Periprocedural complication of image guided venous access port implantation in ukmmc

PERIPROCEDURAL COMPLICATIONS OF IMAGE GUIDED VENOUS ACCESS PORT IMPLANTATION IN UKMMCDR NGUYEN VU DANG UNIVERSITY KEBANGSAAN MALAYSIA KUALA LUMPUR... PERIPROCEDURAL COMPLICATIONS OF IMAG

PERIPROCEDURAL COMPLICATIONS OF IMAGE GUIDED VENOUS ACCESS PORT IMPLANTATION IN UKMMC

DR NGUYEN VU DANG

UNIVERSITY KEBANGSAAN MALAYSIA

KUALA LUMPUR

PERIPROCEDURAL COMPLICATIONS OF IMAGE GUIDED VENOUS ACCESS PORT IMPLANTATION IN UKMMC

DR NGUYEN VU DANG

P46369

THESIS SUBMITTED IN PARTIAL FULFILMENT FOR THE

DOCTOR OF RADIOLOGY DEGREE

FACULTY OF MEDICINE UNIVERSITY KEBANGSAAN MALAYSIA MEDICAL CENTER

KUALA LUMPUR

I would like to express my deepest gratitude to the followings for their helps in this thesis:

A Prof Sobri Muda, for his encouragement, guidance and helps along the course

of this thesis from initial ideas, preparation, conduction till completing this

I would like to forward my appreciation and respects to my wife, Pham Thi Huong, for her supports and sacrify during my studying, to my son, Nguyen Hoang Vinh Nghi, for his continuous inspiration

Last but not least, I also would like to send my gratitude to my father-Nguyen Hoang Anh, my mother-Quach Ngoc Le, my sisters, brothers for their

understanding and encouragements during this training program.

Objective: to determine periprocedural complications of image guided implantable

venous access ports in EIR-UKMMC

Methods and meterials: totally 157 patient with 161 catheter implanted in Radiology

Department, UKMMC since August 2008 to December 2010 Patient files were reviewed for periprocedural complications within 14 days post implantation

Results: most of the patients are adult 158 cases (98%), 3 pediatric patients with age from 3 to 76 year old Male to female ratio is 1.2:1 53.6% Malay, 41%

Chinese, 5.6% Indian, 0.6% others Most indication is for chemotherapy, 52.2% early cancers, 42,7% late cancer or with co-morbidities Successful rate is

160/161 cases (99.4%) 145 cases (90.1%) with catheters inserted in the right IJV, 16 catheters (9.9%) have alternative approaches including left IJV(12/161), left subclavian(3/161), translumbar(1/161) 8 catheter (5%) were removed due to complication, the rest 153 catheters last more than 2 weeks Complication rate is 13.7%, including 2 cases of malposition (1.2%), 1 catheter dislodge (0.6%), 3 vessel injury (1.9%), 9 catheter infection (5.6%), 2 venous thrombosis (1.2%) and 12 catheter blockage (7.5%) Compared with other study, our results are consistent with literatures and favourable to surgical results.

Conclusion:

Radiologically implanted venous access ports have high successful rate and low

complication rate Our result is comparable to other radiological results and favourable to surgical results.

LIST OF FIGURES

FIGURE 1 Age distribution

FIGURE 2 Gender distribution

FIGURE 3 Race distribution

FIGURE 5 Complication in patients with early diseases vs late

diseases FIGURE 6 Complication of patients in angio suite vs OT

FIGURE 8 Catheter malposition The catheter is

shrinking and coiling into the right IJV.

FIGURE 9 Venous perforation Extravasation of contrast at the left

brachiocephalic vein adjacent to the catheter tip There is also left brachiocephalic venous thrombosis.

FIGURE 10 Infection in group of patient with neutropenia vs without

neutropenia.

FIGURE 11 Infection in group of angiosuite vs OT

FIGURE 12 Catheter blockage and catheter infection

FIGURE 13A, 12B Venous thrombosis Figure 12A: left brachiocephalic

vein is not well opacified Figure 12B: After 6months, bilateral brachiocephalic veins are totally occluded with collaterals.

FIGURE 14 Catheter blockage in patient with right IJV approaches vs

other approaches.

