Adjunctive antibiotic/anticoagulant lock therapy in the treatment of bacteremia associated with the use of a subcutaneously implanted hemodialysis access device.

To improve vascular access for hemodialysis, a new device (Dialock Hemodialysis Access System, Biolink Corporation, Middleboro, MA) has been developed. Implanted subcutaneously, the device is accessed by percutaneous puncture. Attached to the device are two catheters that are implanted into the superior vena cava or right atrium. Clinical results thus far have been promising. However, use of this device is not free from infectious complications. In the present pilot study, 25 maintenance hemodialysis patients were implanted with 26 Dialock devices. The incidence of bacteremia was 2.9/1,000 catheter days. In 14 episodes of bacteremia in 8 patients the infection was successfully treated with a combination of systemic antibiotic treatment and adjunctive antibiotic/anticoagulant lock therapy. The lock therapy entailed the instillation of both an antibiotic and an anticoagulant into the device. We believe that the antibiotic/anticoagulant lock technique is an effective, adjunctive therapeutic modality in the treatment of infections related to the use of indwelling vascular access devices.

Development of a new approach to vascular access.

Three modes of access for hemodialysis (HD) have been available for over 20 years, the native arterial to venous (A-V) fistula, the polytetrafluorethylene (PTFE) graft fistula, and the central venous catheter. Overall, vascular access remains the single most costly source of morbidity and hospitalization in HD patients, indicating a severe need for improvement in this area. A significant contributor to access morbidity is the HD catheter, which protrudes through the skin and is subject to frequent infection. Subcutaneous ports have been developed to overcome this problem with catheters, but their application to HD has been elusive for 2 reasons, the use of a degradable septum that becomes vulnerable to infection with the use of large bore needles and the presence of a nonlinear flow path which produces damage to blood cells and stimulates thrombus formation at the required high flow rates. A new device, the Dialock, overcomes these objections by its use of a mechanical valve that maintains a linear flow path without directly contacting the blood. Results of a pilot study with 23 patients demonstrated a 78% cumulative survival rate after 1 year with a reduced rate of infection compared to catheters and sustained blood flow of 330 ml/min. The device represents a most promising advance in vascular access.

Initial results of a new access device for hemodialysis technical note.

BACKGROUND: A new subcutaneous device (DIALOCKtrade mark) provides vascular access to patients who currently require hemodialysis (HD). The device consists of a port-like valve, implanted subcutaneously below the clavicle, which provides a linear flow passage to two catheters placed in the right atrium via the internal or external jugular vein. The valve is accessed percutaneously with needle-cannulas that functionally convert the device to twin catheters for connecting the patient to the HD lines. METHODS: The device was implanted in 10 outpatients under local anesthesia. Patients used the device during dialysis 3 times/week, and data were collected on blood flow, pressures, adverse events and patient and nurse satisfaction. RESULTS: The device was used for HD almost immediately (median 3 days after implantation) and functioned successfully for more than nine months (mean +/- SD 7.3 +/- 1.5) in all but one patient who died of unrelated causes after one month; there were >800 dialysis sessions total. Blood flows over 300 ml/min were consistently achieved (average 326 +/- 40) with venous and arterial pressures of 200 +/- 44 and -246 +/- 29 mm Hg, respectively. After 66 patient-months, condition of the needle puncture sites remained satisfactory. Five systemic infections occurred in four patients, producing 2.3 bacteremic episodes per 1000 patient-days. All resolved without the need for device removal. There were no infections at the puncture sites. Two patients required fibrin sheath stripping of their catheters, one whose heparin lock was not changed for 23 days (for reasons unrelated to the device). Patient and nurse acceptance was excellent. CONCLUSION: The device represents a positive improvement in the area of HD access.

New access device for hemodialysis.

A new subcutaneous device (Dialock; Biolink Corp., Middleboro, MA) provides vascular access to patients who currently require hemodialysis (HD). The device consists of a port-like valve, implanted subcutaneously below the clavicle, which provides a linear flow passage to two catheters placed in the right atrium via the jugular vein. The valve is accessed percutaneously with needle-cannulas that functionally convert the device to twin catheters for connecting the patient to the HD lines. Interdialytic patency is maintained using a standard heparin lock. The device has been implanted in 10 outpatients under local anesthesia, with almost immediate use for HD (median, 3 days) and has functioned successfully for more than 6 months (mean +/- SD, 4.0 +/- 1.7; > 400 dialysis sessions). Blood flows over 300 ml/min were consistently achieved (average, 320 +/- 50) with venous and arterial pressures of 197 +/- 42 mmHg and -241 +/- 31 mmHg, respectively. After 40 patient-months, condition of the needle puncture sites remains satisfactory. Four systemic infections have occurred in three patients; all have resolved without the need for device removal. There have been no infections at the puncture sites. One patient whose heparin lock was not changed for 23 days (for reasons unrelated to the device) required fibrin sheath stripping of his catheters. Patient and nurse acceptance has been excellent. The device may offer substantial improvement over conventional devices for HD access.

