Finding solutions in PICC-related thrombosis
David Hahn, M.D.
The origination of the central venous catheter technique is attributed to Werner Forrsmann in 1929, who won a Nobel Prize for Medicine in 1956 for his idea of delivering a drug directly into the heart during emergency surgery.[i] Intravenous access is vital to the care of any patient, and many require long-term delivery of medicine to the larger central veins.
Peripherally Inserted Central Venous Catheters (PICCs) are indispensible to medical treatments such as chemotherapy, bone marrow transplantation, dialysis and parenteral nutrition, driving technology to constantly produce better central venous access and address the two most common problems: infection and thrombosis. These can be especially troublesome in a long-term care environment.
Deep Venous Thrombosis and Catheter-related Thrombosis
The prevalence of Deep Venous Thrombosis (DVT) remains elusive, but there are estimated to be between 130,000 and 550,000 cases per year in the United States, with 4% of all cases being upper extremity DVT.[ii] Recent placement of a central venous catheter increases the risk of upper extremity DVT by 5- to 7-fold.[iii] Occlusion is the most common noninfectious complication in the long-term use of central venous catheters[iv], with data showing that it occurs in up to 25% of patients with catheters.[v] However, lack of consistent diagnostic techniques, low rates of autopsy and other factors have led to the belief that this number is greatly underestimated. Moreover, pulmonary embolism is present in up to one third of patients with upper-extremity DVT.[vi]
When a blood clot develops around a catheter or inside the vein, multiple problems ensue. Peri-catheter thrombus, or thrombus around the catheter, can cause inflammation in the vein, impact drainage of the arm and result in a painful, swollen limb. Thrombus within the catheter clogs the line, necessitating instillation of clot dissolving medicines or even and exchange of the catheter causing delay in treatment. Occasionally, the line may need to be removed altogether. Disabling and devastating effects such as persistent upper-extremity pain and swelling and superior vena cava syndrome are added the risks and complications from the blood clot itself and the necessary anticoagulants.
The risk factors associated with central venous catheter-related thrombosis are varied. Increased risks can be related to techniques such as: large diameter catheters, larger number of catheter lumens, catheter tip malposition, multiple attempts at insertion, left-sided placement or subclavian vein insertion. Patient conditions that may increase risk of thrombosis include cancer, prolonged surgery, previous history of DVT, hypercoagulable states, and existing upper extremity DVT. Even certain treatment agents such as L-asparaginase, estrogen or progesterone, recombitant human interleukin-2, granulocyte-macrophage CSF or thalidomide may increase risk of catheter-related thrombis.[vii]
Upper-extremity DVT has become more common over the last several decades in proportion to the increase in use of PICCs, and companies are responding with advances in technology. PICCs have evolved over time to be smaller, thinner plastics that allow increased flow rates and are made of better materials. Newer PICCs occupy less space in the vein, which is directly linked to thrombus, and allow longer dwell times. The newest generation of products addresses infection and upper extremity DVT.
Recently, the US Food and Drug Administration granted 510(k) clearance to Navilyst Medical Inc., an AngioDynamics company, for the BioFlo PICC*, which uses Endexo Technology to minimize the accumulation of blood components such as thrombus on the catheter interior and outer surfaces. This proprietary, permanent and non-eluting polymer is integrated directly into the base polyurethane and present throughout the outer and inner surfaces of the catheter, including the cut tip.
In-vitro blood loop model test results show that on average, the BioFlo PICC has 87% less thrombus accumulation on its surface compared to commonly used PICCS based on platelet count.[viii] This is based on benchtop test results, which may not be indicative of clinical results. Side-by-side in vivo tests demonstrate that the BioFlo's thrombo-resistant characteristics are substantially equivalent to heparin-coated vascular access catheters. In addition, it does not contain any agents that may be associated with bacterial resistance such as antibiotics or antimicrobials.
The cost to the patient and hospital for upper extremity DVT as a result of a PICC is significant. DVT and all of the surrounding complications can lengthen hospitals stays by up to a week in order to diagnose the pathology, replace the PICC line, start blood thinners and then stabilize the patient on pills. The estimated cost of hospital-acquired DVT in the US is between $5 and $26.5 billion dollars,[ix] with an estimated average cost of $11,957 per incident.[x] Healthcare reform makes reduction of costs a priority. Medicare is poised to begin pushing back on hospitals and denying reimbursement for stays that are considered longer than standard duration.
Everything that a clinician does is aimed to eliminate treatment-related complications. When a patient needs a PICC and develops a complication, it adds unnecessary complexity to an already ill patient. There is more risk, inconvenience to the patient and family, and increased medical costs. Long-term care nurses are well acquainted with the issues of flushing PICC lines and dealing with patients on blood thinners and long-term antibiotics. Creating secondary problems is of no service to anyone.
Moreover, there is a lot of confusion in terms of diagnosing and treating DVT, in part due to the wide range of patients that it impacts. Varied patient profiles make it difficult to develop consistent treatment protocols. Prevention is always preferable to treatment and ideally, we will minimize the incidence of DVT rather than try to find a way to deal with the problem. New technologies in PICC lines are a major step forward in this endeavor.
*“The BioFlo PICC is cleared by the FDA for short- or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to the administration of fluids, medications and nutrients, the sampling of blood and for power injection of contrast media.”
[i] Central Venous Catheters (Wiley Series in Nursing) Andy Bodenham (Author), Helen Hamilton (Editor). Wiley-Blackwell, 2009.
[ii] Anderson FA Jr, Wheeler HB, Goldberg RJ, et al. A population-based perspective of the hospital incidence and case- fatality rates of deep vein thrombosis and pulmonary embolism. The Worcester DVT Study. Arch Intern Med. 1991;151:933-938.
[iii] Heit JA, et al. Risk Factors for Deep Vein thrombosis and Pulmonary Embolism: A Population-Based Case-Control Study. Arch Intern Med. 2000;160(6):809-815.
[iv] McKnight S. Medsurg Nurs 2004;13(6):377-382.
[v] Stephens LC, Haire WD, Kotulak GD. J Parenter Enteral Nutr 1995;19(1):75-79.
[vi] Joffe HV, Goldhaber SZ. Upper-Extremity Deep Vein Thrombosis. Circulation. 2002; 106: 1874-1880.
[vii] Linenberger ML. Catheter-Related thrombosis: Risks, Diagnosis, and Management. J Natl Comp Canc Netw 2006;4:889-901.
[viii] Data on file. AngioDynamics, Latham, NY.
[ix] Mahan CE, et al. Deep-vein thrombosis: A United States cost model for a preventable and costly adverse event. Thrombosis and Haemostasis 2011: 106(3);405-415.
[x] Lissovoy Gd, et al. Cost for Inpatient Care of Venous Thrombosis. Arch Intern Med. 2000;160:3160-3165.