The Annals of thoracic surgery
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Randomized Controlled Trial Multicenter Study Comparative Study
Sternal closure with rigid plate fixation versus wire closure: a randomized controlled multicenter trial.
Rigid bone fixation is the standard of care for all bone reconstructions except that after sternotomy. Sternal reconstruction after median sternotomy using rigid fixation with plates may improve bone healing and reduce pain when compared with wire cerclage. ⋯ Sternal reconstruction using rigid fixation with plates improved bone healing and reduced early postoperative pain compared with wire cerclage.
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The incorporation of complex medical device technologies into clinical practice is governed by critical oversight of the US Food and Drug Administration. This regulatory process requires a judicious balance between assuring safety and efficacy, while providing efficient review to facilitate access to innovative therapies. Recent contrasting views of the regulatory process have emphasized the difficulties in obtaining an optimal balance. ⋯ Physicians representing key surgical and cardiology societies, and representatives from the Food and Drug Administration, National Heart Lung, and Blood Institute, Centers for Medicare and Medicaid Services, Interagency Registry of Mechanically Assisted Circulatory Support, and industry partners gathered to discuss relevant issues regarding the current regulatory environment assessing ventricular assist devices. The goal of the meeting was to explore innovative ways to foster the introduction of technologically advanced, safe, and effective ventricular assist devices. The following summary reflects opinions and conclusions endorsed by The Society of Thoracic Surgeons, American Association for Thoracic Surgery, American Heart Association, Heart Failure Society of America, International Society for Heart and Lung Transplantation, and Interagency Registry of Mechanically Assisted Circulatory Support.
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Multicenter Study Comparative Study
Major infection after pediatric cardiac surgery: external validation of risk estimation model.
A multivariable risk estimation model, in which the primary outcome was major infection, was recently developed and published using The Society of Thoracic Surgeons (STS) Congenital Heart Surgery Database. We have applied this risk estimation model to our congenital heart surgery program over a 16-year time interval to validate this risk estimation model and verify its specific risk factors for major infection. ⋯ Our external validation study confirmed that the STS model can be used as a preoperative risk stratification tool for major infection risk at the single institutional level.
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A new multisite registry for congenital cardiac anesthesia patients has now been incorporated into The Society of Thoracic Surgeons Congenital Heart Surgery Database. This new registry, "The Joint Congenital Cardiac Anesthesia Society-Society of Thoracic Surgeons Congenital Cardiac Anesthesia Database," is part of the Congenital Cardiac Anesthesia Society's commitment to patient care and research on outcomes improvement. This report will review the planning and funding of the initial start-up as well as the data elements being used in the registry. ⋯ Initial results from the first data harvests are reported, including site participation, patient population submitted, and adverse outcomes observed. These initial results validate the concept and serve as a benchmark for further development and implementation of the registry. Because of the relative infrequency of anesthesia-related events in this low-volume procedure, a multisite data harvest is the most reasonable approach to capture a sufficient number of patient encounters in a timely manner to support outcomes analysis, quality assessment, and quality improvement.
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Multicenter Study Comparative Study
Hybrid coronary revascularization using robotic totally endoscopic surgery: perioperative outcomes and 5-year results.
Hybrid coronary revascularization combines minimally invasive coronary artery bypass grafting and catheter-based interventions. This treatment option represents a viable alternative to both open multivessel coronary bypass surgery through sternotomy and multivessel percutaneous coronary intervention. The surgical component of hybrid coronary intervention can be offered in a completely endoscopic fashion using robotic technology. We report on one of the largest series to date. ⋯ Robotically assisted hybrid coronary intervention enables surgical treatment of multivessel coronary artery disease with minimal trauma. Perioperative results and intermediate-term outcomes meet the standards of open coronary artery bypass grafting. Recovery time is short, and reintervention rates are acceptable.