When will the VasoNova Picc insertion system be the norm and replace the system now widely used? The ultrasound/Sherlock system. It seems like the way to go and no need for CXR from what I read. Our large HMO still using the latter.
ECG tip location will become the standard of practice for PICC insertion when we have published evidence about its outcomes when compared to chest xray. We have very little published evidence about these outcomes now. However, there are numerous studies from Europe available now about better outcomes with ECG tip location in Europe. I do not think that ECG will replace chest xray in 100% of all PICC insertions. There are patients with no identifiable P wave - atrial fibrillation or flutter, cardiomyopathy, presence of pacemaker. So a cardiac assessment including looking at a current ECG should be part of your patient assessment to see if the patient has an identifiable P wave before using this technology to place PICCs. There could be 10 to 25% of patients that still require a chest xray, depending upon your patient populations, but I do believe that ECG is much more accurate than chest xray. Lynn
Thankyou, that is very interesting. I was mistaken as I thought it was being used more often in the USA. I surely understand about the concerns with heart patients as I have a pacemaker and A fib! Is it not possible to validate the studies produced in Europe for use in the USA. Or, do we have to replicate them here. Are there any studies being done?
Thankyou, that is very interesting. I was mistaken as I thought it was being used more often in the USA. I surely understand about the concerns with heart patients as I have a pacemaker and A fib! Is it not possible to validate the studies produced in Europe for use in the USA. Or, do we have to replicate them here. Are there any studies being done?
European studies are not PICCs but other typesof CVADs. There are studies being done in the US now, but it just takes a long time to get the study designed, approved through the facility IRB, conducted, analyzed, a manuscript written, submitted, blindly reviewed, accepted and published. The publications process alone can take a year or more. The study process and take several years. Lynn
There is a published study in the US by Nancy Moureau and myself published in AVA Spring of 2009. We demonstrated that EKG guidance resulted in accurate tip placement 98% of the time and reproduced the study done by Dr. Pitteruti in Rome, Italy. I now use Vasonova guidance system and find that the results are even more precise using the algorythm in the console with the tip at the cavo-atrial junction. I have not used chest x-ray for most PICC placements for about 3 years. There is the occasional atrial fib or pacemaker patient for whom I need a cxr but it is not uncommon to be able to precisely place the tip at the CA junction using doppler only and check a later, routine cxr.
While I agree with Lynn that many of the studies used to show safety and efficacy of ECG/EKG positioning of devices were performed on CVCs and ports alone, we now have additional studies, and some rather large, that demonstrate effectiveness with PICCs. With FDA clearance of these tip confirmation processes replacing x-rays, I do believe there is a huge change happening right now, moving to better technology to speed our processes and improve safety. So many hospitals are trialing or now using the ECG/EKG confirmation for PICCs. From a legal perspective these systems provide the inserter with greater safety and knowledge knowing that positioning is venous and in the best location for the patient. I appreciate some of the fine points my colleagues might address about legal issues, movement of the patient and a variety of details, bottomline is ECG/EKG, and now the addition of doppler and flow, really do make it safer, much safer than x-ray alone. I am glad to share the information about any of the articles with anyone who needs them [email protected]
Thanks for the comment. I took my first Picc class from you MANY MANY years ago! I have since then sent many more nurses to your company for classes on Picc's!! I still remember the class well. I am looking forward to trying this new system for Picc placement.
There are currently two EKG type systems approved by the FDA for use in the US, SAPIENS (BARD) and VASONOVA (Teleflex). Both were approved by the FDA using study information from studies conducted in Europe, where EKG has replaced CXR for ALL types of Central Vascular access devices, PICCs, Acute CVCs (triple lumens) Tunneled catheters and Ports for more than 20 years. RNs at the bedside routinely use EKG only to place PICCs in Europe, when there is an RN placing these lines. The reality is that in many hospitals, it is still an MD responsiblitiy, or is done by both RNs and MDs.
The problem with Pacemakers or patients with AFib only applies to EKG only systems. These systems rely soley on the patients P wave to determine catheter location, and if the patient does not have a visble P wave, the EKG cannot report changes in the intercavitary P wave.
