There are several technologies that will assist with locating the catheter tip following initial insertion. But any one who is trying to say that a product or technology is "approved" to do something that will alter a standard of care is sadly misinformed. First of all, the FDA does not approve devices. Devices are cleared for market. This concept is thoroughly explained in the INS textbook in my chapter on IV Equipment. The national standards are not established by one device, product or technology. Standards of practice are established by professionals, not the manufacturer, based on solid scientific evidence. I do believe that these technologies such as ECG guidance will allow us to remove the need for a chest xray from the standard of care at some point in the future, but we are not there yet. So a chest xray is what you would be held accountable for doing in a court of law. We did not remove the need for a chest xray after the insertion of all CVCs in the 2011 INS Standards of Practice. The legal standard of care is established in a given legal case with numerous documents, published research etc. It is based on testimony of experts relying on those documents. I believe that any manufacturer of one of these technologies claiming that no chest xray is needed is posing a serious hazard legally. Is ECG guidance better than a chest xray? For many, but not all, patients it probably is. But this has not been totally established yet. Nor do we have published evidence about how to evaluate each patient to determine who is not a candidate for ECG guidance. So do not rush to eliminate those chest xrays just yet. Lynn
I must disclose that I am on the Scientific Advisory Board for Vasonova that has invented the Vascular Positioning System. VPS uses the individual patient's intravascular flow dynamics with Doppler and intravascular ECG to identify the distal SVC at the time of bedside placement. I have been studying this for the past 6 years.
The chest radiograph is the current standard for identifying the location of the catheter tip post bedside placement but it is fraught with problems. In the radiology world there are NO consistent universally agreed upon radiologic anatomic landmarks that are used to identify the relative location of the catheter tip. Radiologists all agree that it is a very soft judgment call. You cannot "see" the distal SVC or te cavoatrial junction on the chest radiograph. If you read the radiology literature, some use the right tracheobronchial angle, some use the top of the atrial appendage and measure down 1 to 2 cms, some use the carina and measure down 3-5 cms, and some use other landmarks because the fact of the matter is that you cannot use any of these landmarks 100% of the time in 100% of patients and it's just a judgment call. It is also a judgment of the location of the tip at that moment in time: what position the patient is in when the CXR is taken (supine, angled in bed, standing), the issues of parallax (AP vs PA vs slight oblique), the respiratory phase (deep inspiration vs expiration), arm position (arms around the bucky vs at the side, up or out), angle and distance of the XR machine vs the patient. All of these positions can change the relative position of the tip by anywhere from 1 to 5 cms. In other words, the chest radiograph is neither precise nor accurate because the landmarks are not consistent in 100% of patients, nor are they read consistently amongst radiologists, even within the same institution. I discussed these issues in my article in the Winter JAVA 2011: Challenges in the Accurate Identification of the Ideal Catheter Tip Position.
An abstract has just been presented by Dr. Justin Lee, an interventional radiologist at Georgetown Medical Center, who conducted the clinical study using VPS for tip navigation and location, and checking the final "blue bullseye" with fluoroscopy. He obtained a "blue bullseye" in 64 cases and had 63 out of 64 cases within the distal SVC or cavoatrial junction. There was one outlier within 1 cm of the lower 1/3 for a total success rate of 98.4%. This technology uses Doppler to detect the unique flow characteristics and intravascular ECG in a complex algorithm to determine accurately that the catheter tip is in the distal SVC or CAJ. It is accurate and precise for locating the catheter tip AT THE TIME OF PLACEMENT. I cannot talk about the other studies that are currently in progress or have not yet been presented or published, but this is a huge paradigm shift in thinking and in practice.
I have placed PICCs for over 20 years and am well aware of the pitfalls of the CXR. Well-designed technology with a computer algorithm with trump human interpretation with this issue.
Nadine, what about the fact that 77 PICCs were actually placed in that trial and only 63 of those got the "blue bullseye"? That is only an 82% success rate. It's 98% accurate ONLY when the blue bullseye is illuminated, correct?
The goal of this study was to prove that the bullseye was the CAJ area, and it did prove this. So the goal of the study was met. The incidental findings are very important to understand in order to realize the true value of this technology. Your wording "it is 98% accurate only when the bullseye is illuminated" isn't a correct statement. The correct statement would be "when the bullseye is obtaind, the system is 98.4% accurate. When the bullseye is not obtained, one can use the doppler component and the abnormal ECG protocol to get the tip at the lower 1/3 / CAJ." I will explain, I know it sounds confusing.
