Sherlock 3CG® Tip Confirmation System for Placement of Peripherally Inserted Central Catheters: A NICE Medical Technology Guidance

Abstract

In current clinical practice, peripherally inserted central catheters (PICCs) are typically inserted using external anatomical measurements and a confirmatory chest X-ray, or using fluoroscopy. The Sherlock 3CG® Tip Confirmation System (TCS) allows magnetic tracking of the PICC tip during insertion and confirmation of the final location using ECG, meaning that most patients will not require a chest X-ray or fluoroscopy. The Sherlock 3CG® TCS was evaluated in 2014 by the UK National Institute for Health and Care Excellence (NICE) as part of the Medical Technologies Evaluation Programme. The company (C.R. Bard Ltd) identified four abstracts, one paper pending publication and questionnaire data from NHS users of the Sherlock 3CG® TCS. None of the evidence included a comparator arm. Placement accuracy of PICCs using the Sherlock 3CG® TCS where a chest X-ray was also used ranged from 79.5 to 100 %. The company reported that 9 out of 16 NHS centres that used the Sherlock 3CG® TCS were no longer using chest X-rays to routinely confirm PICC tip location. The evidence did not report the need for catheter repositioning, re-insertion, staff time savings, treatment delays, length of stay, quality of life outcomes or complications. The company’s model found that the Sherlock 3CG® TCS was cost saving by GBP25.67 per patient compared to blind bedside PICC insertion. The External Assessment Centre (EAC) adapted the company’s model to test alternative assumptions for nurse time, theatre cost, malposition rate and reinsertion method, and found that the Sherlock 3CG® TCS was cost incurring by GBP9.37 per patient compared to blind bedside PICC insertion. The use of the Sherlock 3CG® TCS in the UK NHS compared to blind PICC insertion using a confirmatory chest X-ray appears to hover around being cost neutral. Staff time and accuracy were key drivers in the model: evidence for these is sparse and the reality will vary in different situations. If evidence became available for outcomes after the initial insertion, such as replacement, complications and adverse events, the cost implications may change. The direction of this potential change is not known. NICE published guidance MTG24 in March 2015 recommending that the case for adoption of Sherlock 3CG® TCS was supported by the evidence.

Accuracy of Intravenous Electrocardiography Confirmation of Peripherally Inserted Central Catheter for Parenteral Nutrition

“…Tip confirmation is performed via fluoroscopy during placement or CXR postplacement. The time required to obtain CXR and for it to be read by a radiologist can add significant delay in utilization of CVC along with the additional cost 18 . Intravascular ECG tip confirmation technology has emerged as a possible answer, allowing tip confirmation to occur at the time of placement bedside.…”

“…Due to these concerns, intravascular electrocardiography (ECG) has been developed to confirm tip position at the time of placement and is in use at a number of medical centers 18 , 19 . This technology allows for the tip to be advanced until the point of maximum p wave, which is felt to correspond to the cavoatrial junction 15 .…”

Evidence‐Based Strategies and Recommendations for Preservation of Central Venous Access in Children

“…High‐quality fluoroscopy is essential for control of central venous guide wire and catheter positioning . Alternative tracking technologies for tip positioning (eg, electrocardiographic and electromagnetic) are promising but have not yet been objectively validated . Transthoracic echocardiography has been suggested to determine catheter tip position, but randomized, controlled trials (RCT) have not been published and expertise with the technique and equipment is not widely available .…”

Clinical evaluation of the use of an intracardiac electrocardiogram to guide the tip positioning of peripherally inserted central catheters

“…The use of peripherally inserted central catheters (PICCs) for central venous access has increased in recent years. In addition to providing long‐term access route for infusions, blood tests and drug delivery, PICCs can also be used to measure circulatory or heart function, and to deliver contrast medium for cardiac imaging . PICCs have been highly recommended in critically ill patients, and their placement may be included within an extended scope of nursing practice .…”

“…In the last few decades, many techniques have been developed to control PICC tip position, such as chest radiography, ultrasound and fluoroscopy . Chest radiography is the traditional method, and had been regarded as the ‘gold standard’ for the assessment of catheter position . However, the efficiency of radiographic assessment can be low, and patients are subjected to repeated radiation exposure, particularly in cases of ectopic positioning .…”