What does this research mean for the field?

Commissural alignment significantly improves coronary access feasibility following TAVR with supra-annular transcatheter heart valves, although misaligned valves and aligned supra-annular valves still carry higher risk of unfeasible or nonselective access compared with SAPIEN 3. Novelty: ClaimNovelty.NOVEL_FINDING. Consensus alignment: ConsensusAlignment.NEUTRAL.

What question did this study set out to answer?

To investigate how commissural alignment impacts the feasibility and selectivity of coronary access following transcatheter aortic valve replacement across different valve designs.

February 1, 2022Circulation Cardiovascular InterventionsOpen Access

Coronary Access After Transcatheter Aortic Valve Replacement With Commissural Alignment: The ALIGN-ACCESS Study

Q: What are the key findings of this study?

Implantation of a misaligned supra-annular THV was an independent predictor of unfeasible or nonselective coronary access after TAVR (OR 4.59; 95% CI 1.81-11.61; P<0.01).

Q: What is the clinical evidence from this study?

Study design: Observational. Population: Patients undergoing transcatheter aortic valve replacement (TAVR) (n=206). Intervention: Misaligned supra-annular THV vs. Aligned supra-annular THV or SAPIEN 3 THV. Primary outcome: Rate of unfeasible and nonselective coronary access after TAVR (OR 4.59, 95% CI 1.81-11.61, p=<0.01).

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Key result

Misaligned supra-annular THVs predict ~359% higher odds of unfeasible or nonselective coronary access post-TAVR.

OR 4.59
95% CI 1.81-11.61
P<0.01
n=206

Why the study?

Coronary access after TAVR with supra-annular transcatheter heart valves can be challenging, leading investigators to evaluate the impact of commissural alignment on coronary access feasibility.

Does commissural alignment improve the feasibility of selective coronary access in patients undergoing TAVR with supra-annular THVs?

Population

206 patients undergoing coronary angiography after TAVR

Comparison

Intra-annular SAPIEN 3 vs supra-annular Evolut R/Pro vs Acurate Neo THVs

Design

Observational study

Discussion

Member takes

Implication

Misaligned supra-annular THV implantation may hinder post-TAVR coronary access; hypothesis-generating and requires prospective confirmation before practice change.

Key Points

To investigate how commissural alignment impacts the feasibility and selectivity of coronary access following transcatheter aortic valve replacement across different valve designs.
Assessed coronary angiography following transcatheter aortic valve replacement in 206 patients receiving intra-annular SAPIEN 3, supra-annular Evolut R/Pro (with alignment attempted), or Acurate Neo valves (assessed retrospectively in 36 and prospectively attempted in 26).
Evaluated primary endpoints of unfeasible and nonselective coronary cannulation across aligned and misaligned valve cohorts.
Selective coronary access occurred in 95% of SAPIEN 3, 71% of aligned supra-annular, and 46% of misaligned supra-annular valves (P < 0.001).
Coronary cannulation was unfeasible in 11% of misaligned supra-annular, 3% of aligned supra-annular, and 0% of SAPIEN 3 valves.
Independent predictors of unfeasible or nonselective access included misaligned supra-annular valve placement (OR: 4.59, 95% CI: 1.81–11.61; P < 0.01), sinus of Valsalva height (OR: 0.83, 95% CI: 0.70–0.98; P = 0.03), and valve-to-sinus relation (OR: 1.06, 95% CI: 1.02–1.10; P < 0.01).

Study Design

Type

Observational (n=206)

Structured PICO

Does commissural alignment improve the feasibility of selective coronary access in patients undergoing TAVR with supra-annular THVs?

Population

206 patients undergoing TAVR with intra-annular SAPIEN 3, supra-annular Evolut R/Pro, or Acurate Neo THVs.

Exposure

TAVR with supra-annular THVs (Evolut R/Pro, Acurate Neo) with intentional commissural alignment.

Comparator

TAVR with misaligned supra-annular THVs or intra-annular SAPIEN 3 THVs.

Outcome

Rate of unfeasible and nonselective coronary access after TAVR.surrogate

Main Result

Odds Ratio: 4.59 (95% CI 1.81–11.61)

p-value: p=<0.01

Commissural alignment improves the feasibility of selective coronary access after TAVR with supra-annular valves, although intra-annular valves still provide the highest access success rates.

Cite This Study

A 2022 study conducted an observational in Patients undergoing transcatheter aortic valve replacement (TAVR) (n=206). Misaligned supra-annular THV vs. Aligned supra-annular THV or SAPIEN 3 THV was evaluated on Rate of unfeasible and nonselective coronary access after TAVR (OR 4.59, 95% CI 1.81-11.61, p=<0.01). Implantation of a misaligned supra-annular THV was an independent predictor of unfeasible or nonselective coronary access after TAVR (OR 4.59; 95% CI 1.81-11.61; P<0.01).

synapsesocial.com/papers/6aaa02c1f8c08cbefbf6b589 https://doi.org/10.1161/circinterventions.121.011045

Topics

Transcatheter aortic valve replacement TAVR in low-risk patients

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Implication

Misaligned supra-annular THV implantation may hinder post-TAVR coronary access; hypothesis-generating and requires prospective confirmation before practice change.

Coronary Access After Transcatheter Aortic Valve Replacement With Commissural Alignment: The ALIGN-ACCESS Study

Discussion

Member takes

Implication

Key Points

Study Design

Structured PICO

Main Result

Cite This Study

Topics

Coronary Access After Transcatheter Aortic Valve Replacement With Commissural Alignment: The ALIGN-ACCESS Study

Discussion

Member takes

Implication

Key Points

Study Design

Structured PICO

Main Result

Cite This Study

Also Consider

Topics

Also Consider