- Email: [email protected]
An alternative technique for totally implantable central venous access devices. A retrospective study of 1311 cases
EJSO 32 (2006) 90–93
www.ejso.com
An alternative technique for totally implantable central venous access devices. A retrospective study of 1311 cases H.M. Changa, C.B. Hsieha, H.F. Hsiehb, T.W. Chena, C.J. Chena, D.C. Chana, J.C. Yua,*, Y.C. Liua, K.L. Shena a
Division of General Surgery, Department of Surgery, National Defense Medical Center, Tri-Service General Hospital, No. 325, Sec 2, Cheng-Kung Road, Neihu 114, Taipei, Taiwan, ROC b Department of Surgery, Yeezen General Hospital, Taoxuan, Taiwan, ROC Accepted 20 September 2005 Available online 10 November 2005
Abstract Aim: The aim of the present study was to report our experience of totally implantable central venous access devices (TICVAD) implantation using two techniques and attempt to define the better technique. Materials and methods: From January 1998 to September 2003, 1131 patients were reviewed and divided into two groups with implantation by cephalic vein cut-down (group A) done by general surgeons and subclavian vein puncture with the Seldinger technique (group B) done by vascular surgeons. The operative time, early and late complications of these two groups were compared. Data were analysed by Student’s t-test. Results: The average of operative time was 43 min in group A (35—70 min) and 40 min in group B (35—60 min) (PO0.05). No postoperative pneumothorax, hemothorax and fragmentation occurred in group A; the incidence of peri-operative complication was higher in group B. The overall and early complications of group A were significantly lower than that of group B (P!0.0001). Conclusion: This retrospective study showed that the cephalic vein cut-down approach for TICVAD placement avoided the risks of pneumothorax, hemothorax and catheter fragmentation. q 2005 Elsevier Ltd. All rights reserved. Keywords: Cephalic vein cut-down; Subclavian vein puncture; Totally implantable central venous access devices
Introduction Totally implantable central venous access devices (TICVAD) represent obvious problems in the administration of chemotherapy because of venous irritation and the need for multiple venipunctures. TICVAD is an important benefit for patients who need to receive chemotherapy. TICVAD are generally placed by the percutaneous subclavian vein approach. The cephalic vein cut-down approach is used infrequently in clinical practice due to technical limitation and a wide range of failure rates (8— 62%) in the literature.1–8 But complications are frequently observed in the percutaneous subclavian vein approach such as pneumothorax and arterial puncture. The major advantages of * Corresponding author. Tel.: C886 2 8792 7191; fax: C886 2 8792 7372. E-mail address: [email protected] (J.C. Yu).
0748-7983/$ - see front matter q 2005 Elsevier Ltd. All rights reserved. doi:10.1016/j.ejso.2005.09.004
the cephalic vein cut-down approach compared to the percutaneous subclavian vein approach is the elimination of the risks of pneumothorax, hemothorax, and injury to the great vessels9 and direct observation of the adequacy of the vein. But comparative studies of the two methods is lacking. The aim of the present study was to analyse our experience of TICVAD implantation by two techniques to evaluate and determine which had lowest risk of technical problems. Materials and methods From January 1998 to September 2003, we reviewed 1131 patients whom had received TICVAD implantation for chemotherapy by either technique. In 95.8% of the patients the tumours were solid and 4.2% had hematological diseases. Patients were divided into two groups, implantation of the catheter by cephalic vein cut-down (group A) by general surgeons and subclavian vein puncture with the Seldinger technique (group B) by vascular surgeons
H.M. Chang et al. / EJSO 32 (2006) 90–93 Table 1 Demographic data of patients
Male/Female Age Operative time (min) Cancer type Colon Breast Gastrointestinal tract Lung Lymphoma Ovarian Liver Pancreas Sarcoma Hematologic disease
Group A cephalic vein cut-down (nZ533)
Group B subclavian vein puncture (nZ598)
328/205 60.2G9.5 43G13
312/286 63.8G7.9 40G16
82 182 85 27 44 25 41 20 5 22
187 58 89 82 53 49 28 11 16 25
