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

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

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.

Deliverables (3)
Sentinel Analytic Package: Cardiovascular Outcomes Following Percutaneous Transluminal Septal Myocardial Ablation (PTSMA) Procedures: An Updated Descriptive Analysis Sentinel Modular Program Report: Cardiovascular Outcomes Following Percutaneous Transluminal Septal Myocardial Ablation (PTSMA) Procedures: An Updated Descriptive Analysis, Report 1 Sentinel Modular Program Report: Cardiovascular Outcomes Following Percutaneous Transluminal Septal Myocardial Ablation (PTSMA) Procedures: An Updated Descriptive Analysis, Report 2
Additional Details
FDA Center
CDER
Time Period
January 1, 2016 - June 30, 2022
Analysis Type
Descriptive
Population / Cohort
Individuals 18 years of age and older
Data Sources
Sentinel Distributed Database (SDD)
Related Links
Sentinel Drug Study: Ablysinol (Dehydrated Alcohol) & Atrioventricular Block, Heart Failure, Myocardial Infarction, Permanent Pacemaker Placement, Septal Myectomy, and Ventricular Arrhythmia
Sentinel Drug Analysis: Cardiovascular Outcomes Following Percutaneous Transluminal Septal Myocardial Ablation (PTSMA) Procedures: A Descriptive Analysis
Heart Failure Algorithm Defined in “Cardiovascular Outcomes Following Percutaneous Transluminal Septal Myocardial Ablation (PTSMA) Procedures: An Updated Descriptive Analysis”
Ventricular Arrhythmia Defined in “Cardiovascular Outcomes Following Percutaneous Transluminal Septal Myocardial Ablation (PTSMA) Procedures: An Updated Descriptive Analysis”
Atrioventricular Block Defined in “Cardiovascular Outcomes Following Percutaneous Transluminal Septal Myocardial Ablation (PTSMA) Procedures: An Updated Descriptive Analysis”
Septal Myectomy Defined in “Cardiovascular Outcomes Following Percutaneous Transluminal Septal Myocardial Ablation (PTSMA) Procedures: An Updated Descriptive Analysis”
Permanent Pacemaker Placement Defined in “Cardiovascular Outcomes Following Percutaneous Transluminal Septal Myocardial Ablation (PTSMA) Procedures: An Updated Descriptive Analysis”
Myocardial Infarction Defined in “Cardiovascular Outcomes Following Percutaneous Transluminal Septal Myocardial Ablation (PTSMA) Procedures: An Updated Descriptive Analysis”