Background: In clinical practice, local anesthesia with conscious sedation (CS) is performed in roughly 50% of patients undergoing transcatheter aortic valve replacement (TAVR). However, no randomized data assessing the safety and efficacy of CS versus general anesthesia (GA) are available. Methods: SOLVE-TAVI is a multicenter, open-label, 2x2 factorial, randomized trial of 447 patients with aortic stenosis undergoing transfemoral TAVR comparing CS versus GA. The primary efficacy endpoint was powered for equivalence (equivalence margin 10% with significance level 0.05) and consisted of the composite of all-cause mortality, stroke, myocardial infarction, infection requiring antibiotic treatment, and acute kidney injury at 30 days. Results: The primary composite endpoint occurred in 27.2% of CS and 26.4% of GA patients (rate difference 0.8 [90%CI -6.2 to 7.8]; P equivalence =0.015). Event rates for the individual components were as follows: all-cause mortality 3.2% versus 2.3% (rate difference 1.0 [90%CI - 2.9 to 4.8]; P equivalence <0.001), stroke 2.4% versus 2.8% (rate difference -0.4 [90%CI -3.8 to 3.8]; P equivalence <0.001), myocardial infarction 0.5% versus 0.0% (rate difference 0.5 [90%CI -3.0 to 3.9]; P equivalence <0.001), infection requiring antibiotics 21.1% versus 22.0% (rate difference -0.9 [90%CI -7.5 to 5.7]; P equivalence =0.011), acute kidney injury 9.0% versus 9.2% (rate difference - 0.2 [90%CI -5.2 to 4.8]; P equivalence =0.0005). There was a lower need for inotropes or vasopressors with CS (62.8%) versus GA (97.3%) (rate difference -34.4 [90%CI -41.0 to -27.8]). Conclusions: Among patients with aortic stenosis undergoing transfemoral TAVR, use of CS compared with GA resulted in similar outcomes for the primary efficacy endpoint. These findings suggest that CS can be safely applied for TAVR. Clinical Trial Registration: URL: https://clinicaltrials.gov Unique Identifier: NCT02737150

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OBJECTIVES Assessment of early outcomes in patients with normal preoperative left ventricular ejection fraction (LVEF) in whom venoarterial extracorporeal membrane oxygenation (VA-ECMO) was implanted for postcardiotomy cardiogenic shock (PCCS) during the first postoperative 48 h. METHODS Retrospective single-centre analysis in adult patients with normal LVEF, who received VA-ECMO support for PCCS from May 1998 to May 2018. The primary outcome was 30-day perioperative mortality during the index hospitalization. RESULTS A total of 62 125 adult patients underwent cardiac surgery at our institution during the study period. Among them, 173 patients (0.3%) with normal preoperative LVEF required VA-ECMO for PCCS. Among them, 71 (41.1%) patients presented PCCS due to coronary malperfusion and in 102 (58.9%) patients, no evident cause was found for PCCS. Median duration of VA-ECMO support was 5 days (interquartile range 2–8 days). A total of 135 (78.0%) patients presented VA-ECMO-related complications and the overall 30-day perioperative mortality was 57.8%. Independent predictors of mortality were: lactate level just before VA-ECMO implantation [odds ratio (OR) 1.27; P &lt; 0.001], major bleeding during VA-ECMO (OR 3.76; P = 0.001), prolonged cardiopulmonary bypass time (OR 1.01; P &lt; 0.001) and female gender (OR 4.87; P &lt; 0.001). CONCLUSIONS Mortality rates of VA-ECMO in PCCS patients are high, even in those with preoperative normal LVEF. Coronary problems are an important cause of PCCS; however, the aetiology remains unknown in the vast majority of the cases. The implantation of VA-ECMO before development of tissue hypoperfusion and the control of VA-ECMO-associated complications are the most important prognostic factors in PCCS patients. Lactate levels may help guide timing of VA-ECMO implantation and define the extent of therapeutic effort.