There are several reasons that the bullseye may not "light up." For example, if the PICC is cut too short to hit the CAJ, naturally, one will not get a bullseye. Or if there is an abnormal p or absent p wave there may not be a bullseye, but this does not mean that you cannot get the catheter to the CAJ. Not every patient has a normal p-wave. Consdier those patients in cardiac or critical care...p wave will not always be present. As we know, a p-wave is a requirement for ECG only systems. The algorithm for the Vasonova system looks at two modalidies, ECG and doppler. When the requirements for the algorithm (ECG and Doppler) are met, one will get a bullseye. When the p wave is unsual or absent, then one can rely on the doppler alone to get them to the CAJ. An abnormal ECG protocol is used which is not a difficult task by any means. Thus, any patient is a candidate for this technology with high accuracy rates.
I work for Teleflex Medical, to be fair in disclosure. Thanks for your great question!
How can we exclude pneumothorax if we don't have a CXR after the procedure? If I was asked by the physicians, what would my answer be? I really want to use the VPS. Thank you.
With PICC insertion, pneumothorax is not an issue. In Europe, physicians have been using intravascular ECG for about 10 years without getting a CXR, and they don't feel it's an issue. If using US GUIDANCE, not ultrasound GUESSING, using the IJ or axillary vein outside the lung field, pneumothorax should not occur.
I have been using ECG guidance without chest x-ray for over 2/1/2 years. I have been using Pacerview (which is no longer available) and have recently used Vasanova's new guidance system. I have only rarely had to get a chest x-ray and am so glad. ECG guidance is more accurate tip location, easy to learn, much faster procedure, and with no radiation exposure. PICC placement can now be done as fast and more safely than an IJ or subclavian line placement. This procedure has been done for more than a decade in Europe without legal problems that I am aware of. This is an exciting time to be a PICC nurse.
In addition to Cheryl's comments, I'd like to add the following. Both Sapiens (Bard) and Vascular Positioning System (Vasonova/Teleflex) have received FDA approval for "no CXR" or CXR equivalency in the patient with a normal P wave. I would be very careful to try out both systems before completely eliminating CXRs and that you have a consistent protocol in your institution for how the CXR is taken and interpretation to gain the confidence that the systems do what you want them to do.
There are several technologies that will assist with locating the catheter tip following initial insertion. But any one who is trying to say that a product or technology is "approved" to do something that will alter a standard of care is sadly misinformed. First of all, the FDA does not approve devices. Devices are cleared for market. This concept is thoroughly explained in the INS textbook in my chapter on IV Equipment. The national standards are not established by one device, product or technology. Standards of practice are established by professionals, not the manufacturer, based on solid scientific evidence. I do believe that these technologies such as ECG guidance will allow us to remove the need for a chest xray from the standard of care at some point in the future, but we are not there yet. So a chest xray is what you would be held accountable for doing in a court of law. We did not remove the need for a chest xray after the insertion of all CVCs in the 2011 INS Standards of Practice. The legal standard of care is established in a given legal case with numerous documents, published research etc. It is based on testimony of experts relying on those documents. I believe that any manufacturer of one of these technologies claiming that no chest xray is needed is posing a serious hazard legally. Is ECG guidance better than a chest xray? For many, but not all, patients it probably is. But this has not been totally established yet. Nor do we have published evidence about how to evaluate each patient to determine who is not a candidate for ECG guidance. So do not rush to eliminate those chest xrays just yet. Lynn
Lynn Hadaway, M.Ed., RN, NPD-BC, CRNI
Lynn Hadaway Associates, Inc.
PO Box 10
Milner, GA 30257
Website http://www.hadawayassociates.com
Office Phone 770-358-7861
I must disclose that I am on the Scientific Advisory Board for Vasonova that has invented the Vascular Positioning System. VPS uses the individual patient's intravascular flow dynamics with Doppler and intravascular ECG to identify the distal SVC at the time of bedside placement. I have been studying this for the past 6 years.
The chest radiograph is the current standard for identifying the location of the catheter tip post bedside placement but it is fraught with problems. In the radiology world there are NO consistent universally agreed upon radiologic anatomic landmarks that are used to identify the relative location of the catheter tip. Radiologists all agree that it is a very soft judgment call. You cannot "see" the distal SVC or te cavoatrial junction on the chest radiograph. If you read the radiology literature, some use the right tracheobronchial angle, some use the top of the atrial appendage and measure down 1 to 2 cms, some use the carina and measure down 3-5 cms, and some use other landmarks because the fact of the matter is that you cannot use any of these landmarks 100% of the time in 100% of patients and it's just a judgment call. It is also a judgment of the location of the tip at that moment in time: what position the patient is in when the CXR is taken (supine, angled in bed, standing), the issues of parallax (AP vs PA vs slight oblique), the respiratory phase (deep inspiration vs expiration), arm position (arms around the bucky vs at the side, up or out), angle and distance of the XR machine vs the patient. All of these positions can change the relative position of the tip by anywhere from 1 to 5 cms. In other words, the chest radiograph is neither precise nor accurate because the landmarks are not consistent in 100% of patients, nor are they read consistently amongst radiologists, even within the same institution. I discussed these issues in my article in the Winter JAVA 2011: Challenges in the Accurate Identification of the Ideal Catheter Tip Position.