(Table 1). All implantations were performed by four surgeons who had more than one hundred operations and 4 years of experience. There was no statistically significant difference in complication rate within individual surgeons in the same group. A pre-operative single dose of a first-generation cephalosporin was given in all cases. Two kinds of TICVAD were used; 28% were Arrow Internationale, USA and 72% were BardPortw titanium implanted single lumen (9.6 or 6.6 Fr.) ports (Salt Lake City, Utah, USA) and all had silicone catheters and titanium ports. The size of implanted catheter was depended on the diameter of vessel in group A and 9.6 Fr catheters were implanted in group B. We initially used 9.6 Fr catheter and changed to 6.6 Fr catheter if there were difficulties to insertion of catheter. If the cephalic vein cut-down approach failed, we converted to external jugular vein cut-down approach. All TICVAD were implanted using local anesthesia combined with sedation for patients with anxiety. Confirmed position of the distal tip of the catheter in the superior vena cava was carried out in all cases by intraoperative fluoroscopic control. In all cases flushing of the catheter was done using a solution of heparin sodium (5000 IU of heparin in 10 mL of isotonic saline). A comparison between the two groups was made in terms of operative time, early and late complications. A complication occurring within 1 week post-operation was defined as an early complication. Procedure of cephalic vein cut-down (Group A) A rolled sheet was placed vertically in the patient’s back to rotate the shoulder posteriorly. Trendelenburg positioning was not necessary. The patient’s entire chest and neck were prepped and draped in a sterile fashion. Under local anesthesia a horizontal 4-cm incision was made in the infraclavicular location. The subcutaneous tissues were dissected down to the fascia overlying the junction of the
91
deltoid muscle and the pectoralis major muscle, thus identifying the deltopectoral groove. The cephalic vein was located in the deltopectoral groove. The cephalic vein was circumferentially dissected out for approximately 2— 3 cm. Two separate 3—0 silk sutures were then placed around the cephalic vein, one proximal and one distal. The suture placed distally around the cephalic vein was tied down securely. The cephalic vein was then partially transected with a No. 11 blade in a transverse fashion along its midportion. Back-bleeding from the proximal end of the cephalic vein was controlled by applying traction to the proximally placed 3—0 silk suture. The catheter was then passed proximally into the lumen of the partially transected cephalic vein and advanced centrally into the subclavian vein, the innominate vein and into the superior vena cava. Once the catheter was correctly positioned, the proximally placed 3—0 silk suture around the catheter and the proximal end of the cephalic vein was tied down in a non-constricting fashion to prevent back-bleeding and catheter migration. For implanted ports, the catheter was connected to the port, and the port was positioned and secured in a port pocket created along the inferior aspect of the infraclavicular incision. The subcutaneous tissues and skin of the infraclavicular incision were then closed in separate layers using absorbable suture. The patency of the catheter lumen was tested by aspirating blood and by flushing the lumen with a dilute heparin saline solution. Procedure of percutaneous subclavian vein puncture (Group B) For the percutaneous subclavian vein puncture approach, the patient is placed supine and in the Trendelenburg position. A rolled sheet placed vertically in the back to rotate the tips of the shoulders posteriorly. The region of the anterior chest, neck, and shoulders is prepped and draped. The skin overlying the anticipated venipuncture site is infiltrated with a local anesthetic. Using a 10 ml syringe with a 14-gauge needle the area of the subclavian vein is explored. Once easy flow of blood into the syringe confirms vein penetration, a flexible J guidewire is advanced through the venipuncture needle. The catheter placement used the Seldinger technique with the peel-away introducer method. Difficulties in advancing the catheter through the peel-away introducer sheath usually imply that the peel-away introducer sheath is bent. This occurs most frequently during subclavian vein approach if the venipuncture is attempted too medially and through the costoclavicular ligament. If the catheter cannot be advanced through the peel-away introducer sheath, repeat venipuncture in a more lateral position may be necessary. The catheter should never be handled with sharp instruments. Only non-toothed forceps should be used, if needed. The procedure for placing a subcutaneous implanted port is similar to that for a tunneled external catheter, except for the creation of a subcutaneous port pocket. Finally, a test puncture was