That is the advantage of such "second generation" devices that use not only EKG but another measurment, such as doppler to determine location of the catheter. These devices can be used on patients with no visible p wave, and not only determine tip location, but confirm venous placement rather than arterial. It also gives the user a second or third opinion as to the location of the cathter, rather than relying only on the EKG information. This improves the confidence of the user and the accuracy of the system
I predict that in 5 years, CXR will rarely be used to detect tip location for central catheters as these types of systems become more commonplace. They are more accurate than CXR (which was never designed for identifying catheters) and involve less risk for the patient. CXR will go the way of direct puncture for PICC placement, you could use it, but why would you?
I think you have a little confusion between these 2 systems. Vasonova using ECG and Dopplar together at the same time. Tip location is relayed to the inserter by a series of lights on the unit without actually displaying the ECG tracing. Sapiens uses ECG, displays the ECG tracing for the inserter to identify the P wave and is also combined with Sherlock, the magnetic tip location device. Lynn
No confusion; we trialed both of those products; my question was, if anyone knew of any other or soon to be available products other than those 2 tip locating devices?
No confusion; we trialed both of those products; my question was, if anyone knew of any other or soon to be available products other than those 2 tip locating devices?
Actually, Vasonova displays the ECG tracing, the doppler sound tracing and the symbols that indicate flow as well as the blue bulls eye when arrival at the caval atrial junction is achieved. I have been using this system for over a year and love it! It really displays reliability by using this three indicator system.
Disclaimer: I occasionally do education regarding this system for Teleflex.
We have trialed both the Vasonova and the Sapiens; does anyone know if there are any other options available or soon to be available? or if it will be a while for other technology and we should just pick from the two systems available?
We have trialed both the Vasonova and the Sapiens; does anyone know if there are any other options available or soon to be available? or if it will be a while for other technology and we should just pick from the two systems available?
Currently, there are two devices FDA cleared to replace Chest XRay for PICC line tip location, Sherlock 3CG (they had to change the name due to a patent conflict, it was Sapiens) by Bard and Vasonova by Teleflex. There are no other systems currently cleared by the FDA. Any other device in the pipeline will still need to be cleared to market by the FDA, which means months to years before they are commercially available. I guess it depends on how long you want to wait to replace chest xrays for PICCs.
Our PICC team just completed a 3 day trial of the VasoNova.
My staff had the following to say about the product.
Ease of use and set up (cumbersome equipment, need to use q-tips to calibrate screen, 2 bedside tables needed)
Lack of obtaining a 10 second bullseye (Yes the bullseye was obtained and we knew the physiological signs told us we were CAJ, but if there is not a 10 second bullseye, we still need a chest xray. This defeats the purpose of using this technology.)
Terrible interference in ICU with the Ultrasound doppler screen (improved some with the filter device but still not very clear)
Poor visualization of the small screen.( Screen needs to be larger to visual ECG from accross the bed)
Perhaps when the VasoNova console has easier portability and the technology is tweeked we may revist this product.
It appears that this technology is just hitting the market. Before I spend money on purchasing a product, I am going to see what other products come on the market in the next 3-5 years
We are considering an evaluation of this new technology. During the trial/evaluation period are CXRs performed to confirm tip location on those PICCs placed using the ECG method? How many or what percentage of accurate placements are necessary to eliminate the CXR? I understand that this will be specific to each facility but what is a reasonable amount, 95%, 98%, 100%?
I have not seen much published on this yet, although I believe there are studies in progress. We are not talking about NEVER doing a chest xray or the total elimination of chest xrays after PICC insertion. Maybe I am reading that into your message when it is not what you meant. Successfully reaching and documenting correct tip location with ECG is a patient-specific decision. Reduction of the routine chest xray for all patients would depend upon your patient population. If you have a large number of cardiac patients, you may be able to eliminate the chest xray in ~70%. In patients without cardiac diseases, you may be able to eliminate the routine chest xray in at least 90%. If there is ever any question in any patient, a chest xray would be needed. Lynn
First of all, my disclaimer. I am a clinical specialist for Arrow International, VPS.
