The Annals of thoracic surgery
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Randomized Controlled Trial Comparative Study
Pulsatile versus nonpulsatile flow during cardiopulmonary bypass: microcirculatory and systemic effects.
Controversy exists regarding the optimal perfusion modality during cardiopulmonary bypass (CPB). Here we compare the effects of pulsatile versus nonpulsatile perfusion on microvascular blood flow during and after CPB. ⋯ Pulsatile perfusion is superior to nonpulsatile perfusion at preserving the microcirculation, which may reflect attenuation of the systemic inflammatory response during CPB. We suggest the implementation of pulsatile flow can better optimize microvascular perfusion, and may lead to improved patient outcomes in high-risk cardiac surgical procedures requiring prolonged CPB time.
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Randomized Controlled Trial Multicenter Study Comparative Study
Effect of sex and race on outcome in patients undergoing congenital heart surgery: an analysis of the society of thoracic surgeons congenital heart surgery database.
Previous studies on the impact of race and sex on outcome in children undergoing cardiac operations were based on analyses of administrative claims data. This study uses clinical registry data to examine potential associations of sex and race with outcomes in congenital cardiac operations, including in-hospital mortality, postoperative length of stay (LOS), and complications. ⋯ These data suggest that black children have higher mortality, a longer LOS, and an increased complication rate. Girls had outcomes similar to those of boys but with a shorter LOS of almost a day. Further study of potential causes underlying these race and sex differences is warranted.
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Comparative Study
Should patients 60 years and older undergo bridge to transplantation with continuous-flow left ventricular assist devices?
Although left ventricular assist devices (LVADs) are now commonly used as a bridge to orthotopic heart transplantation (OHT), the upper patient age limit for this therapy has not been defined. Smaller studies have suggested that advanced age should not be a contraindication to bridge to transplantation (BTT) LVAD placement. The purpose of this study was to examine outcomes in patients 60 years and older undergoing BTT with continuous-flow LVADs. ⋯ This study represents the largest modern cohort in which survival after OHT has been evaluated in patients 60 years or older who received BTT. Older patients have lower short-term survival after OHT when BTT is carried out with a continuous-flow LVAD compared with inotropic agents or direct transplantation.
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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.