92
H.M. Chang et al. / EJSO 32 (2006) 90–93
performed to check patency and flow through the system with dilute heparinized saline solution. Statistical analysis The software program Statistical Package for the Social Sciences (SPSS) for Windows (version 8.0) was utilized to analyse the data by the Student’s t-test. A P value of less than 0.05 was considered statistically significant. Results In this retrospective study, the demographic data of both groups of patients are summarized in Table 1. Based on the Independent t-test, there were no statistically significant differences within the types of malignancy for either technique. Mean operative time was 43 min in group A (25—70 min) and 40 min in group B (25—60 min) (PO 0.05). The failure rate of the cephalic vein cut-down was 12% (64/533). The cephalic vein was absent in 21 patients, too small in 39 patients, and iatrogenic injury in four patients. Due to the multiple factors of influences, the long term patency/durability of TICVAD is not studied by this project. The overall and early complications of group A was significantly lower than that of group B. The complication rate is summarized in Table 2. The most common complications were infection (93/1131) during post-operative use. The most serious complication was fragmentation (6/1131). There was one intraoperative mortality in group A due to an underlying cardiovascular problem. Pneumothorax, arterial puncture, and hemothorax only developed in group B. Twenty patients had pneumothorax and five patients required chest tube drainage. In the other 15 patients, pneumothorax was resolved by conservative treatment. Hemothorax (four patients in group B) and hematoma (six in group A and seven in group B) resolved spontaneously. The catheter tip was placed in the lower portion of the superior vena cava. Malposition of the Table 2 Comparison between cephalic vein cut-down and subclavian vein puncture in complication rate
Early complication Pneumothorax Hemothorax Arterial puncture Malposition Hematoma Late complication Fragmentation Infection Occlusion Dehiscence Total complication
Group A cephalic vein cut-down
Group B subclavian vein puncture
P value
11/533 (2.1%) 0 0 0 5 6 64/533 (12%) 0 41 20 3 75/533 (14.1%)
63/598 (10.5%) 20 4 20 12 7 83/598 (13.9%) 6 52 23 2 146/598 (24.4%)
!0.0001 !0.0001 0.0586 !0.0001 0.1406 0.9437 0.3504 0.0204 0.5402 0.93 0.5637 !0.0001
catheter tips to the right atrium was observed in 17 patients (five in group A and 12 in group B). There was statistically significant difference between group A and B in fragmentation. Fragmentation only occurred in six patients in group B and all fractured catheter segments were removed with a retrieval snare wire under fluoroscopic observation using the femoral route. Discussion TICVAD have been widely used by the oncologists. They achieve safe and less painful vascular access, facilitate treatment of many medical disorders, and improve patients’ quality of life by giving them unrestricted mobility and freedom in their activities. These devices can be implanted through either a surgical or percutaneous procedure. The cephalic vein cut-down is used infrequently due to the reported high failure rate and the requirement for surgical expertise. Two earlier cadaver-based studies2,4 explain the high failure rates. LeSaout et al.2 found that the cephalic vein was absent in 5% and too small to pass a 3.4-mm pacemaker wire in 15% of the cadavers dissected. Chuter and Starker4 found that the cephalic vein was absent or too small to pass a 6.6-Fr catheter in 23% of the cadavers dissected. Coit and Turnbull10 have described a modified Seldinger technique for insertion of a catheter into the cephalic vein when it appears to be too small to accept the catheter directly. There were 7.3% (39/533) patients who had a small cephalic vein and we did not use this technique. In group B, there was no information as to how many different sites were used prior to successful catheter placement. Although many surgical teams use percutaneous access for placement of the TIVAD, both early and late complications are frequently observed. Pneumothorax is the most life-threatening complication which result the most clinical, economic, and psychological implications.9 Pneumothorax may occur during the subclavian vein puncture, arterial puncture, and related complications