Bioprosthetic Valve Fracture: In-Depth Techniques and ... · Implant Aiming for High Implant....
Transcript of Bioprosthetic Valve Fracture: In-Depth Techniques and ... · Implant Aiming for High Implant....
![Page 1: Bioprosthetic Valve Fracture: In-Depth Techniques and ... · Implant Aiming for High Implant. Post-TAVR and Post-Dilation Mean gradient = 44 mmHg AVA 1.0 cm2 . In-Lab Conversation](https://reader033.fdocuments.net/reader033/viewer/2022060609/6060541a90f73757581bc50f/html5/thumbnails/1.jpg)
Bioprosthetic Valve Fracture:
In-Depth Techniques and
Updated Data
David J. Cohen, M.D., M.Sc.
Director of Cardiovascular ResearchSaint Luke’s Mid America Heart Institute
Professor of MedicineUniversity of Missouri-Kansas City
AP Valves 2018- 10 mins
![Page 2: Bioprosthetic Valve Fracture: In-Depth Techniques and ... · Implant Aiming for High Implant. Post-TAVR and Post-Dilation Mean gradient = 44 mmHg AVA 1.0 cm2 . In-Lab Conversation](https://reader033.fdocuments.net/reader033/viewer/2022060609/6060541a90f73757581bc50f/html5/thumbnails/2.jpg)
Disclosures
Grant Support/Drugs
– Daiichi-Sankyo - Merck
– Astra-Zeneca
Grant Support/Devices
– Edwards Lifesciences - Abbott Vascular
– Medtronic - Boston Scientific
– CSI - Corvia
Consulting/Advisory Boards
– Medtronic - Amgen
– Edwards Lifesciences
DJC: 8/18
![Page 3: Bioprosthetic Valve Fracture: In-Depth Techniques and ... · Implant Aiming for High Implant. Post-TAVR and Post-Dilation Mean gradient = 44 mmHg AVA 1.0 cm2 . In-Lab Conversation](https://reader033.fdocuments.net/reader033/viewer/2022060609/6060541a90f73757581bc50f/html5/thumbnails/3.jpg)
➢ VIV TAVR is an effective
alternative to redo surgery in
high or intermediate risk
patients with failing tissue
valves.
➢ However, VIV TAVR can be
problematic with small
surgical bioprostheses
because of further reduction
in the effective orifice
leading to high residual
gradients.
Valve-in-Valve TAVR
![Page 4: Bioprosthetic Valve Fracture: In-Depth Techniques and ... · Implant Aiming for High Implant. Post-TAVR and Post-Dilation Mean gradient = 44 mmHg AVA 1.0 cm2 . In-Lab Conversation](https://reader033.fdocuments.net/reader033/viewer/2022060609/6060541a90f73757581bc50f/html5/thumbnails/4.jpg)
Impact of Surgical Valve Size on 1-Year Mortality
VIVID Registry
• 459 pts with failed surgical
bioprostheses treated with ViV
TAVR (59% balloon expandable,
41% self-expanding)
• Patients stratified based on size of
original surgical valve
‒ Small ≤ 21 (n=133)
‒ Medium 22-24 (n=176)
‒ Large ≥ 25 (n=139)
• Small surgical valve
independently associated with 1-
year mortality (HR 2.04, p=0.02)
Dvir D, et al. JAMA 2014;312:162-170
![Page 5: Bioprosthetic Valve Fracture: In-Depth Techniques and ... · Implant Aiming for High Implant. Post-TAVR and Post-Dilation Mean gradient = 44 mmHg AVA 1.0 cm2 . In-Lab Conversation](https://reader033.fdocuments.net/reader033/viewer/2022060609/6060541a90f73757581bc50f/html5/thumbnails/5.jpg)
Patient P.M.
