Electrosurgical Leaflet Modification to Prevent Coronary Obstruction During Transcatheter Aortic Valve Replacement in Failing Native and Bioprosthetic Valves.

ABSTRACT:

Background

In patients with high-risk anatomy, transcatheter aortic valve replacement (TAVR) risks coronary obstruction which is associated with high morbidity and mortality. Bioprosthetic or native aortic scallop intentional laceration to prevent iatrogenic coronary artery obstruction (BASILICA) is effective at preventing coronary obstruction.

Objectives

The authors sought to test the safety and effectiveness of TELLTALE (Transmural Electrosurgery LeafLet Traversal And Laceration Equipment), the first dedicated transcatheter electrosurgery leaflet modification system.

Methods

The TELLTALE trial (NCT05666713) enrolled participants with high or prohibitive surgical risk undergoing TAVR for native aortic stenosis or bioprosthetic valve failure and in whom computed tomography core laboratory confirmed high risk of coronary obstruction. The primary efficacy endpoint was technical success in the catheterization lab and the primary safety endpoint was inpatient safety.

Results

A total of ninety participants (age 79 [75-82] years, 66% [59/90] female, 30 native aortic stenosis, 60 bioprosthetic valve failure) were enrolled at 11 centers in the United States. High risk of coronary obstruction was confirmed by computed tomography (coronary height 8.2 [6.3-10.8] mm, valve-to-coronary distance 3.4 [2.7-3.7] mm, valve-to-sinotubular-junction distance 1.2 [0.7-1.7] mm). Leaflet modification was easy and reliable with median 1 traversal and laceration attempt per participant. The primary efficacy endpoint was met in 100% (95% CI: 95%-100%) of participants. The primary safety endpoint was met in 96% (95% CI: 88%-99%) of participants, including zero mortality, 3 strokes (1 disabling, 2 nondisabling), and 1 coronary obstruction from transcatheter heart valve commissural suture pos-malalignment. At 30 days, there was zero mortality and zero delayed coronary obstruction.

Conclusions

Electrosurgical leaflet modification using the TELLTALE system is safe and effective in patients undergoing TAVR for native aortic stenosis or bioprosthetic valve failure at high risk of coronary obstruction.

SUBMITTER: Rogers T 

PROVIDER: S-EPMC12914756 | biostudies-literature | 2025 Oct

REPOSITORIES: biostudies-literature