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Cardiovascular Outcomes Following Percutaneous Transluminal Septal Myocardial Ablation (PTSMA) Procedures: An Updated Descriptive Analysis

    Basic Details
    Date Posted
    Medical Product
    dehydrated alcohol
    Health Outcome(s)
    atrioventricular block
    heart failure
    myocardial infarction
    permanent pacemaker placement
    septal myectomy
    ventricular arrhythmia

    The goals of this analysis were to identify and count percutaneous transluminal septal myocardial ablation (PTSMA) procedures and to estimate incidence rates of post-PTSMA cardiovascular outcomes in the Sentinel Distributed Database (SDD). We distributed this request to six Sentinel Data Partners on December 6, 2022. The study period includes data from January 1, 2016 to June 30, 2022. Report 1 contains data from January 1, 2016 to June 21, 2018. Report 2 contains data from June 22, 2018 to June 30, 2022.

    This analysis is a follow-up to a previous study. This analysis incorporated the following analytic design changes: 1) the study period was restricted to data from 2016 forward; 2) myocardial infarction was included as an additional cardiovascular outcome of interest; and 3) the outcome follow-up period for all outcomes of interest (excluding atrioventricular block) was restricted to 90 days.

    The analytic package associated with this analysis can be found externally in Sentinel's Git Repository located here. The Git Repository serves as Sentinel's version control tracking system for analytic packages and technical documentation.

    Additional Details
    FDA Center
    Time Period
    January 1, 2016 - June 30, 2022
    Analysis Type
    Population / Cohort
    Individuals 18 years of age and older
    Data Sources
    Sentinel Distributed Database (SDD)