Missed Central Venous Guide Wires: A Systematic Analysis of Published Case Reports Krishna Pokharel, MD1; Binay Kumar Biswas, MD2; Mukesh Tripathi, MD3; Asish Subedi, MD1
Objective: The inadvertent loss of an entire guide wire during central venous catheterization can lead to serious patient harm and require additional investigations as well as retrieval procedures. We aimed to analyze globally published reports of lost wires during central venous catheterization to understand its possible etiology, presentation, treatment, and outcomes with an objective of finding solutions to make the procedure safer. Data Sources: MEDLINE, Scopus, and CINAHL, supplemented by scanning the reference lists of relevant publications. Study Selection: All reports describing an inadvertent intravascular loss of a complete guide wire during placement of central venous catheters published up to December 2014 were included. Reports exclusively describing the 1) retrieval method, 2) partially retained guide wires, and 3) entrapped guide wires during withdrawal were excluded. Data Extraction: In each instance, we collected data about the method of the missed guide wire detection, the time interval between the procedure and detection, the supplementary investigations performed to confirm the diagnosis, and the risk factors associated with such events as well as the complications, the final outcome, and the wire retrieval methods used. Data Synthesis: A systematic analysis of the accessed publications was performed. Conclusions: Over the last decade, the number of reported instances of lost guide wires during central venous catheterization has increased rapidly. Unsupervised or improperly supervised insertions of the central catheters by trainees, distractions during insertions, and high workload are the main risk factors. A retained guide wire increases the risk and cost of additional diagnostic and therapeutic interventions, as well as imposing many minor-to-serious life-threatening
Department of Anesthesiology and Critical Care, B.P. Koirala Institute of Health Sciences, Dharan, Nepal. 2 Department of Anesthesiology, ESI-Post Graduate Institute of Medical Science & Research, Kolkata, India. 3 Department of Anesthesiology, Sanjay Gandhi Post Graduate Institute of Medical Sciences, Lucknow, India. The authors have disclosed that they do not have any potential conflicts of interest. For information regarding this article, E-mail: [email protected] 1
Copyright © 2015 by the Society of Critical Care Medicine and Wolters Kluwer Health, Inc. All Rights Reserved. DOI: 10.1097/CCM.0000000000001012
Critical Care Medicine
complications. Continuing education along with simulator-based skill development, vigilant supervision, and a shared workload during out of hours working are likely to prevent such occurrences. (Crit Care Med 2015; 43:1745–1756) Key Words: adverse effect; arrhythmia; central venous catheter insertion; complications; guide wire; lost; missed; retained
P
ercutaneous central venous catheterization (CVC) is an integral part of patient care in the ICU, emergency department, and operating theater. The use of guide wires appears to be inherently safe in the hands of well-trained practitioners (1). The Seldinger technique (catheter over a guide wire) has established its superiority over other methods and is now the technique of choice worldwide (2). The guide wire should be retrieved from the body following the insertion of the catheter. Omission of this crucial step is an example of a “serious reportable event” that is more commonly referred to as a “never event.” A “never event” is defined as a serious, but largely preventable error in medical care that should never occur if healthcare workers have implemented the relevant preventive measures (3). A retained guide wire can cause serious harm to the patient, resulting in further costly investigations and additional procedures for its retrieval that are potentially harmful to the patient and may also result in medicolegal cases. The number of reports describing the loss of the entire guide wire has increased over the years, implying the lack of a foolproof mechanism for elimination of this problem. Therefore, we reviewed each instance of the inadvertent intravascular loss of the entire guide wire during CVC reported in the literature until December 2014 to understand its etiology, presentation, treatment, and outcome. We aimed to perform a root cause analysis of such instances with an objective of finding solutions to make this procedure safer.
MATERIALS AND METHODS Literature Search and Case Report Selection Two authors (K.P., A.S.) independently searched the MEDLINE, Scopus, and CINAHL databases (Appendix 1) to mark the articles eligible for further review by screening the titles and abstracts. The reports published until December 2014 describing the inadvertent loss of the entire guide wire within www.ccmjournal.org
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the vascular system were included. Relevant case reports in all languages were reviewed. If a publication could not be accessed electronically or in print, the authors were contacted by e-mail. Non-English publications were translated into English, using Google’s translation service. In addition, bibliographies of included citations and other relevant articles were also hand searched. This search strategy was done iteratively, until no new potential citations were found. Agreement between the two authors on case report selection was calculated using a Cohen κ statistic and reported with a 95% CI. Data Extraction Two authors (K.P., A.S.) then, independently, extracted data from all relevant reports (4–67) using a standardized form. The data were grouped as: the detection methods of the lost guide wires, investigations used to confirm/supplement the diagnosis, the time taken to detect the lost guide wire, the risk factors associated with such events, related complications, the fate of the guide wire, and the methods used for its retrieval. We also noted the operator’s qualifications, experience, and specialty as well as the presence of
distractions and other problems at the time the procedure was performed. All disagreements were resolved through discussion between two authors (K.P., A.S.) and, when necessary, with the third author (B.K.B.). We contacted the authors of the individual reports for clarification or missing information. The collected data were entered into a Microsoft Excel Spreadsheet (version 7.0; Microsoft Corporation, Redmond, WA) and analyzed using SPSS version 11.5 (SPSS Inc., Chicago, IL). Values were generally expressed as a percentage and as the number of patients. The fractional incidence was calculated using the software GraphPad Prism (version 6.1, San Diego, CA). The odds ratio was calculated to estimate the relative risk (benefit in our context).
RESULTS All abstracts and titles from 12,913 unique publications retrieved from the electronic database search were thoroughly screened. Among these, 146 publications were selected for fulltext review. Seventy-six incidents obtained from 64 publications met the inclusion criteria for analysis. Agreement between
Figure 1. A flow diagram describing the reports selection process.
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reporting the lost guide wire has increased rapidly since 2005 (Fig. 3). Reports of total eight cases had complete information. Additionally, we could retrieve most of the missing information in 34 cases (44.7%) through personal communication with the corresponding authors. For others (n = 34; 44.7%), it could not be done because the authors did not respond (n = 21), because they had incomplete records (n = 6), or because the e-mail addresses were not working/published (n = 7). The distal end of the lost guide wires got lodged at various intravascular sites—the majority in the inferior vena cava (Table 1). Twenty-six CVCs were performed for emergency conditions, 42 were performed for routine management of Figure 2. Publications from various continents. patients, and clear descriptions of indications for catheter inserthe two investigators at the full-text review stage was excellent, tions were not available in eight cases. Operator’s details were available in only 57 of the cases. as indicated by a κ of 0.96 (95% CI, 0.93–0.98) (Fig. 1). Asian continent accounted for a little less than half (n = 31; The majority (n = 47; 82.4%) were performed either by doc46.9%) of the publications (Fig. 2). The number of publications tors without prior exposure to the central catheter insertions with the Seldinger technique or by trainees. The status of supervision was not clear from the reports describing four procedures. Among the remaining 43 cannulations performed by these clinicians, 25 (58.1%) were unsupervised (Table 2). Distraction (n = 16) was the most frequently reported risk factor as perceived by the performer for the loss of guide wires (fractional incidence, 0.280; 95% CI, 0.182–0.396). Distraction as a cause included factors like ongoing care of other sick patients (n = 4), simultaneous other procedures like transesophageal echocardiography (n = 3), surgery (n = 1), nursing care (n = 1), and handing over of patient information (n = 1). Distractors were not specified in six instances. High workload Figure 3. Trend in reporting retained central venous guide wires in the literature. CVC = central venous or busy day (n = 14), very sick catheterization. Critical Care Medicine
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Table 1.
