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. 2024 Dec 4;12(12):2762.
doi: 10.3390/biomedicines12122762.

Trans-Coronary Sinus Intra-Septal Radiofrequency Ablation (TIRA) for Hypertrophic Obstructive Cardiomyopathy: First-in-Human Results

Ji-Soo Oh  1 , Jae-Young Seo  2 , Cheol-Min Lee  3 , Su-Jin Jung  3 , June-Hong Kim  4 , Min-Ku Chon  4
Affiliations

Trans-Coronary Sinus Intra-Septal Radiofrequency Ablation (TIRA) for Hypertrophic Obstructive Cardiomyopathy: First-in-Human Results

Ji-Soo Oh et al. Biomedicines. .

Abstract

Background: Current treatments for hypertrophic obstructive cardiomyopathy (HOCM), including medication, surgery, and alcohol septal ablation (ASA), have limitations in terms of efficacy and safety. To address these challenges, we developed the trans-coronary intra-septal radiofrequency ablation (TIRA) device.

Methods: This first-in-human trial was conducted to assess the efficacy and safety of the TIRA device. Moreover, evaluations were conducted before the procedure and at 3, 6, and 12 months post-procedure using computed tomography, magnetic resonance imaging, echocardiography, and the 6 min walk distance (6MWD) test.

Results: Four patients were enrolled, and follow-up imaging at 3, 6, and 12 months showed a reduction in the interventricular septal (IVS) thickness (baseline mean: 22.6 mm; 12-month mean: 18.9 mm) and a decrease in the LVOT pressure gradient at 12 months (resting baseline mean: 84.64 mmHg; resting 12-month mean: 43.56 mmHg; Valsalva baseline mean: 129.96 mmHg; Valsalva 12-month mean: 108.16 mmHg). However, reductions in the IVS thickness on echocardiography and improvements in 6MWD were observed in only two patients.

Conclusions: No significant adverse events, such as arrhythmias or vascular injuries, were reported. These findings suggest that the TIRA device may be a safe and effective option for treating HOCM. However, further studies are required to confirm these results.

Keywords: TIRA-HOCM device; coronary venous system access; first in-human clinical trial; hypertrophic obstructive cardiomyopathy (HOCM); left ventricular outflow tract (LVOT) obstruction.

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Conflict of interest statement

The corresponding author (Min-Ku Chon) has intellectual property of the spacer device, stock of TAU MEDICAL, is currently working as the clinical director of TAU MEDICAL Inc. The other authors declare no conflicts of interest.

Figures

Figure 1
Figure 1
Overview of the TIRA device and associated components. (A) TIRA device, (B) the radio frequency generator connected to the TIRA device, which delivers controlled energy during the procedure. (C) A detailed view of the TIRA device, highlighting key components such as the coil electrode and cooling lumen.
Figure 2
Figure 2
Route of the TIRA Catheter from the jugular vein to the coronary sinus and septal perforator veins. (A) An illustration of the TIRA procedure, showing the catheter route starting from the jugular vein (①), passing through the coronary sinus (②), and reaching the target septal veins (③). (B) Confirmation of the catheter’s movement during the TIRA procedure using angiography.
Figure 3
Figure 3
Imaging of IVS and LVOT using echocardiogram, CT, and MRI (pre-procedure). (A) Echocardiographic image showing the interventricular septum (IVS) with white arrows. (B) Echocardiographic image showing the measurement of the LVOT gradient during a Valsalva maneuver. (C) A 3D snapshot from CT imaging showing the anatomical structure of the coronary sinus. (D) MRI image showing the baseline IVS.
Figure 4
Figure 4
CT or MRI measurements of interventricular septal thickness taken during the follow-up period demonstrated a reduction in septal thickness over time.
Figure 5
Figure 5
Changes in defect size over the follow-up period, based on MRI measurements.
See this image and copyright information in PMC

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