Precision in Central Venous Catheter Tip Placement: A Review of the Literature

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Ê,iۈiÜʜvÊ̅iʈÌiÀ>ÌÕÀi Russell Hostetter, Ph.D. - Russell Hostetter & Associates, Pleasanton, CA Nadine Nakasawa, RN, BS, OCN, CRNI - Stanford Hospitals and Clinics, Stanford, CA Kim Tompkins, RN, MBA - VasoNova, Inc., Sunnyvale, CA Bradley Hill, MD - Kaiser Permanente, Santa Clara, CA

Abstract Background: Long term venous catheters have been used to deliver specialized therapies since 1968. The ideal tip position of a central venous catheter provides reliable venous access with optimal therapeutic delivery, while minimizing short-and long-term complications. Ideal position limits have evolved and narrowed over time, making successful placement difficult and unreliable when depending exclusively on the landmark technique. Objective: To review and analyze contemporary literature and calculate an overall accuracy rate for first attempt placement of a PICC catheter in the ideal tip position. Methods: Key PICC placement terms were used to search the database PubMED-indexed for MEDLINE in June and October, 2009. The selection of studies required: a patient cohort without tip placement guidance technology; a documented landmark technique to place catheter tips; data documenting initial catheter placement and, that the lower third of the SVC and the cavo-atrial junction (CAJ) were included in the placement criteria. With few exceptions, articles written between 1993 and 2009 met the stated selection criteria. A composite of outcomes associated with tip placement was analyzed, and an overall percent proficiency of accurate catheter tip placement calculated. Results: Nine studies in eight articles met the selection criteria and were included for analysis. Rates of first placement success per study ranged from 39% to 75%, with the majority (7/9) being single center studies. The combined overall proficiency of these studies calculated as a weighted average was 45.87%.

Introduction ince 1968, long term venous catheters have provided a means for delivering specialized therapies. Through improvements of these catheters and strategic modifications of how and where they are inserted (Seldinger, 1953; Broviac, Cole, and Scribner, 1973; Hickman et al., 1979; Higgs, Macafee, Braitwaite and Maxwell-Armstrong, 2005), the central venous catheter has become a critical device for administering therapeutics, blood sampling for monitoring and diagnostics, and parenteral nutrition (Hackert et al., 2005; Neuman, Murphy, and Rosen,1998; Schwarz, Coit and Groeger, 2000; Tan and Gibson, 2006; Vesely, 2003). The initial drivers for developing CVCs were the need for reliable venous access for long term IV treatment regimes and the need for reliable venous access (Lyon, 2005). Issues currently driving development are accurate placement of the catheter tip for optimal delivery of therapeutic regimens while minimizing short- and long-term

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Correspondence concerning this article should be addressed to [email protected] DOI: 10.2309/java.15-3-3

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complications (McGee et al., 1993; Fuchs, Pollak and Gilon, 1999; Schummer et al., 2004; Pittiruti et al., 2008; Pawlik, Kutz, Keyl, Lemberger and Hansen, 2004; Madan, Shah, Alexander, Taylor and McMahon, 1994; Schummer et al., 2004; Flectcher and Bodenham, 2000; Scott, 1988). There remains an ongoing debate about the ideal tip location (Tan and Gibson, 2006; Vesely, 2003; Wirsing et al., 2008; Board of Directors NAVAN, 1998) that has stimulated the development of techniques and technologies for placement (Starr and Cornicelli, 1986; Jeon, Ryu, Yoon, Kim and Bahk, 2006; Gallieni, Pittiruti and Biffi, 2008; Wirsing et al., 2008). When deciding catheter type, insertion point, route, and ideal tip placement, clinicians are faced with balancing required treatment regimes with collateral damage control that could occur if the catheter tip is in the “wrong” place (McGee et al., 1993; Pawlik et al., 2004; Pittiruti et al., 2008; Schummer et al., 2004; Schwarz et al., 2000; Board of Directors NAVAN, 1998). To make matters worse, serious limitations have been identified with the “gold standard” of catheter tip confirmation--the chest x-ray (CXR) (Chu et al., 2004; Aslamy, Dewald and Heffner, 1998; Verhey, Gosselin, Primack, Blackburn and Kraemer, 2008). In addition, new clinical information has sug-

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gested that certain catheter insertion points and routes may be better at minimizing short- and long-term complications (Gallieni et al., 2008). Such trends emphasize the value of accurate initial CVC tip placement. Purpose: This paper is a review and analysis of catheter tip placement data from contemporary literature, conducted to determine the published accuracy rate for first attempt placement in the ideal position. Methodology: A review of the literature was conducted. With few exceptions, articles covered the period from 1993 to 2009. Search terms used to identify articles included: PICC position, ECG PICC, Central venous placement, Catheter ECG placement, Cavoatrial junction, PICC catheter placement, PICC tip position, PICC tip placement, Anatomical Landmarks PICC, Central venous catheter tip placement, surface landmarks and PICC/catheter placement. The database source was online PubMed - indexed for MEDLINE. The search was conducted in June and October 2009. Articles not meeting the selection criteria were reviewed only for discussion points relevant to the accurate placement of catheters. Studies selected for inclusion in the current review met the following criteria: 1) a patient cohort that was treated with catheters placed without the use of a guidance system; 2) documentation of a surface landmark technique that was used to place catheter tips; 3) data from initial catheter placement were available for use; 4) the lower third of the SVC up to and including the cavoatrial junction (CAJ) were used to define a successful placement and this information was either provided by the author or could be extrapolated by analysis of study results as noted in the data summary (Table 1). Nine studies in eight articles met the study criteria. An analysis of the results was performed on a composite of outcomes associated with the success or failure of tip placement as reported. For each of the nine studies, the percent primary placement success rate cited in the article was used, in conjunction with the number of individual first time successful placements, to determine the weighted average of the total successful first time placements. This number was summed and divided by the total number of successful first time placements from all nine studies, to determine the overall outcome composite of successful placements (McGee, 1993; Chu et al., 2004; Cadman, Lawrance, Fitzsimmons, Spencer-Shaw and Swindell, 2004; Lum, 2004; Neuman et al., 1998; Gebhard et al., 2007; Hockley et al., 2007; Trerotola, Thompson, Chittams and Vierregger, 2007). This value was presented as the overall percent proficiency accurate placement of catheter tips (Table 1). The data from three studies were reanalyzed by extrapolation or subset analysis to identify catheters that were accurately placed within a target zone representative of the defined placement target criteria, i.e. the lower third of the SVC including the CAJ (Cadman et al., 2004; Gebhard et al., 2007; Board of Directors NAVAN, 1998; Trerotola et al., 2007). The published results included positions that incorporated the heart and/or the upper half of the SVC, but only data falling into the target zone were used as an indicator of successful placement for

