October 1, 2025КАРДИОЛОГИЯ УЗБЕКИСТАНА20 citationsOpen Access
View Full PaperElectrosurgical Leaflet Modification to Prevent Coronary Obstruction During Transcatheter Aortic Valve Replacement in Failing Native and Bioprosthetic Valves
Key Result
Electrosurgical leaflet modification using the TELLTALE system achieved 100% technical success (95% CI: 95-100%) and 96% inpatient safety (95% CI: 88-99%) during TAVR.
Structured PICO
Does electrosurgical leaflet modification using the TELLTALE system improve technical success and safety in high-risk patients undergoing TAVR?
P
Population
90 high-risk patients (median age 79, 66% female) undergoing TAVR for native aortic stenosis or bioprosthetic valve failure with high risk of coronary obstruction, followed for 30 days.
I
Intervention
Electrosurgical leaflet modification using the TELLTALE (Transmural Electrosurgery LeafLet Traversal And Laceration Equipment) system during transcatheter aortic valve replacement (TAVR)
O
Outcome
Technical success in the catheterization lab (primary efficacy endpoint) and inpatient safety (primary safety endpoint)safety
The TELLTALE dedicated transcatheter electrosurgery leaflet modification system is safe and highly effective at preventing coronary obstruction during TAVR in patients with high-risk anatomy.
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.