Efficacy and Safety of Over-the-Wire Technique versus Direct Catheter Insertion Technique in Peripherally Inserted Central Venous Catheter Placement: A Randomized-Controlled Study

doi:10.21203/rs.3.rs-1622062/v1

Purpose To assess the effectiveness and safety of the over-the-wire (OTW) technique as compared to the direct catheter insertion (DCI) technique in ultrasound (US) guided peripherally inserted central venous catheter (PICC) placement with fluoroscopic catheter tip location.

Methods In a non-inferiority randomized-controlled study, 60 PICCs were implanted by an interventional radiologist into the basilic, cephalic, or brachial vein of the mid-upper arm. The effectiveness as primary endpoint was measured by implantation time. Placement accuracy was detected as secondary endpoint by tip location under chest x-ray, whereas safety was measured by the rate of periprocedural and early complications occurring within two weeks.

Results Implantation time of 8.34 ± 2.14 minutes applying the OTW technique showed to be significantly more time-consuming than DCI technique with 5.53

0.96 minutes (p<0.001). The results for the secondary endpoints were not allowing a statistically significant statement due to the patient number. The exploratory analysis showed however no significant difference (p=0.3) regarding tip placement accuracy between both insertion techniques (optimal tip localization of 100% with the DCI technique; 97% with the OTW technique). Periprocedural bleeding events from the introducer occurred in 26.7% of the patients with OTW technique towards not considerable bleeding in the DCI group (p=0.003).

Conclusion For US-guided fluoroscopic PICC insertion in adults, the DCI technique was superior as compared to the OTW technique in terms of procedure time.

Trial registration NCT 04303052

Peripherally inserted central catheter

Seldinger technique

Guidewire

Fluoroscopy

The number of peripherally inserted central venous catheter (PICC) placements is continuously increasing due to the wide range of medical use, successful insertion rate, and low insertion related complications [1]. With growing demand, PICC insertion performed by trained and certified PICC nurses becomes more common in hospitals in the U.S., where PICCs are still primarily inserted by physicians [2, 3]. Dedicated PICC teams make a bed-site approach more practicable with different insertion options, including blind insertion as well as insertion with intraprocedural ultrasound (US) guidance, electrocardiogram (ECG) guidance or magnetic tip tracking [4, 5]. Expected catheter length can be estimated before the procedure by using topographical anatomy landmarks or algorithms based on anthropometric data of the patient, like height in adults [6, 7]. In complicated insertions and in some countries in Europe PICC implantation is still primarily being done in the radiological department. Catheter placement with radiological approach includes fluoroscopic guidance, which requires a dedicated interventional fluoroscopy room [8, 9]. Fluoroscopy makes an intraprocedural prediction of catheter length possible with the help of the exposed markings on the guidewire at the exit site of the vessel cannulation. As PICCs have been inserted for over 40 years, there are varying implantation techniques. Peel-away sheath technique was used at the beginning where the catheter was threaded over the opening into the vessel created by a breakaway sheath [10]. In the Seldinger technique, the catheter is advanced through a long J-tipped guidewire [11]. Nowadays, the preferred modified Seldinger technique (MST) represents a catheter advancement directly through an introducer [12]. Under fluoroscopy, MST can be performed either with a long guidewire as an over-the-wire (OTW) technique or with a short guidewire as direct catheter insertion (DCI) technique. Radiological interventionalists seem to prefer one of both methods depending on their experience and personal preference. To the best of our knowledge, no randomized-controlled study comparing both PICC insertion techniques regarding efficacy and safety has been conducted.

Study design

This monocentric randomized-controlled study was conducted in our tertiary radiology department at a university teaching hospital. All patients who were referred to undergo a PICC insertion, as indicated by their clinical condition, were considered for inclusion. Patient baseline characteristics are summarized in table I. There were no significant differences in the demographic characteristics of the two study arms. Informed consent was obtained for all patients. PICC placements were performed by the same radiologist with a prior experience of more than 60 insertions in both techniques. From February 2018 to October 2018 60 patients were recruited and randomized by a computer-generated list in a 1:1 allocation by envelopes. One patient was excluded due to the use of an inadequate implantation kit not matching to the investigational product. The local ethical committee approved the study protocol which was registered at ClinicalTrials.gov with the Identifier NCT 04303052.

