Original Title: Inserción de catéter central de inserción periférica con reservorio (PICC-port) en pacientes diagnosticados con tumores sólidos y hematológicos con indicación de quimioterapia

Authors' objectives: The objective of this report is to evaluate the effectiveness, safety, economic impact, cost-effectiveness and organizational implications of the use of PICC line insertion systems with ECG-IC catheter tip navigation and confirmation (VPS Rhythm® with TipTracker™ technology, Sherlock 3CG™ TCS, Nautilus Delta™ TCS and PICC Tip Positioning Aid).

Authors' results and conclusions: After conducting an exhaustive literature search, 558 records were located for reading the title and abstract. From these records, 61 articles were selected for full-text reading. Finally, 8 studies were included, 5 of which evaluated insertion with the Sherlock 3CG™ TCS device versus fluoroscopically guided or blind insertion with CXR verification. One study compared the Sherlock 3CG™ TCS versus Nautilus (without navigation). No studies were found that studied the VPS Rhythm® device with TipTracker™ technology, the Nautilus Delta™ TCS device or the PICC Tip Positioning Aid. Of the included studies on PICC insertion with the Sherlock 3CG™ TCS device, 6 were observational (two single cohort and four cohort with comparison group). The remaining two studies, one had a crosssectional design and one was a randomized clinical trial. Six of the studies provided safety results. Two of these studies reported no complications during insertion. The percentage of complications or adverse effects originating as a result of insertion of the Sherlock 3CG™ TCS device in the remaining four studies ranged from 0.60% to 12.00%. The complications analyzed were: bleeding (0.60%-8.10%), infection (2.00%-3.80%), thrombosis (0%-2.55%), pain (8.10%), bacteremia (1.09%), fever (3.64%), phlebitis (0.36%), skin injury (2.91%), allergic reaction (2.90%) and nerve damage (no case reported). In one of the studies they observed that 1.90% of cases in which the Sherlock 3CG™ TCS device was used for insertion suffered bloodstream infections versus 4.90% when fluoroscopy was used for PICC line tip testing. Thus, the relative risk (RR) of bloodstream infection when using the Sherlock 3CG™ TCS device for insertion was 0.40 (95%CI 0.08-1.80). In another of the studies the RRs associated with the occurrence of complications when using the Sherlock 3CG™ TCS device compared to insertion by fluoroscopy were 0.60 (95%CI 0.30-1.50) for bleeding, 0.70 (95%CI 0.30-1.60) for pain, 1.00 (95%CI 0.10-7.20) for infection and 0.09 (95%CI 0.00-1.66) for allergic reaction. In another study they reported one case of bleeding (0.6%) in the group in which insertion was performed with the Sherlock 3CG™ TCS device, while no case of bleeding was found in the group in which tip verification with CXR was employed. Thus, the RR of bleeding was 3.30 (95%CI 0.14-80.46). In another study they found that using a combination of the blind technique with CXR and the Sherlock 3CG™ TCS device compared to only using the Sherlock 3CG™ TCS device increased the probability of complications by 3.28 times (95%CI 1.19-9.02). Of the 8 studies included in this review, catheter tip malposition was assessed in 6. Of these 6 total studies, 3 cohort studies assessed catheter tip malposition with the Sherlock 3CG™ TCS device versus CXR. The RR of malposition was 0.11 (95%CI 0.01-0.85). Although, the heterogeneity is substantial (I2 = 84,00%). Two studies evaluated the success of the procedure versus insertion by fluoroscopy. In one of the studies they observed non-correct catheter co-positioning in 1,00% of cases when using fluoroscopy as the tip checking technique, while this percentage was 17.70% when using the Sherlock 3CG™ TCS device. Thus, the risk of malposition when using the Sherlock 3CG™ TCS device was 18.35 (95%CI 2.49-134.94). In another of the studies they observed that in 0.60% of people who had the PICC line inserted and fluoroscopy used there was tip malposition, while this percentage was 2.90% for the Sherlock 3CG™ TCS device. The RR of malposition when using the Sherlock 3CG™ TCS device compared to fluoroscopy was 4.70 (95%CI 0.50- 44.70). A study (cross-sectional) comparing the feasibility and accuracy of tip localization of the Sherlock 3CG™ TCS versus the Nautilus system (without navigation) was retrieved. Feasibility of tip localization was unsuccessful in 6,00% of cases versus 0% respectively. The odds ratio (OR) of unsuccessful tip localization feasibility was 9.60 (95%CI 1.20- 76.87). In relation to tip location accuracy, 100% of precision was observed in cases in which insertion was performed with the Sherlock 3CG™ TCS device, as well as in those in which the Nautilus system (without navigation) was used. Another of the results assessed in relation to effectiveness was catheter occlusion and failure where in one of the studies catheter failure due to occlusion was observed in 1.20% of patients with Sherlock 3CG™ TCS insertion and in 1.90% of patients with fluoroscopy insertion. The RR of catheter failure was 1.60 (95%CI 0.20-11.00). The repositioning rate was also assessed in one study. It was observed that 1.50% of cases in which insertion was done with the Sherlock 3CG™ TCS device required repositioning of the PICC line versus 10.30% of cases in which PICC was done with verification with the CXR. Thus, the risk of repositioning when using the Sherlock 3CG™ TCS device was 7.14 times lower than when checking with the CXR (RR: 0.14 (95%CI 0.02-1.13)). According to information provided by a study in which patient satisfaction with the Sherlock 3CG™ TCS device was assessed, it is better rated than blind insertion with CXR verification. Among the studies selected in this review, we found several studies that evaluated the organizational impact such as the duration of the procedure or the need for complementary tests. In one study, it was observed that, after the first insertion, patients who used the Sherlock 3CG™ TCS device did not require complementary CXR, while those who used the blind technique with CXR required in some cases up to 3 checks. In relation to procedure time, in all the studies in which the procedure time was compared between the use of the Sherlock 3CG™ TCS device and CXR, it was observed that it was always longer when the insertion was performed using CXR as the checking technique. For the VPS Rhythm® device with TipTracker™ technology, the Nautilus Delta™ TCS device and the PICC Tip Positioning Aid no studies were found that evaluated cost-effectiveness or budget impact relative to other catheter tip testing techniques. Although, budget impact was evaluated for the Sherlock 3CG™ TCS device in two studies. One of these studies evaluated the budgetary impact of performing insertion with the Sherlock 3CG™ TCS device versus performing the technique blindly with CXR checking and another versus fluoroscopy. In both studies a lower cost was observed for the Sherlock 3CG™ TCS device, although these results should be taken with caution as they are context-dependent. Three other studies evaluating the economic cost of its use compared to other techniques such as CXR and fluoroscopy also found that the Sherlock 3CG™ TCS device was less expensive. In conclusion there is no evidence regarding the effectiveness or safety, as well as about organizational and/or economic impact of PICC line insertion systems using the VPS Rhythm® device with TipTracker™ technology, the Nautilus Delta™ TCS device and the PICC Tip Positioning Aid. Regarding the Sherlock 3CG™ TCS device there is insufficient evidence to determine whether it is more or less effective than PICC with tip checking via CXR or another comparator. Although no cost-utility studies of these devices have been located, it seems that the implementation of the Sherlock 3CG™ TCS device could lead to savings. In addition, PICC line insertion with this device can be performed by a single healthcare professional and the degree of satisfaction of both patients and healthcare professionals in relation to this device seems to be high. Well-designed randomized clinical trials are required to establish the comparative effectiveness and safety, as well as to establish the most suitable candidates for PICC line insertion with this type of device.