have been reported. In our opinion, cephalic cut-down method can avoid these early complications as compared with the percutaneous approach. Catheter fragmentation is a rare finding, with an overall prevalence of 0.1—1%.11,12 The cause of fragmentation can occur for three reasons: pinch-off syndrome,13,14 use of the incorrect equipment to damage catheter and using small syringes lead to increased pressure within the catheter.15 The Pinch-off syndrome arises when a subclavian catheter passes between the clavicle and the first rib and becomes compressed or kinked. The syndrome is observed in about 1% of TICVAD,13 and is a valuable warning prior to occlusion and fragmentation.16,17 The anatomy of the subclavian in this region can explains the possible cause of fragmentation. The region is bounded anteriorly by the clavicle, subclavius muscle, and costocoracoid ligament. Posterior borders are defined by the first rib and anterior
H.M. Chang et al. / EJSO 32 (2006) 90–93
scalene muscle. Medially, the clavicle and first rib are joined by the costoclavicular ligament. A catheter passes through this space outside the subclavian vein before it pierces the vessel medially. This anteromedial portion of the canal is smaller than the posterolateral region, which contains the subclavian vein. Thus, a catheter located in this areolar tissue is more susceptible to compression between the clavicle and first rib.9 Free shoulder joint movement exerts additional forces on this point and can result in catheter fragmentation. The following precautions can early identify this problem. Careful subclavian puncture should be made in the mid-clavicular location rather than more medially. Alternatively the lateral subclavian vein or the internal jugular vein may be the better routes. Fluoroscopic assessment at the time of insertion can help eliminate this complication.18 Klotz et al.19 suggest the removal of the device within 6 months when the pinch-off syndrome is present. In our study, no pinch-off syndrome or catheter fragmentation was seen in group A. Fragmentation was occurred in six patients of group B, pinch-off syndrome was noted in three patients and one of them developing tachydysrhythmia. We believe that pinch-off syndrome is the major cause of fragmentation and suggest immediate removal of device. The percutaneous subclavian vein puncture method has wide acceptance because of the ease of insertion when initially successful. But the complications of pneumothorax, hemothorax, and catheter fragmentation cause significant morbidity. Our results suggest that the cephalic vein cutdown technique is a safer method for TICVAD implantation, although this technique requires surgical expertise. We concluded that although the validity of these differences maybe limited by the retrospective character of this study, we consider that cephalic vein cut-down technique can prevent life threatening complications such as pneumothorax, hemothorax and catheter fragmentation. Similar findings were reported in previous studies.9,20
References 1. Wade JC, Newman KA, Schimpff SC, VanEcho DA, Gelber RA, Reed WP, et al. Two methods for improved venous access in acute leukemia patients. JAMA 1981;246:140–4.
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2. Le Saout J, Vallee B, Person H, Doutriaux M, Blanc J, Huu N. Bases anatomiques de l’utilisation chirurgicale de la veine ce’phalique (V. Cephalica). J Chir (Paris) 1983;120:131–4. 3. Davis SJ, Thompson JS, Edney JA. Insertion of Hickman catheters. A comparison of cutdown and percutaneous techniques. Am Surg 1984; 50:673–6. 4. Chuter T, Starker PM. Placement of Hickman-Broviac catheters in the cephalic vein. Surg Gynecol Obstet 1988;166:163–4. 5. Au FC. The anatomy of the cephalic vein. Am Surg 1989;55:638–9. 6. Perry EP, Nash JR, Klidjian AM. Direct cephalic vein cannulation for safe subclavian access. J R Coll Surg Edinb 1990;35:218–20. 7. Torramade’ JR, Cienfuegos JA, Hernandez J-L, Pardo F, Benito C, Gonzalez J, et al. The complications of central venous access systems: a study of 218 patients. Eur J Surg 1993;159:323–7. 8. Gallichio MH, Kahn D, Lempert N, Conti DJ. Placement of a double lumen Silastic catheter for hemodialysis access through the cephalic vein. J Am Coll Surg 1994;178:171–2. 9. Di Carlo I, Cordio S, La Greca G, Privitera G, Russello D, Puleo S, et al. Totally implantable venous access devices implanted surgically: a retrospective study on early and late complications. Arch Surg 2001; 136(9):1050–3. 