We report 1-year outcomes from a single-center experience evaluating the J-Valvefor TA-TAVR in patients with AR. The key findings include 7.4% and 2.2% 1-year mortality and stroke rate, respectively. Echocardiographic measurements confirmed adequate hemodynamic function with a significant improvement in LVEF, a reduction in LVEDD, LVESD, a low rate of residual leakage after TAVR, and excellent aortic valve hemodynamics, with low mean gradients of 8.2±3.2 mmHg maintained to 1-year follow-up.
Severa observational studies show that TAVR is a viable option for patients with pure AR6, 7, 16, 17. It is well known that the first-generation THV primarily relying on calcification of the native leaflets for sufficient anchoring of the expanded prosthesis. Patients with AR have more complex and variable anatomy, and the lack of calcification may lead to inaccurate positioning and difficulty of anchoring, or even worse, valve embolization or residual PVL 18. TAVR using the new-generation devices was associated with improved procedural outcomes in treating patients with AR 19, 20. Importantly, with the second-generation valves and advanced technique J-Valve has even been certified in the indication AR. With a novel fixation mechanism associated with a significantly higher procedural success rate, these devices are a reasonable option in AR patients 21, 22. In the present study, the device’s success is consistent with previous reports of the same valve in patients with AS 23.
The device's success was 96.3%, which corresponds to the J-Valve's initially reported experience for AR treatment, which was 97.6%9. A recent meta-analysis has reported that, based on nineteen studies, with a total number of 988 patients, the rate of devices success was 86.2% (78.8%-92.2%) 24. Our study demonstrated a higher success rate and a lower mortality rate than the studies mentioned above, indicating a novel device's viable safety profile. However, there was no difference in the device success rate between both devices [J-valve and JeneValve (96.3% vs. 96.8%)]16.
The feelers in JenaValve have a rigid connection with the support frames and J-valve with mobile nitinol graspers, which are both designed to be placed into the sinus of the aortic root to achieve an anatomically correct position. The unique design make it possible to ensure the optimal positioning of the valve stent after deployment.
Mortality and Stroke
In the present study, the low 1-year mortality rate of 7.4% was consistent with the 1-year rate of 4.7% in forty-three high-risk patients from the China Trial9 and a 5.5% mortality of TA-TAVR procedures in Germany in 201425. The 1-year mortality rates reported with the J-Valve device are lower than the first-generation reported in other studies, namely the CoreValve, 31% in 26 high-risk patients 7 and 21.4% in the other CoreValve study (n=43)6. Silaschi et al reported transapical TAVR with higher a 1-year mortality rate (20.1%) than that the present study 26. The initial German experience 6-month mortality was 19.3% with JeneValve for the treatment of AR16. Compare to AS, although AR is younger and lower mean STS score, howerver the mortality was no differences 27 . These differences suggest differing pathophysiology of the larger left ventricle and the lower LVEF after treatment of AR is quantitatively and qualitatively different from AS28. Notebly, a recent meta-analysis of AR patients who underwent TAVR showed that the one-year mortality is 25%24.
The incidence of disabling stroke at 1-year (2.2%) in the present study was consistent with the 2.3% reported in the China clinical Trial 9. At 1-year, stroke was 4.7% in CoreValve experience and 3.3%7 in JeneValve of the JUPITER registry 26, which was slightly higher than the present study. However, stroke is uncommon in TAVR treatment for AR. Mainly due to a lack of valve calcification and the simplicity and reliability of the THV implantation in patients.
In the present study, the low mean aortic valve gradient of 8.2±3.2 at 30-day, 10.2±4.1 mmHg at 1-year is consistent with previous reports of the same valve 9. The study result is similar to the 1-month mean valve gradients of other valves (7.9±4.0 mmHg and 7.7±5.1 mmHg reported with the Jenevalve6 and Direct Flow Medical valve 29), although the results provided little information on the effects of the stent on AR hemodynamics. All patients had mild or less PVL at 1-year in the study, with no patients having moderate or severe PVL. These results compare favorably to a recent study that residual moderate or severe aortic regurgitation rate after the procedure was high as 9.2% in other studies 24. Several characteristics include enhanced positioning accuracy, controlled and anatomically correct implantation and improved sealing even in eccentric annular calcifications. The low rates of moderate to severe PVL might be a contributing factor in low all-cause mortality rate at 1-year. However, with the low mortality rate at 1-year compared to patients with AS, patients with AR were younger and faced the risk of bioprosthetic valve deterioration and the need for reintervention.
In the first year, a PPM was implanted in 8.9% of patients. Ten patients received PPM at 30-day, although it was lower than reported with the self-expanding CoreValve6, 7 and higher than reported from the JeneValve registry 16, 26. AR usually have a larger annulus and lack calcification. These reasons may have contributed to require a deeper depth of implantation and larger size of prosthesis. There is some evidence that THV deeper position in the LVOT is independently associated with a higher PPMI rate and the larger prosthesis size, valve oversizing is also relevant to risk factors for pacemakers 30.
Study limitations: Data were obtained in a non-randomized fashion, with the lack of comparative arms of patients with severe AR treated by surgery or medical therapy alone. Also, the sample size was relatively small, and the results were single-center collected, potentially introducing selection bias.
This single-center study reported the outcomes of TAVR in treating pure AR. Our results have demonstrated a favorable 1-year survival rate and symptomatic relieving benefits of TAVR in AR patients.