Journal of Surgical Oncology 4452-54 (1990)
Early and Late Complications of Totally Implantable Venous Access Devices KEVIN 1. GRANNAN,
MD, AND
PHILIP
H.TAYLOR,
MD
From the Surgical Residency Program (K.I.C.) and Department of Surgery (P.H.T.), Good Samaritan Hospital, Cincinnati
We reviewed the records of 66 consecutive patients who underwent placement of totally implantable venous access devices (TIVADs). Fourteen patients (21 7%) experienced complications related to the TIVAD. Complications included hematoma, infection, pneumothorax, subclavian vein thrombosis, and chronic clavicular pain. The I month mortality rate following insertion of a TIVAD was 24% (16 of 66 patients); however, none of the patients died as a direct consequence of port insertion or its associated complications. Overall patient and physician acceptance of TIVADs was good, and we encourage continued use and study of this device. KEY WORDS:antineoplastic agents, catheters, indwelling, implants, artificial, infusion, subclavian vein
INTRODUCTION Limited peripheral venous access in a chronically ill patient is a difficult and frustrating problem for both the physician and the patient. Various techniques are used to combat this problem. Arteriovenous fistulas and conduits of assorted materials have been employed, with limited success. Methods for percutaneous cannulation of the subclavian and internal jugular veins were described by Broviac et al. [l] and Hickman et al. [2] in the 1970s. External devices are effective; however, they are cumbersome for the patient, are prone to complications, and require significant maintenance. During the past decade, totally implantable venous access devices (TIVADs) have been developed. In our opinion, these devices represent a technologically superior solution to the problem of limited peripheral access in chronically ill patients. Patients with poor peripheral veins who require frequent infusions of narcotics. antibiotics, chemotherapy, blood products, and total parenteral nutrition are ideal candidates for TIVADs. TIVADs have gained acceptance because they are easy to implant and access, comfortable for the patient, and relatively free of complications. The following report documents our experience with TIVADs in 66 consecutive patients and describes the complications associated with the implantation and use of these devices. 0 1990 Wiley-Liss, Inc.
MATERIALS AND METHODS Between February, 1985, and January, 1987, 66 patients received TIVADs at our institution, a large coinmunity teaching hospital. We retrospectively collected data on these patients from hospital charts, attending surgeons’ charts, and outpatient oncology records. The patient population consisted of 27 men and 39 women ranging in age from 22 to 82 years. The mean age was 55 years. Each patient had been referred by one of eight attending physicians for placement of a TIVAD. Fifty-nine of the TIVADs (89%) were implanted in patients with malignant disease; the other seven (1 1 %) were implanted for nonmalignant disease (chronic heart failure, chronic anemia, sickle cell anemia, blastomycosis, brittle diabetes, aplastic anemia, and cardioniyopathy) (Fig. 1). The primary reasons for implantation were chemotherapy, continuous pain control, and venous access. Three types of TIVADs were used: Port-A-Cath by Pharmacia Deltec (St. Paul, MN) (54 patients, 82%);
Accepted for publication December 29. 1990. Address reprint requests to Kevin Grannan. MD, Department of Surgery. Good Samaritan Hospital, 3217 Clifton Avenue, Cincinnati, OH 45220-2489.
Complications of TIVADs
Fig. 1, Underlying disease in 66 patients with totally implantable venous access devices.
Implantofix by Burron Medical Inc. (Bethlehem, PA) (six patients, 9%); and Mediport by Norfolk Medical Products Inc. (Skokie, IL) (six patients, 9%). Fifty-nine of the TIVADs had single-lumen catheters; the other seven had double-lumen catheters. Each TIVAD was placed by one of nine surgeons. Implantation techniques have been described elsewhere and will not be addressed in this report [3,4]. Thirty-five patients (53%)had general anesthesia during implantation; the other 3 1 patients had local anesthesia. Thirty-three patients (50%) received intraoperative antibiotics.