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these three studies. One other study included as a successful tip placement locations of potential “usable access,” even if the primary designated target was not reached or approximated by the catheter tip (Neuman et al., 1998). Because these tip placements were outside and above the SVC, they were not included in the successful placement data subset used from the study. Results Nine studies in eight articles qualified for inclusion in the analysis of catheter tip placement proficiency evaluation. Abbreviated study details for the nine studies are provided in Table 1. Of the nine studies, seven were prospective and two were retrospective. Most of the studies were randomized (7/9) but of those, only two were blinded (2/7). Almost all the studies were single center (7/9). Rates of first placement success are listed by study and ranged from 39% (42 accurate placements) in a single center study to 75% (97 accurate placements) in a single center study. A weighted average per study was calculated by multiplying the stated rate by the number of accurately placed catheters (N). The overall proficiency in accurate placement was calculated by dividing the sum of the weighted averages by the total number of accurate placements and determined to be 45.87%.

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DISCUSSION Central Venous Access Devices (CVADs) and Treatment Indications for use of CVADs (centrally inserted venous catheters (CVCs) and peripherally inserted central catheters (PICCs)) include chemotherapy, total parenteral nutrition, hemodialysis, administration of antibiotics, blood product delivery, hemodynamic monitoring, fluid replacement, and drug administration (Gebhard et al., 2007; Tan and Gibson, 2006; Neuman et al., 1998). Catheters are generally categorized into four insertion types: PICCs, tunneled central venous catheters, non-tunneled central venous catheters and implanted venous ports. Each must be positioned with the catheter tip in a large vessel of the heart (i.e., superior vena cava) or the right atrium to be considered a central venous access device. Access to the venous system can be percutaneous or through a surgical cut down. Catheter material (e.g. silicone, polyurethane, polyvinylchloride, tetrafluoroethylene, polyethylene), number of lumens (1-3), method of venous access (peripheral or central), technique for attachment, and specialized applications (e.g. high pressure delivery of contrast agents for angiography applications) has evolved (Gallieni et al., 2008; Lyon, 2005). Access sites vary, but commonly, tunneled CVC’s and ports are placed by accessing the jugular or subclavian/axillary veins. PICCs most commonly enter the central venous veins through the basilic, brachial or cephalic veins (Lyon, 2005). In general and for the purpose of this paper, VADs are considered “ideally” positioned when the distal tip of the catheter is located at the junction of the superior vena cava (SVC) and right atrium (RA) also referred to as the atrial-caval junction (ACJ) or cavo-atrial junction (CAJ) (Jeon et al., 2006; Pittiruti et al., 2008; Gallieni et al., 2008; Lum, 2004). The authors acknowledge that there remains controversy on the identification of the “ideal”tip position (Neuman et al., 1998; Tan and Gibson, 2006; Vesely, 2003; Wirsing et al., 2008). Adverse Events (AEs) Adverse events (AEs) are considered procedural or indwelling. Procedural AEs have two standards; one for image guided catheters and one for landmark positioned catheters (Lum, 2004; Neuman et al., 1998; Lyon, 2005; Peres, 1990). A third standard--non-image guided catheter tip positioning--is in development (McGee, 1993; Chu et al., 2004; Starr and Cornicelli, 1986; Schummer et al., 2004; Pawlik et al., 2004; Jeon et al., 2006; Pittiruti et al., 2008; Madan et al., 1994; Schummer et al., 2003; Flectcher and Bodenham, 2000; Gallieni et al., 2008; Wirsing et al., 2008). Examples of procedural AEs include catheter malposition, pneumothorax, arterial puncture, and tamponade. Image guided CVC access and placement adverse event rates above 3% are considered significant (Hackert et al., 2005; Lyon, 2005). Non-image guided access and placement procedural AE rates may reach 10% to 20%, while landmark guided access and placement AE rates could be as high as 70%. Adverse events associated with thrombosis can be directly influenced by the position of the central venous catheter tip position. Catheter malfunction, fracture, infection and thrombosis represent indwelling complications. Breakage is very rare, but

