Summary
Background
For patients with end-stage renal disease who are not candidates for fistula, dialysis access grafts are the best option for chronic haemodialysis. However, polytetrafluoroethylene arteriovenous grafts are prone to thrombosis, infection, and intimal hyperplasia at the venous anastomosis. We developed and tested a bioengineered human acellular vessel as a potential solution to these limitations in dialysis access.
Methods
We did two single-arm phase 2 trials at six centres in the USA and Poland. We enrolled adults with end-stage renal disease. A novel bioengineered human acellular vessel was implanted into the arms of patients for haemodialysis access. Primary endpoints were safety (freedom from immune response or infection, aneurysm, or mechanical failure, and incidence of adverse events), and efficacy as assessed by primary, primary assisted, and secondary patencies at 6 months. All patients were followed up for at least 1 year, or had a censoring event. These trials are registered with ClinicalTrials.gov, NCT01744418 and NCT01840956.
Findings
Human acellular vessels were implanted into 60 patients. Mean follow-up was 16 months (SD 7·6). One vessel became infected during 82 patient-years of follow-up. The vessels had no dilatation and rarely had post-cannulation bleeding. At 6 months, 63% (95% CI 47–72) of patients had primary patency, 73% (57–81) had primary assisted patency, and 97% (85–98) had secondary patency, with most loss of primary patency because of thrombosis. At 12 months, 28% (17–40) had primary patency, 38% (26–51) had primary assisted patency, and 89% (74–93) had secondary patency.
Interpretation
Bioengineered human acellular vessels seem to provide safe and functional haemodialysis access, and warrant further study in randomised controlled trials.
Funding
Humacyte and US National Institutes of Health.
The present study has shown that in some patients parathyroid cell allotransplantation may be considered a method of treatment for permanent hypoparathyroidism after thyroid surgery. Graft function and/or survival did not depend on the baseline viability or secretory activity of cultured cells used for transplantation.
Although the risk of aneurysm rupture after EVAR is low, all patients treated endovascularly should be routinely monitored, in order to select cases with potential endoleaks or stentgraft migration which may lead to fatal complications. When rupture occurs open aneurysmectomy is feasible, although it requires careful management in these high-risk patients.
BackgroundParathyroid reoperations are challenging and achieving a cure requires multidisciplinary treatment team cooperation.The aims of this study were to summarize our experience in revision surgery for persistent (pHPT) or recurrent primary hyperparathyroidism (rHPT) and to explore factors underlying failure to cure at initial surgery.Material/MethodsThis was a retrospective cohort study of patients who underwent reoperations for pHPT or rHPT at a tertiary referral center. The database of parathyroid surgery was searched for eligible patients (treated in the years 2000–2012). The primary outcome was the cure rate. All the patients were followed-up for at least 12 months postoperatively. Factors underlying failure to cure at initial surgery were reviewed based on hospital records.ResultsThe study group comprised 88 patients (69 women, 19 men) operated on for persistent (n=57) or recurrent disease (n=31), who underwent 98 reoperations, including 26 (2.4%) patients first operated on at our institution, and 72 (81.8%) patients operated on elsewhere, but referred for revision surgery. A long-term cure was achieved in 83/88 patients (94.3%). The mean post-reoperation follow-up was 91.7 (12–176) months. Missed hyperfunctioning parathyroid gland was found on reoperation in eutopic position in 49 (55.5%) patients, and in ectopic position in 39 (44.3%) patients, including 20 (22.7%) cases of cervical ectopy and 19 (21.6%) cases of mediastinal ectopy.ConclusionsMultidisciplinary treatment team cooperation at a tertiary referral center, consisting of an accurate preoperative localization, expertise in parathyroid re-explorations, and correct use of intraoperative adjuncts, contribute to the high success rate of parathyroid reoperations.
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