Transcatheter Aortic Valve Replacement With the Latest-Iteration Self-Expanding or Balloon-Expandable Valves: The...

Area of Science:

• Cardiovascular Medicine
• Interventional Cardiology
• Medical Devices

Background:

• Advancements in transcatheter aortic valve replacement (TAVR) devices aim to enhance patient outcomes.
• The study focuses on recent iterations of self-expanding (SE) and balloon-expandable (BE) TAVR systems.

Purpose of the Study:

• To compare the early clinical outcomes of TAVR using the Evolut PRO/PRO+ (SE) and Sapien 3 ULTRA (BE) devices.
• To evaluate device success and early safety endpoints in a real-world setting.

Main Methods:

• The OPERA-TAVI registry collected data from 14 high-volume centers globally.
• Propensity score matching (1:1) was used to compare 683 pairs of patients who received either SE or BE TAVR devices.
• Primary endpoints included Valve Academic Research Consortium-3 (VARC-3) device success and early safety.

Main Results:

• No significant difference in VARC-3 device success was observed between SE and BE TAVR groups (87.4% vs. 85.9%, P=0.47).
• The BE device demonstrated a significantly higher rate of early safety compared to the SE device (82.6% vs. 69.1%, P<0.01).
• Higher rates of permanent pacemaker implantation (17.9% vs. 10.1%, P<0.01) and disabling stroke (2.3% vs. 0.7%, P=0.03) were noted in the SE group.

Conclusions:

• Both SE and BE TAVR devices achieve comparable device success rates.
• The Sapien 3 ULTRA (BE) device exhibited superior early safety outcomes compared to the Evolut PRO/PRO+ (SE) device in this registry.
• The composite early safety endpoint was primarily influenced by higher rates of permanent pacemaker implantation and disabling stroke associated with the SE device.