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the occurrence of malfunctions range from 10%-20% and is frequently linked to catheter related thrombosis or fibrin sheath formation (Scott, 1988; Vesely, 2003; Tan and Gibson, 2006; Cadman et al., 2004; Fuchs et al., 1999). Thrombosis will not always cause catheter malfunctions, but 41% of CVCs have been reported as being associated with blood vessel thrombosis. This may increase the risk of infection. Infection represents a significant cause of morbidity, mortality, and increased health costs associated with the use of catheters (Lyon, 2005). It has been estimated that catheter related sepsis is associated with a mortality rate as high as 25% (Sivasubramaniam and Hiremath, 2008). In addition, tip location may be associated with the above mentioned 41% thrombosis rate, as well as related catheter malfunctions. Driving Forces for Catheter Tip Position Throughout the literature, certain anatomic locations are cited as the best catheter tip position based upon the therapeutic requirement of the patient (Neuman et al., 1998; Tan and Gibson, 2006). This remains a controversial subject (Chu et al., 2004; Schummer et al., 2004; Vesely, 2003). The lower third of the SVC is often referenced for “general use” but recommendations for tip position range from the upper half of the SVC for taking central venous pressure measurements to the right atrium for hemodialysis (Vesely, 2003; Gallieni et al., 2008; Tan and Gibson, 2006; Hackert et al., 2005; Stoneham, 2001; Chu et al., 2004). Frequently noted is that catheter tip positioning variables may have only a small effect on outcome compared to disease type, treatment, and individual patient characteristics. This may help explain why, in the past, many authors did not make distinctions between various SVC and RA locations, believing that any of these locations were acceptable (Starr and Cornicelli, 1986). More recent research has provided support for catheter tip position as a critical independent variable for predicting complications (Cadman et al., 2004; Gallieni et al., 2008; Schwarz et al., 2000). Tip position recommendations are driven by an attempt to balance the benefit of the use of catheters to deliver the appropriate therapy with the potential for collateral damage from mechanical contact of the catheter and/or the delivery of caustic or toxic therapeutic compounds. Thrombosis rates, vascular tissue damage from caustic or highly osmolar agents, extreme pH vesicant chemicals or mechanical vascular and cardiac damage are surfacing as complications directly related to catheter tip position (Fuchs et al., 1999; Gallieni et al., 2008; Hackert et al., 2005; Puel et al., 1993; Stoneham, 2001). Catheter tips located in the upper third of the SVC are associated with an incidence of thrombosis that can be as much as 16 times higher, than tips placed in the lower third of the SVC or CAJ (Gallieni et al., 2008; Flectcher and Bodenham, 2000). As a result, oncology patients are targeted for CAJ positioning of the catheter tip. This places the delivery of treatment compounds next to a relatively large vascular area with a high flow volume, resulting in maximal dilution and minimized potential for chemical damage to the SVC (Schummer et al., 2004; Schummer et al., 2003; Wirsing et al., 2008; Sivasubramaniam and Hiremath, 2008; Vesely, 2003). This tip position is also in accordance with FDA and the Association for Vascular Access (formally NAVAN) guidelines

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for avoiding the placement of catheter tips within the RA (McGee, 1993; Board of Directors NAVAN, 1998). An additional driver for accurate tip position is the potential for litigation, specifically lawsuits predicated on the risk to patient safety. Documentation of specific catheter tip position post-placement is essential (Flectcher and Bodenham, 2000). Hemodialysis or apheresis therapy requires high flow rates and large volumes of blood products. To this end, many clinicians justify the use of the RA as a unique target for this treatment (Gallieni et al., 2008; Vesely, 2003). The concept of “usable access” has also contributed to a broader use of the SVC, predicated on a therapeutic compound’s characteristics rather than the location of the catheter (Neuman et al., 1998). These criteria for placement may no longer be justifiable considering the compelling information supporting the unique role of catheter placement and its relationship to potential complications, including vascular or cardiac tissue damage or perforations, leading to thrombosis, extra vascular discharge of therapeutic substances and associated tissue damage, adjacent organ perforations, or cardiac tamponade (Fuchs et al., 1999; Hackert et al., 2005; Puel et al., 1993; Stoneham, 2001; Vesely, 2003; Scott, 1988). Access routes for tip placement are also becoming more important as new information becomes available for long term complications (Schwengel et al., 2004; Gallieni et al., 2008; Schwarz et al., 2000; Lyon, 2005). Left-sided access can significantly contribute to the malposition of the catheter tip causing a severe angle of contact. The left internal jugular vein (LIJV) has a tortuous route via the left brachiocephalic vein and then a sharp turn, almost 90 degrees, from the brachiocephalic vein into the SVC. If not corrected by moving the catheter past the junction and parallel with the SVC, there is a strong possibility for the catheter tip to erode or perforate the vascular wall (Schummer et al., 2004; Hackert et al., 2005). Even soft silicone catheter tips can erode through or damage the wall of the SVC or right atrium (Kulvatunyou, Rucinski and Schein, 1997). This is especially critical since the pericardium can extend up the medial side of the SVC an average distance of 3.5 cm, creating the potential for cardiac tamponade (McGee, 1993; Schummer et al., 2004; Jeon et al., 2006; Caruso, et al., 2002; Flectcher et al., 2000; Sivasubramaniam and Hiremath, 2008; Gebhard et al., 2007; Wirsing et al., 2008; Kowalski, Kaufman, Rivitz, Geller and Waltman, 1997; Vesely, 2003). Although this is considered a rare event, the consequences are life threatening, with a mortality rate of 65%78% (Pawlik et al., 2004). The use of the left subclavian vein for placing catheter tips within the SVC has been associated with an increase in thrombosis and vessel wall perforation. Evidence from a clinical study of 1,201 patients suggests that the internal jugular vein is superior to the use of the subclavian when comparing immediate complications (1.5% vs. 5.0% respectively; P <0.001). This implies that the left handedness of the subclavian may be superseded by a more intrinsic propensity to form thrombosis (subclavian 2.0% vs. internal jugular 0.6%) (Gallieni et al., 2008). Additional clinical trials are required to confirm the integrity of these observational trends. Litigation: Lawsuits have been filed for tamponade associated with catheter tips placed within the heart and for access nerve damage resulting in significant injury settlements rang-

