Page 143 - Journal of Structural Heart Disease Volume 5, Issue 4

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Meeting Abstracts
187. Figure 3. Frontal view of the chest radiograph shows im- proving of both pleural effusions after transcutaneous fontan fenestration with stent implantation.
a mouse wire injury model will be able to identify the detail effect of calpain-9 on intimal hyperplasia, which could develop a new target for the treatment of PV stenosis.
188. PRELIMINARY ASSESSMENT OF PERCUTANEOUS RADIOFREQUENCY ABLATION BASED INTRA-ATRIAL SHUNT THERAPY IN HEART FAILURE WITH PRESERVED EJECTION FRACTION
Huayiyang Zou
Nanjing Medical University, Nanjing, China
Background: Standard medical or device therapy have limited effects on chronic heart failure with preserved ejection fraction (HFpEF). Increased left atrial pressure is thought to be a key contributor to the symptoms associ- ated with HFpEF, especially during physical activity.
Objective: In this study we aim to evaluate the safety and efficacy of a novel approach for intra-atrial shunting by a percutaneous radiofrequency ablation device.
Methods: The percutaneous radiofrequency ablation based intra-atrial shunt (RFIAS) therapy was firstly tested in 12 domestic pigs under fluoroscopy and intracardiac echocardiography (ICE) guidance. Treatment parameters
were set as the first power of 45 watts for 60 seconds plus second power of 60 watts for 60 seconds. The diameter of the intra-atrial shunt was measured by ICE. The chamber filling pressure along with the oxygen saturation analysis of arterial and mixed venous blood were evaluated with high heart catheterization (RHC). Follow-up were per- formed at 1, 3, 6 months post-procedure and a gross anat- omy examination was carried out after 6-month follow-up. A first-in-man study was then performed after the permis- sion of the ethic committee of the First Affiliated Hospital of Nanjing Medical University. Ten patients with HFpEF were enrolled and receiving one-time RFIAS therapy and 6 months follow-up.
Results: 12 swine (52.3 ±10.9kg) received the RFIAS ther- apy under general anesthesia. Two swine were dead, 1 of which was dead for ventilator malfunction during the pro- cedure and the other was dead for intestinal infection at the fourth month. None of the dead were associated with the procedure and no other major safety event was observed. For the 11 surviving swine, mean diameter of intra-atrial shunt and Qp/Qs post-procedure were 5.5±2.2mm and 1.2±0.24, respectively. The closure of intra-atrial shunt was observed in two swine at 3-m and one swine at 6-m fol- low-up. The remaining swine (n=8) showed a mean dimen- sion of 4.1±1.5mm at 6-month. A subsequent first-in-man study of 10 symptomatic heart failure patients with pre- served or mildly reduced ejection fraction, who received RFIAS therapy (mean diameter of 5.3±0.95mm) with the treatment power of 45w60s+60w60s, showed symptoms of relief with a reduction of NT-proBNP (-1630.1±1346.5 ng/L, p=0.004) and an increase of 6-minute walk distance (129.2±98.9m, p=0.003) without major safety events at 6 months follow-up.
Conclusions: Our preclinical and clinical pilot studies suggest that a non-implantable radiofrequency ablation based intra-atrial shunt therapy may provide a new option for HFpEF. A further randomized study is needed to evalu- ate the long-term efficacy and safety.
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Hijazi, Z
22nd Annual PICS/AICS Meeting
Cite this article as: Hijazi ZM. The Pediatric and Adult Interventional Cardiac Symposium (PICS/AICS) 22nd Annual Meeting, San Diego, CA. Structural Heart Disease. 2019;5(4):75- 205. DOI: https://doi.org/10.12945/j.jshd.2019.018.19