Lodged
Various Sites Where the Distal Tip of the Lost Guide Wire Was Reported to be Access Sites
Location of the Distal Tip of Guide Wire
Cubital Vein (n = 4)
Internal Jugular Vein (n = 45)
Subclavian Vein (n = 9)
Femoral Vein (n = 17)
Cubital vein
1
Internal jugular vein
4
Subclavian vein
5
Superior vena cava
1
Right ventricle
1
Right ventricular outflow tract
1
3
Multiplea (n = 1)
1 1
Heart
1
Inferior vena cava
1
16
Hepatic vein
2
Common iliac vein
7
Internal iliac vein
2
External iliac vein
1
Common femoral vein
2
Femoral vein
7
Abdominal aorta
1
Extravascular
1b
2c,d
Unknown
3
4
2 2 1e
1f
Not mentioned
1
1
Multiple catheters were inserted from different sites. b Protruded out in peritoneal cavity from the gall bladder. c Subcutaneous tissue in neck. d Pelvis. e Projected out of the body from back of the neck. f Radiograph not taken. a
patient with unstable hemodynamics (n = 13), procedure performed during the night shift (n = 13), and use of two catheter kits (n = 12) were reported as other important risk factors (Fig. 4). Altogether, in 23 cases (30.3%), the loss of the guide wire was detected either during the procedure (n = 21) or just immediately after its completion while checking the equipment tray (n = 2) (Table 3). In the rest of the cases, the absence of the guide wire in the equipment tray remained undetected following completion of the procedures (n = 53; 69.7%). Postprocedural radiograph was performed in 61 patients. Among these, 19 radiographs were done to locate or confirm the lost guide wire and 42 radiographs were performed as a part of the routine protocol of CVC. Interestingly, in all those radiographs (n = 19) done following realization of the loss of the guide wire, the guide wire was easily identified at first glance. Surprisingly, despite being clearly visible, the guide wires went unnoticed at the initial reading of the majority (n = 29; 69%) 1748
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of routine radiographs performed as part of routine protocol following CVC. They were detected later retrospectively by reevaluating the radiographs. This gives a relative benefit of 0.7 of getting a radiograph done for immediate identification of the missed guide wire. Interestingly, a missing guide wire was completely absent in one postinsertion radiograph. In a small number of patients (n = 6), the check radiographs were not performed at the end of the CVC. Four of these central catheters were placed through the femoral vein. The information about the check radiograph was not available in the reports of the remaining patients (n = 9). Various other modalities, such as neck, chest, abdominal, and pelvic radiographs, CT scans, ultrasonography, echocardiography, and angiography, were used for the detection of the lost guide wires. In one patient, the guide wire was noticed when it had projected out of the body (Table 3). In over half of the cases (n = 39; 51.3%), the intravascular loss of the guide wires was only suspected after a lag period of a few days to years (Table 3). August 2015 • Volume 43 • Number 8
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Table 2. Explaining the Operator Qualification and Supervision During the Central Catheter Insertion Serial Number
Operator Qualification
Years in Training/ Experience (Yr)
Prior Insertions (n)
Supervision
1
Intern
—
—
Unknown
2
Intern
—
—
No
3
Intern
—
—
Yes
4
Trainee anesthetist
First year
—
Yes
5
Trainee anesthetist
First year
0
No
6
Trainee anesthetist
First year
0
Yes
7
Trainee anesthetist
First year
21
Yes
8
Trainee anesthetist
First year
20–30
Yes
9
Trainee anesthetist
Second year
12
Yes
10
Trainee anesthetist
Second year
10
Yes
11
Trainee anesthetist
Second year
48
Yes
12
Trainee anesthetist
Second year
20
No
13
Trainee anesthetist
Second year
—
No
14
Trainee anesthetist
Third year
83
Yes
15
Trainee anesthetist
Third year
7
Yes
16
Trainee anesthetist
Third year
—
Yes
17
Trainee anesthetist
Third year
Few times
Yes
18
Trainee anesthetist
Fourth year
—
No
19
Trainee anesthetist
Fifth year
—
No
20
Trainee anesthetist
—
—
Yes
21
Senior resident anesthetist
First year
10
No
22
Senior resident anesthetist
Fourth year
0
Yes
23
Senior resident anesthetist
—
—
No
24
Senior resident anesthetist
Many years
—
No
25
Registrar anesthetist
Second year
—
Yes
26
Registrar anesthetist
Second year
—
No
27
Registrar anesthetist
Second year
—
No
28
Trainee
—
—
Unknown
29
Trainee surgeon
First year
—
No
30
Trainee surgeon
First year
—
No
31
Trainee surgeon
Second year
5
No
32
Senior resident plastic surgery
—
500
No
33
Resident surgeon
—
—
Yes
34
Junior resident in critical care
—
50
No
35
Resident
—
—
Yes
36
Resident
—
—
Unknown
37
Resident
—
—
Unknown
(Continued) Critical Care Medicine
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Table 2. (Continued ). Explaining the Operator Qualification and Supervision During the Central Catheter Insertion Serial Number
Operator Qualification
Years in Training/ Experience (Yr)
Prior Insertions (n)
Third year
—
No
Second year
—
No
Supervision
38
Resident internal medicine
39
Trainee physician
40
Emergency physician
—
—
No
41
Emergency physician
One
—
Yes
42
Emergency physician
—
—
No
43
Senior resident at Emergency unit
—
—
No
44
Physician
—
0
No
45
Cardiologist
Two
0
No
46
Consultant neurologist
—
a
0
No
47
Hospitalist
Newly graduated
—
No
48
Nephrologist
—
—
Unknown
49
Clinician
Several years
—
NA
50
Internal medicine specialist
—
—
NA
51
Intensivist
Eight
—
NA
52
Consultant intensivist
—
—
NA
53
Consultant anesthesiologist
Two
—
NA
54
Consultant anesthesiologist
Twelve
—
NA
55
Consultant anesthesiologist
Twenty seven
—
NA
56
Anesthesiologist
Thirty seven
—
NA
57
Anesthesiologist
Twenty three
—
NA
NA = not applicable. a Experienced at central venous catheterizations, but not Seldinger technique. Dash (—) indicates not mentioned.
The longest gap was 20 years. The guide wires were incidentally detected at centers other than where originally inserted on seven occasions. In one patient, the retained guide wire was incidentally detected during the postmortem examination. The loss of the guide wire was realized before aspirating and flushing of catheters during CVC in 15 patients; hence, these steps were not performed. The reports of 17 cases had no clear information related to these steps after catheter insertion. Among the remaining 44 cases, warning signs of the left-behind guide wires, such as inadequate flow of fluids, nonfunctional catheter, or resistance during aspirating and flushing through the catheter, were present in 14 patients (31.8%). Apart from the functional problems of the catheter, the majority of patients (n = 58; 76.3%) with the retained guide wire remained asymptomatic until detection. Other patients (n = 18; 23.7%) developed a variety of problems while the guide wire was retained inside the body. Problems that occurred within a few days of catheter insertion include retroperitoneal hematoma (n = 1); gall bladder perforation, causing biliary peritonitis (n = 1); pulmonary embolism (n = 1); and vertebral artery 1750
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thrombosis, resulting in posterior cerebral infarction (n = 1). There were several others that had a delayed presentation of a period of a few months to years following catheter insertion like ventricular perforation (n = 1), cardiac tamponade (n = 1), severe chest pain with palpitations (n = 1), massive pulmonary embolism (n = 1), infective endocarditis (n = 1), and sepsis (n = 2) (Table 4). All of these potentially life-threatening conditions had strong clinical and laboratory evidence to support the causal relation to the retained guide wire, except in the case of the development of a mild pulmonary embolism in one patient. Less severe problems following retention of the guide wire included mild neck pain on the 2nd postprocedure day, fever on the 12th day, leukocytosis on the 8th day, and pain and swelling of lower limbs on the 4th day, 4th week, and 5th month. Among the latter, one patient had the guide wire embedded inside a thrombus (Table 4). A patient with a retained guide wire for more than 9 years had developed low-grade hemostatic activation and increased fibrin turnover (elevated d-dimer and plasminogen activator inhibitor-1 activity). Among all the retained guide wires, four were fragmented inside the body (Table 5). August 2015 • Volume 43 • Number 8
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Figure 4. Frequency of identified risk factors for guide wire loss.
Seventy-one patients were subjected to removal procedures. Percutaneous extraction was the preferred method (n = 55; 77.5%) (Table 5). Some of the guide wires were easily retrieved by simply pulling the entire catheter-guide wire assembly after clamping and/or aspiration through the catheter (n = 12), whereas many others required additional devices, such as snares (n = 17), catheter/forceps/wire (n = 3), and dormia basket (n = 3). The technique of percutaneous guide wire removal was not specified in 20 patients. Surgical exploration was done mostly when the percutaneous removal had failed or the setup and expertise were unavailable. In one patient, a guide wire was firmly incorporated into the vessel and the attempts to pull it triggered ventricular arrhythmia, causing clinicians to decide to terminate the retrieval procedure. Removal was not attempted when the guide wires were adhered to the blood vessel wall (n = 2), fragmented into multiple pieces (n = 1), or coiled in a difficult location such as the pulmonary artery (n = 1).
