Frequent Hemodialysis Network (FHN) randomized trials: study design.

Observational studies suggest improvements with frequent hemodialysis (HD), but its true efficacy and safety remain uncertain. The Frequent Hemodialysis Network Trials Group is conducting two multicenter randomized trials of 250 subjects each, comparing conventional three times weekly HD with (1) in-center daily HD and (2) home nocturnal HD. Daily HD will be delivered for 1.5-2.75 h, 6 days/week, with target eK(t)/V(n) > or = 0.9/session, whereas nocturnal HD will be delivered for > or = 6 h, 6 nights/week, with target stdK(t)/V of > or = 4.0/week. Subjects will be followed for 1 year. The composite of mortality with the 12-month change in (i) left ventricular mass index (LVMI) by magnetic resonance imaging, and (ii) SF-36 RAND Physical Health Composite (PHC) are specified as co-primary outcomes. The seven main secondary outcomes are between group comparisons of: change in LVMI, change in PHC, change in Beck Depression Inventory score, change in Trail Making Test B score, change in pre-HD serum albumin, change in pre-HD serum phosphorus, and rates of non-access hospitalization or death. Changes in blood pressure and erythropoiesis will also be assessed. Safety outcomes will focus on vascular access complications and burden of treatment. Data will be obtained on the cost of delivering frequent HD compared to conventional HD. Efforts will be made to reduce bias, including blinding assessment of subjective outcomes. Because no large-scale randomized trials of frequent HD have been previously conducted, the first year has been designated a Vanguard Phase, during which feasibility of randomization, ability to deliver the interventions, and adherence will be evaluated.

Effects of hypertonic saline, alternate day and daily rhDNase on healthcare use, costs and outcomes in children with cystic fibrosis.

BACKGROUND: Daily recombinant human deoxyribonuclease (rhDNase) is an established but expensive treatment in cystic fibrosis (CF). An alternative lower cost therapy is hypertonic saline (HS), which has been shown to improve lung function in short term studies. This study compares the costs and consequences of daily rhDNase with alternate day rhDNase and HS in children with CF. METHODS: In an open, randomised, crossover trial, 48 children with CF were allocated consecutively to 12 weeks of once daily 2.5 mg rhDNase, alternate day 2.5 mg rhDNase, and twice daily 5 ml 7% HS. Outcomes assessed included forced expiratory volume in 1 second (FEV(1)) and quality of life. All healthcare resource use was prospectively recorded for each patient. Unit costs were collected and combined with resource use data to give the total health service costs per patient for each treatment strategy. RESULTS: Daily rhDNase resulted in a significantly greater increase in mean FEV(1) than HS (8%, 95% CI 2 to 14) but there was no significant difference in FEV(1) between daily and alternate day rhDNase (2%, 95% CI -4 to 9). Over a 12 week period the mean incremental costs of daily rhDNase compared with HS was pound 1409 (95% CI pound 440 to pound 2318), and the incremental cost of using daily rather than alternate day rhDNase was pound 513 (95% CI - pound 546 to pound 1510). CONCLUSIONS: Daily rhDNase is more effective than 5 ml 7% HS twice daily delivered by jet nebuliser, but significantly increases healthcare costs. Administering rhDNase on an alternate day rather than a daily basis is as effective, with a potential for cost savings.

Pulmonary arteriography for the assessment of technical feasibility of sleeve resection in lung cancer.

BACKGROUND: Pulmonary arteriography has been reported to be useful in the preoperative assessment of patients with lung cancer to determine the technical resectability and feasibility of pneumonectomy by imaging the main right and left pulmonary arteries. In this report, we describe the use of selective pulmonary arteriography in the assessment of lobar resectability. METHODS: Selective pulmonary arteriography provides a detailed anatomic view of the lobar branches and has been used at our institution for the past 30 years to preoperatively investigate patients who are candidates for a sleeve lobectomy. RESULTS: Three cases are described that demonstrate the usefulness of selective pulmonary arteriography in the assessment of the technical feasibility of sleeve resection in patients with lung cancer. CONCLUSIONS: Arteriographic findings may accurately show whether a sleeve lobectomy is technically possible, that only a pneumonectomy is possible, or that the only safe way to ensure clearance of the pulmonary artery is to perform arterioplasty. This information may obviate an unnecessary thoracotomy in patients who are judged on the basis of a physiologic assessment to be unable to tolerate a pneumonectomy.

Closed mitral valvotomy for mitral restenosis: experience in 113 consecutive cases.

The costs of heart operations and the problems related to anticoagulation after prosthetic valve replacement are among the limitations faced by patients in nonindustrialized countries with mitral stenosis caused by chronic rheumatic heart disease. The young age at which these patients are seen also compels the surgeon to preserve the native valve. The least costly and optimal way to achieve this objective is by closed mitral valvotomy. After closed mitral valvotomy, mitral restenosis is commonly encountered. We report here our 10-year experience with operation on 113 consecutive patients with mitral restenosis. Closed transventricular revalvotomy was performed with Tubbs dilator in 105 of 113 patients. Mean age was 343 years, with a male to female ratio of 1:1.5. Most patients were in New York Heart Association functional classes III and IV (74.3% and 19.4%, respectively). Mean interval between first and second valvotomy was 9.4 years, Hospital mortality rate was 2.8%, trivial postoperative mitral regurgitation occurred in 16.1%, and moderately severe regurgitation occurred in 1.9%. Early postoperative systemic embolism occurred in 3.8% of the cases. Moderate to excellent symptomatic improvement was noted in 89.4% of the cases and poor results were seen in 10.2%. Late follow-up of 76 patients ranged from 2 to 10 years (mean 3.8 years), with 39.4% patients in New York Heart Association class I and 50% in class II. Close mitral revalvotomy is thus an economical, simple, and safe palliative procedure that carries good long-term results.

One year review of the blood cell separator programme.

Using the Haemonetic Model 30 intermittent continuous flow centrifuge, 142 procedures, including 64 granulocytes and platelets, 68 platelet collection, 8 therapeutic leukapheresis and 2 plasmapheresis were performed. Granulocyte transfusions (mean collection 1.39 x 10(10) granulocytes) were given to 27 neutropenic patients for febrile episodes which were unresponsive to systemic antibiotics. Thirty-eight thrombocytopenic patients received a mean of 4.2 x 10(11) platelets per collection. Bleeding was controlled in most of the patients who received transfusion with a mean rise in platelet count of 30.6 x 10(9)/L. Therapeutic leukapheresis were performed on 3 patients with chronic leukaemias. A mean of 2.53 x 10(11) cells were collected per run with a mean fall of 58.2 x 10(9)/L in the patients' white blood cell count. Plasmapheresis was used to treat 1 patient with multiple myeloma. The authors' experience demonstrates that cell separator support is essential for patients with bone marrow depression and that the therapeutic leukapheresis is effective therapy for selected patients with chronic leukaemias. Plasmapheresis is effective in patients with hyperviscosity syndrome.