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PubMed1998

Totally implantable central venous access ports for long-term chemotherapy. A prospective study analyzing complications and costs of 333 devices with a minimum follow-up of 180 days.

BACKGROUND: A few data are available from analyses of the complications and costs of central venous access ports for chemotherapy. This prospective study deals with the complications and global costs of central venous ports connected to a Groshong catheter for deliverance of long-term chemotherapy. PATIENTS AND METHODS: Patients with a variety of solid neoplastic diseases requiring chemotherapy who were undergoing placement of implantable ports over a 30-month period (1 October 1994 to 31 March 1997) have been prospectively studied. Follow-up continued until the device was removed or the study was closed (30 September 1997); patients with uneventful implant experience and subsequent follow-ups of less than 180 days were not considered for this study. A single port, constructed of titanium and silicone rubber (Dome Port, Bard Inc., Salt Lake City, USA), was used, connected to an 8 F silastic Groshong catheter tubing (Bard Inc., Salt Lake City, USA). Two-hundred ninety-six devices were placed in the operating room under fluoroscopic control even in the patients treated and monitored in a day-hospital setting: 37 of them were in an angiographic suite. A central venous access form was filled in by the operator after the procedure and all ports were followed prospectively for device-related and overall complications. The average purchase cost of the device was obtained from the hospital charges, based on the costs applied during the 30-month period of the study. Insertion and maintenance costs were estimated by obtaining the charges for an average TIAP implant and its subsequent use; the costs of complication management were assessed analytically. The total cost of each device was defined as the purchase cost plus the insertion cost plus the maintenance cost plus the cost of treatment of the complications, if any. The cost of removing the TIAP was also included in the economic analysis when required by the treatment of the complication. RESULTS: Three hundred thirty-three devices, for a total of 79,178 days in situ, were placed in 328 patients. Five patients received second devices after removal of the first. In all cases the follow-up was appropriate (median 237 days, range 180-732). Early complications included 10 pneumothoraxes (3.4%; six tube-thoracostomies were applied, 1.8%) and six revisions for port and/or catheter malfunction (overall early complications = 16, 4.48%). Late complications comprised five instances of catheter rupture and embolization (1.5%, 0.063 episodes/1000 days of use), five of venous thrombosis (1.5%, 0.063 episodes/1000 days of use), one of pocket infection (0.3%, 0.012 episodes/1000 days of use), and eight of port-related bacteremia (2.4%, 0.101 episodes/1000 days of use). The infections were caused by coagulase-negative Staphylococcus aureus (five cases), Bacillus subtilis (one case), Streptococcus lactaceae (one case) and an unknown agent (one case); port removal was necessary in six of eight cases. The total cost per patient treated for a six-month period, consisting of the costs of purchase and implantation, treatment of early and late complications, and of maintenance of the device, is US$1,970. CONCLUSIONS: This study represents the largest published series of patients with totally implantable access ports connected to a Groshong catheter. We have shown that US$2,000 are sufficient to cover six months of chemotherapy in one patient using the most expensive commercially available implantable port. According to the present study, totally implantable access ports connected to a Groshong catheter are associated with high purchase and insertion costs, a low complication rate and low maintenance costs. These data support their increasing use in current oncologic medical practice.

Adolescent↗
PubMed1998

Clinical, physiological, and radiological study of a new purpose-designed artificial bowel sphincter.

BACKGROUND: Studies of the use of artificial urinary sphincters for faecal incontinence have led to refinement and adaptation of such sphincters to the anatomy of the anal region. We aimed to test this new device. METHODS: Six women, median age 53 (range 32-58) years, who were unsuitable for sphincter repair, had an artificial bowel sphincter implanted as a one-stage procedure without colostomy cover. Clinical assessment, physiological testing, and endosonography were done before and after the operation. Plain radiography, three-dimensional endosonography, and magnetic-resonance imaging were done after the operation, to define its anatomical location. RESULTS: Median follow-up was 10 (range 5-13) months and the device was functional in five patients. In one patient, the device was removed after ulceration through the skin. Of the patients with intact devices, Wexner incontinence scores improved from a median of 19 (18-20) of 20 before the operation, to 3 (0-6) of 20 after the operation. Median anal pressure at rest significantly increased from 60 (range 30-80) cm H2O to 110 (100-120) cm H2O. Functional anal-canal length varied after the operation from 3.3 cm to 3.8 cm. There was no significant change in the maximum tolerated volume of the rectum (140 [80-230] vs 100 [75-250] mL), or rectal compliance (2.9 [2.8-6.0] cm H2O/mL vs 3.5 [2.3-7.3] cm H2O/mL). All the imaging techniques accurately located the implant relative to the anal canal and pelvic floor in each patient. INTERPRETATION: The new artificial bowel sphincter provided a good functional result in five of the six patients, the surgical procedure was straightforward, and the maximum resting anal pressure rose without affecting rectal function. The ease of visualisation of such implants in situ should aid simple management of complications, should they arise.

