- Email: [email protected]
Debris Exist in Today's Vascular Access Ports?
O R I G I N A L
A R T I C L E
Does Sludge/Debris Exist in Today’s Vascular Access Ports? Michael Dalton, MSIA Natan Pheil, BSBE Jim Lacy, RN, BSN, CRNIÒ, VA-BCÔ Jordan Dalton, MBA Norfolk Medical, Skokie, IL
Abstract Sludge is defined as a slushy mass, deposit, or sediment. In vascular access ports (VAPs), it appears to be the buildup of clotted blood, blood components, drug and mineral precipitates or residues, and lipids that adhere to or reside in the internal path of the reservoir. Several studies note the presence of sludge as a risk factor for increased incidence of VAPrelated bloodstream infections as well as higher occlusion rates. Overall, the occurrence of sludge in implanted vascular ports may increase patient-associated risks and costs to health care providers by as much as $40,000 per incident. Understanding the significance of these associated risks and costs may lead to solutions that save health care facilities money; better serve health care providers; and ultimately, improve patient outcomes. Keywords: cost savings, CVAD, occlusion, spherical chamber, sludge, thrombosis, VAP, VAP-BSI
Introduction ludge is defined as a slushy mass, deposit, or sediment. In vascular access ports (VAPs), it appears to be the buildup of clotted blood, blood components, drug and mineral precipitates or residues, and lipids adhering to or residing in the internal path of the reservoir. It is believed that when blood is aspirated from a port, small amounts of residual blood can adhere to the catheter and/or portal reservoir causing fibrin buildup that can lead to infection. Additionally, sludge that accumulates within the reservoir can obstruct the entrance to the internal catheter.1 During the mid-1990s, the issue of sludge in totally implanted VAPs was a topical issue. Investigation at that time demonstrated that sludge existed (M.D., unpublished data, 1992-1994). The literature suggests that such sludge is related to the incidence of infections and total or partial withdrawal occlusions.1-5 However, whereas port reservoir design has remained nearly unchanged since that initial study, the sludge discussion has gone relatively quiet. Is this because sludge has disappeared from VAPs? To investigate, Norfolk
S
Correspondence concerning this article should be addressed to [email protected] http://dx.doi.org/10.1016/j.java.2013.12.002 Copyright Ó 2014, ASSOCIATION FOR VASCULAR ACCESS. Published by Elsevier Inc. All rights reserved.
Medical Products, Inc, commissioned a study to determine if sludge, often located underneath the septum in VAPs, still exists in today’s ports. For more than 30 years, the septum has remained a flat, circular silicone rubber disk. Aside from the Vortex (Angiodynamics, Latham, NY), which offers a toroidal chamber, and the SportPort (Norfolk Medical Products, Inc, Skokie, IL), which offers a spherical chamber, the chamber has remained a cylindrical space with a flat bottom and straight walls with corners. This design creates a cylindrical chamber with a flat top and bottom. Because these technologies have remained largely unchanged, the problems associated with this configuration have been documented and have been compensated for through various medical interventions such as the use of thrombolytics, lysing agents, and pulsatile flushing of ports. The cylindrical chamber design of such ports promotes the formation of sludge in the corners and in the dead spaces. In addition, the conventional perpendicular outlet produces chaotic chamber flow and inadequate clearance, thereby contributing to sludge buildup. The major issues encountered with this design are the presence of sludge and sludge-related patient risks such as occlusion, VAP-related bloodstream infections (VAP-BSIs), increased costs for health care providers to remedy such complications, and a lack of awareness by the medical community of specific chamber flushing volumes for different ports. Several studies note the presence of sludge as a risk factor for increased incidence of VAP-BSIs. A study by Douard
2014
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et al2 analyzed the relationship between accumulation of infected clots under the silicone septum of the reservoir and the occurrence of VAP-BSIs, finding that the “infected deposits that accumulate under the VAP septum are the source of VAP-BSI.” Similarly, a study by Longuet et al3 found that “the reservoir is the key piece of the catheter-involved bateremia.” Whitman et al4 found that “the most predictive culture specimen in a potentially infected port is the thrombotic material inside the reservoir.” Furthermore, the presence of sludge is directly correlated to higher occlusion rates. A study by Athale et al5 demonstrated “rates of partial occlusion of up to 33%, and total occlusion up to 28% in VAPs.” Of all VAP-related complications, occlusion is the most frequent. Overall, the occurrence of sludge in implanted vascular ports may increase patient-associated risks as well as costs to health care providers.6-8 For the most part, existing technologies have not adequately addressed these issues, so where has the