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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 DECLARATION I hereby declare that this thesis is my own work and efforts The sources of all references are acknowledged 04th March 2012 Dr Dang Nguyen P46369 ACKNOWLEDGEMENT 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 dissertation Dr Yazmin Yaacob, for her encouragement, guidance and helps to conduct this thesis A Prof Zahiah, A Prof Hamzaini, Prof Zulfiqar and all UKM Radiology Lecturers, for their instruction and teaching I also would like to extend my gratefulness to my colleagues, radiographers as well and staffs at Radiology Department in University Kebangsaan Malaysia Medical Center (UKMMC) for their intellectual and technical supports 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 ABSTRACT 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%), pediatric patients with age from 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) catheter (5%) were removed due to complication, the rest 153 catheters last more than weeks Complication rate is 13.7%, including cases of malposition (1.2%), catheter dislodge (0.6%), vessel injury (1.9%), catheter infection (5.6%), 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 CONTENT DECLARATION ACKNOWLEDGEMENT ABSTRACT CONTENTS LIST OF FIGURES LIST OF TABLES LIST OF ABRREVIATION LIST OF APPENDIX INTRODUCTION LITERATURE REVIEW OBJECTIVE GENERAL OBJECTIVE SPECIFIC OBJECTIVE BENEFIT OF THIS STUDY METHODOLOGY METHODS AND MATERIALS RESULTS DISCUSSION CONCLUSION APPENDIX LIST OF FIGURES FIGURE FIGURE FIGURE FIGURE FIGURE FIGURE FIGURE FIGURE FIGURE Age distribution Gender distribution Race distribution Complication Complication in patients with early diseases vs late diseases Complication of patients in angio suite vs OT Catheter kinking Catheter malposition The catheter is shrinking and coiling into the right IJV 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 FIGURE 12 FIGURE 13A, 12B Infection in group of angiosuite vs OT Catheter blockage and catheter infection Venous thrombosis Figure 12A: left brachiocephalic vein is not well opacified Figure 12B: After 6months, bilateral brachiocephalic veins are totally occluded with collaterals Catheter blockage in patient with right IJV approaches vs other approaches FIGURE 14 LIST OF TABLES TABLE 1A, 1B TABLE 2A, 2B TABLE 3A, 3B TABLE TABLE TABLE 6A, 6B TABLE 7A, 7B TABLE 8A, 8B TABLE 9A, 9B TABLE 10A, 10B TABLE 11A, 11B TABLE 12A, 12B TABLE 13A, 13B TABLE 14A, 14B DIAGNOSIS INSERTION SITES TECHNICAL DIFFICULTY & SUCCESSFUL RATE COMPLICATION CATHETER REMOVAL COMPLICATION AND DIAGNOSIS COMPLICATION OF PATIENT IN OT VS ANGIO SUITE COMPLICATION AND CATHETER SITES CATHETER BLOCKAGE AND MALPOSITION INFECTION AND NEUTROPENIA INFECTION IN OT VS ANGIO SUITE INFECTION AND CATHETER BLOCKAGE VENOUS THROMBOSIS AND CATHETER SITE 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 V METHOD & METERIALS: Study design: This is a descriptive, cross-sectional study of 18 months from January 2008 until June 2010 Study location: Data will be collected from EIR-UKM and ED databases, UKMMC Sample size: Calculating sample size using formula: N=(z/∆)^2 x p(1-p) N: is number of sample 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 VI RESULTS Totally 157 patient’s records were reviewed with a total of 161 catheters were inserted since June/2008 to June/2010 To simplify, one catheter is considered case VI.1 AGE DISTRIBUTION Patient’s ages range from to 76 yr old Mean age about 49 Most patients are adults with 158 cases (98.1%), pediatrics are cases (1.9%) (FIGURE 1: AGE DISTRIBUTION) VI.2 GENDER DISTRIBUTION M: F ratio is 87:74 – 1.2 : (FIGURE 2: GENDER DISTRIBUTION) VI.3 RACE DISTRIBUTION Malay 86 cases (53.6%) Chinese 65 cases (41%) Indian case (5.6%) Others: case (0.6%) (FIGURE 3: RACE DISTRIBUTION) VI.4 DIAGNOSIS OR INDICATION: Most indications are for chemotherapy 160/161 ( 99.4%) Only one case had indication for TPN (0.6%) due to short bowel syndrome Patient further are divided into two groups depending on the disease status The first includes patients with only early cancer 84cases (52.2%), in which they are quite well The rest are of the second group (47.8%) including primary cancer in late stage (local or distant metastases) 45 cases (28%), early cancer with other disease 12 cases (8%), metastatic cancer with other disease 12 cases (8%) The patient with short bowel syndrome is categorized into the second group (0.6%) (TABLE 1A, 1B: DIAGNOSIS OR INDICATION) VI.5 ANTIBIOTICS 99.4% cases had been administered IV antibiotics before, during or after procedure One patient was not given antibiotics due to antibiotic allergy Those with infected catheter were indicated 2-5 antibiotics from 10-20 days VI.6 INSERTION SITE The procedure was done typically with right IJV puncture The chemoports were located at the right upper chest wall in 145 cases (90.1%) The alternatives are left IJV (12 cases), left subclavian (3 cases) and translumbar approach (1case) depending on the patient status In a total of16 patients (9.9%) experienced alternative approaches, five