DISCUSSION Our literature search indicated that the prevalence of inadvertent IV loss of a complete guide wire is not uncommon and takes place globally. Although only six reports were published before 2000, there has been an abrupt rise in the reporting of such incidents since 2005. This may be because of the increasing access to journals where it is easier to publish cases rather than the actual increase in the frequency. To some extent, this may also be the result of the fact that there has been a paradigm shift in the culture of “blaming an individual performance” to “learning from root cause analysis” (68). The latter identifies and attempts to rectify the underlying system failure that may Critical Care Medicine
have been responsible for such “never events.” Existing national reporting systems are mostly voluntary and nongovernmental, so critical event reporting remains largely variable (69). In the United States, for example, there is no national government reporting system with well-defined reportable events and the type of information reported varies between states (69). Guide wire retention is included in the National Quality Forum (United States)-endorsed list of 27 “serious reportable events” that should be reported and investigated by all healthcare facilities when it occurs (70). A uniform global reporting mechanism might help to generate reliable data and identify errors that may be associated with such serious events, like loss of the guide wire during CVC. We cannot comment on the prevalence of the lost guide wires based on this review of the published reports. It is widely agreed that such events are likely to remain grossly underreported due to the clinicians’ fear of blame as well as retaliation, lawsuits, and accusations of incompetence (7, 71). As a majority of the retained guide wires in our analysis was an incidental finding, we assume that many errors might have remained undetected and hence unreported. Although human error was a factor in these cases, there was evidence of system failures in many of the cases. In our pooled data from 76 cases, the major identifiable risk factors for the intravascular loss of the guide wire during CVC included the practitioner’s inexperience in either the Seldinger technique or the CVC equipment and the lack of adequate supervision during the procedure. We were able to obtain the information regarding the experience of prior central catheter insertions on 17 operators. Surprisingly, the procedure in which the incident had taken place was their first opportunity of performing CVC www.ccmjournal.org
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Various Observations Related to the Diagnosis of Retained Guide Wire, Timing of Detection, How It Was Detected, and the Additional Investigations Performed
Table 3.
Factors Related to the Diagnosis of Retained Guide Wires
Table 4. Complications Related to the Retained Guide Wire
n (%)
Lag time between procedure and detection of retained guide wire
Complications Related to the Guide Wire
n
Retroperitoneal hematoma
1
Gall bladder perforation with biliary peritonitis
1
Pulmonary embolism (massive)
1
20 (26.3)
Vertebral artery thrombosis causing posterior cerebral infarction
1
Immediately (during the procedure) Hours
17 (22.4)
Ventricular perforation causing pericardial effusion
1
Days
17 (22.4)
Cardiac tamponade
1
Months
13 (17.1)
Palpitation and chest pain
1
Years
8 (10.5)
Infective endocarditis
1
Not clearly mentioned (days to months)
1 (1.3)
Intra-abdominal fluid collection causing sepsis
1
Sternoclavicular abscess causing sepsis
1
Lower limb thrombosis
1
Guide wire retention first detected by The operator during the procedure
20 (26.3)
Inspection of the catheter tray after the procedure
2 (2.6)
Inspection of the catheter/check radiograph
2 (2.6)
Inspection when it projected out of the body
1 (1.3)
a
Check radiograph
11 (14.5)
Radiographs done later for problems unrelated to guide wire
18 (23.7)
Radiographs done later for problems related to guide wire
10 (13.2)
Values are expressed as numbers (n).
Table 5. The Fate of the Retained Guide Wire and Retrieval Methods Used Fate of Retained Guide Wires and Various Methods Applied for Their Retrieval
Condition of the guide wire during diagnosis or retrieval Adhered to the vessel wall/not adhered to vessel wall
9/67
Broken/intact
4/72
Coiled/not coiled
6/70 5/71
CT (abdomen/chest)
4 (5.3)
Echocardiography
3 (3.9)
Positron emission tomography scan
1 (1.3)
Coronary angiography
1 (1.3)
Partly or wholly lodged at extravascular site/ completely intravascular
Fluoroscopy while placing inferior vena cava filter
1 (1.3)
Retrieval of guide wire
Laparoscopy
1 (1.3)
Postmortem examination
1 (1.3)
Successful/failed/not attempted/not applicablea
28 (36.8)
CT scan
12 (15.8)
70/1/4/1
Method used for retrieval
Additional investigations because of the retained guide wire Radiograph
n
Percutaneous
51
Surgical exploration of soft tissues and vessels
14
Ultrasonography
8 (10.5)
Cardiac surgery
1
Echocardiography (transthoracic and transesophageal)
3 (3.9)
Laparoscopy assisted
1
2 (2.6)
Percutaneous and surgical exploration combined
4
CT angiography Electrocardiography
2 (2.6)
Not applicable
5
Pulmonary perfusion scintigraphy
1 (1.3)
MRI/magnetic resonance angiography
1 (1.3)
Laparoscopy
1 (1.3)
hile the official reading of check radiograph was pending, the nurse W handling the catheter also recognized the guide wire inside it. Values are expressed as numbers (percentage).
a
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Diagnosed postmortem. Values are expressed as numbers (n).
a
for six clinicians, and four of them performed it unsupervised (5, 23, 28, 44, 57). These are clear examples of inadequacy or lack of training. The use of a simulation exercise for vascular access can be incorporated into training programs with special August 2015 • Volume 43 • Number 8
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emphasis on patient safety (72). Lack of awareness about this complication may also be an important contributory factor (7, 51). Continuing medical education for generating awareness of this situation and its associated complications should be incorporated in ongoing credentialing programs for trainees and staff physicians at regular intervals. Guide wires were retained in spite of supervision in 17 cases, which suggests a lack of adequate close supervision or ineffective supervision during the procedure and which may be a result of ongoing management of the patient or concurrent management of other patients while supervising the procedure. In some cases, the supervision was focused on the aspiration of blood with the needle and easy passage of the guide wire and not on ensuring that the guide wire was removed (26, 54). Analysis of the events suggested that a few operators, while performing the procedure, were busy discussing patientrelated information with other physicians and were also making decisions about other sick patients (5, 17, 34, 43, 52). This might have worked as a distraction to the person performing the procedure. Unrealistic expectations of staff to cope with time pressures and workload are quite common at busy hospitals. Managing a very sick or unstable patient in such circumstances can even force quick completion of the CVC procedure as the entire team’s attention may get focused on other aspects of patient care (4, 8, 18, 21, 28, 32, 36, 42, 45, 50, 55, 61). High workload, especially outside routine hours with reduced number of clinicians, has also been highlighted by other authors as a contributing factor for performing the procedure without complete attention (5, 9, 12, 13, 24, 34, 41, 43, 49, 50, 63). Ensuring an adequate workforce, especially outside of normal working hours, and avoiding CVC outside routine hours unless urgent might help in reducing this avoidable complication. The second most important step in any complication lies in its timely detection for quick rectification. Interestingly, we found that the mistake was detected only while doing the procedure in less than one third of patients (6, 8–13, 29, 33, 41, 43–46, 48, 52, 56–58, 60). With the exception of two patients (61, 63), none of the remaining records mentioned the absence of the guide wire in the tray after the procedure. A focused, experienced nurse/paramedical staff (mandatory counting of the items at the end of the procedure) may help in the timely detection of such events (21). Another simple measure to detect such an error can be by looking at the correct central venous pressure waveform at the end of the procedure. The absence of free flow of the IV fluid through the catheter should also raise suspicion (5, 8, 23, 25, 28, 30, 36, 55, 56, 59, 63, 65, 67). Sick patients often have various other wires and tubes around their bodies, such as an electrocardiography wire and a feeding tube. These objects are mostly radio-opaque, and they can both mask and mimic a guide wire. Unfortunately, the lost guide wires were overlooked in more than two thirds of the routine check radiographs. The retained guide wires were detected only after suspicious and specific relook into the radiographs in many cases (7, 18, 20, 22, 27, 28, 38, 64, 66, 67). Clinicians also need to be wary of this complication. For instance, a physician Critical Care Medicine
had dismissed a radiologist report suggesting a lost guide wire (26). Hence, while reviewing the radiograph after a procedure, a high index of suspicion is needed to detect this complication. A lost guide wire inserted via the neck vein may not be visualized in the chest radiograph because of its possible migration to the inferior vena cava or the femoral vein (23). Furthermore, a postinsertion radiograph is not routinely practiced after the femoral vein puncture at many centers (25). Therefore, routine inspection of CVC set for the presence of a guide wire at the end of the procedure is a beneficial step toward early detection of a lost guide wire. Although the majority of patients with the retained guide wire have remained asymptomatic, they had to undergo additional interventions for its diagnosis and retrieval. Furthermore, a retained guide wire has caused serious complications in many instances too (16, 20, 24, 27, 34, 35, 37–39, 42). Minor symptoms, such as mild pain or lower limb swelling, are likely to remain overlooked and uninvestigated (7, 23). In some patients, problems such as persistently raised leukocytes, fever, swelling and tenderness of lower limb, or pulmonary embolism have also prompted further investigations, only to find a retained guide wire (7, 18, 21, 66, 67). As these nonspecific problems are very common in critically ill postoperative patients, it is difficult to attribute these conditions to a guide wire alone unless there is clear evidence, such as multiple thrombi or vegetations attached to a retained wire, as happened in three patients included in our analysis (16, 38, 66). The next important step for a retained intravascular guide wire is its safe retrieval soon after detection. In a small number of patients, however, the extraction of a retained guide wire was not attempted for reasons, including the absence of any symptoms and poor general condition of the patient, firm adherence of a guide wire to the vessel wall, or a difficult location or fragmentation in situ (14, 19, 20, 37, 47, 62). Removal in these patients was assumed to cause more harm than good. Among them, a patient developed sepsis after 1 month (37) and another patient developed cardiac tamponade after 2 years when the guide wire had spontaneously broken in the right atrium (20). The guide wires had to be removed later in both patients. These examples reemphasize the importance of retrieving a lost guide wire at the earliest opportunity. CVC with a Seldinger wire gained popularity because of its safety and ease of insertion compared with “on-a-needle” or “through-a-needle” techniques (2). Over the past 60 years, since its introduction, many technical advances have been accomplished for this technique of catheterization (2). Considering the safety of patients, its design may further be improved by changing the color/consistency of the last portion of a guide wire (18) or modifying the proximal tip of the wire that would latch onto the catheter hub if accidentally released (21). No modification can be a foolproof way to prevent human error; yet, adherence to the strict guideline of not inserting the guide wire beyond the 18–20 cm mark visible outside the skin may be a good preventive option (13, 29). Holding the guide wire firmly in one hand throughout the procedure is another recognized way to prevent its overinsertion inside the vascular system (5). www.ccmjournal.org
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There are several important limitations to our analysis. The first major limitation is that the reports provided variable information related to the loss of the guide wire. The data were incomplete in some cases. However, the majority of authors have subsequently provided additional information, making the data more authentic and reliable. Another limitation is that our interpretation is based on the analysis of only the detected and reported cases. A publication bias may have affected our analysis because we are dealing with an issue that is underreported in the literature. We do not know about the unreported or undetected cases. Nevertheless, from the existing reports in the literature, we have been able to generate detailed knowledge about the causative factors and consequences of lost guide wires. This may help to prevent such iatrogenic complication in the future.