sludge gone? This article presents the results of Norfolk Medical’s pilot study. Methods At the onset of the study, a mailer was sent to Association for Vascular Access members describing the study and requesting that explanted ports be sent to Norfolk Medical for examination. All Health Insurance Portability and Accountability Act of 1996 guidelines were followed. Members were encouraged to provide 1 or more of the following: a photo of an explanted port, an explanted port with the septum intact, or an explanted port with the septum removed and containing sludge. A prepaid return envelope along with appropriate packaging, conforming to regulations concerning handling and transportation of biohazardous waste, was supplied on request to participants. In addition, a kit with gloves, scalpel, biohazard bag, and cotton swabs was supplied. Participants were asked to complete a form identifying the port and the catheter; if possible, the implantation site; the reason for placement; the length of use; and the reason for explantation. Information pertaining to flushing frequency, chemotherapy regimen, or problems related to the use of the port was not requested because the goal of this work was just to determine the presence of sludge. Upon receipt of the explanted port(s), the information on the form was recorded and a photograph of the port was taken. The port septum was carefully removed to examine for the presence of debris under the septum. Another photograph was taken of the removed septum and the exposed port chamber. Gross inspection of the port was also performed and observations recorded. No analysis of the debris was performed. Explanted ports were received between March 2012 and September 2012. Following port analysis, a report with photographs of the removed septum and the port chamber was sent to the participant. Results The study was undertaken as a limited, uncontrolled prospective study requesting recently explanted ports for examination. There were no exclusion criteria. Explanted ports (N ¼ 82)
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were received from several locations in both the United States and Canada. The results of the study indicated: d Sludge exists: 18.6% of explanted vascular access ports examined contained sludge in the port chamber. d Sludge was found in ports from all manufacturers represented in the study. d Sludge does not have a common appearance or consistency. Gross examination revealed that some sludge is dull and irregular, some bright and smooth with evidence of what appears to by crystals, and some irregularly colored with white areas throughout. Sludge consistency varied from thick and viscous to gelatinous to thin and fluid. The Figure highlights some sludge-filled examples of explanted ports received during the study. Conclusions Sludge does occur in today’s ports. Although our pilot study confirmed the incidence of sludge in explanted ports, it did not attempt to answer many vital questions related to the occurrence of sludge. That is, only gross analysis was performed and any sludge found was not cultured. The occurrence of sludge in implanted VAPs may have a significant influence on patient outcomes as well as patient satisfaction. We believe our study lays the groundwork for this program/analysis to be continued and enhanced by an independent medical organization, such as the Association for Vascular Access, that focuses on the significance of sludge and its effect on patient outcomes, both clinically and from a cost standpoint. With significant cost containment measures coming, the need for methods and improved practices to reduce the costs related to complications should be paramount in clinical settings. The results of our work indicate that a randomized prospective clinical study should be undertaken to answer specific medical clinic-related prevention questions and to determine: d The makeup of sludge and how drugs and/or infusates, including contrast media used during power injections, contribute to the buildup of sludge. d Risks associated with sludge formation related to intravascular device-related infection as well as thrombotic and nonthrombotic partial and complete occlusion. d Best practices for flushing and locking implanted ports and or ways to reduce the incidence of sludge. Although more than 1,000 requests to participate were mailed to Association for Vascular Access members and other health care professionals, we believe our pilot study was largely limited because it was performed by a medical device manufacturer with a specific agenda. Although the ports received covered a wide variety of manufacturers and models, statistically, the number of ports received (N ¼ 82) was insignificant compared with the number of ports implanted per year (w400,000). In any case, the results indicate that sludge does indeed exist in today’s ports and that the incidence seen in the pilot study strongly suggests that this is an area where further study is appropriate. Furthermore, we believe that given a viable solution that reduces the incidence of sludge buildup and resulting infections in addition to the costs related to the
2014
Figure. Examples of sludgefilled ports.