Adult↗
PubMed2001

Impact of exclusion criteria on patient selection for endovascular abdominal aortic aneurysm repair.

PURPOSE: Wide-ranging predictions have been made about the usefulness of endovascular repair for patients with abdominal aortic aneurysms (AAAs). The availability of US Food and Drug Administration-approved devices has removed the restrictions on patient selection, which had been controlled by device trials. This study examined the applicability of endovascular AAA repair and identified the anatomic barriers to successful endovascular AAA repair that should guide future device development. METHODS: All patients who came to our institution for infrarenal AAA repair between April 1998 and June 2000 were offered evaluation for endovascular repair. Thin-cut spiral computed tomography scans and arteriograms were obtained on all patients, and their anatomic characteristics were prospectively entered into a database. A wide selection of available devices allowed the treatment of diverse AAA anatomic features. RESULTS: A total of 307 patients were examined (264 men, 43 women). Of these, 204 patients (66%; 185 men, 19 women) underwent endovascular repair, and 103 patients (34%, 79 men, 24 women) were rejected. Reasons for exclusion included short aneurysm neck (56, 54%), inadequate access because of small iliac arteries (48, 47%), wide aneurysm neck (41, 40%), presence of bilateral common iliac aneurysms extending to the hypogastric artery (22, 21%), excessive neck angulation (14, 14%), extensive mural thrombus in the aneurysm neck (10, 10%), extreme tortuosity of the iliac arteries (10, 10%), accessory renal arteries originating from the AAA (6, 6%), malignancy discovered during the examination (5, 5%), and death during the examination interval (2, 2%). Rejected patients had an average of 1.9 exclusion criteria (range, 1 to 4). A disproportionate number of women were excluded because of anatomic findings (P = .0009). Although 80% of patients who were at low risk for surgery qualified for endovascular repair, only 49% of our patients who were at high risk for surgery were acceptable candidates (P < .001). Of the 103 patients who were excluded, 34 (33%) underwent open surgical repair, and the remaining 69 (67%) were deemed to be unfit for open surgery. Three patients (1.4%) failed endograft placement because of inadequate vascular access. CONCLUSION: Most infrarenal AAAs (66%) can be treated with endovascular devices currently available commercially or through US Food and Drug Administration-approved clinical trials. However, patients who are at high risk for surgery and might benefit most from endovascular repair are less likely to qualify for the procedure (49%). Men (70%) are more likely than women (40%) to meet the anatomic criteria for endografting. Difficulties with vascular access and attachment site geometry predominate as reasons for exclusion. Our findings suggest that smaller profile devices, which can negotiate small and tortuous iliac arteries, are needed. Proximal and distal attachment site problems require devices that can accommodate wide and angulated attachment necks and achieve short seal zones.

Aged↗
PubMed2002

Immediate versus delayed midface distraction in a primate model using a new intraoral internal device.

