Re: Autopulse News

[Guest guest]

>>> I would believe that the services that has pulled the units are

going on statements that has been made and most likely injury that

was sustained due to misuse. <<<

The cities didn't stop using the Autopulse because of rumors they

heard, they were forced to remove the devices from the ambulances by

an ethics committee in the Institutional Review Board.

An IRB, will stop an investigation early for one of two reasons.

One, if the benefits of the device are so overwhelmingly convincing

in preliminary review that it would be unethical to deny the control

group access to the lifesaving care.

Or two, if the harm associated with the device was so overwhelmingly

convincing that it created an ethical dilemma to continue to harm

the study group.

If the ASPIRE trial was stopped for the first reason, they would

still be on the ambulances.

The people in these trials are not dying because of the injuries

allegedly caused by the devices. They are dying from the primary

event - cardiac arrest. The trial was stopped because application

of the device appears to increase the patient's chances of death.

The FDA has pulled medications from store shelves for less evidence

than this.

Now it is possible that the device, used in a different way could

increase survival from cardiac arrest. However, the evidence

appears, at this time not to support continued use of the Autopulse.

Kenny Navarro

[Guest guest]

In a message dated 14-Nov-05 19:17:52 Central Standard Time,

kenneth.navarro@... writes:

The device was not meant to be placed on dead people. It was

designed for the " partially " dead. The end point for the ASPIRE

trial was to see who was still alive four hours after return of

spontaneous circulation. It APPEARS that the device increased the

chances that the " partially dead " would become " totally dead " at four

hours compared to manual CPR. This is not a leap – it was reported

by the principal investigators.

I'm having a " Princess Bride " moment here....I wonder if the Autopulse would

have worked for the Dread Pirate....

S. Krin, DO FAAFP

[Guest guest]

In a message dated 14-Nov-05 19:17:52 Central Standard Time,

kenneth.navarro@... writes:

The device was not meant to be placed on dead people. It was

designed for the " partially " dead. The end point for the ASPIRE

trial was to see who was still alive four hours after return of

spontaneous circulation. It APPEARS that the device increased the

chances that the " partially dead " would become " totally dead " at four

hours compared to manual CPR. This is not a leap – it was reported

by the principal investigators.

I'm having a " Princess Bride " moment here....I wonder if the Autopulse would

have worked for the Dread Pirate....

S. Krin, DO FAAFP

[Guest guest]

In a message dated 14-Nov-05 19:17:52 Central Standard Time,

kenneth.navarro@... writes:

The device was not meant to be placed on dead people. It was

designed for the " partially " dead. The end point for the ASPIRE

trial was to see who was still alive four hours after return of

spontaneous circulation. It APPEARS that the device increased the

chances that the " partially dead " would become " totally dead " at four

hours compared to manual CPR. This is not a leap – it was reported

by the principal investigators.

I'm having a " Princess Bride " moment here....I wonder if the Autopulse would

have worked for the Dread Pirate....

S. Krin, DO FAAFP

[Guest guest]

I have to ask. Is this machine doing so well with CPR compressions that it is

killing patients?

Or are the medics in the field doing so badly with CPR compressions it is

saving lives?

Or is it vice versa?

I know it sounds stupid to ask. Either of the first two theories are disturbing.

Kenny Navarro wrote:

>>> I would believe that the services that has pulled the units are

going on statements that has been made and most likely injury that

was sustained due to misuse. <<<

The cities didn't stop using the Autopulse because of rumors they

heard, they were forced to remove the devices from the ambulances by

an ethics committee in the Institutional Review Board.

An IRB, will stop an investigation early for one of two reasons.

One, if the benefits of the device are so overwhelmingly convincing

in preliminary review that it would be unethical to deny the control

group access to the lifesaving care.

Or two, if the harm associated with the device was so overwhelmingly

convincing that it created an ethical dilemma to continue to harm

the study group.

If the ASPIRE trial was stopped for the first reason, they would

still be on the ambulances.

The people in these trials are not dying because of the injuries

allegedly caused by the devices. They are dying from the primary

event - cardiac arrest. The trial was stopped because application

of the device appears to increase the patient's chances of death.

The FDA has pulled medications from store shelves for less evidence

than this.

Now it is possible that the device, used in a different way could

increase survival from cardiac arrest. However, the evidence

appears, at this time not to support continued use of the Autopulse.

Kenny Navarro

[Guest guest]

Well should this equipment be so dangerous for use, why is it still

marketed for sale as well as why is Houston for example placing

orders for them? Now I will work on answering this scenario.

First, I mean no disrespect. But, how would you react in the

following scenario. You use the AutoPulse and the patient dies. Now,

that by no means indicates the AutoPulse contributed to the patient'

death. But, you are sued over the case and it goes to trial. The

plaintiff's attorney will say:

" Paramedic Jeff, please tell the jury and the family of the

decedent why you chose to use the AutoPulse device when it is clear

that there is no scientific evidence supporting its use and some

evidence that it worsens victims of cardiac arrest? "

" What do you know and the [insert name] fire department know about

the AutoPulse that other departments do not know? Are you saying

the medical directors in Austin, San Francisco, Seattle, Columbus,

Calgary, Vancouver and Riverside County California were wrong in

removing these devices from their ambulances? "

* I am not aware of any findings that other agencies don't already

have. Although it has some literature noting that there has been

injury sustained, by notification of this departments medical

director the information stated has not proven in nor to this

department or its medical director to futher cause harm or injury to

a high percentage of patients that it was properly applied to and

operated on as well as noted patients presented by this department

to the ER with pulse and attempted respirations that it was used on.

>

" Paramedic Jeff, please provide us the scientific evidence on which

you based your decision to continue to use the device in light of

the report to the American Heart Association report that indicated

patients did better when they received manual CPR compared to the

AutoPulse? "

* Although use of some equipment is an option of the Incharge

Paramedic, after many meeting and inservices with the departments

medical director it is approved by the doctor for which I operate

under for use and again, reports interpreted by the medical director

has not justified the discontinue of this unit.

>

" Paramedic Jeff, please explain to the jury and the family of the

decedent where the Institutional Review Board for the University of

Washington was wrong in ordering the study stopped and the reason

you elected to continue to use the device in [insert name], Texas "

* Again, the IRB for UW may have found an issue with the unit but

has not been enough evidence for my medical director to stop the

usage of this unit in this department. Therefore, department wide

has been approved to continue use the unit as deemed appropriate.

>

Again, I am not picking on you--but making a point. The answer " I

have seen in work " only flies in church and on late-night TV ads. As

a textbook author, I am frequently contacted to be an expert in EMS

legal cases. And I assure you (as Wes, and Gene will attest to-

-under oath), the questions I posed are mellow compared to what you

will get on the stand.

* Well I am not sure what " I seen in work " is to fly for but I have

seen it operate and a successful save happen on friday night and my

patient is still in ICU as of 2PM today. Again its a personal choice

for the departments MD. I work at 2 departments that have them in

use and the MD are not convenced by the reports.

>

Again, an academic discussion--no need to cremate me (yet)?

* Well as an Instructor to an Author, I have seen the results good

and bad and with all the times I personally used it and seen it used

compiled to atleast 100+, I have not seen any abnormal injuries to

the patients through physical or Xrays on arrival to the ER and this

also includes precepted rotations at the Hospital with students..

Jeff

[Guest guest]

There are a couple of issues here:

1. We place too much emphasis and money on CPR and cardiac arrest

resuscitation. The literature has shown that EMS is of little benefit if it

cannot arrive in 4 minutes or less; or in 8 minutes or less with bystanders

doing CPR and using AEDs.

2. We really don't understand fully the physiology of CPR and cardiac

arrest. A study in the October issue of ls of Emergency Medicine looked

at the effect of PEEP on pigs in hemorrhagic shock. The pigs were bled into

hemorrhagic shock and then ventilated (1 group with 0 cm/H2O PEEP, the

second group with 5 cm/H2O PEEP, and the third with 10 cm/H2O PEEP). None of

the animals who received PEEP survived while 7 of 8 in the 0 cm/H2O group

survived. 8 of 8 of the 5 cm/H2O group died within 30 minutes and 8 of 8 in

the 10 cm/H2O group died within 20 minutes. All of the PEEP groups had

elevated lactate levels.

Although this was a hemorrhagic shock model, one has to wonder whether the

PEEP that occurs with all forms of CPR is detrimental. The boast that the

AutoPulse improves blood flow may be correct. But, it may increase airway

pressures to a point where outcomes are unfavorable because of accumulated

lactate. Perhaps needling each side of the chest with a device that opens

the needle during ventilations and closes it during compressions might work.

This then takes us back to the Lurie paper:

Emerg Med Clin North Am. 2002 Nov;20(4):771-84

Mechanical devices for cardiopulmonary resuscitation: an update.

<http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed & cmd=Search & term=%22

Lurie+K%22%5BAuthor%5D> Lurie K.

Cardiac Arrhythmia Center, University of Minnesota, Box 508, 420 Delaware

Street SE, Minneapolis, MN 55455, USA. lurie002@...

Despite the promise and universal use of the Kouwenhoven technique for

closed chest cardiac massage, this method has been shown repeatedly to

suffer from lack of clinical efficacy. Although the Kouwenhoven technique

can clearly save lives, the inherent inefficiency of this approach and the

challenges related to teaching and retaining the skills needed to perform

the technique correctly have limited its overall effectiveness. This has

prompted the development of newer lifesaving CPR techniques and devices.

Some of the advances, such as the vest approach, active

compression-decompression, and the impedance threshold valve, offer a

benefit when compared with the Kouwenhoven technique. It is clear, however,

that challenges related to implementation of these newer approaches will

determine their ultimate utility. It is not sufficient to have a better

technique or device available. Challenges to implementation of the newer

approaches include overcoming the inertia of a universal mindset on the

already-familiar Kouwenhoven technique and creating a cost-effective

justification for change. Each year, approximately 10 million people in the

United States are trained in the Kouwenhoven technique. Americans spend

nearly $500,000,000 annually on this form of CPR training and retraining.

Given the less than 5% survival rate for the 300,000 patients who experience

out-of-hospital cardiac arrest each year in the United States, the prudence

of this societal investment when compared with other ways health care

dollars are spent should be questioned. It is hoped that this mismatch

between costs and benefits will be recognized and will lead to the adoption

of more effective means to resuscitate patients.

_____

From: [mailto: ] On

Behalf Of Danny

Sent: Monday, November 14, 2005 4:02 PM

To:

Subject: Re: Re: Autopulse News

I have to ask. Is this machine doing so well with CPR compressions that it

is killing patients?

Or are the medics in the field doing so badly with CPR compressions it is

saving lives?

Or is it vice versa?

I know it sounds stupid to ask. Either of the first two theories are

disturbing.

[Guest guest]

There are a couple of issues here:

1. We place too much emphasis and money on CPR and cardiac arrest

resuscitation. The literature has shown that EMS is of little benefit if it

cannot arrive in 4 minutes or less; or in 8 minutes or less with bystanders

doing CPR and using AEDs.