To answer your question "during hte trial/evaluation are CXRs performed to confirm tip location"
During a trial it is entirely the decision of the account as to the correlation with a bluebullseye and CXR. In some accounts they have opted not to correlate, accepting the clearance of the FDA and the Georgetown Study as the basis of that decision.
The FDA has cleared the VasoNova Device, or VPS to eliminate CXR in the presence of a stable BlueBullseye. The Georgetown study showed in the presence of a stable Bluebullseye, 98.4 % correlation was achieved.
We have had many trials across the US. Some hospitals have not correlated at all during the trial, some have correlated only during the trial period, some correlated during the trial period and then again when they implemented VPS in their facility. It is an individual decision, and one that is agreed upon before the trial.
Most facilities have chosen to at least correlate some Bluebullseyes and CXR, to prove to themselves this device is accurate and precise. Once they have seen it for themselves, they opt only to obtain a CXR when you do not achieve a bluebullseye. It is expected that you achieve at least a 90% bluebullseye in all of your PICC cases.
I agree that 3 days is not very long to trial a product but it gives you an idea of the value you can potentially achieve. Just like it takes longer than 3 insertions to become an efficient PICC nurse, it takes longer than 3 days to fully realize the value of a tip positioning system. With Vasonova, I have found that I use all of my senses in getting the PICC to the CAJ. I see ECG changes, I hear the doppler changes and can see the wave forms, and I feel the resistance or lack thereof during the insertion. I know that the Q tips are a bit cumbersome and loading the stylet is a bit time consuming, but then, so is waiting for a chest x-ray. The difference is that CXR is not going to get better and with a little more time, you will get better and faster at using this exciting technology. Also the technology is going to get better, the hardware will get smaller and the Q tips will be replaced with something better, and the stylets will be preloaded in the PICC. The future looks good to me.
Recently our facility trialed the Vasanova system. I have to say I was very excited learning this new technology. But putting it to practice was different. Getting a bullseye for 10 seconds did not occur as often as I thought it should. One of the PICC insertions went jugular, but the device did not alert us to this fact. I would love to hear other hospitals experiences with the Vasanova.
When obtaining blood cultures from a central line and there is no blood return, how long should one wait after patency has been established, either by flushing the line or cathflo has been instilled?
We've had the same experiences as rnrobin and lois rajcan with the Vasanova. Since we were using the Sherlock system, we trialed the Sapiens system also and found it was easier to incorporate the Sapiens system into our practice. We still like to use the Groshong catheters, so the Sherlock system was still needed. With the Vasanova, one must really tune into the tones and need to estimate where your picc tip is when the sounds change. Ideally the doppler and the tip navigation would be the best system- visual and auditory cues.
When I started using VasoNova, I was fooled by the PICC in the IJ too. When the PICC loops in the IJ instead of going tip first into it, the doppler appropriately senses the blood flow behind it. It only took that once for me to learn that if I am not getting to where I want to go and I am getting the green arrow, I have the loop malposition and I need to pull back and reposition. A loop in the SVC can do the same thing just further along. If I am not getting a blue bulls eye when I have inserted the full length, that is often the issue. I pull back and reposition. The best advice I have is to really slow down the insertion. You don't miss the bulls eye so often that way. Some patients have a fairly large landing zone and others a very small one and it takes moving the tip along slowly to get it perfect. This is very reliable technology but takes a bit of practice.
I have been using VasoNova for about 1 1/2 years and occasionally do some work for Teleflex.
ECG tip location will become the standard of practice for PICC insertion when we have published evidence about its outcomes when compared to chest xray. We have very little published evidence about these outcomes now. However, there are numerous studies from Europe available now about better outcomes with ECG tip location in Europe. I do not think that ECG will replace chest xray in 100% of all PICC insertions. There are patients with no identifiable P wave - atrial fibrillation or flutter, cardiomyopathy, presence of pacemaker. So a cardiac assessment including looking at a current ECG should be part of your patient assessment to see if the patient has an identifiable P wave before using this technology to place PICCs. There could be 10 to 25% of patients that still require a chest xray, depending upon your patient populations, but I do believe that ECG is much more accurate than chest xray. Lynn
Lynn Hadaway, M.Ed., RN, CRNI
Lynn Hadaway Associates, Inc.