Epoprostenol (PGI2, prostacyclin) during high-risk hemodialysis: preventing further bleeding complications.

The frequency of hemodialysis-associated hemorrhage was studied prospectively in two successive, parallel, heparin-controlled studies using epoprostenol (PGI2; average dose, 4.1 ng/kg.min) as the sole antithrombotic agent. Sixty-three patients with active or recently active bleeding underwent 163 hemodialysis treatments in each of which prospective bleeding risk was assessed. PGI2 was associated with up to 50% overall reduction in the frequency of bleeding, particularly in the highest risk circumstances. PGI2 also allowed successful completion of the full, prospectively prescribed hemodialysis time in the most treatments (82% versus 93% with heparin). Furthermore, the efficiency of hemodialysis using PGI2, as indicated by the reduction in concentration of blood urea nitrogen and serum creatinine, was equal to that using heparin, even though there was a tendency toward modest reduction in residual volume of the hollow fiber dialyzer and slightly more frequent early termination of treatment from dialyzer clotting with PGI2. No severe vasodilatory side effects of PGI2 were observed during these studies. Hypotension was equally frequent during hemodialysis with heparin as with PGI2. The current results suggest that PGI2 should be considered as a substitute for heparin during high-risk hemodialysis because PGI2 may reduce the incidence of dialysis-associated bleeding without severe adverse side effects.

Treatment of hypertension in the elderly.

The objective of treating the elderly patient with hypertension should be to reduce blood pressure to safe levels (systolic blood pressure less than 180 mm Hg), while minimizing adverse effects and changes in life-style. If the clinician considers the unique physiologic, pharmacologic, and psychosocial characteristics of this population, he will be successful in attaining these goals.

Safety and efficacy of guanabenz in hypertensive patients with moderate renal insufficiency.

Eight hypertensive patients with moderate renal insufficiency were treated with gradually increasing oral doses of guanabenz acetate to a maximum dose of 8 mg BID. Patients' medications were titrated over 8 weeks. Once blood pressure control was achieved (seated diastolic blood pressure, 90 mmHg, or decrease of 10 mmHg from baseline values), drug dosages were maintained for up to a 12-week total treatment phase. Patients had significant reductions of blood pressure during treatment with guanabenz as compared to that during pretreatment levels. No changes in body weight or creatinine clearance were evident, as compared to baseline values. Our data suggest that guanabenz, in relatively small doses, can be used as safe and effective monotherapy of essential hypertension in patients with moderate renal insufficiency.

The changing spectrum of heroin-associated nephropathy.

Thirty-five renal biopsies were performed on heroin abusers at our institution between January 1977 and June 1983 as part of the evaluation of unexplained heavy proteinuria. Twenty-eight patients (80%) had histopathologic diagnoses of either focal segmental glomerulosclerosis or renal amyloidosis. Patients having a diagnosis of renal amyloidosis were older (P = 0.025), had a longer history of heroin abuse (P = 0.05), and 13/14 demonstrated clear evidence of chronic subcutaneous suppurative lesions. The remaining seven patients demonstrated a spectrum of disease similar to that seen in the nonaddicted population. We compared the clinical and biopsy characteristics of patients evaluated between 1977 and 1980 with those seen between 1981 and 1983. The relative incidences of renal amyloidosis and focal glomerulosclerosis changed significantly (P = 0.025). Whereas 29% of patients in the early series had renal amyloidosis and 57% had focal glomerulosclerosis, the relative incidences in the later series were 48% and 29%, respectively. The development of renal amyloidosis in our patients appears to be related to a longer duration of heroin abuse with increased incidence of subcutaneous injection of the narcotic. Chronic, suppurative skin ulcerations tend to occur at the site of injection, resulting in a persistent acute-phase inflammatory state important for the initiation and potentiation of secondary amyloidosis.