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ing from hundreds of thousands to millions of dollars (Sivasubramaniam et al., 2008). Assuring patient safety by minimizing these potential risks may mitigate financial liability litigation. This financial threat can act as an ally in generating momentum for improvements (Kokotis, 2005). Positioning Catheter Tips Placing a catheter tip accurately requires venous access, catheter placement and positioning and confirmation of catheter tip location. Historically lines have been placed using a particular procedure—referred to as the “landmark” or “blind placement” technique and set the foundation for central venous catheter tip placement at a specific location within the SVC (Kokotis, 2005; Chu et al., 2004; McGee, 1993; Cadman et al., 2004; Gallieni et al., 2008; Tan and Gibson, 2006; Gebhard et al., 2007; Peres, 1990). The landmark procedure requires palpation and knowledge of surface anatomical landmarks to estimate the length of the catheter for a specific patient (Lum, 2004). Access is usually achieved with ultrasound or by the traditional landmark approach. (Placement directed by “feel,” experience, and knowledge of vascular anatomy). Final tip positioning depends upon the estimated length of the catheter because successful placement required only that the catheter be located within one of the great vessels of the heart. Over time this was differentiated into midline and central venous catheters. In general, for the venous system, a central venous catheter is located within the SVC, while a midline is located within one of the “feeder” vessels that eventually join the SVC (Gallieni et al., 2008; Vesely, 2003; Amerasekera, Jones, Patel and Cleasby, 2009). Time and experience once again dictated further delineations regarding the location of a catheter tip within the SVC. Catheter tips positioned in the upper portion of the SVC were shown to be associated with exceptionally high levels of thrombosis (Cadman et al., 2004). Catheter tips positioned in the middle portion of the SVC were prone to move upward 2 to 3 cm into the upper portion of the SVC, or the related feeder veins, due to movement of the associated neck or arm access sites or changing patient position from a supine to upright, and more subtly by changes in thoracic pressures (Chu et al., 2004; Schummer et al., 2004; Gallieni et al., 2008; Hackert et al., 2005; Kowalski et al., 1997; Lum, 2004; Sivasubramaniam and Hiremath, 2008; Stoneham, 2001; Wirsing et al., 2008; Forauuer and Alonzo, 2000). In addition, caustic and cytotoxic treatment agents were demonstrated to produce severe damage to the endothelial lining of feeder veins. Left sided access could result in chemical or mechanical damage to the SVC wall including perforation, if not corrected (Fuchs et al., 1999; Hackert et al., 2005; Puel et al., 1993; Stoneham, 2001; Vesely, 2003). Specific treatments (i.e. hemodialysis) and diagnostics (i.e. venous pressure measurements) may define where a catheter tip should be positioned, to maximize therapeutic value and minimize catheter-related complications (Starr and Cornicelli, 1986; Tan and Gibson, 2006; Gebhard et al., 2007). The confluence of the aforementioned issues “forced” the positioning of catheter tips into the lower third of the SVC and the upper portion of the RA (Kowalski et al., 1997; Lum, 2004; Tan and Gibson, 2006; Chu et al., 2004). Although use of the lower portion of the SVC appears to have satisfied many needs for the

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appropriate positioning of catheter tips, RA placement is still a major source of debate (Schummer et al., 2004; Vesely, 2003). A significant development in this contentious deliberation was the FDA’s 1989 position statement that no catheters should be placed within or allowed to enter the heart (McGee, 1993; Flectcher and Bodenham, 2000; Sivasubramaniam and Hiremath, 2008). Validation of Tip Placement The described scenario forces the question of how catheter tips can accurately and consistently be positioned within the lower third of the SVC and confirm that the heart has not been entered. Ultrasound: Technology has provided a foundation for accomplishing this task. Ultrasound (US) has revolutionized the ability to consistently locate and access a venous site (Kokotis, 2005; Schwengel et al., 2004; Gebhard et al., 2007; Tan and Gibson, 2006; Lyon, 2005). Several studies evaluating the effectiveness of ultrasound guidance technology used unguided percutaneous access as the control arm. Unsuccessful cannulation rates of over 40% were reported in this group, implying an access success rate of 60% or less compared to greater than 95% for ultrasound access guidance. High success rates create an accompanying reduction in the number of attempts, complications, and failures (Gallieni et al., 2008). Electro- and Echo-cardiography: The use of electrocardiograms (ECG/EKG) and trans-esophageal echocardiography (TEE) have been instrumental in developing guidance systems that can support the positioning of catheter tips (McGee, 1993; Chu et al., 2004; Starr and Cornicelli, 1986; Schummer et al., 2004; Pawlik et al., 2004; Jeon et al., 2006; Pittiruti et al., 2008; Madan, Shah, Alexander, Taylor and McMahon, 1994; Schummer et al., 2003; Flectcher and Bodenham, 2000; Gallieni et al., 2008; Wirsing et al., 2008). The use of the Landmark technique provided reasonable reliability in placing catheter tips within the feeder veins and the SVC but this is a relatively large target compared to the lower third of the SVC. The length of the SVC can vary from 5 cm to 11 cm (avg. 7 cm), not including the feeder veins (Jeon et al., 2006; Caruso et al., 2002; Vesely, 2003; Aslamy et al., 1998; Peres, 1990; Verhey et al., 2008). Dividing that into thirds creates a target size of 1.6 cm to 3.6 cm (0.64 in

