effectiveness Data approved by Food & Drug Administration 2015
3FDA-approved indication for use: The ResQCPR System is intended for use as a CPR adjunct to improve the likelihood of survival in adult patients with non-traumatic cardiac arrest.
4Pre-clinical study results are not necessarily representative of clinical study results.
5Metzger et al. Improved cerebral perfusion pressures and 24-hour neurological survival in a porcine model of cardiac arrest with ACD-CPR and augmentation of negative intrathoracic pressure. Crit Care Med 2012;40(6):1851-6.
6Voelckel et al. Effects of ACD-CPR with the inspiratory threshold valve in a young porcine model of cardiac arrest. Pediatr Res 2002;51(4):523-7.
7Plaisance et al. Inspiratory impedance during ACD-CPR: a randomized evaluation in patients in cardiac arrest.
8Plaisance et al. Use of an inspiratory ITD on a facemask and ET tube to reduce intrathoracic pressure during the decompression phase of ACD-CPR. Crit Care Med 2005;33(5):990-994.
9See product insert for complete instructions for use.


Improper use of the ResQCPR System could cause ineffective chest compressions and decompressions, leading to suboptimal circulation during CPR and possible serious injury to the patient. The ResQCPR System should only be used by personnel who have been trained in its use. The ResQPUMP should not be used in patients who have had a recent sternotomy as this may potentially cause serious injury. Improper positioning of the ResQPUMP suction cup may result in possible injury to the rib cage and/or internal organs, and may also result in suboptimal circulation during ACD-CPR.

9 comments:

  1. Hello Steve,
    Hope all has been well with you. This is great that survival is increased, but is it neuro intact survival? In other words the patients that have increased survival, are they trach and pegged or can they still perform activities of daily living? I think it is important to clarify this point, as are we increasing the medical burden on the families of those who have survived? Thank you as always for a great blog and another great post.

    Salim

    ReplyDelete
    Replies
    1. Salim,
      Good question.
      Neuro intact survival increased by 50% at one year.
      That was a requirement of the FDA to approve any device.
      Steve

      Delete
  2. Thanks Dr Smtih for this good information. We had avoided using the ITD's based on the ROC Primed trial data. This new paper from Dr Yannopoulos will make us reconsider the cost benefit on this device. Are any trials planned with just the decompression device w/o the ITD?
    I noticed that the recommended rate is below that of manual CPR (80 vs 110 ish). Is that what the pre clinical trials determined was optimal? This would seem to extend the decompression phase which intuitively makes sense.

    It seems that many of the older trials that did not account for CPR quality may have to be reconsidered. The CPR fraction/quality may be an integral part to all future studies including possibly revisiting some of the ACLS medication trials.

    As always great information.

    Petar

    ReplyDelete
    Replies
    1. Petar,

      Dr. Lurie answers:

      Many studies were done with just ACD CPR alone in the 1990’s – air rushes into the lungs and negates the critical vacuum generated by the device combination. Some were positive, some were neutral, none were negative. That is how we discovered the concept of the ITD. But like anything else, you need high quality CPR that includes correct compression rate, depth, and full chest wall recoil. With that you see a benefit with the ITD and conventional CPR. Blood flow to the brain and heart is 3-fold higher with ACD+ITD versus conventional CPR with no ITD.



      Preclinical studies were done starting in 1995. Lurie et al, Circulation 91:1629-1632.



      At 80 per minute, there is more time for diastolic filling and less work of CPR. When we started, the recommended compression rate was 60, then increased to 80 and then increased to 100, in part because everyone was pushing too slowly. We now know there is a different optimal compression rates depending upon the method of CPR an use of the ITD: not surprising since we are really just creating different motors or pumps with different levels of efficiency (I like to think about this as a 2-, 3-, and 4-cylinder motor) and different optimal RPMs.

      Steve Smith

      Delete
  3. This is a terrific post and I certainly applaud Dr. Lurie's efforts to improve CPR. I have reservations about generating negative intra-thoracic pressure during CPR as it can potentially retard venous return to the heart by generating Starling Resistors at the thoracic inlet. This tends to occur in patients who are euvolemic or hypovolemic. Negative intrathoracic pressure augments venous return only when the patient is hypervolemic [work by Takata et al in the early 1990s] see also my blog review [http://pulmccm.org/main/2015/review-articles/icu-physiology-1000-words-cardiopulmonary-resuscitation/]

    I also find it curious that the intervention in Dr. Lurie's trial did not improve ROSC or hospital admission rates from the field. If the effect of enhanced CPR is immediate, one would expect these numbers to be higher. Lastly, this trial was mathematically underpowered on account of funding insufficiency. I truly hope that these interventions work to save lives on neurocognitive status, but in medicine we have been thwarted before by adopting a therapy based on animal data and a single RCT.

    Thanks for this post, sorry for my skeptical nature

    ReplyDelete
    Replies
    1. Jon-Emile,
      Read the above answer to a previous question.
      Almost every other study of CPR (studies of epinephrine, etc.) are criticized because they only improve ROSC, not 1 year neurologic survival. It is ironic that you are now criticizing one year neurologic survival!! That is what counts. The system improves brain blood flow.

      Here is more from Dr. Lurie, in reply:

      Hi Steve,

      The abstract is likely correct. But ROSC is not neurologically intact survival.

      The ResQCPR System improves circulation, lowers ICP, and improves the number of patients discharged from the hospital with good neurological function.

      There are lots of ways to increase ROSC rates, the question is, do those patients ever wake up?
      One of the interesting findings from the ResQCPR is that if you look at all of the patients discharged alive from the hospital, significantly more patients are alive one year later. The Kaplan Meier curve is attached. So the benefit is seen first by increasing the number of patients who survive to hospital discharge with good brain function, the primary study endpoint – yes your readers should read the study – AND the number of patients who lived for a year starting with hospital discharge (see the attached graph). [I have pasted this in the post above]

      Why: because ROSC does not equal survival benefit with good function. You can increase ROSC with high dose epinephrine for example – but hat also vasoconstricts and can cause brain ischemia. ACD+ITD lowers ICP, increases cerebral perfusion, and helps more brain and heart cells survive and eventually recovery. That recovery can take months but in the end of the day results in significantly more function living beings.

      The abstract points out the fallacy, yet another, of the way many look at CPR. ROSC should not be our surrogate outcome: it has not been shown to be a predictor of long term survival with good brain function with epinephrine, amiodarone, and now ACD+ITD to predict survival rates. A similar observation was made in the ROC PRIMED study in the group that received high quality CPR.

      Good question!

      Hope this helps.

      Keith

      Delete
    2. Also this from Keith:

      Venous return is enhanced by negative intrathoracic pressure under states of hypovolemia and euvolemia: that is the physics of breathing.

      There were 5 RCT…This person should also read the Lancet.

      Skepticism is good, logic and data are important. The FDA approval was granted by highly skeptical FDA officials who could not ultimately refute the logics, physics, and data from the ResQTrial, 4 European trials, and multiple animal studies and computer simulations. They could not explain away the one year increase in survival ResQCPR – because it happens to be real!

      It continues…

      Best

      Keith

      Delete
  4. Hi Steve,

    Any research comparing other mechanical CPR with this device?

    ReplyDelete
    Replies
    1. Mohd,
      Not yet. Perhaps in the future?
      Thanks for the question.
      Steve

      Delete

Recommended Resources