CONCLUSIONS Based on this systematic analysis of published reports, we conclude that the reported instances of the loss of a guide wire during CVC are increasing rapidly. It may be undetected if the catheter tray is not checked properly at the end of a catheter insertion. A retained guide wire increases the risk of additional diagnostic and therapeutic interventions and many minor-to-serious life-threatening complications. Insertion of central catheters by trainees without adequate supervision, distractions during performance of the procedure, and a high workload are the main risk factors. Important steps to avoid this “never event” include continuing education as well as skill development, such as preinsertion training on a mannikin; creating awareness of the possibility of retained guide wires and its complications; effective supervision; strong vigilance during insertion; and provision of an adequate workforce, especially outside routine hours, as well as avoiding insertion at night unless essential.
ACKNOWLEDGMENT We acknowledge Dr. Milan Piya, University Hospitals Coventry and Warwickshire NHS Trust; Dr. Rahul Kashyap, Mayo Clinic; Professor Balkrishna Bhattarai, BPKIHS; and Dr Moritoki Egi, Kobe University Hospital, for their valuable literary contribution in the preparation of this article. We also thank Dr. Surendra Uraw and Dr. Surya Niraula, BPKIHS, for their valuable suggestions on statistics.
REFERENCES
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Review Articles 30. Sadek BH, Hanin H, Batta FZ, et al: Unrecognized migration of an entire guide wire during hemodialysis catheter placement. Saudi J Kidney Dis Transpl 2012; 23:1059–1060 31. Trabattoni D, Andreini D, Bartorelli AL: Unintentional embolization of a guide wire in the inferior vena cava during central venous catheter insertion successfully retrieved percutaneously 9 months later. Catheter Cardiovasc Interv 2014; 83:E109–E111 32. Chong CF: An unexpected image on chest radiograph—Dislodged central venous catheter guide wire. Resuscitation 2006; 68:162–163 33. Bream PR, Heffernan DS, Shukrallah B: Retrieval of a wire lost during central venous catheter replacement. A case report using a new technique for wire retrieval and a review of the literature. Endovasc Today 2008; 7:38–41 34. Bugnicourt JM, Belhomme D, Bonnaire B, et al: Posterior cerebral infarction following loss of guide wire. Case Rep Neurol Med 2013; 2013:164710 35. Kent J, Nedumpara T: Perforation of the gall bladder by a peripherally inserted central catheter guidewire: ‘If it can happen it will’. ANZ J Surg 2007; 77:190–191 36. Umesh G, Tim TJ, Paul A, et al: Difficulty in the diagnosis of a retained guidewire within the central venous catheter. J Cardiothorac Vasc Anesth 2013; 27:e25–e26 37. Chu FS, Tso WK, Lie AK: Percutaneous retrieval of a chronic foreign body with both intravascular and extravascular components. Australas Radiol 2007; 51:179–181 38. Gulel O, Soylu K, Yuksel S, et al: A forgotten guidewire causing intracardiac multiple thrombi with paradoxical and pulmonary embolism. Can J Cardiol 2013; 29:751.e15–751.e16 39. deGoma EM, Goldberg NJ, Karlsberg RP: Guidewire embolization and right ventricular perforation visualized by cardiac CT. J Cardiovasc Comput Tomogr 2011; 5:61–62 40. Rai R, Lawton N, Ullah J, et al: Lost guide wire during central venous cannulation and its surgical retrieval. Case Rep Clin Pract Rev 2002; 3:139–140 41. Pokharel K, Tripathi M, Rao SV, et al: Yet another missed central venous guidewire! Anaesth Intensive Care 2014; 42:263 42. Lin YN, Chou JW, Chen YH, et al: A 20-year retained guidewire, should it be removed? QJM 2013; 106:373–374 43. Struck MF, Kaden I, Heiser A, et al: Cross-over endovascular retrieval of a lost guide wire from the subclavian vein. J Vasc Access 2008; 9:304–306 44. Dowais AA, Hayeg OA, Samei H: Loss of guide wire, a rare completely avoidable complication of central venous catheterization. Internet J Surg 2009; 21:1 45. Ismael GY, Kamal DM: The lost guide wire. Bahrain Med Bull 2010; 32:2 46. Valero J, Barrerio J, Scez E: Central embolization of guide wire in a burn patient. Ann Burns Fire Dis 1996; 9:142–144 47. Turkmen M, Bitigen A, Tanalp AC, et al: A guidewire accidentally left in the venous system for 6 years. Turkish J Thorac Cardiovasc Surg 2004; 12:138–140 4 8. Collin GR, Russell JC: Lost guide wires: A case report showing a complication of central vein cannulation. Conn Med 1988; 52:521–523 49. Maddah G, Abdollahi A, Ali N, et al: Minimally invasive surgery in loss of the guide wire: Case report. J Minim Invasive Surg Sci 2012; 1:108–110 50. Sarkar PK, Mubarak K: A lost guidewire. Indian J Crit Care Med 2014; 18:481–482 51. Khasawneh FA, Smalligan RD: Guidewire-related complications during central venous catheter placement: A case report and review of the literature. Case Rep Crit Care 2011; 2011:287261
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52. Huang CC, Cha CM, Chen JH, et al: Emergency femoral central venous catheterization in an elderly patient complicated by distal guidewire migration. Int J Gerontol 2008; 2:133–135 53. Lee A, Lau K, Stuckey S: An endless line on the chest radiograph. BMJ Case Rep 2014; 10:2014 54. Yap KH, Lee PT, Buch M, et al: Incidental finding of a left-over guidewire on a positron emission tomography. Nucl Med Mol Imaging 2012; 46:320–321 55. Anwari JS, Imran S: Retention of central line guide wire. Saudi J Anaesth 2014; 8:443–445 56. Makhija N, Kiran U, Gandhi R: Malfunction of distal port of central venous catheter: Guide-wire embolization. J Anaesthesiol Clin Pharmacol 2009; 25:103–104 57. Bhosale G, Shah V: Guide-wire embolism: A preventable complication. J Anaesth Clin Pharmacol 2010; 26:425–426 58. Ramachandran R, Gaur A, Tyagi A, et al: An unusual complication of central venous cannulation. J Anaesthesiol Clin Pharmacol 2005; 21:225–227 59. Pearl JM, Donaldson NE: Surprise wire. AORN J 2010; 92: 250, 208 60. Hehir DJ, Cross KS, Kirkham R, et al: Foreign body complications of central venous catheterisation in critically ill patients. Ir J Med Sci 1992; 161:49–51 61. Srivastav R, Yadav V, Sharma D, et al: Loss of guide wire: A lesson learnt review of literature. J Surg Tech Case Rep 2013; 5:78–81 62. Tokarz SR, Aktas MK, Kroening D, et al: Identification of a retained intravascular wire by three-dimensional transesophageal echocardiography. Echocardiography 2009; 26:463–464 63. Parikh GP, Shonde S, Shah R, et al: A case of guidewire embolism during central venous catheterization: Better safe than sorry! Indian J Crit Care Med 2014; 18:831–833 64. Belhadj A, Balkhi H, Kechna H, et al: [Forgetting guidewire during central venous catheterization]. Ann Fr Anesth Reanim 2010; 29:253–254 65. Richa F, Yazigi A, El-Hage C, et al: [A simple technique to retrieve a guidewire forgotten within a central venous catheter]. Ann Fr Anesth Reanim 2010; 29:742–743 66. Flessenkämper I, Marcus M: [A lost Seldinger technique guide wire as the cause of deep venous thrombosis]. Anaesthesist 2001; 50:679–683 67. Huusom J, Kristensen PL: [Don’t always rely on PACS: Undetected loss of a central venous catheter guide wire]. Ugeskr Laeger 2005; 167:3891–3892 68. Larizgoitia I, Bouesseau MC, Kelley E: WHO efforts to promote reporting of adverse events and global learning. J Public Health Res 2013; 2:e29 69. World Health Organization: World Alliance for Patient Safety: WHO Draft Guidelines for Adverse Event Reporting and Learning Systems: From Information to Action. Geneva, Switzerland, WHO Press, 2005. Available at: http://www.who.int/patientsafety/events/05/Reporting_ Guidelines.pdf. Accessed December 21, 2013 70. National Quality Forum (NQF): Serious Reportable Events in Healthcare—2011 Update: A Consensus Report. Washington, DC, NQF, 2011 71. Mariyaselvam M, Clare T, Wijewardena G, et al: The incidence and complications of retained central line guide wires. In: Abstracts of the AAGBI Annual Congress, 17–19 September 2014, Harrogate, UK. Anaesthesia 2014; 69(Suppl 4):11–88 72. Barsuk JH, McGaghie WC, Cohen ER, et al: Simulation-based mastery learning reduces complications during central venous catheter insertion in a medical intensive care unit. Crit Care Med 2009; 37:2697–2701
