Breakthrough｜Valgen Medtech's Transcatheter Hypertrophic Cardiomyopathy (HCM) Ablation Technique Successfully Used for Exploratory Clinical Application in 10 Patients

According to the follow-up data from the first nine patients, the mean peak left ventricular outflow tract gradient (LVOTG) values of the subjects at baseline, before discharge, 30 days, 3 months, and 6 months after the operation were: 74.78±30.47mmHg, 37.22±30.4mmHg, 25.63±14.24mmHg, 23.33±17.83mmHg, 21.00±9.00mmHg. The study results initially verified the feasibility and safety of the application of DragonFire for the treatment of oHCM. It looks like DragonFire could be a promising new solution for the treatment of HCM in China.

Variation of peak LVOTG values of patients at rest following surgery in the first in-man (FIM) study

A group photo after the first operation on October 13, 2022 in the FIM study

A 65 year-old female patient, who presented with such symptoms as tightness of the chest, and aggravating anhelation with nocturnal paroxysmal dyspnea, etc.; the symptoms were not been relieved following drug therapy. Echocardiography findings: LVEDD 42mm, LAD 36mm, EF 65%. Uneven significant thickening of the interventricular septum; maximum thickness 22mm; posterior wall of left ventricle thickened to 14mm; (severe) left ventricle outflow tract obstruction, symptoms of SAM syndrome (+). The symptoms were accompanied by mild mitral tricuspid regurgitation, calcification of aortic valve, and mild regurgitation. LVOT systolic flow rate increased significantly to approximately 6.1m/s, PGmax: 150mmHg.

Before the operation, the technical team made use of a 3-D reconstruction technique to customize a device approach that fit the anatomical features of the patient's disease and precisely identified the area of thickening. Afterwards, a simulated ablation route was determined for the patient; a plan was made for ablation at eight sites in succession. Prior to the operation, the required ablation energy range and depth for each of the sites were estimated and a strategy for ablation from anterior septum to posterior septum was established.

During the operation, Professor Fang Zhenfei skillfully manipulated DragonFire to precisely position and puncture the thickest part of the myocardium at the basilar part of the anterior septum, intermediate septum, and the area was ablated with energy within the appropriate range.

Postoperative color Doppler echocardiography suggested that the symptoms of SAM syndrome had disappeared and mitral regurgitation had improved; the LVOT systolic flow rate decreased from a pre-operative value of 6.1m/s to a post-operative value of 2.1m/s; the peak LVOTG decreased from a pre-operative value of 150mmHg to a post-operative value of 17mmHg. The immediate intraoperative ablation result was a decrease of 133mmHg in outflow tract pressure gradient.

The catheter was removed from the patient immediately after the operation and the patient's clinical symptoms significantly improved without any common post-ablation complications in oHCM patients such as arrhythmia or left ventricle low cardiac output syndrome. The patient was discharged one week after the operation.