Quality-of-life assessment

JVA ISSN 1129-7298

J Vasc Access 2016; 17 (6): 527-534 DOI: 10.5301/jva.5000609

ORIGINAL RESEARCH ARTICLE

Quality-of-life assessment: arm TIVAD versus chest TIVAD Brent Burbridge1, Kunal Goyal2 Medical Imaging, Royal University Hospital, Saskatoon, Saskatchewan - Canada Department of Diagnostic Radiology, Regina General Hospital, Regina, Saskatchewan - Canada

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Abstract Introduction: Venous access devices are essential for the provision of care for patients requiring chemotherapy. Totally implanted venous access devices (TIVADs), also known as ports, are an option for infusion care. Medical devices have an impact upon patient quality of life. We assessed the impact on quality of life and satisfaction with their venous device, for patients with a chest TIVAD versus an upper arm TIVAD. Materials and methods: Sequential subjects were administered a questionnaire, “Quality of Life Assessment, Venous Device - Port (QLAVD-P)” at the time of their TIVAD removal. All subjects consented to complete the questionnaire and volunteered for this assessment. The TIVADs were all implanted and removed in the medical imaging department. Results: Between March 1, 2014 and August 30, 2015, 127 subjects completed the QLAVD-P. At the time of their port removal, 51 had chest ports while 76 had arm ports. There were some negative features of the chest ports that were statistically significant in comparison to the arm ports. Most of the subjects felt that their port had a positive impact upon their treatment and they would have another port inserted if required for future treatment. Discussion: Quality of life for those requiring intravenous chemotherapy is very important. This should be considered when selecting an infusion device. Venous ports were positively received by the subjects in our study and there were fewer negative impacts upon subject satisfaction and quality of life for those with upper-arm devices. Keywords: Arm implantation, Chest implantation, Quality of life, TIVADs

Introduction

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Implanted medical devices have an impact upon patient quality of life (1). There are a wide variety of possible venous access devices available to facilitate infusion therapy. Some of these devices are external while others are implanted subcutaneously. Two different anatomic sites for totally implanted venous access devices (TIVADs), or port devices, were investigated to determine if there was any discernible differential in quality of life. The anatomic sites investigated were the chest and the upper arm. Venous access device-specific assessment tools that evaluate the impact of TIVADS upon patient quality of life and satisfaction with their infusion device are lacking. There are Accepted: July 22, 2016 Published online: October 15, 2016 Corresponding author: Dr. Brent Burbridge Medical Imaging Royal University Hospital 103 Hospital Drive Saskatoon, SK S7N 0W8, Canada [email protected]

© 2016 Wichtig Publishing

no standardized, validated, tools that have been deployed in a clinical setting. Marcy et al (2), have recently published findings about their development, and validation, of a qualityof-life survey for patients with venous access devices. Their project began with a large number of patient questions that they tested, revised and shortened to 27 questions in total. They called this assessment tool the Questionnaire for Acceptance of and Satisfaction with Implanted Central Venous Catheter (QASICC). They felt that this survey tool required further testing and utilization for more specific patient groups in order to assess the utility and value of their work. Also, the majority of their work was done in French and then translated into English, which also will require further testing and analysis (2). In order to perform an assessment of the effects of implanted chest and arm ports in our jurisdiction, we created a locally designed, paper-based, questionnaire to evaluate patient satisfaction with their venous device and the impact of their TIVAD upon their quality of life. This questionnaire was entitled, Quality of Life Assessment, Venous Device - Port (QLAVD-P). This questionnaire was created by a group of interventional radiologists in consultation with a medical oncologist by incorporating some of the questions used by Marcy et al (2), and by developing unique local content to result in the QLAVD-P. The QLAVD-P comprised 32 questions.