• 71 y.o. man with bioprosthetic valve degeneration
• Underwent AVR/CABG x 3 in 2007 (19 mm Magna)
• Did well until late 2015 when he began to notice increasing
DOE and fatigue
• Echo: normal LV and RV size, LVEF 65%, aortic valve
gradient 60 mmHg (peak 79 mmHg) with trivial AI
• Referred for redo AVR vs. TAVR→ felt to be high risk due to
patent grafts and proximity of RV to sternum→ ViV TAVR
#19 Magna Valve: True Internal Diameter 17 mmHg
Planned for 23 mm CoreValve EVOLUT
![Page 6: Bioprosthetic Valve Fracture: In-Depth Techniques and ... · Implant Aiming for High Implant. Post-TAVR and Post-Dilation Mean gradient = 44 mmHg AVA 1.0 cm2 . In-Lab Conversation](https://reader033.fdocuments.net/reader033/viewer/2022060609/6060541a90f73757581bc50f/html5/thumbnails/6.jpg)
Baseline Hemodynamics
Mean gradient = 63 mmHg AVA 0.8 cm2
![Page 7: Bioprosthetic Valve Fracture: In-Depth Techniques and ... · Implant Aiming for High Implant. Post-TAVR and Post-Dilation Mean gradient = 44 mmHg AVA 1.0 cm2 . In-Lab Conversation](https://reader033.fdocuments.net/reader033/viewer/2022060609/6060541a90f73757581bc50f/html5/thumbnails/7.jpg)
Valve
Implant
Aiming for
High
Implant
![Page 8: Bioprosthetic Valve Fracture: In-Depth Techniques and ... · Implant Aiming for High Implant. Post-TAVR and Post-Dilation Mean gradient = 44 mmHg AVA 1.0 cm2 . In-Lab Conversation](https://reader033.fdocuments.net/reader033/viewer/2022060609/6060541a90f73757581bc50f/html5/thumbnails/8.jpg)
Post-TAVR and Post-Dilation
Mean gradient = 44 mmHg AVA 1.0 cm2
![Page 9: Bioprosthetic Valve Fracture: In-Depth Techniques and ... · Implant Aiming for High Implant. Post-TAVR and Post-Dilation Mean gradient = 44 mmHg AVA 1.0 cm2 . In-Lab Conversation](https://reader033.fdocuments.net/reader033/viewer/2022060609/6060541a90f73757581bc50f/html5/thumbnails/9.jpg)
In-Lab Conversation (Paraphrased)
• IC: This isn’t good. We still have almost as high a
gradient as when we started
• CTS: I know how to treat this. We can break the
surgical valve.
• IC: What??? Are you crazy?
• CTS: I heard about it at a meeting recently. A surgeon
from LA said he had done it a few times
• IC: Really? I still think you’re crazy. Just like when
you told us that transcarotid TAVR was a good idea.
![Page 10: Bioprosthetic Valve Fracture: In-Depth Techniques and ... · Implant Aiming for High Implant. Post-TAVR and Post-Dilation Mean gradient = 44 mmHg AVA 1.0 cm2 . In-Lab Conversation](https://reader033.fdocuments.net/reader033/viewer/2022060609/6060541a90f73757581bc50f/html5/thumbnails/10.jpg)
Here’s what you’ll need…
• 1 True Dilatation, ATLAS,
or ATLAS-GOLD Balloon
(Bard)→ Kevlar wrapped
• 1 60 cc luer lock syrine
filled with dilute contrast
• 1 PTCA indeflator
• 1 high-pressure stopcock
* Disclaimer: This is 100%
off-label use and may require
exceeding balloon RBP
considerably
![Page 11: Bioprosthetic Valve Fracture: In-Depth Techniques and ... · Implant Aiming for High Implant. Post-TAVR and Post-Dilation Mean gradient = 44 mmHg AVA 1.0 cm2 . In-Lab Conversation](https://reader033.fdocuments.net/reader033/viewer/2022060609/6060541a90f73757581bc50f/html5/thumbnails/11.jpg)
3 4
And here’s the set-up…
1
2Hand Inflation
![Page 12: Bioprosthetic Valve Fracture: In-Depth Techniques and ... · Implant Aiming for High Implant. Post-TAVR and Post-Dilation Mean gradient = 44 mmHg AVA 1.0 cm2 . In-Lab Conversation](https://reader033.fdocuments.net/reader033/viewer/2022060609/6060541a90f73757581bc50f/html5/thumbnails/12.jpg)
