The Journal of thoracic and cardiovascular surgery
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J. Thorac. Cardiovasc. Surg. · Dec 2014
Bayesian stopping guidelines for heart valve premarket approval studies.
The Data Monitoring Committee (DMC) for the premarket approval (PMA) study of a new heart valve prosthesis convenes periodically to review the accumulating results of the study, and determines, among other things, whether there is enough concern with safety to stop the study. Their deliberations are largely subjective, based on their combined experience and expertise, but an objective aid to evaluating complication rates, usually called a stopping rule, is desirable. ⋯ Although the DMC ultimately uses combined experience and expertise to make the decision to stop a PMA valve study, we have provided an objective assessment of the probability of the valve ultimately passing the OPC test to aid in making that decision.
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J. Thorac. Cardiovasc. Surg. · Dec 2014
Endovascular repair for blunt thoracic aortic injury: 11-year outcomes and postoperative surveillance experience.
Surveillance for patients undergoing thoracic endovascular aortic repair (TEVAR) for blunt thoracic aortic injury (BTAI) varies. Annual chest computed tomographic angiography (CTA) is often recommended but concerns about the risks and costs have emerged. The aim of this study was to examine the optimal follow-up frequency based on 11-year outcomes and surveillance experience. ⋯ Midterm outcomes of TEVAR for patients with stable repair after BTAI are excellent, both with timely (1.0-1.5 years) and delayed (>1.5 years) follow-up intervals after a median surveillance period of 3 years. A larger prospective randomized study could lead to a more relaxed, but equally safe surveillance schedule for these patients, lowering risks and costs.
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J. Thorac. Cardiovasc. Surg. · Dec 2014
Safety and efficacy of retrograde cerebral perfusion as an adjunct for cerebral protection during surgery on the aortic arch.
The best adjunct for cerebral protection during aortic arch reconstruction remains controversial. Retrograde cerebral perfusion (RCP) as an adjunct to profound hypothermic circulatory arrest (PHCA) extends the tolerable period of brain ischemia by flushing emboli and air from the cerebral circulation while maintaining hypothermia. We examined our experience with RCP to determine its efficacy in patients undergoing complex arch reconstruction. ⋯ RCP is a safe and effective adjunct for cerebral protection during arch surgery. Patients requiring more extensive arch reconstruction are not at greater risk of permanent neurologic dysfunction or perioperative mortality.
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J. Thorac. Cardiovasc. Surg. · Dec 2014
Open aortic arch reconstruction after previous cardiac surgery: outcomes of 168 consecutive operations.
Open arch interventions after previous cardiac surgery are considered high risk. We reviewed our outcomes in patients requiring aortic arch reconstruction after previous cardiovascular surgery. ⋯ Reoperations to address the aortic arch have acceptable mortality and morbidity. Open repair under circulatory arrest is the benchmark to which endovascular therapies should be compared.