2. We really don't understand fully the physiology of CPR and cardiac

arrest. A study in the October issue of ls of Emergency Medicine looked

at the effect of PEEP on pigs in hemorrhagic shock. The pigs were bled into

hemorrhagic shock and then ventilated (1 group with 0 cm/H2O PEEP, the

second group with 5 cm/H2O PEEP, and the third with 10 cm/H2O PEEP). None of

the animals who received PEEP survived while 7 of 8 in the 0 cm/H2O group

survived. 8 of 8 of the 5 cm/H2O group died within 30 minutes and 8 of 8 in

the 10 cm/H2O group died within 20 minutes. All of the PEEP groups had

elevated lactate levels.

Although this was a hemorrhagic shock model, one has to wonder whether the

PEEP that occurs with all forms of CPR is detrimental. The boast that the

AutoPulse improves blood flow may be correct. But, it may increase airway

pressures to a point where outcomes are unfavorable because of accumulated

lactate. Perhaps needling each side of the chest with a device that opens

the needle during ventilations and closes it during compressions might work.

This then takes us back to the Lurie paper:

Emerg Med Clin North Am. 2002 Nov;20(4):771-84

Mechanical devices for cardiopulmonary resuscitation: an update.

<http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed & cmd=Search & term=%22

Lurie+K%22%5BAuthor%5D> Lurie K.

Cardiac Arrhythmia Center, University of Minnesota, Box 508, 420 Delaware

Street SE, Minneapolis, MN 55455, USA. lurie002@...

Despite the promise and universal use of the Kouwenhoven technique for

closed chest cardiac massage, this method has been shown repeatedly to

suffer from lack of clinical efficacy. Although the Kouwenhoven technique

can clearly save lives, the inherent inefficiency of this approach and the

challenges related to teaching and retaining the skills needed to perform

the technique correctly have limited its overall effectiveness. This has

prompted the development of newer lifesaving CPR techniques and devices.

Some of the advances, such as the vest approach, active

compression-decompression, and the impedance threshold valve, offer a

benefit when compared with the Kouwenhoven technique. It is clear, however,

that challenges related to implementation of these newer approaches will

determine their ultimate utility. It is not sufficient to have a better

technique or device available. Challenges to implementation of the newer

approaches include overcoming the inertia of a universal mindset on the

already-familiar Kouwenhoven technique and creating a cost-effective

justification for change. Each year, approximately 10 million people in the

United States are trained in the Kouwenhoven technique. Americans spend

nearly $500,000,000 annually on this form of CPR training and retraining.

Given the less than 5% survival rate for the 300,000 patients who experience

out-of-hospital cardiac arrest each year in the United States, the prudence

of this societal investment when compared with other ways health care

dollars are spent should be questioned. It is hoped that this mismatch

between costs and benefits will be recognized and will lead to the adoption

of more effective means to resuscitate patients.

_____

From: [mailto: ] On

Behalf Of Danny

Sent: Monday, November 14, 2005 4:02 PM

To:

Subject: Re: Re: Autopulse News

I have to ask. Is this machine doing so well with CPR compressions that it

is killing patients?

Or are the medics in the field doing so badly with CPR compressions it is

saving lives?

Or is it vice versa?

I know it sounds stupid to ask. Either of the first two theories are

disturbing.

[Guest guest]

Well. then use it.

_____

From: [mailto: ] On

Behalf Of Jeff

Sent: Monday, November 14, 2005 4:03 PM

To:

Subject: Re: Autopulse News

Well should this equipment be so dangerous for use, why is it still

marketed for sale as well as why is Houston for example placing

orders for them? Now I will work on answering this scenario.

First, I mean no disrespect. But, how would you react in the

following scenario. You use the AutoPulse and the patient dies. Now,

that by no means indicates the AutoPulse contributed to the patient'

death. But, you are sued over the case and it goes to trial. The

plaintiff's attorney will say:

" Paramedic Jeff, please tell the jury and the family of the

decedent why you chose to use the AutoPulse device when it is clear

that there is no scientific evidence supporting its use and some

evidence that it worsens victims of cardiac arrest? "

" What do you know and the [insert name] fire department know about

the AutoPulse that other departments do not know? Are you saying

the medical directors in Austin, San Francisco, Seattle, Columbus,

Calgary, Vancouver and Riverside County California were wrong in

removing these devices from their ambulances? "

* I am not aware of any findings that other agencies don't already

have. Although it has some literature noting that there has been

injury sustained, by notification of this departments medical

director the information stated has not proven in nor to this

department or its medical director to futher cause harm or injury to

a high percentage of patients that it was properly applied to and

operated on as well as noted patients presented by this department

to the ER with pulse and attempted respirations that it was used on.

>

" Paramedic Jeff, please provide us the scientific evidence on which

you based your decision to continue to use the device in light of

the report to the American Heart Association report that indicated

patients did better when they received manual CPR compared to the

AutoPulse? "

* Although use of some equipment is an option of the Incharge

Paramedic, after many meeting and inservices with the departments

medical director it is approved by the doctor for which I operate

under for use and again, reports interpreted by the medical director

has not justified the discontinue of this unit.

>

" Paramedic Jeff, please explain to the jury and the family of the

decedent where the Institutional Review Board for the University of

Washington was wrong in ordering the study stopped and the reason

you elected to continue to use the device in [insert name], Texas "

* Again, the IRB for UW may have found an issue with the unit but

has not been enough evidence for my medical director to stop the

usage of this unit in this department. Therefore, department wide

has been approved to continue use the unit as deemed appropriate.

>

Again, I am not picking on you--but making a point. The answer " I

have seen in work " only flies in church and on late-night TV ads. As

a textbook author, I am frequently contacted to be an expert in EMS

legal cases. And I assure you (as Wes, and Gene will attest to-

-under oath), the questions I posed are mellow compared to what you

will get on the stand.

* Well I am not sure what " I seen in work " is to fly for but I have

seen it operate and a successful save happen on friday night and my

patient is still in ICU as of 2PM today. Again its a personal choice

for the departments MD. I work at 2 departments that have them in

use and the MD are not convenced by the reports.

>

Again, an academic discussion--no need to cremate me (yet)?

* Well as an Instructor to an Author, I have seen the results good

and bad and with all the times I personally used it and seen it used

compiled to atleast 100+, I have not seen any abnormal injuries to

the patients through physical or Xrays on arrival to the ER and this

also includes precepted rotations at the Hospital with students..

Jeff

[Guest guest]

Well. then use it.

_____

From: [mailto: ] On

Behalf Of Jeff

Sent: Monday, November 14, 2005 4:03 PM

To:

Subject: Re: Autopulse News

Well should this equipment be so dangerous for use, why is it still

marketed for sale as well as why is Houston for example placing

orders for them? Now I will work on answering this scenario.

First, I mean no disrespect. But, how would you react in the

following scenario. You use the AutoPulse and the patient dies. Now,

that by no means indicates the AutoPulse contributed to the patient'

death. But, you are sued over the case and it goes to trial. The

plaintiff's attorney will say:

" Paramedic Jeff, please tell the jury and the family of the

decedent why you chose to use the AutoPulse device when it is clear

that there is no scientific evidence supporting its use and some

evidence that it worsens victims of cardiac arrest? "

" What do you know and the [insert name] fire department know about

the AutoPulse that other departments do not know? Are you saying

the medical directors in Austin, San Francisco, Seattle, Columbus,

Calgary, Vancouver and Riverside County California were wrong in

removing these devices from their ambulances? "

* I am not aware of any findings that other agencies don't already

have. Although it has some literature noting that there has been

injury sustained, by notification of this departments medical

director the information stated has not proven in nor to this

department or its medical director to futher cause harm or injury to

a high percentage of patients that it was properly applied to and

operated on as well as noted patients presented by this department

to the ER with pulse and attempted respirations that it was used on.

>

" Paramedic Jeff, please provide us the scientific evidence on which

you based your decision to continue to use the device in light of

the report to the American Heart Association report that indicated

patients did better when they received manual CPR compared to the

AutoPulse? "

* Although use of some equipment is an option of the Incharge

Paramedic, after many meeting and inservices with the departments

medical director it is approved by the doctor for which I operate

under for use and again, reports interpreted by the medical director

has not justified the discontinue of this unit.

>

" Paramedic Jeff, please explain to the jury and the family of the

decedent where the Institutional Review Board for the University of

Washington was wrong in ordering the study stopped and the reason

you elected to continue to use the device in [insert name], Texas "

* Again, the IRB for UW may have found an issue with the unit but

has not been enough evidence for my medical director to stop the

usage of this unit in this department. Therefore, department wide

has been approved to continue use the unit as deemed appropriate.

>

Again, I am not picking on you--but making a point. The answer " I

have seen in work " only flies in church and on late-night TV ads. As

a textbook author, I am frequently contacted to be an expert in EMS

legal cases. And I assure you (as Wes, and Gene will attest to-

-under oath), the questions I posed are mellow compared to what you

will get on the stand.

* Well I am not sure what " I seen in work " is to fly for but I have

seen it operate and a successful save happen on friday night and my

patient is still in ICU as of 2PM today. Again its a personal choice

for the departments MD. I work at 2 departments that have them in

use and the MD are not convenced by the reports.

>

Again, an academic discussion--no need to cremate me (yet)?

* Well as an Instructor to an Author, I have seen the results good

and bad and with all the times I personally used it and seen it used

compiled to atleast 100+, I have not seen any abnormal injuries to

the patients through physical or Xrays on arrival to the ER and this

also includes precepted rotations at the Hospital with students..

Jeff

[Guest guest]

Well. then use it.

_____

From: [mailto: ] On

Behalf Of Jeff

Sent: Monday, November 14, 2005 4:03 PM

To:

Subject: Re: Autopulse News

Well should this equipment be so dangerous for use, why is it still

marketed for sale as well as why is Houston for example placing

orders for them? Now I will work on answering this scenario.

First, I mean no disrespect. But, how would you react in the

following scenario. You use the AutoPulse and the patient dies. Now,

that by no means indicates the AutoPulse contributed to the patient'

death. But, you are sued over the case and it goes to trial. The

plaintiff's attorney will say:

" Paramedic Jeff, please tell the jury and the family of the

decedent why you chose to use the AutoPulse device when it is clear

that there is no scientific evidence supporting its use and some

evidence that it worsens victims of cardiac arrest? "

" What do you know and the [insert name] fire department know about

the AutoPulse that other departments do not know? Are you saying

the medical directors in Austin, San Francisco, Seattle, Columbus,

Calgary, Vancouver and Riverside County California were wrong in

removing these devices from their ambulances? "

* I am not aware of any findings that other agencies don't already

have. Although it has some literature noting that there has been

injury sustained, by notification of this departments medical

director the information stated has not proven in nor to this

department or its medical director to futher cause harm or injury to

a high percentage of patients that it was properly applied to and

operated on as well as noted patients presented by this department

to the ER with pulse and attempted respirations that it was used on.

>

" Paramedic Jeff, please provide us the scientific evidence on which

you based your decision to continue to use the device in light of

the report to the American Heart Association report that indicated

patients did better when they received manual CPR compared to the

AutoPulse? "

* Although use of some equipment is an option of the Incharge

Paramedic, after many meeting and inservices with the departments

medical director it is approved by the doctor for which I operate

under for use and again, reports interpreted by the medical director

has not justified the discontinue of this unit.