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APPENDIX 1: Search Terms and Strategies for the Three Data Bases Employed (i.e., Pubmed, Scopus, and CINAHL) Pubmed: (“Catheterization, Central Venous/adverse effects”[Mesh] OR “Catheterization, Central Venous/instrumentation”[Mesh]) OR ((“guidewire”[All Fields] OR “guide wire”[All Fields]) AND (“retained”[All Fields] OR “missed”[All Fields] OR “missing”[All Fields] OR “lost”[All Fields] OR “loss”[All Fields] OR “forgotten”[All Fields] OR “migration”[All Fields] OR “embolism”[All Fields] OR “complications”[All Fields] OR “retrieval”[All Fields])) Scopus: (TITLE-ABS-KEY (catheter* AND central venous AND adverse events) OR TITLE-ABS-KEY ((retain* OR miss* OR loss* OR forgot* OR embolism* OR embolize OR retrieve* OR migrate* OR malposition*) AND (guidewire OR (guide AND wire)))) CINAHL: (MM “Catheterization, Central Venous+/AE/EI/ED”) OR central venous catheter guidewire OR missing guidewire OR lost guidewire OR guidewire loss OR retained guidewire OR guidewire retention OR missed guidewire OR guidewire embolism OR embolized guidewire OR forgotten guidewire OR misplaced guidewire OR malpositioned guidewire OR missing guide wire OR missed guide wire OR lost guide wire OR guide wire loss OR retained guide wire OR guide wire retention OR guide wire embolism OR embolized guide wire OR forgotten guide wire OR misplaced guide wire OR malpositioned guide wire
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Objective: The inadvertent loss of an entire guide wire during central venous catheterization can lead to serious patient harm and require additional investigations as well as retrieval procedures. We aimed to analyze globally published reports of lost wires during central venous catheterization to understand its possible etiology, presentation, treatment, and outcomes with an objective of finding solutions to make the procedure safer. Data Sources: MEDLINE, Scopus, and CINAHL, supplemented by scanning the reference lists of relevant publications. Study Selection: All reports describing an inadvertent intravascular loss of a complete guide wire during placement of central venous catheters published up to December 2014 were included. Reports exclusively describing the 1) retrieval method, 2) partially retained guide wires, and 3) entrapped guide wires during withdrawal were excluded. Data Extraction: In each instance, we collected data about the method of the missed guide wire detection, the time interval between the procedure and detection, the supplementary investigations performed to confirm the diagnosis, and the risk factors associated with such events as well as the complications, the final outcome, and the wire retrieval methods used. Data Synthesis: A systematic analysis of the accessed publications was performed. Conclusions: Over the last decade, the number of reported instances of lost guide wires during central venous catheterization has increased rapidly. Unsupervised or improperly supervised insertions of the central catheters by trainees, distractions during insertions, and high workload are the main risk factors. A retained guide wire increases the risk and cost of additional diagnostic and therapeutic interventions, as well as imposing many minor-to-serious life-threatening
Department of Anesthesiology and Critical Care, B.P. Koirala Institute of Health Sciences, Dharan, Nepal. 2 Department of Anesthesiology, ESI-Post Graduate Institute of Medical Science & Research, Kolkata, India. 3 Department of Anesthesiology, Sanjay Gandhi Post Graduate Institute of Medical Sciences, Lucknow, India. The authors have disclosed that they do not have any potential conflicts of interest. For information regarding this article, E-mail: [email protected] 1
Copyright © 2015 by the Society of Critical Care Medicine and Wolters Kluwer Health, Inc. All Rights Reserved. DOI: 10.1097/CCM.0000000000001012
Critical Care Medicine
complications. Continuing education along with simulator-based skill development, vigilant supervision, and a shared workload during out of hours working are likely to prevent such occurrences. (Crit Care Med 2015; 43:1745–1756) Key Words: adverse effect; arrhythmia; central venous catheter insertion; complications; guide wire; lost; missed; retained
P
ercutaneous central venous catheterization (CVC) is an integral part of patient care in the ICU, emergency department, and operating theater. The use of guide wires appears to be inherently safe in the hands of well-trained practitioners (1). The Seldinger technique (catheter over a guide wire) has established its superiority over other methods and is now the technique of choice worldwide (2). The guide wire should be retrieved from the body following the insertion of the catheter. Omission of this crucial step is an example of a “serious reportable event” that is more commonly referred to as a “never event.” A “never event” is defined as a serious, but largely preventable error in medical care that should never occur if healthcare workers have implemented the relevant preventive measures (3). A retained guide wire can cause serious harm to the patient, resulting in further costly investigations and additional procedures for its retrieval that are potentially harmful to the patient and may also result in medicolegal cases. The number of reports describing the loss of the entire guide wire has increased over the years, implying the lack of a foolproof mechanism for elimination of this problem. Therefore, we reviewed each instance of the inadvertent intravascular loss of the entire guide wire during CVC reported in the literature until December 2014 to understand its etiology, presentation, treatment, and outcome. We aimed to perform a root cause analysis of such instances with an objective of finding solutions to make this procedure safer.
MATERIALS AND METHODS Literature Search and Case Report Selection Two authors (K.P., A.S.) independently searched the MEDLINE, Scopus, and CINAHL databases (Appendix 1) to mark the articles eligible for further review by screening the titles and abstracts. The reports published until December 2014 describing the inadvertent loss of the entire guide wire within www.ccmjournal.org
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the vascular system were included. Relevant case reports in all languages were reviewed. If a publication could not be accessed electronically or in print, the authors were contacted by e-mail. Non-English publications were translated into English, using Google’s translation service. In addition, bibliographies of included citations and other relevant articles were also hand searched. This search strategy was done iteratively, until no new potential citations were found. Agreement between the two authors on case report selection was calculated using a Cohen κ statistic and reported with a 95% CI. Data Extraction Two authors (K.P., A.S.) then, independently, extracted data from all relevant reports (4–67) using a standardized form. The data were grouped as: the detection methods of the lost guide wires, investigations used to confirm/supplement the diagnosis, the time taken to detect the lost guide wire, the risk factors associated with such events, related complications, the fate of the guide wire, and the methods used for its retrieval. We also noted the operator’s qualifications, experience, and specialty as well as the presence of
distractions and other problems at the time the procedure was performed. All disagreements were resolved through discussion between two authors (K.P., A.S.) and, when necessary, with the third author (B.K.B.). We contacted the authors of the individual reports for clarification or missing information. The collected data were entered into a Microsoft Excel Spreadsheet (version 7.0; Microsoft Corporation, Redmond, WA) and analyzed using SPSS version 11.5 (SPSS Inc., Chicago, IL). Values were generally expressed as a percentage and as the number of patients. The fractional incidence was calculated using the software GraphPad Prism (version 6.1, San Diego, CA). The odds ratio was calculated to estimate the relative risk (benefit in our context).