RESULTS As of January, 1987, the 66 TIVADs had been in place a total of 10,016 patient-days. The range per patient was 2-716 days, and the mean was 152 days (Fig. 2). The number of reservoir punctures was not tabulated. There were 16 complications in 14 patients (Table I). Four patients developed infections (Candicla albiccins, Pseudomonus aeruginosa, Staphylococcus aureus, and Sta~~}i.vloc.oc.cris epidmnidis), all of which necessitated removal of their ports. Prophylactic antibiotics had been given t o three of the four patients with infected ports. Three of the four infections occurred more than 6 months after insertion of the TIVAD. Three of the seven ports implanted for nonmalignant disease became infected (43%), in contrast to only one of the 59 ports implanted for malignant disease (2%). This difference was highly significant ( P < 0.003) according to Fisher's exact test. No correlation was found between the rate of infection and either the brand of TIVAD or the type of catheter. Five patients developed hematomas at the insertion site. Four patients sustained pneumothoraces, which were treated with chest tubes. Subclavian vein thronibosis developed in two patients, both of whom also had infections. One port was removed for chronic clavicular pain at the insertion site. The mortality rate 1 month after
53
Fig. 2. Implant time (to date) of totally implantable venous access devices i n 66 patients.
TABLE I. Complications of Totally Implantable Venous Access Devices Used in 66 Patients for 10,016 Patient-Days Complication Heniatoma Infection" Pneumothordx Chronic clavicular pain Total
Number of patients (%)
5 (8) 4 (6) 4 (6)
I(I) 14 (21)
"Two of the four patients with infection also developed subclavian vein thrombosis.
insertion was 24% (16/66). None of the patients died art a direct consequence of port insertion or its coniplications; all the deaths were related to the underlying disease process.
DISCUSSION TIVADs have been established as a relatively safe and dependable means of long-term venous access [5,6]. Multiple studies have documented the relative superiority of TIVADs over transcutaneous methods of permanent venous access [e.g., Hickman, (Davol Inc., Cranston, RI)] [7]. The majority of our patients tolerated the insertion and long-term use of a TIVAD without significant complications. The most serious complication in our series of patients was infection of the TIVAD; this invariably led to rehospitalization and removal of the port. In our series, patients with nonmalignant disease were significantly more likely to develop port infections than were patients with malignancies. This suggests that patients with chronic nonmalignant diseases have a higher degree of imniuno~suppression than patients with malignant diseases. Although none of our patients died as a direct result omf TIVAD insertion or subsequent complications, our mor-
54
Grannan and Taylor
tality rate 30 days after insertion was 24% (16/66). This most likely represents the low threshold on the part of oncologists and surgeons in our institution to place TIVADs. In retrospect, some of these patients could have been managed with more temporary forms of venous access. This might have minimized the risk, discomfort, and cost of long-term venous access in this terminally ill group of patients.
CONCLUSIONS During a 24-month period beginning in February, 1985,66 consecutive patients received TIVADs. Overall patient and physician acceptance of this form of venous access was good. Complications, which occurred in 14 patients (2 1%), included infection, pneumothorax, hematoma, thrombosis, and chronic pain. Infection was the most serious complication, necessitating removal of the port in four patients. The incidence of port infection was significantly higher in patients with underlying nonmalignant disease (43%) than in patients with malignant disease (2%). The 1 month mortality rate might have been decreased by better patient selection. Continued use
and study of TIVADs in chronically ill patients with limited peripheral access are justified.
REFERENCES 1. Broviac JW, Cole JJ, Scribner BH: A silicone rubber atrial catheter
for prolonged alimentation. Surg Gynecol Obstet I36:602-606, 1973. 2. Hickman RO, Buckner CD, Clift RA, Sanders JE, Stewart P. Thomas ED: A modified right atrial catheter for access to the venous system in marrow transplant recipients. Surg Gynecol Obstet 148:871-875. 1979. 3. Sterchi JM, Fulks D, Cruz J, Paschold E: Operative technique for insertion of a totally implantable system for venous access. Surg Gynecol Obstet 163:381-382, 1986. 4. Wile AG: Technique for placement of an implantable venous access system. Am J Surg 152543-544, 1986. 5. Welling RE, Hall JM. Meyer RL, Arbaugh JJ: Implantable venous access devices: An alternative method of extended cancer care. J Surg Oncol 33:73-75, 1986. 6. Bothe A Jr. Piccione W, Ambrosino JJ, Benotti PN, Lokich JJ: Implantable central venous access system. Am J Surg 147:565569, 1984. 7. Stanislav GV. Fitzgibbons RJ Jr, Bailey RT Jr. Mailliard JA, Johnson PS. Feole JB: Reliability of implantable central venous access devices in patients with cancer. Arch Surg 122:1280-1283. 1987.