10. Coit DG, Turnbull ADM. A safe technique for the placement of implantable vascular access devices in patients with thrombocytopenia. Surg Gynecol Obstet 1988;167:429–31. 11. Hinke DH, Zandt-Stastny DA, Goodman LR, Quebbeman EJ, Krzywda EA, Andris DA. Pinch off Syndrome: a complication of implantable subclavian venous access devices. Radiology 1990;177(2): 353–6. 12. Stanislav GV, Fitzgibbons Jr RJ, Bailey Jr RT, Mailliard JA, Johnson S, Feole JB. Reliability of implantable central venous access devices in patients with cancer. Arch Surg 1987;122:1280–3. 13. Aitken DR, Minton JP. The ‘Pinch-Off Sign’: a warning of impeding problems with permanent subclavian catheters. Am J Surg 1984;148: 633–6. 14. Fazeny-Dorner B, Wenzel C, Berzlanovich A, Sunder-Plassmann G, Greinix H, Marosi C, et al. Central venous catheter pinch-off and fracture: recognition, prevention and management. Bone Marrow Transplant 2003;31(10):927–30. 15. Dougherty L. Central venous access devices. Nurs Stand 2000;14(43): 45–50. 16. Ouaknine-Orlando B, Desruennes E, Cosset MF, De Baere T, Roche A. The pinch-off syndrome: main cause of catheter embolism. Ann Fr Anesth Reanim 1999;18(9):949–55. 17. Chow LM, Friedman JN, Macarthur C, Restrepo R, Temple M, Chait PG, et al. Peripherally inserted central catheter (PICC) fracture and embolization in the pediatric population. J Pediatr 2003;142(2):141–4. 18. Lafreniere R. Indwelling subclavian catheters and a visit with the ‘Pinched-off Sign’. Surg Oncol 1991;47(4):261–4. 19. Klotz HP, Schopke W, Kohler A, Pestalozzi B, Largiader F. Catheter fracture: a rare complication of totally implantable subclavian venous access device. J Surg Oncol 1996;62:222–5. 20. Povoski SP. A prospective analysis of the cephalic vein cutdown approach for chronic indwelling central venous access in 100 consecutive cancer patients. Ann Surg Oncol 2000;7:496–502.
www.ejso.com
An alternative technique for totally implantable central venous access devices. A retrospective study of 1311 cases H.M. Changa, C.B. Hsieha, H.F. Hsiehb, T.W. Chena, C.J. Chena, D.C. Chana, J.C. Yua,*, Y.C. Liua, K.L. Shena a
Division of General Surgery, Department of Surgery, National Defense Medical Center, Tri-Service General Hospital, No. 325, Sec 2, Cheng-Kung Road, Neihu 114, Taipei, Taiwan, ROC b Department of Surgery, Yeezen General Hospital, Taoxuan, Taiwan, ROC Accepted 20 September 2005 Available online 10 November 2005
Abstract Aim: The aim of the present study was to report our experience of totally implantable central venous access devices (TICVAD) implantation using two techniques and attempt to define the better technique. Materials and methods: From January 1998 to September 2003, 1131 patients were reviewed and divided into two groups with implantation by cephalic vein cut-down (group A) done by general surgeons and subclavian vein puncture with the Seldinger technique (group B) done by vascular surgeons. The operative time, early and late complications of these two groups were compared. Data were analysed by Student’s t-test. Results: The average of operative time was 43 min in group A (35—70 min) and 40 min in group B (35—60 min) (PO0.05). No postoperative pneumothorax, hemothorax and fragmentation occurred in group A; the incidence of peri-operative complication was higher in group B. The overall and early complications of group A were significantly lower than that of group B (P!0.0001). Conclusion: This retrospective study showed that the cephalic vein cut-down approach for TICVAD placement avoided the risks of pneumothorax, hemothorax and catheter fragmentation. q 2005 Elsevier Ltd. All rights reserved. Keywords: Cephalic vein cut-down; Subclavian vein puncture; Totally implantable central venous access devices
Introduction Totally implantable central venous access devices (TICVAD) represent obvious problems in the administration of chemotherapy because of venous irritation and the need for multiple venipunctures. TICVAD is an important benefit for patients who need to receive chemotherapy. TICVAD are generally placed by the percutaneous subclavian vein approach. The cephalic vein cut-down approach is used infrequently in clinical practice due to technical limitation and a wide range of failure rates (8— 62%) in the literature.1–8 But complications are frequently observed in the percutaneous subclavian vein approach such as pneumothorax and arterial puncture. The major advantages of * Corresponding author. Tel.: C886 2 8792 7191; fax: C886 2 8792 7372. E-mail address: [email protected] (J.C. Yu).