alternatives were due to disease location (4 right breast Ca, right humerus Ewing sarcoma), one case got enlarged cervical lymph nodes compressing right IJV, one patient was with necrotic metastatic lymph node causing skin ulcer, seven cases had thrombosis of the right IJV and two cases had infection of previous right IJV catheters (TABLE 2A, 2B: INSERTION SITES) VI.7 USABILITY There are cases with usability period approached or less than weeks which were removed due to complication (5%) The rest of the patients (151 / 161) have usability period more than weeks (95%) VI.8 TECHNICAL DIFFICULTY & SUCCESSFUL RATE: Four cases (2.5%) have technical difficulty due to venous thrombosis Among them, Three cases were successfully inserted (2 after venoplasty, undered translumbar) One case (0.6%) was abandoned because of extensive venous thrombosis in right IJV and both brachiocephalic veins The successful insertion rate is 99.4% (160/161) No statistical relation between technical difficulty and complication (TABLE 3A, 3B: TECHNICAL DIFFICULTY AND SUCCESSFUL RATE) VI.9 COMPLICATIONS The general complication rate is 22/161 (13.7%) including malposition, catheter dislodge, vessel injury, infection, venous thrombosis and catheter blockage (FIGURE 4: COMPLICATIONS) (TABLE 4: COMPLICATIONS) Among 22 complications, the total removal of catheter is 8/161 cases (5%) None of patients were dead due to periprocedural complication (TABLE 5: CATHETER REMOVAL) There is more propensity for patients with late cancers and combining diseases to have complication than those with early cancers (FIGURE 5: COMPLICATION IN GROUPS OF EARLY DISEASES VS LATE DISEASES) (TABLE 6A, 6B: RELATION BETWEEN COMPLICATIONS AND DISEASE STAGES) Comparing between the patients in OT and angiosuite, there is no relation between complication rates and venue to the procedure (FIGURE 6: COMPLICATION OF GROUP IN OT VS ANGIO SUITE) (TABLE 7A, 7B: COMPLICATION OF GROUP IN OT VS ANGIO SUITE) There is association between catheter sites and complications Patient with catheter in other sites tend to have more complication than patients with catheter in the right IJV However, among 16 cases with alternative approaches, 11 patients have co-morbidities including right IJV thrombosis, right IJV compression, right neck ulcer which may exert as predisposing factors This indicates study bias (TABLE 8A, 8B: RELATION BETWEEN COMPLICATIONS AND CATHETER SITES) VI.10 CATHETER MALPOSITION: There are cases (1.2%) of malposition In the first case, the catheter had shrunken and coiled into the right IJV It was also blocked and then was removed The 2nd patient had catheter kinking and blockage This catheter has been salvaged after adjustment and flush with heparinized saline There is relation between catheter blockage and malposition However, the number of complication is small (1 cells have count less than 5, cell is zero) which could contain type1 error (FIGURE 7, FIGURE 8: CATHETER MALPOSITION.) (TABLE 9A, 9B: RELATION OF CATHETER MALPOSITION AND CATHETER BLOCKAGE) VI.11 CATHETER DISLODGE: There is case (0.6%) of catheter dislodge at the port-tube junction causing leakage few days after insertion This catheter was removed VI.12 VESSEL INJURY: Totally cases of (1.9%) vessel injury Two patients have arterial puncture, however, the patients were hemodynamically stable One patient had contrast extravasation at the catheter tip in keeping with venous perforation This patient also had venous thrombosis in the left brachiocephalic vein This catheter was removed (0.6%) (FIGURE 9: VENOUS PERFORATION) VI.13 INFECTION: Totally cases (5.6%) of catheter infection, among which, cases need to be remove (3%) The rest are successfully treated with antibiotics and salvage The most common pathogen is Staphylococcus Aureus 33% There are 5/9 cases of catheter infection have neutropenia which demonstrate strong relation to infection Those with neutropenia have more tendency to get catheter infection than those without neutropenia (FIGURE 10: INFECTION IN PATIENTS WITH NEUTROPENIA VS THOSE WITHOUT NEUTROPENIA) (TABLE 10A, 10B: CATHETER INFECTION IN PATIENTS WITH NEUTROPENIA VS PATIENTS WITHOUT NEUTROPENIA) There is no relation between infection and venue of doing procedure (OT or Angiosuite) (FIGURE 11: INFECTION IN GROUP OF ANGIO SUITE VS OT) (TABLE 11A, 11B: INFECTION IN GROUP OF ANGIO SUITE VS OT) There is relation between infection and catheter blockage (FIGURE 12: RELATION OF CATHETER INFECTION AND CATHETER BLOCKAGE) (TABLE 12A, 12B: RELATION OF CATHETER INFECTION AND CATHETER BLOCKAGE) VI.14 VENOUS THROMBOSIS: There are cases (1.2%) of venous thrombosis Both of them had right IJV thrombosis at starting of the procedure, thus the patients had got alternative approaches The 1st case develops thrombosis few days after procedure and become progressively worse The 2nd cases have venous thrombosis at the left brachiocephalic vein with also venous injury at catheter tip causing extravasation The catheter was removed There is relation between venous thrombosis and alternative catheter sites However, the number of complication are small ( 1cell