Implantation techniques

PICCs were placed under sterile conditions with fluoroscopic guidance. Due to the clinical setting in the department both methods were performed in a one-operator-catheterization technique without a sterile assistance. The technician operated the fluoroscopy unit. Patients were placed in a supine position with an abducted arm, on a lateral armrest. After the local anesthesia, a US-guided puncture of the basilic, cephalic, or the brachial vein was performed with an 18G puncture needle in the mid-upper arm. Subsequently, the guidewire insertion and the introducer sheath placement in MST took place as described in the literature [13]. Both kits contained a power injectable double-lumen 55 cm 5F polyurethane catheter and a nitinol guidewire (BioFlo® PICC, AngioDynamics Inc., Queensbury, NY, US). For the DCI technique, a kit with a 70 cm guidewire (MST Kit) and for the OTW technique, a kit with a 145 cm guidewire (IR Kit) were used. The optimal position of the guidewire tip was confirmed via fluoroscopy. Required catheter length was determined by measuring the distance from the vessel cannulation site to the distal guidewire markings. The catheter was trimmed to the final length. In the DCI technique, the 70 cm guidewire and the dilator were removed when the catheter was inserted directly through the introducer. In the OTW technique, only the dilator was removed, and the catheter was inserted over the 145 cm guidewire through the introducer. Thereafter, the guidewire and peel-away sheath were removed, respectively. The external catheter was fixed into the upper arm via a sutureless securement device (StatLock®, Bard Access Systems, Becton, Dickinson and Company, Franklin Lakes, NJ, US)[14](Fig. I).

Endpoints

The primary endpoint was defined as the procedure time needed for PICC placement. The recording of the implantation time was standardized. For both techniques, time measurement started with the insertion of the guidewire into the puncture needle after the US-guided puncture and ended with the fixation of the catheter. The secondary endpoint, placement accuracy, was detected by fluoroscopic catheter tip location. The tip position was classified as optimal, inoptimal and nonoptimal based on the

European Guidelines [15]. The optimal position was defined between the middle third of the superior vena cava (SVC) and the cavoatrial junction (CAJ). An inoptimal tip position was still in a central vessel and didn´t require correction. A nonoptimal tip location would have been corrected in the same session. The tip location was verified by an anteroposterior chest x-ray in inspiration and a supine position with an abducted arm. The evaluation of the imaging was made considering the carina criteria [16]. The second endpoint safety was measured by the rate of periprocedural and early complications. Early complications were assessed with a follow-up from 24 hours up to 2 weeks. The reporting of the results followed the CONSORT (Consolidated Standards of Reporting of Trials) guidelines for randomized trials [17](Fig. 2).

Statistical Methods

The sample size calculation was based on a pilot study of 15 patients. This study determined a difference of 1.35 minutes in procedure time between the two study groups. The mean duration for the OTW technique was 7.13 ± 0.47 minutes and for the DCI 5.78 ± 1.35 minutes. To detect this effect with a power of 90%, data of 28 patients were needed. Assuming a drop-out rate of 20%, a minimum 36 patients (18 per group) needed to be included in the study. Considering possible additional information loss, we agreed on a sample size of 60 patients. The patient number was not enough for a statistically significant statement regarding the secondary endpoints. Thus, the analysis of the secondary endpoints was of exploratory nature. Data are expressed as mean (SD) or percentage. \({\chi }^{2}\) test and Student’s t-test were used to compare the baseline characteristics of the two study groups. The Shapiro-Wilk test was used to determine the normality of the distribution. The primary outcome was evaluated using the Mann-Whitney U-test. \({\chi }^{2}\) test was used to compare the secondary outcomes. P-value < 0.05 was considered as statistically significant. For the statistical analysis IBM^® SPSS^® Version 26.0 (SPSS Inc., IBM Corp., Armonk, NY, USA) was used.

