New data from the first large consecutive evaluation of commissural alignment using a novel technique across all patients receiving an ACURATE Neo2 transcatheter aortic valve replacement (TAVR) device show that alignment was achieved in nearly all patients without safety concerns or impact to procedure duration.

The study, published online Monday and in the March 27 issue of the JACC: Cardiovascular Interventions, presents data from an evaluation of a “using a simple and quick dedicated alignment technique” for the ACURATE neo2 device – reporting that alignment was achieved in 97% of patients.

Led by Christopher U. Meduri, MD, MPH, from the Karolinska University Hospital, Stockholm, the team noted that with the field of TAVR progressing to younger and lower-risk patients, there is an increasing focus on the need for lifetime management and optimization of these valves – adding that commissural alignment has become an important topic in TAVR, because it may improve coronary access, facilitate future valve procedures and possibly improve valve durability.

“TAVR patients may need future coronary artery access for treatment of coronary artery disease and may require multiple valves over the course of their lives, noted the team.

“Commissural alignment during transcatheter heart valve (THV) implantation may allow easier coronary access. Additionally, optimized valve-in-valve procedures may depend on commissural alignment to allow potential leaflet modification procedures.”

Study details

The authors sought to determine the feasibility and success of attempting commissural alignment in an unselected TAVR population treated with the ACURATE neo2 device – a self-expanding bioprosthetic aortic valve comprising a nitinol frame with axial, self-aligning stabilization arches, supra-annular porcine pericardium leaflets and a sealing skirt to reduce paravalvular leak.

A total of 170 consecutive patients underwent TAVR with a dedicated implantation technique to align the TAVR valve to the native valve. Using right-left overlap and three-cusp views, valve orientation was adjusted by rotation of the unexpanded valve at the level of the aortic root.

Effectiveness was assessed post-procedure as the degree of misalignment determined by analyzing fluoroscopic valve orientation to corresponding cusp orientation on preprocedural computed tomography, while safety endpoints included mortality, stroke/transient ischemic attack and additional complications through 30 days.

The mean age of enrolled patients was 80 years old, and the majority (55%) were female. All valves were implanted transfemorally, while 44% were implanted with a large valve.

Of 170 patients, 167 (98.2%) could be analyzed for alignment, and all 170 for safety outcomes, said Meduri and colleagues, noting that most patients (97%) had successful alignment (classed as ≤mild misalignment), with 80% with commissural alignment – while the degrees of misalignment were 17% mild, 1.2% moderate, 1.8% severe.

“This is the first large-scale, consecutively enrolled investigation of a dedicated commissural alignment technique in a real-world all-comers TAVR population,” said Meduri and colleagues, adding that the study demonstrated “the applicability of a dedicated alignment technique across all patients that leads to highly accurate commissural alignment.”

Furthermore, they noted that the novel technique was not time intensive, taking a total of approximately 120 seconds, and that the additional steps required “do not lead to high complication or adverse event rates in this cohort of patients.”

Novel technique

Writing in an accompanying editorial, Hemal Gada, MD, Mahmoud Salem, MD, and Amit N. Vora, MD, MPH, from the University of Pittsburgh Medical Center, Harrisburg, Pennsylvania, noted that over the last decades, TAVR has progressed to become the established treatment for symptomatic severe aortic stenosis across surgical risk strata.

“With TAVR use expanding to younger and less comorbid patients with a longer life expectancy, there has been heightened attention toward lifetime management of these patients and optimizing implantation to facilitate subsequent coronary angiography, percutaneous coronary intervention, and valve-in-valve procedures,” they said.

The editorialists noted that preprocedural computed tomography (CT) was used to identify the optimum fluoroscopic angles for three-cusp and right-left overlap views for every patient before commissural alignment was attempted using a standardized technique in which the THV was inserted through in all patients with the flush port positioned toward 6 o’clock relative to the delivery catheter (i.e., flush port down).

The positioning of the unexpanded valve was adjusted in two views (right-left overlap and three-cusp views) based on the orientation of the stent posts and the visible wings, before the delivery catheter was rotated based on the orientation of the stent posts to achieve proper positioning, they said.

“The investigators should be congratulated for demonstrating the utility of a technique that leverages design elements of the ACURATE Neo THV while also utilizing common fluoroscopic views to obtain an optimal result with this platform,” they said, noting that the technique depended on isolating one of the posts and one of the free stent struts to the right of the screen and that should result in THV implantation with neocommissural alignment.

Sources:

Meduri CU, Rück A, Linder R, et al. Commissural Alignment With ACURATE neo2 Valve in an Unselected Population. JACC Cardiovasc Interv 2023;16:670-677.

Gada H, Salem M, Vora AN. Commissural Alignment During TAVR: Flush Ports and Goal Posts. JACC Cardiovasc Interv 2023;16:678-680.

Image Credit: Boston Scientific