The Annals of thoracic surgery
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Device malposition and dysfunction with resultant severe aortic insufficiency are known complications of transcatheter aortic valve implantation (TAVI). Fortunately, these complications can often be successfully treated with a transcatheter valve-in-valve (VinV) implantation. However, prosthetic leaflet dysfunction or immobility from the VinV configuration can lead to severe central aortic insufficiency. We report the first known case of implantation of a third SAPIEN prosthesis (Edwards Lifesciences, Irvine, CA) during TAVI as a valuable bailout strategy to deal with severe aortic insufficiency after VinV implantation.
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Comparative Study
Perventricular device closure of doubly committed subarterial ventral septal defect through left anterior minithoracotomy on beating hearts.
Surgical repair of doubly committed subarterial ventricular septal defect (VSD) under cardiopulmonary bypass has been the gold standard with full median sternotomy, complicated by skin scarring and potential mortalities and morbidities from cardiopulmonary bypass. Perventricular device closure of muscular and then perimembranous VSD on beating heats with a small subxiphoid or inferior sternotomy has been attempted in the past few years with good results. We have tried perventricular closure of doubly committed subarterial VSD through a left anterior minithoracotomy as an alternative procedure with a modified occluder. ⋯ Selected doubly committed subarterial VSD can be safely closed with a proper occluder through left anterior minithoracotomy. The Cosmetic results are highly satisfactory.
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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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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.