PO Box 10
Milner, GA 30257
Website http://www.hadawayassociates.com
Office Phone 770-358-7861
Thankyou, that is very interesting. I was mistaken as I thought it was being used more often in the USA. I surely understand about the concerns with heart patients as I have a pacemaker and A fib! Is it not possible to validate the studies produced in Europe for use in the USA. Or, do we have to replicate them here. Are there any studies being done?
Thankyou, that is very interesting. I was mistaken as I thought it was being used more often in the USA. I surely understand about the concerns with heart patients as I have a pacemaker and A fib! Is it not possible to validate the studies produced in Europe for use in the USA. Or, do we have to replicate them here. Are there any studies being done?
European studies are not PICCs but other typesof CVADs. There are studies being done in the US now, but it just takes a long time to get the study designed, approved through the facility IRB, conducted, analyzed, a manuscript written, submitted, blindly reviewed, accepted and published. The publications process alone can take a year or more. The study process and take several years. Lynn
Lynn Hadaway, M.Ed., RN, CRNI
Lynn Hadaway Associates, Inc.
PO Box 10
Milner, GA 30257
Website http://www.hadawayassociates.com
Office Phone 770-358-7861
There is a published study in the US by Nancy Moureau and myself published in AVA Spring of 2009. We demonstrated that EKG guidance resulted in accurate tip placement 98% of the time and reproduced the study done by Dr. Pitteruti in Rome, Italy. I now use Vasonova guidance system and find that the results are even more precise using the algorythm in the console with the tip at the cavo-atrial junction. I have not used chest x-ray for most PICC placements for about 3 years. There is the occasional atrial fib or pacemaker patient for whom I need a cxr but it is not uncommon to be able to precisely place the tip at the CA junction using doppler only and check a later, routine cxr.
While I agree with Lynn that many of the studies used to show safety and efficacy of ECG/EKG positioning of devices were performed on CVCs and ports alone, we now have additional studies, and some rather large, that demonstrate effectiveness with PICCs. With FDA clearance of these tip confirmation processes replacing x-rays, I do believe there is a huge change happening right now, moving to better technology to speed our processes and improve safety. So many hospitals are trialing or now using the ECG/EKG confirmation for PICCs. From a legal perspective these systems provide the inserter with greater safety and knowledge knowing that positioning is venous and in the best location for the patient. I appreciate some of the fine points my colleagues might address about legal issues, movement of the patient and a variety of details, bottomline is ECG/EKG, and now the addition of doppler and flow, really do make it safer, much safer than x-ray alone. I am glad to share the information about any of the articles with anyone who needs them [email protected]
Nancy Moureau, www.piccexcellence.com
Nancy L. Moureau, PhD, RN, CRNI, CPUI, VA-BC
PICC Excellence, Inc.
[email protected]
www.piccexcellence.com
Thanks for the comment. I took my first Picc class from you MANY MANY years ago! I have since then sent many more nurses to your company for classes on Picc's!! I still remember the class well. I am looking forward to trying this new system for Picc placement.
There are currently two EKG type systems approved by the FDA for use in the US, SAPIENS (BARD) and VASONOVA (Teleflex). Both were approved by the FDA using study information from studies conducted in Europe, where EKG has replaced CXR for ALL types of Central Vascular access devices, PICCs, Acute CVCs (triple lumens) Tunneled catheters and Ports for more than 20 years. RNs at the bedside routinely use EKG only to place PICCs in Europe, when there is an RN placing these lines. The reality is that in many hospitals, it is still an MD responsiblitiy, or is done by both RNs and MDs.
The problem with Pacemakers or patients with AFib only applies to EKG only systems. These systems rely soley on the patients P wave to determine catheter location, and if the patient does not have a visble P wave, the EKG cannot report changes in the intercavitary P wave.
