A prospective observational study of the outcome of central venous catheterization in 100 patients

Abstract

Context:

To Study the outcome following central vein catheterization in patients receiving chemotherapy.

Aims:

To Study the outcome of central venous catheterization in terms of difficulty during insertion, duration, incidence of infections and other complications and reasons for removal.

Settings and Designs:

Prospective observational study conducted in 100 patients attending to Gujarat Cancer and Research Institute.

Materials and Methods:

Both onco-medical and onco-surgical patients who required insertion of central venous catheters were enrolled after ethical approval from June 2008 to November 2010. The study comprised 100 patients.

Statistical Analysis Used:

Mean and percentage.

Results:

Mean duration of the indwelling catheter was 109 days for Hickman catheter, 39 days for cavafix and 59 days for certofix. Difficulty in insertion and arrhythmias were common complications. There were no incidences of major life threatening complications. Catheter related infection was 30%. The commonest reason for catheter removal was treatment completion 72%. The next frequent cause was catheter infection 14% and patient death 6%.

Conclusions:

Even though central venous catheterization is associated with acceptable complications, they serve a useful aid in management of patients on chemotherapy.

INTRODUCTION

Access to peripheral veins is a frequently encountered problem in critical care units and surgical patients especially in patients with malignancy.[1] This problem is complicated by the need to administer chemotherapy and drugs which are highly irritant to the peripheral veins for a prolonged period, need for repeated blood sampling, short life span of the catheters inserted into peripheral veins and frequent incidence of superficial thrombophlebitis with attending discomfort to the patient, need for hyperalimentation, monitoring of central venous pressure to guide fluid resuscitation in hypovolemic surgical patients.

Introduction of central venous catheterization has greatly simplified these problems and facilitated the management of patients with poor peripheral venous access, especially cancer patients.

Complications may occur during catheter insertion or at a later time. They may be thrombotic and infectious in origin, or related to other causes such as inadvertent device damage, device malfunction, and mechanical occlusion.[2]

We decided to conduct a prospective study of 100 patients with various malignancies who were advised to undergo central venous catheter insertion with an aim

1. To compare different catheter types and routes of central venous access

2. To study the mechanical and technical difficulties encountered during insertion of central venous catheters

3. To study the duration of catheter indwelling period among various types of central vein catheters

4. Compare the incidence of infections, mechanical and thrombotic/embolic complications that may appear during catheter indwelling period and their management

5. To assess the reasons for catheter removal in various types and routes of central venous catheters.

MATERIALS AND METHODS

Both onco-medical and onco-surgical patients who required insertion of central venous catheters were enrolled from June 2008 to November 2010 after obtaining approval from the Institutional Ethical Committee. The study comprised 100 patients. The indications of central venous catheter included

1. Need to administer chemotherapy that was to extend over one or more months

2. Hyper alimentation in surgical patients

3. Need for repeated blood sampling while on treatment for diagnostic and monitoring purposes

4. Need for monitoring of central venous pressure as a guide to volume resuscitation in critical care units, operation theatres, in patients scheduled for complicated long duration surgeries like colorectal resection, thoracic surgeries, cerebrovascular, aneurysm, renal and hepatic surgeries

5. To aspirate air from right heart in cases of air embolism in patients at high risk for the same

Patients refusing to comply with informed consent, evidence of infection at the insertion site, absolute neutrophil count < 500/mm³ and platelet count < 50000/mm³ and those with abnormal coagulation profile were excluded from the study.

Among the various types of long term venous access material like, Brovic, Hickman, Leonard, Groshong catheters, peripherally inserted central catheters, totally implantable venous access ports, and externalized catheters like Certofix^® and Cavafix^®, we have selected only Hickman, Cavafix^®, Certofix^® catheters in our study.