RESULTS All abstracts and titles from 12,913 unique publications retrieved from the electronic database search were thoroughly screened. Among these, 146 publications were selected for fulltext review. Seventy-six incidents obtained from 64 publications met the inclusion criteria for analysis. Agreement between
Figure 1. A flow diagram describing the reports selection process.
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reporting the lost guide wire has increased rapidly since 2005 (Fig. 3). Reports of total eight cases had complete information. Additionally, we could retrieve most of the missing information in 34 cases (44.7%) through personal communication with the corresponding authors. For others (n = 34; 44.7%), it could not be done because the authors did not respond (n = 21), because they had incomplete records (n = 6), or because the e-mail addresses were not working/published (n = 7). The distal end of the lost guide wires got lodged at various intravascular sites—the majority in the inferior vena cava (Table 1). Twenty-six CVCs were performed for emergency conditions, 42 were performed for routine management of Figure 2. Publications from various continents. patients, and clear descriptions of indications for catheter inserthe two investigators at the full-text review stage was excellent, tions were not available in eight cases. Operator’s details were available in only 57 of the cases. as indicated by a κ of 0.96 (95% CI, 0.93–0.98) (Fig. 1). Asian continent accounted for a little less than half (n = 31; The majority (n = 47; 82.4%) were performed either by doc46.9%) of the publications (Fig. 2). The number of publications tors without prior exposure to the central catheter insertions with the Seldinger technique or by trainees. The status of supervision was not clear from the reports describing four procedures. Among the remaining 43 cannulations performed by these clinicians, 25 (58.1%) were unsupervised (Table 2). Distraction (n = 16) was the most frequently reported risk factor as perceived by the performer for the loss of guide wires (fractional incidence, 0.280; 95% CI, 0.182–0.396). Distraction as a cause included factors like ongoing care of other sick patients (n = 4), simultaneous other procedures like transesophageal echocardiography (n = 3), surgery (n = 1), nursing care (n = 1), and handing over of patient information (n = 1). Distractors were not specified in six instances. High workload Figure 3. Trend in reporting retained central venous guide wires in the literature. CVC = central venous or busy day (n = 14), very sick catheterization. Critical Care Medicine
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Table 1.
Lodged
Various Sites Where the Distal Tip of the Lost Guide Wire Was Reported to be Access Sites
Location of the Distal Tip of Guide Wire
Cubital Vein (n = 4)
Internal Jugular Vein (n = 45)
Subclavian Vein (n = 9)
Femoral Vein (n = 17)
Cubital vein
1
Internal jugular vein
4
Subclavian vein
5
Superior vena cava
1
Right ventricle
1
Right ventricular outflow tract
1
3
Multiplea (n = 1)
1 1
Heart
1
Inferior vena cava
1
16
Hepatic vein
2
Common iliac vein
7
Internal iliac vein
2
External iliac vein
1
Common femoral vein
2
Femoral vein
7
Abdominal aorta
1
Extravascular
1b
2c,d
Unknown
3
4
2 2 1e
1f
Not mentioned
1
1
Multiple catheters were inserted from different sites. b Protruded out in peritoneal cavity from the gall bladder. c Subcutaneous tissue in neck. d Pelvis. e Projected out of the body from back of the neck. f Radiograph not taken. a
patient with unstable hemodynamics (n = 13), procedure performed during the night shift (n = 13), and use of two catheter kits (n = 12) were reported as other important risk factors (Fig. 4). Altogether, in 23 cases (30.3%), the loss of the guide wire was detected either during the procedure (n = 21) or just immediately after its completion while checking the equipment tray (n = 2) (Table 3). In the rest of the cases, the absence of the guide wire in the equipment tray remained undetected following completion of the procedures (n = 53; 69.7%). Postprocedural radiograph was performed in 61 patients. Among these, 19 radiographs were done to locate or confirm the lost guide wire and 42 radiographs were performed as a part of the routine protocol of CVC. Interestingly, in all those radiographs (n = 19) done following realization of the loss of the guide wire, the guide wire was easily identified at first glance. Surprisingly, despite being clearly visible, the guide wires went unnoticed at the initial reading of the majority (n = 29; 69%) 1748
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of routine radiographs performed as part of routine protocol following CVC. They were detected later retrospectively by reevaluating the radiographs. This gives a relative benefit of 0.7 of getting a radiograph done for immediate identification of the missed guide wire. Interestingly, a missing guide wire was completely absent in one postinsertion radiograph. In a small number of patients (n = 6), the check radiographs were not performed at the end of the CVC. Four of these central catheters were placed through the femoral vein. The information about the check radiograph was not available in the reports of the remaining patients (n = 9). Various other modalities, such as neck, chest, abdominal, and pelvic radiographs, CT scans, ultrasonography, echocardiography, and angiography, were used for the detection of the lost guide wires. In one patient, the guide wire was noticed when it had projected out of the body (Table 3). In over half of the cases (n = 39; 51.3%), the intravascular loss of the guide wires was only suspected after a lag period of a few days to years (Table 3). August 2015 • Volume 43 • Number 8
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Table 2. Explaining the Operator Qualification and Supervision During the Central Catheter Insertion Serial Number
Operator Qualification
Years in Training/ Experience (Yr)
Prior Insertions (n)
Supervision
1
Intern
—
—
Unknown
2
Intern
—
—
No
3
Intern
—
—
Yes
4
Trainee anesthetist
First year
—
Yes
5
Trainee anesthetist
First year
0
No
6
Trainee anesthetist
First year
0
Yes
7
Trainee anesthetist
First year
21
Yes
8
Trainee anesthetist
First year
20–30
Yes
9
Trainee anesthetist
Second year
12
Yes
10
Trainee anesthetist
Second year
10
Yes
11
Trainee anesthetist
Second year
48
Yes
12
Trainee anesthetist
Second year
20
No
13
Trainee anesthetist
Second year
—
No
14
Trainee anesthetist
Third year
83
Yes
15
Trainee anesthetist
Third year
7
Yes
16
Trainee anesthetist
Third year
—
Yes
17
Trainee anesthetist
Third year
Few times
Yes
18
Trainee anesthetist
Fourth year
—
No
19
Trainee anesthetist
Fifth year
—
No
20
Trainee anesthetist
—
—
Yes
21
Senior resident anesthetist
First year
10
No
22
Senior resident anesthetist
Fourth year
0
Yes
23
Senior resident anesthetist
—
—
No
24
Senior resident anesthetist
Many years
—
No
25
Registrar anesthetist
Second year
—
Yes
26
Registrar anesthetist
Second year
—
No
27
Registrar anesthetist
Second year
—
No
28
Trainee
—
—
Unknown
29
Trainee surgeon
First year
—
No
30
Trainee surgeon
First year
—
No
31
Trainee surgeon
Second year
5
No
32
Senior resident plastic surgery
—
500
No
33
Resident surgeon
—
—
Yes
34
Junior resident in critical care
—
50
No
35
Resident
—
—
Yes
36
Resident
—
—
Unknown
37
Resident
—
—
Unknown
(Continued) Critical Care Medicine
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Table 2. (Continued ). Explaining the Operator Qualification and Supervision During the Central Catheter Insertion Serial Number
Operator Qualification
Years in Training/ Experience (Yr)
Prior Insertions (n)
Third year
—
No
Second year
—
No
Supervision
38
Resident internal medicine
39
Trainee physician
40
Emergency physician
—
—
No
41
Emergency physician
One
—
Yes
42
Emergency physician
—
—
No
43
Senior resident at Emergency unit
—
—
No
44
Physician
—
0
No
45
Cardiologist
Two
0
No
46
Consultant neurologist
—
a
0
No
47
Hospitalist
Newly graduated
—
No
48
Nephrologist
—
—
Unknown
49
Clinician
Several years
—
NA
50
Internal medicine specialist
—
—
NA
51
Intensivist
Eight
—
NA
52
Consultant intensivist
—
—
NA
53
Consultant anesthesiologist
Two
—
NA
54
Consultant anesthesiologist
Twelve
—
NA
55
Consultant anesthesiologist
Twenty seven
—
NA
56
Anesthesiologist
Thirty seven
—
NA
57
Anesthesiologist
Twenty three
—
NA
NA = not applicable. a Experienced at central venous catheterizations, but not Seldinger technique. Dash (—) indicates not mentioned.