Final
Appearance
(1 week f/u)
High Pressure Post-Dilation with 20 mm True Balloon
![Page 13: Bioprosthetic Valve Fracture: In-Depth Techniques and ... · Implant Aiming for High Implant. Post-TAVR and Post-Dilation Mean gradient = 44 mmHg AVA 1.0 cm2 . In-Lab Conversation](https://reader033.fdocuments.net/reader033/viewer/2022060609/6060541a90f73757581bc50f/html5/thumbnails/13.jpg)
Post- 20 mm True Balloon (16 atm)
Mean gradient = 18 mmHg AVA 1.9 cm2
![Page 14: Bioprosthetic Valve Fracture: In-Depth Techniques and ... · Implant Aiming for High Implant. Post-TAVR and Post-Dilation Mean gradient = 44 mmHg AVA 1.0 cm2 . In-Lab Conversation](https://reader033.fdocuments.net/reader033/viewer/2022060609/6060541a90f73757581bc50f/html5/thumbnails/14.jpg)
How Valves Fracture
![Page 15: Bioprosthetic Valve Fracture: In-Depth Techniques and ... · Implant Aiming for High Implant. Post-TAVR and Post-Dilation Mean gradient = 44 mmHg AVA 1.0 cm2 . In-Lab Conversation](https://reader033.fdocuments.net/reader033/viewer/2022060609/6060541a90f73757581bc50f/html5/thumbnails/15.jpg)
CT Reconstruction
Single Fracture Point
23 mm CoreValve in a
21 mm Magna
Sewing Ring Otherwise Intact
How Valves Fracture
![Page 16: Bioprosthetic Valve Fracture: In-Depth Techniques and ... · Implant Aiming for High Implant. Post-TAVR and Post-Dilation Mean gradient = 44 mmHg AVA 1.0 cm2 . In-Lab Conversation](https://reader033.fdocuments.net/reader033/viewer/2022060609/6060541a90f73757581bc50f/html5/thumbnails/16.jpg)
Valves that can
and cannot be
fractured
To date, the only
valves that cannot be
fractured are:
Trifecta (St. Jude)
Hancock II (MDT)
Avalus (MDT)*
Allen KB, et al. Ann Thorac Surg 2017
![Page 17: Bioprosthetic Valve Fracture: In-Depth Techniques and ... · Implant Aiming for High Implant. Post-TAVR and Post-Dilation Mean gradient = 44 mmHg AVA 1.0 cm2 . In-Lab Conversation](https://reader033.fdocuments.net/reader033/viewer/2022060609/6060541a90f73757581bc50f/html5/thumbnails/17.jpg)
Some Valves can also be “Remodeled”
Valves that can be
fractured
Valves that can be
remodeledNeither
Biocor Epic C-E Standard Avalus
Magna/Magna Ease C-E SAV Hancock II
MitroflowPerimount
(older generation)
Mosaic Trifecta
Perimount (newer
generation)
Inspiris
Chhatrwialla AK, et al. Circ Cardiovasc Interv. 2018, in press
![Page 18: Bioprosthetic Valve Fracture: In-Depth Techniques and ... · Implant Aiming for High Implant. Post-TAVR and Post-Dilation Mean gradient = 44 mmHg AVA 1.0 cm2 . In-Lab Conversation](https://reader033.fdocuments.net/reader033/viewer/2022060609/6060541a90f73757581bc50f/html5/thumbnails/18.jpg)
BVF Clinical Series
• 20 consecutive patients* from 7 US
centers treated with bioprosthetic
valve fracture at the time of ViV
TAVR (8 at MAHI)
• Mean age 76 years; mean STS-
PROM 8.4%
• Valves treated: Mitroflow,
Perimount, Magna/Magna-Ease,
Biocor Epic/Epic-Supra, and Mosaic
• Treated with both self-expanding
(n=12) and balloon expandable
(n=8) TAVR valves
• 15/20 underwent BVF after TAVR
valve deployed
* 75 cases in full series as of 6/1/18
![Page 19: Bioprosthetic Valve Fracture: In-Depth Techniques and ... · Implant Aiming for High Implant. Post-TAVR and Post-Dilation Mean gradient = 44 mmHg AVA 1.0 cm2 . In-Lab Conversation](https://reader033.fdocuments.net/reader033/viewer/2022060609/6060541a90f73757581bc50f/html5/thumbnails/19.jpg)
Mean Gradient
0
20
40
60
80
100
Baseline Post-TAVR Post-BVF
Me
an
Gra
die
nt
(mm
Hg
)
42 ± 11
21 ± 7
7 ± 4
P<0.001
P<0.001
