TRANSCATHETER VALVE-IN-VALVE FROM PROCEDURE TIPS TO CURRENT EVIDENCE - NICOLAS M. VAN MIEGHEM, MD, PHD, FACC, FESC PROFESSOR & DIRECTOR OF ...

Transcatheter Valve-in-Valve
From Procedure Tips to Current Evidence
Nicolas M. Van Mieghem, MD, PhD, FACC, FESC
Professor & Director of Interventional Cardiology
Thoraxcenter, Erasmus University Medical Center
Rotterdam, the Netherlands

Conflict of Interest

➢Research Grant Support: Abbott, Boston Scientific, Edwards

Lifesciences, Medtronic, PulseCath, Daiichi Sankyo , Teleflex,

Abiomed

TAVI vs. redo SAVR for failed bioprosthesis

             Hirji et al. EHJ 2020;41:2747-55

TAV in Stented vs. Stentless Bioprosthesis

VIVID Registry
N = 1598 ViV TAVI
291 Stentless & 1307 stented bioprostheses
STS > 9%
1st Gen THV’s

                       Stentless        Stented

Device malposition       10.3              6.2

2nd THV                  7.9               3.4

Coronary obstruction      6                1.5

> Mild PVL                11               4.5

New pacemaker            5.7               6.8

                                    Duncan et al. JACC CVI 2019;12:1256-63

Example of TAVI in Stentless Bioprosthesis (Freestyle)

EVOLUT in Failed Bioprosthesis – VIVA Regsitry

Post market Registry
23 centers
France, Italy, Israel, Germany
Mean age 80 years
STS 6.6%
Repositioning feature applied in 17%

                                    Tchetche et al. JACC CVI 2019;12:923-32

EVOLUT in Failed Bioprosthesis – VIVA Registry

             Tchetche et al. JACC CVI 2019;12:923-32

PARTNER II Valve-in-Valve Registry

                                                                      Severe PPM 58%!
o N = 365 ViV TAVI
o 79 years, STS 9.1%
o Bioprosthesis age > 10 years in 2/3
o Stented 92%
o Labeled size ≼ 21mm in 27% of cases
o 23mm Sapien XT in 69%
o Cave: no BVF

                                   Webb et al. JACC 2017;69:2253-62

BASELINE Trial

➢ Investigator driven initiative
     o   Canada                                     Failing Surgical Aortic Bioprosthesis
     o   Germany
     o   Italy
                                                      Pre-stratification
     o   Netherlands                                               ➢ Bioprosthesis labelled size
                                                                   ➢ Externally mounted design
     o   Portugal
     o   Spain
                                                                     1:1
     o   UK                                                      Randomization
     o   USA
➢ Corelab
     o   TTE                                           Primary Endpoint @ 30 days: Device success
     o   MSCT                Safety Endpoint @ 1 year: all-cause death, disabling stroke, rehospitalization for heart failure or
     o   Angiography                                               valve related problems

Prosthesis Patient Mismatch/residual aortic gradient – Bioprosthetic Valve Fracture

Bioprosthetic Valve Fracture - Rule of Thumb

1. Know which bioprosthesis is eligible
2. Non-compliant balloon
    ✓ True
    ✓ Atlas
3. Size: True ID + 3 mm (use MSCT) or Bioprosthesis labelled size + 1mm
4. Caveat
    ✓ Small SOV/LVOT/Root
    ✓ Low coronary take-off
5. May want to avoid constraint area with Evolut
6. Before or after TAV-in-failed bioprosthesis
7. Consider cerebral embolic protection

                  Images: Saxon et al. Interventional Cardiology Review 2018;13(1):20–6.

Bioprosthesis Valve Fracture

  Fracture-able                           Remodeling                              No option

o Biocor/Epic (-Supra)               o Carpentier Edwards                         o Avalus
o Dokimos                            o Perimount 2700                             o Hancock II
o Lacor Porcine                      o Inspiris
o Magna 3000                         o Trifecta
o Magna Ease 33000                   o Perimount
o Mitroflow                          (older generation/no perforated ribbon)

o Medtronic Mosaic
o Perimount 2700

                               Chhatriwalla et al. Circ CVI 2018;13:751-61
                         Allen et al. J Thorac Cardiovasc Surg 2019;158:1317-28

Coronary Obstruction – BASILICA & Chimney Technique

Coronary obstruction Risk Factors

    Jabour et al. J Am Coll Cardiol 2018;71:1513-24

Coronary obstruction after TAV in Failing Bioprosthesis

o VIVID Registry, 135 centers
o N = 1612 ViV TAVI
o 37 Coronary obstructions
   ➢ STEMI in 2/3
   ➢ 53% 30-day mortality
o Predictors
   ➢ Valve to Coronary Distance
       ✓ < 4mm
       ✓ OR 0.22 per mm increase

   ➢ Small SOV
   ➢ Bioprosthesis type

                                   Ribeiro et al. EHJ 2018;39:687-95

Externally mounted Leaflets

✓ Mitroflow                            ✓ Trifecta

                               Perimount

BASILICA

Khan et al. J Am Coll Cardiol Intv 2018;11:677–89

Chimney Stent Technique

  Mercanti et al. JACC CVI 2019;13:751-61

VTC distance LM 4.3 mm   VTC distance RCA 3.7 mm

Redo TAVI in THV Failure

                   68 ⇐︎ days post index ⇒ 5 years

   Landes et al. JACC 2020;75:1882-93

Redo TAVI in THV Failure

   Landes et al. JACC 2020;75:1882-93

TAV in Failed THV

o   82 y/o male
o   Hemodialysis
o   Peripheral artery disease
o   STS 9
o   TAVI SAPIEN3 29 3 years prior

TAV in Failed THV

In conclusion

➢Treatment of failing surgical/transcatheter bioprosthesis requires planning

    o   Root dimensions incl. SOV

    o   Risk for coronary obstruction

    o   Bioprosthesis type & size

➢TAV in failed surgical bioprosthesis is lower-risk procedure than redo SAVR

➢Bioprosthesis Valve Fracture & Coronary obstruction prevention are important considerations

➢Scientific comparison and clinical relevance of THV performance differences are unknown

➢Randomized BASELINE Trial is expected to start enrollment Q2 2021