First-in-Human Results of TIRA for Hypertrophic Obstructive Cardiomyopathy
Author Information
Author(s): Oh Ji-Soo, Seo Jae-Young, Lee Cheol-Min, Jung Su-Jin, Kim June-Hong, Chon Min-Ku
Primary Institution: Pusan National University Yangsan Hospital
Hypothesis
The TIRA device is a safe and effective option for treating hypertrophic obstructive cardiomyopathy (HOCM).
Conclusion
The TIRA device may be a safe and effective option for treating HOCM, with no significant adverse events reported.
Supporting Evidence
- Follow-up imaging showed a reduction in interventricular septal thickness from 22.6 mm to 18.9 mm over 12 months.
- Two patients showed improvements in their 6-minute walk distance after the procedure.
- No significant adverse events, such as arrhythmias or vascular injuries, were reported.
Takeaway
Doctors tested a new device to help people with a heart problem called HOCM, and it seems to work well without causing harm.
Methodology
This was a first-in-human trial assessing the efficacy and safety of the TIRA device with follow-up imaging and tests at 3, 6, and 12 months.
Potential Biases
Potential risks include venous injury, thrombus formation, and arrhythmias.
Limitations
The small sample size limits the ability to draw definitive conclusions.
Participant Demographics
Three female and one male participant, mean age 69.5 years, all diagnosed with dyslipidemia.
Digital Object Identifier (DOI)
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