Outcomes of transcatheter aortic valve replacement for pure native aortic regurgitation with the use of newer- vs. early-generation devices

Abstract

Background: Accumulated experience and advances in device technology have led to the increasing off-label use of transcatheter aortic valve replacement (TAVR) for pure native aortic valve regurgitation (PNAR). This study aimed to evaluate the procedural and long-term outcomes of using newer-generation transcatheter heart valves (THVs) versus early-generation self-expanding CoreValve (Medtronic, Minneapolis, USA) to treat PNAR. Methods: TAVRs were performed with the use of early-(N=15) and newer-generation (N=10) THVs in a total of 25 consecutive PNAR patients at an intermediate-to-high risk for surgical aortic valve replacement [mean Society of Thoracic Surgeons (STS) score of 6.8±4.5]. Procedural and clinical outcomes were reported according to the Valve Academic Research Consortium 2 criteria. The primary end-point of the study was all-cause mortality, myocardial infarction (MI), disabling stroke, and readmission due to heart failure. Results:The device success rate of the newer-generation THVs was significantly higher than that of the early-generation CoreValve (100% vs. 33%, P<0.01), which was mainly driven by less frequent need for implanting a second THV (0% vs. 53%, P<0.01). Although the procedural success rates were 100% for both early-and newer-generation valves, the mean procedure fluoroscopic times which the newer-generation device group required, were significantly shorter (P<0.01) and the amount of contrast medium used in this group, markedly smaller (P<0.01), compared to those of the early-generation CoreValve group. During a median follow-up of 14 months, event-free survival was better in patients undergoing TAVR with the newer-generation THVs, although the differences were not statistically significant (log-rank test, P=0.137).According to multivariate analysis, a higher baseline STS score and longer intensive care unit stays are independent predictors of adverse outcomes.Conclusions: Evidently, the treatment of PNAR with TAVR using the newer-generation THVs yielded better procedural outcomes and is a valuable therapeutic option in selective patients.

Anatomic predictor of severe prosthesis malposition following transcatheter aortic valve replacement with self- expandable Venus-A Valve among pure aortic regurgitation: A multicenter retrospective study

“…In the current study, 95.0% (19/20) of severe prosthesis malpositions were toward the ventricular direction, and there was only one case of valve embolization toward the ascending aortic aorta. Consistent with our findings, Yin et al ( 6 ) reported that the malposition rate of the CoreValve device in patients with pure NAVR was 62%, all of which were caused by too-low implantation. In another study involving Chinese patients with aortic stenosis who underwent TAVR with Venus-A Valve, all valve malpositions were toward the ventricular direction ( 9 ), which may be partly explained by greater radial force at the bottom section of the Venus A-valve that could enhance the downward pushing force during delivering the prosthesis ( 16 ).…”

“…In another study involving Chinese patients with aortic stenosis who underwent TAVR with Venus-A Valve, all valve malpositions were toward the ventricular direction ( 9 ), which may be partly explained by greater radial force at the bottom section of the Venus A-valve that could enhance the downward pushing force during delivering the prosthesis ( 16 ). Another possible reason is that the operator deliberately selected a somewhat deeper position to avoid prosthesis embolization to the aorta ( 6 ). Nevertheless, in a patient with the upward valve migration, the AA and STJ were quite slender, and the strong interaction between the prosthesis crown and STJ/AA was deemed to generate the upward force, which ultimately led to upward skipping of the prosthesis valve.…”

“…It is generally believed that suitable candidates should not have too large an annulus. Also, at least a 15–20% device oversize ratio is recommended ( 6 , 11 , 17 ). In the present study, the mean diameter of the annulus was 24.6 mm and the oversize ratio was 17.4%, which certainly represented a “selected” patient population.…”

“…In a previous study, the incidence of device malposition has been reported to amount to 33.0% using early-generation devices ( 2 ). Furthermore, the incidence of residual AR and the need for implanting a second valve (valve-in-valve procedures) were found to remain high in the NAVR population who received TAVR ( 6 , 7 ). Several devices have shown favorable results in NAVR, such as JenaValve THV (JenaValve Technology, Inc., Irvine, CA, USA) and Acurate neo (Boston Scientific, Marlborough MA, USA), while none of which were approved for use in Mainland China.…”

Transcatheter Aortic Valve Implantation for Pure Native Aortic Regurgitation: The Last Frontier

“…Most recently, Yin WH et al also showed a higher success rate (100% vs. 33%; p < 0.01), a less frequent need for a second THV implanting (0% vs. 53%; p < 0.01), and a better event-free survival for newer- compared with early-generation devices [ 30 ].…”