8th World Congress on Vascular Access 2024

Real World Evidence Study of a New ECG-Guided Tip Positioning Device for Central Venous Catheter Placement

Amy Bardin, EdD, EMBA, RRT, FAARC, VA-BC; Thomas Philbeck, PhD, MBA Nick Potochick, MS; John McDonald, PhD Teleflex Incorporated Clinical & Medical Affairs

Background and Objectives

The Arrow VPS Rhythm DLX with Tip Tracker Technology is indicated for the positioning of central venous access devices as, including peripherally-inserted central catheters (PICCs) an alternative to chest X-ray/fluoroscopy for confirmation of catheter tip placement in adults. Introduced in 2022, a retrospective study was performed to collect real-world evidence to substantiate performance and safety of the device.

Methods and Materials

•Primary endpoint was the success rate for catheter tip location (proportion of cases in which the catheter was successfully placed using the patient’s ECG p-wave).

•Secondary endpoint was the rate of device related adverse events.

•Study protocol was reviewed by a central IRB and determined to be exempt from consent/continued review.

•The study was conducted in US by clinicians who had used the device.

Results

•Investigators at two sites collected data for 85 cases

•In most cases (56.5%), the patients were male and 87.1% were >55 years old.

•In 65 (76.4%) and 20 (23.5%) cases, the NaviCurve and the VPS TipTracker stylets were used, respectively

•All PICCs placed and ready to use between 5 and 30 minutes after initiation of placement procedure

•In 100% of qualifying cases, catheter tip navigation and placement confirmation were successful

•No malpositioned catheters; no adverse events.

Conclusions

•In first study describing Arrow VPS Rhythm DLX, the device showed positive outcomes regarding performance and safety.

•Device performed as intended with a high level of success and no adverse events

•For all patients who qualified for ECG guided insertion, the device consistently facilitated successful placement of a PICC, determined by the ECG P-wave deflection

•Demonstrated ability to safely place PICCs at the bedside and immediate use of the catheter other advantages

•Avoided X-ray exposure and the associated time and costs

•Study confirmed general safety and performance of the device

8th World Congress on Vascular Access 2024

Real world evidence study of a new ECG-guided tip positioning device for central venous catheter placement

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