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to 1.46 in) for the lower third of the SVC. Outside of the United States, landmarks are used for insertion with a 50% to 73% first attempt access success rate (Chu et al., 2004; Fuchs et al., 1999; Schummer et al., 2004; Pawlik et al., 2004; Jeon et al., 2006; Pittiruti et al., 2008; Madan et al., 1994; Schummer et al., 2003; Cadman et al., 2004; Flectcher and Bodenham, 2000; Gallieni et al., 2008; Hackert et al., 2005; Puel et al., 1993; Stoneham, 2001; Tan and Gibson, 2006; Lyon, 2005; Wirsing et al., 2008; Rutherford, Merryt and Occleshaw, 1994; Peres, 1990; Hockley et al., 2007; Amerasekera et al., 2009). This reduces the total number of “successful” placements that are placed within the venous system, diminishing the number of accurately placed catheter tips by 27% to 50% (Kokotis, 2005). Now consider a simple model depicting placement success rates of 75% - 90% using the entire SVC as the target. Assuming catheter tips can be placed anywhere within the SVC and still be considered a successful placement, obtaining a reasonable success rate of tip position is relatively easy. Studies using the blind landmark placement technique as a control group support this concept (Cadman et al., 2004; Lum, 2004; Peres, 1990). But what would happen to the success rate if we use only the lower third of the SVC to define a successful tip placement? Applying the above success rates and assuming an even distribution of catheter tips within the SVC, the number of successful catheter tip placements drops to 25% -30% (one third of the total tips within the SVC). Achieving a successful placement rate of 75% - 90% within the lower third of the SVC requires an additional 50% - 60% of the total number of tips, originally placed throughout the SVC, to be positioned within the margins of the lower third of the SVC. That represents a requirement for a 300% increase in positioning accuracy. In addition, precision must be improved in order to reduce the relative scatter of the catheter tip placements within the SVC. Targeting the lower third of the SVC requires an accuracy of +/- 0.8 cm to +/- 1.8 cm with a precision that will allow repeatable positioning of 85% to 98% proficiency (Kokotis, 2005). This is a significant and challenging departure from targeting the entire length of the SVC, an average of 7 cm. A real example of the above model is summarized in Table 2

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(Cadman et al., 2004). All catheters were positioned at bedside, using the landmark method only. No image guidance technology was used. Post insertion CXRs were used to confirm tip location. Tip positions were identified and categorized into location groups. The number of tips and percent of total tips were recorded for each location group. This information was then combined to provide a sequential set of values (number of catheters and percent of total placed catheters) for a diminishing set of pooled location groups represented as histograms. As the histograms proceed to the right, fewer groups are included and the corresponding percent of “successful” placements (indicated at the top of each histogram) diminish. This proceeds until the final two groups, the lower third of the SVC and the SVC-RA junction are represented as the target set for successful catheter tip placement. This sequence of data groups supports the above discussion related to the size of the target for catheter placement and the percent of successful catheter placements. As the choices of tip placement locations diminish, the success rate decreases. Including all of the SVC and the SVC-RA junction provides a respectable 76% success rate for catheter placement. Reducing the target region to just the lower third of the SVC resulted in a 31% placement success rate, while adding the SVC-RA to the lower third of the SVC provided a 40% placement success rate. If the target here was the group combination of the middle and lower thirds of the SVC, representing 60% of all the catheter placements, then the accuracy and precision associated with the landmark technique used in this study requires adjustments to capture a significant portion of the “lost” 40% of misplaced catheter tips. Accuracy reflects the degree of proximity to a designated placement target position. Precision reflects the degree of reproducibility of accomplishing the proximity value. The example presented in Table 2 provides some insight into 15 years of evolving changes in the definition of the “target” used to characterize an “appropriately” placed central line, and the challenge of accurately placing a catheter tip within this newly defined, confined and restricted location. However, by defining accuracy and precision requirements, a foundation has been provided for appreciating how much more difficult it is to “properly” place a catheter tip when considering the evolution of transitioning from the entire SVC and its feeder veins to the lower third of the SVC as a target. Although the landmark process of positioning catheter tips appears to represent the past when compared to the development of ultrasound and ECG applications for access and placement, it should not be overlooked that since the 1970s this technique has been applied, modified, and continues to be refined for better accuracy and precision. Independent of the landmark technique’s ability to place catheters within the SVC, it has contributed to lowering their placement within the heart. Additionally, observations on post-placement catheter movement suggest that placing catheters more proximal may reduce secondary malpositioning within the heart due to movements of the head and upper extremities (Lum, 2004; Forauuer and Alonzo, 2000). Positioning Analysis Results The results summarized in Table 1 represent a mix of direct (unmodified) and extrapolated (modified) data. Independent

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analysis of the five studies containing the direct data indicates a 50.28% (range 42% - 53%, n=148) proficiency rate in the accurate position of a catheter tip within the distal third of the SVC or cavo-atrial junction (Lum, 2004; Chu et al., 2004; McGee, 1993; Hockley et al., 2007). Independent analysis of the four studies containing the extrapolated data indicates a 45.14% (range 39% - 75%, n=894) proficiency rate in accurate placement (Cadman et al., 2004; Neuman, Murphy and Rosen, 1998; Gebhard et al., 2007; Trerotola et al., 2007). Eliminating the largest study from the extrapolated data (n=622) results in a proficiency rate of 51.60% (range 39% - 75%, n=420). Although the remaining sample size for the extrapolated data is 184% larger than that for the direct data, the difference does not skew the results extensively from the direct data proficiency rate (51.60% extrapolated and direct vs. 50.28% direct) and diminishes the argument that the modified data artificially created a significantly different proficiency value than expected for the landmark technique. The results support the argument that the landmark method is errorprone due to misjudgment or miscalculation of the landmarks, resulting in catheter lengths that position the tips too high in the SVC or beyond the SVC into the RA (Lum, 2004; Peres, 1990). Although landmark measurements can be relatively accurate, adding simple averages of vessel lengths to calculate catheter length are only close estimates. Measurements must be tailored to the patient’s height and the catheter insertion site. Even then, a first attempt placement accuracy rate of 96% to 100% is dependent upon placing a catheter tip within the distal half of the SVC, not the lower third of the SVC (Lum, 2004). Evaluating the proficiency of the tailored placements and considering targeting only the lower third of the SVC and the CAJ, the above tailored measurement results in a 55% (197/359) accuracy rate. If this outcome represents the state of the art in landmark placement, the results from the literature review look very reasonable and support the need for improvements in positioning techniques. Guidance Technology These conclusions bring us back to technology driven guidance and the use of electrocardiogram (ECG/EKG) signals to provide the accuracy and precision necessary to consistently position catheter tips within the lower third of the SVC. The signals represent the depolarization and repolarization of the heart’s electrical currents. A classic ECG depicts these currents in time and location as they pass through the atria and ventricles. The P wave represents the depolarization from the sino-atrial node (SA node) and within the atria. Since the SA node is located near the CAJ in the posterior wall of the right atrium, the P wave acts like a beacon and can be used to guide a catheter tip, containing an internal electrode, towards the CAJ region. Changes in the shape and size of the P wave provide feedback about the relative position of the catheter tip as it passes from the access vein, enters the SVC and approaches the CAJ or enters the right atrium (Jeon et al., 2006; Schummer et al., 2004; Pawlik et al., 2004; Schummer et al., 2003; McGee, 1993; Madan et al., 1994; Chu et al., 2004; Starr and Cornicelli, 1986). Issues remain with this technique that may limit its usefulness in certain catheter guidance applications. Pacemakers, atrial fibrillation or supra-ventricular arrhythmias will interfere