Quality of life TIVADs

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TABLE I - The QLAVD-P questionnaire

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This project was reviewed, and approved, by the imaging departments of the health regions involved, and the project received ethics approval from the University of Saskatchewan Research Ethics Committee. All subjects in the project provided written consent for participation. There were no incentives offered to subjects of this study. Sequential subjects were prospectively administered a paper-based quality-of-life assessment tool to evaluate the impact of the port they had implanted for chemotherapy to treat a malignancy. The QLAVD-P was used as the questionnaire document. The content of the questionnaire utilized is provided for review in Table I. The questionnaire was completed by the subject when they attended to have their vein port removed at completion of their treatment or for a port-related complication. Data collection took place between March 1, 2014 and August 30, 2015. The two ports compared were the Bard PowerPort® MRI (Bard Access Systems Inc., Salt Lake City, UT, USA) chest

port and the Cook Vital Petite Mini Titanium arm port (Cook Medical, Bloomington, IN, USA). Both of the devices evaluated were implanted by vascular interventional radiologists utilizing ultrasound, venography, and fluoroscopy for imaging guidance. The arm ports were implanted proximal to the antecubital fossa. The port implantation procedures were facilitated by local anesthetic. Conscious sedation was administered at the discretion of the responsible radiologist. Implantation techniques for these devices have been extensively discussed by previous authors (3, 4). The chest vein ports were implanted in the Regina Qu’Appelle Health Region and the arm ports were implanted in the Saskatoon Health Region. Subjects were not given the choice to receive an arm or chest port. The health regions in question were separated by 250 kilometers geographically, and patient care was planned and administered by two totally different healthcare teams. There was no cross-over of subjects from one health region to the other. The catheter size for the Bard port was 8F while the Cook port had a 5F catheter. Technical specifications of the devices used are provided in Table II. The ports are demonstrated in Figure 1.

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Materials and methods

Appendix 1. Subject satisfaction and quality-of-life questionnaire Are you right or left handed?

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Arm used for port implantation?

3

Did you choose which arm you wanted the port implanted in?

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Right

Left

Right

Left

Yes

No

Yes

No

If No, please explain why, if possible. 4

Do you find it easy to present your port for treatment or blood sampling? If No, what issues do you encounter?

5

Please tell us how painful it was for you to have your port implanted. (Circle a number) 1 2 3 4 5 6 7 8 9 10

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Minimal Discomfort

Moderate Severe Discomfort Discomfort

Do you feel that your port is too visible?

Yes

No

7

Do you feel that your port is unsightly or ugly?

Yes

No

Do you feel that you have changed the way you dress due to your port?

Yes

No

8 9

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6

Have people commented on your port when they see it?

Yes

No

10

Do you try and cover your port with clothing?

Yes

No

11

Does your port make you feel anxious (worried)?

Yes

No

12

Does your port make you feel angry?

Yes

No

13

Does your port make you feel self-conscious?

Yes

No

14

Does your port remind you of your illness?

Yes

No

15

Does your port make you feel embarrassed?

Yes

No

16

Are you worried that your port might become damaged?

Yes

No

17

Are you worried that your port might become blocked?

Yes

No

18

Are you worried that your port might become infected?

Yes

No

To be continued


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TABLE I - Continued 19

Does your port bother you when performing your work related activities?

Yes

No

Yes

No

Yes

No

Yes

No

Yes

No

Yes

No

If Yes, please explain how. 20

Does your port bother you when you shower, bath, or perform personal hygiene? If Yes, please explain how.

21

Does your port bother you when you engage in sports or exercise? If Yes, please explain how. Does your port bother you during social activities?

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If Yes, please explain how. 23

Does your port bother you when you are lying down in bed? If Yes, please explain how.

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Does your port hurt? If Yes, please explain how.

Rate the degree of discomfort you experience during needle insertion into the port. (Circle a number)

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1 2 3 4 5 6 7 8 9 10

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Minimal Discomfort

Rate the degree of discomfort you experience during treatment infusion. (Circle a number) 1 2 3 4 5 6 7 8 9 10

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Minimal Discomfort

Rate the degree of discomfort you experience during needle removal after treatment. (Circle a number) 1 2 3 4 5 6 7 8 9 10 Minimal Discomfort

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Do you believe that insertion of your port was a good thing to have done? (Circle a number) 1 2 3 4 5 6 7 8 9 10 No

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Probably

Definitely

Assess your degree of satisfaction with your port. (Circle a number) 1 2 3 4 5 6 7 8 9 10

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Not Satisfied

30

Moderately Satisfied

Very Satisfied

If you had to have a port implanted for another session of treatment during your life, would you have another one inserted? (Circle a number) 1 2 3 4 5 6 7 8 9 10 No

31

32

Probably

Definitely

Why are you having your ports removed? (Please check one answer below) –

My treatment is complete my port is no longer needed.