use of thrombolytic agents and diagnostic studies, significant cost savings and improved patient outcomes are possible. Discussion Concern, prevalence, and prevention of intravascular device-related infection have been at the forefront of clinical research for more than a decade.9 A correlation between thrombotic complications and infection is accepted although not well studied.2,5,10-12 Device occlusion is the most frequent of all complications resulting in additional costs, delays in treatment, rehospitalization, treatment with thrombolytics, or device replacement.3,5,10-16 Unfortunately, sludge as a risk factor for infection and occlusion has not been well studied and was mentioned in only 5 articles in our review.2-4,17,18 A paucity of implanted vascular port studies in the literature during the past 10 years was noted, and such studies focused mainly on implantation-related complications rather than overall patient complications such as occlusion and infection. The cost of intravascular device-related infection is high. “The complications of VAPs in today’s health care setting is creating a financial burden, increasing the expenditures of resources, and consuming the time of health care providers to resolve.”7 VAP-associated infections increase morbidity, mortality, hospital stay length, and costs. Specifically, VAP-BSIs are thought to extend lengths of stay and contribute to increased costs, reported to be as high as $40,000 per patient survivor.8 Although this number is a general figure for vascular device-related BSI, a detailed study examining the actual costs of a problem port (ie, cost of dye studies, use of thrombolytic
agents, and delays in treatment) or of an infected port where port replacement is required would be of value. We found no such articles or references in our literature search. Whereas specific data relating sludge to port-related infections and complications are difficult to obtain, it is obvious that opportunities exist to provide cost savings. Based on the numbers referenced in the literature, the Table shows the potential costs per year associated with port related BSIs. Understandably, the potential cost of VAP-BSIs will vary from facility to facility and may not all be attributable to sludge, but this number is eye opening on a macro scale. Although we believe the 18% sludge rate seen in our study
Table. Potential Costs of Vascular Access Port (VAP) Bloodstream-Related Infection (BSI) Incidence of sludge in portsa 18.6 Total number of ports implanted per yearb
400,000
Potential cost of an infection per individualc
$40,000
Potential overall cost of VAP-BSIs
(18.6% 400,000) $40,000 ¼ $2.98 billion
2014
a
Based on this study. Based on average port cost and total port sales reported by iData Research, Inc.20 c Based on data from Brown S.8 b
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may be excessive, it is still easy to see how a sample facility could largely benefit from eliminating VAP-BSIs. For example, allowing that a particular facility uses 200 ports per year and only sees a sludge rate half of what was found in our study, or 9%, and only half of those results in an infection, or 4.5%, this amounts to 9 VAP-BSIs per year. At a potential cost of $40,000 per infection (not including lysing agents and dye studies), eliminating VAP-BSIs could save this facility $360,000.00 per year. To date, this issue has been inadequately addressed. Only 2 ports in the marketplace use a noncylindrical chamber design: the Vortex port and the SportPort. Both present radical changes from the standard accepted cylindrical chamber design and both claim to improve patient outcomes because of their design. Although the septum of the Vortex remains flat, the chamber forms a toroid. Coupled with a tangential outlet, the Vortex promotes more efficient flushing. In the case of the SportPort, the chamber design is spherical, meaning no corners or dead spaces exist where sludge is known to develop. This is accomplished by marrying the round chamber with a radiused septum. The exit is both at the bottom of the chamber and tangential to the chamber to promote complete and total flushing. Clearance volume testing was performed to analyze and compare the chamber flushing volumes of currently marketed ports from leading manufacturers, and the results showed the SportPort to have the best performance, followed by the Vortex, and finally, cylindrical chambered ports.19 As this study highlights, sludge still exists. Unfortunately, no other studies take a comprehensive look at the incidence of sludge in ports. With the potential cost savings and improved patient outcomes that research in this field could generate, certainly, the relationship between sludge buildup in ports and VAP-BSI merits further investigation. Acknowledgment These results were presented in a poster at the 2012 Association for Vascular Access Annual Scientific Meeting, October 16-19, 2012, San Antonio, TX.19 References 1. ArcMesa Educators. The use and maintenance of implanted port vascular devices. http://nursinglink. monster.com/training/articles/302-the-use-and-maintenanceof-implanted-port-vascular-access-devices. Updated June 20, 2007. Accessed July 8, 2013. 2. Douard MC, Arlet G, Longuet P, et al. Diagnosis of venous access port-related infections. Clin Infect Dis. 1999;29(5): 1197-1202. 3. Longuet P, Douard MC, Arlet G, Molina JM, Benoit C, Leport C. Venous access port related bacteremia in patients with acquired immunodeficiency syndrome or cancer: the reservoir as a diagnostic and therapeutic tool. Clin Infect Dis. 2001;32(12):1776-1783. 4. Whitman ED, Boatman AM. Comparison of diagnostic specimens and methods to evaluate infected venous access ports. Am J Surg. 1995;170(6):665-669.
