First-in-man application of Liwen RF™ ablation system in the treatment of drug-resistant hypertrophic obstructive cardiomyopathy

Abstract

ObjectivesThis study sought to evaluate the clinical applicability of the Liwen Liu RF™ ablation system for percutaneous intramyocardial septal radiofrequency ablation (PIMSRA).BackgroundData on new cardiac radiofrequency ablation devices for the treatment of hypertrophic obstructive cardiomyopathy (HOCM) are limited.Materials and methodsFrom July 2019 to July 2020, a total of 68 patients with drug-resistant HOCM, who underwent PIMSRA with the Liwen RF™ ablation system, which has an ablation electrode of stepless adjustable length, were prospectively enrolled. Safety endpoints included, amongst others, the occurrence of pericardial effusion and/or hemorrhage, cardiac arrhythmias, device failure and procedural death. The reduction in left ventricular outflow tract (LVOT) gradients at 12 months follow-up were used as a surrogate marker for device efficacy.ResultsAll procedures were technically successful. The total energy output time of the system was 75.8 (IQR: 30.0) min, and the average power was 43.61 ± 13.34 watts. No ablation system error occurred. The incidence of pericardial effusion or hemorrhage, transient arrhythmia and resuscitation was 8.8, 39.7, and 1.5% during procedure, respectively. None of the patients died. During 30-day follow-up, there were no complications with the exception of a pericardial effusion in one patient (1.5%). No further complications were reported after 30 days. The patients’ resting [baseline: 75 (IQR: 48) vs. 12-months: 12 (IQR: 19) mmHg, p < 0.001] and provoked [baseline: 122 (IQR: 53) vs. 12-months: 41 (IQR: 59) mmHg, p < 0.001] LVOT gradients decreased significantly during follow-up.ConclusionIn this study, we demonstrate the safety and feasibility of the Liwen RF™ ablation system to treat HOCM. The system allows for significant and sustainable LVOT gradient reduction during 12-months of follow-up. Hence, the Liwen RF™ ablation system is a promising new device that has the potential to become an alternative to existing septal reduction concepts in HOCM patients.

Short time effects of two radiofrequency ablation methods on hypertrophic obstructive cardiomyopathy

“…This is evident through a low LVOT peak gradient at rest and a greater improvement of SAM‐mediated MR. We have witnessed PIMSRA in 12 cases and compared it to previous treatment reports. Our observations have indicated that the decrease in LVOT peak gradient at rest is comparable to the findings reported by Liu et al 21 Moreover, it is similar to the observed effect of SM and superior to that of ASA 22,23 …”

Case Report: Integrated echocardiographic assessment guided Liwen procedure for treating obstructive hypertrophic cardiomyopathy with ventricular aneurysm

“…All procedures were technically successful, and the ablation functioned without errors. The research demonstrates that the Liwen procedure effectively reduces LVOT gradients over a 12-month follow-up period, indicating its potential as an alternative treatment for HOCM patients with promising safety and efficacy (14).…”

“…For HOCM patients with ventricular septal hypertrophy, Liwen surgery may be an effective treatment option, while alcohol septal ablation may be more suitable for specific patients, especially those who are not suitable for Liwen surgery or require rapid symptom relief. Wang et al reported 68 patients with drug resistant HOCM who underwent PIMSRA with Liwen procedure (14). All procedures were technically successful, and the ablation functioned without errors.…”

Analysis of risk factors for complications in echocardiography-guided percutaneous intramyocardial septal radiofrequency ablation

“…Septal reduction therapies, such as surgical septal myectomy and alcohol septal ablation (ASA), have demonstrated ongoing improvements in safety and efficacy. Recently, percutaneous intramyocardial septal radiofrequency ablation (PIMSRA) has emerged as a novel and clinically feasible procedure for treating HOCM [ 3 , 4 ]. The technique utilizes radiofrequency energy to ablate a small area of heart muscle causing obstruction.…”