That is the advantage of such "second generation" devices that use not only EKG but another measurment, such as doppler to determine location of the catheter. These devices can be used on patients with no visible p wave, and not only determine tip location, but confirm venous placement rather than arterial. It also gives the user a second or third opinion as to the location of the cathter, rather than relying only on the EKG information. This improves the confidence of the user and the accuracy of the system
I predict that in 5 years, CXR will rarely be used to detect tip location for central catheters as these types of systems become more commonplace. They are more accurate than CXR (which was never designed for identifying catheters) and involve less risk for the patient. CXR will go the way of direct puncture for PICC placement, you could use it, but why would you?
Chris Cavanaugh, RN, BSN, CRNI, VA-BC
Very interesting. Thanks for the info. Is the Sapiens and or Vasonova capable of the EKG and Doppler tip location both at the same time?
I think you have a little confusion between these 2 systems. Vasonova using ECG and Dopplar together at the same time. Tip location is relayed to the inserter by a series of lights on the unit without actually displaying the ECG tracing. Sapiens uses ECG, displays the ECG tracing for the inserter to identify the P wave and is also combined with Sherlock, the magnetic tip location device. Lynn
Lynn Hadaway, M.Ed., RN, CRNI
Lynn Hadaway Associates, Inc.
PO Box 10
Milner, GA 30257
Website http://www.hadawayassociates.com
Office Phone 770-358-7861
No confusion; we trialed both of those products; my question was, if anyone knew of any other or soon to be available products other than those 2 tip locating devices?
No confusion; we trialed both of those products; my question was, if anyone knew of any other or soon to be available products other than those 2 tip locating devices?
Actually, Vasonova displays the ECG tracing, the doppler sound tracing and the symbols that indicate flow as well as the blue bulls eye when arrival at the caval atrial junction is achieved. I have been using this system for over a year and love it! It really displays reliability by using this three indicator system.
Disclaimer: I occasionally do education regarding this system for Teleflex.
We have trialed both the Vasonova and the Sapiens; does anyone know if there are any other options available or soon to be available? or if it will be a while for other technology and we should just pick from the two systems available?
thank you.
We have trialed both the Vasonova and the Sapiens; does anyone know if there are any other options available or soon to be available? or if it will be a while for other technology and we should just pick from the two systems available?
thank you.
More devices are coming......
Yes...more devices are coming from differenct vendors....
Currently, there are two devices FDA cleared to replace Chest XRay for PICC line tip location, Sherlock 3CG (they had to change the name due to a patent conflict, it was Sapiens) by Bard and Vasonova by Teleflex. There are no other systems currently cleared by the FDA. Any other device in the pipeline will still need to be cleared to market by the FDA, which means months to years before they are commercially available. I guess it depends on how long you want to wait to replace chest xrays for PICCs.
Chris Cavanaugh, RN, BSN, CRNI, VA-BC
Our PICC team just completed a 3 day trial of the VasoNova.
My staff had the following to say about the product.
Perhaps when the VasoNova console has easier portability and the technology is tweeked we may revist this product.
It appears that this technology is just hitting the market. Before I spend money on purchasing a product, I am going to see what other products come on the market in the next 3-5 years
Lois Rajcan MSN, RN, CRNI
Chester County Hospital IV/PICC Team
3 days is kinda short to trial anything.
We are considering an evaluation of this new technology. During the trial/evaluation period are CXRs performed to confirm tip location on those PICCs placed using the ECG method? How many or what percentage of accurate placements are necessary to eliminate the CXR? I understand that this will be specific to each facility but what is a reasonable amount, 95%, 98%, 100%?
I have not seen much published on this yet, although I believe there are studies in progress. We are not talking about NEVER doing a chest xray or the total elimination of chest xrays after PICC insertion. Maybe I am reading that into your message when it is not what you meant. Successfully reaching and documenting correct tip location with ECG is a patient-specific decision. Reduction of the routine chest xray for all patients would depend upon your patient population. If you have a large number of cardiac patients, you may be able to eliminate the chest xray in ~70%. In patients without cardiac diseases, you may be able to eliminate the routine chest xray in at least 90%. If there is ever any question in any patient, a chest xray would be needed. Lynn
Lynn Hadaway, M.Ed., RN, CRNI
Lynn Hadaway Associates, Inc.