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5. Athale UH, Siciliano S, Cheng J, Thabane L, Chan AK. Central venous line dysfunction is an independent predictor of poor survival in children with cancer. J Pediatr Hematol Oncol. 2012;34(3):188-193. 6. Shannon RP, Patel B, Cummins D, Shannon AH, Ganguli G, Lu Y. Economics of central line associated bloodstream infections. Am J Med Qual. 2006;21(6 Suppl):7S-16S. 7. Beerman AL. Making the case for a nurse-led vascular access team utilizing a quality assurance conceptual framework. J Assoc Vasc Access. 2009;14(2):77-82. 8. Brown S. Complications with the use of venous access devices. U.S. Pharmacist. 1998;23(8). http://legacy.uspharmacist.com/ oldformat.asp?url¼newlook/files/Feat/ACF2FF9.cfm&pub_ id¼8&article_id¼131. Accessed July 8, 2013. 9. O’Grady NP, Alexander M, Burns LA, et al. Guidelines for the prevention of intravascular catheter-related infections. Am J Infect Control. 2011;39(4 Suppl 1):S1-S34. 10. Bucki B, Tomaszewska R, Karpe J, Stoksik P, SontaJakimczyk D, Szczepanski T. Central venous access ports in children treated for hematopoietic malignancies. Pediatr Hematol Oncol. 2008;25(8):751-755. 11. Royle TJ, Davies RE, Gannon MX. Totally implantable venous access devices - 20 years’ experience of implantation in cystic fibrosis patients. Ann Royal Coll Surg Engl. 2008;90(8):679-684. 12. Moureau N, Poole S, Murdock MA, Gray SM, Semba CP. Central venous catheters in home infusion care: outcomes analysis in 50,470 patients. J Vasc Intervent Radiol. 2002;13(10):1009-1016. 13. Lorch H, Zwaan M, Kagel C, Weiss HD. Central venous access ports placed by interventional radiologists: experience with 125 consecutive patients. Cardiovasc Intervent Radiol. 2001;24(3):180-184. 14. Nishinari K, Wolosker N, Bernardi CV, Yazbek G. Totally implantable ports connected to valved catheters for chemotherapy: experience from 350 Groshong devices. J Vasc Access. 2010;11(1):17-22. 15. Suslu H, Arslan G, Tural K. Venous port implantation in adult patients: retrospective evaluation [in Turkish]. Agri. 2012;24(1):32-36. 16. Zhang Q, Jiao L, Zhou H. Comparison of implantable central venous ports with catheter insertion via external jugular cut down and subclavian puncture in children: single center experience. Pediatr Surg Int. 2009;25(6):499-501. 17. deSwarte J. Experience with residue in the reservoirs of implanted ports. J Vasc Access Network. 1993;3(3):16-18. 18. Herbst S. Accumulation of blood products and drug precipitates in VADs: a set up for trouble. J Vasc Access Networks. 1993;3(3):9-13. 19. Dalton M, Pheil N, Lacy J. The port clearance test: why it is important to the clinician. Poster presented at Association of Vascular Access Annual Scientific Meeting, October 16-19, 2012, San Antonio, TX. 20. iData Research, Inc. U.S. Market for Vascular Access Devices and Accessories. Vancouver, Canada, iData Research, Inc, 2011.