![Page 20: Bioprosthetic Valve Fracture: In-Depth Techniques and ... · Implant Aiming for High Implant. Post-TAVR and Post-Dilation Mean gradient = 44 mmHg AVA 1.0 cm2 . In-Lab Conversation](https://reader033.fdocuments.net/reader033/viewer/2022060609/6060541a90f73757581bc50f/html5/thumbnails/20.jpg)
Effective Orifice Area
0.0
0.5
1.0
1.5
2.0
2.5
3.0
3.5
Baseline Post-TAVR FinalBaseline Post-TAVR Post-BVF
* Measurements only available for pts treated with BVF after ViV TAVR
0.6 ± 0.2
1.0 ± 0.4
1.8 ± 0.6P<0.001
P<0.001
Aort
ic V
alv
e A
rea (
cm
2)
![Page 21: Bioprosthetic Valve Fracture: In-Depth Techniques and ... · Implant Aiming for High Implant. Post-TAVR and Post-Dilation Mean gradient = 44 mmHg AVA 1.0 cm2 . In-Lab Conversation](https://reader033.fdocuments.net/reader033/viewer/2022060609/6060541a90f73757581bc50f/html5/thumbnails/21.jpg)
BVF Complications (n= 75 pts/21 centers)
• 2 minor strokes
• 1 chordal tear → moderate-severe MR (Mitraclip)
• 1 severe AI from disruption of TAVR valve → treated
with second valve-in-valve
• No in-hospital death
• No coronary occlusion
• No annular rupture (clinical or subclinical)
• No PPM
* 75 cases in full series as of 6/1/18
![Page 22: Bioprosthetic Valve Fracture: In-Depth Techniques and ... · Implant Aiming for High Implant. Post-TAVR and Post-Dilation Mean gradient = 44 mmHg AVA 1.0 cm2 . In-Lab Conversation](https://reader033.fdocuments.net/reader033/viewer/2022060609/6060541a90f73757581bc50f/html5/thumbnails/22.jpg)
When to Consider BVF
• Patients with small or intermediate sized surgical
bioprostheses
– True ID ≤ 21 mm in prior studies
• Pts with high residual gradients following VIV TAVR
– Severe PPM generally defined as a residual mean
gradient ≥ 20 mmHg
– Our threshold is much lower
• ? All patients undergoing VIV TAVR
– By facilitating optimal THV expansion, BVF/BVR might improve
leaflet function and THV durability regardless of surgical valve
size or residual gradient
![Page 23: Bioprosthetic Valve Fracture: In-Depth Techniques and ... · Implant Aiming for High Implant. Post-TAVR and Post-Dilation Mean gradient = 44 mmHg AVA 1.0 cm2 . In-Lab Conversation](https://reader033.fdocuments.net/reader033/viewer/2022060609/6060541a90f73757581bc50f/html5/thumbnails/23.jpg)
When not to Fracture
• Surgical valves that cannot be fractured/remodeled
– Hancock II, Avalus
• Concern for coronary artery/STJ obstruction
– Assess virtual THV to coronary distance
– Consider coronary protection or BASILICA if < 3mm
• Small STJ or LVOT
– Ensure that the anatomy can accommodate the balloon used to
perform BVF
– Assess calcium burden
![Page 24: Bioprosthetic Valve Fracture: In-Depth Techniques and ... · Implant Aiming for High Implant. Post-TAVR and Post-Dilation Mean gradient = 44 mmHg AVA 1.0 cm2 . In-Lab Conversation](https://reader033.fdocuments.net/reader033/viewer/2022060609/6060541a90f73757581bc50f/html5/thumbnails/24.jpg)
Summary: BVF for ViV TAVR
• For patients with small bioprosthetic valves who are high risk
for re-do AVR, BVF/BVR may offer a “solution” to high
residual gradients after ViV implantation
• Most contemporary surgical valves can be fractured (or at
least remodeled)
• Clinical experience to date suggests the procedure is
generally safe (although not entirely risk-free)
• Unresolved questions
– Timing of BVF (pre vs. post-TAVR)→ impact on safety and long-term
TAVR valve durability
– Should all ViV procedures undergo BVF (even with a low gradient) to
allow for better TAVR valve geometry and function