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Background: In ST-segment-elevation myocardial infarction (STEMI), infarct size correlates directly with heart failure and mortality. Preclinical testing has shown that, in comparison with reperfusion alone, mechanically unloading the left ventricle (LV) before reperfusion reduces infarct size and that 30 minutes of unloading activates a cardioprotective program that limits reperfusion injury. The DTU-STEMI pilot trial (Door-To-Unload in STEMI Pilot Trial) represents the first exploratory study testing whether LV unloading and delayed reperfusion in patients with STEMI without cardiogenic shock is safe and feasible., Methods: In a multicenter, prospective, randomized exploratory safety and feasibility trial, we assigned 50 patients with anterior STEMI to LV unloading by using the Impella CP followed by immediate reperfusion (U-IR) versus delayed reperfusion after 30 minutes of unloading (U-DR). The primary safety outcome was a composite of major adverse cardiovascular and cerebrovascular events at 30 days. Efficacy parameters included the assessment of infarct size by using cardiac magnetic resonance imaging., Results: All patients completed the U-IR (n=25) or U-DR (n=25) protocols with respective mean door-to-balloon times of 72 versus 97 minutes. Major adverse cardiovascular and cerebrovascular event rates were not statistically different between the U-IR versus U-DR groups (8% versus 12%, respectively, P=0.99). In comparison with the U-IR group, delaying reperfusion in the U-DR group did not affect 30-day mean infarct size measured as a percentage of LV mass (15±12% versus 13±11%, U-IR versus U-DR, P=0.53)., Conclusions: We report that LV unloading using the Impella CP device with a 30-minute delay before reperfusion is feasible within a relatively short time period in anterior STEMI. The DTU-STEMI pilot trial did not identify prohibitive safety signals that would preclude proceeding to a larger pivotal study of LV unloading before reperfusion. An appropriately powered pivotal trial comparing LV unloading before reperfusion to the current standard of care is required., Clinical Trial Registration: URL: https://www.clinicaltrials.gov . Unique identifier: NCT03000270.

Percutaneous ventricular assist devices (pVADs) are indicated to provide hemodynamic support in high-risk percutaneous interventions and cardiogenic shock. However, there is a paucity of published data regarding the etiologies and predictors of 90-day readmissions following pVAD use. We studied the data from the US Nationwide Readmissions Database (NRD) for the years 2013 and 2014. Patients with a primary discharge diagnosis of pVAD use were collected by searching the database for International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) procedural code 37.68 (Impella and TandemHeart devices). Amongst this group, we examined 90-day readmission rates. Comorbidities as identified by "CM_" variables provided by the NRD were also extracted. The Charlson Comorbidity Index was calculated using appropriate ICD-9-CM codes, as a secondary diagnosis. A 2-level hierarchical logistic regression model was then used to identify predictors of 90-day readmission following pVAD use. Records from 7074 patients requiring pVAD support during hospitalization showed that 1562 (22%) patients were readmitted within 90 days. Acute decompensated heart failure (22.6%) and acute coronary syndromes (11.2%) were the most common etiologies and heart failure (odds ratio [OR]: 1.39, 95% confidence interval [CI]: 1.17-1.67), chronic obstructive pulmonary disease (OR: 1.26, 95% CI: 1.07-1.49), peripheral vascular disease (OR: 1.305, 95% CI: 1.09-1.56), and discharge into short- or long-term facility (OR: 1.28, 95% CI: 1.08-1.51) were independently associated with an increased risk of 90-day readmission following pVAD use. This study identifies important etiologies and predictors of short-term readmission in this high-risk patient group that can be used for risk stratification, optimizing discharge, and healthcare transition decisions., (© 2018 Wiley Periodicals, Inc.)

Objectives: In this study, we examined the predictive value of the left ventricular end-diastolic pressure (LVEDP) in patients undergoing balloon aortic valvuloplasty (BAV)., Background: The LVEDP is a useful indicator of hemodynamic status in patients with severe aortic stenosis. In BAV, decompensated heart failure is associated with worse outcomes., Methods: We identified all consecutive patients with severe symptomatic aortic stenosis who underwent retrograde BAV at the Massachusetts General Hospital from 2004 to 2008. Patients were stratified and compared according to their baseline LVEDP into ≤15 mm Hg, 16-20 mm Hg, 21-25 mm Hg, and ≥26 mm Hg. Procedural and in-hospital outcomes and adverse events were compared. Multivariate logistic regression was used for the adjusted analysis., Results: A total of 111 patients with a mean age of 83±11 years underwent BAV. Of these, the LVEDP was ≤15 mm Hg in 29 (26%), 16-20 mm Hg in 41 (37%), 21-25 mm Hg in 16 (14%), and ≥26 mm Hg in 25 (23%) patients. Baseline characteristics were similar among the four groups. Noticeably, patients with high LVEDP levels had significantly higher rates of the combined endpoint of in-hospital death, myocardial infarction (MI), cardiopulmonary arrest, and tamponade was P = 0.02. Periprocedural MI was more common among those with higher LVEDP (16% vs. 2.3%; P = 0.04). Multivariate analysis revealed LVEDP (OR 1.08, for each mm Hg increase in pressure, 95 % CI 1.02-1.14), small LV chamber size, and New York Heart Association class as independent predictors of adverse outcomes., Conclusions: The LVEDP is an important independent predictor of poor in-hospital outcome during BAV. In these patients, the immediate hemodynamic status may be more important than the baseline left ventricular systolic function. Hemodynamic optimization before or during BAV should be considered and may be beneficial., (Copyright © 2013 Wiley Periodicals, Inc., a Wiley company.)