ABSTRACT
BACKGROUND: The gold-standard treatment of severe mitral regurgitation (MR) due to degenerative disease is valve repair, which is surgically performed with either a leaflet resection or leaflet preservation approach. Recent data suggest that functional mitral stenosis (MS) may occur following valve repair using a leaflet resection strategy, which adversely affects patient prognosis. A randomised comparison of these two approaches to mitral repair on functional MS has not been conducted. METHODS AND ANALYSIS: This is a prospective, multicentre randomised controlled trial designed to test the hypothesis that leaflet preservation leads to better preservation of mitral valve geometry, and therefore, will be superior to leaflet resection for the primary outcome of functional MS as assessed by 12-month mean mitral valve gradient at peak exercise. Eighty-eight patients with posterior leaflet prolapse will be randomised intraoperatively once deemed by the operating surgeon to feasibly undergo mitral repair using either a leaflet resection or leaflet preservation approach. Secondary end points include comparison of repair strategies with regard to mitral valve orifice area, leaflet coaptation height, 6 min walk test and a composite major adverse event end point consisting of recurrent MR ≥2+, death or hospital readmission for congestive heart failure within 12 months of surgery. ETHICS AND DISSEMINATION: Institutional ethics approval has been obtained from all enrolling sites. Overall, there remains clinical equipoise regarding the mitral valve repair strategy that is associated with the least likelihood of functional MS. This trial hopes to introduce high-quality evidence to help surgical decision making in this context. TRIAL REGISTRATION NUMBER: NCT02552771.
Subject(s)
Cardiac Surgical Procedures/adverse effects , Cardiac Surgical Procedures/methods , Mitral Valve Insufficiency/surgery , Mitral Valve Stenosis/etiology , Death , Echocardiography , Heart Failure/etiology , Humans , Mitral Valve Insufficiency/diagnostic imaging , Patient Readmission , Prospective Studies , Recurrence , Research Design , Walk TestABSTRACT
Despite probably being the most effective prophylactic drug for postoperative atrial fibrillation (POAF), amiodarone is reserved as a second-line agent because of its potential systemic side effects. Herein, we review the available experimental and clinical trials examining the effectiveness of intrapericardial (IPC) amiodarone administration in preventing POAF which, if confirmed by future studies, can have a significant impact on cardiac surgery practice.
Subject(s)
Amiodarone/administration & dosage , Anti-Arrhythmia Agents/administration & dosage , Atrial Fibrillation/prevention & control , Postoperative Complications/prevention & control , Amiodarone/adverse effects , Anti-Arrhythmia Agents/adverse effects , Clinical Trials as Topic , Humans , Infusions, Intralesional , PericardiumABSTRACT
Repeated therapeutic plasma exchange (TPE) has been advocated to remove heparin-induced thrombocytopenia (HIT) IgG antibodies before cardiac/vascular surgery in patients who have serologically-confirmed acute or subacute HIT; for this situation, a negative platelet activation assay (eg, platelet serotonin-release assay [SRA]) has been recommended as the target serological end point to permit safe surgery. We compared reactivities in the SRA and an anti-PF4/heparin IgG-specific enzyme immunoassay (EIA), testing serial serum samples in a patient with recent (subacute) HIT who underwent serial TPE precardiac surgery, as well as for 15 other serially-diluted HIT sera. We observed that post-TPE/diluted HIT sera-when first testing SRA-negative-continue to test strongly positive by EIA-IgG. This dissociation between the platelet activation assay and a PF4-dependent immunoassay for HIT antibodies indicates that patients with subacute HIT undergoing repeated TPE before heparin reexposure should be tested by serial platelet activation assays even when their EIAs remain strongly positive.
