Key result
The Liwen RF ablation system significantly reduced resting left ventricular outflow tract gradients from a median of 75 mmHg at baseline to 12 mmHg at 12 months in patients with drug-resistant hypertrophic obstructive cardiomyopathy.
Why the study?
Data on new cardiac radiofrequency ablation devices for treating hypertrophic obstructive cardiomyopathy are limited.
Does percutaneous intramyocardial septal radiofrequency ablation using the Liwen RF system safely reduce LVOT gradients in patients with drug-resistant hypertrophic obstructive cardiomyopathy?
Does percutaneous intramyocardial septal radiofrequency ablation using the Liwen RF system safely reduce LVOT gradients in patients with drug-resistant hypertrophic obstructive cardiomyopathy?
Absolute Event Rate: 12% vs 75%
p-value: p=<0.001
The Liwen RF ablation system is a safe and feasible alternative for septal reduction in drug-resistant HOCM, significantly reducing LVOT gradients and improving symptoms at 12 months.
Supports PIMSRA feasibility with new RF system in drug-resistant HOCM; leaves open need for randomized efficacy and safety data.
Objectives This study sought to evaluate the clinical applicability of the Liwen Liu RF™ ablation system for percutaneous intramyocardial septal radiofrequency ablation (PIMSRA). Background Data on new cardiac radiofrequency ablation devices for the treatment of hypertrophic obstructive cardiomyopathy (HOCM) are limited. Materials and methods From 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. Results All 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. Conclusion In 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.
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Wang et al. (2022) studied Drug-resistant hypertrophic obstructive cardiomyopathy (n=68). Liwen RF ablation system vs. Baseline was evaluated on Resting left ventricular outflow tract (LVOT) gradient at 12 months (mmHg) (p=<0.001). The Liwen RF ablation system significantly reduced resting left ventricular outflow tract gradients from a median of 75 mmHg at baseline to 12 mmHg at 12 months in patients with drug-resistant hypertrophic obstructive cardiomyopathy.
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