PO Box 10
Milner, GA 30257
Website http://www.hadawayassociates.com
Office Phone 770-358-7861
First of all, my disclaimer. I am a clinical specialist for Arrow International, VPS.
To answer your question "during hte trial/evaluation are CXRs performed to confirm tip location"
During a trial it is entirely the decision of the account as to the correlation with a bluebullseye and CXR. In some accounts they have opted not to correlate, accepting the clearance of the FDA and the Georgetown Study as the basis of that decision.
The FDA has cleared the VasoNova Device, or VPS to eliminate CXR in the presence of a stable BlueBullseye. The Georgetown study showed in the presence of a stable Bluebullseye, 98.4 % correlation was achieved.
We have had many trials across the US. Some hospitals have not correlated at all during the trial, some have correlated only during the trial period, some correlated during the trial period and then again when they implemented VPS in their facility. It is an individual decision, and one that is agreed upon before the trial.
Most facilities have chosen to at least correlate some Bluebullseyes and CXR, to prove to themselves this device is accurate and precise. Once they have seen it for themselves, they opt only to obtain a CXR when you do not achieve a bluebullseye. It is expected that you achieve at least a 90% bluebullseye in all of your PICC cases.
Rita M.Larson RN,BSN,CRNI,MBA,VA-BC
Clinical Specialist
VPS Arrow/Teleflex
I agree that 3 days is not very long to trial a product but it gives you an idea of the value you can potentially achieve. Just like it takes longer than 3 insertions to become an efficient PICC nurse, it takes longer than 3 days to fully realize the value of a tip positioning system. With Vasonova, I have found that I use all of my senses in getting the PICC to the CAJ. I see ECG changes, I hear the doppler changes and can see the wave forms, and I feel the resistance or lack thereof during the insertion. I know that the Q tips are a bit cumbersome and loading the stylet is a bit time consuming, but then, so is waiting for a chest x-ray. The difference is that CXR is not going to get better and with a little more time, you will get better and faster at using this exciting technology. Also the technology is going to get better, the hardware will get smaller and the Q tips will be replaced with something better, and the stylets will be preloaded in the PICC. The future looks good to me.
Recently our facility trialed the Vasanova system. I have to say I was very excited learning this new technology. But putting it to practice was different. Getting a bullseye for 10 seconds did not occur as often as I thought it should. One of the PICC insertions went jugular, but the device did not alert us to this fact. I would love to hear other hospitals experiences with the Vasanova.
When obtaining blood cultures from a central line and there is no blood return, how long should one wait after patency has been established, either by flushing the line or cathflo has been instilled?
We've had the same experiences as rnrobin and lois rajcan with the Vasanova. Since we were using the Sherlock system, we trialed the Sapiens system also and found it was easier to incorporate the Sapiens system into our practice. We still like to use the Groshong catheters, so the Sherlock system was still needed. With the Vasanova, one must really tune into the tones and need to estimate where your picc tip is when the sounds change. Ideally the doppler and the tip navigation would be the best system- visual and auditory cues.
When I started using VasoNova, I was fooled by the PICC in the IJ too. When the PICC loops in the IJ instead of going tip first into it, the doppler appropriately senses the blood flow behind it. It only took that once for me to learn that if I am not getting to where I want to go and I am getting the green arrow, I have the loop malposition and I need to pull back and reposition. A loop in the SVC can do the same thing just further along. If I am not getting a blue bulls eye when I have inserted the full length, that is often the issue. I pull back and reposition. The best advice I have is to really slow down the insertion. You don't miss the bulls eye so often that way. Some patients have a fairly large landing zone and others a very small one and it takes moving the tip along slowly to get it perfect. This is very reliable technology but takes a bit of practice.
I have been using VasoNova for about 1 1/2 years and occasionally do some work for Teleflex.