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Pure Echocardiography-guided Radiation-free Tavr For Patients With Severe Aortic Regurgitation: First-in-man
Yao Wang
1, Ye Yang
1, Lili Dong
1, Peng Zhu
2, Shaoyi Zheng
2, Chunsheng Wang
1,
Lai Wei1.
1Zhongshan Hospital, Fudan University, Shanghai, China,
2Nanfang Hospital, Southern Medical University, Guangzhou, China.
BACKGROUND: Transcatheter aortic valve replacement (TAVR) has emerged as an effective option for treating severe aortic regurgitation (AR) in patients with contraindications to surgical valve replacement. However, TAVR procedures are typically conducted with the assistance of both radiation and contrast agents. The prolonged accumulation of radiation impacts the health of both patients and medical practitioners. Meanwhile, using contrast agents poses a significant burden for patients with renal insufficiency or allergies to contrast agents. Furthermore, the equipment in the existing interventional operating rooms is sophisticated, and many developing countries are deficient in the financial support required for promoting TAVR. Therefore, it is of great significance to establish a fully ultrasound-guided TAVR procedure, which avoids the use of radiation and contrast agents and enhances the feasibility and safety of the TAVR operation.
METHODS: Data from 10 patients with aortic regurgitation who had undergone transapical TAVR (TA-TAVR) using the J-Valve system (JieCheng Medical Technology Co., Ltd., Suzhou, China) were collected in Zhongshan Hospital and Nanfang Hospital from May 2023 to November 2024. All valve prostheses were implanted and guided by pure echocardiogram and radiation-free. The primary safety endpoint was a composite of 30-day all-cause mortality, all strokes, life-threatening bleeding, major vascular complications, acute kidney injury (AKI), device-related surgery or reintervention, new permanent pacemaker implantation, and ≥moderate-to-severe perivalvular regurgitation (PVR).
RESULTS: All 10 patients successfully received pure echocardiography-guided radiation-free TAVR. The mean age was 70.2 years, 8 (80%) patients were male, and all patients had more than moderate-severe regurgitation (50% moderate-severe and 50% severe). The mean aortic annulus perimeter-derived diameter measured by preoperative CT was 27.4mm (from 23.9 to 30.5 mm), and the mean LVEF measured by echocardiogram was 46.7%, with 40% of patients having an LVEF less than 40%. The J-Valve was performed on 25mm (3 patients)/27mm (4 patients)/29mm (3 patients) sizes. Post-operative evaluation of valve function showed that all patients had great valve function with no or minimal PVR and a mean aortic transvalvular pressure difference of 3.7 mmHg. None of the patients suffered post-operative complications such as valve dislocation, coronary embolism, apical bleeding, or conduction block. The mean duration of the procedure was 117 minutes. The mean duration of catheter manipulation was 49 minutes and the mean length of hospital stay was 6 days.
CONCLUSIONS: The results showed that TA-TAVR under full echocardiography guidance could reduce the use of radiation and contrast agents and effectively solve problems in traditional TAVR methods. In this process, the J-Valve anchor ring design ensures the accuracy and stability of the valve implantation position and further improves the success rate and safety of the operation. This study provides preliminary clinical evidence for fully ultrasound-guided TAVR that is feasible in the treatment of noncalcified AR. Future studies will need to accumulate more case data and perform long-term follow-ups to verify the long-term efficacy and safety of fully ultrasound-guided TA-TAVR. Through the continuous improvement and perfection of this method, we look forward to providing a safe and effective treatment plan for more patients with AR.
Keywords: Pure Echocardiography-guided, Transapical TAVR, Aortic Regurgitation.
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