Culprit Lesion Coronary Intervention Before Complete Angiography in ST-Elevation Myocardial Infarction: A Randomized Clinical Trial.

Importance: Rapid reperfusion during primary percutaneous coronary intervention (PCI) is associated with improved outcomes among patients with ST-elevation myocardial infarction (STEMI). Although attempts at reducing the time from STEMI diagnosis to arrival at the catheterization laboratory have been widely investigated, intraprocedural strategies aimed at reducing the time to reperfusion are lacking. Objective: To evaluate the effect of culprit lesion PCI before complete diagnostic coronary angiography (CAG) vs complete CAG followed by culprit lesion PCI on reperfusion times among patients with STEMI. Design, Setting, and Participants: This open-label, prospective, randomized clinical trial was conducted between April 1, 2021, and August 31, 2022, among patients admitted to a tertiary center in Jerusalem, Israel, with a diagnosis of STEMI undergoing primary PCI. All patients were followed up for 1 year. Analysis was on an intention-to-treat basis. Intervention: Patients were randomized in a 1:1 ratio to undergo either culprit lesion PCI before complete CAG or complete CAG followed by culprit lesion PCI. Main Outcomes and Measures: A needle-to-balloon time of 10 minutes or less. Results: A total of 216 patients were randomized, with 184 patients (mean [SD] age, 62.9 [12.2] years; 155 men [84.2%]) included in the final intention-to-treat analysis; 90 patients (48.9%) were randomized to undergo culprit lesion PCI before CAG, and 94 (51.1%) were randomized to undergo to CAG followed by PCI. Patients who underwent culprit lesion PCI before complete CAG had a shorter mean (SD) needle-to-balloon time (11.4 [5.9] vs 17.3 [13.3] minutes; P < .001). The primary outcome of a needle-to-balloon time of 10 minutes or less was achieved for 51.1% of patients (46 of 90) who underwent culprit lesion PCI before CAG and for 19.1% of patients (18 of 94) who underwent complete CAG followed by culprit lesion PCI (odds ratio, 4.4 [95% CI, 2.2-9.1]; P < .001). Rates of adverse events were similar between groups. In a subgroup analysis, the effect of culprit lesion PCI before complete CAG on the primary outcome was consistent. There were no differences in rates of in-hospital, 30-day, and 1-year all-cause mortality. Conclusions and Relevance: In this randomized clinical trial of patients with STEMI, culprit lesion PCI before complete CAG resulted in shorter reperfusion times. Larger trials are needed to validate these results and to evaluate the effect on clinical outcomes. Trial Registration: ClinicalTrials.gov Identifier: NCT05415085.

Early safety of the Amplatzer Cardiac Plug™ for left atrial appendage occlusion.

OBJECTIVE: To assess the cumulative experience of a single operator using a strict set of deployment and release criteria for the Amplatzer Cardiac Plug™ (ACP) and the impact of these criteria on procedural success and complications. BACKGROUND: Following strong evidence that the left atrial appendage (LAA) is the site of the majority of thrombus formation within the left atrium in patients with non-valvular atrial fibrillation, non-pharmacological approaches to LAA exclusion have been developed and shown to be effective. METHODS: Procedural and in-hospital outcomes of LAA occlusion performed by or under the supervision of a single operator using the ACP™ in 100 anticoagulant ineligible patients with a high stroke risk were assessed. RESULTS: One hundred patients with a mean CHADS2 score of 3.21 ± 1.23 underwent catheterization for closure of LAA with the ACP™. The mean landing zone as assessed by TEE was 20.01 ± 3.21 mm, and 20.8 ± 3.19 mm by fluoroscopy. The mean difference between the TEE and the fluoroscopic measurements was 0.8 ± 1.13 mm. Device deployment was successful in 100/100 attempted cases with a mean deployed device size of 24.36 ± 3.27 mm. Procedural complications were limited to a single case of pericardial tamponade and one post-procedural pulmonary edema both of which were adequately treated with no long-term sequelae. CONCLUSIONS: In this single operator report, LAA occlusion using the double element ACP™ can be safely performed with excellent success rates. Using very specific deployment success, stability and release criteria, this device can achieve LAA occlusion with extremely low complication rates in an extremely frail oral anticoagulant ineligible population with multiple co-morbidities.