LIST OF TABLES

TABLE 1A, 1B DIAGNOSIS

TABLE 2A, 2B INSERTION SITES

TABLE 3A, 3B TECHNICAL DIFFICULTY & SUCCESSFUL RATE

TABLE 6A, 6B COMPLICATION AND DIAGNOSIS

TABLE 7A, 7B COMPLICATION OF PATIENT IN OT VS ANGIO SUITE TABLE 8A, 8B COMPLICATION AND CATHETER SITES

TABLE 9A, 9B CATHETER BLOCKAGE AND MALPOSITION

TABLE 10A, 10B INFECTION AND NEUTROPENIA

TABLE 11A, 11B INFECTION IN OT VS ANGIO SUITE

TABLE 12A, 12B INFECTION AND CATHETER BLOCKAGE

TABLE 13A, 13B VENOUS THROMBOSIS AND CATHETER SITE

TABLE 14A, 14B CATHETER BLOCKAGE AND CATHETER SITE

LIST OF ABBREVIATION

UKMMC: University Kebangsaan Malaysia Medical Center IJV: Internal jurgular vein

OT: operation theatre

CATHBLOCK: catheter blockage

TECHDIFFICULTY: technical difficulty

CATH: catheter

FFP: fresh frozen plasma

GA: general anesthesia

LA: local anestheis

IVC: inferior vena cava

STO: suture to out

EIR: endovascular interventional radiology

ED: emmergency department

HSAJB:

LIST OF APPENDIX

APPENDIX : PROFORMA

FIGURES

FIGURE 1: AGE DISTRIBUTION

FIGURE 2: GENDER DISTRIBUTION

FIGURE 3: RACE DISTRIBUTION

FIGURE

FIGURE 4: COMPLICATION

12 2 9 3 1 2 8

CATHETER BLOCKAGE

FIGURE 5: COMPLICATION IN GROUPS OF EARLY DISEASE VS OTHERS

FIGURE 6: COMPLICATION OF PATIENTS IN OT VS ANGIO SUITE

FIGURE 7: CATHETER KINKING

FIGURE 8: CATHETER MALPOSITION The catheter shrinks and coils into the right IJV

FIGURE 9: VESSEL INJURY Extravasation of contrast at the left brachiocephalic vein adjacent to the catheter tip suggestive of venous perforation There is also left

brachiocephalic venous thrombosis

FIGURE 10: Infection in patients with neutropenia vs without neutropenia

FIGURE 11: Infection in group of angiosuite vs OT

FIGURE 12: RELATION OF CATHETER INFECTION AND CATHETER BLOCKAGE

FIGURE 13A: VENOUS THROMBOSIS The left brachiocephalic vein is not well opacified

FIGURE 13B: VENOUS THROMBOSIS After 6 months

FIGURE 14: CATHETER BLOCKAGE IN GROUP OF RIGHT IJV APPROACH VS OTHER APPROACHES.

TABLES

TABLE 1A

DIAGNOSISFrequency Percent Valid Percent

Cumulative PercentEarly stage 84 52.2 52.2 52.2

Cumulative Percent

TABLE 2A

CATHETER SITESFrequency Percent Valid Percent

Cumulative PercentRight IJV 145 90.1 90.1 90.1Other site 16 9.9 9.9 100.0Valid

Total 161 100.0 100.0

TABLE 2B

CATHETER SITESFrequency Percent Valid Percent

Cumulative PercentRight IJV 145 90.1 90.1 90.1

TABLE 3A

TECHDIFFICULTY * SUCCESSFUL Crosstabulation

SUCCESSFULLYAbandoned Yes Total

% within TECHDIFFICULTY

.0% 100.0% 100.0%No

% within SUCCESSFUL

.0% 98.1% 97.5%

% within TECHDIFFICULTY

33.3% 66.7% 100.0%

Due to venous thrombosis

% within SUCCESSFUL

100.0% 1.3% 1.9%

% within TECHDIFFICULTY

.0% 100.0% 100.0%

TECHDIFFICULTY

Due to approach

% within SUCCESSFUL

.0% 6% 6%

% within TECHDIFFICULTY

.6% 99.4% 100.0%Total

% within SUCCESSFUL

100.0% 100.0% 100.0%

TABLE 3B

TECHDIFFICULTY * SUCCESSFUL Crosstabulation

Count

SUCCESSFULAbandoned Yes Total

Cumulative Percent

With

complication

22 13.7 13.7 100.0Valid

TABLE 6A

DIAGNOSIS * COMPLICATION Crosstabulation

Count

COMPLICATIONNo

With complication TotalEarly stage 77 7 84

Asymp Sig

(2-sided)

Exact Sig sided)