The longest gap was 20 years. The guide wires were incidentally detected at centers other than where originally inserted on seven occasions. In one patient, the retained guide wire was incidentally detected during the postmortem examination. The loss of the guide wire was realized before aspirating and flushing of catheters during CVC in 15 patients; hence, these steps were not performed. The reports of 17 cases had no clear information related to these steps after catheter insertion. Among the remaining 44 cases, warning signs of the left-behind guide wires, such as inadequate flow of fluids, nonfunctional catheter, or resistance during aspirating and flushing through the catheter, were present in 14 patients (31.8%). Apart from the functional problems of the catheter, the majority of patients (n = 58; 76.3%) with the retained guide wire remained asymptomatic until detection. Other patients (n = 18; 23.7%) developed a variety of problems while the guide wire was retained inside the body. Problems that occurred within a few days of catheter insertion include retroperitoneal hematoma (n = 1); gall bladder perforation, causing biliary peritonitis (n = 1); pulmonary embolism (n = 1); and vertebral artery 1750
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thrombosis, resulting in posterior cerebral infarction (n = 1). There were several others that had a delayed presentation of a period of a few months to years following catheter insertion like ventricular perforation (n = 1), cardiac tamponade (n = 1), severe chest pain with palpitations (n = 1), massive pulmonary embolism (n = 1), infective endocarditis (n = 1), and sepsis (n = 2) (Table 4). All of these potentially life-threatening conditions had strong clinical and laboratory evidence to support the causal relation to the retained guide wire, except in the case of the development of a mild pulmonary embolism in one patient. Less severe problems following retention of the guide wire included mild neck pain on the 2nd postprocedure day, fever on the 12th day, leukocytosis on the 8th day, and pain and swelling of lower limbs on the 4th day, 4th week, and 5th month. Among the latter, one patient had the guide wire embedded inside a thrombus (Table 4). A patient with a retained guide wire for more than 9 years had developed low-grade hemostatic activation and increased fibrin turnover (elevated d-dimer and plasminogen activator inhibitor-1 activity). Among all the retained guide wires, four were fragmented inside the body (Table 5). August 2015 • Volume 43 • Number 8
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Review Articles
Figure 4. Frequency of identified risk factors for guide wire loss.
Seventy-one patients were subjected to removal procedures. Percutaneous extraction was the preferred method (n = 55; 77.5%) (Table 5). Some of the guide wires were easily retrieved by simply pulling the entire catheter-guide wire assembly after clamping and/or aspiration through the catheter (n = 12), whereas many others required additional devices, such as snares (n = 17), catheter/forceps/wire (n = 3), and dormia basket (n = 3). The technique of percutaneous guide wire removal was not specified in 20 patients. Surgical exploration was done mostly when the percutaneous removal had failed or the setup and expertise were unavailable. In one patient, a guide wire was firmly incorporated into the vessel and the attempts to pull it triggered ventricular arrhythmia, causing clinicians to decide to terminate the retrieval procedure. Removal was not attempted when the guide wires were adhered to the blood vessel wall (n = 2), fragmented into multiple pieces (n = 1), or coiled in a difficult location such as the pulmonary artery (n = 1).
DISCUSSION Our literature search indicated that the prevalence of inadvertent IV loss of a complete guide wire is not uncommon and takes place globally. Although only six reports were published before 2000, there has been an abrupt rise in the reporting of such incidents since 2005. This may be because of the increasing access to journals where it is easier to publish cases rather than the actual increase in the frequency. To some extent, this may also be the result of the fact that there has been a paradigm shift in the culture of “blaming an individual performance” to “learning from root cause analysis” (68). The latter identifies and attempts to rectify the underlying system failure that may Critical Care Medicine
have been responsible for such “never events.” Existing national reporting systems are mostly voluntary and nongovernmental, so critical event reporting remains largely variable (69). In the United States, for example, there is no national government reporting system with well-defined reportable events and the type of information reported varies between states (69). Guide wire retention is included in the National Quality Forum (United States)-endorsed list of 27 “serious reportable events” that should be reported and investigated by all healthcare facilities when it occurs (70). A uniform global reporting mechanism might help to generate reliable data and identify errors that may be associated with such serious events, like loss of the guide wire during CVC. We cannot comment on the prevalence of the lost guide wires based on this review of the published reports. It is widely agreed that such events are likely to remain grossly underreported due to the clinicians’ fear of blame as well as retaliation, lawsuits, and accusations of incompetence (7, 71). As a majority of the retained guide wires in our analysis was an incidental finding, we assume that many errors might have remained undetected and hence unreported. Although human error was a factor in these cases, there was evidence of system failures in many of the cases. In our pooled data from 76 cases, the major identifiable risk factors for the intravascular loss of the guide wire during CVC included the practitioner’s inexperience in either the Seldinger technique or the CVC equipment and the lack of adequate supervision during the procedure. We were able to obtain the information regarding the experience of prior central catheter insertions on 17 operators. Surprisingly, the procedure in which the incident had taken place was their first opportunity of performing CVC www.ccmjournal.org
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Various Observations Related to the Diagnosis of Retained Guide Wire, Timing of Detection, How It Was Detected, and the Additional Investigations Performed
Table 3.
Factors Related to the Diagnosis of Retained Guide Wires
Table 4. Complications Related to the Retained Guide Wire
n (%)
Lag time between procedure and detection of retained guide wire
Complications Related to the Guide Wire
n
Retroperitoneal hematoma
1
Gall bladder perforation with biliary peritonitis
1
Pulmonary embolism (massive)
1
20 (26.3)
Vertebral artery thrombosis causing posterior cerebral infarction
1
Immediately (during the procedure) Hours
17 (22.4)
Ventricular perforation causing pericardial effusion
1
Days
17 (22.4)
Cardiac tamponade
1
Months
13 (17.1)
Palpitation and chest pain
1
Years
8 (10.5)
Infective endocarditis
1
Not clearly mentioned (days to months)
1 (1.3)
Intra-abdominal fluid collection causing sepsis
1
Sternoclavicular abscess causing sepsis
1
Lower limb thrombosis
1
Guide wire retention first detected by The operator during the procedure
20 (26.3)
Inspection of the catheter tray after the procedure
2 (2.6)
Inspection of the catheter/check radiograph
2 (2.6)
Inspection when it projected out of the body
1 (1.3)
a
Check radiograph
11 (14.5)
Radiographs done later for problems unrelated to guide wire
18 (23.7)
Radiographs done later for problems related to guide wire
10 (13.2)
Values are expressed as numbers (n).
Table 5. The Fate of the Retained Guide Wire and Retrieval Methods Used Fate of Retained Guide Wires and Various Methods Applied for Their Retrieval
Condition of the guide wire during diagnosis or retrieval Adhered to the vessel wall/not adhered to vessel wall
9/67
Broken/intact
4/72
Coiled/not coiled
6/70 5/71
CT (abdomen/chest)
4 (5.3)
Echocardiography
3 (3.9)
Positron emission tomography scan
1 (1.3)
Coronary angiography
1 (1.3)
Partly or wholly lodged at extravascular site/ completely intravascular
Fluoroscopy while placing inferior vena cava filter
1 (1.3)
Retrieval of guide wire
Laparoscopy
1 (1.3)
Postmortem examination
1 (1.3)
Successful/failed/not attempted/not applicablea
28 (36.8)
CT scan
12 (15.8)
70/1/4/1
Method used for retrieval
Additional investigations because of the retained guide wire Radiograph
n
Percutaneous
51
Surgical exploration of soft tissues and vessels
14
Ultrasonography
8 (10.5)
Cardiac surgery
1
Echocardiography (transthoracic and transesophageal)
3 (3.9)
Laparoscopy assisted
1
2 (2.6)
Percutaneous and surgical exploration combined
4
CT angiography Electrocardiography
2 (2.6)
Not applicable
5
Pulmonary perfusion scintigraphy
1 (1.3)
MRI/magnetic resonance angiography
1 (1.3)
Laparoscopy
1 (1.3)
hile the official reading of check radiograph was pending, the nurse W handling the catheter also recognized the guide wire inside it. Values are expressed as numbers (percentage).
a
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Diagnosed postmortem. Values are expressed as numbers (n).