Hickman device are single, double, or triple catheters of various sizes. They are barium impregnated silicone elastomer catheters. These catheters are implanted in subcutaneous tissue just above the exit site. The Dacron cuff attached approximately 30 cm from external hub promotes fibrous in growth and scarring thus reducing the likelihood of inadvertent catheter removal and also prevents bacterial migration along the catheter tunnel.

The Cavafix^® devices are single lumen radio-opaque catheters made of polyurethane available in different size. It has a hub with luer lock fitting.

Certofix^® devices are single, double, or triple catheters of various sizes made of polyurethane.

Standard catheter insertion techniques were followed for inserting these devices.

Anticubital approach was followed for Cavafix^® insertion, Subclavian approach was used for Certofix^® and Hickman catheter insertion.

Standard protocol for catheter care was followed.

Care was taken not to introduce air into catheter. All catheters were connected to extension tubing with luer-lock connector.

Dressing changes were done under strict aseptic precautions every alternate day in case of Cavafix^® and twice a week in Certofix^® and once a week in Hickman catheters.

Patients were followed daily and examined for signs/symptoms of catheter related complications like exit site infections, venous thrombosis, pneumothorax, catheter occlusion, arrhythmias, pyrexia of unknown origin and sepsis.

At each dressing change, catheter exit site was examined for presence of infection, erythema, induration, catheter leak, and retrograde flow, pyogenic discharge, evidence of venous thrombosis, catheter occlusion extravasation.

Heparin flush using 2 cc of 100 U/ml was done daily. Catheters not in continuous use were flushed with heparinized saline 5 ml after each intermittent use and with 10 ml after each blood sample collection or infusion of blood products. In case of Hickman catheters, use of injection caps were limited and changed only once or at maximum twice a week. Catheter removal was done under aseptic precautions. Local pressure at exit site applied for 5 min and sterile dressing applied after removal. The removed catheter was examined for breakages, obstruction and thrombosis.

The criteria for catheter removal included

1. Un-resolving infection at exit site/catheter tunnel in spite of antibiotic therapy or septicemia not responding to antibiotic treatment.

2. Catheter's inserted via Subclavian or Brachial vein entering the Jugular vein or contralateral subclavian vein in spite of attempts to manipulate the migrated catheter so as to position the tip correctly.

3. Impending venous thrombosis not resolving with conservative measures with catheter in situ.

4. Persistent blockage of catheter not relieved by gentle pressure flushes with heparin in 5 ml syringe and aspiration.

5. Completion of proposed treatment regimen.

6. Death of the patient who is having an indwelling catheter.

RESULTS

Total number of male patients were 63 and female patients 37 [Table 1]. Mean duration of the indwelling catheter was 109 days for Hickman catheter, 39 days for Cavafix and 59 days for Certofix [Table 2]. Complications encountered during catheterization shows that difficulty in inserting the catheter was seen in 0.7% of patients, arrhythmias in 25% of patients, pneumothorax in 2% of patients [Table 3]. Complications during catheter indwelling were commonly migration (10%), occlusion (21%) and catheter related infections (15%). Overall infectious complications were 29% [Table 4]. The overall infection rate was 29% and the common microbes involved in catheter related infections were staphylococcus epidermidis followed by staphylococcus aureus [Table 5]. Among the common reasons for catheter removal were treatment completion (72%) and unresolving infection (14%) [Table 6].

Table 1.

Demographic data

Table 2.

Duration of indwelling catheter period

Table 3.

Complications during catheter insertion

Table 4.

Complications during catheter indwelling period

Table 5.

Microbes involved in catheter related infections

Table 6.

Reason for catheter removal

DISCUSSION

Vascular access is a major problem in cancer patients requiring diagnostic and therapeutic regimens for a longer period of time. Large bore catheters like Hickman Cavafix^®, Certofix^® catheters provide long term vascular access with satisfactory patient acceptability. They are also useful for frequent blood sampling, central venous pressure monitoring, fluid therapy and hyperalimentation.

