Cardioplastic Approach to Omental Flap Coverage for Severe Aortic Root Infections in the Opioid Era

Aortic root abscesses are severe sequelae of endocarditis that clinically manifest as life-threatening infection. As the opioid epidemic continues to yield a national crisis, the incidence and severity of this disease process have increased. Reconstruction of the aortic root is a challenging undertaking and carries the risk of recurrent infection. The omentum has an established reputation as a reliable flap in thoracic reconstruction, given its amorphous form and immunogenic properties, but it has not been utilized for aortic root infections. We present a novel indication for the omental flap using a cardioplastic approach in coverage of aortic root reconstruction. Four patients were treated with pedicled omental flap coverage after aortic root reconstruction. All patients had successful flap healing with no evidence of recurrent infection. This series demonstrates the technical feasibility and clinical utility for providing soft tissue coverage and antimicrobial protection when used in aortic root reconstruction

Low-Dose Versus Standard Warfarin After Mechanical Mitral Valve Replacement: A Randomized Controlled Trial.

Background: Current guidelines recommend a target international normalized ratio (INR) range of 2.5 to 3.5 in patients with a mechanical mitral prosthesis. The Prospective Randomized On-X Anticoagulation Clinical Trial (PROACT) Mitral randomized controlled trial assessed the safety and efficacy of warfarin at doses lower than currently recommended, in patients with an On-X mechanical mitral valve. Methods: After On-X mechanical mitral valve replacement followed by at least 3 months of standard anticoagulation, 401 patients at 44 North American centers were randomized to low-dose warfarin (target INR 2.0 to 2.5) or standard-dose warfarin (target INR 2.5 to 3.5). All patients were prescribed aspirin 81 mg daily and encouraged to use home INR testing. The primary endpoint was the sum of the linearized rates of thromboembolism, valve thrombosis, and bleeding events. Secondary endpoints included death, valve-related events, New York Heart Association classification, and valve hemodynamics. Results: Mean patient follow-up was 4.1 years. Mean INR was 2.47 and 2.92 (P \u3c.001) in the low-dose and standard-dose warfarin groups, respectively. Primary endpoint rates were 11.9%/patient-year in the low-dose group and 12.0%/patient-year in the standard-dose group (P = .97). The -0.07% difference (95% confidence interval: -0.07, -0.06) was noninferior (\u3c1.5% margin). Individual rates (expressed as %/patient-year) of thromboembolism (2.3% vs 2.5%), valve thrombosis (0.5% vs 0.5%), and major bleeding (4.9% vs 4.3%) were also similar and noninferior. Conclusions: Low-dose warfarin was noninferior to standard-dose warfarin in patients with an On-X mechanical mitral prosthesis, following \u3e3 postoperative months of standard anticoagulation therapy. (PROACT Clinicaltrials.gov number, NCT00291525)

Low-Dose vs Standard Warfarin After Mechanical Mitral Valve Replacement: A Randomized Trial.

BACKGROUND: Current guidelines recommend a target international normalized ratio (INR) range of 2.5 to 3.5 in patients with a mechanical mitral prosthesis. The Prospective Randomized On-X Anticoagulation Clinical Trial (PROACT) Mitral randomized controlled noninferiority trial assessed safety and efficacy of warfarin at doses lower than currently recommended in patients with an On-X (Artivion, Inc) mechanical mitral valve. METHODS: After On-X mechanical mitral valve replacement, followed by at least 3 months of standard anticoagulation, 401 patients at 44 North American centers were randomized to low-dose warfarin (target INR, 2.0-2.5) or standard-dose warfarin (target INR, 2.5-3.5). All patients were prescribed aspirin, 81 mg daily, and encouraged to use home INR testing. The primary end point was the sum of the linearized rates of thromboembolism, valve thrombosis, and bleeding events. The design was based on an expected 7.3% event rate and 1.5% noninferiority margin. RESULTS: Mean patient follow-up was 4.1 years. Mean INR was 2.47 and 2.92 (P1.5%, thus noninferiority was not achieved. Rates (percentage per patient-year) of the individual components of the primary end point were 2.3% vs 2.5% for thromboembolism, 0.5% vs 0.5% for valve thrombosis, and 9.13% vs 9.04% for bleeding. CONCLUSIONS: Compared with standard-dose warfarin, low-dose warfarin did not achieve noninferiority for the composite primary end point. (PROACT Clinicaltrials.gov number, NCT00291525)

Additional file 1 of Evaluation of the efficacy and safety of amustaline/glutathione pathogen-reduced RBCs in complex cardiac surgery: the Red Cell Pathogen Inactivation (ReCePI) study—protocol for a phase 3, randomized, controlled trial

Additional file 1. SPIRIT Checklist for Trials