2014
A R T I C L E
Does Sludge/Debris Exist in Today’s Vascular Access Ports? Michael Dalton, MSIA Natan Pheil, BSBE Jim Lacy, RN, BSN, CRNIÒ, VA-BCÔ Jordan Dalton, MBA Norfolk Medical, Skokie, IL
Abstract Sludge is defined as a slushy mass, deposit, or sediment. In vascular access ports (VAPs), it appears to be the buildup of clotted blood, blood components, drug and mineral precipitates or residues, and lipids that adhere to or reside in the internal path of the reservoir. Several studies note the presence of sludge as a risk factor for increased incidence of VAPrelated bloodstream infections as well as higher occlusion rates. Overall, the occurrence of sludge in implanted vascular ports may increase patient-associated risks and costs to health care providers by as much as $40,000 per incident. Understanding the significance of these associated risks and costs may lead to solutions that save health care facilities money; better serve health care providers; and ultimately, improve patient outcomes. Keywords: cost savings, CVAD, occlusion, spherical chamber, sludge, thrombosis, VAP, VAP-BSI
Introduction ludge is defined as a slushy mass, deposit, or sediment. In vascular access ports (VAPs), it appears to be the buildup of clotted blood, blood components, drug and mineral precipitates or residues, and lipids adhering to or residing in the internal path of the reservoir. It is believed that when blood is aspirated from a port, small amounts of residual blood can adhere to the catheter and/or portal reservoir causing fibrin buildup that can lead to infection. Additionally, sludge that accumulates within the reservoir can obstruct the entrance to the internal catheter.1 During the mid-1990s, the issue of sludge in totally implanted VAPs was a topical issue. Investigation at that time demonstrated that sludge existed (M.D., unpublished data, 1992-1994). The literature suggests that such sludge is related to the incidence of infections and total or partial withdrawal occlusions.1-5 However, whereas port reservoir design has remained nearly unchanged since that initial study, the sludge discussion has gone relatively quiet. Is this because sludge has disappeared from VAPs? To investigate, Norfolk
S
Correspondence concerning this article should be addressed to [email protected] http://dx.doi.org/10.1016/j.java.2013.12.002 Copyright Ó 2014, ASSOCIATION FOR VASCULAR ACCESS. Published by Elsevier Inc. All rights reserved.
Medical Products, Inc, commissioned a study to determine if sludge, often located underneath the septum in VAPs, still exists in today’s ports. For more than 30 years, the septum has remained a flat, circular silicone rubber disk. Aside from the Vortex (Angiodynamics, Latham, NY), which offers a toroidal chamber, and the SportPort (Norfolk Medical Products, Inc, Skokie, IL), which offers a spherical chamber, the chamber has remained a cylindrical space with a flat bottom and straight walls with corners. This design creates a cylindrical chamber with a flat top and bottom. Because these technologies have remained largely unchanged, the problems associated with this configuration have been documented and have been compensated for through various medical interventions such as the use of thrombolytics, lysing agents, and pulsatile flushing of ports. The cylindrical chamber design of such ports promotes the formation of sludge in the corners and in the dead spaces. In addition, the conventional perpendicular outlet produces chaotic chamber flow and inadequate clearance, thereby contributing to sludge buildup. The major issues encountered with this design are the presence of sludge and sludge-related patient risks such as occlusion, VAP-related bloodstream infections (VAP-BSIs), increased costs for health care providers to remedy such complications, and a lack of awareness by the medical community of specific chamber flushing volumes for different ports. Several studies note the presence of sludge as a risk factor for increased incidence of VAP-BSIs. A study by Douard
2014
j
Vol 19 No 1
j
JAVA
j
23
et al2 analyzed the relationship between accumulation of infected clots under the silicone septum of the reservoir and the occurrence of VAP-BSIs, finding that the “infected deposits that accumulate under the VAP septum are the source of VAP-BSI.” Similarly, a study by Longuet et al3 found that “the reservoir is the key piece of the catheter-involved bateremia.” Whitman et al4 found that “the most predictive culture specimen in a potentially infected port is the thrombotic material inside the reservoir.” Furthermore, the presence of sludge is directly correlated to higher occlusion rates. A study by Athale et al5 demonstrated “rates of partial occlusion of up to 33%, and total occlusion up to 28% in VAPs.” Of all VAP-related complications, occlusion is the most frequent. Overall, the occurrence of sludge in implanted vascular ports may increase patient-associated risks as well as costs to health care providers.6-8 For the most part, existing technologies have not adequately addressed these issues, so where has the sludge gone? This article presents the results of Norfolk