>

" Paramedic Jeff, please explain to the jury and the family of the

decedent where the Institutional Review Board for the University of

Washington was wrong in ordering the study stopped and the reason

you elected to continue to use the device in [insert name], Texas "

* Again, the IRB for UW may have found an issue with the unit but

has not been enough evidence for my medical director to stop the

usage of this unit in this department. Therefore, department wide

has been approved to continue use the unit as deemed appropriate.

>

Again, I am not picking on you--but making a point. The answer " I

have seen in work " only flies in church and on late-night TV ads. As

a textbook author, I am frequently contacted to be an expert in EMS

legal cases. And I assure you (as Wes, and Gene will attest to-

-under oath), the questions I posed are mellow compared to what you

will get on the stand.

* Well I am not sure what " I seen in work " is to fly for but I have

seen it operate and a successful save happen on friday night and my

patient is still in ICU as of 2PM today. Again its a personal choice

for the departments MD. I work at 2 departments that have them in

use and the MD are not convenced by the reports.

>

Again, an academic discussion--no need to cremate me (yet)?

* Well as an Instructor to an Author, I have seen the results good

and bad and with all the times I personally used it and seen it used

compiled to atleast 100+, I have not seen any abnormal injuries to

the patients through physical or Xrays on arrival to the ER and this

also includes precepted rotations at the Hospital with students..

Jeff

[Guest guest]

I have seen one person from A-TC on this list state a reason why they were

pulled off A-TC trucks...and it was a " I believe " statement...I believe it was

because the study was completed.

It is quite a leap to say that all the cities pulled them from the trucks

because they killed more people...oh, wait a minute...I mean it increases the

dead person's chances of remaining dead.

Can we please get links to all these studies from ALL these clinical sights on

the list so that we can all read how bad this device is? I really hate to sound

like a Zoll apologist...but when we throw innuendo around like this while

degrading Zoll because they say things like " SF thanks it is the best thing

since sliced bread " ...then we are not any better.

Why don't we get the links to all these agencies findings and reasoning for

pulling them off the trucks...then we can have a realistic discussion about the

facts...instead of everyone going off " I heards " and " the study will show " ....

Thanks,

Dudley

Re: Autopulse News

>>> I would believe that the services that has pulled the units are

going on statements that has been made and most likely injury that

was sustained due to misuse. <<<

The cities didn't stop using the Autopulse because of rumors they

heard, they were forced to remove the devices from the ambulances by

an ethics committee in the Institutional Review Board.

An IRB, will stop an investigation early for one of two reasons.

One, if the benefits of the device are so overwhelmingly convincing

in preliminary review that it would be unethical to deny the control

group access to the lifesaving care.

Or two, if the harm associated with the device was so overwhelmingly

convincing that it created an ethical dilemma to continue to harm

the study group.

If the ASPIRE trial was stopped for the first reason, they would

still be on the ambulances.

The people in these trials are not dying because of the injuries

allegedly caused by the devices. They are dying from the primary

event - cardiac arrest. The trial was stopped because application

of the device appears to increase the patient's chances of death.

The FDA has pulled medications from store shelves for less evidence

than this.

Now it is possible that the device, used in a different way could

increase survival from cardiac arrest. However, the evidence

appears, at this time not to support continued use of the Autopulse.

Kenny Navarro

[Guest guest]

I have seen one person from A-TC on this list state a reason why they were

pulled off A-TC trucks...and it was a " I believe " statement...I believe it was

because the study was completed.

It is quite a leap to say that all the cities pulled them from the trucks

because they killed more people...oh, wait a minute...I mean it increases the

dead person's chances of remaining dead.

Can we please get links to all these studies from ALL these clinical sights on

the list so that we can all read how bad this device is? I really hate to sound

like a Zoll apologist...but when we throw innuendo around like this while

degrading Zoll because they say things like " SF thanks it is the best thing

since sliced bread " ...then we are not any better.

Why don't we get the links to all these agencies findings and reasoning for

pulling them off the trucks...then we can have a realistic discussion about the

facts...instead of everyone going off " I heards " and " the study will show " ....

Thanks,

Dudley

Re: Autopulse News

>>> I would believe that the services that has pulled the units are

going on statements that has been made and most likely injury that

was sustained due to misuse. <<<

The cities didn't stop using the Autopulse because of rumors they

heard, they were forced to remove the devices from the ambulances by

an ethics committee in the Institutional Review Board.

An IRB, will stop an investigation early for one of two reasons.

One, if the benefits of the device are so overwhelmingly convincing

in preliminary review that it would be unethical to deny the control

group access to the lifesaving care.

Or two, if the harm associated with the device was so overwhelmingly

convincing that it created an ethical dilemma to continue to harm

the study group.

If the ASPIRE trial was stopped for the first reason, they would

still be on the ambulances.

The people in these trials are not dying because of the injuries

allegedly caused by the devices. They are dying from the primary

event - cardiac arrest. The trial was stopped because application

of the device appears to increase the patient's chances of death.

The FDA has pulled medications from store shelves for less evidence

than this.

Now it is possible that the device, used in a different way could

increase survival from cardiac arrest. However, the evidence

appears, at this time not to support continued use of the Autopulse.

Kenny Navarro

[Guest guest]

I have seen one person from A-TC on this list state a reason why they were

pulled off A-TC trucks...and it was a " I believe " statement...I believe it was

because the study was completed.

It is quite a leap to say that all the cities pulled them from the trucks

because they killed more people...oh, wait a minute...I mean it increases the

dead person's chances of remaining dead.

Can we please get links to all these studies from ALL these clinical sights on

the list so that we can all read how bad this device is? I really hate to sound

like a Zoll apologist...but when we throw innuendo around like this while

degrading Zoll because they say things like " SF thanks it is the best thing

since sliced bread " ...then we are not any better.

Why don't we get the links to all these agencies findings and reasoning for

pulling them off the trucks...then we can have a realistic discussion about the

facts...instead of everyone going off " I heards " and " the study will show " ....

Thanks,

Dudley

Re: Autopulse News

>>> I would believe that the services that has pulled the units are

going on statements that has been made and most likely injury that

was sustained due to misuse. <<<

The cities didn't stop using the Autopulse because of rumors they

heard, they were forced to remove the devices from the ambulances by

an ethics committee in the Institutional Review Board.

An IRB, will stop an investigation early for one of two reasons.

One, if the benefits of the device are so overwhelmingly convincing

in preliminary review that it would be unethical to deny the control

group access to the lifesaving care.

Or two, if the harm associated with the device was so overwhelmingly

convincing that it created an ethical dilemma to continue to harm

the study group.

If the ASPIRE trial was stopped for the first reason, they would

still be on the ambulances.

The people in these trials are not dying because of the injuries

allegedly caused by the devices. They are dying from the primary

event - cardiac arrest. The trial was stopped because application

of the device appears to increase the patient's chances of death.

The FDA has pulled medications from store shelves for less evidence

than this.

Now it is possible that the device, used in a different way could

increase survival from cardiac arrest. However, the evidence

appears, at this time not to support continued use of the Autopulse.

Kenny Navarro

[Guest guest]

Excellent question Jeff...if the FDA has pulled meds off shelves for less than

this...why is this not being pulled? Hmmmmmm.....

Dudley

Re: Autopulse News

Well should this equipment be so dangerous for use, why is it still

marketed for sale as well as why is Houston for example placing

orders for them? Now I will work on answering this scenario.

First, I mean no disrespect. But, how would you react in the

following scenario. You use the AutoPulse and the patient dies. Now,

that by no means indicates the AutoPulse contributed to the patient'

death. But, you are sued over the case and it goes to trial. The

plaintiff's attorney will say:

" Paramedic Jeff, please tell the jury and the family of the

decedent why you chose to use the AutoPulse device when it is clear

that there is no scientific evidence supporting its use and some

evidence that it worsens victims of cardiac arrest? "

" What do you know and the [insert name] fire department know about

the AutoPulse that other departments do not know? Are you saying

the medical directors in Austin, San Francisco, Seattle, Columbus,

Calgary, Vancouver and Riverside County California were wrong in

removing these devices from their ambulances? "

* I am not aware of any findings that other agencies don't already

have. Although it has some literature noting that there has been

injury sustained, by notification of this departments medical

director the information stated has not proven in nor to this

department or its medical director to futher cause harm or injury to

a high percentage of patients that it was properly applied to and

operated on as well as noted patients presented by this department

to the ER with pulse and attempted respirations that it was used on.

>

" Paramedic Jeff, please provide us the scientific evidence on which

you based your decision to continue to use the device in light of

the report to the American Heart Association report that indicated

patients did better when they received manual CPR compared to the

AutoPulse? "

* Although use of some equipment is an option of the Incharge

Paramedic, after many meeting and inservices with the departments

medical director it is approved by the doctor for which I operate

under for use and again, reports interpreted by the medical director

has not justified the discontinue of this unit.

>

" Paramedic Jeff, please explain to the jury and the family of the

decedent where the Institutional Review Board for the University of

Washington was wrong in ordering the study stopped and the reason

you elected to continue to use the device in [insert name], Texas "

* Again, the IRB for UW may have found an issue with the unit but

has not been enough evidence for my medical director to stop the

usage of this unit in this department. Therefore, department wide

has been approved to continue use the unit as deemed appropriate.

>

Again, I am not picking on you--but making a point. The answer " I

have seen in work " only flies in church and on late-night TV ads. As

a textbook author, I am frequently contacted to be an expert in EMS

legal cases. And I assure you (as Wes, and Gene will attest to-

-under oath), the questions I posed are mellow compared to what you

will get on the stand.

* Well I am not sure what " I seen in work " is to fly for but I have

seen it operate and a successful save happen on friday night and my

patient is still in ICU as of 2PM today. Again its a personal choice

for the departments MD. I work at 2 departments that have them in

use and the MD are not convenced by the reports.

>

Again, an academic discussion--no need to cremate me (yet)?

* Well as an Instructor to an Author, I have seen the results good

and bad and with all the times I personally used it and seen it used

compiled to atleast 100+, I have not seen any abnormal injuries to

the patients through physical or Xrays on arrival to the ER and this

also includes precepted rotations at the Hospital with students..

Jeff

[Guest guest]

Excellent question Jeff...if the FDA has pulled meds off shelves for less than

this...why is this not being pulled? Hmmmmmm.....

Dudley

Re: Autopulse News

Well should this equipment be so dangerous for use, why is it still

marketed for sale as well as why is Houston for example placing

orders for them? Now I will work on answering this scenario.

First, I mean no disrespect. But, how would you react in the

following scenario. You use the AutoPulse and the patient dies. Now,

that by no means indicates the AutoPulse contributed to the patient'

death. But, you are sued over the case and it goes to trial. The

plaintiff's attorney will say:

" Paramedic Jeff, please tell the jury and the family of the

decedent why you chose to use the AutoPulse device when it is clear

that there is no scientific evidence supporting its use and some

evidence that it worsens victims of cardiac arrest? "

" What do you know and the [insert name] fire department know about

the AutoPulse that other departments do not know? Are you saying

the medical directors in Austin, San Francisco, Seattle, Columbus,

Calgary, Vancouver and Riverside County California were wrong in

removing these devices from their ambulances? "

* I am not aware of any findings that other agencies don't already

have. Although it has some literature noting that there has been

injury sustained, by notification of this departments medical

director the information stated has not proven in nor to this

department or its medical director to futher cause harm or injury to

a high percentage of patients that it was properly applied to and

operated on as well as noted patients presented by this department

to the ER with pulse and attempted respirations that it was used on.

