The Journal of thoracic and cardiovascular surgery
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J. Thorac. Cardiovasc. Surg. · May 2019
Multicenter Study Clinical TrialProspective US investigational device exemption trial of a sutureless aortic bioprosthesis: One-year outcomes.
We performed a prospective, single-arm clinical trial approved under a Food and Drug Administration Investigational Device Exemption to assess safety and efficacy of Perceval, a sutureless bovine pericardial aortic valve representing the initial US experience. ⋯ These results confirm the safety and effectiveness of the Perceval sutureless aortic valve replacement in study patients with lower mortality than expected from a risk prediction model. Persistent hemodynamic benefit and improvement in quality of life at 1 year support the importance of this device in the management of aortic valve disease.
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J. Thorac. Cardiovasc. Surg. · May 2019
Carinal surgery: A single-institution experience spanning 2 decades.
Complete resection of neoplasms involving the carina are technically challenging and have high operative morbidity and mortality. This study examines the last 2 decades of clinical experience at our institution. ⋯ Despite advances in perioperative management, carinal resection poses challenges for both patient and surgeon. Preoperative chemotherapy, radiation, and concomitant pulmonary resection were associated with increased risk of complications. Patient selection and meticulous surgical technique contribute to reduction in morbidity and mortality.