Medical’s pilot study. Methods At the onset of the study, a mailer was sent to Association for Vascular Access members describing the study and requesting that explanted ports be sent to Norfolk Medical for examination. All Health Insurance Portability and Accountability Act of 1996 guidelines were followed. Members were encouraged to provide 1 or more of the following: a photo of an explanted port, an explanted port with the septum intact, or an explanted port with the septum removed and containing sludge. A prepaid return envelope along with appropriate packaging, conforming to regulations concerning handling and transportation of biohazardous waste, was supplied on request to participants. In addition, a kit with gloves, scalpel, biohazard bag, and cotton swabs was supplied. Participants were asked to complete a form identifying the port and the catheter; if possible, the implantation site; the reason for placement; the length of use; and the reason for explantation. Information pertaining to flushing frequency, chemotherapy regimen, or problems related to the use of the port was not requested because the goal of this work was just to determine the presence of sludge. Upon receipt of the explanted port(s), the information on the form was recorded and a photograph of the port was taken. The port septum was carefully removed to examine for the presence of debris under the septum. Another photograph was taken of the removed septum and the exposed port chamber. Gross inspection of the port was also performed and observations recorded. No analysis of the debris was performed. Explanted ports were received between March 2012 and September 2012. Following port analysis, a report with photographs of the removed septum and the port chamber was sent to the participant. Results The study was undertaken as a limited, uncontrolled prospective study requesting recently explanted ports for examination. There were no exclusion criteria. Explanted ports (N ¼ 82)
24
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were received from several locations in both the United States and Canada. The results of the study indicated: d Sludge exists: 18.6% of explanted vascular access ports examined contained sludge in the port chamber. d Sludge was found in ports from all manufacturers represented in the study. d Sludge does not have a common appearance or consistency. Gross examination revealed that some sludge is dull and irregular, some bright and smooth with evidence of what appears to by crystals, and some irregularly colored with white areas throughout. Sludge consistency varied from thick and viscous to gelatinous to thin and fluid. The Figure highlights some sludge-filled examples of explanted ports received during the study. Conclusions Sludge does occur in today’s ports. Although our pilot study confirmed the incidence of sludge in explanted ports, it did not attempt to answer many vital questions related to the occurrence of sludge. That is, only gross analysis was performed and any sludge found was not cultured. The occurrence of sludge in implanted VAPs may have a significant influence on patient outcomes as well as patient satisfaction. We believe our study lays the groundwork for this program/analysis to be continued and enhanced by an independent medical organization, such as the Association for Vascular Access, that focuses on the significance of sludge and its effect on patient outcomes, both clinically and from a cost standpoint. With significant cost containment measures coming, the need for methods and improved practices to reduce the costs related to complications should be paramount in clinical settings. The results of our work indicate that a randomized prospective clinical study should be undertaken to answer specific medical clinic-related prevention questions and to determine: d The makeup of sludge and how drugs and/or infusates, including contrast media used during power injections, contribute to the buildup of sludge. d Risks associated with sludge formation related to intravascular device-related infection as well as thrombotic and nonthrombotic partial and complete occlusion. d Best practices for flushing and locking implanted ports and or ways to reduce the incidence of sludge. Although more than 1,000 requests to participate were mailed to Association for Vascular Access members and other health care professionals, we believe our pilot study was largely limited because it was performed by a medical device manufacturer with a specific agenda. Although the ports received covered a wide variety of manufacturers and models, statistically, the number of ports received (N ¼ 82) was insignificant compared with the number of ports implanted per year (w400,000). In any case, the results indicate that sludge does indeed exist in today’s ports and that the incidence seen in the pilot study strongly suggests that this is an area where further study is appropriate. Furthermore, we believe that given a viable solution that reduces the incidence of sludge buildup and resulting infections in addition to the costs related to the
2014
Figure. Examples of sludgefilled ports.
