2.2 Lifelong TAVR Management and How to Deal with Leaflet Degeneration

These proceedings summarize the educational activity of the 17th Biennial Meeting of the International Andreas Gruentzig Society held January 30 to February 2, 2024 in Chiang Rai, Thailand.

Faculty Disclosures     Vendor Acknowledgments

2024 IAGS Summary Document

Statement of the problem or issue

Last year there were over 100,000 TAVR procedures performed worldwide, and there are presently approximately one million patients living with TAVR valves. Procedures are now being performed in younger and lower-risk patients, and therefore lifelong management of these patients must be considered. Leaflet degeneration of implanted TAVR valves will necessitate increasing numbers of TAV-in-TAV procedures in the future. One of the most important considerations with TAV-in-TAV is prevention of coronary artery obstruction. Some of the mechanisms of coronary obstruction after TAV-in-TAV include: (1) Direct coronary obstruction; (2) Sequestered coronary sinus; (3) Skirt or strut interference; (4) Commissural misalignment. (See Figure 1). It is estimated that 10%-25% of TAVR patients might not be candidates for TAV-in-TAV due to high risk for coronary obstruction. Factors that influence risk for obstruction include: (1) Anatomic (coronary height, sinus of Valsalva diameter, sinotubular junction height and diameter); (2) index procedural factors (index valve design, implant depth, commissural alignment); (3) TAV-in-TAV factors (valve choice, possibility for expansion of index valve, depth of TAV-in-TAV implant). Valve design and leaflet modification techniques are the primary approaches to dealing with potential coronary obstruction. Novel valve designs may help obviate coronary obstruction, but implantation technique and valve positioning may still put the coronaries at risk.

Figure 1. Valve features and risk of coronary obstruction with TAV-in-TAV. From: JACC Cardiovasc Interv. 2022;15:1777–1793.

Gaps in current knowledge

Almost everything about TAV-in-TAV is a knowledge gap area.

1. What percentage of TAVR patients will not be candidates for TAV-in-TAV? Only several small studies have explored this.

2. What is the risk of TAVR explant for structural valve deterioration? Current studies include many patients with endocarditis as well as high surgical risk patients which may skew outcomes.

3. In which patients will balloon-assisted BASILICA be feasible to prevent coronary occlusion or sinus sequestration? Can dedicated devices improve procedural efficiency and success?

4. Is leaflet excision a pipe dream? With evolution of technology will leaflet excision become the dominant form of leaflet modification? What is the stroke risk? 

Possible solutions and future directions

Preventing or mitigating coronary obstruction is the most important objective. Some options for accomplishing this are outlined in Table 1.

Table 1. Options to mitigate risk of coronary obstruction in TAV-in-TAV.

• Assessment at the index procedure whether TAV-in-TAV is likely in the patient’s future. If not, then should SAVR be the first intervention, especially in young, low-risk patients?
• Careful implantation technique to increase likelihood of future TAV-in-TAV success (e.g. commissural alignment; lower rather than higher implant position)
• Don’t perform TAV-in-TAV
  • Consider medications (no intervention)
  • Consider TAVR explant and SAVR
• Snorkel stenting not an option (interaction with valve stent frame – crushing of stent between valve frames)
• BASILICA (bioprosthetic or native aortic scallop intentional laceration to prevent iatrogenic coronary artery obstruction – Figure 2)
  • Traditional BASILICA yields minimal splay since leaflets are constrained by TAVR valve frame
  • Balloon-assisted (BA-)BASILICA provides greater splay and therefore increased coronary perfusion. (>20% more in bench-top models).
  • Dedicated leaflet laceration devices may streamline procedure
  • Commissural misalignment may preclude BA-BASILICA
• Leaflet excision
  • CATHEDRAL – transcatheter leaflet removal using electrified wire (Figure 3).
  • SURPLUS – surgical leaflet removal with concomitant TAVR.

Figure 2. Balloon-assisted BASILICA for leaflet modification. From: JACC Cardiovasc Interv. 2021;14(5):578–580 and Circ Cardiovasc Interv. 2021;14(11):e011028.

Figure 3. The CATHEDRAL procedure for leaflet excision. From: JACC Cardiovasc Interv. 2022;15(16):1678-1680.

References

1. Tarantini, G, Sathananthan, J, Fabris, T. et al. Transcatheter aortic valve replacement in failed transcatheter bioprosthetic valves JACC Cardiovasc Interv. 2022;15(18):1777–1793. doi 10.1016/j.jcin.2022.07.035
2. Greenbaum, A, Kamioka, N, Vavalle, J. et al. Balloon-assisted BASILICA to facilitate redo TAVR. JACC Cardiovasc Interv. 2021;14(5):578–580. doi.10.1016/j.jcin.2020.10.056
3. Perdoncin E, Bruce CG, Babaliaros VC, et al. Balloon-augmented leaflet modification with bioprosthetic or native aortic scallop intentional laceration to prevent iatrogenic coronary artery obstruction and laceration of the anterior mitral leaflet to prevent outflow obstruction: benchtop validation and first in-man experience. Circ Cardiovasc Interv. 2021;14(11):e011028. doi: 10.1161/CIRCINTERVENTIONS.121.011028 PMID: 34674556
4. Babaliaros VC, Gleason PT, Xie JX, et al. Toward transcatheter leaflet removal with the CATHEDRAL procedure: CATHeter Electrosurgical Debulking and RemovAL. JACC Cardiovasc Interv. 2022;15(16):1678-1680. doi: 10.1016/j.jcin.2022.05.038 PMID: 35981843