>

" Paramedic Jeff, please provide us the scientific evidence on which

you based your decision to continue to use the device in light of

the report to the American Heart Association report that indicated

patients did better when they received manual CPR compared to the

AutoPulse? "

* Although use of some equipment is an option of the Incharge

Paramedic, after many meeting and inservices with the departments

medical director it is approved by the doctor for which I operate

under for use and again, reports interpreted by the medical director

has not justified the discontinue of this unit.

>

" Paramedic Jeff, please explain to the jury and the family of the

decedent where the Institutional Review Board for the University of

Washington was wrong in ordering the study stopped and the reason

you elected to continue to use the device in [insert name], Texas "

* Again, the IRB for UW may have found an issue with the unit but

has not been enough evidence for my medical director to stop the

usage of this unit in this department. Therefore, department wide

has been approved to continue use the unit as deemed appropriate.

>

Again, I am not picking on you--but making a point. The answer " I

have seen in work " only flies in church and on late-night TV ads. As

a textbook author, I am frequently contacted to be an expert in EMS

legal cases. And I assure you (as Wes, and Gene will attest to-

-under oath), the questions I posed are mellow compared to what you

will get on the stand.

* Well I am not sure what " I seen in work " is to fly for but I have

seen it operate and a successful save happen on friday night and my

patient is still in ICU as of 2PM today. Again its a personal choice

for the departments MD. I work at 2 departments that have them in

use and the MD are not convenced by the reports.

>

Again, an academic discussion--no need to cremate me (yet)?

* Well as an Instructor to an Author, I have seen the results good

and bad and with all the times I personally used it and seen it used

compiled to atleast 100+, I have not seen any abnormal injuries to

the patients through physical or Xrays on arrival to the ER and this

also includes precepted rotations at the Hospital with students..

Jeff

[Guest guest]

Excellent question Jeff...if the FDA has pulled meds off shelves for less than

this...why is this not being pulled? Hmmmmmm.....

Dudley

Re: Autopulse News

Well should this equipment be so dangerous for use, why is it still

marketed for sale as well as why is Houston for example placing

orders for them? Now I will work on answering this scenario.

First, I mean no disrespect. But, how would you react in the

following scenario. You use the AutoPulse and the patient dies. Now,

that by no means indicates the AutoPulse contributed to the patient'

death. But, you are sued over the case and it goes to trial. The

plaintiff's attorney will say:

" Paramedic Jeff, please tell the jury and the family of the

decedent why you chose to use the AutoPulse device when it is clear

that there is no scientific evidence supporting its use and some

evidence that it worsens victims of cardiac arrest? "

" What do you know and the [insert name] fire department know about

the AutoPulse that other departments do not know? Are you saying

the medical directors in Austin, San Francisco, Seattle, Columbus,

Calgary, Vancouver and Riverside County California were wrong in

removing these devices from their ambulances? "

* I am not aware of any findings that other agencies don't already

have. Although it has some literature noting that there has been

injury sustained, by notification of this departments medical

director the information stated has not proven in nor to this

department or its medical director to futher cause harm or injury to

a high percentage of patients that it was properly applied to and

operated on as well as noted patients presented by this department

to the ER with pulse and attempted respirations that it was used on.

>

" Paramedic Jeff, please provide us the scientific evidence on which

you based your decision to continue to use the device in light of

the report to the American Heart Association report that indicated

patients did better when they received manual CPR compared to the

AutoPulse? "

* Although use of some equipment is an option of the Incharge

Paramedic, after many meeting and inservices with the departments

medical director it is approved by the doctor for which I operate

under for use and again, reports interpreted by the medical director

has not justified the discontinue of this unit.

>

" Paramedic Jeff, please explain to the jury and the family of the

decedent where the Institutional Review Board for the University of

Washington was wrong in ordering the study stopped and the reason

you elected to continue to use the device in [insert name], Texas "

* Again, the IRB for UW may have found an issue with the unit but

has not been enough evidence for my medical director to stop the

usage of this unit in this department. Therefore, department wide

has been approved to continue use the unit as deemed appropriate.

>

Again, I am not picking on you--but making a point. The answer " I

have seen in work " only flies in church and on late-night TV ads. As

a textbook author, I am frequently contacted to be an expert in EMS

legal cases. And I assure you (as Wes, and Gene will attest to-

-under oath), the questions I posed are mellow compared to what you

will get on the stand.

* Well I am not sure what " I seen in work " is to fly for but I have

seen it operate and a successful save happen on friday night and my

patient is still in ICU as of 2PM today. Again its a personal choice

for the departments MD. I work at 2 departments that have them in

use and the MD are not convenced by the reports.

>

Again, an academic discussion--no need to cremate me (yet)?

* Well as an Instructor to an Author, I have seen the results good

and bad and with all the times I personally used it and seen it used

compiled to atleast 100+, I have not seen any abnormal injuries to

the patients through physical or Xrays on arrival to the ER and this

also includes precepted rotations at the Hospital with students..

Jeff

[Guest guest]

Well Dr B, with your approval now, I will until it is taken off

ether of my units. Also on another note maybe we can cross paths

next week, I would like to shake your hand just for the general

purposes.

Jeff

>

> Well. then use it.

>

> _____

>

> From: [mailto:texasems-

l ] On

> Behalf Of Jeff

> Sent: Monday, November 14, 2005 4:03 PM

> To:

> Subject: Re: Autopulse News

>

>

> Well should this equipment be so dangerous for use, why is it

still

> marketed for sale as well as why is Houston for example placing

> orders for them? Now I will work on answering this scenario.

>

>

> First, I mean no disrespect. But, how would you react in the

> following scenario. You use the AutoPulse and the patient dies.

Now,

> that by no means indicates the AutoPulse contributed to the

patient'

> death. But, you are sued over the case and it goes to trial. The

> plaintiff's attorney will say:

> " Paramedic Jeff, please tell the jury and the family of the

> decedent why you chose to use the AutoPulse device when it is

clear

> that there is no scientific evidence supporting its use and some

> evidence that it worsens victims of cardiac arrest? "

>

> " What do you know and the [insert name] fire department know about

> the AutoPulse that other departments do not know? Are you saying

> the medical directors in Austin, San Francisco, Seattle, Columbus,

> Calgary, Vancouver and Riverside County California were wrong in

> removing these devices from their ambulances? "

>

> * I am not aware of any findings that other agencies don't already

> have. Although it has some literature noting that there has been

> injury sustained, by notification of this departments medical

> director the information stated has not proven in nor to this

> department or its medical director to futher cause harm or injury

to

> a high percentage of patients that it was properly applied to and

> operated on as well as noted patients presented by this department

> to the ER with pulse and attempted respirations that it was used

on.

>

> >

> " Paramedic Jeff, please provide us the scientific evidence on

which

> you based your decision to continue to use the device in light of

> the report to the American Heart Association report that indicated

> patients did better when they received manual CPR compared to the

> AutoPulse? "

>

> * Although use of some equipment is an option of the Incharge

> Paramedic, after many meeting and inservices with the departments

> medical director it is approved by the doctor for which I operate

> under for use and again, reports interpreted by the medical

director

> has not justified the discontinue of this unit.

>

> >

> " Paramedic Jeff, please explain to the jury and the family of the

> decedent where the Institutional Review Board for the University

of

> Washington was wrong in ordering the study stopped and the reason

> you elected to continue to use the device in [insert name], Texas "

>

> * Again, the IRB for UW may have found an issue with the unit but

> has not been enough evidence for my medical director to stop the

> usage of this unit in this department. Therefore, department wide

> has been approved to continue use the unit as deemed appropriate.

>

> >

> Again, I am not picking on you--but making a point. The answer " I

> have seen in work " only flies in church and on late-night TV ads.

As

> a textbook author, I am frequently contacted to be an expert in

EMS

> legal cases. And I assure you (as Wes, and Gene will attest

to-

> -under oath), the questions I posed are mellow compared to what

you

> will get on the stand.

>

> * Well I am not sure what " I seen in work " is to fly for but I

have

> seen it operate and a successful save happen on friday night and

my

> patient is still in ICU as of 2PM today. Again its a personal

choice

> for the departments MD. I work at 2 departments that have them in

> use and the MD are not convenced by the reports.

>

> >

>

> Again, an academic discussion--no need to cremate me (yet)?

>

> * Well as an Instructor to an Author, I have seen the results good

> and bad and with all the times I personally used it and seen it

used

> compiled to atleast 100+, I have not seen any abnormal injuries to

> the patients through physical or Xrays on arrival to the ER and

this

> also includes precepted rotations at the Hospital with students..

>

> Jeff

>

>

>

>

>

>

>

>

>

>

>

>

>

>

[Guest guest]

It would be my pleasure. It is fun to stir the crap on these lists. But, in

the end we are all trying to help the patient. Such discussions make it fun

and interesting--even if you are wrong

BEB

_____

From: [mailto: ] On

Behalf Of Jeff

Sent: Monday, November 14, 2005 4:51 PM

To:

Subject: Re: Autopulse News

Well Dr B, with your approval now, I will until it is taken off

ether of my units. Also on another note maybe we can cross paths

next week, I would like to shake your hand just for the general

purposes.

Jeff

>

> Well. then use it.

>

> _____

>

> From: [mailto:texasems-

l ] On

> Behalf Of Jeff

> Sent: Monday, November 14, 2005 4:03 PM

> To:

> Subject: Re: Autopulse News

>

>

> Well should this equipment be so dangerous for use, why is it

still

> marketed for sale as well as why is Houston for example placing

> orders for them? Now I will work on answering this scenario.

>

>

> First, I mean no disrespect. But, how would you react in the

> following scenario. You use the AutoPulse and the patient dies.

Now,

> that by no means indicates the AutoPulse contributed to the

patient'

> death. But, you are sued over the case and it goes to trial. The

> plaintiff's attorney will say:

> " Paramedic Jeff, please tell the jury and the family of the

> decedent why you chose to use the AutoPulse device when it is

clear

> that there is no scientific evidence supporting its use and some

> evidence that it worsens victims of cardiac arrest? "

>

> " What do you know and the [insert name] fire department know about

> the AutoPulse that other departments do not know? Are you saying

> the medical directors in Austin, San Francisco, Seattle, Columbus,

> Calgary, Vancouver and Riverside County California were wrong in

> removing these devices from their ambulances? "

>

> * I am not aware of any findings that other agencies don't already

> have. Although it has some literature noting that there has been

> injury sustained, by notification of this departments medical

> director the information stated has not proven in nor to this

> department or its medical director to futher cause harm or injury

to

> a high percentage of patients that it was properly applied to and

> operated on as well as noted patients presented by this department

> to the ER with pulse and attempted respirations that it was used

on.

>

> >

> " Paramedic Jeff, please provide us the scientific evidence on

which

> you based your decision to continue to use the device in light of

> the report to the American Heart Association report that indicated

> patients did better when they received manual CPR compared to the

> AutoPulse? "

>

> * Although use of some equipment is an option of the Incharge

> Paramedic, after many meeting and inservices with the departments

> medical director it is approved by the doctor for which I operate

> under for use and again, reports interpreted by the medical

director

> has not justified the discontinue of this unit.

