Complications of Penumbra Indigo Aspiration Device in Pulmonary Embolism: Insights From MAUDE Database.

Background: The Penumbra Indigo aspiration system (Penumbra Inc., Alameda, CA, USA) is a suction embolectomy device that was cleared by the Food and Drug Administration for use in acute pulmonary embolism (PE). While this device has proven to be safe in clinical trials, real-world data are minimal.

Algorithmic Versus Expert Human Interpretation of Instantaneous Wave-Free Ratio Coronary Pressure-Wire Pull Back Data.

Objectives: The aim of this study was to investigate whether algorithmic interpretation (AI) of instantaneous wave-free ratio (iFR) pressure-wire pull back data would be noninferior to expert human interpretation.

Background: Interpretation of iFR pressure-wire pull back data can be complex and is subjective.

Methods: Fifteen human experts interpreted 1,008 iFR pull back traces (691 unique, 317 duplicate).

Safety of the Deferral of Coronary Revascularization on the Basis of Instantaneous Wave-Free Ratio and Fractional Flow Reserve Measurements in Stable Coronary Artery Disease and Acute Coronary Syndromes.

Objectives: The aim of this study was to investigate the clinical outcomes of patients deferred from coronary revascularization on the basis of instantaneous wave-free ratio (iFR) or fractional flow reserve (FFR) measurements in stable angina pectoris (SAP) and acute coronary syndromes (ACS).

Background: Assessment of coronary stenosis severity with pressure guidewires is recommended to determine the need for myocardial revascularization.

Methods: The safety of deferral of coronary revascularization in the pooled per-protocol population (n = 4,486) of the DEFINE-FLAIR (Functional Lesion Assessment of Intermediate Stenosis to Guide Revascularisation) and iFR-SWEDEHEART (Instantaneous Wave-Free Ratio Versus Fractional Flow Reserve in Patients With Stable Angina Pectoris or Acute Coronary Syndrome) randomized clinical trials was investigated.