–

I am having a problem with the port that requires it to be removed.

–

If you are having a problem with your port that requires it to be removed, please provide an explanation of the problem.

Please feel free to provide any other comments that you feel are relevant.



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Feature

Cook, Vital, Bard, Petite, Mini Port PowerPort MRI

Height

7.2 mm

14.5 mm

Width of the port base

19 mm

29.9 mm

Septum diameter

6.6 mm

12 mm

Septum surface area

35 mm

113 mm2

Volume of the port chamber

0.15 mL

0.6 mL

Outer diameter of the port catheter

5 French

8 French

Catheter material

Silicone

Polyurethane

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The port was usually removed at completion of chemotherapy treatment (88% chest, 88% arm), but some were removed for management of a device complication (12% chest, 12% arm). For the chest port, complications were: three total occlusions; two tip displacements (irremediable); and one possible infection (not culture proven). For the arm ports, complications were: two deep venous thromboses; two culture positive infections (one Candida albicans); one catheter fracture with embolization; one port site pain; one total occlusion; one wound dehiscence; and one catheter tip displacement (irremediable). There were no statistically significant differences between the two anatomic sites for those subjects having their port removed for a complication. There was a statistical difference in the sidedness of port insertion. A greater number of subjects had their arm port implanted on their non-dominant side, and they were able to opt to have the port implanted on this side more frequently, than for the chest port cohort. The chest ports were predominantly implanted on the right side (68.6%, p = 0.005). The vein used for catheter insertion was itemized and data for these parameters are summarized in Table III. With regards to pain associated with the two different anatomic port locations, there were no statistically significant differences for pain at implantation, pain at needle insertion, or a sense of constant port-site pain. However, subjects did find pain at infusion and pain at needle removal to be slightly more frequent with the arm implantation site, although the frequency of pain with these activities was very low. There were perceptions that the devices did create a negative impact upon the quality of life for the subjects in this trial. Most of the negative perceptions were low in frequency. However, some of them were more frequent, e.g., roughly 20% of respondents worried about port damage, or infection, while 39%-47% felt that the device reminded them of their disease. A summary of whether the patient felt that their device had negative impact upon them is provided in Table IV. It is apparent from the data in Table V that for eight of the features assessed there was a statistically significantly greater degree of negative impact for the chest implantation site. The statistically significant differential negative features for the chest ports were: too visible, felt to be ugly, commented upon by others, changed manner of dressing, attempted to cover the port with clothing, worried about blockage, negatively affected social events and bothered them when lying in bed. Despite the negative perceptions of these devices, it is generally apparent that there was a general positive reception for both of the TIVADs, despite anatomic location, and there was no anatomic location that diminished the general positive perception of both devices. These positive perceptions are summarized in Table V. Most subjects felt that TIVAD implantation had been convenient for laboratory work and infusions and that the decision to have a TIVAD implanted had a positive impact upon their care. The majority felt that they were, for the most part, satisfied with their device and would have another port implanted if further treatment was required in the future.

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TABLE II - Technical specifications of the Bard chest port versus the Cook arm port

Fig. 1 - (A) The Cook Vital Petite Mini Titanium Port, anteroposterior view; (B) Cook Vital Petite Mini Titanium, lateral view; (C) Bard PowerPort® MRI port, anteroposterior view; (D) Bard PowerPort® MRI, lateral view.

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TIVAD removal was performed by the same vascular/ interventional radiologists, at the same hospital that the device had been implanted. Local anesthetic was utilized. Conscious sedation was administered at the discretion of the radiologist. Port removal consisted of the administration of local anesthetic at the port housing implantation site, an incision was made in the skin at the location of the incision for port implantation, blunt dissection liberated the port housing and the attached catheter for extraction. Fluoroscopy was used at the discretion of the radiologist. The skin incision was sutured closed, using standard techniques, and a pressure dressing was applied.

