Video-assisted mediastinoscopy (VAM) for surgical resection of ectopic parathyroid adenoma

<p>Abstract</p> <p>Background</p> <p>Ectopic mediastinal parathyroid adenomas or hyperplasia account for up to 25% of primary hyperparathyroidism (HPT). Two percent of them are not accessible by standard cervical surgical approaches. Surgical resection has traditionally been performed via median sternotomy or thoracotomy and more recently, via video assisted thoracoscopic surgery (VATS). We present our experience with the novel use of Video-Assisted Mediastinoscopy (VAM) for resection of ectopic mediastinal parathyroid glands.</p> <p>Case presentation</p> <p>4 patients underwent VAM for removal of an ectopic intramediastinal parathyroid gland. All of them had at least one previous unsuccessful neck exploration.</p> <p>In all cases histology confirmed complete resection of ectopic parathyroid glands (3 parathyroid adenomas and one parathyroid hyperplasia). Two of the patients required a partial sternal split to facilitate exploration.</p> <p>Conclusion</p> <p>The cervical approach for resection of ectopic parathyroid adenomas is frequently unsuccessful. Previously, the standard surgical approach in such cases was sternotomy and exploration of the mediastinum. Recently, a number of less invasive modalities have been introduced.</p> <p>We found that VAM has several advantages. It has a short theatre time does not require a complex anaesthetic and is performed with the patient in classic supine position utilising often a previous cervical scar with good cosmetic results. It offers a short hospital stay; it is cost effective with minimal use of fancy and pricy consumables with a comfortable incision and no violation of the pleural space.</p> <p>Additionally the use of digital Video imaging has increased the sensitivity of the mediastinoscopy and has added safety and confidence in performing a detailed mediastinal exploration with an additional great training value as well.</p

Sparsentan in patients with IgA nephropathy: a prespecified interim analysis from a randomised, double-blind, active-controlled clinical trial

Background: Sparsentan is a novel, non-immunosuppressive, single-molecule, dual endothelin and angiotensin receptor antagonist being examined in an ongoing phase 3 trial in adults with IgA nephropathy. We report the prespecified interim analysis of the primary proteinuria efficacy endpoint, and safety. Methods: PROTECT is an international, randomised, double-blind, active-controlled study, being conducted in 134 clinical practice sites in 18 countries. The study examines sparsentan versus irbesartan in adults (aged ≥18 years) with biopsy-proven IgA nephropathy and proteinuria of 1·0 g/day or higher despite maximised renin-angiotensin system inhibitor treatment for at least 12 weeks. Participants were randomly assigned in a 1:1 ratio to receive sparsentan 400 mg once daily or irbesartan 300 mg once daily, stratified by estimated glomerular filtration rate at screening (30 to 1·75 g/day). The primary efficacy endpoint was change from baseline to week 36 in urine protein-creatinine ratio based on a 24-h urine sample, assessed using mixed model repeated measures. Treatment-emergent adverse events (TEAEs) were safety endpoints. All endpoints were examined in all participants who received at least one dose of randomised treatment. The study is ongoing and is registered with ClinicalTrials.gov, NCT03762850. Findings: Between Dec 20, 2018, and May 26, 2021, 404 participants were randomly assigned to sparsentan (n=202) or irbesartan (n=202) and received treatment. At week 36, the geometric least squares mean percent change from baseline in urine protein-creatinine ratio was statistically significantly greater in the sparsentan group (-49·8%) than the irbesartan group (-15·1%), resulting in a between-group relative reduction of 41% (least squares mean ratio=0·59; 95% CI 0·51-0·69; p<0·0001). TEAEs with sparsentan were similar to irbesartan. There were no cases of severe oedema, heart failure, hepatotoxicity, or oedema-related discontinuations. Bodyweight changes from baseline were not different between the sparsentan and irbesartan groups. Interpretation: Once-daily treatment with sparsentan produced meaningful reduction in proteinuria compared with irbesartan in adults with IgA nephropathy. Safety of sparsentan was similar to irbesartan. Future analyses after completion of the 2-year double-blind period will show whether these beneficial effects translate into a long-term nephroprotective potential of sparsentan. Funding: Travere Therapeutics