In our study of central venous, catheters comprising 100 patients with various malignancies and different age group, Hickman catheters were used in 20 patients Cavafix^® was used in forty patients and Certofix^® was used in forty patients [Table 1]. The mean duration of indwelling catheter period was 39 days for Cavafix^® (range 13-67 days), 59 days for Certofix^® (range 28 to 197 days) and 109 days for Hickman (range 28 to 197 days) [Table 2].

Significant neutropenia or thrombocytopenia secondary to recent administration of chemotherapeutic agents requires careful assessment of general condition of the patient to maximize the safety of procedure. Patients whose catheters were inserted during the period of neutropenia have a higher incidence of infection. In the study by Gorelick MH, the infection was as high as 27% compared to those not having neutropenia during insertion time.[3] In our study, we have excluded neutropenic patients.

Those with thrombocytopenia were given platelet rich plasma, fresh frozen plasma or whole blood prior to the procedure to minimize the incidence of postoperative hemorrhage complications. One patient with Certofix^® who manifested excessive exit site bleeding did not respond to supportive treatment and necessitated catheter removal. In our study, total incidence of exit site oozing was 8%, out of which 7% of patients could be managed conservatively [Table 4].

Mean duration of catheter indwelling period was greatest in Hickman group of patients (109 days) and least for Cavafix^® (39 days). Experience with extended use of these catheters is still limited, however, because in majority of patients the reason for removal of catheters was completion of treatment. Hsieh and colleagues reported a median duration of 178 days for ports implanted at a cancer center in Taiwan, China.[4] Ignatov et al., from Germany retrospectively reviewed the medical records of 550 patients who had ports implanted for chemotherapy treatment (median time of port duration, 22.5 months) over all, 104 complications occurred and 48 patients experienced complications that required removal of port. Overweight patients and those with left-sided ports were at higher risk for complications.[5]

Patients having borderline coagulation profile and or haematological malignancies manifested excessive oozing via exit site, overall incidence was 8%. Mumtaz et al., studied 2010 central venous catheters over 2 year period. Three hundred and thirty placements were in patients with disorders of hemostasis. In 88 of 330 patients the underlying coagulopathy was not corrected. Only 3 bleeding complications were there requiring placement of purse string suture at entry site. Only low platelet count (<50 × 10⁽⁹⁾/L) was significantly associated with bleeding complications.[6]

Difficulties in placement of catheters were noted in 5% cases of Certofix^® due to cervical rib and mediastinal tumor. Twelve point five percent in Cavafix^® and none with Hickman catheterization [Table 3]. The problems encountered during Cavafix^® catheterization were also attributable to poor peripheral venous status and to the longer length the catheter has to pass [Table 4]. Randolph and colleagues in their study showed that real-time ultrasound guidance significantly decreased the risk for jugular and subclavian catheter placement failure (RR 0.32, 95% CI 0.18–0.55), for complications during catheter placement (RR 0.22, 95% CI 0.10–0.45) and for multiple catheter placement attempts (RR 0.6, 95% CI 0.45–0.79) as compared with the standard landmark placement technique.[7]

Arrhythmias were observed in 25% patients during catheter insertion. They were treated by intravenous preservative free lignocaine 2 mg/kg [Table 4]. Stuart and colleagues performed cardiac monitoring on patients during 51 central venous catheter insertions to determine the incidence of cardiac arrhythmias. Forty-One percent of procedures resulted in atrial arrhythmias and 25% produced some degree of ventricular ectopy, 30% of these were ventricular couplets or greater. Ventricular ectopy was significantly more common in shorter patients (160+/- 8 vs. 168+/- 11 cm, P less than 0.05) and when the catheter was inserted from the right subclavian position[8] (43% ventricular ectopy vs. 10% at the other sites).