Results A total of 127 subjects completed the questionnaire between March 1, 2014 and August 30, 2015. At the time of their port removal, 51 of the respondents had chest ports while 76 had arm ports. The study group was matched for age, gender, port days in situ, and tumor type and stage at the time of port implantation, with none of these variables being statistically different.


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TABLE III - Demographics and port placement factors/characteristics, stratified by port type (n = 127)* Feature

Anatomic site

p value*

Chest, n = 51

Arm, n = 76

Age, mean (SD)

55.9 (16.4)

54.2 (14.2)

0.48

Age, median (IQR)

58.0 (48.7)

56.0 (45.3, 64.8)

0.67 0.45

10 (19.6)

11 (14.5)

Female

41 (86.4)

65 (85.5)

Stage, n (%)‡ In situ/1

11 (22.4)

2

13 (26.5)

3

13 (26.5)

4

12 (24.5)

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Sex, n (%) Male

15 (21.1)

27 (38.0) 17 (23.9)

12 (16.9)

Diagnosis categories, n (%) Colon

10 (19.6)

Other

6 (11.8)

Port placement factors/characteristics Handedness, n (%) Right Left Right Left

Vein used for catheter insertion Internal jugular Subclavian Basilic Brachial Unknown

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Cephalic

11 (14.5)

70 (92.1)

4 (7.8)

6 (7.9)

35 (68.6)

33 (43.4)

16 (31.4)

43 (56.6)

Right

0.71

11 (14.5)

47 (92.2)

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Port location, n (%)

54 (71.1)

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35 (68.6)

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Breast

0.56

Left

Right

>0.999†

0.005 Left

30 17

0 0

3 1

0 0

0 0

25 24

0 0

3 6

0 0

1 1

0

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Subject chose location (right or left), n (%) Yes

9 (17.6)

26 (34.2)

42 (82.4)

50 (65.8)

Yes

31 (60.8)

31 (40.8)

No

20 (39.2)

45 (59.2)

45 (88.2)

67 (88.1)

No

0.04

Placed in dominant arm, n (%)

0.03

Reason for port removal, n (%)

Treatment completed

Port complication

6 (11.8)

9 (11.8)

Days in situ, mean (SD)

427.8 (272.4)

517.6 (591.7)

0.31

383.0 (219, 513)

386.5 (214, 498.5)

0.96

Days in situ, median (IQR)

* Means compared by t-test; Medians compared by Mann-Whitney U-test; proportions compared by chi-square test unless indicated. † Fisher’s exact test used due to small expected cell sizes. ‡ Stage at diagnosis was unavailable for two chest port subjects and five arm port subjects, data otherwise complete. SD = standard deviation; IQR = interquartile range.


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532 TABLE IV - Negative perceptions around port, compared by port type (n = 127)

p value*

14 (27.5) 37 (72.5)

9 (11.8) 67 (88.2)

0.03

16 (31.4) 35 (68.6)

9 (11.8) 67 (88.2)

0.007

22 (43.1) 29 (56.9)

16 (21.1) 60 (78.9)

0.008

9 (11.8) 67 (88.2)

0.002

14 (18.4) 62 (81.6)

0.009

7 (9.2) 69 (90.8)

0.16

4 (5.3) 72 (94.7)

0.41†

2 (3.9) 49 (96.1)

3 (3.9) 73 (96.1)

>0.999†

5 (9.8) 46 (90.2)

4 (5.3) 72 (94.7)

0.48†

20 (39.2) 31 (60.8)

36 (47.4) 40 (52.6)

0.36

16 (31.4) 35 (68.6)

18 (23.7) 58 (76.3)

0.34

23 (45.1) 28 (54.1)

18 (23.7) 58 (76.3)

0.01

10 (19.6) 41 (80.4)

17 (22.4) 59 (77.6)

0.71

9 (17.6) 42 (82.4)

11 (14.5) 65 (85.5)

0.63

5 (9.8) 46 (90.2)

1 (1.3) 75 (98.7)

0.04

5 (9.8) 46 (90.2)

9 (11.8) 67 (88.2)

0.72

14 (27.5) 37 (72.5)

10 (13.2) 66 (86.8)

0.04

1 (2.0) 50 (98.0)

1 (1.3) 75 (98.7)