(2-Exact Sig sided)Pearson Chi-Square 4.231a 1 040

OTorANGIO * COMPLICATION Crosstabulation

Count

COMPLICATIONNo

With complication Total

Asymp Sig

(2-sided)

Exact Sig sided)

(2-Exact Sig sided)Pearson Chi-Square 133a 1 715

TABLE 8A

TABLE 8B

Chi-Square TestsValue df

Asymp Sig

(2-sided)

Exact Sig sided)

(2-Exact Sig sided)Pearson Chi-Square 13.630a 1 000

a 0 cells (.0%) have expected count less than 5 The minimum expected count is 2.19

b Computed only for a 2x2 table

COMPLICATION * CATHETER SITES Crosstabulation

Count

COMPLICATIONNo

With complication TotalRight IJV 130 12 142

SITES

TABLE 9B

Chi-Square TestsValue Df

Asymp Sig

(2-sided)

Exact Sig sided)

(2-Exact Sig sided)Pearson Chi-Square 25.146a 1 000

TABLE 10A

INFECTION * NEUTROPENIA Crosstabulation

Count

INFECTIONNo

Catheter infection Total

NEUTROPENIA

With neutropenia

TABLE 10B

Chi-Square TestsValue Df

Asymp Sig

(2-sided)

Exact Sig sided)

(2-Exact Sig sided)Pearson Chi-Square 11.644a 1 001

INFECTION * OTorANGIO Crosstabulation

Count

INFECTIONNo

Catheter infection Total

Asymp Sig

(2-sided)

Exact Sig sided)

(2-Exact Sig sided)Pearson Chi-Square 161a 1 689

INFECTION * CATHETERBLOCKAGE Crosstabulation

Count

INFECTIONNo

Catheter infection Total

CATHETERBLOCKAGE

Catheter blockage

TABLE 12B

Chi-Square TestsValue df

Asymp Sig

(2-sided)

Exact Sig sided)

(2-Exact Sig sided)Pearson Chi-Square 9.256a 1 002

VENOTHROMBOSISNo

Have venous thrombosis TotalRight IJV 145 0 145

Asymp Sig

(2-sided)

Exact Sig sided)

(2-Exact Sig sided)Pearson Chi-Square 18.353a 1 000

CATHETERBLOCKAGENo

Catheter blockage TotalRight IJV 138 7 145

Asymp Sig

(2-sided)

Exact Sig sided)

(2-Exact Sig sided)Pearson Chi-Square 14.584a 1 000

Venous access ports or chemoports are totally subcutaneously tunneled central venous access catheters They are used as venous access for transfusion therapy like chemotherapy or total parenteral nutrition Since the first demonstration of central

venous catheterization by Werner Forssman in 1929, its usability has become more popular ( )

In patients undergoing chemotherapy, after several initial cycles, venous access would be a problem due to direct damage of the cytotoxic agent to the vessels The implantable venous access port is a good alternative for long-term venous lines They are easy to use and get a good route to the circulation system

Typically, interventional radiologist implants image-guided venous access ports However in some centers, surgeon and oncologist also perform the procedure The implantation of venous access port is considered as a short and relatively safe

procedure, but there are still risks The complications of this procedure, assumed as periprocedural complications, could be mild like a small hematoma at the implantation site or could be severe complications as pneumothorax, infection or catheter migration (1-2)

In recent years, interventional radiologist, using image guidances under local anesthesia has increasingly popularized this new technique In Universiti Kebangsaan Malaysia Medical Center (UKMMC), interventional radiologist started image-guided port catheter implantation since late 2007 Cases of image-guided port implantation have been increasing steadily, but the complications have not been well described This study aims to evaluate the periprocedural complication of this procedure

II LITERATURE REVIEW:

1 Definition of periprocedural complication

In general, complications of central venous access are divided into 3 types (1):

i periprocedural complication:

Occurs within 7 days and assumed to be due to or related to the procedures

ii Early post-procedural:

Occurs between 7-30 days, such as catheter migration, catheter thrombosis, catheter leakage, and sepsis

iii Late complication:

Occurs after 30 days, such as infection, venous thrombosis, catheter malfunction,

2-Device related: catheter dislocation, catheter migration, torsion of port

reservoir, kinking of catheter

3-Those affected to cardiovascular system: cardiac arrhythmia, air embolism and cardiac arrhythmia

4-Infection: this early infection is believed to be due to breakdown of sterile technique during device placement leading to wound infection, skin necrosis, wound dehiscence