Ayas reported an incidence 1.9% per CVC of pneumothorax.[9] Patients in our study manifested bradycardia, fall in oxygen saturation and decreased breath sounds and were diagnosed as pneumothorax. The risk factors for pneumothorax were chronic obstructive lung disease, thoracic deformity, inexperience and venipuncture made during deep inspiration.

Catheter tip migration can occur any time during indwelling period. It is enhanced by some factors like vomiting, valsalva manoeuvre. These complication were seen in 15% Cavafix^® and 10% Certofix^®. These were detected during follow up of patients and were repositioned under fluoroscopy. Those that were not amenable for replacement were removed.

Persistent withdrawal occlusion defined as inability to aspirate blood via catheter while the ability to infuse is being preserved. This may be due to catheter tip abutting the vessel wall, catheter migration, catheter kinking or coiling, partial occlusion of catheter lumen or patient posture related. The incidence of this complication in our study was 22.5% for Cavafix^®, 10% for Certofix^®. Manipulation of the catheter with heparin and antibiotic therapy were able to solve the problem in all cases without use of thrombolytic agents. Study by Tschirhart showed an incidence of persistent withdrawal occlusion to be 19% and success rate of overcoming it by instilling 5000 units of urokinase to be 98.6%.[10] Haire et al., showed that a 2 mg dose of alteplase was more effective than urokinase (5000 IU) for treating radiographically proven thrombotic occlusion of a CVC after a dwell time of 120 min.[11] In the COOL trial (Cardiovascular thrombolytic used to Open Occluded Lines), one 2 mg dose of alteplase cleared the catheter occlusion after 120 min in 74% of patients, compared to only 17% of patients who received placebo. The overall catheter clearance rate for alteplase was 90% after up to 2 doses with no reports of major hemorrhage.[12]

Although, newer catheter materials like silicone and polyurethane are less thrombogenic, any foreign material in the blood vessels enhances thrombogenicity. The situation is compounded by hypercoagulable state of certain malignancies. One patient in our study having Hickman catheter suffered from subclavian vein partial thrombosis which was diagnosed by venography. Various authors have reported the incidence ranging from 4 to 40%.[13]

The incidence of accidental withdrawal of catheter in our study was 2.5% for Certofix^® and 2.5% for Cavafix^®. This problem was not seen in Hickman group. Greenberg ML reported an incidence of 11% for Certofix^® and Cavafix^® combined and 1.4% for Hickman catheters.

Exit site infections were seen were seen in 20% of Hickman, 7.5% Cavafix^®, and 20% of Certofix^® catheterization. Study of infectious complications by Gorelick MH showed an incidence of 14% in non-neutropenic patients and 27% in neutropenic patients. The incidence rate of catheter sepsis in standard catheters was 7.5% in a study done by Pemberton et al.,[14] Trick et al., in their study of 106 CVCs with 682 catheter-days reported that the primary BSI rate was 4.4 per 1000 catheter-days.[15] Deshpande et al., in 2005 in their study reported that the incidence of catheter infection was 4.01/1000 catheter-days (2.29% catheter) and colonization was 5.07/1000 catheter-days (2.89% catheters), which was low.[16]

Catheter related bacteremia/septicemia showed comparable results with study conducted by Gorelick MH which was 25%.[3]

In catheter related infections, gram positive organisms account for majority of isolates of which half being staphylococci. In our study, staphylococcus epidermidis was the commonest isolate 33.3%. Others are 27% for Staphylococcus aureus, 17% Pseudomonas species, 10% Escherichia coli and 9% for coagulase negative Staphylococcus aureus [Table 5]. Mueller also reported higher incidence of gram positive bacteremia with Staphylococcus aureus being 40%. The highest incidence of infectious complications in our study was for Certofix^® (40%), Hickman (40%) and least for Cavafix^® (15%).[17]

Majority of catheters were functioning at the time of catheter removal. Treatment completion was the most common reason for catheter removal (72%) [Table 6] suggesting that most of central venous catheters served the purpose they were meant for.