a
for six clinicians, and four of them performed it unsupervised (5, 23, 28, 44, 57). These are clear examples of inadequacy or lack of training. The use of a simulation exercise for vascular access can be incorporated into training programs with special August 2015 • Volume 43 • Number 8
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Review Articles
emphasis on patient safety (72). Lack of awareness about this complication may also be an important contributory factor (7, 51). Continuing medical education for generating awareness of this situation and its associated complications should be incorporated in ongoing credentialing programs for trainees and staff physicians at regular intervals. Guide wires were retained in spite of supervision in 17 cases, which suggests a lack of adequate close supervision or ineffective supervision during the procedure and which may be a result of ongoing management of the patient or concurrent management of other patients while supervising the procedure. In some cases, the supervision was focused on the aspiration of blood with the needle and easy passage of the guide wire and not on ensuring that the guide wire was removed (26, 54). Analysis of the events suggested that a few operators, while performing the procedure, were busy discussing patientrelated information with other physicians and were also making decisions about other sick patients (5, 17, 34, 43, 52). This might have worked as a distraction to the person performing the procedure. Unrealistic expectations of staff to cope with time pressures and workload are quite common at busy hospitals. Managing a very sick or unstable patient in such circumstances can even force quick completion of the CVC procedure as the entire team’s attention may get focused on other aspects of patient care (4, 8, 18, 21, 28, 32, 36, 42, 45, 50, 55, 61). High workload, especially outside routine hours with reduced number of clinicians, has also been highlighted by other authors as a contributing factor for performing the procedure without complete attention (5, 9, 12, 13, 24, 34, 41, 43, 49, 50, 63). Ensuring an adequate workforce, especially outside of normal working hours, and avoiding CVC outside routine hours unless urgent might help in reducing this avoidable complication. The second most important step in any complication lies in its timely detection for quick rectification. Interestingly, we found that the mistake was detected only while doing the procedure in less than one third of patients (6, 8–13, 29, 33, 41, 43–46, 48, 52, 56–58, 60). With the exception of two patients (61, 63), none of the remaining records mentioned the absence of the guide wire in the tray after the procedure. A focused, experienced nurse/paramedical staff (mandatory counting of the items at the end of the procedure) may help in the timely detection of such events (21). Another simple measure to detect such an error can be by looking at the correct central venous pressure waveform at the end of the procedure. The absence of free flow of the IV fluid through the catheter should also raise suspicion (5, 8, 23, 25, 28, 30, 36, 55, 56, 59, 63, 65, 67). Sick patients often have various other wires and tubes around their bodies, such as an electrocardiography wire and a feeding tube. These objects are mostly radio-opaque, and they can both mask and mimic a guide wire. Unfortunately, the lost guide wires were overlooked in more than two thirds of the routine check radiographs. The retained guide wires were detected only after suspicious and specific relook into the radiographs in many cases (7, 18, 20, 22, 27, 28, 38, 64, 66, 67). Clinicians also need to be wary of this complication. For instance, a physician Critical Care Medicine
had dismissed a radiologist report suggesting a lost guide wire (26). Hence, while reviewing the radiograph after a procedure, a high index of suspicion is needed to detect this complication. A lost guide wire inserted via the neck vein may not be visualized in the chest radiograph because of its possible migration to the inferior vena cava or the femoral vein (23). Furthermore, a postinsertion radiograph is not routinely practiced after the femoral vein puncture at many centers (25). Therefore, routine inspection of CVC set for the presence of a guide wire at the end of the procedure is a beneficial step toward early detection of a lost guide wire. Although the majority of patients with the retained guide wire have remained asymptomatic, they had to undergo additional interventions for its diagnosis and retrieval. Furthermore, a retained guide wire has caused serious complications in many instances too (16, 20, 24, 27, 34, 35, 37–39, 42). Minor symptoms, such as mild pain or lower limb swelling, are likely to remain overlooked and uninvestigated (7, 23). In some patients, problems such as persistently raised leukocytes, fever, swelling and tenderness of lower limb, or pulmonary embolism have also prompted further investigations, only to find a retained guide wire (7, 18, 21, 66, 67). As these nonspecific problems are very common in critically ill postoperative patients, it is difficult to attribute these conditions to a guide wire alone unless there is clear evidence, such as multiple thrombi or vegetations attached to a retained wire, as happened in three patients included in our analysis (16, 38, 66). The next important step for a retained intravascular guide wire is its safe retrieval soon after detection. In a small number of patients, however, the extraction of a retained guide wire was not attempted for reasons, including the absence of any symptoms and poor general condition of the patient, firm adherence of a guide wire to the vessel wall, or a difficult location or fragmentation in situ (14, 19, 20, 37, 47, 62). Removal in these patients was assumed to cause more harm than good. Among them, a patient developed sepsis after 1 month (37) and another patient developed cardiac tamponade after 2 years when the guide wire had spontaneously broken in the right atrium (20). The guide wires had to be removed later in both patients. These examples reemphasize the importance of retrieving a lost guide wire at the earliest opportunity. CVC with a Seldinger wire gained popularity because of its safety and ease of insertion compared with “on-a-needle” or “through-a-needle” techniques (2). Over the past 60 years, since its introduction, many technical advances have been accomplished for this technique of catheterization (2). Considering the safety of patients, its design may further be improved by changing the color/consistency of the last portion of a guide wire (18) or modifying the proximal tip of the wire that would latch onto the catheter hub if accidentally released (21). No modification can be a foolproof way to prevent human error; yet, adherence to the strict guideline of not inserting the guide wire beyond the 18–20 cm mark visible outside the skin may be a good preventive option (13, 29). Holding the guide wire firmly in one hand throughout the procedure is another recognized way to prevent its overinsertion inside the vascular system (5). www.ccmjournal.org
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There are several important limitations to our analysis. The first major limitation is that the reports provided variable information related to the loss of the guide wire. The data were incomplete in some cases. However, the majority of authors have subsequently provided additional information, making the data more authentic and reliable. Another limitation is that our interpretation is based on the analysis of only the detected and reported cases. A publication bias may have affected our analysis because we are dealing with an issue that is underreported in the literature. We do not know about the unreported or undetected cases. Nevertheless, from the existing reports in the literature, we have been able to generate detailed knowledge about the causative factors and consequences of lost guide wires. This may help to prevent such iatrogenic complication in the future.
CONCLUSIONS Based on this systematic analysis of published reports, we conclude that the reported instances of the loss of a guide wire during CVC are increasing rapidly. It may be undetected if the catheter tray is not checked properly at the end of a catheter insertion. A retained guide wire increases the risk of additional diagnostic and therapeutic interventions and many minor-to-serious life-threatening complications. Insertion of central catheters by trainees without adequate supervision, distractions during performance of the procedure, and a high workload are the main risk factors. Important steps to avoid this “never event” include continuing education as well as skill development, such as preinsertion training on a mannikin; creating awareness of the possibility of retained guide wires and its complications; effective supervision; strong vigilance during insertion; and provision of an adequate workforce, especially outside routine hours, as well as avoiding insertion at night unless essential.
ACKNOWLEDGMENT We acknowledge Dr. Milan Piya, University Hospitals Coventry and Warwickshire NHS Trust; Dr. Rahul Kashyap, Mayo Clinic; Professor Balkrishna Bhattarai, BPKIHS; and Dr Moritoki Egi, Kobe University Hospital, for their valuable literary contribution in the preparation of this article. We also thank Dr. Surendra Uraw and Dr. Surya Niraula, BPKIHS, for their valuable suggestions on statistics.
REFERENCES
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APPENDIX 1: Search Terms and Strategies for the Three Data Bases Employed (i.e., Pubmed, Scopus, and CINAHL) Pubmed: (“Catheterization, Central Venous/adverse effects”[Mesh] OR “Catheterization, Central Venous/instrumentation”[Mesh]) OR ((“guidewire”[All Fields] OR “guide wire”[All Fields]) AND (“retained”[All Fields] OR “missed”[All Fields] OR “missing”[All Fields] OR “lost”[All Fields] OR “loss”[All Fields] OR “forgotten”[All Fields] OR “migration”[All Fields] OR “embolism”[All Fields] OR “complications”[All Fields] OR “retrieval”[All Fields])) Scopus: (TITLE-ABS-KEY (catheter* AND central venous AND adverse events) OR TITLE-ABS-KEY ((retain* OR miss* OR loss* OR forgot* OR embolism* OR embolize OR retrieve* OR migrate* OR malposition*) AND (guidewire OR (guide AND wire)))) CINAHL: (MM “Catheterization, Central Venous+/AE/EI/ED”) OR central venous catheter guidewire OR missing guidewire OR lost guidewire OR guidewire loss OR retained guidewire OR guidewire retention OR missed guidewire OR guidewire embolism OR embolized guidewire OR forgotten guidewire OR misplaced guidewire OR malpositioned guidewire OR missing guide wire OR missed guide wire OR lost guide wire OR guide wire loss OR retained guide wire OR guide wire retention OR guide wire embolism OR embolized guide wire OR forgotten guide wire OR misplaced guide wire OR malpositioned guide wire
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August 2015 • Volume 43 • Number 8
Copyright © 2015 by the Society of Critical Care Medicine and Wolters Kluwer Health, Inc. All Rights Reserved.