Early and Late Complications of Totally Implantable Venous Access Devices KEVIN 1. GRANNAN,
MD, AND
PHILIP
H.TAYLOR,
MD
From the Surgical Residency Program (K.I.C.) and Department of Surgery (P.H.T.), Good Samaritan Hospital, Cincinnati
We reviewed the records of 66 consecutive patients who underwent placement of totally implantable venous access devices (TIVADs). Fourteen patients (21 7%) experienced complications related to the TIVAD. Complications included hematoma, infection, pneumothorax, subclavian vein thrombosis, and chronic clavicular pain. The I month mortality rate following insertion of a TIVAD was 24% (16 of 66 patients); however, none of the patients died as a direct consequence of port insertion or its associated complications. Overall patient and physician acceptance of TIVADs was good, and we encourage continued use and study of this device. KEY WORDS:antineoplastic agents, catheters, indwelling, implants, artificial, infusion, subclavian vein
INTRODUCTION Limited peripheral venous access in a chronically ill patient is a difficult and frustrating problem for both the physician and the patient. Various techniques are used to combat this problem. Arteriovenous fistulas and conduits of assorted materials have been employed, with limited success. Methods for percutaneous cannulation of the subclavian and internal jugular veins were described by Broviac et al. [l] and Hickman et al. [2] in the 1970s. External devices are effective; however, they are cumbersome for the patient, are prone to complications, and require significant maintenance. During the past decade, totally implantable venous access devices (TIVADs) have been developed. In our opinion, these devices represent a technologically superior solution to the problem of limited peripheral access in chronically ill patients. Patients with poor peripheral veins who require frequent infusions of narcotics. antibiotics, chemotherapy, blood products, and total parenteral nutrition are ideal candidates for TIVADs. TIVADs have gained acceptance because they are easy to implant and access, comfortable for the patient, and relatively free of complications. The following report documents our experience with TIVADs in 66 consecutive patients and describes the complications associated with the implantation and use of these devices. 0 1990 Wiley-Liss, Inc.
MATERIALS AND METHODS Between February, 1985, and January, 1987, 66 patients received TIVADs at our institution, a large coinmunity teaching hospital. We retrospectively collected data on these patients from hospital charts, attending surgeons’ charts, and outpatient oncology records. The patient population consisted of 27 men and 39 women ranging in age from 22 to 82 years. The mean age was 55 years. Each patient had been referred by one of eight attending physicians for placement of a TIVAD. Fifty-nine of the TIVADs (89%) were implanted in patients with malignant disease; the other seven (1 1 %) were implanted for nonmalignant disease (chronic heart failure, chronic anemia, sickle cell anemia, blastomycosis, brittle diabetes, aplastic anemia, and cardioniyopathy) (Fig. 1). The primary reasons for implantation were chemotherapy, continuous pain control, and venous access. Three types of TIVADs were used: Port-A-Cath by Pharmacia Deltec (St. Paul, MN) (54 patients, 82%);
Accepted for publication December 29. 1990. Address reprint requests to Kevin Grannan. MD, Department of Surgery. Good Samaritan Hospital, 3217 Clifton Avenue, Cincinnati, OH 45220-2489.
Complications of TIVADs
Fig. 1, Underlying disease in 66 patients with totally implantable venous access devices.
Implantofix by Burron Medical Inc. (Bethlehem, PA) (six patients, 9%); and Mediport by Norfolk Medical Products Inc. (Skokie, IL) (six patients, 9%). Fifty-nine of the TIVADs had single-lumen catheters; the other seven had double-lumen catheters. Each TIVAD was placed by one of nine surgeons. Implantation techniques have been described elsewhere and will not be addressed in this report [3,4]. Thirty-five patients (53%)had general anesthesia during implantation; the other 3 1 patients had local anesthesia. Thirty-three patients (50%) received intraoperative antibiotics.