>

> >

> " Paramedic Jeff, please explain to the jury and the family of the

> decedent where the Institutional Review Board for the University

of

> Washington was wrong in ordering the study stopped and the reason

> you elected to continue to use the device in [insert name], Texas "

>

> * Again, the IRB for UW may have found an issue with the unit but

> has not been enough evidence for my medical director to stop the

> usage of this unit in this department. Therefore, department wide

> has been approved to continue use the unit as deemed appropriate.

>

> >

> Again, I am not picking on you--but making a point. The answer " I

> have seen in work " only flies in church and on late-night TV ads.

As

> a textbook author, I am frequently contacted to be an expert in

EMS

> legal cases. And I assure you (as Wes, and Gene will attest

to-

> -under oath), the questions I posed are mellow compared to what

you

> will get on the stand.

>

> * Well I am not sure what " I seen in work " is to fly for but I

have

> seen it operate and a successful save happen on friday night and

my

> patient is still in ICU as of 2PM today. Again its a personal

choice

> for the departments MD. I work at 2 departments that have them in

> use and the MD are not convenced by the reports.

>

> >

>

> Again, an academic discussion--no need to cremate me (yet)?

>

> * Well as an Instructor to an Author, I have seen the results good

> and bad and with all the times I personally used it and seen it

used

> compiled to atleast 100+, I have not seen any abnormal injuries to

> the patients through physical or Xrays on arrival to the ER and

this

> also includes precepted rotations at the Hospital with students..

>

> Jeff

>

>

>

>

>

>

>

>

>

>

>

>

>

>

[Guest guest]

It would be my pleasure. It is fun to stir the crap on these lists. But, in

the end we are all trying to help the patient. Such discussions make it fun

and interesting--even if you are wrong

BEB

_____

From: [mailto: ] On

Behalf Of Jeff

Sent: Monday, November 14, 2005 4:51 PM

To:

Subject: Re: Autopulse News

Well Dr B, with your approval now, I will until it is taken off

ether of my units. Also on another note maybe we can cross paths

next week, I would like to shake your hand just for the general

purposes.

Jeff

>

> Well. then use it.

>

> _____

>

> From: [mailto:texasems-

l ] On

> Behalf Of Jeff

> Sent: Monday, November 14, 2005 4:03 PM

> To:

> Subject: Re: Autopulse News

>

>

> Well should this equipment be so dangerous for use, why is it

still

> marketed for sale as well as why is Houston for example placing

> orders for them? Now I will work on answering this scenario.

>

>

> First, I mean no disrespect. But, how would you react in the

> following scenario. You use the AutoPulse and the patient dies.

Now,

> that by no means indicates the AutoPulse contributed to the

patient'

> death. But, you are sued over the case and it goes to trial. The

> plaintiff's attorney will say:

> " Paramedic Jeff, please tell the jury and the family of the

> decedent why you chose to use the AutoPulse device when it is

clear

> that there is no scientific evidence supporting its use and some

> evidence that it worsens victims of cardiac arrest? "

>

> " What do you know and the [insert name] fire department know about

> the AutoPulse that other departments do not know? Are you saying

> the medical directors in Austin, San Francisco, Seattle, Columbus,

> Calgary, Vancouver and Riverside County California were wrong in

> removing these devices from their ambulances? "

>

> * I am not aware of any findings that other agencies don't already

> have. Although it has some literature noting that there has been

> injury sustained, by notification of this departments medical

> director the information stated has not proven in nor to this

> department or its medical director to futher cause harm or injury

to

> a high percentage of patients that it was properly applied to and

> operated on as well as noted patients presented by this department

> to the ER with pulse and attempted respirations that it was used

on.

>

> >

> " Paramedic Jeff, please provide us the scientific evidence on

which

> you based your decision to continue to use the device in light of

> the report to the American Heart Association report that indicated

> patients did better when they received manual CPR compared to the

> AutoPulse? "

>

> * Although use of some equipment is an option of the Incharge

> Paramedic, after many meeting and inservices with the departments

> medical director it is approved by the doctor for which I operate

> under for use and again, reports interpreted by the medical

director

> has not justified the discontinue of this unit.

>

> >

> " Paramedic Jeff, please explain to the jury and the family of the

> decedent where the Institutional Review Board for the University

of

> Washington was wrong in ordering the study stopped and the reason

> you elected to continue to use the device in [insert name], Texas "

>

> * Again, the IRB for UW may have found an issue with the unit but

> has not been enough evidence for my medical director to stop the

> usage of this unit in this department. Therefore, department wide

> has been approved to continue use the unit as deemed appropriate.

>

> >

> Again, I am not picking on you--but making a point. The answer " I

> have seen in work " only flies in church and on late-night TV ads.

As

> a textbook author, I am frequently contacted to be an expert in

EMS

> legal cases. And I assure you (as Wes, and Gene will attest

to-

> -under oath), the questions I posed are mellow compared to what

you

> will get on the stand.

>

> * Well I am not sure what " I seen in work " is to fly for but I

have

> seen it operate and a successful save happen on friday night and

my

> patient is still in ICU as of 2PM today. Again its a personal

choice

> for the departments MD. I work at 2 departments that have them in

> use and the MD are not convenced by the reports.

>

> >

>

> Again, an academic discussion--no need to cremate me (yet)?

>

> * Well as an Instructor to an Author, I have seen the results good

> and bad and with all the times I personally used it and seen it

used

> compiled to atleast 100+, I have not seen any abnormal injuries to

> the patients through physical or Xrays on arrival to the ER and

this

> also includes precepted rotations at the Hospital with students..

>

> Jeff

>

>

>

>

>

>

>

>

>

>

>

>

>

>

[Guest guest]

It would be my pleasure. It is fun to stir the crap on these lists. But, in

the end we are all trying to help the patient. Such discussions make it fun

and interesting--even if you are wrong

BEB

_____

From: [mailto: ] On

Behalf Of Jeff

Sent: Monday, November 14, 2005 4:51 PM

To:

Subject: Re: Autopulse News

Well Dr B, with your approval now, I will until it is taken off

ether of my units. Also on another note maybe we can cross paths

next week, I would like to shake your hand just for the general

purposes.

Jeff

>

> Well. then use it.

>

> _____

>

> From: [mailto:texasems-

l ] On

> Behalf Of Jeff

> Sent: Monday, November 14, 2005 4:03 PM

> To:

> Subject: Re: Autopulse News

>

>

> Well should this equipment be so dangerous for use, why is it

still

> marketed for sale as well as why is Houston for example placing

> orders for them? Now I will work on answering this scenario.

>

>

> First, I mean no disrespect. But, how would you react in the

> following scenario. You use the AutoPulse and the patient dies.

Now,

> that by no means indicates the AutoPulse contributed to the

patient'

> death. But, you are sued over the case and it goes to trial. The

> plaintiff's attorney will say:

> " Paramedic Jeff, please tell the jury and the family of the

> decedent why you chose to use the AutoPulse device when it is

clear

> that there is no scientific evidence supporting its use and some

> evidence that it worsens victims of cardiac arrest? "

>

> " What do you know and the [insert name] fire department know about

> the AutoPulse that other departments do not know? Are you saying

> the medical directors in Austin, San Francisco, Seattle, Columbus,

> Calgary, Vancouver and Riverside County California were wrong in

> removing these devices from their ambulances? "

>

> * I am not aware of any findings that other agencies don't already

> have. Although it has some literature noting that there has been

> injury sustained, by notification of this departments medical

> director the information stated has not proven in nor to this

> department or its medical director to futher cause harm or injury

to

> a high percentage of patients that it was properly applied to and

> operated on as well as noted patients presented by this department

> to the ER with pulse and attempted respirations that it was used

on.

>

> >

> " Paramedic Jeff, please provide us the scientific evidence on

which

> you based your decision to continue to use the device in light of

> the report to the American Heart Association report that indicated

> patients did better when they received manual CPR compared to the

> AutoPulse? "

>

> * Although use of some equipment is an option of the Incharge

> Paramedic, after many meeting and inservices with the departments

> medical director it is approved by the doctor for which I operate

> under for use and again, reports interpreted by the medical

director

> has not justified the discontinue of this unit.

>

> >

> " Paramedic Jeff, please explain to the jury and the family of the

> decedent where the Institutional Review Board for the University

of

> Washington was wrong in ordering the study stopped and the reason

> you elected to continue to use the device in [insert name], Texas "

>

> * Again, the IRB for UW may have found an issue with the unit but

> has not been enough evidence for my medical director to stop the

> usage of this unit in this department. Therefore, department wide

> has been approved to continue use the unit as deemed appropriate.

>

> >

> Again, I am not picking on you--but making a point. The answer " I

> have seen in work " only flies in church and on late-night TV ads.

As

> a textbook author, I am frequently contacted to be an expert in

EMS

> legal cases. And I assure you (as Wes, and Gene will attest

to-

> -under oath), the questions I posed are mellow compared to what

you

> will get on the stand.

>

> * Well I am not sure what " I seen in work " is to fly for but I

have

> seen it operate and a successful save happen on friday night and

my

> patient is still in ICU as of 2PM today. Again its a personal

choice

> for the departments MD. I work at 2 departments that have them in

> use and the MD are not convenced by the reports.

>

> >

>

> Again, an academic discussion--no need to cremate me (yet)?

>

> * Well as an Instructor to an Author, I have seen the results good

> and bad and with all the times I personally used it and seen it

used

> compiled to atleast 100+, I have not seen any abnormal injuries to

> the patients through physical or Xrays on arrival to the ER and

this

> also includes precepted rotations at the Hospital with students..

>

> Jeff

>

>

>

>

>

>

>

>

>

>

>

>

>

>

[Guest guest]

Reminds me of a saying I like to use on my wife occasionally to " stir the

pot "

" If a man speaks in the forest, and there is no woman there to hear him, is

he still wrong? "

Re: Autopulse News

>

>

> Well should this equipment be so dangerous for use, why is it

still

> marketed for sale as well as why is Houston for example placing

> orders for them? Now I will work on answering this scenario.

>

>

> First, I mean no disrespect. But, how would you react in the

> following scenario. You use the AutoPulse and the patient dies.

Now,

> that by no means indicates the AutoPulse contributed to the

patient'

> death. But, you are sued over the case and it goes to trial. The

> plaintiff's attorney will say:

> " Paramedic Jeff, please tell the jury and the family of the

> decedent why you chose to use the AutoPulse device when it is

clear

> that there is no scientific evidence supporting its use and some

> evidence that it worsens victims of cardiac arrest? "

>

> " What do you know and the [insert name] fire department know about

> the AutoPulse that other departments do not know? Are you saying

> the medical directors in Austin, San Francisco, Seattle, Columbus,

> Calgary, Vancouver and Riverside County California were wrong in

> removing these devices from their ambulances? "

>

> * I am not aware of any findings that other agencies don't already

> have. Although it has some literature noting that there has been

> injury sustained, by notification of this departments medical

> director the information stated has not proven in nor to this

> department or its medical director to futher cause harm or injury

to

> a high percentage of patients that it was properly applied to and

> operated on as well as noted patients presented by this department

> to the ER with pulse and attempted respirations that it was used

on.