0748-7983/$ - see front matter q 2005 Elsevier Ltd. All rights reserved. doi:10.1016/j.ejso.2005.09.004
the cephalic vein cut-down approach compared to the percutaneous subclavian vein approach is the elimination of the risks of pneumothorax, hemothorax, and injury to the great vessels9 and direct observation of the adequacy of the vein. But comparative studies of the two methods is lacking. The aim of the present study was to analyse our experience of TICVAD implantation by two techniques to evaluate and determine which had lowest risk of technical problems. Materials and methods From January 1998 to September 2003, we reviewed 1131 patients whom had received TICVAD implantation for chemotherapy by either technique. In 95.8% of the patients the tumours were solid and 4.2% had hematological diseases. Patients were divided into two groups, implantation of the catheter by cephalic vein cut-down (group A) by general surgeons and subclavian vein puncture with the Seldinger technique (group B) by vascular surgeons
H.M. Chang et al. / EJSO 32 (2006) 90–93 Table 1 Demographic data of patients
Male/Female Age Operative time (min) Cancer type Colon Breast Gastrointestinal tract Lung Lymphoma Ovarian Liver Pancreas Sarcoma Hematologic disease
Group A cephalic vein cut-down (nZ533)
Group B subclavian vein puncture (nZ598)
328/205 60.2G9.5 43G13
312/286 63.8G7.9 40G16
82 182 85 27 44 25 41 20 5 22
187 58 89 82 53 49 28 11 16 25
(Table 1). All implantations were performed by four surgeons who had more than one hundred operations and 4 years of experience. There was no statistically significant difference in complication rate within individual surgeons in the same group. A pre-operative single dose of a first-generation cephalosporin was given in all cases. Two kinds of TICVAD were used; 28% were Arrow Internationale, USA and 72% were BardPortw titanium implanted single lumen (9.6 or 6.6 Fr.) ports (Salt Lake City, Utah, USA) and all had silicone catheters and titanium ports. The size of implanted catheter was depended on the diameter of vessel in group A and 9.6 Fr catheters were implanted in group B. We initially used 9.6 Fr catheter and changed to 6.6 Fr catheter if there were difficulties to insertion of catheter. If the cephalic vein cut-down approach failed, we converted to external jugular vein cut-down approach. All TICVAD were implanted using local anesthesia combined with sedation for patients with anxiety. Confirmed position of the distal tip of the catheter in the superior vena cava was carried out in all cases by intraoperative fluoroscopic control. In all cases flushing of the catheter was done using a solution of heparin sodium (5000 IU of heparin in 10 mL of isotonic saline). A comparison between the two groups was made in terms of operative time, early and late complications. A complication occurring within 1 week post-operation was defined as an early complication. Procedure of cephalic vein cut-down (Group A) A rolled sheet was placed vertically in the patient’s back to rotate the shoulder posteriorly. Trendelenburg positioning was not necessary. The patient’s entire chest and neck were prepped and draped in a sterile fashion. Under local anesthesia a horizontal 4-cm incision was made in the infraclavicular location. The subcutaneous tissues were dissected down to the fascia overlying the junction of the
91
deltoid muscle and the pectoralis major muscle, thus identifying the deltopectoral groove. The cephalic vein was located in the deltopectoral groove. The cephalic vein was circumferentially dissected out for approximately 2— 3 cm. Two separate 3—0 silk sutures were then placed around the cephalic vein, one proximal and one distal. The suture placed distally around the cephalic vein was tied down securely. The cephalic vein was then partially transected with a No. 11 blade in a transverse fashion along its midportion. Back-bleeding from the proximal end of the cephalic vein was controlled by applying traction to the proximally placed 3—0 silk suture. The catheter was then passed proximally into the lumen of the partially transected cephalic vein and advanced centrally into the subclavian vein, the innominate vein and into the superior vena cava. Once the catheter was correctly positioned, the proximally placed 3—0 silk suture around the catheter and the proximal end of the cephalic vein was tied down in a non-constricting fashion to prevent back-bleeding and catheter migration. For implanted ports, the catheter was connected to the port, and the port was positioned and secured in a port pocket created along the inferior aspect of the