Unloading the Left Ventricle Before Reperfusion in Patients With Anterior ST-Segment-Elevation Myocardial Infarction.

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.

Radial versus femoral access for percutaneous coronary intervention in patients with ST-segment elevation myocardial infarction: Trial sequential analysis.

BACKGROUND: Randomized controlled trials (RCTs) have yielded conflicting results about the impact of transradial access (TRA) versus transfemoral access (TFA) in patients with ST-segment elevation myocardial infarction (STEMI). METHODS: We performed a trial sequential analysis (TSA) of RCTs comparing TRA and TFA in patients with STEMI. The outcomes of interest were 30-day mortality, major bleeding, major adverse cardiovascular events (MACE), myocardial infarction (MI), stroke, and access site complications. RESULTS: A total of 17 studies with 11,992 patients were included in the current TSA. The TRA group had lower 30-day mortality (risk ratio [RR] 0.72, 95% CI 0.58-0.90, P = .003), major bleeding (RR 0.62, 95% CI 0.49-0.79, P = .0001), MACE (RR 0.74, 95% CI 0.58-0.93, P = .01), and access site complications (RR 0.37, 95% CI 0.28-0.48, P < .00001). There was no difference in MI and stroke between the 2groups. Applying TSA boundaries, the z-curve for 30-day mortality, major bleeding, MACE and access site complications crossed the conventional and the TSA boundaries, indicating firm evidence for better outcomes in the TRA group. For MI and stroke, the z-curve failed to cross the conventional and the TSA boundaries for both outcomes, indicating lack of signals of benefit or harm. CONCLUSIONS: In the current TSA, the available data from RCTs support improved 30-day mortality, major bleeding, MACE and access site complication rates in STEMI patients treated by PCI through the radial access.

Ticagrelor after pharmacological thrombolysis in patients with ST-segment elevation myocardial infarctions: insight from a trial sequential analysis.

Few randomized controlled trials (RCTs) have compared ticagrelor to clopidogrel after thrombolytic therapy in patients with ST-segment elevation myocardial infarction (STEMI). To assess the quality of the current evidence, a trial sequential analysis (TSA) of all the available RCTs was performed. A literature search through electronic databases for relevant RCTs was completed. Trial sequential boundaries were applied to the meta-analysis to guard against statistical error, calculate the information size (IS), and assess the quality of the currently available evidence. The safety outcome was bleeding at 30-days and the efficacy outcome was major adverse cardiovascular events at 30-days. There were 3 RCTs with a total of 3999 patients were included. For the safety and efficacy outcomes, there was no difference between the ticagrelor and clopidogrel groups (RR 0.94; 95% CI 0.56-1.60, p = 0.83) and (RR 0.87; 95% CI 0.49-1.52, p = 0.62), respectively. The corresponding TSA revealed an IS of 20,928 and 37,266 for safety and efficacy outcomes, respectively. The Z-curves for both outcomes failed to cross the conventional boundary of significance and TSA boundary, indicating no statistical difference between the ticagrelor and clopidogrel group and lack of firm evidence from the currently available RCTs to draw conclusion. Based on the current available RCTs, there is not enough evidence to support or refute better outcomes with ticagrelor in patients with STEMI treated with thrombolytics. Larger RCTs with enough power are needed before firm recommendations can be applied.

A rare cause of postpartum chest pain.

We report the case of a 45-year-old postpartum female at low risk for coronary artery disease (CAD) who presented with chest pain, a normal electrocardiogram (ECG) and elevation of serial troponin-T levels. Coronary angiography revealed dissection of the first obtuse marginal branch of the left circumflex coronary artery. The patient was treated medically and discharged home safely. Spontaneous coronary artery dissection (SCAD) is a rare condition. In the absence of CAD, it is seen most frequently in young females during the peripartum period. Insult from the hemodynamic stresses during pregnancy and labor combined with the underlying pregnancy related arterial wall changes is the proposed mechanism of dissection in this setting. The normal ECG in the presence of an acute myocardial infarction (AMI) in this case also demonstrates the occasional electrically silent ECG that can occur during acute compromise of the left circumflex coronary artery.

Axillary Artery Pseudoaneurysm Following Percutaneous Transaxillary Access for Impella Device Placement During Percutaneous Coronary Intervention.

Percutaneous transaxillary access is currently considered an acceptable alternative to transfemoral approach for large-bore access, especially in the setting of hostile iliofemoral arteries. Few published reports exist concerning complications of upper extremity access. We describe development of an axillary artery pseudoaneurysm and its management following transaxillary access. (Level of Difficulty: Advanced.).