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

Basic Details
Date Posted
Thursday, February 9, 2023
Status
In progress
Medical Product
dehydrated alcohol
Health Outcome(s)
atrioventricular block
heart failure
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 August 5, 2022. The study period includes data from January 1, 2014 to December 31, 2021. 

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 (1)
Sentinel Analytic Package: Cardiovascular Outcomes Following Percutaneous Transluminal Septal Myocardial Ablation (PTSMA) Procedures: A Descriptive Analysis
Additional Details
FDA Center
CDER
Time Period
January 1, 2014 – December 31, 2021
Study Type
Modular Program
Assessment Type
Safety Analyses
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, Death, 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: An Updated Descriptive Analysis
Heart Failure Algorithm Defined in “Cardiovascular Outcomes Following Percutaneous Transluminal Septal Myocardial Ablation (PTSMA) Procedures: A Descriptive Analysis”
Ventricular Arrhythmia Algorithm Defined in “Cardiovascular Outcomes Following Percutaneous Transluminal Septal Myocardial Ablation (PTSMA) Procedures: A Descriptive Analysis”
Atrioventricular Block Algorithm Defined in “Cardiovascular Outcomes Following Percutaneous Transluminal Septal Myocardial Ablation (PTSMA) Procedures: A Descriptive Analysis”
Septal Myectomy Algorithm Defined in “Cardiovascular Outcomes Following Percutaneous Transluminal Septal Myocardial Ablation (PTSMA) Procedures: A Descriptive Analysis”
Permanent Pacemaker Placement Algorithm Defined in “Cardiovascular Outcomes Following Percutaneous Transluminal Septal Myocardial Ablation (PTSMA) Procedures: A Descriptive Analysis”