Authors' methods: A systematic review was performed. The search strategy was conducted in December 2022, without temporal limits, in databases of health technology assessment reports and systematic reviews such as the International HTA database, the Cochrane Library and Epistemonikos, in general databases such as Medline (PubMed) Embase and CINAHL, and in clinical trial databases such as the US National Institute of Health, the EU Clinical Trial Register and the International Clinical Trials Registry. The studies were selected by two independent investigators according to previously established eligibility criteria. Depending on the outcome variable, randomized clinical trials, comparative and non-comparative observational studies, systematic reviews and meta-analyses were included. Conference proceedings, letters to the editor, editorials and narrative reviews were excluded. The risk of bias was assessed using the specific scales for each type of study and the synthesis of results was performed using the GRADE (Grading of Recommendations Assessment, Development and Evaluation) system.

Project Status: Completed

URL for project: https://acis.sergas.gal/cartafol/avalia-t202271PICCecoguia

Year Published: 2023

URL for published report: http://hdl.handle.net/20.500.11940/18141

English language abstract: An English language summary is available

Publication Type: Full HTA

Country: Spain

Organisation Name: Scientific Advice Unit, avalia-t; The Galician Health Knowledge Agency (ACIS)

Contact Address: Conselleria de Sanidade, Xunta de Galicia, San Lazaro s/n 15781 Santiago de Compostela, Spain. Tel: 34 981 541831; Fax: 34 981 542854;

Contact Name: avalia-t@sergas.es

Contact Email: avalia-t@sergas.es

Copyright: <p>Galician Agency for Health Technology Assessment (AVALIA-T)</p>