RESUMO
The utilisation of mechanical circulatory support devices in patients undergoing high-risk coronary artery bypass continues to increase. The Impella is a ventricular assist device commonly used in the setting of post-cardiotomy cardiogenic shock. This device can be implanted directly into the ascending aorta during open cardiac surgery. Device fracture is a documented complication of the Impella; however, the management of device fracture during direct explantation from an aortic graft has not yet been described. We report a case of Impella device fracture during its removal from a prosthetic aortic graft and discuss the management of this complication.
RESUMO
INTRODUCTION: Previous studies have established a baseline of minimal reproducibility in the social science and biomedical literature. Clinical research is especially deficient in factors of reproducibility. Surgical journals contain fewer clinical trials than non-surgical areas of medicine, suggesting that it should be easier to reproduce the outcomes of surgical literature. METHODS: In this study, we evaluated a broad range of indicators related to transparency and reproducibility in a random sample of 387 articles published in Surgery journals between 2014 and 2018. RESULTS: A small minority of our sample made available their materials (5.3%, 95% C.I. 2.4%-8.2%), protocols (1.2%, 0-2.5%), data (2.5%, 0.7%-4.2%), or analysis scripts (0.04%). Four studies were adequately pre-registered. No studies were explicit replications of previous literature. Most studies (58%), declined to provide a funding statement, while conflicts of interest were declared in a small fraction (9.3%). Most have not been cited by systematic reviews (83%) or meta-analyses (87%), and most were only accessible to paying subscribers (59%). CONCLUSIONS: The transparency of the surgical literature could improve with adherence to baseline standards of reproducibility.