>

> >

> " Paramedic Jeff, please provide us the scientific evidence on

which

> you based your decision to continue to use the device in light of

> the report to the American Heart Association report that indicated

> patients did better when they received manual CPR compared to the

> AutoPulse? "

>

> * Although use of some equipment is an option of the Incharge

> Paramedic, after many meeting and inservices with the departments

> medical director it is approved by the doctor for which I operate

> under for use and again, reports interpreted by the medical

director

> has not justified the discontinue of this unit.

>

> >

> " Paramedic Jeff, please explain to the jury and the family of the

> decedent where the Institutional Review Board for the University

of

> Washington was wrong in ordering the study stopped and the reason

> you elected to continue to use the device in [insert name], Texas "

>

> * Again, the IRB for UW may have found an issue with the unit but

> has not been enough evidence for my medical director to stop the

> usage of this unit in this department. Therefore, department wide

> has been approved to continue use the unit as deemed appropriate.

>

> >

> Again, I am not picking on you--but making a point. The answer " I

> have seen in work " only flies in church and on late-night TV ads.

As

> a textbook author, I am frequently contacted to be an expert in

EMS

> legal cases. And I assure you (as Wes, and Gene will attest

to-

> -under oath), the questions I posed are mellow compared to what

you

> will get on the stand.

>

> * Well I am not sure what " I seen in work " is to fly for but I

have

> seen it operate and a successful save happen on friday night and

my

> patient is still in ICU as of 2PM today. Again its a personal

choice

> for the departments MD. I work at 2 departments that have them in

> use and the MD are not convenced by the reports.

>

> >

>

> Again, an academic discussion--no need to cremate me (yet)?

>

> * Well as an Instructor to an Author, I have seen the results good

> and bad and with all the times I personally used it and seen it

used

> compiled to atleast 100+, I have not seen any abnormal injuries to

> the patients through physical or Xrays on arrival to the ER and

this

> also includes precepted rotations at the Hospital with students..

>

> Jeff

>

>

>

>

>

>

>

>

>

>

>

>

>

>

[Guest guest]

Reminds me of a saying I like to use on my wife occasionally to " stir the

pot "

" If a man speaks in the forest, and there is no woman there to hear him, is

he still wrong? "

Re: Autopulse News

>

>

> Well should this equipment be so dangerous for use, why is it

still

> marketed for sale as well as why is Houston for example placing

> orders for them? Now I will work on answering this scenario.

>

>

> First, I mean no disrespect. But, how would you react in the

> following scenario. You use the AutoPulse and the patient dies.

Now,

> that by no means indicates the AutoPulse contributed to the

patient'

> death. But, you are sued over the case and it goes to trial. The

> plaintiff's attorney will say:

> " Paramedic Jeff, please tell the jury and the family of the

> decedent why you chose to use the AutoPulse device when it is

clear

> that there is no scientific evidence supporting its use and some

> evidence that it worsens victims of cardiac arrest? "

>

> " What do you know and the [insert name] fire department know about

> the AutoPulse that other departments do not know? Are you saying

> the medical directors in Austin, San Francisco, Seattle, Columbus,

> Calgary, Vancouver and Riverside County California were wrong in

> removing these devices from their ambulances? "

>

> * I am not aware of any findings that other agencies don't already

> have. Although it has some literature noting that there has been

> injury sustained, by notification of this departments medical

> director the information stated has not proven in nor to this

> department or its medical director to futher cause harm or injury

to

> a high percentage of patients that it was properly applied to and

> operated on as well as noted patients presented by this department

> to the ER with pulse and attempted respirations that it was used

on.

>

> >

> " Paramedic Jeff, please provide us the scientific evidence on

which

> you based your decision to continue to use the device in light of

> the report to the American Heart Association report that indicated

> patients did better when they received manual CPR compared to the

> AutoPulse? "

>

> * Although use of some equipment is an option of the Incharge

> Paramedic, after many meeting and inservices with the departments

> medical director it is approved by the doctor for which I operate

> under for use and again, reports interpreted by the medical

director

> has not justified the discontinue of this unit.

>

> >

> " Paramedic Jeff, please explain to the jury and the family of the

> decedent where the Institutional Review Board for the University

of

> Washington was wrong in ordering the study stopped and the reason

> you elected to continue to use the device in [insert name], Texas "

>

> * Again, the IRB for UW may have found an issue with the unit but

> has not been enough evidence for my medical director to stop the

> usage of this unit in this department. Therefore, department wide

> has been approved to continue use the unit as deemed appropriate.

>

> >

> Again, I am not picking on you--but making a point. The answer " I

> have seen in work " only flies in church and on late-night TV ads.

As

> a textbook author, I am frequently contacted to be an expert in

EMS

> legal cases. And I assure you (as Wes, and Gene will attest

to-

> -under oath), the questions I posed are mellow compared to what

you

> will get on the stand.

>

> * Well I am not sure what " I seen in work " is to fly for but I

have

> seen it operate and a successful save happen on friday night and

my

> patient is still in ICU as of 2PM today. Again its a personal

choice

> for the departments MD. I work at 2 departments that have them in

> use and the MD are not convenced by the reports.

>

> >

>

> Again, an academic discussion--no need to cremate me (yet)?

>

> * Well as an Instructor to an Author, I have seen the results good

> and bad and with all the times I personally used it and seen it

used

> compiled to atleast 100+, I have not seen any abnormal injuries to

> the patients through physical or Xrays on arrival to the ER and

this

> also includes precepted rotations at the Hospital with students..

>

> Jeff

>

>

>

>

>

>

>

>

>

>

>

>

>

>

[Guest guest]

Dr. Greg Cynamoun (not even a real doctor) sold millions of dollars worth of

worthless Corti-Slim despite FDA warnings. It takes time for the FDA to pull

a device and they may want additional studies. Here are the published

studies so far. As far as Austin, I saw Dr. Racht yesterday and he said they

were pulled because of concerns over a flailed chest and early word of the

ASPIRE study. San Francisco was not studying the devices per se although

Cassner published some low-validity data from San Francisco.

---------------------------------------

Prehosp Emerg Care. 2005 Jan-Mar;9(1):61-7

The impact of a new CPR assist device on rate of return of spontaneous

circulation in out-of-hospital cardiac arrest.

<http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed & cmd=Search & term=%22

Casner+M%22%5BAuthor%5D> Casner M,

<http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed & cmd=Search & term=%22

Andersen+D%22%5BAuthor%5D> Andersen D,

<http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed & cmd=Search & term=%22

Isaacs+SM%22%5BAuthor%5D> Isaacs SM.

San Francisco Fire Department, San Francisco, California 94107, USA.

michael.casner@...

OBJECTIVE: The San Francisco Fire Department deployed an automated,

load-distributing-band chest compression device (AutoPulse, Revivant

Corporation) to evaluate its function in a large urban emergency medical

services (EMS) service. A retrospective chart review was undertaken to

determine whether the AutoPulse had altered short-term patient outcome,

specifically, return of spontaneous circulation (ROSC). METHODS: AutoPulse

cardiopulmonary resuscitation (A-CPR) was used by paramedic captains

responding to adult cardiac arrests with an average +/-SD response time of

15 +/- 5 minutes. The primary endpoint was patient arrival to an emergency

department with measurable spontaneous pulses. The manual CPR comparison

group was case-matched for age, gender, initial presenting electrocardiogram

rhythm, and the number of doses of Advanced Cardiac Life Support medications

as a proxy for treatment time. Matching was performed by an investigator

blinded to outcome and treatment group. RESULTS: Sixty-nine AutoPulse uses

were matched to 93 manual-CPR-only cases. A-CPR showed improvement in the

primary outcome when compared with manual CPR with any presenting rhythm

(A-CPR 39%, manual 29%, p = 0.003). When patients were classified by first

presenting rhythm, shockable rhythms showed no difference in outcome (A-CPR

44%, manual 50%, p = 0.340). Outcome was improved with A-CPR in initial

presenting asystole and approached significance with pulseless electrical

activity (PEA)(asystole: A-CPR 37%, manual 22%, p = 0.008; PEA: A-CPR 38%,

manual 23%, p = 0.079). CONCLUSION: The AutoPulse may improve the overall

likelihood of sustained ROSC and may particularly benefit patients with

nonshockable rhythms. A prospective randomized trial comparing the AutoPulse

with manual CPR in the setting of out-of-hospital sudden cardiac arrest is

under way.

This study showed that ROSC was better (mininally) for asystole, but worse

for V-fib.

-----------------------------------------------

J Forensic Sci. 2005 Jan;50(1):164-8.

Autopsy artifact created by the Revivant AutoPulse resuscitation device.

<http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed & cmd=Search & term=%22

Hart+AP%22%5BAuthor%5D> Hart AP,

<http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed & cmd=Search & term=%22

Azar+VJ%22%5BAuthor%5D> Azar VJ,

<http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed & cmd=Search & term=%22

Hart+KR%22%5BAuthor%5D> Hart KR,

<http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed & cmd=Search & term=%22

s+BG%22%5BAuthor%5D> s BG.

Office of the Chief Medical Examiner, City and County of San Francisco, Hall

of Justice, 850 St., San Francisco, CA 94103, USA. amy.hart@...

In certain cases, the evaluation and correct identification of resuscitative

artifacts is critical to the correct diagnosis and determination of the

cause and manner of death. Resuscitative artifacts can resemble homicidal or

accidental injury and thus possibly be misinterpreted. Occasionally, new

technologies and/or medical procedures will create original and/or

distinctive artifacts. In 2003, the San Francisco Fire Department emergency

personnel began field-testing the Revivant AutoPulse, an automated chest

compression device. This device is currently being used in two other

counties in the San Francisco Bay Area as well as regions of Florida,

Virginia, and Ohio. We present three cases of resuscitative artifact that

could be potentially confused with homicidal or accidental injury. These

cases illustrate resuscitative artifacts, specifically lateral chest and

horizontally oriented upper abdomen cutaneous abrasions created by this

automated chest compression device.

---------------------------------------------

J Am Coll Cardiol. 2004 Dec 7;44(11):2214-20

Cardiopulmonary resuscitation with a novel chest compression device in a

porcine model of cardiac arrest: improved hemodynamics and mechanisms.

<http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed & cmd=Search & term=%22

Halperin+HR%22%5BAuthor%5D> Halperin HR,

<http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed & cmd=Search & term=%22

Paradis+N%22%5BAuthor%5D> Paradis N,

<http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed & cmd=Search & term=%22

Ornato+JP%22%5BAuthor%5D> Ornato JP,

<http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed & cmd=Search & term=%22

Zviman+M%22%5BAuthor%5D> Zviman M,

<http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed & cmd=Search & term=%22

Lacorte+J%22%5BAuthor%5D> Lacorte J,

<http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed & cmd=Search & term=%22

Lardo+A%22%5BAuthor%5D> Lardo A,

<http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed & cmd=Search & term=%22

Kern+KB%22%5BAuthor%5D> Kern KB.

s Hopkins University, Department of Medicine, Baltimore, land, USA.

hhalper@...