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with the interpretation of the P wave (Pittiruti et al., 2008). When using a saline or fluid filled catheter as an intra-intracavity electrode, the amplitude of the P wave may be lower (less sensitive) than a catheter equipped with a wire conductor (Pawlik et al., 2004; Pittiruti et al., 2008; Gebhard et al., 2007). The technology may indicate if the tip is located within the atrium, but does not reveal where it is within the venous system (Flectcher and Bodenham, 2000). ECG based guidance, a widely accepted positioning technique for catheters in Europe, is not widely used in the US (Schummer et al., 2004; Pawlik et al., 2004; Schummer et al., 2003; McGee, 1993, Madan et al., 1994; Chu et al., 2004; Starr and Cornicelli, 1986). With experience and attention to the variations in the P wave it is possible to avoid positioning within the RA while accurately placing catheter tips in the lower SVC/CAJ (Jeon et al., 2006; Pittiruti et al., 2008). The full advantage of using these systems is the potential to reduce the need for post-placement CXRs to confirm catheter tip position as well as to avoid the need for repositioning and the corresponding confirmatory CXR. A significant user advantage is the potential to perform at a much higher level of efficacy with less experience so long as the operator’s ECG assessment is proficient. This can be important for patient safety, because the operator can perform placement procedures at a high level of proficiency without having to acquire the “50 practice placements” necessary to achieve consistently successful catheter tip placements with minimal risks (Gallieni et al., 2008). The procedure is easy to perform, and the knowledge is easy to assimilate (Pittiruti et al., 2008). Confirmation of Catheter Tip Position Conventional Radiography: Traditionally anterior/posterior or posterior/anterior chest radiographs have been used to determine the position of a central venous catheter tip (Pittiruti et al., 2008; Hackert et al., 2005; Vesely, 2003; Wirsing et al., 2008). When the placement target included the entire length of the SVC these radiographs may have been adequate, but after the target changed to a much smaller region (i.e. the lower third of the SVC/CAJ), the determination of catheter tip position became compromised by the lack of defined visible borders delineating the SVC/CAJ. Imprecise soft tissue imaging resulted in inter-observer inconsistency (Vesely, 2003; Wirsing et al., 2008). Efforts to rectify this resulted in defining the upper and lower boundaries of the SVC in terms of identifiable radiographic anatomical landmarks such as the clavicle, the fifth and sixth thoracic vertebrae, and the intersection of the right lateral wall of the SVC and the right lateral border of the cardiac silhouette, defined by the right atrium (Chu et al., 2004; Schwarz et al., 2000; Tan and Gibson, 2006; Peres, 1990; Verhey et al., 2008). These skeletal structures are not in the same anatomical plane as the SVC, resulting in a parallax effect on the radiographic image that can lead to significant errors in tip position validation (20%-47% incorrect intra-atrial classification of catheter tips) (Lum, 2004; Vesely, 2003; Wirsing et al., 2008; Aslamy et al., 1998). In addition, use of multiplanar magnetic resonance imaging suggested that the SVC and cardiac intersection silhouette, used to define the CAJ, are not reliable landmarks (Wirsing et al., 2008). In 38% of patients,

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the superior right heart border was created by the lateral border of the left atrium, not the right atrium In such circumstances the actual CAJ was located 1.0 cm (range: 0.5 cm – 4.5 cm) caudal (inferior) to the right superior heart border. This would have the effect of making catheter tips positioned within the cardiac silhouette appear to be located within the upper right atrium when they were actually placed in the lower third of the SVC above the CAJ (Vesely, 2003; Aslamy et al., 1998). In order to make the CXR more reliable, the right tracheobronchial angle was selected as an alternative radiographic landmark defining the upper and lower boundaries of the SVC (Aslamy et al., 1998; Rutherford et al., 1994). This selection was later replaced by the carina because this structure can be identified more easily (32% vs. 96% respectively). The use of the vertical distance from a catheter tip to the carina was developed to reduce variations in radiologist interpretations of radiographic markers when identifying post insertion tip positions. The catheter tip distance to the carina is an easy to use method and has specificity equal to that of an experienced radiologist (Wirsing et al., 2008); Pittiruti et al., 2008). Unfortunately variations in results have complicated the use of the carina as a standard reference point (Vesely, 2003). Without better landmarks or other confirmations of radiological anatomy the accurate assessment of catheter tip position will continue to be compromised (Aslamy et al., 1998; Rutherford et al., 1994; Peres, 1990; Caruso et al., 2002; Flectcher and Bodenham, 2000; Pittiruti et al., 2008;). Contrast-Enhanced Computed Tomographic Scans: A 2008 study used intravenous contrast-enhanced computed tomographic scans (eCT) and scout tomographic scans of the thorax to critically identify and measure the mediastinal contents, focusing on the composition of the right mediastinal border (Verhey et al., 2008). What was thought to be the lateral border of the left atrium was confirmed as the right atrial appendage (RAA) and represents the most superior right cardiac border-forming structure, with the CAJ located below this structure. Accurate distances from the carina to the CAJ provide renewed value in the use of radiographic landmarks that can be used to validate the position of a catheter. Combination Techniques: To control for the limitations related to the use of CXRs in validating the position of catheter tips, the use of TEE has been used in many clinical studies evaluating the effectiveness of ECG assisted positioning of catheter tips. The ultrasound probe located within the esophagus can provide clearer images of the surrounding cardiac and vascular anatomy, while eliminating the parallax and false silhouette distortions that can compromise CXR results used to validate the position of catheter tips after placement in a targeted location (Chu et al., 2004; Jeon et al., 2006; Wirsing et al., 2008). Although useful for clinical studies, the invasiveness, the presence of gastric or esophageal pathology, and the impractically of TEE at bedside, limit its usefulness in replacing CXRs as the current standard used to confirm catheter tip position (Wirsing et al., 2008). An increase in research using the carina as a critical landmark for placing catheters may renew interest in using this approach to further improve the accuracy of CXRs (Pittiruti et al., 2008; Wirsing et al., 2008 Lum, 2004; Kowalski et al., 1997). More recent publications are focused on the carina as a marker for the loca-

