Background-There is scant information on the prevalence and factors associated with preoperative anemia in patients undergoing transcatheter aortic valve implantation (TAVI) and whether it is associated with mortality. We sought to determine the prevalence and factors associated with preoperative anemia in addition to the prognostic effects of the various levels of preoperative hemoglobin level on mortality in patients undergoing TAVI. Methods and Results-Ten-center observational study encompassing 1696 patients with aortic stenosis who underwent TAVI was conducted. Anemia was defined by the World Health Organization criteria (hemoglobin <12.0 g/dL in women and <13.0 g/dL in men). but showed the strongest association with 1-year mortality with a hazard ratio (95% confidence interval) of 2.78 (1.60-4.82) in patients with hemoglobin <10 g/dL. Patients with anemia received ≥1 blood transfusion 2× more often, but the indication of transfusion was unrelated to overt bleeding in 60%. Blood transfusion was associated with mortality at 30 days (odds ratio, 1.25 [95% confidence interval, 1.08-3.67]) and during follow-up (hazard ratio, 1.09 [95% confidence interval, 1.03-1.14]). Conclusions-Preoperative anemia is prevalent in >50% of patients undergoing TAVI. Various baseline factors were related to anemia, which in turn was associated with 1-year mortality. Patients with anemia received more transfusions but mostly for indications unrelated to overt bleeding, whereas transfusion was independently associated with both early and 1-year mortality. These findings indicate that optimization of baseline factors related to preoperative anemia, in addition to more strict criteria of the use of blood products, may improve outcome after TAVI. (Circ Cardiovasc Interv. 2013;6:625-634.)

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IntroductionCardiac adipose tissue is a source of progenitor cells with regenerative capacity. Studies in rodents demonstrated that the intramyocardial delivery of cells derived from this tissue improves cardiac function after myocardial infarction (MI). We developed a new reparative approach for damaged myocardium that integrates the regenerative properties of cardiac adipose tissue with tissue engineering. In the adipose graft transposition procedure (AGTP), we dissect a vascularised flap of autologous pericardial adipose tissue and position it over the myocardial scarred area. Following encouraging results in acute and chronic MI porcine models, we performed the clinical trial (NCT01473433, AdiFLAP trial) to evaluate safety in patients with chronic MI undergoing coronary artery bypass graft. The good safety profile and trends in efficacy warranted a larger trial.Study designThe AGTP II trial (NCT02798276) is an investigator initiated, prospective, randomised, controlled, multicentre study to assess the efficacy of the AGTP in 108 patients with non-revascularisable MI. Patients will be assigned to standard clinical practice or the AGTP. The primary endpoint is change in necrotic mass ratio by gadolinium enhancement at 91 and 365 days. Secondary endpoints include improvement in regional contractibility by MRI at 91 and 365 days; changes in functional MRI parameters (left ventricular ejection fraction, left and right ventricular geometric remodelling) at 91 and 365 days; levels of N-terminal prohormone of brain natriuretic peptide (NT-proBNP) at 7, 91 and 365 days; appearance of arrhythmias from 24 hour Holter monitoring at 24 hours, and at 91 and 365 days; all cause death or re-hospitalisation at 365 days; and cardiovascular death or re-hospitalisation at 365 days.Ethics and disseminationThe institutional review board approved the trial which will comply with the Declaration of Helsinki. All patients will provide informed consent. It may offer a novel, effective and technically simple technique for patients with no other therapeutic options. The results will be submitted to indexed medical journals and national and international meetings.Trial registration numberClinicalTrials.gov: NCT02798276, pre-results.