use of thrombolytic agents and diagnostic studies, significant cost savings and improved patient outcomes are possible. Discussion Concern, prevalence, and prevention of intravascular device-related infection have been at the forefront of clinical research for more than a decade.9 A correlation between thrombotic complications and infection is accepted although not well studied.2,5,10-12 Device occlusion is the most frequent of all complications resulting in additional costs, delays in treatment, rehospitalization, treatment with thrombolytics, or device replacement.3,5,10-16 Unfortunately, sludge as a risk factor for infection and occlusion has not been well studied and was mentioned in only 5 articles in our review.2-4,17,18 A paucity of implanted vascular port studies in the literature during the past 10 years was noted, and such studies focused mainly on implantation-related complications rather than overall patient complications such as occlusion and infection. The cost of intravascular device-related infection is high. “The complications of VAPs in today’s health care setting is creating a financial burden, increasing the expenditures of resources, and consuming the time of health care providers to resolve.”7 VAP-associated infections increase morbidity, mortality, hospital stay length, and costs. Specifically, VAP-BSIs are thought to extend lengths of stay and contribute to increased costs, reported to be as high as $40,000 per patient survivor.8 Although this number is a general figure for vascular device-related BSI, a detailed study examining the actual costs of a problem port (ie, cost of dye studies, use of thrombolytic
agents, and delays in treatment) or of an infected port where port replacement is required would be of value. We found no such articles or references in our literature search. Whereas specific data relating sludge to port-related infections and complications are difficult to obtain, it is obvious that opportunities exist to provide cost savings. Based on the numbers referenced in the literature, the Table shows the potential costs per year associated with port related BSIs. Understandably, the potential cost of VAP-BSIs will vary from facility to facility and may not all be attributable to sludge, but this number is eye opening on a macro scale. Although we believe the 18% sludge rate seen in our study
Table. Potential Costs of Vascular Access Port (VAP) Bloodstream-Related Infection (BSI) Incidence of sludge in portsa 18.6 Total number of ports implanted per yearb
400,000
Potential cost of an infection per individualc
$40,000
Potential overall cost of VAP-BSIs
(18.6% 400,000) $40,000 ¼ $2.98 billion
2014
a
Based on this study. Based on average port cost and total port sales reported by iData Research, Inc.20 c Based on data from Brown S.8 b
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may be excessive, it is still easy to see how a sample facility could largely benefit from eliminating VAP-BSIs. For example, allowing that a particular facility uses 200 ports per year and only sees a sludge rate half of what was found in our study, or 9%, and only half of those results in an infection, or 4.5%, this amounts to 9 VAP-BSIs per year. At a potential cost of $40,000 per infection (not including lysing agents and dye studies), eliminating VAP-BSIs could save this facility $360,000.00 per year. To date, this issue has been inadequately addressed. Only 2 ports in the marketplace use a noncylindrical chamber design: the Vortex port and the SportPort. Both present radical changes from the standard accepted cylindrical chamber design and both claim to improve patient outcomes because of their design. Although the septum of the Vortex remains flat, the chamber forms a toroid. Coupled with a tangential outlet, the Vortex promotes more efficient flushing. In the case of the SportPort, the chamber design is spherical, meaning no corners or dead spaces exist where sludge is known to develop. This is accomplished by marrying the round chamber with a radiused septum. The exit is both at the bottom of the chamber and tangential to the chamber to promote complete and total flushing. Clearance volume testing was performed to analyze and compare the chamber flushing volumes of currently marketed ports from leading manufacturers, and the results showed the SportPort to have the best performance, followed by the Vortex, and finally, cylindrical chambered ports.19 As this study highlights, sludge still exists. Unfortunately, no other studies take a comprehensive look at the incidence of sludge in ports. With the potential cost savings and improved patient outcomes that research in this field could generate, certainly, the relationship between sludge buildup in ports and VAP-BSI merits further investigation. Acknowledgment These results were presented in a poster at the 2012 Association for Vascular Access Annual Scientific Meeting, October 16-19, 2012, San Antonio, TX.19 References 1. ArcMesa Educators. The use and maintenance of implanted port vascular devices. http://nursinglink. monster.com/training/articles/302-the-use-and-maintenanceof-implanted-port-vascular-access-devices. Updated June 20, 2007. Accessed July 8, 2013. 2. Douard MC, Arlet G, Longuet P, et al. Diagnosis of venous access port-related infections. Clin Infect Dis. 1999;29(5): 1197-1202. 3. Longuet P, Douard MC, Arlet G, Molina JM, Benoit C, Leport C. Venous access port related bacteremia in patients with acquired immunodeficiency syndrome or cancer: the reservoir as a diagnostic and therapeutic tool. Clin Infect Dis. 2001;32(12):1776-1783. 4. Whitman ED, Boatman AM. Comparison of diagnostic specimens and methods to evaluate infected venous access ports. Am J Surg. 1995;170(6):665-669.
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