>0.999†

20 (39.2) 31 (60.8) 9 (17.6) 42 (82.4) 2 (3.9) 49 (96.1)

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18 (35.3) 33 (64.7)

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Arm, n = 76

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Too visible - n (%) Yes No Ugly - n (%) Yes No Commented on by others - n (%) Yes No Changed manner of dressing due to port - n (%) Yes No Attempted to cover port with clothing, n (%) Yes No Creates self-consciousness - n (%) Yes No Embarrassing - n (%) Yes No Creates anger - n (%) Yes No Creates anxiety - n (%) Yes No Reminds of illness - n (%) Yes No Worry about damage - n (%) Yes No Worry about blockage - n (%) Yes No Worry about infection - n (%) Yes No Bothers activities Work - n (%) Yes No Social events - n (%) Yes No Sports/exercise - n (%) Yes No Lying in bed - n (%) Yes No Personal hygiene - n (%) Yes No

Chest, n = 51

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Negative perception

* Proportions compared by chi-square testing unless indicated. † Fisher’s exact test used due to small expected cell sizes.


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TABLE V - Positive perceptions around port, compared by port type (n = 127)* Positive perception

Chest, n = 51

Arm, n = 76

p value

49 (96.1)

70 (92.1)

0.47

2 (3.9)

6 (7.9)

Convenient for lab work/treatment - n (%) Yes

No

Degree to which port has been a positive decision (1-10) Mean (SD)

9.3 (1.6)

9.3 (1.5)

0.88

Median (IQR)

10 (9, 10)

10 (9, 10)

0.88

Degree of satisfaction with port

Mean (SD)

8.9 (1.7)

Median (IQR)

10 (8, 10)

Willingness to repeat placement if required (1-10)

Mean (SD)

8.8 (2.0)

Median (IQR)

10 (8, 10)

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8.8 (1.9)

0.61

9.5 (8.3, 10)

0.41

9.0 (2.0)

0.77

10 (9, 10)

0.81

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* Mean compared by t-test; medians compared by Mann-Whitney U-test; proportions compared by Fisher’s exact test. Data complete. SD = standard deviation; IQR = interquartile range.

Region while all of the arm port were inserted and removed in the Saskatoon Health Region. It is possible that there was an uncontrolled for geographic bias that we were unaware of when analyzing the data. However, the two health regions were 250 kilometers apart and neither the healthcare teams nor the project subjects crossed jurisdictional boundaries and could not discuss the differences in their TIVADs. Additionally, none of the volunteers knew that a questionnaire was to be administered at the time of device removal and could not have prepared in advance for this. Both groups of subjects experienced a similar rate of complications, 12%. However, despite the complications encountered, there was no statistical difference in quality of life or satisfaction based upon the types of complications encountered. A limitation of our statistical analysis was the inability to assess if the degree of severity of the complications encountered varied between devices and if this had an impact upon subject responses. There were some negative impressions of the chest device in that the right-sided implantation site, that was favored by those inserting the devices, left some subjects feeling that they had no say in what side the device should be implanted, and if it could be on the non-dominant side of the body. This, associated with the feelings that the chest device was too visible, ugly, and led to subjects changing their manner of dressing in order to cover the device, suggests that there are concerns about the cosmetic impact of the chest devices. Additionally, the chest subjects also were statistically found to be worried about their device blocking and found the chest port adversely affected their social life and bothered them while lying in bed. Due to the anatomic constraints of the arm anatomy, port infusion devices implanted in the arm have had to be miniaturized in comparison to chest ports. Lilienberg et al, found that peripherally inserted vein ports, due to their smaller size, were prone to difficulties associated with aspiration and rate of injection versus chest ports (10).

