Author + information
- Da Zhu, MD,
- Lai Wei, MD,
- Anson Cheung, MD,
- Yingqiang Guo, MD∗ (, )
- Yucheng Chen, MD,
- Liming Zhu, MD,
- Huan Liu, MD,
- Ye Yang, MD,
- Ji Zhang, MD and
- Chunsheng Wang, MD
- ↵∗Department of Cardiovascular Surgery, West China Hospital, Wai Nan Guo Xue Road 37, Chengdu, Sichuan 610041, China
Transcatheter aortic valve implantation (TAVI) procedure is truly challenging in patients with pure aortic regurgitation (AR). The J-Valve TAVI device (JC Medical Inc., Burlingame, California) is characterized by a U-shaped anatomically orientating device—the “clasper” (1). This design could facilitate intuitive “self-positioning” valve implantation and provide extra-axial fixation by embracing the native valve leaflets. We report the results of TAVI in patients with pure AR using this valve.
From March 1 to December 30, 2014, 33 patients with pure AR and high surgical risk underwent TAVI using this valve including 7 women and 26 men, with mean age 74.2 ± 5.2 years. Mean logistic EuroSCORE I (European System for Cardiac Operative Risk Evaluation) was 24.4 ± 5.1%. Eighty-two percent of patients were symptomatic with New York Heart Association functional class III/IV.
The transapical-based procedure with this valve has been described previously (1). Briefly, the delivery system was inserted into the left ventricle via the apex and then advanced into the ascending aorta over a guidewire. The self-expanding clasper was released and positioned into the corresponding aortic sinus by gentle traction ventricularly. Gentle rotation or adjustment of the delivery system angulation allows the clasper to seat evenly into the aortic sinus, confirming by root angiogram and echocardiography. The valve stent was positioned in the annular plane under the guidance of the clasper and deployed without rapid ventricular pacing (Figure 1). All patients were followed for 6 months. Outcomes were analyzed according to Valve Academic Research Consortium-2 (VARC-2) criteria.
Eleven 25-mm and 22 27-mm prostheses were used with mean aortic annulus diameter of 25.2 ± 1.1 mm. VARC-defined device success was obtained in 94% of patients (31 of 33). One patient was converted to open-heart surgery due to valve embolism caused by insufficient fluoroscopic imaging guidance. One patient had moderate degree paravalvular leakage (PVL) post-implantation. No operative mortality and major complications such as third-degree atrioventricular block, myocardium infraction, cerebrovascular events, or major bleeding event were noted periprocedurally. Minor access site complications occurred in 1 patient. Planned concurrent percutaneous coronary intervention was performed in 2 patients.
All-cause mortality rate was 3% at 30 days, and the patient with moderate-degree PVL died 20 days after surgery due to congestive heart failure. Acute renal injury requiring hemodialysis occurred in 1 patient (3%). The 30-day freedom from event rate was 91% (31 of 33 patients). No patient had greater than mild PVL, whereas 72% (23 of 31 patients) had none or trivial PVL. Two patients underwent permanent pacemaker implantation due to third-degree atrioventricular block.
At 6 months, no structural valve-related dysfunction or reintervention was noted. Mean aortic valve gradient remained stable compared with the 30-day follow-up (8.4 ± 2.8 vs. 8.7 ± 2.8 mm Hg, p = 0.59 using paired t test). PVL remained low throughout follow-up with 87% (27 of 31) of the patients graded as none or trivial. These 31 patients with successful valve implantations were alive with improved exercise tolerance.
The present study demonstrates a high successful implantation rate with low complication rate and excellent hemodynamic performance of this valve in patients with pure AR. The design of this valve relies on the U-shaped anatomical orientating clasper and 2-stage deployment design. The clasper facilitates self-positioning valve implantation, simplifying the implantation procedure, increasing procedural success, and minimizing the risk of coronary ostial obstruction. The clip-fixation between the valve stent and the clasper provides extra-axial fixation force, which makes this device uniquely suitable for AR patient. In contrast to the commercially available JenaValve (JenaValve Technology, Munich, Germany) (2), the anatomically orientating device of the J-Valve is not directly attached to the prosthesis and is flexibly connected to the valve stent by Darcon cords. It has a 2-stage releasing design concept: stage I: the clasper is completely released and accurately positioned; stage II: the valve stent is then deployed with the guidance of the clasper. This unique feature makes it possible for the axial alignment between the valve stent and the clasper to be adjusted separately as needed in order to achieve optimal alignment and positioning of the valve stent.
Our results demonstrated that this new valve could become a potentially feasible treatment option in AR patients who are at high risk for open-heart surgery.
Please note: This study was supported, in part, by grant no. 81200144 from the National Research Foundation of Nature Science, People's Republic of China and grant no. 1 from JC Medical Inc. Burlingame, California. Dr. Zhang is the designer of the J-Valve system and the shareholder of JC Medical Inc., Burlingame, California. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose. This study was presented at TCT 2015 Annual Meeting, San Francisco, California. Drs. Wei and Zhu contributed equally to this work. (Evaluation of the Performance, Efficacy, and Safety of Transapical Aortic Valve Implantation of the J-Valve System in Patients With Severe Symptomatic Native Aortic Valve Stenosis and/or Regurgitation With Elevated Surgical Risk; ChiCTR-OPC-15006354).
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