The mean procedure time of the patients in the DCI group was 5.53 \(\pm\) 0.96 minutes. Patients in the OTW group had a mean procedure time of 8.34 \(\pm\) 2.14 minutes (p = < 0.001). The time difference of both methods was thus 2,81 minutes (p < 0.001). The final tip localization of the catheter was in both methods comparably accurate. The tip was within the defined optimal target area, in 100% of the patients in the DCI group and 96.7% of the patients in the OTW group (p = 0.305). There was no noniptimal catheter tip position. A relative, clinically not relevant periprocedural blood discharge from the introducer after the removal of the dilator was seen in 26.7% of the patients in the OTW group in contrast to almost no bleeding in the DCI group (p = 0.003) (Fig. 3C and 3D). No other differences were reported in other incidences (Tab. III).

MST is commonly used in PICC insertion due to its high success rate [12]. In the radiological approach supported by fluoroscopy, there are different variations of the MST depending on the catheter insertion method. In this study, two of these methods, OTW technique, and DCI technique, were compared regarding the efficacy and safety. To our knowledge, there have been no other randomized controlled trials comparing these two methods so far.

The overall incidence of successful catheterization in both methods was comparable. DCI technique showed a shorter catheterization time and less periprocedural bleeding. Despite the significant outcome the procedure time in the OTW-Technique was not long enough to make a difference in everyday clinical routine. The bleeding in the OTW-Method continued in some patients until the catheter reached the opening of the introducer but not from clinical relevance. The problem was rather the distinctive contamination of the operating area with blood. Accuracy of tip localization and other complications were similar in both study groups.

In the OTW technique, handling of the 145 cm long guidewire is more challenging in a one-operator technique without assistance. To enable a smooth sliding of the catheter kinking of the guidewire must be precluded. Additionally, a constant manual securement of the guidewire is required to prevent dislocation of the guidewire tip from the prearranged optimal central position and to prevent contamination. Some methods to ease the handling of the guidewire are, laying it down on a prepared sterile covered back table or placing wetted gauze on the guidewire to hold it in place. In contrast, the DCI technique allows more flexible and stable handling of the catheter while insertion resulting in shorter procedure time.

A secondary dislocation of the catheter tip after guidewire removal has been described by Wang et al. [18]. In our study, after the removal of the guidewire, no dislocation of the catheter tip was observed. This would have been detected immediately with the use of fluoroscopy.

Other commonly reported mechanical complications in PICC insertion include arterial puncture, catheter malposition, and hematoma [19–21]. In our follow-up, we noticed no difference between both methods regarding these complications. Pain and small hematomas were the observed. Catheter dysfunction with occlusion of only one lumen occurred in 3 patients. The catheter was not removed or replaced in these cases. Table II summarizes the main complications.

In 2 cases in DCI technique the use of an additional long guidewire was necessary to finalize the insertion, as the catheter wasn’t progressing as expected even after stylet use. The application of the OTW technique has been described in challenging procedures with unsuspected central venous obstruction. For example, in patients with complicated venous status, such as anatomic variations of the central veins or scarring from previous therapies [22]. In these cases, the long guidewire can improve the stability, avoid the resistance due to valves and prevent a kinking or looping of the catheter. In more complicated cases like advanced venous stricture or superior vena cava syndrome, alternative vascular access such as femoral access or an angioplasty should be considered [23, 24].

There are several limitations to our study. The study was monocentric single-blinded. All the catheterizations were performed by the same radiologist. Implantation kits of only one manufacturer were applied. A different set with a valve sheath may have avoided the bleeding at the insertion site in the OTW group. The patient number was not enough for a statistically significant statement regarding the secondary endpoints. Finally, early complications were registered only for 2 weeks, which is a relative short follow-up time considering the literature with a mean time of 16.1 days till the onset of complications [25].

For US-guided fluoroscopic PICC implantation in adults the DCI and OTW technique are both accurate and feasible. The DCI technique has a significantly shorter implantation time and shows relatively less periprocedural bleeding, both not being relevant in everyday clinical routine. If done as one-operator-catheterization the OTW technique is more challenging due to the long guidewire. Despite the challenging procedure, we assume that the OTW technique is especially superior in patients with anatomically complicated venous status. An essential task for future studies would be to identify patient groups that would benefit from both methods by including more complicated cases and by comparing the complication rates with a larger number of patients and a longer follow-up window.

