Leaflet Modification for Redo-TAVR

Q: What is the clinical evidence from this study?

Population: Redo-TAVR. Intervention: Leaflet modification (BASILICA, BA-BASILICA, balloon laceration). Primary outcome: Splay area, functional splay area, and variability in splay geometry across repeated deployments.

David Meier; Lucca Loretz; Edward Quine; A.M. Kane; David Elison; Brooke MacLeod; Colin Jamieson; Sheryl Munshan; Andrew Chatfield; Thomas Puehler; Nina Pommert; Gilbert H.L. Tang; Vasilis Babaliaros; Alessandro Beneduce; Arif A. Khokhar; James M. McCabe; John G. Webb; Ole De Backer; David A. Wood; Shinichi Fukuhara; Jaffar M. Khan; Stephanie L. Sellers

doi:10.1016/j.jcin.2026.04.012

Key result

Leaflet splay after redo-TAVR modification varies widely based on THV type, constraint, and laceration pattern.

Why the study?

Factors impacting the efficacy of leaflet modification techniques in redo transcatheter aortic valve replacement are poorly understood.

What factors impact the efficacy of leaflet modification techniques in redo-TAVR?

Key Points

To investigate how annular constraint, valve sizing, hemodynamic flow, and leaflet degeneration affect the efficacy of leaflet modification techniques during redo transcatheter aortic valve replacement.
Evaluated BASILICA, balloon-assisted BASILICA (BA-BASILICA), and balloon laceration in naive and degenerated transcatheter heart valves (SAPIEN, Evolut, ACURATE, and Navitor).
Modeled experimental conditions including annular constraint, pulsatile versus continuous flow during deployment, laceration geometry, second-valve oversizing, and leaflet pathology (fibrosis and calcification).
Measured splay area, functional splay area, and geometric splay variability across repeated valve deployments.
BASILICA created leaflet splay in unconstrained SAPIEN, Evolut, and ACURATE valves but not Navitor, while BA-BASILICA improved splay for ACURATE and Evolut valves.
Annular constraint reduced leaflet splay across all valve types (with the greatest reduction in Evolut valves), whereas oversizing the second valve increased splay area, and dynamic flow introduced deployment variability.
Leaflet fibrosis reduced functional splay area, severe calcification caused irregular lacerations and diminished splay, and balloon laceration produced erratic results ranging from total clearance to obstruction.

Structured PICO

What factors impact the efficacy of leaflet modification techniques in redo-TAVR?

P

Population

In vitro study evaluating naive and degenerated transcatheter heart valves to assess leaflet modification techniques for redo-TAVR.

I

Intervention

Leaflet modification techniques (BASILICA, balloon-assisted BASILICA, and balloon laceration) under varying conditions of annular constraint, flow, laceration pattern, redo-TAVR oversizing, and leaflet degeneration

C

Comparator

Comparison across different THV types, constraint levels, flow conditions, laceration patterns, and degrees of valve degeneration

O

Outcome

Splay area, functional splay area, and variability in splay geometry across repeated deploymentssurrogate

Implication

Leaflet splay after modification for redo-TAVR is highly variable and depends on THV type, constraint, laceration pattern, and index valve degeneration, highlighting the need for patient-specific planning.

Abstract

BACKGROUND: Leaflet modification (LM) techniques are of interest in redo transcatheter aortic valve replacement (TAVR). However, factors impacting the efficacy of LM are poorly understood. OBJECTIVES: The aim of this study was to investigate the effects of valve constraint, redo-TAVR sizing, flow, and valve pathology on LM efficacy. METHODS: Naive and degenerated transcatheter heart valves (THVs) were used to evaluate BASILICA (bioprosthetic or native aortic scallop intentional laceration to prevent iatrogenic coronary artery obstruction), balloon-assisted BASILICA (BA-BASILICA), and balloon laceration. Conditions included: 1) degree of annular constraint of the index THV (modeled using different annular sizes); 2) flow conditions during deployment of the second THV (pulsatile vs continuous flow in a simulated deployment system); 3) leaflet modification pattern; 4) degree of oversizing of the second THV; and 5) extent and type of leaflet degeneration in the index THV. Quantitative outcomes included splay area, functional splay area, and variability in splay geometry across repeated deployments. RESULTS: When unconstrained, BASILICA created a splay in SAPIEN, Evolut, and ACURATE valves but not in Navitor valves, with BA-BASILICA improving splay for ACURATE and Evolut valves. Annular constraint at the minimum diameter per the THV instructions for use reduced splay in all THVs, with the greatest effect in Evolut valves. Nonbasal and angled leaflet splits impacted leaflet splay. Simulated redo-TAVR under flow conditions caused variability of leaflet splay for all THVs. Balloon laceration resulted in highly variable splay patterns ranging from complete clearance to obstruction. Oversizing of the second THV resulted in larger splay areas. Leaflet fibrosis diminished functional splay area. Increasing calcification resulted in irregular cuts and decreased splay. CONCLUSIONS: Leaflet splay following LM for redo-TAVR is highly dependent on THV type and constraint, implantation of the second THV, laceration pattern, and the nature of index THV degeneration.

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Cite This Study

Meier et al. (2026) studied Redo-TAVR. Leaflet modification (BASILICA, BA-BASILICA, balloon laceration) was evaluated on Splay area, functional splay area, and variability in splay geometry across repeated deployments. Leaflet splay following leaflet modification for redo-TAVR is highly dependent on THV type and constraint, implantation of the second THV, laceration pattern, and index THV degeneration.

synapsesocial.com/papers/6a2902dc6f82f25be989de8a https://doi.org/10.1016/j.jcin.2026.04.012

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Leaflet Modification for Redo-TAVR

Key Points

Structured PICO

Implication

Abstract

Discussion

Cite This Study

Leaflet Modification for Redo-TAVR

Key Points

Structured PICO

Implication

Abstract

Discussion

Cite This Study

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