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tion of the pericardial reflection associated with the heart and the SVC (Schummer et al., 2004; Caruso et al., 2002; Schummer et al., 2004; Flectcher and Bodenham, 2000; Sivasubramaniam and Hiremath, 2008; Tan and Gibson, 2006). Applying this to catheter placement, in an effort to minimize cardiac tamponade and misplacement within the heart, it is thought that catheter tips placed above the carina would not pose a risk. More refined uses of the carina, including the relative location of the CAJ are also being explored. There is some evidence that the carina is positioned within a distance of about 5.5 cm from the CAJ (more precisely the crista terminalis, which is just below this). Recent studies using eCT and scout tomograms support this measurement (4.7 cm (2.5 – 7.2 cm) +/- 1.1 cm). Since the carina is centrally located, the parallax issues associated with other anatomical radiological landmarks (i.e. vertebrae, ribs, intercostals spaces) are eliminated. It may therefore provide a more accurate landmark for confirming the post-placement position of catheter tips on CXRs. The use of the carina, in conjunction with the crista terminalis, to establish the distance between these two structures, provides a significant measurement interval to confirm the location of a catheter tip within the lower third of the SVC or RA (Wirsing et al., 2008; Verhey et al., 2008). The use of this procedure provides a tool that avoids catheter tip placement in the atrium with the accuracy (93%) of an experienced radiologist. Variables that need to be evaluated include: (1) placing tips above the carina that may result in a mid level or high location within the SVC, resulting in increased complications of thrombosis or migration and; (2) identifying the variables affecting the location of the carina relative to the SVC. Both structures have dynamic ranges of length which may be independent of each other. These need to be evaluated for their effect on the accuracy and precision of using this landmark to determine the location of the CAJ. The use of ECG is a potential replacement for CXRs, but is currently limited to determining if a catheter tip is in the atrium and unable to identify its position within the SVC or feeder veins (Flectcher and Bodenham, 2000). Additional evaluation of the P wave and its characteristics, relative to a catheter’s position within the SVC, may provide information that can be useful in accurately positioning catheter tips at any specific location. Secondary Malposition: There is another driver challenging the use of ECG technology and our selection of the optimal location to place catheter tips at the currently accepted placement target in the lower third of the SVC/CAJ. This driver is the issue of secondary malposition of catheter tips resulting from movements of the upper extremities, head and neck changes in patient posture (supine to upright), and deep breathing. These movements can displace catheter tips cranially or caudally as much as 3-4 cm or 2-3 cm respectively (Chu et al., 2004; Pawlik et al., 2004; McGee, 1993; Sivasubramaniam and Hiremath, 2008). This movement can influence the catheter tip position as it relates to the heart, the upper SVC, and the left brachiocephalic-SVC junction (left brachiocephalic-SVCJ). The new “ideal” location has been defined as “central to the CAJ, at a distance, within the SVC, that will not allow migration into the RA with arm movement (Neuman et al., 1998). Although catheter tips entrance into the RA is a serious potential issue, movement cranially into the upper SVC or feeder veins is also problematic because it can

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result in thrombus formation or severe endothelial damage to feeder veins. Mechanical or chemical damage may develop at the left brachiocephalic-SVC junction due to the creation of a sharp angle between the catheter tip and the wall of the SVC. Repositioning may be required if initial placement is high in the SVC, and will include adjusting the catheter at the insertion site and follow-up with a confirmatory CXR (Vesely, 2003). Positioning a catheter tip at the CAJ or the lower third of the SVC with the arm abducted may cause the tip to become malpositioned within the RA following adduction of the access arm. Positioning with the arm adducted should move the catheter tip to a more cranial position within the SVC compared to when the arm is abducted, but could also cause it to enter the upper SVC or feeder veins including the left brachiocephalicSVC junction. It is possible that a correctly placed catheter tip may travel 2 cm to 3 cm or more within the SVC and upper RA. Therefore it seems logical to place the tip at a position similar to the “new ideal” location described above (Vesely, 2003). This positioning will require a new set of demands for accuracy and precision in the placement of catheter tips. Simply backing off an average distance from the CAJ may not satisfy all patients’ requirements. The average length of the SVC is ~ 7 cm, but can vary from 5 cm to 11 cm (Verhey et al., 2008). The clinician will not only need to know if the catheter tip is within the heart or not, but also where the SVC begins. By understanding the dimensions of the individual patient’s SVC a proper offset can be determined that will satisfy the requirements of minimizing entering the RA or upper SVC or feeder veins while remaining within the SVC. The real challenge will be applying these limits to the smaller than average SVC length, which may be smaller than the range of “passive” catheter movements. Quantification of Resources No matter how well technology may improve our ability to provide better healthcare, one of the most critical factors contributing to unusually high central venous catheter complication rates and unsuccessful catheter tip placement is the training and level of experience of the team members performing these procedures (40% for less experienced operators vs. 5% for more experience operators) (Tan and Gibson, 2006; Schwengel et al., 2004; Wirsing et al., 2008; Puel et al., 1993; Scott, 1988). In a 2year multi-center clinical trial totaling 905 catheter placements, thirteen clinicians placed 10 or fewer catheters each, totaling 59 placements, while ten clinicians placed 12 to 282 central lines each, totaling 846 placements. Results confirmed that catheter tip position and clinician insertion volume were the only independent covariates with multivariate significance (Schwarz et al., 2000). The insertion of a catheter by a clinician who had performed fifty or more catheterizations was half as likely to result in mechanical complications as one inserted by a clinician who had performed fewer than fifty procedures (Gallieni et al., 2008). Best Practices The combined results of the reviewed papers generated a litany of approaches that clinicians can incorporate into their work routines to improve the efficiency, efficacy and economics of the services they provide. A brief summary of the key

