TAVI is a well-established minimally invasive treatment for calcific aortic stenosis and has become a therapeutic option even in low-risk patients. However, most currently available transcatheter heart valve designs were developed for calcific aortic stenosis and depend on device anchoring within a calcified valve and annulus. Consequently, currently available off-label transcatheter valves are not optimal for pure aortic regurgitation, with a high incidence of valve migration or embolization requiring implantation of a second valve, excessive oversizing with the attendant risk of annular rupture, and residual regurgitation.

The J-Valve® is a second-generation valve approved for the treatment of aortic stenosis and pure aortic regurgitation. This valve features a self-expanding short-stent design with 3 U-shaped anchoring rings for optimal positioning. Early multicenter experience with 2-year follow-up has already been reported. However, long-term TAVI follow-up data for the treatment of aortic stenosis or pure aortic regurgitation remain limited. The aim of this study was to assess 5-year clinical and echocardiographic outcomes after TAVI with the J-Valve® in patients with aortic stenosis or pure aortic regurgitation.

This was a retrospective multicenter study that consecutively included all patients with severe aortic stenosis or pure aortic regurgitation treated with the J-Valve® at 3 centers in China between March 2014 and August 2015. Clinical follow-up, through either outpatient visits or telephone contact, and echocardiographic follow-up were performed at 7 days, 1 month, 6 months, and annually thereafter. Patients who required conversion to open surgery within 30 days after TAVI were excluded from the analysis. The primary end point was all-cause mortality. Secondary end points included cardiovascular mortality, acute myocardial infarction, stroke, permanent pacemaker implantation, prosthetic valve dysfunction, and reintervention. Additional secondary end points included assessment of functional status according to NYHA class and quality of life using EQ-5D.

A total of 98 patients were ultimately included (mean age 73.9 ± 5.18 years), with aortic stenosis in 62 patients (63.27%) and pure aortic regurgitation in 36 (36.73%). All surviving patients completed 5-year clinical follow-up after the procedure.

At 5 years, the all-cause mortality rate was 15.31%, whereas cardiovascular mortality was 7.14%. Stroke occurred in 7.14% of patients, and permanent pacemaker implantation in 8.16%. Echocardiographic follow-up showed a significant improvement in left ventricular ejection fraction over time in both patients with stenosis and those with pure aortic regurgitation. Structural valve deterioration was documented in 3 cases (3.06%). A total of 97.59% of patients experienced a marked improvement in functional class, which was accompanied by a significant gain in quality of life. Independent predictors of mortality were age, preprocedural anemia, and moderate or greater PVL, underscoring the importance of appropriate patient selection and meticulous procedural planning.

COMMENTARY:

TAVI is currently a well-established treatment for calcific aortic stenosis and has become a therapeutic option even in low-risk patients. However, most currently available transcatheter heart valves were specifically designed for calcific aortic stenosis. The J-Valve® is a second-generation valve approved for the treatment of both aortic stenosis and pure aortic regurgitation.

This study is particularly relevant because it includes pure aortic regurgitation, a historically challenging indication for TAVI due to the technical difficulty posed by the absence of valvular calcification for device anchoring, the higher risk of embolization, and the greater incidence of PVL. The J-Valve®, through its anchoring rings, was specifically designed to address these limitations. Its relevance also lies in the prolonged 5-year follow-up and in the assessment of structural durability.

From a hemodynamic standpoint, the device performed well in both stenosis and aortic regurgitation. In aortic stenosis, there was a sustained reduction in transvalvular gradient together with progressive improvement in ejection fraction, whereas in pure aortic regurgitation the most notable findings were a marked reduction in ventricular diameter and significant recovery of systolic function.

Important limitations of the study include the small sample size (n = 98), the lack of a comparator group, the exclusive inclusion of a Chinese population, which limits generalizability, the use of transapical access only rather than transfemoral access, and the absence of a direct comparison with surgery, which remains the reference treatment for pure aortic regurgitation.

This study suggests that TAVI may represent a valid alternative for the treatment of pure aortic regurgitation. Nevertheless, although 5-year durability appears promising, it remains insufficient for young low-risk patients. At present, randomized studies and longer follow-up are still required before indications can be extended to lower-risk populations.

REFERENCE:

Wang Y, Wei L, Liu L, Shi J, Wang W, Cao T, et al. A multicenter prospective clinical study on transcatheter aortic valve implantation for aortic stenosis or pure aortic regurgitation: 5-year outcomes. J Thorac Cardiovasc Surg. 2025 Nov;170(5):1379-1391.e3. doi: 10.1016/j.jtcvs.2025.03.036.