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 ResQPUMP^â
ACD-CPR Device and the ResQPOD^â 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.