The Annals of thoracic surgery
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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 the Interagency Registry of Mechanically Assisted Circulatory Support.
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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.
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Comparative Study
Isolated reoperative minimally invasive tricuspid valve operations.
Tricuspid valve (TV) regurgitation has recently been identified as a major risk factor for long-term mortality. Isolated reoperative tricuspid valve repair/replacement (TVR/r) carries an excessively high operative risk. Currently, isolated TVR/r with minimally invasive access through a right lateral thoracotomy is being used increasingly in our institution to treat progressive TV pathologic processes after previous cardiac operations. We analyzed our early and midterm results with reoperative TVR/r in this unique patient cohort. ⋯ Minimally invasive access through a right thoracotomy provides a safe option for reoperative TVR and offers excellent early outcome, particularly in elective cases. Surgical intervention should be performed earlier rather than later.
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Empiric experiences suggest higher mortality and complication risk for patients with cirrhosis of the liver after cardiac surgery. However, cirrhosis is not considered a risk factor in either the EuroSCORE or The Society of Thoracic Surgeons score. We report a large single-center experience of patients with cirrhosis undergoing cardiac surgery with extracorporeal circulation and aimed to evaluate the severity of cirrhosis as a predictor of outcome. ⋯ Patients with cirrhosis undergoing heart surgery with extracorporeal circulation have a poor prognosis. Several preoperative factors are related to outcome. EuroSCORE and MELD score may help to evaluate operation risk and indication.