The theoretic advantage of distraction osteogenesis of the craniofacial skeleton, especially in cases of severe midface retrusion and in the presence of maxillary scarring, is prevention of relapse following significant advancements. The purpose of this study is to demonstrate the utility of a new low-profile, intraoral, internal device for midface distraction at the conventional or high Le Fort I level. In addition, the present study compares the efficacy of immediate versus delayed distraction on subsequent maxillary relapse. Four adult rhesus Macaca mulatta monkeys were divided into two groups. Group 1 underwent immediate midface distraction; group 2 underwent delayed distraction. All four monkeys underwent a modified Le Fort I osteotomy through an upper buccal sulcus incision and bilateral application of the intraoral midface distraction devices. No other osteotomies or incisions were necessary. Immediate distraction, performed in group 1, entailed intraoperative activation of the devices and distraction of 10 mm followed by a 5-day lag period before postoperative activation and distraction of an additional 10 mm at the rate of 1 mm/day. Delayed distraction, performed in group 2, entailed a 5-day postoperative lag period before device activation and distraction of 20 mm at the rate of 1 mm/day. Both groups thus underwent 20 mm of midface distraction. All devices were removed 6 weeks after completion of distraction. All monkeys tolerated the devices and daily distraction uneventfully. On the basis of serial cephalograms and dental models obtained throughout the experimental period, there was no evidence of relapse in either the immediate or delayed groups 6 months after distraction. In addition, on the basis of histologic, ultrastructural, and dry skull analysis, no significant differences were observed in the quality of regenerate bone obtained when comparing the immediate and delayed distraction groups. Significant midface advancement is thus feasible using this new internal, intraoral distraction device, which presents several advantages over other internal devices that require coronal incisions and additional osteotomies to achieve midface advancement. In addition, immediate distraction may abbreviate the distraction period without adverse sequelae.

Animals↗
PubMed2002

Biofilms: survival mechanisms of clinically relevant microorganisms.

Though biofilms were first described by Antonie van Leeuwenhoek, the theory describing the biofilm process was not developed until 1978. We now understand that biofilms are universal, occurring in aquatic and industrial water systems as well as a large number of environments and medical devices relevant for public health. Using tools such as the scanning electron microscope and, more recently, the confocal laser scanning microscope, biofilm researchers now understand that biofilms are not unstructured, homogeneous deposits of cells and accumulated slime, but complex communities of surface-associated cells enclosed in a polymer matrix containing open water channels. Further studies have shown that the biofilm phenotype can be described in terms of the genes expressed by biofilm-associated cells. Microorganisms growing in a biofilm are highly resistant to antimicrobial agents by one or more mechanisms. Biofilm-associated microorganisms have been shown to be associated with several human diseases, such as native valve endocarditis and cystic fibrosis, and to colonize a wide variety of medical devices. Though epidemiologic evidence points to biofilms as a source of several infectious diseases, the exact mechanisms by which biofilm-associated microorganisms elicit disease are poorly understood. Detachment of cells or cell aggregates, production of endotoxin, increased resistance to the host immune system, and provision of a niche for the generation of resistant organisms are all biofilm processes which could initiate the disease process. Effective strategies to prevent or control biofilms on medical devices must take into consideration the unique and tenacious nature of biofilms. Current intervention strategies are designed to prevent initial device colonization, minimize microbial cell attachment to the device, penetrate the biofilm matrix and kill the associated cells, or remove the device from the patient. In the future, treatments may be based on inhibition of genes involved in cell attachment and biofilm formation.

Bacteria↗
PubMed1993

Catheter-related Malassezia furfur fungemia in immunocompromised patients.

PURPOSE, PATIENTS, AND METHODS: Malassezia furfur has usually been described as a cause of catheter-related sepsis in neonates receiving intravenous lipid emulsion. We report seven cases of catheter-related M. furfur fungemia that occurred in seven immunocompromised patients including four adults and three children who were not neonates. Only two of these patients were receiving concurrent intravenous lipid emulsion. RESULTS: All positive blood cultures were obtained from a central venous access device, one of which was a port device. Quantitative M. furfur colony counts ranged from 50 cfu/mL to greater than 1,000 cfu/mL. All seven patients were treated with amphotericin B. Blood drawn through the central lines of three patients yielded additional organisms. One central venous access device required removal due to persistently positive M. furfur blood cultures despite treatment with amphotericin B. CONCLUSION: We conclude that catheter-related M. furfur fungemia occurs in immunocompromised patients with central venous access devices whether or not they are receiving intravenous lipids. Prompt, aggressive treatment with amphotericin B (1 mg/kg/d) may spare patients removal of their central venous access device. Further studies are needed to determine the role of endogenous lipids in the development of catheter-related M. furfur fungemia and to determine if there is a seasonal incidence in populations other than neonates, since all of our cases occurred between late March and July.

Adult↗
PubMed1992

Tibial fractures. The Ilizarov alternative.

