The Journal of thoracic and cardiovascular surgery
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J. Thorac. Cardiovasc. Surg. · Jul 2013
Randomized Controlled TrialErythropoietin neuroprotection in neonatal cardiac surgery: a phase I/II safety and efficacy trial.
Neonates undergoing complex congenital heart surgery have a significant incidence of neurologic problems. Erythropoietin has antiapoptotic, antiexcitatory, and anti-inflammatory properties to prevent neuronal cell death in animal models, and improves neurodevelopmental outcomes in full-term neonates with hypoxic ischemic encephalopathy. We designed a prospective phase I/II trial of erythropoietin neuroprotection in neonatal cardiac surgery to assess safety and indicate efficacy. ⋯ Safety profile for erythropoietin administration was not different than placebo. Neurodevelopmental outcomes were not different between groups; however, this pilot study was not powered to definitively address this outcome. Lessons learned suggest optimized study design features for a larger prospective trial to definitively address the utility of erythropoietin for neuroprotection in this population.
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J. Thorac. Cardiovasc. Surg. · Jul 2013
Multicenter StudyRadiographically determined noninvasive adenocarcinoma of the lung: survival outcomes of Japan Clinical Oncology Group 0201.
The study objective was to evaluate the long-term survival of patients with radiographically determined noninvasive lung adenocarcinomas. ⋯ The radiologic criteria of a consolidation/tumor ratio 0.25 or less in cT1a (≤2.0 cm) and 0.50 in cT1a-b (≤3.0 cm) were both able to define a homogeneous group of patients with an excellent prognosis before surgery.
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J. Thorac. Cardiovasc. Surg. · Jul 2013
Comparative StudyRestraint to the left ventricle alone is superior to standard restraint.
In standard ventricular restraint therapy, a single level of restraint is applied to the entire ventricular surface. We showed previously that at high restraint levels, cardiac tamponade develops because of the thin-walled right ventricle, even while the left ventricle remains unaffected. We now hypothesize that applying restraint exclusively to the left ventricle permits higher levels of restraint, resulting in increased benefit to the left ventricle. ⋯ We showed previously that, with standard restraint, right ventricle tamponade develops at high restraint levels, limiting restraint therapy. We now show that restraint applied to the left ventricle alone permits increased restraint levels, without causing right ventricle or left ventricle tamponade, for greater therapeutic benefit. We conclude that partial left ventricle restraint may be more effective than standard restraint.
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J. Thorac. Cardiovasc. Surg. · Jul 2013
Multicenter StudyProspective phase II trial of preresection thoracoscopic mediastinal restaging after neoadjuvant therapy for IIIA (N2) non-small cell lung cancer: results of CALGB Protocol 39803.
Accurate pathologic restaging of N2 stations after neoadjuvant therapy in stage IIIA (N2) non-small cell lung cancer is needed. ⋯ Videothoracoscopy restaging was "feasible" in this prospective multi-institutional trial and provided pathologic specimens of the ipsilateral nodes. Videothoracoscopy restaging was limited by radiation and the 4R nodal station.
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J. Thorac. Cardiovasc. Surg. · Jul 2013
Comparative StudyCost-effectiveness of the Edwards SAPIEN transcatheter heart valve compared with standard management and surgical aortic valve replacement in patients with severe symptomatic aortic stenosis: a Canadian perspective.
The primary analysis estimated the cost-effectiveness of transfemoral transcatheter aortic valve implantation (Edwards SAPIEN heart valve; Edwards Lifesciences LLC, Irvine, Calif) compared with standard management in inoperable patients with severe, symptomatic aortic stenosis. The secondary analysis estimated the cost-effectiveness of transcatheter aortic valve implantation (transfemoral or transapical approaches) (SAPIEN heart valve) compared with surgical aortic valve replacement in operable patients with severe, symptomatic aortic stenosis. ⋯ This economic evaluation suggested that transfemoral transcatheter aortic valve implantation was a cost-effective option compared with standard management for inoperable patients with severe, symptomatic aortic stenosis, but it might not be a cost-effective treatment compared with surgical aortic valve replacement for operable patients.