OBJECTIVES: The goal of this study was to determine the magnitude and

mechanisms of hemodynamic improvement of an automated, load-distributing

band device (AutoPulse, Revivant Corp., Sunnyvale, California) compared with

conventional cardiopulmonary resuscitation (C-CPR). BACKGROUND: Improved

blood flow during cardiopulmonary resuscitation (CPR) enhances survival from

cardiac arrest. METHODS: AutoPulse CPR (A-CPR) and C-CPR were performed on

30 pigs (16 +/- 4 kg) 1 min after induction of ventricular fibrillation.

Aortic and right atrial pressures were measured with micromanometers.

Regional flows were measured with microspheres; A-CPR and C-CPR were

performed with 20% anterior-posterior chest compression, with (n = 10) and

without (n = 10) epinephrine. A pressure transducer was advanced down the

airways during chest compressions (n = 10), and magnetic resonance imaging

(MRI) was performed. RESULTS: AutoPulse CPR improved coronary perfusion

pressure (CPP) (aortic - right atrial pressure) without epinephrine (A-CPR

21 +/- 8 mm Hg vs. C-CPR 14 +/- 6 mm Hg, mean +/- SD, p < 0.0001) and with

epinephrine (A-CPR 45 +/- 11 mm Hg vs. C-CPR 17 +/- 6 mm Hg, p < 0.0001).

AutoPulse CPR improved myocardial flow without epinephrine and cerebral and

myocardial flow with epinephrine (p < 0.05). AutoPulse CPR also produced

greater myocardial flow at every CPP (p < 0.01). With A-CPR, high airway

pressure was noted distal to the carina, which corresponded to an area of

airway collapse on MRI, and which was not present with C-CPR. CONCLUSIONS:

AutoPulse CPR improved hemodynamics over C-CPR in this pig model. AutoPulse

CPR with epinephrine can produce pre-arrest levels of myocardial and

cerebral flow. The improved hemodynamics with A-CPR appear to be mediated

through airway collapse, which likely impedes airflow and helps maintain

higher levels of intrathoracic pressure.

The AutoPulse showed increased coronary perfusion pressures in pigs. No

look at survivability or outcome. Halperin, Paredis and Ornato had or have a

financial interest in the device.

---------------------------------------------------

Resuscitation. 2004 Jun;61(3):273-80

Improved hemodynamic performance with a novel chest compression device

during treatment of in-hospital cardiac arrest.

<http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed & cmd=Search & term=%22

Timerman+S%22%5BAuthor%5D> Timerman S,

<http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed & cmd=Search & term=%22

Cardoso+LF%22%5BAuthor%5D> Cardoso LF,

<http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed & cmd=Search & term=%22

Ramires+JA%22%5BAuthor%5D> Ramires JA,

<http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed & cmd=Search & term=%22

Halperin+H%22%5BAuthor%5D> Halperin H.

The Heart Institute (InCor), Sao o University School of Medicine, Sao

o, Brazil.

INTRODUCTION: The purpose of this pilot clinical study was to determine if a

novel chest compression device would improve hemodynamics when compared to

manual chest compression during cardiopulmonary resuscitation (CPR) in

humans. The device is an automated self-adjusting electromechanical chest

compressor based on AutoPulse technology (Revivant Corporation) that uses a

load distributing compression band (A-CPR) to compress the anterior chest.

METHODS: A total of 31 sequential subjects with in-hospital sudden cardiac

arrest were screened with institutional review board approval. All subjects

had received prior treatment for cardiac disease and most had

co-morbidities. Subjects were included following 10 min of failed standard

advanced life support (ALS) protocol. Fluid-filled catheters were advanced

into the thoracic aorta and the right atrium and placement was confirmed by

pressure waveforms and chest radiograph. The coronary perfusion pressure

(CPP) was measured as the difference between the aortic and right atrial

pressure during the chest compression's decompressed state. Following 10 min

of failed ALS and catheter placement, subjects received alternating manual

and A-CPR chest compressions for 90 s each. Chest compressions were

administered without ventilation pauses at 100 compressions/min for manual

CPR and 60 compressions/min for A-CPR. All subjects were intubated and

ventilated by bag-valve at 12 breaths/min between compressions. Epinephrine

(adrenaline) (1mg i.v. bolus) was given at the request of the attending

physician at 3-5 min intervals. Usable pressure signals were present in 16

patients (68 +/- 6 years, 5 female), and data are reported from those

patients only. A-CPR chest compressions increased peak aortic pressure when

compared to manual chest compression (153 +/- 28 mmHg versus 115 +/- 42

mmHg, P < 0.0001, mean +/- S.D.). Similarly, A-CPR increased peak right

atrial pressure when compared to manual chest compression (129 +/- 32 mmHg

versus 83 +/- 40 mmHg, P < 0.0001). Furthermore, A-CPR increased CPP over

manual chest compression (20 +/- 12 mmHg versus 15 +/- 11 mmHg, P < 0.015).

Manual chest compressions were of consistent high quality (51 +/- 20 kg) and

in all cases met or exceeded American Heart Association guidelines for depth

of compression. CONCLUSION: Previous research has shown that increased CPP

is correlated to increased coronary blood flow and increased rates of

restored native circulation from sudden cardiac arrest. The A-CPR system

using AutoPulse technology demonstrated increased coronary perfusion

pressure over manual chest compression during CPR in this terminally ill

patient population.

Here the AutoPulse increased coronary perfusion pressures. No look at

survivability or outcomes.

-----------------------------------------------------------

Prehospital Emergency Care 2005;9(1):104

IMPROVEMENT IN FIELD RETURN OF SPONTANEOUS CIRCULATION USING CIRCUMFERENTIAL

CHEST COMPRESSION CARDIOPULMONARY RESUSCITATION

ph P. Ornato, Ann Peberdy, P. , Harinder Dhindsa,

Jerry L. Overton, Richmond Ambulance Authority, Richmond, Virginia

Background: There is evidence that circumferential chest compression (CCC)

can improve arterial perfusion pressure compared to that which can be

achieved with standard (STD) cardiopulmonary resuscitation (CPR) in animal

models and critically ill patients undergoing CPR in the intensive care

unit. It is unknown whether this hemodynamic difference will result in any

improvement in the rate of return of spontaneous circulation (ROSC) from

out-of-hospital cardiac arrest. Objective: To compare the rates of ROSC

before and after an all–advanced life support (all-ALS) urban emergency

medical services system converted from using STD-CPR to CCC-CPR as standard

of care. Methods: CCC-CPR was performed using Autopulse devices (Revivant

Corp., Sunnyvale, CA) which were placed into service on all ALS ambulances

in Richmond, VA, on December 20, 2003. The percentages ROSC from all adult,

out-of-hospital, non-traumatic cardiac arrest cases of presumed cardiac

origin were compared from 5 years before, and for the first 6 months

following, conversion from STD-CPR to CCC-CPR in the Richmond Ambulance

Authority. No other significant operational or medical protocol changes were

made in the EMS system during the changeover period. Results: ROSC for all

patients rose dramatically from 21.6 ± 3.1% (95% CI 17.7–25.4%) to 37.5%

from the STD-CPR (n = 1,007) to CCC-CPR (n = 79) periods, representing a 74%

relative increase in ROSC. The improvement occurred regardless of the

patient’s initial cardiac arrest rhythm: ventricular fibrillation or

ventricular tachycardia [25.2 ± 4.1% (95% CI 20.1–30.3%) STD-CPR (n = 239)

to 47.4% with CCC-CPR (n = 19)]; asystole [12.3 ± 4.7% (95% CI 6.5–18.1%)

STD-CPR (n = 536) to 29.3% with CCC-CPR (n = 41)]; and pulseless electrical

activity [33.2 ± 10.1% (95% CI 20.5–45.8%) STD-CPR (n = 232) to 47.4% with

CCC-CPR (n = 19)]. Conclusions: In this preliminary before-and-after case

series comparison, the use of CCC-CPR resulted in a significant improvement

in field ROSC that occurred independent of the initial presenting rhythm.

This hypothesis-generating observation strongly supports the need for an

adequately powered, prospective randomized clinical trial comparing the two

CPR techniques.

In this study, they did not look any further than ROSC. The numbers in the

study group are low and thus there were wide CIs. Ornato is on Revivant's

Advisory Board and thus a financial interest.

-------------------------------------------------------------

The ASPIRE study has not been published (Zoll gagged researchers). This

constitutes all of the publised data on the device.

-------------------------------------------------------------

In regard to the Austin and Riverside County flail chest, information

regarding the cases was obtained directly from the medical directors of the

systems involved.

[Guest guest]

Dr. Greg Cynamoun (not even a real doctor) sold millions of dollars worth of

worthless Corti-Slim despite FDA warnings. It takes time for the FDA to pull

a device and they may want additional studies. Here are the published

studies so far. As far as Austin, I saw Dr. Racht yesterday and he said they

were pulled because of concerns over a flailed chest and early word of the

ASPIRE study. San Francisco was not studying the devices per se although

Cassner published some low-validity data from San Francisco.

---------------------------------------

Prehosp Emerg Care. 2005 Jan-Mar;9(1):61-7

The impact of a new CPR assist device on rate of return of spontaneous

circulation in out-of-hospital cardiac arrest.

<http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed & cmd=Search & term=%22

Casner+M%22%5BAuthor%5D> Casner M,

<http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed & cmd=Search & term=%22

Andersen+D%22%5BAuthor%5D> Andersen D,

<http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed & cmd=Search & term=%22

Isaacs+SM%22%5BAuthor%5D> Isaacs SM.

San Francisco Fire Department, San Francisco, California 94107, USA.

michael.casner@...

OBJECTIVE: The San Francisco Fire Department deployed an automated,

load-distributing-band chest compression device (AutoPulse, Revivant

Corporation) to evaluate its function in a large urban emergency medical

services (EMS) service. A retrospective chart review was undertaken to

determine whether the AutoPulse had altered short-term patient outcome,

specifically, return of spontaneous circulation (ROSC). METHODS: AutoPulse

cardiopulmonary resuscitation (A-CPR) was used by paramedic captains

responding to adult cardiac arrests with an average +/-SD response time of

15 +/- 5 minutes. The primary endpoint was patient arrival to an emergency

department with measurable spontaneous pulses. The manual CPR comparison

group was case-matched for age, gender, initial presenting electrocardiogram

rhythm, and the number of doses of Advanced Cardiac Life Support medications

as a proxy for treatment time. Matching was performed by an investigator

blinded to outcome and treatment group. RESULTS: Sixty-nine AutoPulse uses

were matched to 93 manual-CPR-only cases. A-CPR showed improvement in the

primary outcome when compared with manual CPR with any presenting rhythm

(A-CPR 39%, manual 29%, p = 0.003). When patients were classified by first

presenting rhythm, shockable rhythms showed no difference in outcome (A-CPR

44%, manual 50%, p = 0.340). Outcome was improved with A-CPR in initial

presenting asystole and approached significance with pulseless electrical

activity (PEA)(asystole: A-CPR 37%, manual 22%, p = 0.008; PEA: A-CPR 38%,

manual 23%, p = 0.079). CONCLUSION: The AutoPulse may improve the overall

likelihood of sustained ROSC and may particularly benefit patients with

nonshockable rhythms. A prospective randomized trial comparing the AutoPulse

with manual CPR in the setting of out-of-hospital sudden cardiac arrest is

under way.