In a study doing on placement of hemodialysis catheter, to define the

periprocedural complication, the author didn’t mention about time and the periprocedural complications are defined by listing one by one like excessive bleeding requiring

transfusion, air embolus, pneumothorax, arrhythmia (5) In the study with infectious complication of peripherally implantable venous access in HIV-positive versus HIV-negative patient, periprocedural complications are defined as those within 14 days after catheter implantation (6) Another study in complications of Hickman catheter in HIV patient inserted radiologically, periprocedural complications are defined as those

happening within a week after the insertion (7)

Different authors have different definitions of periprocedural complication with different periods of time and the maximal time interval is 14 days Most authors defined it

up to 7 days ( ) We decided to use 14 days, as we believe procedure related

complication should be manifested within 14 days

2 Protocol of venous access port implantation

a Patients are admitted 1 day before procedure for:

1 Screening test:

Coagulation profile checked with full blood picture or equivalent with Hb should be more than 8g/l Patient may have FFP or platelet transfusion during procedure for those whose coagulation profile are unable to be corrected.Renal profile: uremia, creatinemia

Liver function test

2 Obtaining history of asthma, allergy,

3 Explain the procedure, possible complication, usability and consent

b Day of procedure

4 Patients have to fast

5 Procedure will be performed by radiologist, at angio-suit or in OT

6 Confirm patient consents

7 Catheter: venous access port set The site determined by radiologist

8 U/S done for venous assessment

9 Sterile condition: scrub, Povidine used as disinfect agent, patient is drapped, U/S machine covered with sterile towel or plastic

10 Lignocain2% for LA, maximally 10ml Sedation Dormicum 2mg and Fentanyl 50mg IV Pediatric patient under GA

11 Right IJV is usually chosen as approached vessels, the substitution is left IJV, translumbar…

12 Small skin incision at puncture site (2-4mm)

13 Puncture with 18G needle under U/S guidance

14 Guidewire 0.0035” inserted with its tip until IVC Puncture needle taken out

15 Port site and the tunnel estimated by correlating the catheter on the chest wall under fluoroscopy

16 Right upper chest chosen as subcutaneous port’s pocket

17 Tunnel is determined LA given along the track Tunneling the catheter from the exit site ( port’s pocket) to punctured site with tracker

18 Dilator bigger than the catheter size 1 number

19 Peel-away sheath used Guidewire taken out

20 Catheter inserted Sheath is peeled off

21 Post-procedure fluoroscopy for checking position and any complication

22 Tip of catheter should be at the atriocaval junction

23 Suturing for skin closure

24 Intravenous Antibiotic, cephalosporin 3rd generation (cefoperozone 1g only one dose, 50mg/kg for pediatrics)

c After implantation

1 Catheter care by ward’s SN, dressing

2 STO usually on day 7-10 No need STO for patient with intracutaneous suture The port can be used immediately

3 If patients are discharged, they are instructed to take care of the catheter, ports and were given appointments for STO or chemotherapy

III OBJECTIVES:

III.1 GERNERAL OBJECTIVE:

This study is performed to determine the rate of periprocedural complications in patients having venous access ports inserted under image guidance in UKMMC III.2 SPECIFIC OBJECTIVES:

1 Determine the periprocedural complication rate

2 To compare the complication rate between cases done in OT versus cases done

in angiography suite

IV BENEFIT OF THIS STUDY:

1 Local experience about periprocedural complications of image guided port implantation

2 If using angiography suite will increase complication rate

3 If using angiography suite will increase infection rate

V METHOD & METERIALS:

Z value=2.58 (for α error 0.01, two tailed or 99% Confidence Interval)

P=proportion of disease or factor under study (5%)

∆=width of the confidence interval 0.05

N= (2.58/0.05)^2 x 0.05x0.95= 126.46, rounding to 127

Study population:

All patients underwent image guided port implantation in radiology department and in ED department’s OT from 01 Jan 2008 to 30th June 2010 Files of patient are reviewed for periprocedural complication

Inclusion criteria:

Patients with all ages, having venous access port inserted by radiologist in Angiography suite and in A&E department’s OT, UKMMC from 01 Jan 2008 to June 2010

Data acquisition:

Data collection by using the attached forms ( Appendix1)

Required information will be attained from UKMMC IRIS, PACS, data from angiography suite and medical records from HSAJB

Patient name and personal information will be anonymous

Data analysis: using SPSS 17