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Discussion

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The choice of a type of venous access device for chemotherapy infusion is multifactorial. It may be impacted upon by the duration of expected treatment, the availability of different venous access devices, the relative cost of one device versus another, the local expertise available to implant the devices, past successes or failures with different devices, personal preferences of the clinical team, and possibly the preference of the patient. The complications encountered that led to removal of the ports were not statistically significantly different. However, the occurrence of deep venous thrombosis and a catheter fracture that resulted in a catheter pulmonary embolism were unique to the arm port cohort. Deep venous thrombosis is a multifactorial condition and may be associated with malignancy. The frequency of this complication does not exceed the 6% threshold level for this complication as established by the Society of Interventional Radiology (5). A discussion of catheter fracture associated with the Cook Vital Port by Burbridge et al, identifies this as a potential complication for which a definitive cause has not been determined (6). The technical process of chest implantation of venous access devices can potentially result in several complications that are not possible with arm implantation: subclavian artery injury, carotid artery injury, pneumothorax, hemothorax, and air embolism, to cite some of the possible unique complications associated with this anatomic location. It has been demonstrated that the use of ultrasound guidance for central venous access can substantially reduce insertion site complications and procedure failure rates. Hence, some of the complications of chest port implantation can be substantially reduced, or eliminated, when ultrasound is used for venous access. This should be taken into consideration based upon the local availability of ultrasound for venous access guidance (7-9). A limitation of our current study is that all chest ports were inserted and removed in the Regina Qu’Appelle Health © 2016 Wichtig Publishing


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Financial support: No grants or funding have been received for this study. Conflict of interest: None of the authors has financial interest related to this study to disclose.

References

Afsar B, Elsurer R, Covic A, Kanbay M. Vascular access type, health-related quality of life, and depression in hemodialysis patients: a preliminary report. J Vasc Access. 2012;13(2): 215-220.

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Marcy P, Mari V, Figl A, et al. Patient satisfaction with and acceptance of their totally-implanted central venous catheter: construction and first validation of a questionnaire. Journal of Cancer Therapy. 2014;5(07):706-716. 3. Funaki B, Szymski GX, Hackworth CA, et al. Radiologic placement of subcutaneous infusion chest ports for long-term central venous access. AJR Am J Roentgenol. 1997;169(5):1431-1434. 4. Burbridge B. Pictorial essay: arm implantation of the Cook, vitalport mini titanium. Vascular Access. 2013;7(2):11-16. Available from: https://www.researchgate.net/publication/269396513_ Pictorial_Essay_Arm_Implantation_of_the_Cook_Vital_Port_-_ Mini_Titanium. Accessed August 7, 2016. 5. Dariushnia SR, Wallace MJ, Siddiqi NH, et al; Society of Interventional Radiology Standards of Practice Committee. Quality improvement guidelines for central venous access. J Vasc Interv Radiol. 2010;21(7):976-981. 6. Burbridge B, Stoneham G, Szkup P, Otani R, Kriegler S. Catheter fracture and embolization associated with arm implantation of the cook vital port. Can Assoc Radiol J. 2013;64(3):269-273. 7. Randolph AG, Cook DJ, Gonzales CA, Pribble CG. Ultrasound guidance for placement of central venous catheters: a meta-analysis of the literature. Crit Care Med. 1996;24(12): 2053-2058. 8. Hind D, Calvert N, McWilliams R, et al. Ultrasonic locating devices for central venous cannulation: meta-analysis. BMJ. 2003;327(7411):361-367. 9. Calvert N, Hind D, McWilliams R, Davidson A, Beverley CA, Thomas SM. Ultrasound for central venous cannulation: economic evaluation of cost-effectiveness. Anaesthesia. 2004; 59(11):1116-1120. 10. Lilienberg A, Bengtsson M, Starkhammar H. Implantable devices for venous access: nurses’ and patients’ evaluation of three different port systems. J Adv Nurs. 1994;19(1):21-28.

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Disclosures

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However, port manufacturers are now marketing smaller port designs, with power-injection capabilities, suitable for arm implantation, e.g., Angiodynamics, Vortex, Smart Port, CT Mini (Angiodynamics, Latham, NY, USA) and the Bard, PowerPort® Slim (Bard Access Systems Inc., Salt Lake City, UT, USA). Other manufacturers will be certain to develop additional devices that are targeted for arm implantation. Overall, the majority of individuals who received a port for chemotherapy felt that it was a good decision to employ one of these devices for their care and would have another implanted if required, which speaks highly to the utility and value these venous access devices have for chemotherapy, regardless of their anatomic location. Based upon the results of the QLAVD-P questionnaire completed at the time of port removal, the arm implantation site lends itself to improvement in subject satisfaction and quality-of-life categories, during chemotherapy.