Between February 1988 and May 1989, 17 consecutive patients with 18 tibial fractures were treated using the Ilizarov method and apparatus. Injuries included four closed fractures and 14 open fractures. There were three Grade I open, four Grade II open, and seven Grade III open tibial fractures. Indications for application of the Ilizarov frame included fractures that were determined to need surgical management primarily, or fractures that had failed to heal by other treatment methods, either operative or nonoperative. Patients averaged 17.7 months of follow-up treatment. One patient was lost to follow-up treatment after the fracture healed and the device was removed. To date, all fractures are healed. There was one delayed union, which subsequently healed with a second application of the device. Complications included two late wound infections, both in Grade III open fractures. These occurred after removal of the Ilizarov apparatus. The average time from application of the device to complete fracture healing was 5.6 months, with a range of 3.25 to 13 months. This compares favorably with the results described for other treatment modalities. These results indicate that the Ilizarov method is indeed a useful adjunct in the orthopedic armamentarium for the treatment of either open or closed tibial fractures. No practical contraindications to the use of the Ilizarov device in the management of tibial fractures were encountered.

Adolescent↗
PubMed1999

Correction of diabetic nod mice with insulinomas implanted within Baxter immunoisolation devices.

Insulin replacement by injection is clearly not a cure for Insulin Dependent Diabetes Mellitus (IDDM). Replacement of the destroyed islets by pancreas or islet allograft transplantation can achieve the good metabolic control required to prevent diabetic complications, but tissue supply is limited. The problem of islet supply to treat the 1 million IDDM patients in the USA could be overcome by using immortalized islet beta-cells as a donor source. However, before either allogeneic or xenogeneic immortalized beta-cells are used, some major problems have to be overcome: control of immortalized cell growth, allograft or xenograft rejection and recurrence of autoimmunity. To tackle these problems we have used a cell impermeable immunoisolation device containing mouse insulinoma cells. Transplantation of devices with insulinomas from NOD mice carrying the Rat-insulin promoter regulated SV40 T-Antigen transgene (RIP-TAg), normalized the blood glucose levels of diabetic NOD mice. Insulinomas from allogeneic CBA/NOD-RIP-TAg mice were also capable of normalizing diabetic NOD mice. Not only were non-fasting blood glucoses normalized but when given an intraperitoneal injection of glucose, the corrected mice had a near normal clearance of glucose from the blood. When the devices were removed from normalized mice they became diabetic again, demonstrating that the immunoisolation device was capable of protecting against both alloimmune and autoimmune destruction. The results with allogeneic mouse beta-cells suggest the possibility that immortalized human beta-cells could be an effective source of tissue to correct diabetes in IDDM patients without the use of immunosuppression.

Animals↗
PubMed2006

Robotically assisted perventricular closure of perimembranous ventricular septal defects: preliminary results in Yucatan pigs.

OBJECTIVE: Robotic systems allow surgeons to perform minimally invasive cardiac surgery in adults. Experience in the pediatric population, however, is limited. Perventricular closure of muscular ventricular septal defects has been reported in humans but requires a median sternotomy. The objective of this study was to assess the feasibility of robotically assisted closure of perimembranous ventricular septal defects by using the perventricular approach. METHODS: The procedure was attempted in 7 pigs with naturally occurring perimembranous ventricular septal defects. Echocardiography was performed to confirm the presence and assess the size of the defect. A 3-armed da Vinci system consisting of two 8-mm instrument ports and a 12-mm endoscopy port was used. A pericardiotomy was performed, and the right ventricular free wall was visualized. A spinal needle was advanced into the right ventricular cavity. By using echocardiographic guidance, a glide wire was advanced through the angiocatheter and manipulated through the defect into the left ventricle or the ascending aorta. A delivery sheath was advanced over the wire. An appropriately sized Amplatzer device was deployed through the sheath. RESULTS: The procedure was successful in 5 pigs. One device was removed because it was smaller than the defect and an appropriately sized device was not available. The placement failed in the second pig in the series. Four pigs were followed up for 1 to 4 months. Angiograms performed before the pigs were killed documented complete occlusion in 3 and mild-to-moderate shunt in 1. CONCLUSIONS: Robotically assisted perventricular closure with the Amplatzer Membranous VSD Occluder is feasible. This approach avoids the associated morbidities of cardiopulmonary bypass and median sternotomy. Further investigation and refinements are needed, however, before application of this approach in humans.

Animals↗