RESULTS As of January, 1987, the 66 TIVADs had been in place a total of 10,016 patient-days. The range per patient was 2-716 days, and the mean was 152 days (Fig. 2). The number of reservoir punctures was not tabulated. There were 16 complications in 14 patients (Table I). Four patients developed infections (Candicla albiccins, Pseudomonus aeruginosa, Staphylococcus aureus, and Sta~~}i.vloc.oc.cris epidmnidis), all of which necessitated removal of their ports. Prophylactic antibiotics had been given t o three of the four patients with infected ports. Three of the four infections occurred more than 6 months after insertion of the TIVAD. Three of the seven ports implanted for nonmalignant disease became infected (43%), in contrast to only one of the 59 ports implanted for malignant disease (2%). This difference was highly significant ( P < 0.003) according to Fisher's exact test. No correlation was found between the rate of infection and either the brand of TIVAD or the type of catheter. Five patients developed hematomas at the insertion site. Four patients sustained pneumothoraces, which were treated with chest tubes. Subclavian vein thronibosis developed in two patients, both of whom also had infections. One port was removed for chronic clavicular pain at the insertion site. The mortality rate 1 month after
53
Fig. 2. Implant time (to date) of totally implantable venous access devices i n 66 patients.
TABLE I. Complications of Totally Implantable Venous Access Devices Used in 66 Patients for 10,016 Patient-Days Complication Heniatoma Infection" Pneumothordx Chronic clavicular pain Total
Number of patients (%)
5 (8) 4 (6) 4 (6)
I(I) 14 (21)
"Two of the four patients with infection also developed subclavian vein thrombosis.
insertion was 24% (16/66). None of the patients died art a direct consequence of port insertion or its coniplications; all the deaths were related to the underlying disease process.
DISCUSSION TIVADs have been established as a relatively safe and dependable means of long-term venous access [5,6]. Multiple studies have documented the relative superiority of TIVADs over transcutaneous methods of permanent venous access [e.g., Hickman, (Davol Inc., Cranston, RI)] [7]. The majority of our patients tolerated the insertion and long-term use of a TIVAD without significant complications. The most serious complication in our series of patients was infection of the TIVAD; this invariably led to rehospitalization and removal of the port. In our series, patients with nonmalignant disease were significantly more likely to develop port infections than were patients with malignancies. This suggests that patients with chronic nonmalignant diseases have a higher degree of imniuno~suppression than patients with malignant diseases. Although none of our patients died as a direct result omf TIVAD insertion or subsequent complications, our mor-
54
Grannan and Taylor
tality rate 30 days after insertion was 24% (16/66). This most likely represents the low threshold on the part of oncologists and surgeons in our institution to place TIVADs. In retrospect, some of these patients could have been managed with more temporary forms of venous access. This might have minimized the risk, discomfort, and cost of long-term venous access in this terminally ill group of patients.
CONCLUSIONS During a 24-month period beginning in February, 1985,66 consecutive patients received TIVADs. Overall patient and physician acceptance of this form of venous access was good. Complications, which occurred in 14 patients (2 1%), included infection, pneumothorax, hematoma, thrombosis, and chronic pain. Infection was the most serious complication, necessitating removal of the port in four patients. The incidence of port infection was significantly higher in patients with underlying nonmalignant disease (43%) than in patients with malignant disease (2%). The 1 month mortality rate might have been decreased by better patient selection. Continued use
and study of TIVADs in chronically ill patients with limited peripheral access are justified.
REFERENCES 1. Broviac JW, Cole JJ, Scribner BH: A silicone rubber atrial catheter
for prolonged alimentation. Surg Gynecol Obstet I36:602-606, 1973. 2. Hickman RO, Buckner CD, Clift RA, Sanders JE, Stewart P. Thomas ED: A modified right atrial catheter for access to the venous system in marrow transplant recipients. Surg Gynecol Obstet 148:871-875. 1979. 3. Sterchi JM, Fulks D, Cruz J, Paschold E: Operative technique for insertion of a totally implantable system for venous access. Surg Gynecol Obstet 163:381-382, 1986. 4. Wile AG: Technique for placement of an implantable venous access system. Am J Surg 152543-544, 1986. 5. Welling RE, Hall JM. Meyer RL, Arbaugh JJ: Implantable venous access devices: An alternative method of extended cancer care. J Surg Oncol 33:73-75, 1986. 6. Bothe A Jr. Piccione W, Ambrosino JJ, Benotti PN, Lokich JJ: Implantable central venous access system. Am J Surg 147:565569, 1984. 7. Stanislav GV. Fitzgibbons RJ Jr, Bailey RT Jr. Mailliard JA, Johnson PS. Feole JB: Reliability of implantable central venous access devices in patients with cancer. Arch Surg 122:1280-1283. 1987.