infraclavicular incision. The subcutaneous tissues and skin of the infraclavicular incision were then closed in separate layers using absorbable suture. The patency of the catheter lumen was tested by aspirating blood and by flushing the lumen with a dilute heparin saline solution. Procedure of percutaneous subclavian vein puncture (Group B) For the percutaneous subclavian vein puncture approach, the patient is placed supine and in the Trendelenburg position. A rolled sheet placed vertically in the back to rotate the tips of the shoulders posteriorly. The region of the anterior chest, neck, and shoulders is prepped and draped. The skin overlying the anticipated venipuncture site is infiltrated with a local anesthetic. Using a 10 ml syringe with a 14-gauge needle the area of the subclavian vein is explored. Once easy flow of blood into the syringe confirms vein penetration, a flexible J guidewire is advanced through the venipuncture needle. The catheter placement used the Seldinger technique with the peel-away introducer method. Difficulties in advancing the catheter through the peel-away introducer sheath usually imply that the peel-away introducer sheath is bent. This occurs most frequently during subclavian vein approach if the venipuncture is attempted too medially and through the costoclavicular ligament. If the catheter cannot be advanced through the peel-away introducer sheath, repeat venipuncture in a more lateral position may be necessary. The catheter should never be handled with sharp instruments. Only non-toothed forceps should be used, if needed. The procedure for placing a subcutaneous implanted port is similar to that for a tunneled external catheter, except for the creation of a subcutaneous port pocket. Finally, a test puncture was
92
H.M. Chang et al. / EJSO 32 (2006) 90–93
performed to check patency and flow through the system with dilute heparinized saline solution. Statistical analysis The software program Statistical Package for the Social Sciences (SPSS) for Windows (version 8.0) was utilized to analyse the data by the Student’s t-test. A P value of less than 0.05 was considered statistically significant. Results In this retrospective study, the demographic data of both groups of patients are summarized in Table 1. Based on the Independent t-test, there were no statistically significant differences within the types of malignancy for either technique. Mean operative time was 43 min in group A (25—70 min) and 40 min in group B (25—60 min) (PO 0.05). The failure rate of the cephalic vein cut-down was 12% (64/533). The cephalic vein was absent in 21 patients, too small in 39 patients, and iatrogenic injury in four patients. Due to the multiple factors of influences, the long term patency/durability of TICVAD is not studied by this project. The overall and early complications of group A was significantly lower than that of group B. The complication rate is summarized in Table 2. The most common complications were infection (93/1131) during post-operative use. The most serious complication was fragmentation (6/1131). There was one intraoperative mortality in group A due to an underlying cardiovascular problem. Pneumothorax, arterial puncture, and hemothorax only developed in group B. Twenty patients had pneumothorax and five patients required chest tube drainage. In the other 15 patients, pneumothorax was resolved by conservative treatment. Hemothorax (four patients in group B) and hematoma (six in group A and seven in group B) resolved spontaneously. The catheter tip was placed in the lower portion of the superior vena cava. Malposition of the Table 2 Comparison between cephalic vein cut-down and subclavian vein puncture in complication rate
Early complication Pneumothorax Hemothorax Arterial puncture Malposition Hematoma Late complication Fragmentation Infection Occlusion Dehiscence Total complication
Group A cephalic vein cut-down
Group B subclavian vein puncture
P value
11/533 (2.1%) 0 0 0 5 6 64/533 (12%) 0 41 20 3 75/533 (14.1%)
63/598 (10.5%) 20 4 20 12 7 83/598 (13.9%) 6 52 23 2 146/598 (24.4%)
!0.0001 !0.0001 0.0586 !0.0001 0.1406 0.9437 0.3504 0.0204 0.5402 0.93 0.5637 !0.0001