BMI body mass index

CAJ cavoatrial junction

CONSORT Consolidated Standards of Reporting of Trials

DCI direct catheter insertion technique

ECG electrocardiogram

F French

G gauge

IR interventional radiology

MST modified Seldinger technique

OTW over-the-wire technique

PICC peripherally inserted central venous catheter

SD standard deviation

SVC superior vena cava

US ultrasound

Ethical Approval and Consent to participate

All procedures performed were in accordance with the ethical standards of the institutional and national research committee and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards. Informed consent was obtained from all individual participants included in the study. Institutional review board of the Friedrich-Schiller-University Jena gave ethical approval on 26th January 2018 with the registration number 5385-12/17.

Consent for publication

All authors have read and approved the manuscript for publication.

Availability of data and materials

The study data and subsequently analysis of the current study are available from the corresponding author on reasonable request. Furthermore, the trial protocol is available on ClinicalTrials.gov with the Identifier NCT 04303052.

Competing interests

The authors declare that there is no conflict of interest.Funding

No funding for this study.

Authors’ contributions

UT contributed to study conception and design, DK recruited the patients, performed the study interventions and data collection, UT, DK performed the analysis and interpretation of results, UT and DK contributed to the draft manuscript preparation. All authors reviewed the results and approved the final version of the manuscript.

Acknowledgements

We thank your study coordinator Laura Graziani for linguistic support.

Trial registration

ClinicalTrials.gov, NCT 04303052. Registered 10 March 2020 - Retrospectively registered, https://www.clinicaltrials.gov/ct2/show/NCT04303052

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Table 1

Baseline patient characteristics

		DCI	OTW	p-value	total
Age [y]		64.7 ± 12,4	63.7 ± 12.7	0.774	64.2 ± 12.4
Gender, n				0.194
	Female	14 (23.3%)	19 (31.7%)		33 (55 %)
	Male	16 (26.7%)	11 (18.3%)		27 (45 %)
Weight [kg]		74.7 ± 21,2	76 ± 16.6	0.787	75.3 ± 18.9
BMI [kg/m2]		25.5 ± 6.4	27.5 ± 6	0.226	26.5 ± 6.2
Thrombocytes [Gpt/l]		218 ± 145.5	216,9 ± 144.4	0.976	217.4 ± 143.7
Quick value [%]		87.9% ± 15.5	85.28% ± 17.7	0.546	86.61% ± 16.5
Thrombosis in the past, n		6 (10%)	3 (5%)	0,278	9 (15%)
Complications with previous central lines		7 (11.9%)	3 (5.1%)	0.148	10 (16.9%)
Indication for the PICC				0.215
	Chemotherapy	21 (36.2%)	21 (36.2 %)		42 (72.4%)
	Antibiotics	0 (0%)	2 (3.4 %)		2 (3.4 %)
	Other	9 (15.5%)	5 (8.6 %)		14 (24.1%)

Values are means ± standard deviation or counts (percentage)

PICC peripherally inserted central catheter, DCI direct catheter insertion

OTW over-the-wire, BMI body mass index

Table 2

Complications

	DCI	OTW	p-value	total
Periprocedural complications
Arterial puncture, n	0	1 (3.3%)	0.321	1(1.7%)
Nerve puncture, n	0	0		0
Allergic reaction	0	0		0
Bleeding from the introducer, n	0	8 (26.7%)	0.003	8 (13.3%)
Early complications
Pain	2 (6.7%)	1 (3.3%)	0.533	3 (5.0%)
Hematoma, n	1 (3.3%)	3 (10.0%)	0.317	4 (6.7%)
Deep vein thrombosis, n	0	0		0
Catheter dysfunction, n	2 (6.7%)	1 (3.3%)	0,533	3 (5,0%)
Catheter dislocation, n	0	0		0

Values are means ± standard deviation or counts (percentage)

DCI direct catheter insertion, OTW over-the-wire

Efficacy and Safety of Over-the-Wire Technique versus Direct Catheter Insertion Technique in Peripherally Inserted Central Venous Catheter Placement: A Randomized-Controlled Study

Status:

Version 1

Abstract

Figures

Introduction

Methods

Study design

Implantation techniques

Endpoints

Statistical Methods

Results

Discussion

Conclusion

Abbreviations

Declarations

References

Tables

Status:

Version 1