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Background/purpose: Optical coherence tomography (OCT) is a high-resolution intravascular imaging modality used to assess coronary arteries and as an adjunctive tool for optimization of percutaneous coronary interventions. Overall, the rate of complications and adverse events related to intravascular imaging is low. Limited data exist on the most commonly reported complications and modes of failure related to the use of OCT. Therefore, we analyzed the post-marketing surveillance data from the Food and Drug Administration Manufacturer and User Facility Device Experience (MAUDE) database to assess the reported complications and failure modes for OCT and reviewed techniques to optimize device use., Methods/materials: The MAUDE database was queried for all event reports involving coronary OCT devices. Two independent reviewers identified 49 device reports included in the final analysis. Modes of failure and device-related patient complications were assessed., Results: Of the 49 cases with reported device-related issues, 6.1% involved malfunction prior to insertion of the OCT catheter, and 30.6% of reported events did not result in an associated patient-related adverse event. The most commonly reported adverse events included coronary dissection and difficulty removing the catheter within a previously stented segment. No events of contrast-induced nephropathy were reported., Conclusions: Findings from the MAUDE database highlight the modes of device-related events associated with OCT. Device issues are uncommon, and as a result, users should be aware of optimal techniques to prevent and minimize adverse events related to device use., (Copyright © 2019 Elsevier Inc. All rights reserved.)

In part 2 of this two-part manuscript on takotsubo syndrome (TTS), we discuss typical biomarkers (particularly excess catecholamines and what kinds of electrocardiographic information operators should look for) and numerous complications the syndrome can cause. This consensus paper is the result of a multinational effort aiming to summarize the current state of the art on TTS. Several novel and unique sections are emphasized in this document, including the current state of the art on genetics of takotsubo syndrome, microRNAs (miRs), racial differences, role of cardiac spectroscopy and intracoronary imaging, as well as mechanical circulatory support. New structured algorithms are also proposed to aid clinicians in the decision-making process as well as future directions for research given the current lack of evidence-based medical approaches., (Copyright © 2018 Elsevier Inc. All rights reserved.)

Takotsubo syndrome (TTS) is an acute cardiac condition independent of epicardial coronary obstruction that mimics acute coronary syndrome and is characterized by acute heart failure with reversible ventricular motion abnormalities. This consensus paper is the result of a multinational effort aiming to summarize the current state of the art on TTS. Experts in the field provide a thorough and detailed review of this syndrome. Several novel and unique sections are emphasized in this document, including the current state of the art on genetics of takotsubo syndrome, microRNAs (miRs), racial differences, role of cardiac spectroscopy and intracoronary imaging, as well as mechanical circulatory support. In part 1 of this two-part manuscript, we discuss how TTS came to be known, several patterns and forms it can take in patients, epidemiology and pathophysiology of the syndrome, and clinical presentation., (Copyright © 2018 Elsevier Inc. All rights reserved.)