catheter tips to the right atrium was observed in 17 patients (five in group A and 12 in group B). There was statistically significant difference between group A and B in fragmentation. Fragmentation only occurred in six patients in group B and all fractured catheter segments were removed with a retrieval snare wire under fluoroscopic observation using the femoral route. Discussion TICVAD have been widely used by the oncologists. They achieve safe and less painful vascular access, facilitate treatment of many medical disorders, and improve patients’ quality of life by giving them unrestricted mobility and freedom in their activities. These devices can be implanted through either a surgical or percutaneous procedure. The cephalic vein cut-down is used infrequently due to the reported high failure rate and the requirement for surgical expertise. Two earlier cadaver-based studies2,4 explain the high failure rates. LeSaout et al.2 found that the cephalic vein was absent in 5% and too small to pass a 3.4-mm pacemaker wire in 15% of the cadavers dissected. Chuter and Starker4 found that the cephalic vein was absent or too small to pass a 6.6-Fr catheter in 23% of the cadavers dissected. Coit and Turnbull10 have described a modified Seldinger technique for insertion of a catheter into the cephalic vein when it appears to be too small to accept the catheter directly. There were 7.3% (39/533) patients who had a small cephalic vein and we did not use this technique. In group B, there was no information as to how many different sites were used prior to successful catheter placement. Although many surgical teams use percutaneous access for placement of the TIVAD, both early and late complications are frequently observed. Pneumothorax is the most life-threatening complication which result the most clinical, economic, and psychological implications.9 Pneumothorax may occur during the subclavian vein puncture, arterial puncture, and related complications have been reported. In our opinion, cephalic cut-down method can avoid these early complications as compared with the percutaneous approach. Catheter fragmentation is a rare finding, with an overall prevalence of 0.1—1%.11,12 The cause of fragmentation can occur for three reasons: pinch-off syndrome,13,14 use of the incorrect equipment to damage catheter and using small syringes lead to increased pressure within the catheter.15 The Pinch-off syndrome arises when a subclavian catheter passes between the clavicle and the first rib and becomes compressed or kinked. The syndrome is observed in about 1% of TICVAD,13 and is a valuable warning prior to occlusion and fragmentation.16,17 The anatomy of the subclavian in this region can explains the possible cause of fragmentation. The region is bounded anteriorly by the clavicle, subclavius muscle, and costocoracoid ligament. Posterior borders are defined by the first rib and anterior
H.M. Chang et al. / EJSO 32 (2006) 90–93
scalene muscle. Medially, the clavicle and first rib are joined by the costoclavicular ligament. A catheter passes through this space outside the subclavian vein before it pierces the vessel medially. This anteromedial portion of the canal is smaller than the posterolateral region, which contains the subclavian vein. Thus, a catheter located in this areolar tissue is more susceptible to compression between the clavicle and first rib.9 Free shoulder joint movement exerts additional forces on this point and can result in catheter fragmentation. The following precautions can early identify this problem. Careful subclavian puncture should be made in the mid-clavicular location rather than more medially. Alternatively the lateral subclavian vein or the internal jugular vein may be the better routes. Fluoroscopic assessment at the time of insertion can help eliminate this complication.18 Klotz et al.19 suggest the removal of the device within 6 months when the pinch-off syndrome is present. In our study, no pinch-off syndrome or catheter fragmentation was seen in group A. Fragmentation was occurred in six patients of group B, pinch-off syndrome was noted in three patients and one of them developing tachydysrhythmia. We believe that pinch-off syndrome is the major cause of fragmentation and suggest immediate removal of device. The percutaneous subclavian vein puncture method has wide acceptance because of the ease of insertion when initially successful. But the complications of pneumothorax, hemothorax, and catheter fragmentation cause significant morbidity. Our results suggest that the cephalic vein cutdown technique is a safer method for TICVAD implantation, although this technique requires surgical expertise. We concluded that although the validity of these differences maybe limited by the retrospective character of this study, we consider that cephalic vein cut-down technique can prevent life threatening complications such as pneumothorax, hemothorax and catheter fragmentation. Similar findings were reported in previous studies.9,20
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