This study showed that ROSC was better (mininally) for asystole, but worse

for V-fib.

-----------------------------------------------

J Forensic Sci. 2005 Jan;50(1):164-8.

Autopsy artifact created by the Revivant AutoPulse resuscitation device.

<http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed & cmd=Search & term=%22

Hart+AP%22%5BAuthor%5D> Hart AP,

<http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed & cmd=Search & term=%22

Azar+VJ%22%5BAuthor%5D> Azar VJ,

<http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed & cmd=Search & term=%22

Hart+KR%22%5BAuthor%5D> Hart KR,

<http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed & cmd=Search & term=%22

s+BG%22%5BAuthor%5D> s BG.

Office of the Chief Medical Examiner, City and County of San Francisco, Hall

of Justice, 850 St., San Francisco, CA 94103, USA. amy.hart@...

In certain cases, the evaluation and correct identification of resuscitative

artifacts is critical to the correct diagnosis and determination of the

cause and manner of death. Resuscitative artifacts can resemble homicidal or

accidental injury and thus possibly be misinterpreted. Occasionally, new

technologies and/or medical procedures will create original and/or

distinctive artifacts. In 2003, the San Francisco Fire Department emergency

personnel began field-testing the Revivant AutoPulse, an automated chest

compression device. This device is currently being used in two other

counties in the San Francisco Bay Area as well as regions of Florida,

Virginia, and Ohio. We present three cases of resuscitative artifact that

could be potentially confused with homicidal or accidental injury. These

cases illustrate resuscitative artifacts, specifically lateral chest and

horizontally oriented upper abdomen cutaneous abrasions created by this

automated chest compression device.

---------------------------------------------

J Am Coll Cardiol. 2004 Dec 7;44(11):2214-20

Cardiopulmonary resuscitation with a novel chest compression device in a

porcine model of cardiac arrest: improved hemodynamics and mechanisms.

<http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed & cmd=Search & term=%22

Halperin+HR%22%5BAuthor%5D> Halperin HR,

<http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed & cmd=Search & term=%22

Paradis+N%22%5BAuthor%5D> Paradis N,

<http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed & cmd=Search & term=%22

Ornato+JP%22%5BAuthor%5D> Ornato JP,

<http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed & cmd=Search & term=%22

Zviman+M%22%5BAuthor%5D> Zviman M,

<http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed & cmd=Search & term=%22

Lacorte+J%22%5BAuthor%5D> Lacorte J,

<http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed & cmd=Search & term=%22

Lardo+A%22%5BAuthor%5D> Lardo A,

<http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed & cmd=Search & term=%22

Kern+KB%22%5BAuthor%5D> Kern KB.

s Hopkins University, Department of Medicine, Baltimore, land, USA.

hhalper@...

OBJECTIVES: The goal of this study was to determine the magnitude and

mechanisms of hemodynamic improvement of an automated, load-distributing

band device (AutoPulse, Revivant Corp., Sunnyvale, California) compared with

conventional cardiopulmonary resuscitation (C-CPR). BACKGROUND: Improved

blood flow during cardiopulmonary resuscitation (CPR) enhances survival from

cardiac arrest. METHODS: AutoPulse CPR (A-CPR) and C-CPR were performed on

30 pigs (16 +/- 4 kg) 1 min after induction of ventricular fibrillation.

Aortic and right atrial pressures were measured with micromanometers.

Regional flows were measured with microspheres; A-CPR and C-CPR were

performed with 20% anterior-posterior chest compression, with (n = 10) and

without (n = 10) epinephrine. A pressure transducer was advanced down the

airways during chest compressions (n = 10), and magnetic resonance imaging

(MRI) was performed. RESULTS: AutoPulse CPR improved coronary perfusion

pressure (CPP) (aortic - right atrial pressure) without epinephrine (A-CPR

21 +/- 8 mm Hg vs. C-CPR 14 +/- 6 mm Hg, mean +/- SD, p < 0.0001) and with

epinephrine (A-CPR 45 +/- 11 mm Hg vs. C-CPR 17 +/- 6 mm Hg, p < 0.0001).

AutoPulse CPR improved myocardial flow without epinephrine and cerebral and

myocardial flow with epinephrine (p < 0.05). AutoPulse CPR also produced

greater myocardial flow at every CPP (p < 0.01). With A-CPR, high airway

pressure was noted distal to the carina, which corresponded to an area of

airway collapse on MRI, and which was not present with C-CPR. CONCLUSIONS:

AutoPulse CPR improved hemodynamics over C-CPR in this pig model. AutoPulse

CPR with epinephrine can produce pre-arrest levels of myocardial and

cerebral flow. The improved hemodynamics with A-CPR appear to be mediated

through airway collapse, which likely impedes airflow and helps maintain

higher levels of intrathoracic pressure.

The AutoPulse showed increased coronary perfusion pressures in pigs. No

look at survivability or outcome. Halperin, Paredis and Ornato had or have a

financial interest in the device.

---------------------------------------------------

Resuscitation. 2004 Jun;61(3):273-80

Improved hemodynamic performance with a novel chest compression device

during treatment of in-hospital cardiac arrest.

<http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed & cmd=Search & term=%22

Timerman+S%22%5BAuthor%5D> Timerman S,

<http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed & cmd=Search & term=%22

Cardoso+LF%22%5BAuthor%5D> Cardoso LF,

<http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed & cmd=Search & term=%22

Ramires+JA%22%5BAuthor%5D> Ramires JA,

<http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed & cmd=Search & term=%22

Halperin+H%22%5BAuthor%5D> Halperin H.

The Heart Institute (InCor), Sao o University School of Medicine, Sao

o, Brazil.

INTRODUCTION: The purpose of this pilot clinical study was to determine if a

novel chest compression device would improve hemodynamics when compared to

manual chest compression during cardiopulmonary resuscitation (CPR) in

humans. The device is an automated self-adjusting electromechanical chest

compressor based on AutoPulse technology (Revivant Corporation) that uses a

load distributing compression band (A-CPR) to compress the anterior chest.

METHODS: A total of 31 sequential subjects with in-hospital sudden cardiac

arrest were screened with institutional review board approval. All subjects

had received prior treatment for cardiac disease and most had

co-morbidities. Subjects were included following 10 min of failed standard

advanced life support (ALS) protocol. Fluid-filled catheters were advanced

into the thoracic aorta and the right atrium and placement was confirmed by

pressure waveforms and chest radiograph. The coronary perfusion pressure

(CPP) was measured as the difference between the aortic and right atrial

pressure during the chest compression's decompressed state. Following 10 min

of failed ALS and catheter placement, subjects received alternating manual

and A-CPR chest compressions for 90 s each. Chest compressions were

administered without ventilation pauses at 100 compressions/min for manual

CPR and 60 compressions/min for A-CPR. All subjects were intubated and

ventilated by bag-valve at 12 breaths/min between compressions. Epinephrine

(adrenaline) (1mg i.v. bolus) was given at the request of the attending

physician at 3-5 min intervals. Usable pressure signals were present in 16

patients (68 +/- 6 years, 5 female), and data are reported from those

patients only. A-CPR chest compressions increased peak aortic pressure when

compared to manual chest compression (153 +/- 28 mmHg versus 115 +/- 42

mmHg, P < 0.0001, mean +/- S.D.). Similarly, A-CPR increased peak right

atrial pressure when compared to manual chest compression (129 +/- 32 mmHg

versus 83 +/- 40 mmHg, P < 0.0001). Furthermore, A-CPR increased CPP over

manual chest compression (20 +/- 12 mmHg versus 15 +/- 11 mmHg, P < 0.015).

Manual chest compressions were of consistent high quality (51 +/- 20 kg) and

in all cases met or exceeded American Heart Association guidelines for depth

of compression. CONCLUSION: Previous research has shown that increased CPP

is correlated to increased coronary blood flow and increased rates of

restored native circulation from sudden cardiac arrest. The A-CPR system

using AutoPulse technology demonstrated increased coronary perfusion

pressure over manual chest compression during CPR in this terminally ill

patient population.

Here the AutoPulse increased coronary perfusion pressures. No look at

survivability or outcomes.

-----------------------------------------------------------

Prehospital Emergency Care 2005;9(1):104

IMPROVEMENT IN FIELD RETURN OF SPONTANEOUS CIRCULATION USING CIRCUMFERENTIAL

CHEST COMPRESSION CARDIOPULMONARY RESUSCITATION

ph P. Ornato, Ann Peberdy, P. , Harinder Dhindsa,

Jerry L. Overton, Richmond Ambulance Authority, Richmond, Virginia

Background: There is evidence that circumferential chest compression (CCC)

can improve arterial perfusion pressure compared to that which can be

achieved with standard (STD) cardiopulmonary resuscitation (CPR) in animal

models and critically ill patients undergoing CPR in the intensive care

unit. It is unknown whether this hemodynamic difference will result in any

improvement in the rate of return of spontaneous circulation (ROSC) from

out-of-hospital cardiac arrest. Objective: To compare the rates of ROSC

before and after an all–advanced life support (all-ALS) urban emergency

medical services system converted from using STD-CPR to CCC-CPR as standard

of care. Methods: CCC-CPR was performed using Autopulse devices (Revivant

Corp., Sunnyvale, CA) which were placed into service on all ALS ambulances

in Richmond, VA, on December 20, 2003. The percentages ROSC from all adult,

out-of-hospital, non-traumatic cardiac arrest cases of presumed cardiac

origin were compared from 5 years before, and for the first 6 months

following, conversion from STD-CPR to CCC-CPR in the Richmond Ambulance

Authority. No other significant operational or medical protocol changes were

made in the EMS system during the changeover period. Results: ROSC for all

patients rose dramatically from 21.6 ± 3.1% (95% CI 17.7–25.4%) to 37.5%

from the STD-CPR (n = 1,007) to CCC-CPR (n = 79) periods, representing a 74%

relative increase in ROSC. The improvement occurred regardless of the

patient’s initial cardiac arrest rhythm: ventricular fibrillation or

ventricular tachycardia [25.2 ± 4.1% (95% CI 20.1–30.3%) STD-CPR (n = 239)

to 47.4% with CCC-CPR (n = 19)]; asystole [12.3 ± 4.7% (95% CI 6.5–18.1%)

STD-CPR (n = 536) to 29.3% with CCC-CPR (n = 41)]; and pulseless electrical

activity [33.2 ± 10.1% (95% CI 20.5–45.8%) STD-CPR (n = 232) to 47.4% with

CCC-CPR (n = 19)]. Conclusions: In this preliminary before-and-after case

series comparison, the use of CCC-CPR resulted in a significant improvement

in field ROSC that occurred independent of the initial presenting rhythm.

This hypothesis-generating observation strongly supports the need for an

adequately powered, prospective randomized clinical trial comparing the two

CPR techniques.

In this study, they did not look any further than ROSC. The numbers in the

study group are low and thus there were wide CIs. Ornato is on Revivant's

Advisory Board and thus a financial interest.

-------------------------------------------------------------

The ASPIRE study has not been published (Zoll gagged researchers). This

constitutes all of the publised data on the device.

-------------------------------------------------------------

In regard to the Austin and Riverside County flail chest, information

regarding the cases was obtained directly from the medical directors of the

systems involved.