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Background: Protection against acute kidney injury (AKI) has been reported with the use of Impella during high-risk percutaneous coronary intervention (HR-PCI). We sought to evaluate this finding by determining the occurrence of AKI during Impellasupported HR-PCI in patients from the Global cVAD Study and compare this incidence with their calculated AKI risk at baseline. Methods and Results:In this prospective, multicenter study, we enrolled 314 consecutive patients. We included 223 patients that underwent nonemergent HR-PCI supported with Impella 2.5 or Impella CP and excluded those requiring hemodialysis prior to HR-PCI (19) and those with insufficient data (72). The primary outcome was AKI postprocedurally at 48 hr versus the predicted risk of AKI according to Mehran risk score. Logistic regression analysis determined predictors of AKI. Overall, 4.9% (11) of Impella-supported patients developed AKI (exclusively stage 1) at 48 hr versus a predicted rate of 21.9%, representing a 77.6% lower AKI rate (p < .0001). In this study, no Impella-supported patients required renal replacement therapy. Estimated glomerular filtration rate (ml/min/1.73 m 2 ) alone predicted AKI (adjusted odds ratio [AOR]: 4.915; 95% confidence intervals [CI]: 1.02-23.53, p = .046), and increasing contrast had insignificant effects on AKI during high-risk PCI (AOR: 1.15; 95% CI: 0.87-1.51, p = .332). In patients not protected from AKI, the postprocedure incidence of AKI was not significantly greater and did not correlate with chronic kidney disease severity.Conclusion: The incidence of AKI was lower during HR-PCI than expected from current risk models. Although further exploration of this finding is warranted, these data support a new protective strategy against AKI during HR-PCI.contrast, hemodynamic support, left ventricular dysfunction, renal protection ABBREVIATIONS: AKI, acute kidney injury; AKIN, acute kidney injury network; CIN, contrast-induced nephropathy; CKD, chronic kidney disease; Cr, creatinine; eGFR, estimated glomerular filtration rate; PCI, percutaneous coronary intervention; pLVAD, percutaneous left ventricular assist device.

Minimally invasive esophagectomy (MIE) is used with hope to decrease the morbidity associated with an open esophagectomy. Reflux and dumping syndromes are the most important functional complaints in patients after esophagectomy. This study compares the functional benefits of MIE with open esophagectomy. The study enrolled patients who underwent either minimally invasive or open esophagectomy for cancer between 2004 and 2009. No patients in the MIE group had a pyloroplasty or myotomy. Each patient in the MIE group was paired to a patient in the open esophagectomy group via propensity matching. Matching variables included age, race, gender, preoperative treatment, history of prior cancer, American Society of Anesthesiologists Risk Scale, performance status, clinical stage, body mass index, histology, level of anastomosis, and time elapsed since surgery. The patients were asked to answer 26 questions about their reflux and dumping using validated questionnaires. A total of 181 patients were included in the study. From this group, 44 pairs of patients were created and used for the analysis. The median follow-up was 12.1 months for the MIE group and 18.3 months for the open group. The reflux score was slightly worse in the MIE group (5.5 versus 3.5, P= 0.021). There was no difference in the dumping symptoms between the two groups. The most common complaints seen in the dumping questionnaire in almost one-third of all patients were early satiety, abdominal discomfort, nausea, and diarrhea. Of the patients, 77% were satisfied or very satisfied with their condition in the MIE group compared with 93% in the open group (P= 0.287). Reflux, dumping, and overall satisfaction after MIE without pyloroplasty are comparable with those obtained after open esophagectomy with a pyloric drainage procedure.

BackgroundThe Transcatheter Valve Therapy (TVT) Coordinated Registry Network (CRN) supported 23 regulatory decisions and ensured evidence-based evaluation of the application of TVT technology. However, there are cost concerns that require value assessment of the TVT CRN compared with traditional study designs.ObjectivesWe aimed to determine the value created by the TVT CRN based on (1) Return on investment (ROI), (2) Time saved (TS) in conducting necessary regulatory studies.MethodsFor both ROI and TS analyses, we compared studies that used the TVT CRN with those that would have been required if the registry did not exist (counterfactual studies). To estimate ROI, we accounted for the costs of investment and gain from investment. Both the counterfactual costs and length of studies were projected using design specifications determined by US Food and Drug Administration (FDA) reviewers.ResultsWe identified 21 studies using the TVT CRN (supporting 23 FDA decisions) that generated evidence on TVT for three device manufacturers. ROI is estimated to be greater than 550%. TS by using the CRN ranged from months to years.ConclusionsThe CRN method to evidence generation creates value for manufacturers and the broader device ecosystem, demonstrated with this example of the TVT CRN. The public health benefits of evidence created by this CRN outweighs the difference in data quality between traditional clinical studies and the CRN method.