An abstract has just been presented by Dr. Justin Lee, an interventional radiologist at Georgetown Medical Center, who conducted the clinical study using VPS for tip navigation and location, and checking the final "blue bullseye" with fluoroscopy. He obtained a "blue bullseye" in 64 cases and had 63 out of 64 cases within the distal SVC or cavoatrial junction. There was one outlier within 1 cm of the lower 1/3 for a total success rate of 98.4%. This technology uses Doppler to detect the unique flow characteristics and intravascular ECG in a complex algorithm to determine accurately that the catheter tip is in the distal SVC or CAJ. It is accurate and precise for locating the catheter tip AT THE TIME OF PLACEMENT. I cannot talk about the other studies that are currently in progress or have not yet been presented or published, but this is a huge paradigm shift in thinking and in practice.
I have placed PICCs for over 20 years and am well aware of the pitfalls of the CXR. Well-designed technology with a computer algorithm with trump human interpretation with this issue.
Bye-bye and good riddance to the CXR!
Nadine Nakazawa, RN, BS, VA-BC
Nadine, what about the fact that 77 PICCs were actually placed in that trial and only 63 of those got the "blue bullseye"? That is only an 82% success rate. It's 98% accurate ONLY when the blue bullseye is illuminated, correct?
Mersadies Wright, RN, BSN, VA-BC
The goal of this study was to prove that the bullseye was the CAJ area, and it did prove this. So the goal of the study was met. The incidental findings are very important to understand in order to realize the true value of this technology. Your wording "it is 98% accurate only when the bullseye is illuminated" isn't a correct statement. The correct statement would be "when the bullseye is obtaind, the system is 98.4% accurate. When the bullseye is not obtained, one can use the doppler component and the abnormal ECG protocol to get the tip at the lower 1/3 / CAJ." I will explain, I know it sounds confusing.
There are several reasons that the bullseye may not "light up." For example, if the PICC is cut too short to hit the CAJ, naturally, one will not get a bullseye. Or if there is an abnormal p or absent p wave there may not be a bullseye, but this does not mean that you cannot get the catheter to the CAJ. Not every patient has a normal p-wave. Consdier those patients in cardiac or critical care...p wave will not always be present. As we know, a p-wave is a requirement for ECG only systems. The algorithm for the Vasonova system looks at two modalidies, ECG and doppler. When the requirements for the algorithm (ECG and Doppler) are met, one will get a bullseye. When the p wave is unsual or absent, then one can rely on the doppler alone to get them to the CAJ. An abnormal ECG protocol is used which is not a difficult task by any means. Thus, any patient is a candidate for this technology with high accuracy rates.
I work for Teleflex Medical, to be fair in disclosure. Thanks for your great question!
Cheryl Kelley RN
Cheryl Kelley RN BSN, VA-BC
Hi Nadine,
How can we exclude pneumothorax if we don't have a CXR after the procedure? If I was asked by the physicians, what would my answer be? I really want to use the VPS. Thank you.
With PICC insertion, pneumothorax is not an issue. In Europe, physicians have been using intravascular ECG for about 10 years without getting a CXR, and they don't feel it's an issue. If using US GUIDANCE, not ultrasound GUESSING, using the IJ or axillary vein outside the lung field, pneumothorax should not occur.
Nadine Nakazawa, RN, BS, VA-BC
I have been using ECG guidance without chest x-ray for over 2/1/2 years. I have been using Pacerview (which is no longer available) and have recently used Vasanova's new guidance system. I have only rarely had to get a chest x-ray and am so glad. ECG guidance is more accurate tip location, easy to learn, much faster procedure, and with no radiation exposure. PICC placement can now be done as fast and more safely than an IJ or subclavian line placement. This procedure has been done for more than a decade in Europe without legal problems that I am aware of. This is an exciting time to be a PICC nurse.
Disclosure: I am a consultant with Vasonova.
In addition to Cheryl's comments, I'd like to add the following. Both Sapiens (Bard) and Vascular Positioning System (Vasonova/Teleflex) have received FDA approval for "no CXR" or CXR equivalency in the patient with a normal P wave. I would be very careful to try out both systems before completely eliminating CXRs and that you have a consistent protocol in your institution for how the CXR is taken and interpretation to gain the confidence that the systems do what you want them to do.
Nadine Nakazawa, RN, BS, VA-BC
do you know if both Sapiens and Vasonova are cleared for Europe? How much do they cost in the US or in Europe?
Mats