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points discussed are presented in Table 3. Evolving Definition of Best Practices This literature review of catheter tip placements illustrates that the definition of adequate catheter tip placement has evolved over time to define an increasingly narrow target area. For most uses, the ideal catheter tip location should be in the distal third of the superior vena cava near the cavo-atrial junction. Bedside placement of CVCs, including PICCs, has required a post-placement chest radiograph to confirm catheter tip location. Even the chest radiograph, however, has been problematic in the consistent identification of catheter tip location as is evidenced by inter-reader discrepancies and interpretation differences, depending upon which anatomic landmarks in the chest radiograph are utilized. Other conundrums in using the chest radiograph include the difficulty in interpreting catheter tip location when superimposed over other structures in the chest such as other CVCs, pacemaker or AICD wires, Harrington rods, et cetera, and patient conditions such as morbid obesity or “wet lungs.” Landmark estimates have been just that: estimates of where the catheter tip is located based on external anatomical landmarks. However, such estimates lack any precision concerning the actual location of the CAJ, and may require adjustments post-placement. Catheter tip guidance technologies such as electromagnetic technologies (Sherlock TLS; Bard Access Systems; Navigator; Corpak) have greatly reduced initial catheter tip malpositioning, but are not specific enough to place the catheter tip accurately in the region of the CAJ. The evolving definition of the ideal catheter tip location has driven the development of novel technologies to aid the bedside clinician to target a more narrowly defined zone with increasing accuracy. Technologies based on internal physiologic parameters will individualize this need for accuracy, and may redefine the CAJ versus the ill-defined anatomic parameters of the chest radiograph. Technology that can accurately identify the location of catheter tips at the time of placement will provide numerous benefits for both the clinician and the patient. The ability to “release” the catheter for use to the bedside nurse at the time of insertion with a very high degree of confidence of having hit the targeted area (lower third of the SVC/CAJ) will avoid the most common complication, venous thrombosis. References Amerasekera, S., Jones, C., Patel, J., & Cleasby, M. (2009). Imaging of the complications of peripherally inserted central venous catheters. Clinical Radiology, 64, 832-840. Aslamy, Z., Dewald, C., & Heffner, J. (1998). MRI of central venous anatomy. Chest, 114, 820-826. Board of Directors of the National Association of Vascular Access Networks. (1998). Tip location of peripherally inserted central catheters. JVAD, summer, 2-4. Broviac,JW, Cole JJ, Scribner BH (April 1973). “A silicone rubber atrial catheter for prolonged parenteral alimentation”. Surg Gynecol Obstet, 136 (4), 602–6. PMID 4632149. Cadman, A., Lawrance, J., Fitzsimmons, L., Spencer-Shaw, A., & Swindell, R. (2004). To clot or not to clot? That is the question in central venous catheters. Clinical Radiology 59,

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349–355. Caruso, L., Gravenstein, N., Layon, A., Peters, K., & Gabrielli, A. (2002). A better landmark for positioning a central venous catheter. J Clin Monit Comput., 17(6), 331-4. Chu, K.-S., Hsu, J.-H., Wang, S.-S., Tang, C.-S., Cheng, K.I., Wang, C.-K., & Wu, J. (2004). Accurate central venous port-a catheter placement: intravenous electrocardiography and surface landmark techniques compared by using transesophageal echocardiography. Anesth Analg, 98(4), 910-4. Flectcher, S., & Bodenham, A. (2000). Safe placement of central venous catheters: where should the tip of the catheter lie? Editorial II, British Journal of Anaesthesia, 85(2), 188-191. Forauuer, A., & Alonzo, M. (2000). Change in peripherally inserted central catheter tip position with abduction and adduction of the upper extremity. JVIR, 11, 1315-1318. Fuchs, S., Pollak, A., & Gilon, D. (1999). Central venous catheter mechanical irritation of the right atrial free wall: a cause for thrombus formation. Cardiology, 91, 169–172. Gallieni, M., Pittiruti, & M., Biffi, R. (2008). Vascular access in oncology patients. CA Cancer J Clin, 58, 323-346. Gebhard, R., Szmuk, P., Pivalizza, E., Melnikov, V., Vogt, C., & Warters, R. (2007). The accuracy of electrocardiogram-controlled central line placement. Anesth Analg, 104(1), 65–70. Hackert, T., Tjaden, C., Kraft, A., Sido, B., Dienemann, H., & Buchler, M. (2005). Case report: Intrapulmonal dislocation of a totally implantable venous access device. World Journal of Surgical Oncology, 3, 19.

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